LD1 Introduction to Laboratory Medicine and Regulations Verlin Janzen, MD, FAAFP Family Physician & Laboratory Director Hutchinson Clinic, Hutchinson, KS Clinical Assistant Professor, University of Kansas School of Medicine, Wichita, KS DESCRIPTION: This opening session for the lab director qualification track is designed for physicians, and will provide the novice laboratory director with an orientation to the medical laboratory. This is your starting point as you seek to qualify as a laboratory director of a moderate complexity lab. Dr. Janzen will discuss the language of the laboratory, acronyms, and terms used in office laboratories today. In addition, he will give an overview of the CLIA law and regulations that will allow the attendee to assimilate the subsequent session material into a coherent body of knowledge. OBJECTIVES: At the end of the session, participants will be able to: Demonstrate a general understanding of what the CLIA regulations entail, and how they affect the POL Differentiate between CLIA and COLA Understand some common laboratory lingo Plan for the upcoming courses in the lab director education qualification track, and summarize the importance of each topic in becoming a competent laboratory director CRI and COLA do not endorse, directly or indirectly, the presentations given at this conference or the products or services provided by the exhibiting vendors. Presentations are intended to be free of bias. The use of any particular product is for demonstration purposes only, and does not imply an endorsement of the product by the presenter or the sponsors of the symposium. 2015 CRI
Verlin K Janzen, MD, FAAFP Family Physician & Laboratory Director Hutchinson Clinic, PA Hutchinson, KS History CLIA, COLA CLIA update Regulatory Process overview Test complexity model Overview of CLIA regulation high level 8 Steps to Regulatory Compliance Laboratory Lingo common terms
C linical L aboratory I mprovement A ct/amendments 1967 - CLIA 67 - regulated Medicare, Medicaid, & interstate commerce testing 1987 Wall Street Journal reports by Walt Bogdanich Deadly Mistakes reported by Lea Thompson on WRC-TV in Washington, D.C. 1988 - CLIA 88 signed by President Reagan 1990 - Proposed Rules & Regulations issued 1992 - Final Rules & Regulations published 1993 Went into effect 1994 PT regulations went into effect 2003 Revised Final Rule published
Laboratory means 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. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories. Laboratories testing for forensic purposes only Sites that test for research only and results not used for diagnosis, treatment or prognosis Laboratories in New York State and Washington These states enforce their own laboratory regulations Some states have requirements beyond CLIA
Law Regulations Interpretive Guidelines Law Passed by Congress Signed by President Regulations developed by Department (HHS) Approved by Secretary of Dept Interpretive Guidelines developed by Dept
Federal Register Proposed Comment Period Final Code of Federal Regulations (CFR) Interpretive Guidelines A General Provisions B Certificate of Waiver C Registration, PPM, CMS certificates D Accreditation Certificate F Fees H Proficiency Testing J Facility Requirements K Quality Systems M Personnel Q Inspection R - Enforcement Code of Federal Regulations 121 pages
291 page.pdf file http://www.cms.hhs.gov/clia/03_interpretive_guidelines_for_laboratories.asp CLIA Regulations Fed Reg, CFR Test Complexities CLIA Forms Survey Procedures Interpretive Guidelines State CLIA offices Links to CMS, FDA
Advises and recommends on technical and scientific aspects of CLIA Composed of laboratory scientists, physicians, laboratory industry representatives, consumer advocate Meets twice each year with representatives of CDC, FDA and CMS
Some states require laboratory to be licensed In some states this may be limited to reference and hospital laboratories Some states require laboratory personnel licensure Contact state CLIA office to determine requirements States may have communicable disease and hazardous waste requirements Laboratory is responsible for adherence Waived Moderate Complexity High Complexity
