Medical Office Laboratory Practices: Strategies to Ensure Compliance with State and Federal Regulations

Transcription

1 Medical Office Laboratory Practices: Strategies to Ensure Compliance with State and Federal Regulations Martha M Smith Service Director, Policy Planning and Regulatory Compliance Service Director, Clinical Laboratory Improvement Services, Public Health and Environmental Laboratories, NJ Department of Health 1

2 Objectives Upon completion of this activity, participants should be better able to: Determine the need for NJ laboratory licensure and/or CLIA certification for office practices based on the testing being offered; Describe and implement office laboratory procedures that conform to regulatory requirements so to improve the quality of laboratory services offered; Assess office laboratory staff s knowledge and skills in implementing Good Laboratory Practices; Formulate appropriate educational interventions for laboratory staff in order to enhance quality and patient safety, and reduce testing errors. 2

3 What is CLIA and why is certification required? Clinical Laboratory Improvement Amendments of CFR Part 430 to end Required for all laboratories performing testing on human specimens Required for laboratories seeking payment under the Medicare and Medicaid programs 3

4 4 Clinical Laboratory: a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body.

5 Any facility performing testing of bodily specimens for the purposes previously described must have a valid CLIA certificate appropriate to the testing performed. Certificate of Waiver Provider Performed Microscopy Registration Compliance Accreditation 5

6 CLIA categorizes laboratory tests as either waived or non-waived. The non-waived tests may be further categorized as moderate complexity, including Provider Performed Microscopy or high complexity. Notices are published in the Federal Register and every test, system, assay, and examination are categorized by complexity. The complexity level of the testing being performed dictates all personnel qualifications. 6

7 7 Is it Waived, Moderate, or High Complexity? 1. Manual white blood cell differential 2. Trichomonas 3. Glucose - J&J One Touch 4. Automated CBC and differential 5. Hepatitis B surface antigen 6. Real Time PCR for Influenza A & B 7. Cholesterol arch.cfm

8 In addition to a CLIA certificate, a facility performing testing shall have a New Jersey Clinical Laboratory license except if testing is limited to the following tests which were designated as CLIA waived in 1992: Dipstick or Tablet Reagent Urinalysis Fecal Occult Blood Ovulation Visual color comparison Urine pregnancy- Visual color comparison Erythrocyte sedimentation rate non-automated Hemoglobin copper sulfate non-automated Blood glucose using FDA cleared home use device Spun microhematocrit 8

9 N.J.S.A. 45: New Jersey Clinical Laboratory Improvement Act, eff. 8/1/75 N.J.A.C. 8:44 Operation of Clinical Laboratories, eff. 9/18/78 NJ Board of Medical Examiners 13: Statute: Article 3A: Bio-Analytical Laboratories (1953) 45:

10 Note that New Jersey s rules for clinical laboratories at N.J.A.C. 8:44 do not recognize tests that have been designated as CLIA waived subsequent to These include drugs of abuse, HIV, rapid group A strep, rapid influenza A & B, tear chemical tests, and others. 10

11 So why two? Both intend to protect the public health. Most state licensure programs were in effect prior to the multiple, large changes of CLIA 88. CLIA 67 basically dealt with interstate laboratory testing the location of the laboratory was more important than the functions of the laboratory. 11

12 Of the 50 states and the District of Columbia: 15 have state regulations for laboratory licensing 6 have state regulations for state certification 22 use the federal CLIA regulations for governing clinical laboratories 8 no data (AK,DE,MI,NE,OK,SC,UT,WY) 12

13 New Jersey s rules for the operation of clinical laboratories are more stringent than Federal CLIA regulations particularly for laboratories performing only CLIA waived tests that are not waived under New Jersey s rules. 13

14 One of the biggest differences between the two regulatory bodies is that CLIA recognizes four different levels of testing method classification. Waived Provider Performed Microscopy Moderate Complexity High Complexity 14

15 New Jersey has two levels. the original eight waived tests everything else 15

16 NJ requires laboratory directors to hold a NJ Board of Medical Examiners Bioanalytical Laboratory Director License, with one exemption. CLIA requires this only if the individual state requires it. 16

