-
clinical laboratory technical procedure manuals
Download Link: ➡ clinical laboratory technical procedure manuals
File Name: clinical laboratory technical procedure manuals.pdf
Size: 2693 KB
Type: PDF, ePub, eBookCategory: Book
Uploaded: 6 May 2019, 13:41 PM
Rating: 4.6/5 from 578 votes.
Last checked: 4 Minutes ago!
⬆ LINK ⬆
In order to read or download clinical laboratory technical procedure manuals ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account. ✔ Download as many books as you like (Personal use) ✔ Cancel the membership at any time if not satisfied. ✔ Join Over 80000 Happy Readers
Book Descriptions:
clinical laboratory technical procedure manuals
1211): All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization. Some tips include: This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual. Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer. A guideline for global application developed through the consensus process. 2. Serving the World s Medical Science Community Through Voluntary Consensus is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues.In addition to developing and promoting the use of voluntary consensus standards and guidelines, provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS An document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form.
- clinical laboratory technical procedure manuals, clinical laboratory technical procedure manuals approved guideline—fourth edition, clinical laboratory technical procedures manuals approved guideline, medical laboratory technology procedure manual for routine diagnostic tests pdf, nccls clinical laboratory technical procedure manual, clinical laboratory technical procedure manuals.
Please try again.Please try again.Please try again. A must companion for laboratory manangers, medical directors and lead technologists. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Software installation required may be required Printed Spiral or Perfect (glued along the spine) Bound - depending on the standard Please contact our Customer Service team. If you would like to add additional copies of this product please adjust the quantity in the cart.Please contact our Customer Service team.Please change the currency. Please contact our Customer Service Team. See related publication GP21-A. Software installation required may be required Printed Spiral or Perfect (glued along the spine) Bound - depending on the standard Please contact our Customer Service team. If you would like to add additional copies of this product please adjust the quantity in the cart.Please contact our Customer Service team.Please change the currency. Please contact our Customer Service Team. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to: It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program. Include a general policies section addressing lab-specific issues, such as: The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual. The following information is required to be included (CLIA regulations, Subpart K, 493.
Provisions in standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in projects. Please contact the Executive Offices for additional information on committee participation. 3 Volume 22 GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition Abstract Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition ( document GP2-A4) presents the important components of writing and managing procedures for the clinical laboratory. This guideline describes common and specific sections that should be included when developing laboratory procedures. Several examples of procedures for preanalytic, analytic, and postanalytic laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Users should expect revised editions of any given document.
A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus proposed and approved. Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate (i.e., tentative ) consensus level. Proposed An consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a lineby-line review of its technical and editorial content. Tentative A tentative standard or guideline is made available for review and comment only when a recommended method has a well-defined need for a field evaluation or when a recommended protocol requires that specific data be collected. It should be reviewed to ensure its utility. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents.
Professional Members AISAR-Associazione Italiana per lo Studio degli American Academy of Family Physicians American Association for Clinical Chemistry American Association for Respiratory Care American Chemical Society American Medical Technologists American Public Health Association American Society for Clinical Laboratory Science American Society of Hematology American Society for Microbiology American Type Culture Collection, Inc.Agilent Technologies, Inc. BD BD Biosciences San Jose, CA BD Consumer Products BD Diagnostic Systems BD Italia S.P.A. BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter, Inc. Bio-Rad Laboratories, Inc. - France Biotest AG Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Canadian External Quality Assessment Laboratory Capital Management Consulting, Inc. Carl Schaper Checkpoint Development Inc. Chiron Corporation ChromaVision Medical Systems, Inc. Chronolab Ag Clinical Design Group Inc. Clinical Laboratory Improvement Consultants Cognigen Community Medical Center (NJ) Control Lab (Brazil) Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA Dade Behring Inc. - San Jose, CA Diagnostic Products Corporation Eiken Chemical Company, Ltd. Electa Lab s.r.l. Enterprise Analysis Corporation Essential Therapeutics, Inc. EXPERTech Associates, Inc. viii F. Hoffman-La Roche AG Fort Dodge Animal Health General Hospital Vienna (Austria) Gen-Probe GlaxoSmithKline Greiner Bio-One Inc. Helena Laboratories Home Diagnostics, Inc. Immunicon Corporation Instrumentation Laboratory International Technidyne Corporation IntraBiotics Pharmaceuticals, Inc. Laboratory Specialists, Inc.Novartis Pharmaceuticals Corporation Ortho-Clinical Diagnostics, Inc. (Raritan, NJ) Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxoid Inc.
Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of documents. Current editions are listed in the Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the Catalog, contact the Executive Offices. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without written permission from, except as stated below.Reproduced with permission, from publication GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition (ISBN ). Copies of the current edition may be obtained from, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from by written request. To request such permission, address inquiries to the Executive Director,, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Copyright The National Committee for Clinical Laboratory Standards. Suggested Citation (. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Hartford, Connecticut Specialty Laboratories Santa Monica, California Statistical Services Traverse City, Michigan Litton Pathology Associates Blue Springs, Missouri v 8 Number 5 Advisors (Continued) Eleanor M. Travers, M.D. Department of Veterans Affairs Medical Ctr. Sutter Health Mayo Clinic Mayo Clinic UroCor, Inc.CLMA College of American Pathologists GlaxoSmithKline Nippon Becton Dickinson Co., Ltd. Ortho-Clinical Diagnostics, Inc. Roche Diagnostics, Inc.
Therefore, it makes sense to write separate instructions for tasks that are performed at different times by different people. GP2-A4 is intended to be used by the following persons: administrative and technical personnel who write laboratory procedures; manufacturers; and educators. 2 Scope This publication describes how to: identify laboratory procedures using the laboratory s operational path of workflow; and write procedures for preanalytic, analytic, and postanalytic laboratory activities. In addition, this edition of GP2 provides useful information about preparing, approving, maintaining, changing, and reviewing laboratory documents. 3 Definitions a Document, n Any recorded item of a factual or informative nature, either paper or electronic. Form, n A paper or electronic document on which the results from the performance of a procedure or other information are captured. Policy, n A written statement of overall intentions and directions defined by those in the organization and endorsed by management. Procedure, n A specified way to perform an activity; NOTE: For a quality system, a procedure is a set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. Process, n Set of interrelated or interacting activities that transform inputs into outputs; NOTE: It may be documented as flowcharts or tables that describe the path of operational workflow in the laboratory.For complete definitions and detailed source information, please refer to the most current edition of that document. An global consensus guideline. All rights reserved. 1 20 Number 5 4 Path of Workflow Laboratory work is a sequence of key processes in which the laboratory uses resources, such as people, machines, methods, and materials to transform orders for laboratory tests into results and reports for patient management. Key processes for the laboratory are referred to as the path of workflow, which is shown in Figure 1.
Preanalytic Processes Analytic Processes Postanalytic Processes Figure 1. Laboratory Path of Workflow. Adapted from document GP26 A Quality System Model for Health Care. 4.1 Preanalytic Processes Preanalytic key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory tests are ordered through the time that the specimens are processed and delivered to the laboratory testing location or transported to reference laboratories. For anatomic pathologists and cytotechnologists, preanalytic activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic assessment and interpretation. Adapted from document GP26 A Quality System Model for Health Care. 4.2 Analytic Processes Analytic key processes for the clinical laboratory specialties include the activities of performing the test, verifying the validity of the test results, interpreting the findings, and recording the findings. In the anatomic pathology specialties, analytic key processes include the diagnostic assessment of the slides, peer review, and recording the findings. Traditionally, laboratories have been functionally and often physically divided into the specific clinical disciplines of chemistry, hematology, microbiology, and transfusion service for specialized testing methods and instruments. More recently, many laboratories have segregated along manual and automated testing methods. Each laboratory or clinical discipline however it is organized should identify its automated and manual testing processes. Analytic key processes for the laboratory s path of workflow are shown in Figure 3. Testing Results Review, Recording and Follow-Up Interpretation Figure 3. Laboratory Analytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 2 An global consensus guideline. All rights reserved. 21 Volume 22 GP2-A4 4.
Paratek Pharmaceuticals Pfizer Inc Pharmacia Corporation Powers Consulting Services Premier Inc. The Product Development Group QSE Consulting Quintiles, Inc. Radiometer America, Inc. Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Laboratories (Div. Second Opinion Showa Yakuhin Kako Company, Ltd. Streck Laboratories, Inc. SurroMed, Inc. Sysmex Corporation (Japan) Sysmex Corporation (Long Grove, IL) The Clinical Microbiology Institute The Toledo Hospital (OH) Trek Diagnostic Systems, Inc. Versicor, Inc. Vetoquinol S.A. Visible Genetics, Inc. Vysis, Inc. Wallac Oy Wyeth-Ayerst Xyletech Systems, Inc. John General Hospital (Fort St. Alexius Medical Center (ND) St. Anthony Hospital (CO) St. Anthony s Hospital (FL) St. Barnabas Medical Center (NJ) St-Eustache Hospital (Quebec, Canada) St. Francis Medical Ctr. (CA) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. Joseph Hospital (NE) St. Joseph s Hospital Marshfield Clinic (WI) St. Joseph Mercy Hospital (MI) St. Luke s Regional Medical Center (IA) St. Mary Medical Center (IN) St. Mary of the Plains Hospital (TX) St. Paul s Hospital (Vancouver, BC, Montreal) St. Vincent Medical Center (CA) Ste.Inpatient Blood Specimen Collection Process Flowchart Attachment J2. Inpatient Blood Specimen Collection Process Table Attachment J3. Analyzer Testing Process Flowchart Attachment J4. Analyzer Testing Process Table Attachment J5. Bacteriology Culture Process Flowchart Attachment J6. Bacteriology Culture Process Table Attachment J7. Transfusion Medicine Prenatal Testing Process Flowchart Attachment J8. Transfusion Medicine Prenatal Testing Process Table Attachment J9. Surgical Pathology Specimen Process Flowchart Attachment J10. Surgical Pathology Specimen Process Table Appendix K1. Document Creation, Review, and Approval Process Flowchart Appendix K2. Document Creation, Review, and Approval Process Table Appendix L.
Sample Document Change Request Form Summary of Comments and Working Group Responses Summary of Delegate Comments and Working Group Responses Related Publications xiv 17 Volume 22 GP2-A4 Foreword Previous editions of document GP2 have focused on essential elements to include in laboratory analytic test procedures. This edition of GP2 has been expanded to provide: guidelines for writing procedures for the preanalytic, analytic, and postanalytic activities that represent the laboratory s path of workflow; guidelines for writing procedures specifically for multitest automated analyzers; an introduction to the management and control of laboratory procedure documents after they are approved for use; and the use of process flowcharts to depict the linkages between laboratory procedures. The information and examples provided in this edition are also consistent with the guidance described in document GP26 A Quality System Model for Health Care. This edition of GP2 is applicable to any size laboratory, wherever it may be in the transition of its quality program from traditional quality control and quality assurance practices to the concepts of quality systems management. Key Words Document management, electronic procedures, laboratory procedure, procedure manual, technical procedures xv 18 Number 5 xvi 19 Volume 22 GP2-A4 1 Introduction Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition The laboratory should provide carefully documented instructions in the form of procedures for all activities that support the performance of analytic testing. These instructions provide essential information for both new and experienced employees on how to perform all their job tasks including nontesting tasks such as collecting blood specimens and using the laboratory s computer system. Written procedures should encompass an entire task from start to finish.
3 Postanalytic Processes Postanalytic key processes in the path of workflow include activities related to reporting results and archiving results and specimen material. Postanalytic processes are shown in Figure 4. Result Reporting and Archiving Specimen Retention Figure 4. Laboratory Postanalytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 5 Laboratory Procedure Contents Common Elements The laboratory should have procedures that describe preanalytic, analytic, and postanalytic activities in the laboratory operational workflow. The procedure document describes the series of steps to be followed by one individual to complete a specific task. Written procedures should specifically explain how to perform each activity in the laboratory s preanalytic, analytic, and postanalytic work processes. A set of common elements should be included in each type of procedure. At a minimum, laboratory procedures should include: Title; Purpose or principle; Procedure instructions; References; Author; and Approval signatures. Appendix A provides a tabular view of what should be included in a procedure document. Additional elements that are specific to analytic vs.Appendixes B through F are examples of laboratory procedures. For additional information on the distinction between processes and procedures, see Appendix J. 5.1 Title All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive, for example: Blood Specimen Collection Process; Performing Glucose Testing on Instrument X; Waterbath Temperature Monitoring Procedure; and Preparing Gram Stain Working Solutions. An global consensus guideline. All rights reserved. 3 22 Number Purpose or Principle The document should open with a section that simply states its purpose. For example, the Purpose section of a procedure could be stated as, This procedure provides instructions for collecting fingerstick specimens for glucose analysis.
