C A L I F O R N I A L A B O R AT O RY P E R S O N N E L Shiu-Land Kwong, CLS Regional Director of Lab Compliance & Risk Management The Permanente Medical Group Speaker Shiu-Land Kwong, CLS, is the Regional Director of Laboratory Compliance and Risk Management of Northern California Kaiser system. In this role, she performs internal inspections to assess compliance of 21 medical center labs with California lab law, CLIA regulations, and accreditation standards. Prior to joining Kaiser, she was the Facility Licensing Program manager for Laboratory Field Services. Shiu-Land obtained her Bachelor s degree and CLS training from UCLA, and had worked for UCLA hospital for 20 years. 1
OBJECTIVES: Upon completion of the session, the participants will be able to: Determine lab personnel requirement based test complexity & testing location Understand the qualifications and responsibilities of lab personnel Describe the limited scope of practice of unlicensed lab personnel Agenda Review California lab licensure and personnel qualification requirements Apply knowledge to case studies Useful resources and references Questions and Answers 2
Introduction - Case Study A physician medical group with 20 physician members is planning to provide laboratory testing onsite. Test menu: Basic metabolic panel, lipid panel, CBC with auto & manual differentials, HbA1c, urinalysis dipstick and microscopic exam and urine drug screens. There are 10 RNs and 10 Medical Assistants working onsite. One of the MD s son has a doctoral degree in Clinical Chemistry and just passed the board examination. Introduction - Case Study The lab manager is planning to apply for lab license or registration and hire lab personnel. 1. What are the licensure requirements? 2. Besides testing personnel, what other laboratory personnel positions are required by law? 3. Can RN or Medical Assistant (MA) perform lab tests? 4. Does MA need to be phlebotomy certified? 5. Can the PhD chemist develop a quality management system for the lab? 6. Should the lab hire MLT instead of CLS? 7. What information do you need to determine licensure and personnel qualification? 3
CLIA Certificates and State License/Registration Test categorization determines the CLIA certificate type and state licensure. CLIA 493.5, BPC 1265 Test Complexity CMS-CLIA California Waived Moderate - Limited to PPMP tests Moderate or High Certificate of Waiver Certificate of Provider Performed Microscopy Certificate of Compliance OR Certificate of Accreditation State Registration State Registration State License Test Complexity Look Up https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfclia/ search.cfm 4
Test Complexity Look Up Examples: 5
Manual Differential Manual differential of normal blood smear = Moderate Complexity Manual differential of abnormal blood smear = High Complexity What is the test complexity of this laboratory? Test Basic Metabolic Panel Lipid Panel ( Total Cholesterol, HDL, LDL, Triglycerides ) CBC with Auto Diff CBC with Manual Diff HbA1c Urinalysis + Manual Micro Urine Drug Screens CLIA Test Complexity Moderate Moderate Moderate Moderate and High Waived Moderate Moderate This is a high complexity lab that performs waived, moderate and high complexity tests. 6
The laboratory must apply for a CLIA Certificate of Compliance or Certificate of Accreditation, and be licensed by the state. Common Misunderstanding Certificate of Compliance (CoC)is for lab performing moderate complexity tests, and Certificate of Accreditation (CoA) is for lab performing high complexity tests. This is incorrect. Both types of certificates are for non-waived ( Moderate and/or high complexity ) laboratories. Labs with CoC are inspected by State Agency for CMS Labs with CoA are inspected by Accreditation Organization for CMS 7
Frequently Asked Question Is State Registration the same as Certificate of Registration? No CLIA Certificate of Registration is a temporary certificate issued to a new non-waived laboratory that is waiting for initial inspection. State Registration is for waived or PPMP lab that is not routinely inspected. For a high complexity lab, what are the laboratory personnel positions required by law? 8
