Prime Labs Llc

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on proficiency testing record review, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to review and evaluate proficiency testing results for 2 of 2 proficiency testing performance evaluations in 2023. Findings: 1. American Proficiency Institute (API) 2023 Chemistry - Core - 1st Event review found a performance of "unacceptable" for samples Myoglobin CM-04, CO2 CH-02, phosphorus CH-05, and cortisol CH-02. 2. API 2023 Chemistry - Core - 2nd Event review found a performance of "unacceptable" for sample HCG (serum-quant) HCG-06. 3. Record review failed to include documentation the laboratory reviewed and evaluated the unacceptable PT results from API 2023 Chemistry - Core - 1st and 2nd Event 4. In an interview on September 6, 2023 at 12:11 PM, the TS confirmed the laboratory failed to review and evaluate the unacceptable PT results. 5. The laboratory performed 20,000 chemistry test annually. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, direct observation, and interview with the Technical Supervisor (TS), the laboratory failed to follow their preanalytic procedure for the acceptability requirements for samples received by the laboratory. Findings: 1. Review of the laboratory's procedure manual revealed the procedure "09-Pre-Analytical" stated the patient sample container must have the patient name and a secondary unique identifier. 2. Direct observation of the laboratory samples on September 6, 2023 at 4:05 PM, found 6 of 22 patient samples that were being prepared to run on a QuantStudio 12K Flex Real-Time PCR System had no patient identification on the original sample tube. 3. In an interview on September 6, 2023 at 2:25 PM, the TS confirmed samples were accepted when they did not have the patients' name and a secondary unique identifier. 4. The laboratory performs 95,000 test annually. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on procedure manual review, record review, and interview with the technical supervisor (TS), the laboratory failed to follow the procedure to repeat critical values. Findings: 1. The laboratory procedure "SOP 12 - Clinical Blood Testing" stated when a test result is critical, the sample will be immediately repeated to ensure the accuracy of the result. 2. Record review of the Beckman Coulter AU480 instrument sample result log revealed 2 of 3 patients that had critical values were not repeated. 3. In an interview on September 6, 2023 at 5:30 PM, the TS confirmed the laboratory did not repeat all critical values. 4. The laboratory performed 20,000 chemistry tests per year. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on laboratory record review and interview with the technical supervisor (TS), the laboratory failed to ensure the twice a year evaluation of two QuantStudio 12K Flex Real-Time PCR Systems that compared the relationship between instruments. Findings: 1. Laboratory record review failed to produce instrument to instrument comparison for the two QuantStudio 12K Flex Real-Time PCR Systems twice a year in 2022 and 2023. 2. In an interview conducted on September 6, 2023, at 2:20 PM, the TS confirmed the laboratory has not performed an evaluation that defines the -- 2 of 3 -- relationship between the two QuantStudio 12K Flex Real-Time PCR Systems. 3. The laboratory performed 50,000 molecular tests per year. D5777 COMPARISON OF TEST RESULTS CFR(s): 493.1281(b)(c) (b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available: (b)(1) Patient age. (b)(2) Sex. (b)(3) Diagnosis or pertinent clinical data. (b)(4) Distribution of patient test results. (b)(5) Relationship with other test parameters. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual and interview with the Technical Supervisor (TS), the laboratory failed to have a system that assessed patient test results that appear inconsistent with relevant criteria, including previous results. Findings: 1. Laboratory procedure manual review failed to produce a system that assessed patient test results that appear inconsistent with relevant criteria, including previous results. 2. In an interview on September 6, 2023 at 5:45 PM, the TS confirmed the laboratory did not have a system that assessed patient test results that appear inconsistent with relevant criteria. 3. The laboratory performed 95,000 test annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient test reports, laboratory procedure manual, and an interview with technical supervisor (TS), the laboratory failed to include the correct reference ranges for chemistry tests. Findings: 1. Review of the patient reports revealed five of the six chemistry reference ranges did not match reference ranges for the chemistry test that were found in the procedure "14 AU480 SOP". 2. The procedure manual showed: Parameter Reference Range Iron 50 - 212 Lactate Dehydrogenase 140 - 271 Glucose 74 - 109 Magnesium 1.9 - 2.7 Phosphorous 3.7 - 7.2 3. The patient report showed: Parameter Reference Range Iron 35 - 145 Lactate Dehydrogenase 122 - 222 Glucose 70 - 105 Magnesium 1.7 - 2.3 Phosphorous 2.5 - 4.5 4. In an interview on September 6, 2023 at 5:50 PM, the TS confirmed the lab failed to provide the correct reference ranges on the test report. 