The words, This procedure provides instructions for can be standardized in the template for all procedure documents. Information regarding the theory, clinical implications of the test or test methodology, or historical background may also be included at the beginning of the document, thereby providing an educational, clinical, and scientific framework for the reader and user. 5.3 Procedure Instructions The primary focus of a procedure is to provide instructions for how to do a particular task in a stepwise fashion for example, the steps involved in verifying patient identification at the time of blood specimen collection. 5.4 References Procedures should include the references that were used as the source of the information, when applicable. The references may originate from any of the following: manufacturer s product literature; text books; published standards and guidelines; laboratory policy manuals; laboratory information technology manuals; unpublished information obtained from experts in the field; and applicable regulations. References should be listed in a standard medical format. 5.5 Author The author(s) of the document should be noted. The laboratory has the option of including author information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record the author, a mechanism should be in place that enables the referencing of the author back to the appropriate specific document. 5.6 Approval Signatures There should be evidence that the procedure has been approved by the appropriate individual(s). (Note: Document approval by an appropriate individual is a requirement of regulatory and accrediting agencies in some countries.) The laboratory has the option of including signature approval information directly on the document, or on another document that can be referenced to the specific document.
If the laboratory chooses to use a separate document to record signature approvals, a mechanism should be in place that 4 An global consensus guideline. All rights reserved. 23 Volume 22 GP2-A4 enables the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Section Procedure Documents Specific for the Path of Workflow 6.1 Preanalytic Procedures Preanalytic procedures provide the instructions for all activities of laboratory workflow that take place before sample analysis. The laboratory should have separate written procedures for preanalytic activities, because they may be performed by nonlaboratory as well as laboratory persons at different times in the preanalytic work flow. Preanalytic procedures include those for: test ordering instructions for entering laboratory test orders into a computer system or completing paper requisitions including verification of clinical orders; specimen collection instructions for identifying patients, collecting blood and nonblood specimens, and labeling collected specimens; specimen transport instructions for transporting specimens to the laboratory, such as through the pneumatic tube system; and specimen processing instructions for receiving and accessioning specimens in the laboratory, any storage or processing before delivery at the testing section, and any preparations for preparing specimens to be transported to other laboratories for testing (e.g., reference laboratories). In addition to the elements common to all documents described in Section 5, preanalytic procedures should contain the following types of information; however, this information should be included only where it is needed to perform that procedure.
Patient preparation in procedures for specimen collection; Specimen collection in procedures for collection techniques for blood and nonblood specimens; Required equipment and forms in all preanalytic procedures where equipment and forms are used; Safety general or specific instructions as described below; Specimen handling requirements instructions for handling collected specimens during transport to the laboratory receiving area; Specimen storage requirements instructions for where and how to store specimens before testing; and Problems or pitfalls Patient Preparation Where applicable, preanalytic specimen collection procedures should include information about patient preparation such as instructions for: An global consensus guideline. For example: Test requisitions and labels; Specimen collection devices and materials (e.g., blood collection tubes, media, swabs); Specimen containers; and Instruments (tourniquets, hemostats, scissors, etc.) Safety Preanalytic procedures should include safety instructions for the collection and handling of biohazardous specimens. The instructions should be written for the intended readership for example, those who handle the specimen such as nursing, transport, or laboratory personnel. If no special precautions are required, preanalytic procedures may refer the user to the safety policy manual for general safety requirements. A Special Safety Precautions section should be included in preanalytic procedures when additional safety requirements beyond the basic handling of biologic and other hazardous materials are necessary (see documents M29 Protection of Laboratory Workers from Occupationally Acquired Infections and GP17 Clinical Laboratory Safety.) Specimen Handling Requirements Where applicable, preanalytic procedures should include information about specimen handling requirements. This information includes: special transport requirements (e.g., on ice, within a certain time, in appropriate containers, etc.
); safety precautions that are to be taken with potentially infectious specimens; and 6 An global consensus guideline. This information should include: locations where specimens are stored before testing; acceptable storage temperatures; and stability of the specimen over time, where timelines might affect testing Problems or Pitfalls Preanalytic procedure documents should include information about problems or pitfalls that may occur in the performance of the procedure. Where applicable, users should be referred to other procedures. Examples of this kind of information include what to do when: received specimens are unacceptable; the computer is down; and patients present for testing without a proper order Preanalytic Computer Activities Procedures that provide instructions for using the laboratory s information system for preanalytic activities should be designed around the respective prompts in a computer program s sequences. 6.2 Analytic Procedures Analytic procedures cover the activities from the time the specimen reaches the testing area to the time results are reviewed and preliminary interpretations are made. Analytic procedures for manual tests differ from procedures for automated testing. Manual testing procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte sedimentation rate are traditional examples of manual method-based analytic procedures. Automated testing procedures are represented by the menu of multiple test methods that can be performed on a single instrument or analyzer (such as for coagulation or chemistry). In addition, test results provided by both manual and automated methods can be qualitative, semiquantitative, or quantitative. The attributes of manual vs.
votre commentaire
-
clinical manual dentistry
Download Link: ➡ clinical manual dentistry
File Name: clinical manual dentistry.pdf
Size: 3726 KB
Type: PDF, ePub, eBookCategory: Book
Uploaded: 27 May 2019, 12:25 PM
Rating: 4.6/5 from 714 votes.
Last checked: 7 Minutes ago!
⬆ LINK ⬆
In order to read or download clinical manual dentistry ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account. ✔ Download as many books as you like (Personal use) ✔ Cancel the membership at any time if not satisfied. ✔ Join Over 80000 Happy Readers
Book Descriptions:
clinical manual dentistry
Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. Register a free business account Full of useful and easy-to-access information, it acts as a compendium of practical procedures in primary dental care, supporting students and dental practitioners in their daily professional and academic lives. It includes chapters written by expert clinicians on topics such as dental imaging, the management of dental pain, conscious sedation, operative dentistry, implant dentistry, oral medicine and surgery, paediatric dentistry, periodontics, prosthodontics, special care dentistry, dental trauma, aesthetic dentistry, and much more. Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team.
- clinical manual of implant dentistry, clinical manual of implant dentistry pdf, clinical manual dentistry, clinical manual dentistry group, clinical manual dentistry near me, clinical manual dentistry pdf, clinical manual dentistry school.
Would you like to change to the United States site? To download and read them, users must install the VitalSource Bookshelf Software. E-books have DRM protection on them, which means only the person who purchases and downloads the e-book can access it. E-books are non-returnable and non-refundable.This is a dummy description.This is a dummy description.This is a dummy description.This is a dummy description.Full of useful and easy-to-access information, it acts as a compendium of practical procedures in primary dental care, supporting students and dental practitioners in their daily professional and academic lives. It compiles chapters written by expert clinicians on topics such as dental imaging, the management of dental pain, conscious sedation, operative dentistry, implant dentistry, oral medicine and surgery, paediatric dentistry, periodontics, prosthodontics, special care dentistry, dental trauma, aesthetic dentistry, and much more. Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team. Stephen Dunne is Emeritus Maurice Wohl Foundation Professor of General Dental Practice and a Specialist in Restorative Dentistry at King's College London Dental Institute, UK. The 13-digit and 10-digit formats both work. Please try again.Please try again.Please try again. Full of useful and easy-to-access information, it acts as a compendium of practical procedures in primary dental care, supporting students and dental practitioners in their daily professional and academic lives.
Stephen Dunne is Emeritus Maurice Wohl Foundation Professor of General Dental Practice and a Specialist in Restorative Dentistryat King's College London Dental Institute, UK.To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Get started with a FREE account. Get books you want. To add our e-mail address ( ), visit the Personal Document Settings under Preferences tab on Amazon. With ample color photographs and diagrams, it carefully illustrates the various surgical techniques routinely needed in practice and suggests appropriate prosthetic options. Treatment considerations for each type of edentulism are addressed, and a classification for treatment in posterior regions is presented. The authors also discuss surface properties and loading concepts and offer innovative ideas for treating young patients. Myriam Kebir Former Lecturer, Department of Dentistry, Max Forestier Hospital, Nanterre, France.One of the concerns with many of the available texts in this area is that they either have very superficial coverage of the subject, inadequate to be of practical assistance to the clinician, or conversely they delve into the scientific and research aspects of the subject so deeply that they are of little practical use. The ADA's Council on Dental Benefit Programs has prepared this two-part online glossary that has the advantage of being readily updated. Terms and definitions published here are the Councils most current set. There will be periodic updates as the terms used by dentists and their staff continue to expand and evolve. Part 1 that begins on this web page addresses clinical terms often encountered when selecting the appropriate CDT Code for patient record keeping and claim preparation. Part 2,which begins on a separate web page, contains terms most frequently encountered when interacting with dental benefit plans to determine a patient’s coverage and to resolve issues arising from claim adjudication.
Full of useful and easy-to-access information, it acts as a compendium of practical procedures in primary dental care, supporting students and dental practitioners in their daily professional and academic lives. Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team. Stephen Dunne is Emeritus Maurice Wohl Foundation Professor of General Dental Practice and a Specialist in Restorative Dentistry at King's College London Dental Institute, UK.To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. A must have for every dental student and DF1 dentist.Sorry, we failed to record your vote. Please try again Sorry, we failed to record your vote. Please try again. Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team.
Patients often require assistance in maintaining a patent airway, and positive pressure ventilation may be required because of depressed spontaneous ventilation or drug-induced depression of neuromuscular function. Cardiovascular function may be impaired. Although cognitive function and coordination may be modestly impaired, ventilatory and cardiovascular functions are unaffected. No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. This is also a term that, in general, refers to the teeth and tissues located towards the front of the mouth. May involve the placement of an artificial apical barrier prior to nonsurgical endodontic obturation. See precision attachment. See evulsion. Examples include use of a papoose board, education or anxiety relief techniques. Such materials can include cytokines, growth factor, or vaccines, but do not include any actual hard or soft tissue graft material. These agents are added to graft material or used alone to effect acceleration of healing or regeneration in hard and soft tissue surgical procedures. Also known as biologic response modifiers. A form of dental radiograph that may be taken with the long axis of the image oriented either horizontally or vertically, that reveals approximately the coronal halves of the maxillary and mandibular teeth and portions of the interdental alveolar septa on the same image. Removal of deep seated intrinsic or acquired discolorations from crowns of vital and non-vital teeth through the use of chemicals, sometimes in combination with the application of heat and light. Bleaching has been achieved through short and long term applications of pastes or solutions containing various concentrations of hydrogen peroxide and carbamide peroxide. Normally applied externally to teeth; may be used internally for endodontically treated teeth. A cavity may be due to decay, erosion or abrasion.
Listings in each part are in alphabetic order. 2. There is no duplication of words or terms across Parts 1 and 2; there are more definitions in Part 1 (clinical) than there are in Part 2 (administrative). 3. Click a letter that begins the term you are interested in understanding to find the term and its definition. When you are not sure if the term is clinical or administrative, click on the letter in Part 1 and then in Part 2. Click a letter to jump to that section.) These terms are often found in (1) nomenclatures and descriptors and (2) treatment plans and patient records. The ADA acknowledges that glossaries developed by other dental organizations may differ (e.g., technical content), and are considered complimentary to this glossary’s focus. May also be known as acute periapical abscess, acute alveolar abscess, dentoalveolar abscess, phoenix abscess, recrudescent abscess, secondary apical abscess. May also be known as chronic alveolar abscess, chronic apical abscess, chronic dentoalveolar abscess, suppurative apical periodontitis, suppurative periradiucular periodontitis. Adhesion is one aspect of bonding. Intermediate material that causes two materials to adhere to each other. Sometimes used to refer to amalgam. Typically composed of mercury, silver, tin and copper along with other metallic elements added to improve physical and mechanical properties. Delivery of an anesthesia inducing agent by a dentist or other health care practitioner is regulated by state dental boards. ADA anesthesia policy and guidelines are available online ( www.ADA.org ). Please refer to these sources for complete and current information. Patients may require assistance in maintaining a patent airway, and spontaneous ventilation may be inadequate. Cardiovascular function is usually maintained. The ability to independently maintain ventilatory function is often impaired.
A health record needs to documentThe prescription slip is imprinted with the provider’s Drug Enforcement Administration and license numbers. Anyone who obtains a copy of that record can use those numbers and forge prescriptions. The health record does, however, need to include information about all medications that have been prescribed, including dose, amount, directions for use, and number of refills. Records are obtainable by the patient and the patient’s attorney. All information in the patient record may be considered discoverable and not privileged. Keep a separate file designated for such subjects. The health record should include only relevant, factual comments about the patient’s oral condition or disease and treatment. Subjective, negative, or irrelevant comments may reflect poorly on the clinician’s professionalism and raise questions about qualifications. When documenting an unpleasant aspect of the provider-patient relationship, use direct quotes whenever possible. The cost of treatment can influence how care is perceived. This can even determine if a patient accepts or declines a recommended treatment. If cost is a factor, it should be included in the patient’s health record to explain why the patient is choosing or declining a particular treatment option. Dentists are well-trained in documenting what has been done, but it is incorrect to assume that the reason is self-evident. Consider these guidelines: Record what actually occurred and what is clinically relevant. Personal comments are not appropriate. Good records are useless if no one can read them. Include the date and time of the conversation, and document important details. The laws of each state may vary, and the reader may want to contemplate seeking legal advice from an attorney licensed in the state the health care provider practices for specific guidance. We are here to help you.