Waived simple tests, no harm if done incorrectly Moderate Complexity most tests PPM (Provider-performed microscopy) KOH/wet mount, microscopic UA (not gram stain) High Complexity a few more complex tests Microbiology Your lab requires a certificate from CMS to operate which certificate is determined by the most complex test you do. Each test is regulated by it s test complexity Personnel QC - etc
Certificate of Waiver -issued to labs performing only waived tests Certificate for PPMP-issued to labs where a physician, midlevel, or dentist performs only PPM procedures or waived tests Certificate of Registration - issued to a laboratory that enables the entity to conduct moderate or high complexity laboratory testing or both until the entity is determined by survey to be in compliance with the CLIA regulations Certificate of Compliance - is issued to a laboratory after an inspection that finds the laboratory to be in compliance with all applicable CLIA requirements Certificate of Accreditation - This is a certificate that is issued to a laboratory on the basis of the laboratory's accreditation by an accreditation organization approved by CMS 1. Dipstick Urinalysis 2. Fecal Occult Blood 3. Ovulation Tests - visual 4. Urine Pregnancy Tests - visual 5. Sed Rate, non-automated 6. Hemoglobin CuSO4 7. Hematocrit - spun 8. Blood Glucose w/ device approved for home use http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm
100 + Analytes now waived Comprehensive Metab Profile Lipids total chol, HDL, trigs FSH, TSH, LH, urine hcg BNP A1c, microalbumin, fructosamine Ketones blood & urine Hb/Hct, platelet aggregation Cannabinoids, cocaine, benzodiazepines, ethanol, methamphetamines, morphine, opiates, propoxyphene, PCP, tricyclics Lyme disease H pylori antibodies Mono, influenza a/b, Grp A strep, RSV, adenovirus (eye) Trichomonas Protime Adenovirus (conj fluid) Bacterial vaginosis Ferning in saliva (ovulation) Lithium Male fertility (motile sperm > 10M) Syphilis (Dec 14) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/analyteswaived.cfm PROVIDER PERFORMED MICROSCOPY 1. Moderate complexity test 2. Uses microscope 3. Personally performed by a provider (MD/PA/NP) 4. Labile specimen 5. QC not available 6. Limited specimen handling or processing required
1. Direct wet mount preps (presence/absence of bacteria, fungi, parasites, and human cellular elements) 2. KOH preps 3. Pinworm examinations 4. Fern tests 5. Post-coital exams (direct, qualitative examinations of vaginal or cervical mucous) 6. Urine sediment examinations 7. Nasal smears for granulocytes 8. Fecal leukocyte examinations 9. Qualitative semen analysis (limited to the presence or absence of sperm and detection of motility) http://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/ppmplist.pdf MODERATE HIGH Automated tests WBC diffs normal cells Microscopic UA Some automated dipstick UA Slide agglutination tests Most non-waived direct Ag tests (strep, etc) Urine colony count kits Strep culture presumptive ID Gram Stain (cervical, urethral) Cytology, histology, genetics Non-automated tests Radioimmunoassay WBC diffs abn cell ID Manual hematology / coag Bacteriology: isolation & ID Gram stains (most) Uncategorized tests Waived tests (if manuf instructions not followed) Searchable database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/search.cfm
MODERATE Normal Cells Automated tests WBC diffs normal cells Microscopic UA Some automated dipstick UA Slide agglutination tests Most non-waived direct Ag tests (strep, etc) Urine colony count kits Strep culture presump ID Gram Stain (cervical, urethral) Usual WBC segs, bands lymphs, monos, eos, basos Viral Lymphs Toxic gran / vacuoles RBC Morphology micro/ macro, aniso, hypo, target, oval-ocytes NOT: premature forms, unusual forms POLICY: define for your lab
Waived Facility Quality Systems Personnel Proficiency Testing Routine Inspections Register follow manuf instructions allow unannounced surveys notify of changes in ownership/director/menu PPM Moderate High Brief Overview
