Thrombosis Research Laboratory

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Thrombosis Research Lab on May 2, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. The specific deficiencies are as follows: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records and an interview with the Technical Consultant (TC), the Laboratory Director (LD) failed to sign two (2) of two (2) PT attestation statements during calendar year 2018. Findings include: 1. Review of the College of American Pathologists (CAP) records for 2018 revealed the following: 2018 CAP PF-B Platelet Aggregation attestation not signed by LD; and 2018 CAP PIA-B Drug specific Platelet Aggregation attestation statement not signed by LD. 2 of 2 attestation statements were not signed by the Laboratory Director. 2. In an exit interview at approximately 1:45 PM, the TC confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records and an interview with the Technical Consultant (TC), the laboratory failed to verify the accuracy of platelet aggregation performed on the Chrono-Log Aggregometer and drug-specific platelet aggregation performed on the Accriva VerifyNow analyzer twice annually in calendar year 2017 and 2018. Findings include: 1. Review of the laboratory's College of American Pathologists (CAP) PT documentation, a total of two (2) events in 2018, revealed the laboratory utilized PT enrollment to verify the accuracy of platelet aggregation testing on the Chrono-Log Aggregometer and drug-specific platelet aggregation on the VerifyNow. Review of the 2017 and 2018 CAP PT reports revealed: a lack of documentation of PT participation in 2017; participation in the CAP 2018 Event Platelet Aggregation PF-B, and CAP 2018 Drug Specific Platelet Aggregation PIA-B. The surveyor requested documentation of the twice annual accuracy verification for 2017 and documentation of an additional verification in 2018 for platelet aggregation and drug specific platelet aggregation. The laboratory did not provide documentation for review. 2. In an exit interview with the TC and Testing Personnel A (TPA) at approximately 1:45 PM, the TC confirmed the findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on a review of the laboratory's policy and procedure manual, Quality Control records, Quality Assessment records, instrument maintenance records, instrument validation records, and interviews, the laboratory failed: to verify the reportable and normal ranges of the ChronoLog Platelet Aggregometer and VerifyNow PRU test (D5421); to perform and document instrument maintenance (Cross Reference D5429); perform two levels of quality control each day of patient testing for the ChronoLog Platelet Aggregometer and VerifyNow PRU test (Cross Reference D5447 A and B); and address analytic failures in the quality assessment system (Cross Reference D5791). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. -- 2 of 7 -- This STANDARD is not met as evidenced by: A. Based on review of the instrument validation records, lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to verify the reportable range and normal range (reference range) for platelet aggregation performed on three ChronoLog Platelet Aggregometer 490s prior to testing patients. Record review was from September 7, 2017 until May 2, 2019. Findings include: 1. Review of initial performance verification records for the ChronoLog Platelet Aggregometer analyzers revealed the following: Serial number 2170060 installed 9/7 /17. Accuracy, precision and calibration performed on 9/7/17. Serial number 2170060- 01 installed 9/7/17. Accuracy, precision and calibration performed on 9/7/17. Serial number 2180010 installed 8/15/18. Accuracy, precision and calibration performed 1/20 /19. The surveyor requested to review additional verification documentation of the reportable range and reference ranges for each of the above-specified analyzers. The laboratory provided no documentation for review. 2. In an exit interview with the TC and Testing Personnel A (TP A) at approximately 1:45 PM, the TC confirmed the findings. B. Based on review of the instrument validation records, lack of documentation and interview with the Technical Consultant (TC), the laboratory failed to verify the reportable range and normal range (reference range) for drug- specific platelet aggregation PRU (P2Y12) testing performed on the Accriva VerifyNow analyzer prior to testing patients. Dates of record review was from September 7, 2017 until May 2, 2019. Findings include: 1. Review of initial performance verification records for the Accriva VerifyNow PRU test revealed the analyzer (serial number 7235) was installed on 3/5/18. The laboratory performed accuracy, precision and calibration on 3/5/18. The surveyor requested to review additional verification documentation of the reportable range and reference ranges for the VerifyNow PRU test. The laboratory provided no documentation for review. 2. In an exit interview with the TC and Testing Personnel A (TP A) at approximately 1:45 PM, the TC confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on the review of the Chrono-Log Platelet Aggregation Procedure, available maintenance documentation, and an interview with the Technical Consultant (TC), the laboratory failed to follow the laboratory's Chrono-log Platelet Aggregation Procedure for performing and documenting instrument maintenance procedures for twelve (12) of twenty-one (21) months from August 1, 2017 to May 2, 2019. 1. Review of the Chrono-Log Platelet Aggregation Procedure revealed the following statements: "A. Daily Maintenance a. Clean Instrument surface with a soft, lint-free cleaning cloth of debris and residual fluids. b. Ensure stir bar speed is set to 1200 RPMs and incubation wells reach 37C. c. Turn off the aggregometer daily after each use. B. Quarterly Maintenance a. Perform optical auto-calibration check procedure. b. Clean aggregometer: Turn of the Aggregometer and any attached peripherals. Disconnect them from the Aggregometer. Unplug the instrument before cleaning to prevent a shock hazard. Use a vacuum cleaner to remove any dust from the slots and holes in the Aggregometer. c. Stirring Motor Speed Check: Visually check the stirring bar by placing an empty cuvette with stir bar into the sample well. Check that the stir bar is -- 3 of 7 -- rotating. C. Annual Maintenance: a. Yearly calibration will be performed by the manufacturer by a factory authorized representative. 2. Review of the available maintenance documentation from 8/1/17 to 5/2/19 revealed a lack of documentation of the daily and quarterly maintenance performed by testing personnel on the Chrono- log Platelet Aggregometers from August 1, 2017 to August 1, 2018. A total of 12 months. The surveyor requested documentation of the daily and quarterly maintenance for the Chrono-Log Platelet Aggregometer from the laboratory. The laboratory provided no documentation for review. In an interview with the TC at approximately 10:30 AM, the TC stated "We do not have the maintenance from August 2017 until August 2018. We discovered the lack of maintenance and have a