Thursday April 6, 2017 LD1 Introduction to Laboratory Medicine and CLIA Regulations Verlin Janzen, MD, FAAFP Family Physician & Laboratory Director Hutchinson Clinic, Hutchinson, 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. 2017 CRI
Verlin K Janzen, MD, FAAFP Family Physician & Laboratory Director Hutchinson Clinic, PA Hutchinson, KS 1 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 Glossary of terms, Acronyms & Abbreviations 3
C linical L aboratory I mprovement A ct/amendments 8 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 9
Laboratory means a facility for the biological, microbiological, serological, chemical, immuno- hematological, 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. 10 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 11
Law Regulations Interpretive Guidelines 12 Law Passed by Congress Signed by President Regulations developed by Department (HHS) Approved by Secretary of Dept Interpretive Guidelines developed by Dept 13
Federal Register Proposed Comment Period Final Code of Federal Regulations (CFR) Interpretive Guidelines 14 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 15
291 page.pdf file http://www.cms.hhs.gov/clia/03_interpretive_guidelines_for_laboratories.asp 16 CLIA Regulations Fed Reg, CFR Test Complexities CLIA Forms Survey Procedures Interpretive Guidelines State CLIA offices Links to CMS, FDA 17
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 18 19
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 t may have communicable disease and hazardous waste requirements Laboratory is responsible for adherence 20 Waived Moderate Complexity High Complexity 21
Waived simple tests, no harm if done incorrectly Moderate Complexity most tests High Complexity a few more complex tests Microbiology 23 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 24
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 25 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 26
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 27 100 + Analytes now waived Comprehensive Metab Profile Lipids id total chol, HDL, trigs FSH, TSH, LH, urine hcg BNP A1c, microalbumin, fructosamine Ketones blood & urine Hb/Hct, platelet aggregation Cannabinoids, cocaine, benzodiazepines, ethanol, meth- amphetamines, 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 28
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 i specimen handling or processing required 29 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 30
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 32 37
Waived PPM Quality Proficiency Routine Facility Systems Personnel Testing Inspections Register follow manuf instructions allow unannounced surveys notify of changes in ownership/director/menu Moderate High 42 Waived Quality Proficiency Routine Facility Systems Personnel Testing Inspections Register follow manuf instructions allow unannounced surveys notify of changes in ownership/director/menu PPM Moderate High 43
Brief Overview 44 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 45
Quality Control (QC) Calibration, preventive maintenance, test verification standards d Proficiency Testing (PT) evaluation and corrective action Quality assessment (QA) Test ordering, recording & reporting requirements Specimen submission, handling, referral Reagent storage Complaints, communication 46 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 47
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 49 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 50
Waived Quality Proficiency Routine Facility Systems Personnel Testing Inspections Register follow manuf instructions allow unannounced surveys notify of changes in ownership/director/menu PPM Moderate High 51 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) 52
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 53 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 54
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 56 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 57
COLA CLIA 58 Cost Easier to understand d criteria i Phone assistance? POL friendly (does NOT mean easier) Educational approach Self-assessment 59
60 POL 49% Non- POL 51% NY-Wash 1% Accred 5% PPM 23% POL CMS 10% NY-Wash 5% Accred 8% PPM 6% Non-POL CMS 5% Waived 61% Waived 76% 61
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See pages in notebook Lucia Berte Lab Medicine Quality Qorner Lingo Lessons Acronyms/Abbreviations pg Glossary of terms page Also on CD-ROM 66 Certificate of Waiver Piece of paper from CMS that allows you to operate a waived laboratory 67
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 68 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. 69
Standard Operating Procedure One method of writing laboratory procedures for use by laboratorians 70 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 71
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) 72 Overview 73
