WFUHS CLIA Self-Survey

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1 Lab Name: Location: Phone: WFU ID#: CLIA ID#: Surveyor: Date: Laboratory Directory: Contact: Position: Test Name CPT code WFUHS internal billing code Manufacturer Equipment CLIA Test Category 1) Are any laboratory services provided as a courtesy to community physicians? If yes, what tests?

2 2) Are Advanced Beneficiary Notices obtained for laboratory services? If yes, where are they maintained? Is a copy of the ABN sent to the billing office with the charge ticket? 3) How many staff perform tests and what percentage of their work time is dedicated to testing? # of full-time: % testing time: ; # of part time: % time testing: 4) Additional comments:

3 Each question is marked: Y (compliance), N (non-compliance), or N/A (not applicable). All compliance documents are available from the Practice Operations Department. If the laboratory is accredited apply all questions as they relate to requirements of the accreditation agency. Additional comments: A. CERTIFICATION (SUBPARTS A, B, C, D) 1. Does the laboratory have a CLIA identification number? Need HCFA 116 Form 2. Has the laboratory notified HCFA of any new specialties performed since applying for certification or changes in directorship? Need CLIA Certificate Requirements and HCFA Notification Letter 3. Is the laboratory accredited by COLA; JCAHO, CAP; or other: agency? If yes, ID# B. PROFICIENCY TESTING (PT) (SUBPART H) 4. Is the laboratory enrolled in an approved PT program for all regulated nonwaived analytes? PT Program: 5. Are PT records kept for two years? Copy completed report form, keep original instrument printouts, and graded results summaries. 6. Are corrective actions taken on failed PT results? Complete the evaluation form and maintain with PT documents for all failed PT tests. 7. Are all PT results reviewed promptly after receipt by an authorized individual? Initial and date review, keep with PT documents. C. QUALITY CONTROL (SUBPART K) 8. Is a manual present that contains written procedures for all tests? (Manufacturer s package inserts and procedure manuals meet this requirement.) 9. Are the procedures exactly those that are performed in the lab? Remove procedures not performed by the lab..maintain written procedures for discontinued tests for two years after the test was discontinued. Need list of regulated analytes Need list of PT Programs and explanation of what PT entails. Need PT Results Review Form and explanation of proper corrective actions and the importance of documenting PT failures. Need explanation of importance of documenting PT reviews Need Procedure(s): Need Protocol For Writing A PM (Highly Complex)

4 10. Is there a written procedure to describe the method for reporting results (including panic values and erroneous results, if applicable)? Manufacturer s instructions do not provide this. Maintain as a policy. 11. Are all procedures signed and dated by the laboratory director? (Note: COLA requires annual signature by the director.) One cover page may be used but list specific tests w/ instruments. Need Procedure For Reporting Results or use the Patient Test Management Policy Need Signature Cover Sheet for

5 Each question is marked: Y (compliance), N (non-compliance), or N/A (not applicable). All compliance documents are available from the Practice Operations Department. If the laboratory is accredited apply all questions as they relate to requirements of the accreditation agency. Additional comments: 12. Are two levels of controls run and documented daily for every nonhematology instrument-based test? (Note: COLA recommends plotting all quantitative (numerical) QC results. Initial, date, note acceptability of result ( OK ), and keep all instrument printouts. 13. For hematology instruments, are two levels of controls run and documented every 8 hours of operation? (Note: QBC users must test both capillary and venous modes, if used.) Initial, date, note acceptability of result ( OK ), and keep all instrument printouts. 14. For manual coagulation (fibrometers included), does each testing analyst run and document two levels of controls with each run of patient tests? 15. For automated coagulation, are two levels of controls run and documented every 8 hours of operation? Initial, date, note acceptability of result ( OK ), and keep all instrument printouts. 16. For all coagulation tests, are two levels of controls run and documented each time there is a complete change of reagents? (This does not apply to whole blood coagulation analyzers.) 17. For all coagulation, are all patients and controls tested in duplicate? (This does not applicable to whole blood coagulation analyzers.) 18. Are remedial actions documented for unacceptable quality control? Document corrective actions on the original QC printout or on a corrective action form. Note what was done to corrective the problem: such as repeated, opened new control, call technical assistance,...) Keep all QC results whether they were acceptable or unacceptable. 19 Are instruments calibrated (and calibration is documented) as often as the manufacturer recommends, or at least once every 6 months? Initial, date, note acceptability of result ( OK ), and keep all instrument printouts. 20. Are reagents and solutions discarded upon their expiration date? Need QC Log Form. Need QC Log Form With Levey-Jennings Plot Need Log for: Need Hematology QC Log Form Need QC Log Form Need QC Log Form Need Protime QC Log Form Need explanation of Importance Of Documenting Remedial Action For Unacceptable QC Results Need QC Policies And Procedures For Testing Need Remedial (Corrective) Action Flowchart Need Remedial (Corrective) Action Form Need Calibration Log Form