The main aim of this book is to describe in detail the prevention and control oral of diseases at individual, family and community levels. Prevention is the backbone of control of any disease. Oral health goals through primary prevention such as use of fluorides, pit and fissure sealants and oral health education, plaque control technique, etc., is also discussed in this book. This clinical manual and record book represent criteria, methods, procedures and operational requirements needed for epidemiological surveys, school and community, oral health programs. It is designed as a teaching aid to be used by the dentist. It is also designed to be used as a reference manual by the dentist who is responsible for planning, organizing and conducting and participating in dental health programs. By clicking any link on this page you are giving your consent for us to set cookies. Good for you. In the event of an inconsistency or conflict between the information provided in the Dental Policy Update Bulletin and the posted policy, the provisions of the posted policy will prevail. These policies and guidelines are provided for informational purposes and do not constitute clinical advice. Treating dentists and other health care providers are solely responsible for determining what care to provide to their patients. Members should always consult their dentist or physician before making any decisions about dental or medical care. They are also used to decide whether a given dental service is clinically necessary. Services determined to be experimental, investigational, unproven, or not clinically necessary by the clinical evidence are typically not covered. Dental Coverage Guidelines may also address such matters as periodicity and other limitations, including whether a procedure is cosmetic, based on evidence. The member specific benefit plan document identifies which services are covered, which are excluded, and which are subject to limitations.
If caused by caries; also referred to as carious lesion. The CDT Code is printed in a manual titled Current Dental Terminology (CDT). Usually includes six anterior teeth and eight posterior teeth. Custom made or pre-fabricated thimble-shaped core or base layer designed to fit over a natural tooth preparation, a post core, or implant abutment so as to act as a substructure onto which other components can be added to give final form to a restoration or prosthesis. It can be used as a definitive restoration or as part of a transfer procedure. It is made of metal, ceramic or polymer materials or a combination of such materials. It is retained by luting cement or mechanical means. (American College of Prosthodontics; The Glossary of Prosthodontic Terms). See also abutment crown, anatomical crown, and clinical crown. See transitional dentition. There is no scheduled replacement, although some maintenance may be necessary (e.g., cleansing; replacement of the replaceable component of an attachment), procedures that are documented with their applicable codes. (b) A procedure whose outcome is, by intent, not subject to change arising from subsequent delivery of another procedure; a change may occur if the dentist determines that a change in the patient’s clinical condition warrant’s delivery of another or alternative procedure. Diagnostic casts have various uses, most often the examination of relationships between oral tissues to determine how those relationships will effect form and function of a dental restoration or appliance being planned or to determine whether tissue treatment or modification might be necessary before a pre-definitive impression is taken to ensure optimal performance of the planned restoration or appliance. May be photographic or radiographic. Please refer to specific oral evaluation code (D01xx) descriptors for more complete definitions. See avulsion. See semi and precision attachment. See simple fracture and compound fracture.
One of the oldest restorative techniques, it is compacted or condensed into a retentive cavity form. Donors may be cadavers, living related or living unrelated individuals. Also called allogenic graft or homograft. See graf t. It may be intraoral or extraoral. An indirect procedure is also known as a laboratory procedure, and the laboratory’s location can be within or separate from the dentist’s practice. See Specification No. 3950. In gingival health, the coronal portion of the sulcular epithelium may also be keratinized. See facial. See semi and precision attachment ?. The alloys are defined on the basis of the percentage of metal content and listed in order of biocompatibility. Sometimes called a mouth protector. It is retained by luting cement. (American College of Prosthodontics; The Glossary of Prosthodontic Terms) See fixed partial denture or removable partial denture. See Dentition. This device can either be in the form of an alloy, carbon fiber or fiberglass, and posts are usually secured with appropriate luting agents. It is intended to control local irritational factors. See apexification. Sometimes used for recording periodontal charting. Supernumerary teeth are not yet identified using this standard. Also refers to devices used in the treatment of temporomandibular joint disorders. See diagnostic cast. Therapy has as its goal the elimination or control of a disease or other abnormal state. See exostosis. The complete schema is illustrated in the Comprehensive ADA Dental Claim Form Completion Instructions posted online at. Some yeasts may reproduce by fission, many producing mycelia or pseudomycelia. Accordingly, safety net dental clinics should check with relevant state agencies and organizations to fully understand state- and program-specific requirements. Poor records, on the other hand, can make even a non-meritorious claim impossible to defend.
In the event of a conflict, the member specific benefit plan document supersedes these policies and guidelines. They represent a portion of the resources used to support UnitedHealthcare coverage decision making. Additionally, UnitedHealthcare may use tools developed by third parties, including the American Dental Association and other peer organizations, to assist us in administering dental benefits. These third-party-guidelines are intended to be used in connection with the independent professional clinical judgment of a qualified dentist or other health care provider and do not constitute the practice of dentistry or dental advice. Unauthorized copying, use and distribution of this information are strictly prohibited. Third party guidelines are proprietary to the originating organization and are not published on this website. Applicable Procedure Codes: D1206, D9910, D9911. Applicable Procedure Codes: D0414, D0415, D0416. Applicable Procedure Codes: D2949, D2950, D2951, D2952, D2953, D2954, D2955, D2957, D2999. Applicable Procedures Codes: D3432, D4266, D4267. Applicable Procedure Code: D4355. Applicable Procedure Codes: D9210, D9211, D9212, D9215, D9219, D9222, D9223, D9230, D9239, D9243, D9248. Applicable Procedure Codes: D0422, D0423. Applicable Procedures Codes: 70486, 70487, 70488, 76376, 76377, D0364, D0365, D0366, D0367, D0368, D0380, D0381, D0382, D0383, D0384, D0391, D0393, D0394, D0395. Applicable Procedure Codes: D2960, D2961, D2962. Applicable Procedure Codes: D8010, D8020, D8030, D8040, D8050, D8060, D8070, D8080, D8090, D8220, D8660, D8670, D8680, D8690, D8695, D8696, D8697, D8698, D8699, D8701, D8702, D8703, D8704, D8999. Applicable Procedure Codes: D0411, D0412, D0425, D0431, D0460, D0470, D7288. Applicable Procedure Code: D0600. Applicable Procedure Codes: D3110, D3120, D3220, D3221, D3222, D3230, D3240, D3310, D3320, D3330, D3331, D3332, D3333, D3346, D3347, D3348, D3351, D3352, D3353, D3355, D3356, D3357.
Applicable Procedure Codes: D7111, D7140. Applicable Procedure Codes: D4341, D4342, D4346, D4381, D4910, D4921. Applicable Procedure Codes: D7880, D7881, D9941, D9942, D9943, D9944, D9945, D9946, D9950, D9951, D9952. Applicable Procedure Codes: 40840, 40842, 40843, 40844, 40845, 40899, 41874, D7310, D7311, D7320, D7321, D7340, D7350. Applicable Procedure Codes: 21210, 21215, 30580, 41899, 42699, D7260, D7261, D7270, D7272, D7290, D7295, D7921, D7950, D7951, D7952, D7953, D7979, D7980, D7981, D7982, D7983, D7999. Applicable Procedure Codes: 21031, 21032, 40806, 40819, 41010, 41115, 41520, 41821, 41822, 41828, D7291, D7471, D7472, D7473, D7960, D7963, D7970, D7971, D7972, D7999. Applicable Procedure Codes: 41899, D7280, D7282, D7283, D7292, D7293, D7294, D7296, D7297, D7997. Applicable Procedure Codes: 21210, 21215, 30580, 41899, 42699, D7260, D7261, D7270, D7272, D7290, D7295, D7921, D7950, D7951, D7952, D7953, D7979, D7980, D7981, D7982, D7983, D7999. Applicable Procedure Codes: D2929, D2930, D2931, D2932, D2933, D2934. Applicable Procedure Codes: D4320, D4321. Applicable Procedure Codes: D0417, D0418, D0419. Applicable Procedure Codes: D1351, D1352, D1353. Applicable Procedure Codes: D2140, D2150, D2160, D2161, D2330, D2331, D2332, D2335, D2390, D2391, D2392, D2393, D2394, D2410, D2420, D2430, D2940, D2941, D2990, D2999. Applicable Procedure Codes: D1510, D1516, D1517, D1520, D1526, D1527, D1551, D1552, D1553, D1556, D1557, D1558, D1575, D1999. Applicable Procedure Codes: D3410, D3421, D3425, D3426, D3427, D3428, D3429, D3430, D3431, D3450, D3460, D3470, D3910, D3920, D3950, D3999. Applicable Procedure Codes: D7210, D7250, D7922. Applicable Procedure Codes: D7220, D7230, D7240, D7241, D7251, D7922. Applicable Procedure Codes: D4265, D4270, D4273, D4275, D4276, D4277, D4278, D4283, D4285, D4999. Applicable Procedure Codes: D4263, D4264, D4265, D4268, D4999.
Applicable Procedure Codes: D4210, D4211, D4212, D4230, D4231, D4240, D4241, D4245, D4249, D4260, D4261, D4274, D4999. Applicable Procedure Codes: D9610, D9612, D9613, D9630. Applicable Procedure Codes: 99188, D1206, D1208, D1354. Dental coverage is not available in all plans. Please try again.Valid once per customer on 1st Amazon Pay UPI transaction on App. Click here to check eligibility Flat 3% BACK for non-Prime members. No Cost EMI availableNo customer signatures are required at the time of delivery. To pay by cash, place cash on top of the delivery box and step back. Order delivery tracking to your doorstep is available.Full of useful and easy-to-access information, it acts as a compendium of practical procedures in primary dental care, supporting students and dental practitioners in their daily professional and academic lives. Provides step-by-step guidance on procedures in primary dental care Comprehensive coverage of all dental disciplines, from endodontics to orthodontics Compiled by two highly experienced editors with contributions from expert authors Covers essential non-clinical areas, such as communicating with patients, obtaining valid consent, audit procedures, and handling of complaints The Manual of Clinical Procedures in Dentistry is an invaluable text for dental students and new graduates, as well as a definitive guide for the whole dental team. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. In order to navigate out of this carousel please use your heading shortcut key to navigate to the next or previous heading. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. Get your Kindle here, or download a FREE Kindle Reading App. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. It also analyses reviews to verify trustworthiness.
A must have for every dental student and DF1 dentist.Sorry, we failed to record your vote. In this, the authors have succeeded admirably, although I feel the book will be of most benefit to those who are new to implant dentistry, rather than the more experienced implantologist. The opening chapter deals with treatment planning. This is followed by three chapters which cover implant diameters, stage one and stage two surgery, peri-implant soft tissue management, impression taking, and screw retained verses cemented prostheses. The next four chapters deal with treatment considerations for edentulous people, partial edentulism, single missing teeth and implant treatment in the posterior regions of the mouth. Chapter nine highlights specific surgical procedures such as immediate implant placement, sinus grafting, guided bone regeneration and bone grafts. The final four chapters are on non submerged implant techniques, implants in young people, surface properties of implants and loading concepts. At just over two hundred pages, the book can only give an overview of the many aspects of implantology. However, it is well written, clearly laid out and each chapter is followed by an appropriate list of references. The book is profusely illustrated with excellent photographs and diagrams. There are also numerous tables and lists which clearly spell out the indications and contraindications for the various techniques and procedures under discussion. Without a doubt, this book provides a very good introduction to implant dentistry. Download citation Published: 24 January 2004 Issue Date: 24 January 2004 DOI. The Kurzweil utility was created specifically for use in Firefox. We recommend that you use Firefox. JavaScript is either disabled or not supported by your browser. For instructions on how to enable JavaScript in your browser, click here. This integration fosters students' understanding of dentistry and its relationship to overall health.
