To advance slide, click anywhere on blank area of screen.

1. Laboratory Waived Testing How to pass a JCAHO inspection This slide presentation is provided to you as an educational service by: Loyola Medical Laboratories - Near Patient Testing Section Loyola University Health System 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.

2. How to pass a JCAHO inspection for Laboratory Waived Testing If you have access to speakers, please turn them on; they will enhance the presentation. If not, the presentation will not be affected. To open presentation to full screen, click on the middle button in the upper most right corner of the screen. To advance slide, click anywhere on blank area of screen. To end show, close the box by clicking on the X in the upper right corner of the box.

3. How to pass a JCAHO inspection for Laboratory Waived Testing This presentation has been designed to provide information needed to pass a JCAHO inspection for laboratory waived testing that is performed in your area or unit. This information will be most helpful for those that are directly responsible for ensuring compliance with the federal regulations. This presentation will provide the following to help you understand and comply with CLIA and JCAHO standards: • Who is responsible for the overall program at LUHS • What federal regulations apply to laboratory waived testing To advance slide, click anywhere on blank area of screen.

4. How to pass a JCAHO inspection for Laboratory Waived Testing • What help is available from the laboratory • What is the laboratory waived testing program? • How can the Laboratory Waived Testing Procedure manual • help you? • What documentation do you need to have available for JCAHO? • Who can I call for additional help?

5. How to pass a JCAHO inspection for Laboratory Waived Testing Who oversees laboratory testing at LUHS? Here at LUHS, all clinical laboratory testing is the responsibility of the Department of Pathology - clinical laboratory. Specifically, the Near Patient section of the laboratory is responsible for all regulatory and technical issues relating to laboratory testing outside the main clinical laboratory. Laboratory testing that is performed by non-laboratory personnel in areas other than the clinical laboratory is generally referred to as near patient or point-of-care testing.

6. How to pass a JCAHO inspection for Laboratory Waived Testing Understanding Federal Laboratory Regulations To understand what constitutes laboratory waived testing and to comply with it’s required federal and JCAHO requirements, it is important to understand a little about federal laboratory law. All laboratory testing is governed by a federal law called CLIA. CLIA is an abbreviation for the Clinical Laboratory Improvement Amendments of 1988.

7. How to pass a JCAHO inspection for Laboratory Waived Testing CLIA laws are administered by CMS (the Centers for Medicare and Medicaid Services) which is the federal agency that oversees Medicare regulations and funding. CMS was formerly known as HCFA (the Health Care Financing Agency). Any area that performs laboratory testing for clinical use must abide by federal CLIA laws or risk removal of Medicare funding to the facility.

8. How to pass a JCAHO inspection for Laboratory Waived Testing 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. • The CLIA laws were: • enacted in 1988 to standardize and enforce good laboratory practices • created to ensure that patient test results were reported accurately

9. How to pass a JCAHO inspection for Laboratory Waived Testing • CLIA goals are accomplished by federal standards which: • establish basic standards of quality assurance • require personnel training and competency • require patient test result documentation and record retention • require the performance of quality control for all tests • require two year inspections for all areas performing testing

10. How to pass a JCAHO inspection for Laboratory Waived Testing When establishing regulatory requirements for laboratory testing, CMS recognized that all laboratory tests are not equal. Some are very simple to perform and some are more difficult and need special training and education. To accommodate this, the CMS had the CDC (FDA as of January 2001) classify all tests that were on the market and all new tests, into categories based on their complexity and possible harm to patients if performed incorrectly. • The basic categories of testing are: • Waived testing - simplest to perform with the least amount of • training required. Many of these tests are sold over the counter. • Moderate complexity - more difficult to perform; needs more • educational background and training. • High complexity - tests performed only by staff educated in • clinical laboratory science.

11. How to pass a JCAHO inspection for Laboratory Waived Testing Laboratory Waived Testing 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 glucose meters, 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. which we will discuss further in this presentation.

12. How to pass a JCAHO inspection for Laboratory Waived Testing • The two other things that CLIA made mandatory are: • all areas performing laboratory testing must purchase or be • covered by a CLIA certificate (license) of the correct complexity • level • and • the medical director listed on the certificate must choose an • accrediting agency that will perform the required inspections. • Whatever agency is chosen dictates what standards an area must • follow to comply with the CLIA regulations.

13. How to pass a JCAHO inspection for Laboratory Waived Testing At the Loyola Medical Center, the laboratory holds the CLIA license for waived testing and is responsible for establishing programs that facilitate compliance with CLIA laws. The clinical laboratory oversees waived testing at the hospital and outpatient facilities and has selected JCAHO to perform our inspection of waived tests.