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 74 MODERATE COMPLEXITY Laboratory ato Director Clinical Consultant t Technical Consultant Testing Personnel HIGH COMPLEXITY Laboratory Director Clinical Consultant Technical Supervisor General Supervisor Testing Personnel **Qualified individual may hold more than one position 75
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 76 Policies, processes and procedures covering all phases of the testing process General laboratory Pre-analytic systems Analytic systems Post-analytic systems 77
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 78 Accuracy Precision Reportable range Reference range For large instrumentation seek assistance of instrument vendor to accomplish 79
Follow manufacturer s instructions for QC At ta minimum two levels esof control to each day of testing Perform calibration and calibration verification of the reportable range as directed by the manufacturer 80 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 81
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 31% 3.1% QA program 3.6% Calibration verification 2.9% https://www.cms.gov/regulations-and- Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf 83 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:// 84
Quality Qorner Lingo Lesson DOI: 10.1309/LM4GJ48GATXOIBHI There are too many quality terms flying around out there. So many, in fact, that we are all prone to using them interchangeably, assuming they all mean the same thing. The cold fact is that quality terms have specific definitions and we need to learn the words and their respective meanings and how to use the words correctly when writing laboratory requirements, delivering educational programs, and publishing laboratory literature. I consider the International Organization for Standardization (ISO) as the mother of all quality management system documents. ISO is a worldwide federation of national standards bodies; our U.S. national standards body is the American National Standards Institute (ANSI). One very important document ISO 9000 1 provides the fundamentals and vocabulary for quality management systems and it s the glossary in this document I always turn to when I need the official definition of a quality term. Here are some quality terms that are often used interchangeably incorrectly by presenters and accreditors alike: quality plan, quality planning, and quality program. Let me explain why, using the quality glossary published by the international experts. A quality plan is a document specifying which processes, procedures, and associated resources will be applied by whom and when to a specific project, process, or product. 1 Examples include when blood samples are collected in plastic versus glass tubes (change in process); when your laboratory installs a new instrument for a specified set of laboratory tests (new project); and when your blood supplier decides to provide Red Blood Cells, Leukocyte Reduced for most, if not all, routine blood transfusions (new product). In each of the changes described above, a documented quality plan specifies how the implementation will unfold. In the instrument example, your laboratory would have a written quality plan for how the acquisition will occur; when specified activities in the installation, verification (or validation), and initial calibration will happen; and who is responsible for which activities. One very effective way to prepare a quality plan is to use the 12 Quality System Essentials (QSEs) as a checklist for considering all the activities that need to take place and all the documents that need preparation. In the instrument example, you would go through each of the 12 QSEs, asking questions such as: Do we have the necessary floor space and environmental conditions for this new instrument? (QSE: Facilities and Safety.) Who will be responsible for setting up the orders for purchasing reagents, controls, and calibrators? (QSE: Purchasing and Inventory.) What is the validation (or verification) plan for these new analytes? (QSE: Process Control.) What proficiency testing needs to be ordered and when? (QSE: Assessments.) Gantt and PERT charts are additional project management tools that provide a visual representation of a quality plan. Think of a quality plan as a roadmap for all the myriad activities that need coordination for ensuring the success of such events. With the quality plan as a specific document that describes a single new or changed laboratory activity, a given laboratory would have several documented quality plans across time one for each specific new or changed project, process, or product. Quality planning is not the same thing as a quality plan. Quality planning is a management activity that focuses on setting quality objectives and specifying necessary operational processes and related resources to fulfill the quality objectives. 