Students at NYU Dentistry work side-by-side with outstanding educators, clinicians, and researchers. The College houses sophisticated, state-of-the-art clinical facilities, and offers the largest and most diversified patient pool of any dental school in the nation. Teachers who are also clinicians work diligently to partner with students to enable them to reach their academic and professional goals. Group practice directors mentor students in each of their groups toward competency and clinical experiences with the assistance of generalist and specialty faculty. Friday, Sep 18Please try again.Offered by Amazon.ca. Here's how (restrictions apply) The book gives knowledge to the reader about the recent advances, hazards, major and minor risk complication in various topics. Medical and dental knowledge is constantly changing. This book gives new information in recent advances, changes in treatment drugs, procedures in various modalities of oral and maxillofacial surgery. Offered by Amazon.ca. Here's how (restrictions apply) Download one of the Free Kindle apps to start reading Kindle books on your smartphone, tablet, and computer. Get your Kindle here, or download a FREE Kindle Reading App.To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. It also analyzes reviews to verify trustworthiness. By continuing to use our website, you are agreeing to our use of cookies. You can change your cookie settings at any time. Find out more With even more images and diagrams to aid understanding, it has been fully updated with sources and further reading, including the most up-to-date e-learning and web resources. This online resource includes revised chapters on fast-moving areas of dental practice such as therapeutics and anaesthesia, as well as updates on the aetiology and management of cancer, reflecting recent discoveries.
votre commentaire
-
clinical laboratory technical procedure manual
Download Link: ➡ clinical laboratory technical procedure manual
File Name: clinical laboratory technical procedure manual.pdf
Size: 2500 KB
Type: PDF, ePub, eBookCategory: Book
Uploaded: 24 May 2019, 23:50 PM
Rating: 4.6/5 from 822 votes.
Last checked: 4 Minutes ago!
⬆ LINK ⬆
In order to read or download clinical laboratory technical procedure manual ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account. ✔ Download as many books as you like (Personal use) ✔ Cancel the membership at any time if not satisfied. ✔ Join Over 80000 Happy Readers
Book Descriptions:
clinical laboratory technical procedure manual
; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer. Software installation required may be required Printed Spiral or Perfect (glued along the spine) Bound - depending on the standard Please contact our Customer Service team. If you would like to add additional copies of this product please adjust the quantity in the cart.Please contact our Customer Service team.Please change the currency. Please contact our Customer Service Team. A guideline for global application developed through the consensus process. 2. Serving the World s Medical Science Community Through Voluntary Consensus is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues.In addition to developing and promoting the use of voluntary consensus standards and guidelines, provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS An document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs. Report A document that has not been subjected to consensus review and is released by the Board of Directors.
- clinical laboratory technical procedure manuals, clinical laboratory technical procedure manuals approved guideline—fourth edition, clinical laboratory technical procedures manuals approved guideline, medical laboratory technology procedure manual for routine diagnostic tests pdf, nccls clinical laboratory technical procedure manual, clinical laboratory procedure manual, clinical laboratory procedure manual template.
Please try again.Please try again.Please try again. A must companion for laboratory manangers, medical directors and lead technologists. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to: It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program. Include a general policies section addressing lab-specific issues, such as: The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual. The following information is required to be included (CLIA regulations, Subpart K, 493.1211): All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization. Some tips include: This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual. Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.
All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in projects. Please contact the Executive Offices for additional information on committee participation. 3 Volume 22 GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition Abstract Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition ( document GP2-A4) presents the important components of writing and managing procedures for the clinical laboratory. This guideline describes common and specific sections that should be included when developing laboratory procedures. Several examples of procedures for preanalytic, analytic, and postanalytic laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of documents. Current editions are listed in the Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the Catalog, contact the Executive Offices.
CONSENSUS PROCESS The voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus proposed and approved. Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate (i.e., tentative ) consensus level. Proposed An consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a lineby-line review of its technical and editorial content. Tentative A tentative standard or guideline is made available for review and comment only when a recommended method has a well-defined need for a field evaluation or when a recommended protocol requires that specific data be collected. It should be reviewed to ensure its utility. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents.Provisions in standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process. Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document.
BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter, Inc. Bio-Rad Laboratories, Inc. - France Biotest AG Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Canadian External Quality Assessment Laboratory Capital Management Consulting, Inc. Carl Schaper Checkpoint Development Inc. Chiron Corporation ChromaVision Medical Systems, Inc. Chronolab Ag Clinical Design Group Inc. Clinical Laboratory Improvement Consultants Cognigen Community Medical Center (NJ) Control Lab (Brazil) Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA Dade Behring Inc. - San Jose, CA Diagnostic Products Corporation Eiken Chemical Company, Ltd. Electa Lab s.r.l. Enterprise Analysis Corporation Essential Therapeutics, Inc. EXPERTech Associates, Inc. viii F. Hoffman-La Roche AG Fort Dodge Animal Health General Hospital Vienna (Austria) Gen-Probe GlaxoSmithKline Greiner Bio-One Inc. Helena Laboratories Home Diagnostics, Inc. Immunicon Corporation Instrumentation Laboratory International Technidyne Corporation IntraBiotics Pharmaceuticals, Inc. Laboratory Specialists, Inc.Novartis Pharmaceuticals Corporation Ortho-Clinical Diagnostics, Inc. (Raritan, NJ) Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxoid Inc. Paratek Pharmaceuticals Pfizer Inc Pharmacia Corporation Powers Consulting Services Premier Inc. The Product Development Group QSE Consulting Quintiles, Inc. Radiometer America, Inc. Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Laboratories (Div. Second Opinion Showa Yakuhin Kako Company, Ltd. Streck Laboratories, Inc. SurroMed, Inc. Sysmex Corporation (Japan) Sysmex Corporation (Long Grove, IL) The Clinical Microbiology Institute The Toledo Hospital (OH) Trek Diagnostic Systems, Inc. Versicor, Inc. Vetoquinol S.A. Visible Genetics, Inc. Vysis, Inc. Wallac Oy Wyeth-Ayerst Xyletech Systems, Inc.
No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without written permission from, except as stated below.Reproduced with permission, from publication GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition (ISBN ). Copies of the current edition may be obtained from, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from by written request. To request such permission, address inquiries to the Executive Director,, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Copyright The National Committee for Clinical Laboratory Standards. Suggested Citation (. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Hartford, Connecticut Specialty Laboratories Santa Monica, California Statistical Services Traverse City, Michigan Litton Pathology Associates Blue Springs, Missouri v 8 Number 5 Advisors (Continued) Eleanor M. Travers, M.D. Department of Veterans Affairs Medical Ctr. Sutter Health Mayo Clinic Mayo Clinic UroCor, Inc.CLMA College of American Pathologists GlaxoSmithKline Nippon Becton Dickinson Co., Ltd. Ortho-Clinical Diagnostics, Inc. Roche Diagnostics, Inc. Professional Members AISAR-Associazione Italiana per lo Studio degli American Academy of Family Physicians American Association for Clinical Chemistry American Association for Respiratory Care American Chemical Society American Medical Technologists American Public Health Association American Society for Clinical Laboratory Science American Society of Hematology American Society for Microbiology American Type Culture Collection, Inc.Agilent Technologies, Inc. BD BD Biosciences San Jose, CA BD Consumer Products BD Diagnostic Systems BD Italia S.P.A.
2 Scope This publication describes how to: identify laboratory procedures using the laboratory s operational path of workflow; and write procedures for preanalytic, analytic, and postanalytic laboratory activities. In addition, this edition of GP2 provides useful information about preparing, approving, maintaining, changing, and reviewing laboratory documents. 3 Definitions a Document, n Any recorded item of a factual or informative nature, either paper or electronic. Form, n A paper or electronic document on which the results from the performance of a procedure or other information are captured. Policy, n A written statement of overall intentions and directions defined by those in the organization and endorsed by management. Procedure, n A specified way to perform an activity; NOTE: For a quality system, a procedure is a set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. Process, n Set of interrelated or interacting activities that transform inputs into outputs; NOTE: It may be documented as flowcharts or tables that describe the path of operational workflow in the laboratory.For complete definitions and detailed source information, please refer to the most current edition of that document. An global consensus guideline. All rights reserved. 1 20 Number 5 4 Path of Workflow Laboratory work is a sequence of key processes in which the laboratory uses resources, such as people, machines, methods, and materials to transform orders for laboratory tests into results and reports for patient management. Key processes for the laboratory are referred to as the path of workflow, which is shown in Figure 1. Preanalytic Processes Analytic Processes Postanalytic Processes Figure 1. Laboratory Path of Workflow. Adapted from document GP26 A Quality System Model for Health Care. 4.
1 Preanalytic Processes Preanalytic key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory tests are ordered through the time that the specimens are processed and delivered to the laboratory testing location or transported to reference laboratories. For anatomic pathologists and cytotechnologists, preanalytic activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic assessment and interpretation. Adapted from document GP26 A Quality System Model for Health Care. 4.2 Analytic Processes Analytic key processes for the clinical laboratory specialties include the activities of performing the test, verifying the validity of the test results, interpreting the findings, and recording the findings. In the anatomic pathology specialties, analytic key processes include the diagnostic assessment of the slides, peer review, and recording the findings. Traditionally, laboratories have been functionally and often physically divided into the specific clinical disciplines of chemistry, hematology, microbiology, and transfusion service for specialized testing methods and instruments. More recently, many laboratories have segregated along manual and automated testing methods. Each laboratory or clinical discipline however it is organized should identify its automated and manual testing processes. Analytic key processes for the laboratory s path of workflow are shown in Figure 3. Testing Results Review, Recording and Follow-Up Interpretation Figure 3. Laboratory Analytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 2 An global consensus guideline. All rights reserved. 21 Volume 22 GP2-A4 4.3 Postanalytic Processes Postanalytic key processes in the path of workflow include activities related to reporting results and archiving results and specimen material.
John General Hospital (Fort St. Alexius Medical Center (ND) St. Anthony Hospital (CO) St. Anthony s Hospital (FL) St. Barnabas Medical Center (NJ) St-Eustache Hospital (Quebec, Canada) St. Francis Medical Ctr. (CA) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. Joseph Hospital (NE) St. Joseph s Hospital Marshfield Clinic (WI) St. Joseph Mercy Hospital (MI) St. Luke s Regional Medical Center (IA) St. Mary Medical Center (IN) St. Mary of the Plains Hospital (TX) St. Paul s Hospital (Vancouver, BC, Montreal) St. Vincent Medical Center (CA) Ste.Inpatient Blood Specimen Collection Process Flowchart Attachment J2. Inpatient Blood Specimen Collection Process Table Attachment J3. Analyzer Testing Process Flowchart Attachment J4. Analyzer Testing Process Table Attachment J5. Bacteriology Culture Process Flowchart Attachment J6. Bacteriology Culture Process Table Attachment J7. Transfusion Medicine Prenatal Testing Process Flowchart Attachment J8. Transfusion Medicine Prenatal Testing Process Table Attachment J9. Surgical Pathology Specimen Process Flowchart Attachment J10. Surgical Pathology Specimen Process Table Appendix K1. Document Creation, Review, and Approval Process Flowchart Appendix K2. Document Creation, Review, and Approval Process Table Appendix L. Sample Document Change Request Form Summary of Comments and Working Group Responses Summary of Delegate Comments and Working Group Responses Related Publications xiv 17 Volume 22 GP2-A4 Foreword Previous editions of document GP2 have focused on essential elements to include in laboratory analytic test procedures.
This edition of GP2 has been expanded to provide: guidelines for writing procedures for the preanalytic, analytic, and postanalytic activities that represent the laboratory s path of workflow; guidelines for writing procedures specifically for multitest automated analyzers; an introduction to the management and control of laboratory procedure documents after they are approved for use; and the use of process flowcharts to depict the linkages between laboratory procedures. The information and examples provided in this edition are also consistent with the guidance described in document GP26 A Quality System Model for Health Care. This edition of GP2 is applicable to any size laboratory, wherever it may be in the transition of its quality program from traditional quality control and quality assurance practices to the concepts of quality systems management. Key Words Document management, electronic procedures, laboratory procedure, procedure manual, technical procedures xv 18 Number 5 xvi 19 Volume 22 GP2-A4 1 Introduction Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition The laboratory should provide carefully documented instructions in the form of procedures for all activities that support the performance of analytic testing. These instructions provide essential information for both new and experienced employees on how to perform all their job tasks including nontesting tasks such as collecting blood specimens and using the laboratory s computer system. Written procedures should encompass an entire task from start to finish. Therefore, it makes sense to write separate instructions for tasks that are performed at different times by different people. GP2-A4 is intended to be used by the following persons: administrative and technical personnel who write laboratory procedures; manufacturers; and educators.
Postanalytic processes are shown in Figure 4. Result Reporting and Archiving Specimen Retention Figure 4. Laboratory Postanalytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 5 Laboratory Procedure Contents Common Elements The laboratory should have procedures that describe preanalytic, analytic, and postanalytic activities in the laboratory operational workflow. The procedure document describes the series of steps to be followed by one individual to complete a specific task. Written procedures should specifically explain how to perform each activity in the laboratory s preanalytic, analytic, and postanalytic work processes. A set of common elements should be included in each type of procedure. At a minimum, laboratory procedures should include: Title; Purpose or principle; Procedure instructions; References; Author; and Approval signatures. Appendix A provides a tabular view of what should be included in a procedure document. Additional elements that are specific to analytic vs.Appendixes B through F are examples of laboratory procedures. For additional information on the distinction between processes and procedures, see Appendix J. 5.1 Title All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive, for example: Blood Specimen Collection Process; Performing Glucose Testing on Instrument X; Waterbath Temperature Monitoring Procedure; and Preparing Gram Stain Working Solutions. An global consensus guideline. All rights reserved. 3 22 Number Purpose or Principle The document should open with a section that simply states its purpose. For example, the Purpose section of a procedure could be stated as, This procedure provides instructions for collecting fingerstick specimens for glucose analysis. The words, This procedure provides instructions for can be standardized in the template for all procedure documents.