Space, ventilation, utilities Minimize contamination Sufficient instrument/supplies for type & volume of testing Compliance with Federal, State, and local laboratory requirements OSHA, Hazmat, etc Safety (physical, chemical, biological, electrical, biohazard) Record retention guidelines Transfusion Service requirements Quality Control (QC) Calibration, preventive maintenance, test verification standards Proficiency Testing (PT) evaluation and corrective action Quality assessment (QA) Test ordering, recording & reporting requirements Specimen submission, handling, referral Reagent storage Complaints, communication
Personnel Category Lab Director Technical Consultant Technical Supervisor General Supervisor Test Complexity PPM Moderate High MD, DO, DPM, NP, PA -- MD/DO w/20hrs, PhD, MS, BS MD, DO, PhD, MS, BS -- -- Pathologist, experience, grandfathered -- Pathologist, MD, DO, PhD, MS, BS MD, DO, PhD, MS, BS Clinical Consultant MD, DO, PhD MD, DO, PhD Testing Personnel MD, DO, DPM, NP, PA Minimum req- HS Grad Minimum Req - AD w/science degree ONLY moderate & high complexity labs Every two years Announced depends Unannounced: CMS, Joint Commission, CAP Announced: COLA (2 wk), JC (5 d - very small labs) Can include observe testing, reporting, specimen collection interview employees access to all laboratory facilities access to all laboratory records/documents copy records for HHS inspectors test on-site PT samples
COMPLAINT FOLLOWUP of previous problems to determine COMPLIANCE with certificate requirements VALIDATION of accrediting agency inspections random unannounced additional $$$ for re-inspections or complaint inspections Waived Facility Quality Systems Personnel Proficiency Testing Routine Inspections Register follow manuf instructions allow unannounced surveys notify of changes in ownership/director/menu PPM Moderate High
1. Certificate Fee paid by all labs to CMS Lab Type # Spec Vol Fee Lab Type # Spec Vol Fee Waived NA Sched E NA 25-50K $650 PPM NA Sched F NA 50-75K $1,100 Low Vol A NA < 2000 $150 Sched G NA 75-100K $1,550 Sched A 3 2-10K $150 Sched H NA 100-500K $2,040 Sched B 4 2-10K $150 Sched I NA 0.5-1 M $6,220 Sched C 3 10-25K $430 Sched J NA > 1M $7,940 Sched D 4 10-25K $440 2. Compliance Fee paid to inspecting entity (State, COLA, CAP, JCAHO, AOA, etc) Kinder & Gentler CLIA Educational Focus Problems if intentional violations cheating on PT willful disregard of regulations immediate jeopardy PT failures (1 st time you fail 2/3) usually 2 nd chance
Principal Sanctions suspension, limitation, or revocation of certificate Intermediate/Alternative Sanctions directed plan of corrections COLA: Plan of Required Improvement (PRI) civil monetary penalties payment for costs on continuous or intermittent on-site monitoring and follow-up inspections suspension of Medicare/Medicaid payments Criminal Sanctions incarceration/fines for intentional violation of CLIA Alternative to CMS CMS labs - surveyed/inspected by State Private, non-profit COLA, Joint Commission, College of American Pathologists (CAP), AOA Requirements must be =/> CMS Validation surveys by CMS/state - 5% sample Fees Certificate fee - paid by all labs to CMS Compliance fee - by inspecting agency
Private, non-profit entity Physician directed: AAFP, ACP, AMA Educational, self-assessment driven Accredits Physician office labs, community hospital labs, mobile labs, VA & DOD facilities Mission COLA is a physician-directed organization whose purpose is to promote excellence in laboratory medicine and patient care through a program of voluntary education, consultation, and accreditation COLA CLIA
Cost Easier to understand criteria Phone assistance? POL friendly (does NOT mean easier) Educational approach Self-assessment
POL 49% Non- POL 51% NY-Wash Accred 1% 5% PPM 23% POL CMS 10% NY-Wash 5% Accred 8% PPM 6% Non-POL CMS 5% Waived 61% Waived 76%
See pages in notebook Lucia Berte Lab Medicine Quality Qorner Lingo Lessons Acronyms/Abbreviations pg Glossary of terms page Also on CD-ROM