California Laboratory Personnel Grid Test Complexity/ CA Lab Position Lab Director (LD) Clinical Consultant (CC) Technical Supervisor (TS) Technical Consultant (TC) General Supervisor (GS) Waived Lab Supervisor (WLS) Testing personnel (TP) Waived Moderate Moderate - PPMP High What are the California qualifications for LD, CC, TS, TC, GS, TP? 9
California Lab Director s Qualifications Waived Lab BPC 1209 (a) The following California licensed persons qualify to direct a waived laboratory that is not part of an acute care hospital: MD ND (Naturopathic Doctor) Director level licenses, e.g., bioanalyst CLS CLS limited specialty Optometrist Pharmacist-in-charge Note: There is no CLIA qualification for waived lab director. California Lab Director s Qualifications Non-Waived Lab BPC 1209, 1264, CLIA 493.1405, & 493.1443 Licensed & Board certified pathologist, or Licensed MD, DO or DPM with appropriate training and experience required by CLIA, or Complexity of Test Moderate Training 20 CME credits in lab medicine Experience 1 year supervising non-waived lab High 1 year 2 years supervising high complexity lab Licensed & Board certified doctoral-degree scientist - limited to the individual s specialty 10
California Lab Director s Qualifications Non-Waived Lab Acute Care Hospital Lab: BPC 1209 (h) Board certified pathologist Non-pathologist MD/DO or licensed bioanalyst if a pathologist is available for consultation Blood Gas Lab located in an Acute Care Hospital: Non-pathologist MD/DO may direct a blood gas lab with testing limited to blood gas and/or electrolytes analysis located at an acute care hospital with a clinical lab directed by a qualified pathologist. Genetics Lab: 17 CCR 1030.6, 1030.7 Board certified pathologist Licensed bioanalyst Licensed Cytogeneticist or Genetic Molecular Biologist Back to the Case Study Who would qualify as the laboratory director of the lab? If the lab does not perform manual differential, will it be easier to meet requirement? Why and why not? 11
Overview of Laboratory Personnel Qualifications Laboratory Supervisors and Consultants Laboratory Testing Personnel Laboratory Supervisors & Consultants - Moderate Complexity Lab Role Qualification Code/Regulation Test Complexity Clinical Consultant MD/DO, or person licensed to direct a California lab 17 CCR 1036 Moderate and/or High Technical Consultant MD/DO or person licensed to perform high complexity test & 2 years of experience 17 CCR 1036.2 Moderate Question: Does an RN qualify as Technical Consultant of a Point of Care lab that performs moderate complexity tests? 12
Laboratory Supervisors & Consultants High Complexity Lab Role Qualification Code/Regulation Test Complexity Clinical Consultant Technical Supervisor General Supervisor MD/DO, or person licensed to direct a California lab MD/DO or person licensed to perform high complexity test & have appropriate years of experience: MD or PhD 1 year MS 2 years BS 4 years Special limitations apply MD/DO or person licensed to perform high complexity test & have 2 years of experience 17 CCR 1036 Moderate and/or High 17 CCR 1036.4 CLIA 493.1449 17 CCR 1036.1 High TC/TS Responsibilities 42 CFR 493.1413 / 1451 1. Accessible to TP to provide onsite, or remote consultation 2. Select test methodology appropriate for the clinical use of the test results 3. Verify or establish test performance specifications 4. Enroll and participate in proficiency testing program 5. Establish QC program 6. Resolve technical issues and ensure corrective actions are taken 7. Ensure patient results are not reported until test /test system is fixed 8. Identify training needs 9. Evaluate testing personnel competency 13
GS Responsibilities High Complexity Lab 42 CFR 493.1463 1. Accessible to TP at all times testing is performed to provide onsite, or remote consultation in accordance with SOP written by TS 2. Provide day to day supervision of high complexity tests 3. Monitor test performance 4. If delegated by LD or TS, Ensure remedial actions are taken when indicated Ensure patient results are not reported until test /test system is fixed Provide orientation to all testing personnel Evaluate testing personnel competency Back to the Case Study For this lab, what are the supervisory role(s) required by law? Can the PhD chemist develop a quality management system for the laboratory? 14
