Loyola Medical Laboratories Laboratory Waived Testing Program

1. Loyola Medical Laboratories Laboratory Waived Testing Program This slide presentation includes an overview of: • Loyola Medical Lab’s Waived Testing Program • Federal Laboratory Regulations • Good Laboratory Practices • General Quality Assurance Requirements for all Tests To advance slide, click anywhere on blank area of screen.

2. Loyola Medical Laboratories Laboratory Waived Testing Program This slide presentation is provided to you as an educational service by Loyola Medical Laboratories. This presentation should not be used or copied without the express permission of Loyola Medical Laboratories. To advance slide, click anywhere on blank area of screen.

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4. Loyola Medical Laboratories Laboratory Waived Testing Program As a service to it’s clients, Loyola Medical Laboratories provides technical assistance in the form of a Laboratory Waived Testing Program created and supported by the section of Outreach Services. The Laboratory Waived Testing Program was created to establish standards for all waived testing performed at LUHS in an effort to ensure quality patient testing and compliance with federal laboratory laws.

5. Loyola Medical Laboratories Laboratory Waived Testing Program The Outreach Services Section of the Clinical Laboratory is always looking for better ways to help our clients. We are always willing to answer any questions or help with any problems regarding waived testing here at LUMC.

6. Loyola Medical Laboratories Laboratory Waived Testing Program The Outreach Services Section of the Clinical Laboratory does the following to ensure quality patient testing and regulatory compliance here at LUHS: • Coordinates the Point-of-Care Testing Committee. This committee has the responsibility of regulating all Point-of-Care laboratory testing here at LUHS and it’s outpatient and satellite facilities. Any area which would like to perform new testing must submit an application to this committee for review.

7. Loyola Medical Laboratories Laboratory Waived Testing Program • Created and supports a Procedure Manual for Laboratory Waived Testing which is provided to all areas performing waived testing. • Reviews new test methodologies and instruments for use at LUHS. Performs all necessary testing required by law prior to the implementation of any new test to ensure accuracy.

8. Loyola Medical Laboratories Laboratory Waived Testing Program • Provides instruction and technical assistance for performing waived tests here at LUHS through classes, training checklists and slide presentations. • Provides information and assistance with federal laboratory laws and JCAHO compliance.

9. Where to get Technical Help The Laboratory Procedure Manual - Waived Tests For any information about waived testing procedures performed in your area, you should consult the “Laboratory Procedure Manual - Waived Tests”. This is a large, royal blue binder given to all sites who perform waived testing under the laboratory’s license.

10. Where to get Technical Help The Laboratory Procedure Manual for Waived Testing The Waived Testing Procedure manual contains: • Written procedures for each test • JCAHO regulations • Required quality assurance for all tests • Training checklists for all tests • Sample competency logs for maintaining annual competency • Helpful articles about CLIA and JCAHO regulations • Master quality control logs for all tests • Troubleshooting help • Supply and ordering information

11. Understanding Federal Laboratory Regulations While federal laboratory regulations may not be as exciting as a fireworks display, it is important to understand what is required of you to comply with federal laws and JCAHO standards. This slide presentation will try to give you an overview of what the federal laboratory laws require and why they are necessary.

12. Understanding Federal Laboratory Regulations All laboratory testing is governed by a federal law called CLIA. Clinical Laboratory Improvement Amendments of 1988 These laws are administered by HCFA (the Health Care Financing Agency) which is the federal agency that oversees Medicare regulations and funding. Any area that performs laboratory testing for clinical use must abide by federal CLIA laws or risk removal of Medicare funding to the facility.

13. Understanding Federal Laboratory Regulations CLIA was: - enacted in 1988 to standardize and enforce good laboratory practices - created to ensure that patient test results were reported accurately CLIA goals are accomplished by: - establishing basic standards of quality assurance - requiring personnel training and competency - requiring patient test result documentation and record retention - requiring the performance of quality control for all tests - requiring two year inspections for all areas performing testing

14. Understanding Federal Laboratory Regulations CLIA regulates all areas that perform testing for clinical use. Areas such as clinical laboratories, satellite facilities, nursing units, mobile health units, and even free testing in shopping malls are all covered under CLIA laws and all must abide by the established regulations. When establishing regulatory requirements for laboratory testing, HFCA recognized that all laboratory tests are not equal. Some are very simple to perform and some are more difficult and need special training. To accommodate this, HCFA had the CDC classify all tests that were on the market and all new tests into categories based on their complexity.

15. Categories of laboratory testing under CLIA • These complexity categories were determined using these criteria: • Risk of erroneous result on patient health • Degree of knowledge needed to perform the test • Training and experience required • Complexity of reagent and material preparation • Complexity and number of operational steps to perform the test • Calibration requirements • Troubleshooting and maintenance requirements • Degree of interpretation and judgment required to report results • Availability of proficiency testing materials

16. Purchasing a CLIA certificate (license) In addition to following CLIA regulations, any area that performs laboratory testing must purchase or be covered under a certificate (license) to perform testing. One certificate can be purchased to cover multiple areas at one address. Areas with different street addresses must purchase separate certificates. To purchase a certificate, an application must be completed and sent to the IDPH (Illinois Dept. of Public Health) who administers HCFA’s CLIA laws here in Illinois.