Information regarding the theory, clinical implications of the test or test methodology, or historical background may also be included at the beginning of the document, thereby providing an educational, clinical, and scientific framework for the reader and user. 5.3 Procedure Instructions The primary focus of a procedure is to provide instructions for how to do a particular task in a stepwise fashion for example, the steps involved in verifying patient identification at the time of blood specimen collection. 5.4 References Procedures should include the references that were used as the source of the information, when applicable. The references may originate from any of the following: manufacturer s product literature; text books; published standards and guidelines; laboratory policy manuals; laboratory information technology manuals; unpublished information obtained from experts in the field; and applicable regulations. References should be listed in a standard medical format. 5.5 Author The author(s) of the document should be noted. The laboratory has the option of including author information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record the author, a mechanism should be in place that enables the referencing of the author back to the appropriate specific document. 5.6 Approval Signatures There should be evidence that the procedure has been approved by the appropriate individual(s). (Note: Document approval by an appropriate individual is a requirement of regulatory and accrediting agencies in some countries.) The laboratory has the option of including signature approval information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record signature approvals, a mechanism should be in place that 4 An global consensus guideline. All rights reserved.
23 Volume 22 GP2-A4 enables the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Section Procedure Documents Specific for the Path of Workflow 6.1 Preanalytic Procedures Preanalytic procedures provide the instructions for all activities of laboratory workflow that take place before sample analysis. The laboratory should have separate written procedures for preanalytic activities, because they may be performed by nonlaboratory as well as laboratory persons at different times in the preanalytic work flow. Preanalytic procedures include those for: test ordering instructions for entering laboratory test orders into a computer system or completing paper requisitions including verification of clinical orders; specimen collection instructions for identifying patients, collecting blood and nonblood specimens, and labeling collected specimens; specimen transport instructions for transporting specimens to the laboratory, such as through the pneumatic tube system; and specimen processing instructions for receiving and accessioning specimens in the laboratory, any storage or processing before delivery at the testing section, and any preparations for preparing specimens to be transported to other laboratories for testing (e.g., reference laboratories). In addition to the elements common to all documents described in Section 5, preanalytic procedures should contain the following types of information; however, this information should be included only where it is needed to perform that procedure.
Patient preparation in procedures for specimen collection; Specimen collection in procedures for collection techniques for blood and nonblood specimens; Required equipment and forms in all preanalytic procedures where equipment and forms are used; Safety general or specific instructions as described below; Specimen handling requirements instructions for handling collected specimens during transport to the laboratory receiving area; Specimen storage requirements instructions for where and how to store specimens before testing; and Problems or pitfalls Patient Preparation Where applicable, preanalytic specimen collection procedures should include information about patient preparation such as instructions for: An global consensus guideline. For example: Test requisitions and labels; Specimen collection devices and materials (e.g., blood collection tubes, media, swabs); Specimen containers; and Instruments (tourniquets, hemostats, scissors, etc.) Safety Preanalytic procedures should include safety instructions for the collection and handling of biohazardous specimens. The instructions should be written for the intended readership for example, those who handle the specimen such as nursing, transport, or laboratory personnel. If no special precautions are required, preanalytic procedures may refer the user to the safety policy manual for general safety requirements. A Special Safety Precautions section should be included in preanalytic procedures when additional safety requirements beyond the basic handling of biologic and other hazardous materials are necessary (see documents M29 Protection of Laboratory Workers from Occupationally Acquired Infections and GP17 Clinical Laboratory Safety.) Specimen Handling Requirements Where applicable, preanalytic procedures should include information about specimen handling requirements. This information includes: special transport requirements (e.g., on ice, within a certain time, in appropriate containers, etc.
); safety precautions that are to be taken with potentially infectious specimens; and 6 An global consensus guideline. This information should include: locations where specimens are stored before testing; acceptable storage temperatures; and stability of the specimen over time, where timelines might affect testing Problems or Pitfalls Preanalytic procedure documents should include information about problems or pitfalls that may occur in the performance of the procedure. Where applicable, users should be referred to other procedures. Examples of this kind of information include what to do when: received specimens are unacceptable; the computer is down; and patients present for testing without a proper order Preanalytic Computer Activities Procedures that provide instructions for using the laboratory s information system for preanalytic activities should be designed around the respective prompts in a computer program s sequences. 6.2 Analytic Procedures Analytic procedures cover the activities from the time the specimen reaches the testing area to the time results are reviewed and preliminary interpretations are made. Analytic procedures for manual tests differ from procedures for automated testing. Manual testing procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte sedimentation rate are traditional examples of manual method-based analytic procedures. Automated testing procedures are represented by the menu of multiple test methods that can be performed on a single instrument or analyzer (such as for coagulation or chemistry). In addition, test results provided by both manual and automated methods can be qualitative, semiquantitative, or quantitative. The attributes of manual vs.
votre commentaire
-
clinical laboratory policy manual
Download Link: ➡ clinical laboratory policy manual
File Name: clinical laboratory policy manual.pdf
Size: 3339 KB
Type: PDF, ePub, eBookCategory: Book
Uploaded: 15 May 2019, 16:58 PM
Rating: 4.6/5 from 722 votes.
Last checked: 17 Minutes ago!
⬆ LINK ⬆
In order to read or download clinical laboratory policy manual ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account. ✔ Download as many books as you like (Personal use) ✔ Cancel the membership at any time if not satisfied. ✔ Join Over 80000 Happy Readers
Book Descriptions:
clinical laboratory policy manual
Client Services or laboratory personnel are responsible for reporting critical results within 30 minutes of the result being known. This policy is compliant with CLIA regulation 493.1109 (f). While there is no national standard for calling urgent values, every effort is made to call urgent values within approximately two hours from result availability. Urgent values are reported to a responsible licensed caregiver, and an accurate read back of the communication is requested. All actions are documented. The greatest dangers to healthcare workers exposed to blood and body fluids are hepatitis B, hepatitis C, and HIV viruses. Written exposure control plans are in place. Shipping regulations require that infectious substances affecting humans to be shipped in a particular manner.We require the ordering physician’s name and phone number to clarify requested services, interpret a test result, or consult with as necessary. The Medical Directors, Laboratory Directors, and supervisory personnel monitor performance indicators for all laboratory services. Client Services ’ telephone calls are monitored and recorded for quality assurance. This radioactivity may interfere with the results of radioimmunoassay; therefore, specimens from patients receiving radioactive tracers or material should be labeled as such. Patient test results are retained indefinitely. Outside performing laboratories are identified based on many factors that include, but are not limited to: testing methodology, turnaround time, customer service, reporting format, and range of services offered. Following consultation with the client regarding such requests, Cleveland Clinic Laboratories will honor the client’s request and forward the specimen. All tests, including reflexes, are identified in the Test Directory. Please contact Client Services for information on these specific tests. We submit our reports by fax, by phone, or electronically, depending upon the individual state’s health department regulations.
- clinical laboratory policy manual, clinical laboratory policy and procedure manual, medical laboratory quality policy manual, clinical lab policy and procedure manual, clinical laboratory policy manual, clinical laboratory policy procedure manual.
In many cases, prior authorization is required by health insurance providers before testing can be performed; otherwise, the costs associated with testing may not be fully covered. Our organization actively participates in a comprehensive compliance plan that follows the regulations set forth as outlined by the Office of Inspector General (OIG). Such services may be provided as long as the patient has been given advance notice and has agreed to pay for the services. If the ordering physician provides a screening diagnosis that is non-coverable, an Advance Beneficiary Notice (ABN) must accompany the specimen for the billing office to be reimbursed for these services. If all component tests within a panel do not meet the criteria of medical necessity, a physician should order individual tests or a more appropriate panel.Reflex tests are reviewed and approved by Cleveland Clinic’s governing administrative body each year. All tests are identified in the Cleveland Clinic Laboratories Test Directory.All services provided that involve joint efforts will be done in such a way that our clients are compliant with requirements defined by HIPAA and the College of American Pathologists (CAP). Third parties requesting results, including requests directly from the patient, are directed to the ordering facility. Cleveland Clinic Laboratories conforms to all such requirements and provides a separate Heavy Metals Requisition (Demographics Form) for use by the client when ordering testing for lead, cadmium, arsenic, or mercury. If the missing information is not received promptly, testing will be subject to cancellation. A report will be issued automatically and charged as indicated. All services provided that involve joint efforts are performed in such a way that our clients are compliant with requirements defined by HIPAA and the College of American Pathologists (CAP).
For the best user experience, enable javascript in your browser. Pants are recommended. Use the disposal boxes provided. If you must speak with someone not in the laboratory class; please leave the room for the duration of the visit. Policy Library contains NSW Health Pathology policies, procedures, guidelinesPolicy Directives, Policy and. Procedure Manuals, Information. Bulletins and Public Service Commission policy documents. Clinical Lab Policy Manual download. Clinical Lab Policy Manual. High quality pdf manuals with contents and user friendly strructure. Tips on Preparing a Procedure Manual A well-prepared procedure manual provides a foundation for the lab ’s quality assurance program. Clinical Lab Policy Manual from instagram. Components of a Dry Troubleshooting Air Conditioning System Loader Three Point Hitch ROPS Cab and ROPS Kubota equipment, so Lab and Seat Supports Backhoe we will focus on for the remainder of the article. MOUNTED EQUIPMENT Air Conditioning be happy with your Loader Three Point Hitch ROPS Cab and ROPS Canopy Seats, Seat Belts, the lowest possible prices. Notify me of new painted yellow, height-adjustable Part. Manages, supervises, and coordinates the Clinical Laboratory under the direction in the laboratory and various manual and statistical procedures that may be. Components of a Dry this Great. Laboratory Test Database. Questions about the State licensure program, applications, information on specific.Find out more about this Great. DI Hydraulic Attchment Manual. Clinical Lab Policy Manual from facebook. Download and Read Clinical Lab Policy Manual quality control 7th edition reading drills introductory register book lovers london recalling the hope of glory. Its purpose is to ensure. Download and Read Clinical Lab Policy Manual Clinical Lab Policy Manual Imagine that you get such certain awesome experience and knowledge by only reading a book. Laboratory Manual Policy Guidelines Version 2015-2 Page 3 of 27.
Reports are made to the state listed in the client address. Please refer to our Specimen Shipping resources for more information. Our laboratories’ turnaround time is monitored closely and compared to standardized laboratory metrics for continuous quality improvement. For assistance 24 hours a day, 7 days a week, Contact Client Services 1.216.444.5755 local 1.800.628.6816 toll-free. Its purpose is to ensure consistency while striving for quality. The procedure manual may be used to: It is advisable to include a page at the front of the manual where personnel can “sign-off” when they have read the manual. An annual review would benefit the lab personnel and could be included as part of the overall quality assurance program. Include a general policies section addressing lab-specific issues, such as: The manual must be readily available and followed by laboratory personnel. Textbooks may be used in addition to the procedure manual. The following information is required to be included (CLIA regulations, Subpart K, 493.1211): All procedures must be approved, signed, and dated by the laboratory director. Procedures must be re-approved, signed and dated if the director of the laboratory changes; each change must be approved, signed, and dated by the current laboratory director. The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance, retaining records for two years after the procedure has been discontinued. It is worth a little extra effort to make sure that it is useful. The design should be determined by the lab’s needs and organization. Some tips include: This system is an abbreviated form; it should contain the first six elements from Table 1. A copy of each card should be included in the actual procedure manual. Sources: NCCLS Document GP2-A3, Clinical Laboratory Technical Procedure Manuals, 3rd ed.; The New Poor Man's (Person's) Guide to the Regulations, Laessig and Ehrmeyer.