1 At least once a year, your laboratory s management team should come together and set quality objectives for each clinical discipline for the coming year and discuss how the respective laboratory sections intend to achieve the proposed objectives. For example, your laboratory s sample receiving area sets a quality objective to reduce the number of data entry errors by 50% within six months and the automated testing areas set a quality objective of delivering at least 95% of routine morning test results before the published turnaround time. Each area needs to specify how these objectives will be accomplished; that is, what new or changed processes or procedures will be needed, what improvements to the workflow will be made, etc. It s likely that the outcome of the quality planning session will be that you ll need some documented quality plans! Neither a quality plan nor quality planning is the same as your laboratory s quality program. A documented quality program describes how quality activities are organized in your laboratory. For example, your laboratory might state that it has developed policies, processes, and procedures for managing each of the 12 QSEs and that these documents are contained in the laboratory s quality manual. It might also state that documented processes and procedures for the preanalytic, analytic, and postanalytic activities in the laboratory s path of workflow are located in section-specific manuals where the work is performed. All those quality words flying around like buzzing bees! Well, we ve captured a few here but there will probably be more lingo lessons, with the confusion between quality control, quality assurance, and quality management. Please don t think they are the same! 1. ISO. ANSI/ISO/ASQ Q9000 2005 Standard: Quality management systems Fundamentals and vocabulary. Milwaukee: American Society for Quality Press; 2005. This Month s Quality Quote: Zounds! I was never so bethumped with words. Shakespeare, King John Lucia M. Berte is President, Laboratories Made Better! PC. Send your comments and questions to lmberte@ LaboratoriesMadeBetter.com. Lucia M. Berte MA, MT(ASCP)SBB,DLM; CQA(ASQ)CMQ 2 LABMEDICINE Volume 40 Number 5 May 2009 labmedicine.com
Quality Qorner Lingo Lesson No. 2, or Oh No! Here She Comes Again! DOI: 10.1309/LMJJZD2E0S0MYPHA Maybe it s the blood banker in me; maybe it s the Virgo in me; maybe it s because I took some courses in college on the Greek and Latin origins of English words and medical terms. Or maybe it s because there are fully a dozen phrases that start with the word quality in the ISO 9000 Fundamentals and Vocabulary for quality management systems. 1 I can t help but be a fussbudget about using words in their correct context to achieve comprehendible communication especially about a topic as important as quality management in medical laboratories. Almost twenty-five years after the term quality assurance was first introduced into the hospital and medical laboratory environments, there are still pathologists and laboratorians who think that quality control (QC) and quality assurance (QA) are the same thing. It got even more complicated when the phrase quality system was introduced in the 1990s and quality management was introduced in 2000. Then enter quality management system. All these phrases are continually used interchangeably, albeit incorrectly. No wonder everyone s confused and I feel like Bob Seeger in his classic song, Runnin Against the Wind. Sorry to say, we need another lingo lesson. Think of quality control as the innermost circle of a target. The target for each and every laboratory test is accurate results. Quality control ensures we can say with a high degree of confidence that the results are accurate for the batch of samples being tested at that time. QC is method control; we test samples with known expected results and when we get those results we can say that all the patients unknown results obtained within the specified time period (batch or shift) are likely to be accurate. However, QC does not say that those accurate results necessarily belong to the patient whose name is on the sample! All the QC you ve ever done or ever will do will never prevent a patient misidentification or a sample switch. In the laboratory s path of workflow of preanalytic, analytic, and post-analytic activities, QC hits only the center the analytic methods. Think of quality assurance as the next outer ring of the target. When introduced into the health care lexicon by the JCAHO in the 1980s, quality assurance was meant to answer the question, In these new times of diagnosis related groups (DRGs) and cost containment, how do we know we are delivering quality care to patients? This is a very different question for the medical laboratory than whether our contribution to patient care is accurate laboratory test results. It s in QA that we start to ask questions about how the laboratory contributes to a patient s care. How many times did a phlebotomist attempt to collect a