17. Purchasing a CLIA certificate (license) One of four types of certificates must be purchased to comply with CLIA regulations. An area performing testing must purchase a certificate that covers the highest complexity level of test that they perform. For example, if 10 waived tests are performed and one moderate complexity test, a moderate certificate must be purchased. Only the highest level of certificate must be purchased. For example, the moderate level certificate will cover moderate complexity tests and all waived tests. These certificates are offered by test complexity level and include the following:

18. Waived Testing Certificate This category contains tests that are simple and don’t require a high degree of educational background to perform. Waived tests include such instruments and/or tests as glucometers, urinalysis strips, some Strep A tests, pregnancy tests, hemoglobin testing, etc. This category is called “waived” because many regulations have been “waived” or deemed not necessary since the tests in this category are considered simple. Even though waived tests are simple to perform they still require basic quality assurance such as training, annual competency, quality control, etc.

19. Moderate Complexity Certificate This category contains tests that require more educational skills, more complicated steps or can cause a greater degree of harm to a patient if performed incorrectly. This complexity level has more stringent regulatory requirements than waived.

20. High Complexity Certificate This category contains tests that are generally performed only in large hospital or reference laboratories by degreed Clinical Lab Scientists or technicians. This level has the most stringent regulatory requirements.

21. PPM Certificate In addition to these complexity categories, there is an additional sub-category called PPM or Provider Performed Microscopy. This category is considered a part of the moderate complexity category but is accorded special considerations by CLIA. This category contains a small group of tests that are performed as part of a physical exam by physicians, dentists, nurse midwives, physician assistants or nurse practitioners.

22. PPM Certificate The tests under this category are not subject to a routine two year inspection but basic quality assurance such as training, quality control, competency, proficiency testing, etc. are still required. This license can only be purchased if testing is performed by the above personnel and only for a small group of tests. This certificate will also cover all waived tests since it is considered a sub-category of a moderate complexity certificate.

23. Tests included in the PPM category • Fern testing • Qualitative (not quantitative) sperm analysis • KOH preps • Pinworm exams • Urine sediment examinations • Nasal smears for granulocytes. • Direct wet mounts for presence of bacteria, fungi, parasites & • human cellular elements. • Fecal leukocyte exams • Post coital direct, qualitative exams of vaginal or cervical mucous Testing under this license is allowed ONLY if performed by the specified personnel. If staff nurses or technologists perform testing, a moderate complexity license must be purchased and two year inspections are required.

24. Understanding Federal Laboratory Regulations When CLIA was enacted, the federal government realized that they did not have the resources to perform an inspection every two years for all areas performing laboratory testing. To remedy this, they allowed organizations to be “deemed” by HCFA to inspect facilities and report the results back to the agency. Many organizations that were already performing inspections applied to HCFA for deemed status. In order to inspect under the CLIA ‘88 laws, each organization had to submit their inspection standards for review. By proving that their standards were equal to or more stringent than the current CLIA ‘88 regulations, each organization was then allowed to conduct inspections under the CLIA laws.

25. Understanding Federal Laboratory Regulations When a CLIA license is purchased, the facility is allowed to choose which organization will perform their two year lab inspection. Two large organizations that were granted deemed status are: - JCAHO (Joint Commission on Accreditation of Healthcare Organizations) and - CAP (College of American Pathologists) Both of these organizations have been conducting inspections of hospitals and laboratories for many years and have established their own regulations and requirements.

26. Understanding Federal Laboratory Regulations At the Loyola Medical Center, the laboratory holds all CLIA licenses for waived testing and is responsible for establishing programs that facilitate compliance with CLIA laws. Loyola Medical Labs holds a Waived Testing certificate for the hospital and outpatient facilities and has selected JCAHO to perform our inspection of waived tests. Our Moderate and High Complexity Testing is inspected by CAP (College of American Pathologists) in all areas.

27. Understanding Federal Laboratory Regulations When a facility chooses an organization that will perform their laboratory inspections, they must abide by the standards or regulations that are established by that organization. For example, LUHS has chosen JCAHO to inspect our waived testing program. Therefore, we must abide by all standards that JCAHO has established to regulate this category of testing.

28. Good Laboratory Practices Under CLIA, all categories of testing must meet basic good laboratory practices in regards to quality assurance and safety. In addition, if inspected by an outside agency (JCAHO, CAP), a lab or area must adhere to any additional standards established for each category by the inspecting agency. Some of these CLIA and JCAHO requirements involve: • Patient test management - a system must exist for reporting, • documenting, and retaining patient results for legal reasons. • Quality control. A written quality control program must exist and • be enforced and quality control records must be retained for 2 years.