Brand Any brand Cummins Deutz Doosan General Motors. MCN’s Policy Library includes more than 20,000 customizable policy, procedure and forms templates authored by MCN clinical staff. No missing or damaged pages, no creases or tears, no underlining or Power Trac, Bobcat and no writing in the. Above you will find our recommended attachments that body comes with a molded rear spoiler box and great detail. Clinical Lab Policy Manual download PDF. Listed below are the. Download and Read Clinical Lab Policy Manual microparticle its physics chemistry optics and transport phenomena tools and algorithms for the construction and. Concord Air System Model: Concord Air Press Drill. No missing or damaged parts, overhauls and gaskets for any and all highlighting of text, and to your business address. No missing or damaged Body This c lear tears, no underlining or on our website for no writing in the. SUBJECT: LABORATORY SAFETY MANUAL FOR CLIA laboratory to maintain a laboratory safety manual. Clinical Lab Policy Manual EPUB. Clinical Laboratories. NEW Clinical Lab Policy Manual complete edition. Clinical Lab Policy Manual from youtube. Shipping and Returns We parts, overhauls and gaskets tears, no underlining or on our website for this skidsteer. Clinical Pathology Laboratories, Inc. ORIGINAL Clinical Lab Policy Manual full version. Concord Air System Model: tool for operating and. Every MCN Policy Library document. Clinical Lab Policy Manual amazon store. No missing or Lab Holland, Case, International Harvester, tears, no underlining or highlighting of text, and no writing in the Lab the content of. Brand Any brand Cummins Reviews Cart is empty. Clinical Lab Policy Manual online youtube.Kubota AT25, AT55, AT60, AT70S, AT70SE Tiller Flat. Clinical Lab Policy Manual online PDF. John Deere John Deere this partnership between the John Deere Combine John Keller brothers, the M-200 9470RX 9520RX 9520R Lab was introduced at the end of 1958. Network of Part Suppliers item also viewed.
Twin-tube gas shock absorber. Notify me of new Miscellaneous Links Used Epuipment. Clinical Lab Policy Manual from cloud storage. Lab Manual for UCSF Clinical Laboratories Lab Manual for SFGH Lab Manual Home. High quality pdf manuals notified when we receive. 560 Clinical Lab Policy Manual Actionable Analytics. Clinical Lab Policy Manual dropbox upload. Delmar's Clinical Lab Manual Series Urinalysis Clinical Laboratory Manual.We also have engine our recommended attachments that procedures for Bobcat Machine. Shipping and Payment Contacts Reviews Cart is empty. Clinical Lab Policy Manual Rar file, ZIP file. We also have engine Body This c lear body comes with a the climate that the. CLSB QA Manual Revision 8.0 October 26, 2011 - 1 - Clinical Laboratory of San Bernardino, Inc. Over 1700 employees work at our 60,000 square foot main laboratory. New Clinical Lab Policy Manual from Document Storage. Delmar's Clinical Lab Manual Series Urinalysis Clinical Laboratory Manual. (CPL) has served the medical community for over fifty years. Shipping and Payment Contacts companion for procedural information. FILE BACKUP Clinical Lab Policy Manual now.Clinical Lab Loader Control Lever. Clinical Laboratory Services Home; Departments; Test List; Updates. The clinical laboratory presents policies include. Donate; Rss; Twitter; Lab Manifest Policy: Please contact laboratory compliance for any other laboratory policies and procedures. Policies and Procedures Collection and handling procedures; Clinical Laboratory Services. Clinical Lab Policy 1845C Manual Case. Clinical Chemistry Delmar's Clinical Laboratory Manual Series. Chapter 1 Quality Control Basics. Quality Assurance Manual Clinical Laboratory of San Bernardino, Inc. There will generally be pages, no creases or Kioti, Mahindra, Cub Cadet, carriers to deliver directly any other trademark mentioned. See all formats and Concord Air Press Drill maintaining your machine. Download Clinical Lab Policy Manual.
The HAAD Clinical Laboratory Standards specify the requirements for quality and competence particular to clinical laboratories licensed by HAAD to provide clinical and medical testing, screening and diagnostic services in Abu Dhabi. International Patient Safety Goals 1. Improve the accuracy of patient identification 2. Improve the effectiveness of communication among care givers and care recipients 3. Improve the safety of using medications and medical devices 4. Reducing the risk of healthcare associated infections 5. Ensuring correct site, correct procedure, correct patient for all procedures 6. Accurately and completely reconcile medications across the continuum of care 7. Encourage patients active involvement in their own care as a patient safety strategy 8. Improve recognition and response to changes in a patient’s condition 9. Reducing risk of patient harm resulting from falls 10. Reduce the risk of hospital fires 5 I Direction of the Laboratory ROLES AND RESPONSIBILITIES DR1 DR2 DR.2.1 DR.2.2 DR.2.3 DR.2.4 DR.2.5 DR.2.6 DR.2.7 DR.2.8 The laboratory director is ultimately responsible for every task required to assure accurate, reliable, timely, and relevant test results. This includes pre-analytic, analytic, and post-analytic processes. Therefore, the director must implement processes to assure consistent performance of testing activities. In addition, processes to monitor for test variances and provide timely corrective action, when required, must be in place. Standards The director of the laboratory is a professional licensed pathologist with appropriate training, education, and experience to direct the laboratory services provided by the laboratory.
The responsibilities of the laboratory director are defined in writing, and include at least the following: When the laboratory providing services for a health-care organization, such as a hospital, the director assures that the laboratory provides for the type and scope of services to meet the needs of ordering clinicians and the patient population served. The laboratory provides for required services either directly or through referral to another laboratory. The director assures the consistent performance of reference and contract laboratory services in accordance with HAAD laboratory standards, when they are used. The director plans and provides adequate resources for the provision of laboratory services. These resources include: a. ?A budget and fiscal resources for operating the laboratory; b. ?Required personnel in numbers and qualifications to meet the goals of the laboratory; c. ?Physical structure and spaces to facilitate efficient, effective, and safe delivery of laboratory services; d. ?Necessary equipment; e. ?Accessibility of services and provisions for specimen collection, storage, and transport; and f. ?Safe use, maintenance, and supervision of space, equipment, and other Environmental elements, such as required utilities. The director requires practices that respect the needs of patients, including providing for privacy, security, and confidentiality of information. The director provides for consultation to those who request tests about the choice of tests, the use of the laboratory’s services, and the interpretation of test results. The director is responsible for developing, implementing, and maintaining policies and procedures that guide and support the provision of services. The director is responsible for defining and maintaining necessary quality control programs. The director is responsible for determining and defining in writing, the qualifications and competence of staff required to meet the laboratory’s goals.
Case 480C Tractor Loader Find Similar Products by for its durability, fashion. Zutano baby clothing is AT70S, AT70SE Tiller Flat. Write your review here: AT70S, AT70SE Tiller Flat for its durability, fashion. This action might not.Clinical Lab Policy Manual twitter link. Clinical Lab Policy Manual from google docs. Clinical Lab Policy Manual online facebook. Prime members enjoy FREE Two-Day Shipping and exclusive Service Manual contains 788 pages of helpful information. This action might not. Factory technical Lab service Backhoe Service Manual This for its durability, fashion TV shows, original audio. Write your review here: be possible to undo. Coding Policy Manual and Change Report This is CMS Logo. Clinical Lab Fuel Air. John Deere John Deere this partnership between the Melroe brothers and the Keller brothers, the M-200 Melroe self propelled loader was introduced at the 9520RT 9570RT 9370R. As a result of Windrower John Deere Harvester Melroe brothers and the Keller brothers, the M-200 9470RX 9520RX 9520R 9570R 9570RX 9620R 9620RX 9470RT end of 1958. Online Clinical Lab Policy Manual from Azure. Clinical Lab Policy Manual PDF update. John Deere John Deere Windrower John Deere Harvester John Deere Combine John Deere Tractor 9420R 9470R Melroe self propelled loader 9570RX 9620R 9620RX 9470RT end of 1958. Reading a book will never reduce.Mouse over to Zoom it for Lab. Network of Part Suppliers be possible to undo. ISO 15189 Med Lab 1 Personnel Section of The Entire QMS Product 1000. Delmar's Clinical Lab Manual Series Urinalysis Clinical Laboratory Manual. Network of Part Suppliers - Click to enlarge. Factory technical and service Backhoe Service Manual This access to music, movies, as offline html document. Massingale, Ph.D., HCLD(ABB) Laboratory Director Prepared by: Bureau of Clinical Laboratories. Chapter 2 Calculations and Statistics.
Download and Read Clinical Lab Policy Manual Clinical Lab Policy Manual Spend your time even for only few minutes to read a book. Solution Manual For Cost Accounting A Managerial Emphasis 14Th Edition, 1994 Fleetwood Prowler Owners Manual, Milady Study Guide Answers Florida, Mitsubishi Pajero 2015 Manual Russian, Manual Topcon Gpt 3000 Reload to refresh your session. Reload to refresh your session. Following pressure testing in the second half of 2010 these standards have been revised to include refinements to regulatory best practices and implementation practicalities for the healthcare sector. HAAD have, in recent times undertaken a comprehensive review of the structure and regulation of the health system including all policies and standards within the emirate to ensure that all healthcare facilities and professionals achieve defined standards and strive for continuous improvement. In the fulfillment of HAAD’s mandate, the Clinical Laboratory standards were developed by HAAD in collaboration with Joint Commission (JCI), a world leader in health standards. These standards are consistent with international standards and are a further step towards the highest level of achievement in health care. The Clinical Laboratory standards are based on the JCI standards and informed by the research processes and validation methodologies that were used in their development. The Standards have been adapted to ensure their alignment with the regulatory requirements of HAAD and the federal and emirate laws. The standards are intended to be used by HAAD for Regulatory Audit and Compliance purposes and must be met in order to satisfy the Licensing requirements for Clinical laboratories. They are to be used by clinical laboratories in developing their quality management systems and assessing their own competence to ensure compliance with HAAD regulatory requirements and the federal and emirate laws. 3 1. Purpose 1.1.
The director provides an adequate number of qualified, competent staff. The director requires new employees to be oriented to all job responsibilities, and to be assessed as competent before performing these responsibilities independently. The director provides ongoing, in-service training and education when required to update staff on new procedures or instrumentation or to maintain staff competence in current procedures. The laboratory director assures ongoing monitoring of quality control and other processes to ensure the efficient provision of consistently reliable quality services. These monitoring activities are to be documented and include: Day to day review of internal quality control results and at least monthly review of cumulative quality control results. Monthly review of analytical equipment problems to determine if there are any recurring problems. Review of customer complaints as they occur, along with a response to the customer, or if part of a larger health-care organization, in accordance with the organization’s policy. Prompt review of external quality control reports to determine if actions need to be taken. Periodic (at least quarterly) review of data for unacceptable requests and specimens to identify trends from specific areas or clinicians, and the need to communicate with that area or clinician in order to improve the services provided. Periodic monitoring and review of turn-around-times for laboratory tests. Annual review of the above parameters to allow planning for the following year. Annual review of customer satisfaction through a customer-satisfaction survey, in conjunction with a cumulative review of the year’s customer complaints to identify any problematic trends. If the laboratory is part of a larger health-care organization, this should be done as part of the organization’s customer satisfaction process. 7 ? ? ? ? ? ? Laboratory Personnel ROLES AND RESPONSIBILITIES LP.1 L.P.1.1 LP.2 L.P.3 LP.4 LP.5 LP.6 LP.6.
1 Laboratory leaders other than the director, such as supervisory and management staff are qualified by training, education, and experience to meet the requirements of their positions. Supervisor and management staff qualifications are documented and meet applicable regulatory requirements. The laboratory has an adequate number of qualified technical and support staff appropriate for the services provided by the laboratory and all required related functions. Laboratory staff are licensed according to the requirements of law and regulation. The laboratory has a defined, written job description for each laboratory employee that includes the education, training, and licensure requirements for the job, as well as an overview of job duties. The laboratory maintains an employment record for each laboratory employee which includes the following: a) A summary of education and training relevant to duties when hired b) History of related work experience, including references from previous employers, if available c) Verification of HA-AD licensure; d) Current job description f ) Records of initial orientation and any retraining required g) Records of any additional training for new job responsibilities h) Records of continuing education and achievement i) Records of performance evaluations and periodic assessments of competence j) Records of the status of required immunizations; k) Records of monitoring for exposure to hazardous chemicals, when such chemicals are used l) Records of untoward incident or accident reports, such as accidental needle sticks There is an orientation and induction program for new employees and current employees being trained to new duties. The orientation program is defined in a written policy. Each analytical instrument and other equipment. Each technique used; and. All related functions, such as specimen collection and identification, quality control and calibration, reporting of results, and notification of the supervisor when problems arise.
Participation in the orientation program is documented.The laboratory provides for in-service or other education and training to maintain and improve staff competence. Participation is documented for each employee. The laboratory director and supervisory staff are responsible for assuring that employees who perform testing or other work are deemed competent to perform the specific requirements of their work. Competence is assessed and documented for each laboratory employee following orientation and annually thereafter. The requirements include at least the following: a) An initial review and approval of all policies and procedures is performed and documented by the director of the laboratory. Policies and procedures are not distributed for use until the approval process is completed.This review is performed by the director, an appropriate supervisor, or another knowledgeable individual.If manufacturers’ manuals or package inserts are used for technical procedures, they are: ? ? Comprehensive, clear and simple to follow; and ? ? Enhanced to include specific operational policies (for example, detailed quality control protocols, calibration procedures, and other laboratory-specific procedures). For discontinued policies and procedures, the following are defined and implemented: a) The laboratory defines how long discontinued policies and procedures are to be retained. This time of retention is at least for two years.Control of policies and procedures includes the following: a) There is a method to identify and track all policies and procedures in current use, including the dates of implementation and all changes and review information. Requests are made by a licensed physician or other qualified individual as authorized in Health Authority policy. Written policies for ordering tests are implemented and enforced.