14. How to pass a JCAHO inspection for Laboratory Waived Testing What help is available from the laboratory? In an effort to assist areas in compliance with federal regulations, the laboratory provides the following assistance: • standardizes and ensures quality testing by requiring approval for • all testing through the Point-of-Care testing committee. • evaluates tests and implements testing programs for tests that are • approved by the committee to ensure that only quality tests are used • here at LUHS. • has established a written waived testing program which is available • for all staff

15. How to pass a JCAHO inspection for Laboratory Waived Testing The laboratory coordinates a point-of-care committee that meets regularly to evaluate the clinical need for testing at LUHS. Once the clinical need is approved, the laboratory will check out the test to see if it is suitable for use and easy to use by staff. Once fully approved, the laboratory will write a procedure, set up a quality control program and provide ordering information for the test to all areas that will perform the test.

16. How to pass a JCAHO inspection for Laboratory Waived Testing What is the laboratory waived testing program? The laboratory waived testing program is a standardized program which provides written procedures and quality control requirement protocols, information on all waived testing supplies and federal regulatory requirements. It also provides help with training and competency for all tests approved for use at LUHS. Most of this information is contained in a procedure manual which is provided to all areas that are performing legal testing. Additional help can be found on the Dept. of Pathology’s web page.

17. How to pass a JCAHO inspection for Laboratory Waived Testing The Laboratory Procedure Manual - Waived Tests This manual is provided to all areas that are performing legal testing. Each manual is updated yearly in the spring with current regulations, new tests and updated supply information.

18. How can the Laboratory Waived Testing Procedure manual help you? The Waived Testing Procedure manual contains: • Written procedures for each test - these are procedures that are • written like cookbooks. You can perform the test by following the • written instructions.

19. How can the Laboratory Waived Testing Procedure manual help you? The Waived Testing Procedure manual contains: • JCAHO regulations - the current regulations that you are required • to follow to be in compliance. Each year the manual is updated with • a copy of the JCAHO standards for waived testing.

20. How can the Laboratory Waived Testing Procedure manual help you? The Waived Testing Procedure manual contains: • Training checklists for all tests - standardized checklists that can • be used to train staff to perform each test correctly. These also • contain a form that can be used to document training for personnel • files.

22. How can the Laboratory Waived Testing Procedure manual help you? The Waived Testing Procedure manual contains: • A quality assurance plan which contains required quality control • procedures for all tests - what quality control procedures are • necessary to ensure that you are accurately performing tests.

23. How can the Laboratory Waived Testing Procedure manual help you? The Waived Testing Procedure manual contains: • Two tables which can be mounted on a cabinet or counter. • These tables contain the quality control requirements, storage • requirements and expiration of all waived tests and supplies.

26. How to pass a JCAHO inspection for Laboratory Waived Testing The Waived Testing Procedure manual contains: • Master quality control logs for all tests - used to document quality • control procedures for JCAHO.

27. How to pass a JCAHO inspection for Laboratory Waived Testing The Waived Testing Procedure manual contains: • Helpful articles about CLIA and JCAHO regulations

28. How to pass a JCAHO inspection for Laboratory Waived Testing • Help sheets for managers regarding what is needed to comply • with the federal regulations.

29. How to pass a JCAHO inspection for Laboratory Waived Testing The Waived Testing Procedure manual contains: • Sample competency logs for maintaining annual competency

30. How to pass a JCAHO inspection for Laboratory Waived Testing The Waived Testing Procedure manual contains: • Troubleshooting help- each procedure contains troubleshooting • suggestions if problems occur with testing.

31. How to pass a JCAHO inspection for Laboratory Waived Testing The Waived Testing Procedure manual contains: • Supply and ordering information - this contains Lawson item • numbers for all supplies used in waived testing as well as helpful • information such as how many in a box, how long is the stability, • etc. that helps in ordering supplies.

32. How to pass a JCAHO inspection for Laboratory Waived Testing Additional help available: Web-based training sessions for waived tests can be found by accessing the department of Pathology’s web page and clicking on Education. This will take you to a list of available Powerpoint presentations that are available for individual tests.

33. How to pass a JCAHO inspection for Laboratory Waived Testing • Who can I call for additional help? Help is always available from the laboratory technical specialist or manager of Near Patient Testing. Just call the laboratory or consult the phone number information in the procedure manual.