5. The laboratory performed 20,000 chemistry tests per year. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a routine desk review of the CMS-155 report for proficiency testing performance and email from the compliance team, the laboratory failed to achieve satisfactory performance scores for Glucose Non-Waived testing for two out of three events in 2022 and 2023. (2022, Event 3 and 2023, Event 1) See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores from the American Proficiency Institute (API) and email communications with the compliance team, the laboratory failed two out of three events in 2022 and 2023. (2022, Event 3 and 2023, Event 1) for Glucose (Non-Waived) Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 03/27/2022, at 12:47 PM, revealed the Glucose (Non-Waived) testing scores for 2022, Event 3 was 0% and 2023, Event 1 was 60%. 2. Email received from the compliance team on 03/29/2023, at 04:52 PM, confirmed two of three unsuccessful proficiency scores for Glucose (Non-Waived). -- 2 of 2 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records for 2021 and confirmed by interview with the general supervisor and testing personnel on 12/09/2021 @ 1:30 PM, the laboratory failed to enroll in an approved PT program in the subspecialties of bacteriology, mycology, and virology which would include organisms the laboratory could potentially identify and report which are listed in subpart I and are performed as part of the Wound (CLCS Version 3) Panel, the Foot Fungus (CLCS Version 2) Panel, the UTI (CLCS Version 2) Panel, the STI (CLCS Version 2) Panel, the Women's Health (CLCS Version 1) Panel, and the Resp (Using Thermo Version 6) Panel as described by the Prime Labs CLCS Panel Summary. At the time of the survey, the laboratory reported performing 50,000 tests annually. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- that provides equivalent quality testing as specified in Appendix C of the State 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 record review and interview with the general supervisor, the laboratory failed to report SARS-CoV-2 negative test results from April 2021 through December 2021. Findings include: 1. In an interview with the general supervisor on 12/09/2021 at 10:45 AM, confirmed that negative SARS-CoV-2 test results were not reported to the state health department. 2. Laboratory procedure failed to include instructions for reporting negative SARS-CoV-2 test results to the state health department. 3. The laboratory performed approximately 3000 SARS-CoV-2 tests annually using the Thermo QuantStudio 12K PCR assay. 4. The technical supervisor confirmed the findings on 12/09/2021 at 1:00 PM. 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 direct observation, and interview with testing personnel, the laboratory failed to store TaqPath COVID-19 controls at a temperature consistent with the manufacturer's instructions. Findings include: 1. TaqPath COVID-19 controls requires to be stored at a temperature colder than -70 C. 2. Direct observation revealed that controls were stored in a freezer that was at a temperature of -21 C. 3. The laboratory performed approximately 3000 SARS-CoV-2 tests annually using the Thermo QuantStudio 12K PCR assay. 4. In an interview on 12/09/2021 at approximately 1:15 PM, the general supervisor confirmed that controls were not store at a temperature colder than -70 C. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory records review and interview with the laboratory staff, the laboratory failed to ensure the twice a year evaluation of the two Kingfisher Duo Prime, one Kingfisher Flex, and three QuantStudio 12K Flex test instruments that compared the relationship between instruments. 1. The laboratory quality assessment procedure failed to include a system that twice a year evaluates and defines the relationship between test results using different instruments. 2. The laboratory records review failed to include instrument to instrument comparison. 3. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 4. In an interview conducted on 12/19/2021 at 12:20 AM, testing personnel stated the laboratory did not have a system in place that twice a year evaluates and defines the relationship between test results using different instruments. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review, direct observation, and interview with laboratory staff, the laboratory director failed to provide management and direction to the laboratory by failure to ensure that the physical plant and environmental conditions of the laboratory are appropriate for uni-directional workflow for molecular testing. (See D6083); failure to ensure that test systems had established performance specifications before reporting patient test result (See D6086); and the failure to ensure that quality control procedures are followed to assure the quality of laboratory services provided (See D6093). D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on direct observation and interview with the general supervisor, the laboratory failed to provide uni-directional workflow for molecular testing such as specimen preparation, amplification, and reagent preparation. Findings include: 1. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 2. Laboratory record review revealed a lack of a log or procedure for contamination checks, including wipe checks. 3. Direct laboratory observation on 12/09/2021 at approximately 10:54 AM, found that the PreAMP Reaction Mix was made in same room as patient specimens were extracted which can lead to contamination of the patient specimens. 4. In an interview on 12/09 -- 3 of 4 -- /2021 at approximately 11:00 AM, the general supervisor confirmed that no checks for contamination, including wipe checks, were performed and that the PreAMP Reaction Mix was made in same room as patient specimens were extracted. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interview with the technical supervisor, the laboratory director failed to ensure that test systems had established performance specifications before reporting patient test results. Findings include: 1. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 2. In an interview on 12/09/2021 at approximately 1:00 PM the technical supervisor confirmed that the laboratory began reporting patient test results on 04/01/2021. 3. Record review of test system performance specifications revealed that the wound test system was approved by the laboratory director on 12/08/2021, the COVID-19 test system was approved by the laboratory director on 12/07/2021, and the foot fungus was approved by the laboratory director on 12/07/2021. 4. In an interview on 12/09/2021 at approximately 1:00 PM the technical supervisor confirmed that patient test results were reported before the laboratory director ensured that test systems had established performance specifications. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview with the general supervisor, the laboratory failed to follow the procedure for running quality controls for the Thermo Fisher TaqMan PCR test panels. Findings include: 1. The "Laboratory Operations Manual for rDNA/RNA Based Pathogen Testing" procedure manual stated that every amplification plate must have an external positive control and must pass for the plate to be valid. 2. Record review of quality controls logs revealed the laboratory did not have an external positive control on every amplification plate. 3. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 4. In an interview on 12/09/2021 at approximately 12:15 PM, the general supervisor confirmed the laboratory failed to follow the procedure manual by not including an external positive control on every amplification plate. -- 4 of 4 --

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) records for 2021 and confirmed by interview with the general supervisor and testing personnel on 12/09/2021 @ 1:30 PM, the laboratory failed to enroll in an approved PT program in the subspecialties of bacteriology, mycology, and virology which would include organisms the laboratory could potentially identify and report which are listed in subpart I and are performed as part of the Wound (CLCS Version 3) Panel, the Foot Fungus (CLCS Version 2) Panel, the UTI (CLCS Version 2) Panel, the STI (CLCS Version 2) Panel, the Women's Health (CLCS Version 1) Panel, and the Resp (Using Thermo Version 6) Panel as described by the Prime Labs CLCS Panel Summary. At the time of the survey, the laboratory reported performing 50,000 tests annually. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- that provides equivalent quality testing as specified in Appendix C of the State 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 record review and interview with the general supervisor, the laboratory failed to report SARS-CoV-2 negative test results from April 2021 through December 2021. Findings include: 1. In an interview with the general supervisor on 12/09/2021 at 10:45 AM, confirmed that negative SARS-CoV-2 test results were not reported to the state health department. 2. Laboratory procedure failed to include instructions for reporting negative SARS-CoV-2 test results to the state health department. 3. The laboratory performed approximately 3000 SARS-CoV-2 tests annually using the Thermo QuantStudio 12K PCR assay. 4. The technical supervisor confirmed the findings on 12/09/2021 at 1:00 PM. 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 direct observation, and interview with testing personnel, the laboratory failed to store TaqPath COVID-19 controls at a temperature consistent with the manufacturer's instructions. Findings include: 1. TaqPath COVID-19 controls requires to be stored at a temperature colder than -70 C. 2. Direct observation revealed that controls were stored in a freezer that was at a temperature of -21 C. 3. The laboratory performed approximately 3000 SARS-CoV-2 tests annually using the Thermo QuantStudio 12K PCR assay. 