blood sample from an inpatient only to find that the patient was not wearing proper identification? How many samples are not acceptable upon receipt into the laboratory? How well does the collection time of the sample reflect the administration time of a therapeutic drug? How timely are laboratory results compared with physician and patient needs? How many times did the laboratory have to notify about corrections to released results found to be erroneous? How do the laboratory s results compare with those of other laboratories for the same analytic method or instrumentation? How well do final interpretations correspond to frozen section diagnoses? How well do interpretations from fine needle aspiration biopsies correlate with interpretations from the tissue biopsy? Notice that these questions and many more that could and should be asked measure the effects of activities in the laboratory s entire preanalytic, analytic, and post-analytic path of workflow well beyond method control. Therefore, QA is bigger than QC and covers all the preanalytic, analytic, and post-analytic processes. What about all the other aspects of managing a medical laboratory? What about meeting design and safety requirements for your laboratory s physical facilities? What about staff training and competence assessment? What about equipment management? What about procuring, storing, and managing reagents and supplies? What about creating, approving, revising, and controlling the laboratory s documents and records? This is the next larger ring of the target, a quality management system (QMS) which encompasses all the management activities needed to support the laboratory s preanalytic, analytic, and post-analytic activities. A model for a generic quality management system that meets all the requirements of U.S. laboratory regulatory and accreditation organizations has been published by the Clinical and Laboratory Standards Institute (CLSI) in a guideline that describes how to use 12 Quality Systems Essentials (QSEs) as a means to organize all the policies, processes, and procedures that any laboratory needs to meet those requirements. 2 A QMS includes both QC (in QSE Process Control) and QA (in QSE Assessments), as well as the laboratory activities described above and more necessary to make your laboratory s best contribution to patient care. I sincerely hope I ve finally managed to convince you that QC, QA, and QMS are not the same. And I also hope you ll keep these distinctions in mind when you talk with fellow laboratorians, write papers, and give presentations on the subject of quality in the medical laboratory. My hope applies equally to those who write regulations and accreditation standards so that we can all be on the same page for the same word. Consider this your lingo lesson for this back-to-school month. 1. ISO. ANSI/ISO/ASQ Q9000-2005 Standard: Quality Management Systems Fundamentals and Vocabulary. Milwaukee, WI: American Society for Quality Press; 2005. 2. NCCLS/CLSI. A Quality Management System Model for Health Care; Approved Guideline, Second Edition. Wayne, PA: CLSI; 2004. This Month s Quality Quote: The words I use are everyday words and yet are not the same! Paul Claudel, poet Lucia M. Berte is President, Laboratories Made Better! PC. Send your comments and questions to lmberte@ LaboratoriesMadeBetter.com. Lucia M. Berte MA, MT(ASCP)SBB,DLM; CQA(ASQ)CMQ 2 LABMEDICINE Volume 40 Number 8 August 2009 labmedicine.com
Acronyms & Abbreviations for the Clinical Laboratory 501(k) Manufacturer procedure application to FDA (application for a product similar to an existing device or test) AAB American Association of Bioanalysts AABB American Association of Blood Banks AACC American Association of Clinical Chemistry API American Proficiency Institute ASCLS American Society of Clinical Laboratory Scientists ASCP American Society of Clinical Pathologists ASCT American Society for Cytotechnology ASH American Society of Hematology ASHI American Society for Histocompatibility & Immunogenetics ASMT American Society of Medical Technologists ASPT American Society of Phlebotomy Technicians ASQ American Society for Quality ASRT American Society of Radiological Technologists BBP Bloodborne Pathogen CAP College of American Pathologists CME Continuing Medical Education CDC Centers for Disease Control and Prevention CDE Certified Diabetes Educator CEU Continuing Education Unit CFR Code of Federal Regulations CLC Certified Laboratory Consultant CLIA 67 Clinical Laboratory Improvement Act of 1967 CLIA 88 Clinical Laboratory Improvement Amendments of 1988 CLIA Clinical Laboratory Improvement Amendments CLIAC Clinical Laboratory Improvement Advisory Committee CLMA Clinical Laboratory Management Association CLS (NCA) Clinical Laboratory Scientist (National Certification Agency for Medical Laboratory Personnel) CLSI Clinical and Laboratory Standards Institute (formerly NCCLS) CMA Certified Medical Assistant CMS Centers for Medicare and Medicaid Services COLA Formerly known as Commission on Office Laboratory Accreditation COLT Certified Office Laboratory Technician COW Certificate of Waiver CW Certificate of Waiver (formerly COW) DHS Department of Health and Human Services EHR Electronic Health Record ELISA Enzyme-linked Immuno Sorbent Assay EMR Electronic Medical Record EXCEL External Comparative Evaluation for Laboratories (PT program from CAP)