6 21. Are equipment function and maintenance checks performed and documented at the frequency specified by the manufacturer? Need Equipment Maintenance Log Need scope Maintenance Schedule Need Centrifuge Maintenance Chart

7 Each question is marked: Y (compliance), N (non-compliance), or N/A (not applicable). All compliance documents are available from the Practice Operations Department. If the laboratory is accredited apply all questions as they relate to requirements of the accreditation agency. Additional comments: Quality Control (cont.) 22. Are temperatures of the refrigerator, room, incubator (if applicable), and freezer (if applicable) checked daily? (Note: COLA requires NIST certification of thermometers and monitoring of humidity.) Streck Laboratories ( ) has thermometers that come with a certificate. 23. QC Kits 24. QC Kits 25. QC Kits 26. QC High 27. QC High 28. QC High 29. QC 30. QC 31. QC Are positive (+) and negative (-)procedural, internal or built-in controls checked and documented each day of patient testing? (This can be recorded with the patient s result on the report form.) Is a + and - control tested and documented (if specified by the manufacturer or the state) whenever a new kit is opened? (Note: This is not required for all EIA test kits) Are + and - controls tested and documented each day of patient testing for kits without internal procedural controls (e.g. slide agglutination)? Are control results plotted on appropriate charts (e.g., Levey-Jennings charts)? Is calibration verification performed every six months (using at least 3 points) to verify reportable range? Was method verification done if the high complexity test was brought into use after 9/1/92 to include: precision, accuracy, reference range, patient reportable ranges Are media checked upon receipt for cosmetic defects and the results recorded? Are media for GC (Thayer Martin, chocolate, Martin-Lewis, and NYC agar) and Campylobacter tested with live organisms for proper performance and the results documented? Are reagents (coagulase, catalase, oxidase, and Beta-lactamase) tested with + and - control organisms daily and the results recorded? Need Temperature Log including: w/ refrigerator, room air, incubator, freezer, other: Need Humidity Log Need Strept. QC Form Need Mono Test QC Form Need Generic QC Form Need Generic QC Form Need Levey-Jennings QC Forms Need Interpretive QC Chart Need explanation of interpretation of Levey-Jennings Need Calibration Verification Logs and explain how to verify reportable range Need suggestion for a protocol for method verification Need Protocol For Method Verification Need Media Inspection QC Form. This Includes Remedial Action Form. Need GC Media QC Form. Need explanation for how to inoculate and interpret QC plates and how to record results. Need biology Reagent QC Form.

8 32. QC 33. QC Are reagents (Gram stains, Acid fast stains, bacitracin, optochin, ONPG, X and V strips) tested weekly with + and - control organisms and the results recorded? Is antisera checked monthly with + and - control organisms and the results recorded? Need biology Reagent QC Form. Need Bacitracin Disc QC Protocol Need Gram Stain Control Log. Need biology Reagent QC Form.

