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.

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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.

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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.

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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.