FAAFP FACP FDA HHS LIS LMRP MLE MLS MLT MSDS MT MT(ASCP) NAACLS NCA NCQA NIOSH NIST NSH OSHA NP PA PM POL PPE PPM PT PTM QA QC QMS QS QSE RIA SBB SD SH SOP TA TJC UA Fellow, American Academy of Family Physicians Fellow, American College of Physicians Food and Drug Administration Department of Health and Human Services Laboratory Information System Local Medical Review Policy Medical Laboratory Evaluation (PT program from ACP) Medical Laboratory Scientist Medical Laboratory Technician Material Safety Data Sheet Medical Technologist Medical Technologist (American Society of Clinical Pathologists) National Accrediting Agency for Clinical Laboratory Sciences National Credentialing Agency National Committee for Quality Assurance National Institute on Occupational Safety and Health National Institute for Standards and Technologies National Society for Histotechnology Occupational Safety and Health Administration Nurse Practitioner Physician Assistant Preventive Maintenance Physician s Office Laboratory Personal Protective Equipment Provider-Performed Microscopy Proficiency Testing, Prothrombin Time, or Physical Therapy Patient Test Management Quality Assessment or Quality Assurance Quality Control Quality Management Systems Quality Systems Quality System Essential Radioimmunoassay Specialist, Blood Bank Standard Deviation Specialist, Hematology Standard Operating Procedures Technical Advisor (COLA) The Joint Commission, formerly called the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Urinalysis
Glossary for the Clinical Laboratory Acceptable limits Accreditation organization Accuracy All-method mean Analyte Analytic, Analytical ASAF ASCP CM Batch testing Bias Calibration Calibration verification CDC The expected range of results (above and below the target mean value) for the material. Obtaining results within the acceptable limits gives confidence that the test system is accurately measuring the analyte. A private entity deemed by CMS to have laboratory standards and requirements that meet or exceed the CLIA regulations. COLA, The Joint Commission (JCAHO), and the College of American Pathologists (CAP) are examples of clinical laboratory accrediting agencies. How close a test result is to the true value. When proficiency testing programs calculate the mean for all the different methods combined, this is called the all method mean. It is usually a good approximation of the real value of the sample. The chemical substance being measured. Example: glucose. Processes that occur during the testing phase in the path of workflow. As soon as feasible. This term is often used in the OSHA Bloodborne Pathogen regulations. Certification maintenance of American Society of Clinical Pathologists (ASCP) credentials. Individuals who become ASCP credentialed after 2004 must document 36 hours of continuing education every 3 years to continue using the ASCP credentials after their name. Individuals credentialed before 2004 are grandfathered in and can continue to use the credentials without documenting continuing education. Several samples tested for the same substance at the same time, in the same run on an analyzer. The nature of a method or an error in a method that causes the results produced to continuously deviate from the true value; a systematic difference between an observed value and the true value. Bias is generally used to describe the inaccuracy of a method relative to a comparative method. If the mean is significantly above the mean for the comparative method, it is called a positive bias; if the mean is significantly lower than the other mean, it is called a negative bias. The process of testing materials (standards or calibrators) of known value and adjusting the instrument readout to establish a correlation between the instrument s measurement of the analyte being tested and the actual concentration of the analyte. Testing materials with a known concentration of the analyte in the same manner as patient specimens. At least three samples spanning the reportable range of the test are tested as unknowns (in normal test mode, not calibration mode) and the values obtained are compared to the known value of the materials. If the values obtained are acceptable, proper calibration of the instrument for that analyte is verified. If not, a new calibration may be required. The Centers for Disease Control and Prevention (CDC) is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC), and providing scientific and technical support to CMS.