4. In an interview on 12/09/2021 at approximately 1:15 PM, the general supervisor confirmed that controls were not store at a temperature colder than -70 C. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory records review and interview with the laboratory staff, the laboratory failed to ensure the twice a year evaluation of the two Kingfisher Duo Prime, one Kingfisher Flex, and three QuantStudio 12K Flex test instruments that compared the relationship between instruments. 1. The laboratory quality assessment procedure failed to include a system that twice a year evaluates and defines the relationship between test results using different instruments. 2. The laboratory records review failed to include instrument to instrument comparison. 3. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 4. In an interview conducted on 12/19/2021 at 12:20 AM, testing personnel stated the laboratory did not have a system in place that twice a year evaluates and defines the relationship between test results using different instruments. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on record review, direct observation, and interview with laboratory staff, the laboratory director failed to provide management and direction to the laboratory by failure to ensure that the physical plant and environmental conditions of the laboratory are appropriate for uni-directional workflow for molecular testing. (See D6083); failure to ensure that test systems had established performance specifications before reporting patient test result (See D6086); and the failure to ensure that quality control procedures are followed to assure the quality of laboratory services provided (See D6093). D6083 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(2) The laboratory director must ensure that the physical plant and environmental conditions of the laboratory are appropriate for the testing performed. This STANDARD is not met as evidenced by: Based on direct observation and interview with the general supervisor, the laboratory failed to provide uni-directional workflow for molecular testing such as specimen preparation, amplification, and reagent preparation. Findings include: 1. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 2. Laboratory record review revealed a lack of a log or procedure for contamination checks, including wipe checks. 3. Direct laboratory observation on 12/09/2021 at approximately 10:54 AM, found that the PreAMP Reaction Mix was made in same room as patient specimens were extracted which can lead to contamination of the patient specimens. 4. In an interview on 12/09 -- 3 of 4 -- /2021 at approximately 11:00 AM, the general supervisor confirmed that no checks for contamination, including wipe checks, were performed and that the PreAMP Reaction Mix was made in same room as patient specimens were extracted. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on record review and interview with the technical supervisor, the laboratory director failed to ensure that test systems had established performance specifications before reporting patient test results. Findings include: 1. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 2. In an interview on 12/09/2021 at approximately 1:00 PM the technical supervisor confirmed that the laboratory began reporting patient test results on 04/01/2021. 3. Record review of test system performance specifications revealed that the wound test system was approved by the laboratory director on 12/08/2021, the COVID-19 test system was approved by the laboratory director on 12/07/2021, and the foot fungus was approved by the laboratory director on 12/07/2021. 4. In an interview on 12/09/2021 at approximately 1:00 PM the technical supervisor confirmed that patient test results were reported before the laboratory director ensured that test systems had established performance specifications. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on record review and interview with the general supervisor, the laboratory failed to follow the procedure for running quality controls for the Thermo Fisher TaqMan PCR test panels. Findings include: 1. The "Laboratory Operations Manual for rDNA/RNA Based Pathogen Testing" procedure manual stated that every amplification plate must have an external positive control and must pass for the plate to be valid. 2. Record review of quality controls logs revealed the laboratory did not have an external positive control on every amplification plate. 3. The laboratory performs approximately 50,000 Thermo Fisher TaqMan PCR wound, foot fungus, urinary tract infection, women's health, sexually transmitted infections, and respiratory molecular panel tests per year. 4. In an interview on 12/09/2021 at approximately 12:15 PM, the general supervisor confirmed the laboratory failed to follow the procedure manual by not including an external positive control on every amplification plate. -- 4 of 4 --