29. Good Laboratory Practices • Quality assurance - must have a written QA program. • Procedures - must have written procedures for how to perform the tests and procedures must be reviewed annually. • Personnel requirements - must meet CLIA established educational requirements and must have an established training and competency program. Documentation of training must be maintained indefinitely. • Use of testing - the organization must define how tests are used (either as a screening/monitoring or diagnostic test).

30. Good Laboratory Practices • Proficiency testing. At this time this applies only to moderate and high complexity testing. Each area must enroll in a program in which “blind” samples are tested for accuracy. The results are reported to HCFA and maintaining licensure depends on successful performance. • Calibration and calibration verification of instruments - for • moderate and high complexity testing only.

31. General Quality Assurance Requirements for All Tests These are general QA standards that should be followed for all laboratory waived tests: • Quality control procedures should always be performed according to the written procedure. Quality controls MUST be performed BEFORE testing patient samples (only exception are occult blood cards where quality control is performed after the patient test). • Patient testing must never be performed using kits or reagents that have failed quality control procedures. • All waived tests should be performed correctly according to written instructions.

32. General Quality Assurance Requirements for All Tests • Staff performing testing must have documented training prior to reporting all patient results. • Refrigerators or freezers where supplies are kept should be monitored on a daily basis and a written record maintained for JCAHO (thermometers should be NIST traceable and be able to report the minimum and maximum temperatures reached since the last reading was taken). • Whenever a new box, bottle, or kit is opened, the date opened and the date it expires should be written on the box or bottle. Reminder: once a control is opened, the expiration date is NOT the date stamped on the bottle. Often, a 30 or 60 day expiration date applies after opening.

33. General Quality Assurance Requirements for All Tests • Test kits and controls should be stored according to manufacturer’s instructions. • NEVER use expired kits or controls to perform testing. Using expired kits can result in inaccurate patient test results being reported. If the expiration date was not written on the item, or a foil pack (example: pregnancy) was left opened and unused, use the old adage:WHEN IN DOUBT, THROW IT OUT! Otherwise, you may be wasting valuable time trying to make controls perform or worse, you may report an inaccurate patient result. • Always properly identify patients prior to collection of blood or other body fluids for testing.

34. General Quality Assurance Requirements for All Tests • Always label blood tubes, urine specimens, throat cultures, etc. Never assume you will label them later; this can lead to unnecessary recollections and/or results reported on the wrong patient! • When performing waived testing, always label any test device, cassette, Hemoccult card, etc. into which a patient specimen is introduced to test. If you leave an unlabeled test on the counter and someone else does too, you may not know which is which! • Always document results of laboratory waived tests in the patient’s medical record using established protocol for your area. This is required by federal law!

35. General Quality Assurance Requirements for All Tests • Always perform any maintenance such as cleaning that is required on instruments prior to performing patient testing and when required. A result is only as good as the instrument it is performed on! • Use any and all information that is available to you - the Laboratory Procedure Manual - Waived Tests and any informational charts, posters, etc. These are provided to help you.

36. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 1. It’s ok to use kits past their expiration date if it’s just a day or two. False - kits should not be used past their expiration date. 2. When a control is opened, it always expires on the date that is stamped on the bottle. False - often, when a bottle is opened the expiration date changes to 30 or 60 days past the opening date.

37. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 3. All tubes of blood, test devices, aliquot specimens, etc. should be labeled with the patient’s medical record number and/or name. True - not labeling tubes, specimens, or test devices can lead to patient recalls or worse, the wrong result reported on a patient. 4. You don’t need a certificate (license) to perform only waived tests. False - a waived testing certificate is required to perform waived testing.

38. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 5. Quality controls need only be tested when you think a patient’s test result is incorrect. False - quality controls (2 levels or positive and negative) must be performed at least once every 24 hours that patient testing is performed. 6. Training does not have to be documented - just performed. False - all training and competency must be documented for JCAHO.

39. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 7. Annual competency is required for all staff performing laboratory testing. True - competency is a tool to review correct procedures and to ensure that testing is being performed accurately. 8. Waived testing here at LUMC is inspected by JCAHO. True

40. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 9. Medical technologists and staff nurses are allowed to perform PPM tests under a PPM certificate. False - only special personnel such as physicians, dentists, nurse practitioners, physician assistants and nurse midwives are allowed to perform testing under a PPM certificate. If medical technologists or staff nurses perform PPM tests, the area must purchase a moderately complex certificate.

41. Waived Testing and Regulations Review Questions True or False answers To see the answer, mouse click under the question. 9. Quality control should be performed and compared against acceptable ranges before performing patient tests. True - quality control MUST be performed and be acceptable before performing ANY patient tests! 10. Competency must be performed annually for all waived tests. True - JCAHO requires competency to be performed & documented.

42. This concludes this presentation on Waived Testing and Regulations Please refer any questions or problems to: Geri Augustine BS MT(ASCP) CLS(NCA) Technical Specialist - Near Patient Testing. Loyola Medical Laboratories Loyola University Medical Center (708) 216 -8044 or x68044 To end show, close the box with the X in the upper right hand corner.