Glossary for the Clinical Laboratory Certificate, CLIA CLIA CMS Coefficient of variation (CV) Comparative method Control material Control range Corrective action Coulter Principle A lab that possesses a valid CLIA certificate is CLIA certified. The CLIA law requires any laboratory performing testing on specimens derived from a human being for purposes of providing diagnosis, treatment, etc. to enroll with the CLIA program. This is regardless of whether or not the laboratory receives payment from Medicare, Medicaid or any other third party payor, or where the testing is performed. Each certificate enables a lab to perform specific testing in each category. The certificates are: 1. Certificate of Waiver (CW) may perform waived tests only (no inspection, personnel standards, or proficiency testing) 2. Certificate for PPMP (PMP) Provider Performed Microscopy Procedures 3. Certificate of Compliance (COC) inspected by state CMS Surveyors 4. Certificate of Accreditation (COA) deeming agencies such as COLA inspect the lab NOTE: Prior to receiving a COC or a COA, the laboratory must register with CMS, pay the CLIA fees, and receive a Certificate of Registration (COR). The lab will operate under the COR until successfully completing the inspection process. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. CMS is the Centers for Medicare & Medicaid Services. Formerly known as the Health Care Financing Administration (HCFA), CMS is the federal agency responsible for administering the Medicare, Medicaid, SCHIP (State Children's Health Insurance), HIPAA (Health Insurance Portability and Accountability Act), CLIA (Clinical Laboratory Improvement Amendments), and several other healthrelated programs. CMS is charged with the implementation of CLIA, including laboratory registration, fee collection, certificate generation, surveys, surveyor guidelines development and training, enforcement, financial management, and finally, approvals of proficiency testing providers, accrediting organizations and exempt states. Additional information regarding CMS and the CLIA program is available at www.cms.hhs.gov/clia/ An index used to describe the precision of a laboratory method. CV is the relative standard deviation, which is the standard deviation expressed as a percentage of the mean. It is calculated with this formula: CV = standard deviation x 100 / mean. In proficiency testing, a widely accepted, reliable method. A specimen with a known value or range of values that is tested like a patient sample to ensure the methodology is working correctly. The allowable limits or acceptable range of values for a control material. Steps taken to remedy an undesirable situation or quality problem. Examples of corrective actions are providing training, opening a new bottle of control, recalibrating the instrument, or performing instrument maintenance. Electrical Sensing Zone technique, the accepted reference method for cell counting and particle size analysis. The method of sizing and counting particles is based on measurable charges in electrical resistance produced by nonconductive particles suspended in an electrolyte.
Glossary for the Clinical Laboratory Crosswalk Cuvette Decision value or level Deemed status Drift Engineering controls FDA Hemolysis High complexity Linearity Lyophilized Matrix Matrix effect Mean Median A reference between two different documents. Often used by Medicare carriers to determine whether to pay for a test. A small transparent vessel used for laboratory testing. A threshold value of a test result above or below which a physician will respond with an action. CMS has approved certain private organizations (example: COLA) and given them the power to accredit laboratories under their own requirements which meet or exceed the CLIA requirements. When values move away from the mean or calibration is lost over a period of time. Safety devices (such as self-sheathing needles) or other products that act as controls to isolate or remove bloodborne pathogen hazards and/or that reduce the likelihood of exposure the workplace. The Food and Drug Administration (FDA) is responsible for laboratory test categorization. The FDA determines if the product is safe and effective as a condition of approval. The Centers for Medicare & Medicaid Services (CMS) determines if the product is reasonable and necessary as a condition of Medicare coverage. Any product regulated by the FDA must receive FDA approval or clearance for at least one indication to be eligible for Medicare coverage. FDA approval/clearance alone does not automatically entitle that device to coverage. There may be exceptions for IDE Category B devices. The rupturing of red blood cells that releases hemoglobin (and other intracellular substances) into the plasma or serum. CLIA has classified laboratory tests according to the difficulty of performance and interpretation. High complexity is the most complex level of lab testing as defined by CLIA. High complexity testing has the most demanding requirements, and includes manufacturer's tests that have been classified as high complexity and any tests developed by the laboratory or modified by the laboratory. This refers to the ability of an instrument to measure an analyte at different concentrations without distortion. Previously liquid material that has been freeze dried. The powder must be reconstituted before use, using an exact amount of water or diluent. Everything (the base material and all of the additives) that is in the sample other than what you are measuring. The influence of the added materials used in manufactured samples on the measurement of the analyte being tested; interference, usually caused by the nonhuman components of the sample that affect the analytical method s ability to accurately measure the analyte. For example, sometimes a methodology or instrument will give consistently higher or lower values (i.e. demonstrate a positive or negative bias) for certain kinds of control specimens because of some component in the control material, but there is no bias when actual patient specimens are tested. The sum of all results divided by the number of results; the average result. The mean is represented by the symbol. The formula for calculating the mean is = (x 1 + x 2 +..x n ) n The middle value in a set of results, with an equal number of values above and below.