17 NJ BME 45: Exemption Physicians or members of other professions who, in their private practices perform bio-analytical laboratory tests in their own offices or laboratories for their own patients pursuant to licenses respectively granted to them according to law. 17

18 The CLIS Clinical Laboratory Licensing Unit recognizes this exemption. Changes in what constitutes a physician practice in the past five to ten years has made this much more difficult to interpret. The NJ regulations need a much better definition of physician office laboratory. 18

19 Personnel Records Both CLIA Non-Waived and NJ Non-Waived require personnel training records which include diplomas, degrees, certificates, training and experience, and continuing education and an assessment of these qualifications with meeting the federal or state testing personnel standards 19 CLIA requires annual competency assessments, semiannually during the 1 st year of employment.

20 What is Quality Control? A generic term that refers to the monitoring and assessment of laboratory testing processes to identify problems and maintain accurate and reproducible results. Why is it performed? checks the instrument checks the reagents checks the operator 20

21 NJ requires 2 levels of control every day of patient testing CLIA requires the same for non-waived testing and will offer what is called the Individualized Quality Control Program beginning 1/1/16 This IQCP is NOT recognized in NJ at this time 21

22 Quality Control Internal vs External Internal Controls or built-in controls are common to waived testing devices/methods. 22 Good internal QC results tell you that the test is working as it should that enough sample was added that it is moving through the device or test strip and that the electronic aspects of the device are working correctly

23 Quality Control Internal vs External External controls may come with a test kit or may need to be ordered separately. Good External QC results tell you that the entire process was performed correctly and provides confidence that the result is a quality result. 23

24 QC Performance Per state and federal non-waived testing regs QC should be run every day that patients are tested by the same personnel who routinely perform patient testing. 24 CLIA Waived tests require at minimum that external controls be run: With each new test kit/reagent shipment received When there is a change in lot numbers With each new testing personnel

25 25 What do you do when QC results are not as expected? Don t report patient results Check that the procedure was followed Check for outdated reagents or test devices Check for proper reagent storage Check that the correct controls were used Follow any package insert troubleshooting steps Call the available hotline for technical assistance

26 Proficiency Testing Why is it performed? To verify the accuracy and reliability of the laboratory test. Who performs it? testing personnel. NJ requires PT for all licensed specialties and tests. CLIA requires PT for all regulated analytes (except those performed used a waived method/kit/or instrument) and recommends PT for waived tests. 26

27 Quality Assurance (QA) What is it and how is it different from Quality Control (QC)? QA is the planned and systematic activities implemented to produce quality results. QC is one of those activities. 27

28 Procedure Manual A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. The manufacturer's test system instructions or operator manuals may supplement but not replace the laboratory's written procedures for testing or examining specimens. 28

29 Record Keeping 29 Documentation is another part of quality assurance. Good laboratory practice is to document all steps of the testing process. This includes: Records of instruments and maintenance Reagent lot numbers and dates received, opened & expired Test kit/reagents manufacturer s instructions QC and proficiency records Patient testing Staff training and competency assessment records

30 Good record keeping makes it easy to retrieve records. Records should be reviewed periodically by the medical director or person overseeing testing to: Verify information Assess test performance Identify & resolve problems that could affect test results Maintain patient and personnel information 30

31 NJ requires the following records: Requisition Work records/instrument printouts Patients test report Most records must be kept for at least 2 years 31

32 Safety Policies and Procedures Blood Borne Pathogens Medical Waste Hepatitis B Vaccination 32

33 Training for Physician Office Laboratories CMS Ready? Set? Test! 33

34 From five NJ offered in-person trainings offered in 2013/14: NJ Licensed Physician Office Laboratories staff were found to be more knowledgeable about Good Laboratory Practices (GLP) 34

35 NJ has set the bar higher is it necessary to maintain? How do the state regulations keep a high quality standard and recognize the 21 st century technology? 35

36 Contact Us At: New Jersey Department of Health Clinical Laboratory Improvement Services Public Health and Environmental Laboratories PO Box 361 Trenton, NJ Phone: Fax: Website: 36