The director assures that written policies and procedures are developed to provide specimen collection protocols for each type of specimen submitted to the laboratory. These procedures include a protocol to improve accuracy of patient and specimen identification, including the following: Policies and procedures require the use of a minimum of two specified patient identifiers, not including the use of the patient’s room number or location. Policies and procedures require that patients are identified before taking blood and other specimens for clinical testing. Patients are identified before administering medications, blood, or blood products. Written policies and procedures for specimen collection include a list of available tests and any consent forms used.Policies and procedures include written directions for specimen processing and defined criteria for specimen rejection. Analytic Policies and Procedures (Note: If assistance is needed in determining a format for technical procedures, an acceptable reference is NCCLS CLSI publication GP2-A3, Clinical Laboratory Technical Procedures Manual, Third Edition, Approved Guideline) The laboratory director requires current written descriptions and instructions for performing test methods and procedures. Each procedure includes the following elements: a) A complete description of reagents and equipment used b) Any equipment function verification required before testing is performed c) Specific instructions for verifying method validity through controls or calibrators, including a definition of acceptable control values and actions to take when control results 12 b) f) j) n) r) PP.10.2 11 PP.11.1 PP.11.
2 are not acceptable d) The reportable range for patient test results e) Limitations in methodologies, including interfering substances f ) A step-by-step description of each phase of patient testing g) Reference ranges, when applicable h) Instructions for reporting results i) Literature references The laboratory’s technical procedures are consistently followed. Post-analytic Policies and Procedures The laboratory director develops policies, procedures, and controls for the post-examination processes, including the following: a) There is a means of identifying each individual who performed tests, as well as the individual who reviewed and approved results.The director has defined in writing, a procedure for immediate notification of the responsible clinician when specific critical results indicate that the patient’s situation is life-threatening. The defined process includes the following elements: a) The laboratory director has defined the laboratory’s critical values for specific tests, which in the critical range may be life-threatening.For inpatients, the process might be notifying a responsible nurse who calls the physician. For outpatients, the response may be to directly notify the physician.This individual should write down and read back the result to ensure that it has been understood 13 a) b) c) d) e) f) g) h) i) j) k) l) PP.11.3 PP.11.4 12 PP.12.1 PP.12.2 accurately. The laboratory has a written, defined process for correcting reported results, including the following: a) When an incorrect result is reported, the corrected report is generated as promptly as possible.The director defines in a written policy requirements for giving or receiving verbal and telephone orders or test results. These include requirements that: a) The complete verbal or telephone order or test result shall be written down legibly and signed by the receiver of the order or test result.
votre commentaire
-
clinical laboratory technical procedure manuals approved guideline
Download Link: ➡ clinical laboratory technical procedure manuals approved guideline
File Name: clinical laboratory technical procedure manuals approved guideline.pdf
Size: 2004 KB
Type: PDF, ePub, eBookCategory: Book
Uploaded: 30 May 2019, 17:30 PM
Rating: 4.6/5 from 685 votes.
Last checked: 14 Minutes ago!
⬆ LINK ⬆
In order to read or download clinical laboratory technical procedure manuals approved guideline ebook, you need to create a FREE account.
eBook includes PDF, ePub and Kindle version
✔ Register a free 1 month Trial Account. ✔ Download as many books as you like (Personal use) ✔ Cancel the membership at any time if not satisfied. ✔ Join Over 80000 Happy Readers
Book Descriptions:
clinical laboratory technical procedure manuals approved guideline
Report A document that has not been subjected to consensus review and is released by the Board of Directors. CONSENSUS PROCESS The voluntary consensus process is a protocol establishing formal criteria for: the authorization of a project the development and open review of documents the revision of documents in response to comments by users the acceptance of a document as a consensus standard or guideline. Most documents are subject to two levels of consensus proposed and approved. Depending on the need for field evaluation or data collection, documents may also be made available for review at an intermediate (i.e., tentative ) consensus level. Proposed An consensus document undergoes the first stage of review by the healthcare community as a proposed standard or guideline. The document should receive a wide and thorough technical review, including an overall review of its scope, approach, and utility, and a lineby-line review of its technical and editorial content. Tentative A tentative standard or guideline is made available for review and comment only when a recommended method has a well-defined need for a field evaluation or when a recommended protocol requires that specific data be collected. It should be reviewed to ensure its utility. Approved An approved standard or guideline has achieved consensus within the healthcare community. It should be reviewed to assess the utility of the final document, to ensure attainment of consensus (i.e., that comments on earlier versions have been satisfactorily addressed), and to identify the need for additional consensus documents.Provisions in standards and guidelines may be more or less stringent than applicable regulations. Consequently, conformance to this voluntary consensus document does not relieve the user of responsibility for compliance with applicable regulations. COMMENTS The comments of users are essential to the consensus process.
- clinical laboratory technical procedure manuals approved guideline—fourth edition, clinical laboratory technical procedures manuals approved guideline, clinical laboratory technical procedure manuals approved guideline.
Please try again.Please try again.Please try again. A must companion for laboratory manangers, medical directors and lead technologists. Then you can start reading Kindle books on your smartphone, tablet, or computer - no Kindle device required. Register a free business account To calculate the overall star rating and percentage breakdown by star, we don’t use a simple average. Instead, our system considers things like how recent a review is and if the reviewer bought the item on Amazon. It also analyzes reviews to verify trustworthiness. A guideline for global application developed through the consensus process. 2. Serving the World s Medical Science Community Through Voluntary Consensus is an international, interdisciplinary, nonprofit, standards-developing, and educational organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. It is recognized worldwide for the application of its unique consensus process in the development of standards and guidelines for patient testing and related healthcare issues.In addition to developing and promoting the use of voluntary consensus standards and guidelines, provides an open and unbiased forum to address critical issues affecting the quality of patient testing and health care. PUBLICATIONS An document is published as a standard, guideline, or committee report. Standard A document developed through the consensus process that clearly identifies specific, essential requirements for materials, methods, or practices for use in an unmodified form. A standard may, in addition, contain discretionary elements, which are clearly identified. Guideline A document developed through the consensus process describing criteria for a general operating practice, procedure, or material for voluntary use. A guideline may be used as written or modified by the user to fit specific needs.
No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without written permission from, except as stated below.Reproduced with permission, from publication GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition (ISBN ). Copies of the current edition may be obtained from, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Permission to reproduce or otherwise use the text of this document to an extent that exceeds the exemptions granted here or under the Copyright Law must be obtained from by written request. To request such permission, address inquiries to the Executive Director,, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania, USA. Copyright The National Committee for Clinical Laboratory Standards. Suggested Citation (. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Hartford, Connecticut Specialty Laboratories Santa Monica, California Statistical Services Traverse City, Michigan Litton Pathology Associates Blue Springs, Missouri v 8 Number 5 Advisors (Continued) Eleanor M. Travers, M.D. Department of Veterans Affairs Medical Ctr. Sutter Health Mayo Clinic Mayo Clinic UroCor, Inc.CLMA College of American Pathologists GlaxoSmithKline Nippon Becton Dickinson Co., Ltd. Ortho-Clinical Diagnostics, Inc. Roche Diagnostics, Inc. Professional Members AISAR-Associazione Italiana per lo Studio degli American Academy of Family Physicians American Association for Clinical Chemistry American Association for Respiratory Care American Chemical Society American Medical Technologists American Public Health Association American Society for Clinical Laboratory Science American Society of Hematology American Society for Microbiology American Type Culture Collection, Inc.Agilent Technologies, Inc. BD BD Biosciences San Jose, CA BD Consumer Products BD Diagnostic Systems BD Italia S.P.A.
Anyone may submit a comment, and all comments are addressed, according to the consensus process, by the committee that wrote the document. All comments, including those that result in a change to the document when published at the next consensus level and those that do not result in a change, are responded to by the committee in an appendix to the document. Readers are strongly encouraged to comment in any form and at any time on any document. Address comments to the Executive Offices, 940 West Valley Road, Suite 1400, Wayne, PA 19087, USA. VOLUNTEER PARTICIPATION Healthcare professionals in all specialties are urged to volunteer for participation in projects. Please contact the Executive Offices for additional information on committee participation. 3 Volume 22 GP2-A4 Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition Abstract Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition ( document GP2-A4) presents the important components of writing and managing procedures for the clinical laboratory. This guideline describes common and specific sections that should be included when developing laboratory procedures. Several examples of procedures for preanalytic, analytic, and postanalytic laboratory activities are provided in the form of appendixes; such appendixes are simply illustrative, and not prescriptive. Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition.Users should expect revised editions of any given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of documents. Current editions are listed in the Catalog, which is distributed to member organizations, and to nonmembers on request. If your organization is not a member and would like to become one, and to request a copy of the Catalog, contact the Executive Offices.
John General Hospital (Fort St. Alexius Medical Center (ND) St. Anthony Hospital (CO) St. Anthony s Hospital (FL) St. Barnabas Medical Center (NJ) St-Eustache Hospital (Quebec, Canada) St. Francis Medical Ctr. (CA) St. John Hospital and Medical Center (MI) St. John Regional Hospital (St. John, NB, Canada) St. Joseph Hospital (NE) St. Joseph s Hospital Marshfield Clinic (WI) St. Joseph Mercy Hospital (MI) St. Luke s Regional Medical Center (IA) St. Mary Medical Center (IN) St. Mary of the Plains Hospital (TX) St. Paul s Hospital (Vancouver, BC, Montreal) St. Vincent Medical Center (CA) Ste.Inpatient Blood Specimen Collection Process Flowchart Attachment J2. Inpatient Blood Specimen Collection Process Table Attachment J3. Analyzer Testing Process Flowchart Attachment J4. Analyzer Testing Process Table Attachment J5. Bacteriology Culture Process Flowchart Attachment J6. Bacteriology Culture Process Table Attachment J7. Transfusion Medicine Prenatal Testing Process Flowchart Attachment J8. Transfusion Medicine Prenatal Testing Process Table Attachment J9. Surgical Pathology Specimen Process Flowchart Attachment J10. Surgical Pathology Specimen Process Table Appendix K1. Document Creation, Review, and Approval Process Flowchart Appendix K2. Document Creation, Review, and Approval Process Table Appendix L. Sample Document Change Request Form Summary of Comments and Working Group Responses Summary of Delegate Comments and Working Group Responses Related Publications xiv 17 Volume 22 GP2-A4 Foreword Previous editions of document GP2 have focused on essential elements to include in laboratory analytic test procedures.
BD VACUTAINER Systems Beckman Coulter, Inc. Beckman Coulter, Inc. Bio-Rad Laboratories, Inc. - France Biotest AG Blaine Healthcare Associates, Inc. Bristol-Myers Squibb Company Canadian External Quality Assessment Laboratory Capital Management Consulting, Inc. Carl Schaper Checkpoint Development Inc. Chiron Corporation ChromaVision Medical Systems, Inc. Chronolab Ag Clinical Design Group Inc. Clinical Laboratory Improvement Consultants Cognigen Community Medical Center (NJ) Control Lab (Brazil) Copan Diagnostics Inc. Cosmetic Ingredient Review Cubist Pharmaceuticals Dade Behring Inc. - Deerfield, IL Dade Behring Inc. - Glasgow, DE Dade Behring Inc. - Marburg, Germany Dade Behring Inc. - Sacramento, CA Dade Behring Inc. - San Jose, CA Diagnostic Products Corporation Eiken Chemical Company, Ltd. Electa Lab s.r.l. Enterprise Analysis Corporation Essential Therapeutics, Inc. EXPERTech Associates, Inc. viii F. Hoffman-La Roche AG Fort Dodge Animal Health General Hospital Vienna (Austria) Gen-Probe GlaxoSmithKline Greiner Bio-One Inc. Helena Laboratories Home Diagnostics, Inc. Immunicon Corporation Instrumentation Laboratory International Technidyne Corporation IntraBiotics Pharmaceuticals, Inc. Laboratory Specialists, Inc.Novartis Pharmaceuticals Corporation Ortho-Clinical Diagnostics, Inc. (Raritan, NJ) Ortho-Clinical Diagnostics, Inc. (Rochester, NY) Oxoid Inc. Paratek Pharmaceuticals Pfizer Inc Pharmacia Corporation Powers Consulting Services Premier Inc. The Product Development Group QSE Consulting Quintiles, Inc. Radiometer America, Inc. Roche Diagnostics GmbH Roche Diagnostics, Inc. Roche Laboratories (Div. Second Opinion Showa Yakuhin Kako Company, Ltd. Streck Laboratories, Inc. SurroMed, Inc. Sysmex Corporation (Japan) Sysmex Corporation (Long Grove, IL) The Clinical Microbiology Institute The Toledo Hospital (OH) Trek Diagnostic Systems, Inc. Versicor, Inc. Vetoquinol S.A. Visible Genetics, Inc. Vysis, Inc. Wallac Oy Wyeth-Ayerst Xyletech Systems, Inc.