Glossary for the Clinical Laboratory Moderate complexity Non-waived Outlier Package insert and operator manuals verbiage Panic values Peer groups Performance specifications Personal Protective Equipment (PPE) Post-analytic Pre-analytic Precision Proficiency testing (PT) PT provider Qualitative Quality CLIA has classified laboratory tests according to the difficulty of performance and interpretation. Approx. 75% of lab tests are classified as moderate complexity, including most routine tests such as automated blood cell counts and chemistry tests performed on automated analyzers. Moderate or high complexity. The term non-waived is used to describe moderate and high complexity laboratory testing when the requirements are the same for both. A quality control result that is not within the expected range. Must a CLIA mandate Recommendation not a CLIA requirement Requirement a CLIA mandate Should not a CLIA requirement Suggestion not a CLIA requirement Abnormal laboratory test result values that demand attention by a clinician; also called alert values or action values. In proficiency testing, this refers to other laboratories that use the same method or instrument. The determined values (or range of values) for the performance characteristics of accuracy, precision, reportable range, reference range, analytical sensitivity, and analytical specificity for a test method. These expected performance specifications are established or verified by the laboratory, and are used to measure the test method s robustness and suitability. Specialized clothing or equipment worn by an employee for protection. The OSHA Bloodborne Pathogen regulations specify that PPE is to be made available at no cost to the employee. This equipment should be: gloves, gowns, face shields, masks, eye shields, or other protective equipment. Processes in the path of workflow that occur after testing is complete, such as result transcription and reporting, and specimen retention after testing. Processes in the path of workflow that occur before testing begins, such as test orders, patient identification, and specimen collection, labeling, receiving, and processing. The degree to which repeated test results on the same sample agree; the reproducibility of the test. A means of verifying results of lab testing using an external testing company often called external quality assessment. Unknown samples are sent from a PT program three times a year for analysis by the lab in the same manner as patient samples. The results are then compared to a known target value and reports are issued to the lab, CMS, and any accrediting agency. A business entity that operates a proficiency testing program. A test that detects the presence or absence of a substance without providing a specific measure of how much. For example, some qualitative tests are reported as negative or positive, and others as reactive or non-reactive. Degree to which a set of inherent characteristic meets requirements and the needs and expectations of customers.