Laboratory Supervisors & Consultants Waived Laboratory - 17 CCR 1036.3 Waived Laboratory Supervisor must meet all of the following requirements: 1. Has a bachelor s degree 2. Qualify as waived lab testing personnel 3. Has one year experience of clinical lab testing in those tests supervised 4. Has competency in the tests supervised Note: No requirement for a Clinical Consultant Testing Personnel qualifications by Test Complexity BPC 1206.5 MD/DO/DDS/ DPM CLS, LD or CLS with limited specialty Public Health Microbiologists Waived Moderate High PPMP Limited to specialty Limited to specialty MLT No Blood Bank, No Microscopy PA NP Midwife completed preceptor program RN LVN completed preceptor program 15
Testing Personnel qualifications by Test Complexity BPC 1206.5 Waived Moderate High PPMP RCP limited limited limited NMT limited limited limited Perfusionist limited limited limited Pharmacist limited limited EMT MA POL personnel Other Limited setting Limited to non-acute care settings Limited setting & completed preceptor training TP Responsibilities 42 CFR 493.1425 / 1495 1. Perform tests after training and competency documented by the lab director or designee 2. Follow lab s SOP for specimen handling, processing, testing, reporting, and maintaining records 3. Maintain records that demonstrate proficiency testing samples are tested in the same manner as patient samples 4. Adhere to the lab s QC policies & document all QC, calibration and PM activities 5. Follow lab s SOP whenever test system performance is not acceptable 6. Identify problems that may adversely affect patient results 7. Document corrective actions taken 16
FAQ Q: Does waived testing personnel require phlebotomy certification? A: It depends. Phlebotomy certification is required if it is outside the scope of practice of the waived testing personnel. Q: Is a certified phlebotomist authorized by law to perform waived tests? A: No. CPT or LPT are not authorized to perform any lab tests unless this individual works in a POL with 5 MDs or less. Unlicensed Lab Personnel BPC 1269 May only perform duties in a licensed clinical laboratory, but not a registered clinical lab. Unlicensed lab personnel may perform lab tests ONLY in a Physician Office Lab with a maximum of 5 MDs. Unlicensed lab personnel require direct and constant supervision during the entire time they are assisting licensed personnel. Unlicensed lab personnel require supervision and control of a licensed person when performing pre-analytical procedures such as specimen preparation and processing. 17
Back to the Case Study Is this laboratory a Physician Office Lab (POL)? Who would qualify to perform fingerstick or venipuncture? Who would qualify to perform HbA1c tests? Who would qualify to perform lipid panel? Who would qualify to perform manual differential? CMS Focus - Lab Personnel qualifications Records of Educational Qualifications Positions License Transcripts or Diplomas CC TS (non-blood Bank), TC, GS TS-Blood Bank Licensed MD, or qualified as LD under CLIA CLS License or limited license in his/her area of supervision MD pathologist with CP certification, or licensed MD with 1 yr training/exp. in BB n/a AND bachelor s degree shown on transcript or diploma n/a TP - Lab CLS or MLT license n/a TP non-lab (RN,RCP, etc. ) n/a. RN/RCP license does not prove qualification Transcript or Diploma 18
Case Study #2 A blood gas lab located at an acute care hospital has its own CLIA certificate of accreditation and own laboratory license. Tests performed include: Blood gas, electrolytes, Glucose, BUN, Calcium and Creatinine. The main lab is directed by a pathologist. The blood gas lab is directed by a pulmonologist Is it compliant? Why and Why Not? Case Study #3 Is it Compliant? A MD from the PPMP lab asks the MA to spin the urine, decant the supernatant, and leave the sediment for his examination under the microscope. This MD of the PPMP lab asks the RN to examine the urine sediments while he is taking care of another patient. A physician member of a large medical group (10 physicians) asks the RN to examine the urine sediments while he is taking care of another patient. The lab is accredited by COLA as a non-waived lab. 19
References California Business Professions Code section 1209, 1206.5, 1260.3, 2069, 2070 Title 17 of California Code of Regulations CDPH 2017 document, titled Issues Specific to California Clinical Laboratory law Q U E S T I O N S? 20
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