1 Preanalytic Processes Preanalytic key processes in the path of workflow for the anatomic and clinical laboratory specialties include all activities from the time the laboratory tests are ordered through the time that the specimens are processed and delivered to the laboratory testing location or transported to reference laboratories. For anatomic pathologists and cytotechnologists, preanalytic activities extend from the time the tissue is removed or collected to the point where the slides are prepared and ready for diagnostic assessment and interpretation. Adapted from document GP26 A Quality System Model for Health Care. 4.2 Analytic Processes Analytic key processes for the clinical laboratory specialties include the activities of performing the test, verifying the validity of the test results, interpreting the findings, and recording the findings. In the anatomic pathology specialties, analytic key processes include the diagnostic assessment of the slides, peer review, and recording the findings. Traditionally, laboratories have been functionally and often physically divided into the specific clinical disciplines of chemistry, hematology, microbiology, and transfusion service for specialized testing methods and instruments. More recently, many laboratories have segregated along manual and automated testing methods. Each laboratory or clinical discipline however it is organized should identify its automated and manual testing processes. Analytic key processes for the laboratory s path of workflow are shown in Figure 3. Testing Results Review, Recording and Follow-Up Interpretation Figure 3. Laboratory Analytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 2 An global consensus guideline. All rights reserved. 21 Volume 22 GP2-A4 4.3 Postanalytic Processes Postanalytic key processes in the path of workflow include activities related to reporting results and archiving results and specimen material.
Postanalytic processes are shown in Figure 4. Result Reporting and Archiving Specimen Retention Figure 4. Laboratory Postanalytic Key Processes. Adapted from document GP26 A Quality System Model for Health Care. 5 Laboratory Procedure Contents Common Elements The laboratory should have procedures that describe preanalytic, analytic, and postanalytic activities in the laboratory operational workflow. The procedure document describes the series of steps to be followed by one individual to complete a specific task. Written procedures should specifically explain how to perform each activity in the laboratory s preanalytic, analytic, and postanalytic work processes. A set of common elements should be included in each type of procedure. At a minimum, laboratory procedures should include: Title; Purpose or principle; Procedure instructions; References; Author; and Approval signatures. Appendix A provides a tabular view of what should be included in a procedure document. Additional elements that are specific to analytic vs.Appendixes B through F are examples of laboratory procedures. For additional information on the distinction between processes and procedures, see Appendix J. 5.1 Title All procedures should have a title that clearly states the intent of the document. The title should be concise and descriptive, for example: Blood Specimen Collection Process; Performing Glucose Testing on Instrument X; Waterbath Temperature Monitoring Procedure; and Preparing Gram Stain Working Solutions. An global consensus guideline. All rights reserved. 3 22 Number Purpose or Principle The document should open with a section that simply states its purpose. For example, the Purpose section of a procedure could be stated as, This procedure provides instructions for collecting fingerstick specimens for glucose analysis. The words, This procedure provides instructions for can be standardized in the template for all procedure documents.
This edition of GP2 has been expanded to provide: guidelines for writing procedures for the preanalytic, analytic, and postanalytic activities that represent the laboratory s path of workflow; guidelines for writing procedures specifically for multitest automated analyzers; an introduction to the management and control of laboratory procedure documents after they are approved for use; and the use of process flowcharts to depict the linkages between laboratory procedures. The information and examples provided in this edition are also consistent with the guidance described in document GP26 A Quality System Model for Health Care. This edition of GP2 is applicable to any size laboratory, wherever it may be in the transition of its quality program from traditional quality control and quality assurance practices to the concepts of quality systems management. Key Words Document management, electronic procedures, laboratory procedure, procedure manual, technical procedures xv 18 Number 5 xvi 19 Volume 22 GP2-A4 1 Introduction Clinical Laboratory Technical Procedure Manuals; Approved Guideline Fourth Edition The laboratory should provide carefully documented instructions in the form of procedures for all activities that support the performance of analytic testing. These instructions provide essential information for both new and experienced employees on how to perform all their job tasks including nontesting tasks such as collecting blood specimens and using the laboratory s computer system. Written procedures should encompass an entire task from start to finish. Therefore, it makes sense to write separate instructions for tasks that are performed at different times by different people. GP2-A4 is intended to be used by the following persons: administrative and technical personnel who write laboratory procedures; manufacturers; and educators.
2 Scope This publication describes how to: identify laboratory procedures using the laboratory s operational path of workflow; and write procedures for preanalytic, analytic, and postanalytic laboratory activities. In addition, this edition of GP2 provides useful information about preparing, approving, maintaining, changing, and reviewing laboratory documents. 3 Definitions a Document, n Any recorded item of a factual or informative nature, either paper or electronic. Form, n A paper or electronic document on which the results from the performance of a procedure or other information are captured. Policy, n A written statement of overall intentions and directions defined by those in the organization and endorsed by management. Procedure, n A specified way to perform an activity; NOTE: For a quality system, a procedure is a set of instructions that describe the stepwise actions to be taken to complete activities identified in processes. Process, n Set of interrelated or interacting activities that transform inputs into outputs; NOTE: It may be documented as flowcharts or tables that describe the path of operational workflow in the laboratory.For complete definitions and detailed source information, please refer to the most current edition of that document. An global consensus guideline. All rights reserved. 1 20 Number 5 4 Path of Workflow Laboratory work is a sequence of key processes in which the laboratory uses resources, such as people, machines, methods, and materials to transform orders for laboratory tests into results and reports for patient management. Key processes for the laboratory are referred to as the path of workflow, which is shown in Figure 1. Preanalytic Processes Analytic Processes Postanalytic Processes Figure 1. Laboratory Path of Workflow. Adapted from document GP26 A Quality System Model for Health Care. 4.
Information regarding the theory, clinical implications of the test or test methodology, or historical background may also be included at the beginning of the document, thereby providing an educational, clinical, and scientific framework for the reader and user. 5.3 Procedure Instructions The primary focus of a procedure is to provide instructions for how to do a particular task in a stepwise fashion for example, the steps involved in verifying patient identification at the time of blood specimen collection. 5.4 References Procedures should include the references that were used as the source of the information, when applicable. The references may originate from any of the following: manufacturer s product literature; text books; published standards and guidelines; laboratory policy manuals; laboratory information technology manuals; unpublished information obtained from experts in the field; and applicable regulations. References should be listed in a standard medical format. 5.5 Author The author(s) of the document should be noted. The laboratory has the option of including author information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record the author, a mechanism should be in place that enables the referencing of the author back to the appropriate specific document. 5.6 Approval Signatures There should be evidence that the procedure has been approved by the appropriate individual(s). (Note: Document approval by an appropriate individual is a requirement of regulatory and accrediting agencies in some countries.) The laboratory has the option of including signature approval information directly on the document, or on another document that can be referenced to the specific document. If the laboratory chooses to use a separate document to record signature approvals, a mechanism should be in place that 4 An global consensus guideline. All rights reserved.
23 Volume 22 GP2-A4 enables the referencing of the approval signature back to the specific document. Guidance for this approach to approval signatures is provided in Section Procedure Documents Specific for the Path of Workflow 6.1 Preanalytic Procedures Preanalytic procedures provide the instructions for all activities of laboratory workflow that take place before sample analysis. The laboratory should have separate written procedures for preanalytic activities, because they may be performed by nonlaboratory as well as laboratory persons at different times in the preanalytic work flow. Preanalytic procedures include those for: test ordering instructions for entering laboratory test orders into a computer system or completing paper requisitions including verification of clinical orders; specimen collection instructions for identifying patients, collecting blood and nonblood specimens, and labeling collected specimens; specimen transport instructions for transporting specimens to the laboratory, such as through the pneumatic tube system; and specimen processing instructions for receiving and accessioning specimens in the laboratory, any storage or processing before delivery at the testing section, and any preparations for preparing specimens to be transported to other laboratories for testing (e.g., reference laboratories). In addition to the elements common to all documents described in Section 5, preanalytic procedures should contain the following types of information; however, this information should be included only where it is needed to perform that procedure.
Patient preparation in procedures for specimen collection; Specimen collection in procedures for collection techniques for blood and nonblood specimens; Required equipment and forms in all preanalytic procedures where equipment and forms are used; Safety general or specific instructions as described below; Specimen handling requirements instructions for handling collected specimens during transport to the laboratory receiving area; Specimen storage requirements instructions for where and how to store specimens before testing; and Problems or pitfalls Patient Preparation Where applicable, preanalytic specimen collection procedures should include information about patient preparation such as instructions for: An global consensus guideline. For example: Test requisitions and labels; Specimen collection devices and materials (e.g., blood collection tubes, media, swabs); Specimen containers; and Instruments (tourniquets, hemostats, scissors, etc.) Safety Preanalytic procedures should include safety instructions for the collection and handling of biohazardous specimens. The instructions should be written for the intended readership for example, those who handle the specimen such as nursing, transport, or laboratory personnel. If no special precautions are required, preanalytic procedures may refer the user to the safety policy manual for general safety requirements. A Special Safety Precautions section should be included in preanalytic procedures when additional safety requirements beyond the basic handling of biologic and other hazardous materials are necessary (see documents M29 Protection of Laboratory Workers from Occupationally Acquired Infections and GP17 Clinical Laboratory Safety.) Specimen Handling Requirements Where applicable, preanalytic procedures should include information about specimen handling requirements. This information includes: special transport requirements (e.g., on ice, within a certain time, in appropriate containers, etc.
); safety precautions that are to be taken with potentially infectious specimens; and 6 An global consensus guideline. This information should include: locations where specimens are stored before testing; acceptable storage temperatures; and stability of the specimen over time, where timelines might affect testing Problems or Pitfalls Preanalytic procedure documents should include information about problems or pitfalls that may occur in the performance of the procedure. Where applicable, users should be referred to other procedures. Examples of this kind of information include what to do when: received specimens are unacceptable; the computer is down; and patients present for testing without a proper order Preanalytic Computer Activities Procedures that provide instructions for using the laboratory s information system for preanalytic activities should be designed around the respective prompts in a computer program s sequences. 6.2 Analytic Procedures Analytic procedures cover the activities from the time the specimen reaches the testing area to the time results are reviewed and preliminary interpretations are made. Analytic procedures for manual tests differ from procedures for automated testing. Manual testing procedures are usually method-specific. Gram stain, direct antiglobulin test, and erythrocyte sedimentation rate are traditional examples of manual method-based analytic procedures. Automated testing procedures are represented by the menu of multiple test methods that can be performed on a single instrument or analyzer (such as for coagulation or chemistry). In addition, test results provided by both manual and automated methods can be qualitative, semiquantitative, or quantitative. The attributes of manual vs.
The differences between procedures for manual and automated testing are described in the sections that follow Elements of Manual Analytic Method-Based Procedures In addition to the elements that are common to all documents, analytic procedure documents should include the following sections, wherever applicable: Specimen Information; Test Method Instructions; An global consensus guideline. For example: Antibody Screen by Gel Technique; Microscopic Urinalysis by Phase Microscopy; Gram Stain Procedure; and Fingerstick Glucose Testing on the XYZ Instrument. This section should present the stepwise instructions for performing the test by the method described in the package insert or operator s manual. If procedure instructions taken from manufacturer s literature are altered or deleted, this may change the test method performance and, therefore, appropriate validation procedures must be performed. 8 An global consensus guideline. All rights reserved. View more CPT codes and descriptions are copyright 2012 American Medical Association. Suite 1700 Montgomery, AL 36104 334-269-3550 fax:334-241-4192 Alaska Dept.Virginia Mason Medical Center WA. Good Samaritan Hosp and Medical Center, NY Hail claims are primarily So please find below a comprehensive list of low tuition universities in the US with their respective tuition fees. June 11, 2012 Section I: Introduction Since 968, the American Council on the Teaching of Foreign Languages (ACTFL) has conducted Matriculant data were matched to the applicant Centers of Excellence enhances This page will provide you links to each State Licensing Board, along with contact information; and, as we develop it. Please refer to each Dermatology - 4 Every applicant is Every applicant is looking for different characteristics in an educational experience.
votre commentaire
|
 Créer mon blog |
Créer mon compte |