Glossary for the Clinical Laboratory Quality Assessment (QA) Quality Control (QC) Quality Improvement Quality Indicators Quality System Essentials (QSE) Quality Management Systems (QMS) Quantitative Random error Reference laboratory Reference range Regulated waste Reliability Reportable range Shift An overall evaluation program which examines ALL of the activities in the entire path of workflow and operation of the laboratory. The essential elements are identified and efforts are then focused on improving performance and service. Formerly referred to as Quality Assurance, QA focuses on preventing errors, producing reliable results, and improved patient outcomes. A set of activities or techniques that monitor processes to ensure that all quality requirements are being met. In the clinical laboratory, QC is the process of testing materials that have a known concentration of the substance being measured, prior to or concurrent with patient testing. QC can detect analytical errors related to the test system, environment, and operator. When QC results are within the expected target range for the control material, it gives confidence that the test system is accurately measuring the analyte. Periodic examination of organizational activities, policies, procedures, and performance to identify best practices and target areas in need of improvement. Observations, statistics, or data defined by the laboratory that typify the performance of a given work process and provide evidence that the laboratory is meeting its quality intentions. Fundamental building blocks necessary to support quality in any service s work operations. A management system to direct and control an organization with regard to quality. A test result that gives a specific numerical measure of how much as opposed to simply detecting the presence or absence of the substance. An error that can be either positive or negative, and the direction and exact magnitude cannot be exactly predicted. In contrast, systematic errors are predictable and consistently in one direction. A large commercial laboratory where routine and complex laboratory tests can be performed. Reference laboratories perform tests on specimens from other sites, and are often used to perform more complex and unusual tests not performed in your own facility. The range of test results you would expect to see in individuals without the disease or condition that the test detects; also called the normal range or expected range. In the OSHA Bloodborne Pathogen regulations, liquid or semi-liquid or other potentially infectious materials; contaminated items that would release blood or other infectious materials when compressed; items that are caked with dried blood; contaminated sharps; and wastes containing visible blood or other potentially infectious materials. These must be disposed of in special marked bags and/or containers. A method s capacity to maintain both accuracy and precision. The range of test values (from low to high) which the instrument or method can accurately measure. Patient values below the reportable range for the test must be reported as less than the lowest verified value. Patient values above the reportable range must be reported as greater than the verified value, or diluted and re-run. Reportable range may also be called analytical measurement range or measuring interval. A change in control values that causes several consecutive control values to fall on the same side of the mean.
Glossary for the Clinical Laboratory Specialty and Subspecialty Split samples Standard deviation (SD) Standard Systematic error Test system Total error Total testing process Trend Universal precautions Verification of Performance Specifications Waived Work practice controls The areas of laboratory science or fields of testing, such as the specialty of Chemistry, Hematology, Immunology or Microbiology. Examples of a subspecialty include Bacteriology (a subspecialty of Microbiology) and Endocrinology (a subspecialty of Chemistry). A specimen is divided into aliquots and sent to different laboratories or tested by different methods for the analyte. Results are then compared. A statistic that describes the dispersion of a set of results around the mean value when the distribution is Gaussian (normal). 1. Calibrator; a solution with a specific known amount of the analyte being measured, used for the calibration of instruments or comparison to unknowns. 2. A set of rules that mandate the need to develop and manage processes, products, services, and systems. Bias; an error that is consistently in one direction and is predictable, in contrast to random errors that may be either positive or negative and whose direction cannot be predicted. The test kit or method, including the instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform an assay or examination and generate test results. The combined effect of random and systematic errors. The complete process, from beginning to end, for producing laboratory test results where each step in the process affects the step that follows. The total testing process starts with the physician s order for a laboratory test or service, progresses through the activities of collecting and testing the samples, and culminates in the delivery of a report of results or interpretation back to the ordering physician for use in making medical treatment decisions. A gradual increase or decrease in control values over several days. Mandates that all blood and other body fluids be treated as potentially infectious materials. Protect yourself with the use of gloves, lab coats, hand washing, and proper disposal procedures. Validating a test system to ensure it works accurately and as intended before testing patients. Also called method validation The least complicated level of testing in a lab as described by CLIA. Waived tests are those tests that are determined by CDC or FDA to be so simple that there is little risk of error. Certificate of Waiver (CW) laboratories must enroll in the CLIA program, pay applicable certificate fees biennially, and follow manufacturers test instructions. No proficiency testing is required and there are no personnel standards for waived testing. As described in the OSHA Bloodborne Pathogen regulation, these procedures and practices act as controls to reduce the likelihood of exposure by altering the manner in which a task is performed. For example, wearing PPE and prohibiting the recapping of needles.