9 Each question is marked: Y (compliance), N (non-compliance), or N/A (not applicable). All compliance documents are available from the Practice Operations Department. If the laboratory is accredited apply all questions as they relate to requirements of the accreditation agency. Additional comments: Quality Control (cont.) 34. QC 35. QC For sensitivity testing, are discs tested daily with ATCC control organisms (E. coli ATCC 25923, S. aureus ATCC 25923, and P. aeruginosa ATCC 27853)? Is remedial action taken for unacceptable control results? D. PATIENT TEST MANAGEMENT (SUBPART J) 36. Are specimen collection instructions available for patients (urine clean catch specimens) and office staff (blood and other specimens)? Note: QBC QAdvantage manual contains blood collection instructions 37. Is there a written policy to ensure that required patient test management documentation is obtained and maintained for the (E. Coli); (S. Aureus); (P. Aeruginosa) Need Sensitivity QC Forms and explanation for sensitivity testing may be performed once per week only if the last 30 consecutive test days no more than 3 zone diameters fell outside control limits. Need Remedial Action Form Need Urine Collection Instruction Need Capillary Blood Collection Instructions. Need Venous Blood Collection Instructions Need Patient Test Management Policy (this can be substituted for the reporting results policy in the QC section) requisition, record, and report? 38. Are all specimens labeled legibly? Need Specimen Labeling Poster 39. Are reference ranges (normal values) available to the person(s) who utilize laboratory results? Usually in written procedures. 40. Is the test requisition in a written form? (written in the patient's chart is acceptable) Need Explanation that oral requests must be followed with a written order.

10 41. Does the patient test management system contain: name and address of the requester? test(s) ordered? any pertinent clinical information? patient name? a unique patient ID? chart #, SS #, or DOB w/name date and time the specimen was collected? test results? units of measure? identification of the testing analyst? address of the testing lab? address stamp or letterhead paper Evaluate The Patient Test Management System For The Possibility Of Specimen Mix-up. Need Specimen Accession Log Need Examples of Report Forms 42. Is there patient test management for reference tests? Need Reference Testing Procedure Form.

11 Each question is marked: Y (compliance), N (non-compliance), or N/A (not applicable). All compliance documents are available from the Practice Operations Department. If the laboratory is accredited apply all questions as they relate to requirements of the accreditation agency. Additional comments: E. PERSONNEL (SUBPART M) 43. Do qualified individuals fill all personnel roles under CLIA'88? MODERATE COMPLEXITY & HIGH COMPLEXITY (list names) Director : Clinical consultant: Technical consultant; supervisor: General supervisor: Testing analyst: how many? Full time: Part time: 44. If the MD. serves as the director, technical consultant and clinical consultant, is he/she qualified and aware of all responsibilities? 45. Are files established for all testing personnel? 46. Do personnel files exist and contain: Training forms or certificates Proof of Education Proof of Continuing Education OSHA training/hepatitis B Vaccination records Personnel Evaluation (twice the first year of patient testing, then annually thereafter) 47. Do all testing personnel know where the procedure manual is located and how to properly perform tests and report test results? Need physician director information about 20 CME programs. Need Personnel Qualification Requirements Need list of physician director responsibilities. Need Training Checklist Need Continuing Education Form Need Personnel Evaluation Form F. QUALITY ASSURANCE (SUBPART P) 48. Does the laboratory have a written QA program? Need Quality Assurance Program. Review.

12 49. Does the Quality Assurance plan include a way to monitor: Patient test management QC Need Monthly Quality Assurance Checklist Need QA Communication Notice PT When NOT to report out patient results (e.g. exceeds patient reportable range) Relationship of patient information to patient test results Personnel competence Communications/complaint investigation 50. Are all CLIA records kept for at least 2 years? Need explanation of record keeping methods 51. Are non-waived analytes for which proficiency testing is not available Need Split Sample Log Form and explain how to checked twice per year to verify accuracy (e.g., microscopic UA)? 52. Are secondary (duplicate or backup) methods verified at least twice per year for accuracy (e.g., split samples)? perform split sample analyses. Need Split Sample Log Form and explain how to perform split sample analyses. SPECIALTY REQUIREMENTS: List any requirements that are unique to the procedure listed below and determine the laboratory s compliance with the requirement(s). Test Requirement(s) Compliance? Y (yes) or N (no)

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