Howard University Molecular Laboratory

Summary Statement of Deficiencies D2061 VIROLOGY CFR(s): 493.831(c) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing (PT) records, interview with the lab manager on July 7, 2022, and lab staff on July 12, 2022, the lab failed to return PT results to the PT agency within the time frame and resulted in a score of "0". Findings: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2. The lab failed to return the College of American Pathologist (CAP) 2021 CoV-2 2nd event results to the PT agency within the time frame. 3. The lab failed to perform an investigation into the failure and failed to perform the self evaluation with results obtained in the lab from unknown samples and the answers from the PT agency website. 4. The lab manager stated on July 7, 2022, at 1:30 PM that there was a delay in getting the PT performed and when she tried to submit the PT agency would not accept the results. 5. Lab personnel performed the PT investigation with a passing score on the self evaluation. The surveyor was presented with the documentation on July 12, 2022, at 1:00 PM. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on review of patient SARS-CoV-2 test results and interview with the clinical consultant, the lab failed to prove that patient COVID-19 results were reported to local health department as required by the Public Health Emergency for the detection of COVID-19. Findings: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2. The lab failed to provide proof of reporting to the health department for positive and negative patient results received from 2020 to 2021. 3. The lab failed to provide documentation showing the health department received submitted patient results. 4. The clinical consultant stated on July 12, 2022 at 3:00 PM that he will get the information and forward to the surveyors. The documentation was not received. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of quality records (QC), error log records, and interview with laboratory staff, the laboratory failed to retain all QC records that are required for analytic review. Findings: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2.On April 27, 2022, the QC did not pass. The QC was repeated and passed. 3. The laboratory did not retain the failed QC results and only retained the passing QC. 4. The testing person and the general supervisor confirmed on July 12, 2022 at 2: 00 PM the all QC records were not retained as required for analytic reviews. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on review of written procedures and interview with staff, the laboratory written procedures did not include rejection criteria for patient specimens that were too old for testing (procedures did not define the acceptable period of time between -- 2 of 9 -- collection, receipt and testing), and did not have rejection criteria for specimens collected in an unsuitable media or container. Findings: 1. The laboratory written procedure did not include rejection criteria for the age of the specimen and for specimens that were not collected in suitable collection media and tubes; and 2. This was confirmed on July 12, 2022 at 2:00 pm during interview with the general supervisor. 44487 II. Based on review of the written procedure manual and interview with laboratory staff, the lab failed to have written procedures for specimen collection, labeling, and transportation. Finding: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2. The lab did not have written procedures for specimen collection. 3. The clinical consultant stated that samples are self collected by the patients off site. Once collected a barcode label is added to the sample. The sample is bagged and transported to the lab by trained personnel. 4. The did not have a procedure for labelling the collected specimens with the barcode nor the patient identifiers that are required on the specimen. 4. Transportation of specimens and the disposition of the samples once received in the lab was not available. 5. The lab did not have the training included in the procedure for collection personnel. 6. The general supervisor confirmed on July 12, 2022 at 1:30 PM that a procedure was not available for the specimen collection, labeling, and transportation of patient samples. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of the written procedure manual, interview with the lab manager, and lab staff, the lab failed to have written procedures for monitoring lab temperatures in the event of power failure and surges. Findings: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2. Observation of refrigerators and freezers on July 7, 2022 at 1:00 PM showed that temperatures were not monitored electronically in the event of problems. 3. The lab manager stated on July 7, 2022, at 1:00 PM that she has being trying to get the Information Technology department to work with her to set up an electronic online monitoring system. 4. The lab did not have written procedures for an alert identification system of lab personnel notified in the event of power and temperature failures. 5. The general supervisor confirmed on July 12, 2022, at 2:00 PM that written procedures for monitoring lab temperatures in the event of power failure and surges was not available. 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 -- 3 of 9 -- 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. This STANDARD is not met as evidenced by: I. Based on review of the validation of the ThermoFisher TaqPath Multiplex COVID- 19 PCR test kit, interview with the lab manager, and lab staff, the lab failed to maintain all required documentation and results of the validation. Findings: 1.The lab failed to maintain all documentation that was acquired during the validation process of the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit for SARS-COV-2 detection. 2. The lab did not maintain the data from samples received from the university hospital that were used in the validation process. 3.The lab did not establish the cut off or threshold values when testing samples to determine positive or negative results. 4. The lab did not maintain the data received in house when testing the samples to verify the manufacturers known statements. 5. The lab manager stated on July 7, 2022 at 2:20 PM that she was not aware that all data acquired during the validation needed to be maintained. 6. The lab staff updated the validation with the missing data and presented it to the surveyor on July 12, 2022. II. Based on record review and interview, the laboratory did not validate the use of saline (0.85%) as the patient specimen collection media used to collect and transport specimens. Findings: 1. The laboratory uses saline to collect specimens for testing, the package insert for the saline states that it is used for collection of baceteriology specimens, but does not state use for virology specimens and maintaing RNA suitability for testing. The FDA's information for use did not specify the use of Remel saline (0.85%) reagent for collectionb ut instead stated that "This test [Taq Path Covid-19 RNASE P Combo Kit 2.0] is also authorized for use with anterior nasal swab specimens that are collected using the Color COVID-19 Self-Swab Collection Kit with Saline when used consistent with its authorization".; 2. The laboratory did not perform validation studies to validate the Remel saline as an acceptable collection and transport media, and did not perform studies to establish suitable conditions for transporting specimens collected in Remel saline (such as time and temperature); and 3. This was confirmed during interview with the general supervisor the afternoon of July 12, 2022. 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 review of the written procedure manual, interview with the lab manager, and the general manager, the lab failed to perform preventative maintenance (PM) and function checks on all laboratory equipment and failed to have written procedures. Findings: 1. The lab performs SARS-COV-2 detection with the ThermoFisher TaqPath Multiplex COVID-19 PCR test kit. Testing began September 14, 2020. 2. Observation of pipettes and the ultraviolet (UV) hood on July 7, 2022, at 1:00 PM showed that PM procedures were not performed. 3. The lab manger stated on July 7, 2022, that the university purchasing department would not sign off on sending the pipettes out for calibration PM's. 4. The general supervisor stated on July12, 2022, at -- 4 of 9 -- 2:00 PM the PM procedures were not available for the UV hood and confirmed that PM procedures were not performed. D5779