34. How to cope with the regulations!

35. How to pass a JCAHO inspection for Laboratory Waived Testing • JCAHO regulations for laboratory waived testing are just basic laboratory good sense. For an accurate result, the test must be performed correctly using good supplies and an analyzer that is functioning correctly. So… the most important things to produce an accurate test result is: • a tester who has been trained to perform the test correctly • an analyzer that has been maintained correctly and • supplies that are not expired

36. How to pass a JCAHO inspection for Laboratory Waived Testing • How does JCAHO score compliance? Compliance with JCAHO regulations is mandatory. For waived tests, JCAHO has a separate standards checklist that surveyors will use to check compliance and when that compliance was achieved. If an area has demonstrated compliance for a substantial period of time (e.g. one year or longer), the area will be scored lower (1=substantial compliance while 5=non-compliance), than an area where compliance was recently achieved (e.g. one month).

37. What documentation will you need for JCAHO? To be in compliance with JCAHO and CLIA requirements, the unit or area performing laboratory waived testing must be able to produce the following records during JCAHO or IDPH inspections: • Current list of all staff members who perform laboratory • waived testing in your area. • Training records for all staff members who perform waived • testing. The records must list test(s) and date of training. • Yearly competency records for all staff members for each • waived test that they perform.

38. What documentation will you need for JCAHO? • Quality control logs (all tests except Hemoccult/Gastroccult) • for each laboratory waived test performed in your area. • All logs must be complete with all information including the date the controls were performed, control results, ranges where appropriate, lot numbers of the controls and reagents, and initials of tester. Any controls that were not in acceptable range should have been repeated and documented along with any corrective action performed. • Quality control logs must be retained for a minimum of two years and be available for inspections on site.

39. What documentation will you need for JCAHO? • Written procedures for all waived tests performed in the area. • The Laboratory Procedure Manual - Waived Tests provides • procedures for all approved tests. • Per JCAHO, procedure manuals must be located where the testing is being performed and where it is available to staff performing the testing. The manual should not be kept in a manager’s office where it is not accessible to staff. • All procedures must have documentation of a yearly review by the director of Near Patient Testing. These are sent out in a yearly update package every spring from the laboratory.

41. What documentation will you need for JCAHO? • Daily refrigerator and freezer temperature records where • laboratory supplies or samples are stored. Records must show • temperatures for each day that the facility is open. • In addition, JCAHO requires you to explain how you would ensure that supplies kept in a refrigerator or freezer have not been compromised. An example of this would be a power failure which is restored before the facility reopens after a weekend. (You can use a minimum/maximum thermometer that shows the lowest and highest temperature that has registered since the thermometer was last read). Alternatively, you can use the “penny” test. If you want information on this, please call the technical specialist of Near Patient Testing.

42. In addition to documentation, what else will JCAHO require? JCAHO also requires that all reagents used in waived testing (controls, kits, etc.) are labeled with a received date, the date the item was opened and an expiration date written on the item after opening if different than the stamped date. Be aware that expiration dates on many of the controls, kits, etc. apply only if UNOPENED. When opened, a shorter expiration date applies. See the your quality assurance policy in the Laboratory Waived Testing Manual for information (tables of information).

43. In addition to documentation, what else will JCAHO require? JCAHO will require you to tell them how the results of patient testing are documented in the medical record or on a separate log. If kept on a separate log, the results must be retained for a minimum of two years. Testing results must have the tester’s initials and any quality control results for tests where no logs are used (Hemoccult or Gastroccult). Outpatient areas may use the Laboratory Waived Testing Outpatient Result Form approved by Medical Records. Built-in control results must be documented along with the patient results and tester’s initials on the form to be complete.

44. In addition to documentation, what else will JCAHO require? The Laboratory Waived Testing Outpatient Result form approved by Medical Records:

45. In addition to documentation, what else will JCAHO require? The unit or area must also demonstrate that safety directives are being followed. For example, no food or beverages should be stored with laboratory controls, reagents, or patient samples. Refrigerators that contain controls made from human blood or urine or where patient samples are stored should have an orange BIOHAZARD sticker on the front. If refrigerator space is limited and controls must be stored with pharmaceuticals, controls should be put into a tupperware container with a lid. A biohazard sticker should be affixed to the top of the container.

46. In addition to documentation, what else will JCAHO require? In addition, all staff should be able to answer inspector questions such as: - the location of the waived testing manual - quality control requirements of all testing that they perform - how they document patients in the medical records Managers should be able to tell inspectors: - who is charge of the program - who holds the CLIA license for testing

47. How to pass a JCAHO inspection for Laboratory Waived Testing If you can produce the records described in this presentation and ensure that reagents are dated and patient results are documented, you should have no problem passing a JCAHO inspection for laboratory waived testing. However, always remember that the laboratory is your technical consultant during an inspection. If an inspector has a question that you don’t understand or relates to the overall program, please refer these questions to the Near Patient Testing section of the clinical laboratory. We will be glad to explain the program to an inspector or clarify any issues relating to waived testing here at LUHS.

48. How to pass a JCAHO inspection for Laboratory Waived Testing 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.