Certificate of Waiver Piece of paper from CMS that allows you to operate a waived laboratory Centers for Medicare & Medicaid Services (CMS) Oversee program Centers for Disease Control and Prevention (CDC) Scientific expertise, CLIAC cmte Food & Drug Administration (FDA) Categorize tests
Quality Control (QC) Process of testing a specimen with an known value like a patient in order to assure methodology is working correctly before testing/reporting patient specimens Quality Assurance (QA) Process of evaluating lab operations retrospectively if problem found, correcting it then reassess. Process to improve operations. Standard Operating Procedure One method of writing laboratory procedures for use by laboratorians
Proficiency Testing (PT) A means of verifying accuracy of laboratory tests using an external testing company sometimes called external quality control. How it works You select PT provider & analytes Unknown samples are sent from a PT provider three times a year for analysis by the POL using the same methodology as patient samples. Results are then graded by the PT company Reports are sent to the lab and CMS/accreditor BS Degree Medical Technologist - MT(ASCP) Clinical Laboratory Scientist CLS(NCA) Medical Laboratory Scientist MLS(ASCP) (1) Associate Degree Medical Laboratory Technician MLT(ASCP) Clinical Laboratory Technician CLT(NCA) Medical Laboratory Technician MLT(ASCP) (1) Other Non-laboratorians Medical Assistant (MA), Certified Medical Assistant (CMA), RN/LPN, HS grads (1) Oct 2009 ASCP BOR & NCA merging to ASCP Board of Certification (8/09 G2 Reports)
Overview COW can only perform waived tests PPMP can perform waived and PPM tests Moderate complexity High complexity testing has more stringent personnel (testing and laboratory director) requirements than moderate complexity testing
MODERATE COMPLEXITY Laboratory Director Clinical Consultant Technical Consultant Testing Personnel HIGH COMPLEXITY Laboratory Director Clinical Consultant Technical Supervisor General Supervisor Testing Personnel **Qualified individual may hold more than one position Enroll every year for REGULATED analytes Perform split sample testing or enroll in PT for UNregulated analytes Evaluate performance, take corrective action, and follow up with quality assessment
Policies, processes and procedures covering all phases of the testing process General laboratory Pre-analytic systems Analytic systems Post-analytic systems Personnel trained in all policies, processes and procedures Including training on laboratory safety and blood borne pathogens Competency for all personnel on procedures they perform Document - maintenance of personnel records of education, training, competency
Accuracy Precision Reportable range Reference range For large instrumentation seek assistance of instrument vendor to accomplish Follow manufacturer s instructions for QC At a minimum two levels of control each day of testing Perform calibration and calibration verification of the reportable range as directed by the manufacturer
INCORPORATE QUALITY ASSESSMENT ACTIVITIES THROUGHOUT THE TESTING PROCESS QA essential for all pre-analytic, analytic and post-analytic processes Demonstrate corrective action as needed Follow up on the effectiveness of corrective action
Description % POL cited Proper storage of reagents & specimens 6.1% Twice annual QA check for analytes without PT 5.3% Analytic systems QA 2.8% Procedure manual contents 4.4% Test reports patient ID 4.3% Lab Director qualifications / job performance 4.0% Test systems lab determined performance specs 3.0% Employee competency P&P, performance 3.1% QA program 3.6% Calibration verification 2.9% https://www.cms.gov/regulations-and- Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf Description Competency assessments employees & consultants Lack of QC on waived tests when manuf requires Lack of PT review by LD & staff Calibration verification Lab Director QC & QA duties Transitional Citation EQC tests that will need IQCP Personnel records documentation of qualifications Calibration failure to perform/document QC materials failure to verify manuf ranges Lab Director PT duties % POL cited https://