Total Md Physician Group Pllc

Summary Statement of Deficiencies D0000 A recertified survey was completed on 02/07/2025. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 the surveyor's direct observation, the review of the manufacturer's user guide, CMS 116 application, the laboratory's room temperature and humidity logs in June 2023 and September 2024 for POST-PCR Room 2, patient results,and confirmed in an interview, the laboratory failed to have correct acceptable temperature and humidity ranges according to the manufacturer's user guide for 43 of 43 days reviewed of temperature and 39 of 43 days of humidity reviewed for 1 of 6 instruments: Agena MassArray System in Post-PCR Room 2. The findings were: 1. The Surveyor's direct observation on 02/06/2025 at 9:10 am during the lab tour revealed the following instruments in Post-PCR Room 2. Biorad CFX OPUS 96 RT- PCR System (SN: 795 BR 04398) Biorad CFX OPUS 384 RT-PCR System (SN: 796 BR 02641) Agena MassArray System (SN: PR2101924/CP2107578) Applied Biosystems Veriti 96-Well Thermal Cycler (SN: 2990246422) Applied Biosystems 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 -- Veriti 96-Well Thermal Cycler (SN: 2990244525) Applied Biosystems Veriti 96-Well Thermal Cycler (SN: 2990244510) 2. Review of the manufacturer's user guide titled Mass ARRAY System with Chip Prep Module 96 User Guide by Agena Bioscience (Doc. USG-CUS-069 R09) under Chapter 1 Introduction of Table 1.9 Environmental Requirements revealed "Temperature 16-24C (61-75F) Humidity 30-75% relative humidity" 3. Review of the laboratory's room temperature and humidity log revealed the laboratory defined "Temperature Range (15C)-(30C) Humidity Range (30%) -(80%)." 4. Review of the laboratory's CMS 116 application, the laboratory director signed on 12/30/2024, revealed Agena MassArray performed PGX tests and NGX tests. 5. Random review of the laboratory's room temperature and humidity logs in June 2023 and September 2024 for POST-PCR Room 2 revealed tthe Post-PCR Room 2 had 42 of 43 days of temperature and 39 of 43 days of humidity reviewed were out of ranges. 06/01/2023 Temperature 26C Humidity 26% 06/02/2023 Temperature 25C Humidity 26% 06/03/2023 Temperature 26C Humidity 26% 06/05/2023 Temperature 24C 06/06/2023 Temperature 25C 06/07/2023 Temperature 26C Humidity 26% 06/08 /2023 Temperature 25C Humidity 29% 06/09/2023 Temperature 26C Humidity 26% 06/10/2023 Temperature 27C Humidity 27% 06/12/2023 Temperature 25C Humidity 26% 06/13/2023 Temperature 25C Humidity 25% 06/14/2023 Temperature 26C Humidity 26% 06/15/2023 Temperature 26C Humidity 23% 06/16/2023 Temperature 27C Humidity 24% 06/17/2023 Temperature 27C Humidity 28% 06/19/2023 Temperature 27C Humidity 28% 06/20/2023 Temperature 27C Humidity 28% 06/21 /2023 Temperature 27C Humidity 23% 06/22/2023 Temperature 26C Humidity 23% 06/23/2023 Temperature 26C Humidity 23% 06/24/2023 Temperature 27C Humidity 27% 06/26/2023 Temperature 28C Humidity 21% 06/27/2023 Temperature 28C Humidity 21% 06/28/2023 Temperature 26C Humidity 23% 06/29/2023 Temperature 26C Humidity 23% 06/30/2023 Temperature 26C Humidity 23% 09/02/2024 Temperature 26C Humidity 25% 09/03/2024 Temperature 27C Humidity 25% 09/04 /2024 Temperature 27C Humidity 25% 09/05/2024 Temperature 26C Humidity 25% 09/06/2024 Temperature 26C Humidity 26% 09/09/2024 Temperature 27C Humidity 26% 09/10/2024 Temperature 27C Humidity 25% 09/11/2024 Temperature 28C Humidity 25% 09/12/2024 Temperature 28C Humidity 25% 09/13/2024 Temperature 28C Humidity 25% 09/16/2024 Temperature 28C Humidity 25% 09/17/2024 Temperature 28C Humidity 25% 09/18/2024 Temperature 28C Humidity 25% 09/19 /2024 Temperature 27C Humidity 25% 09/20/2024 Temperature 27C Humidity 26% 09/23/2024 Temperature 28C Humidity 25% 09/24/2024 Temperature 28C Humidity 25% 09/25/2024 Temperature 28C Humidity 26% 09/26/2024 Temperature 28C Humidity 26% 09/27/2024 Temperature 27C Humidity 27% 09/30/2024 Temperature 28C Humidity 24% 6. Review patient results for the above dates revealed 34 patients had PGX and NGX testing. 06/07/2023 19 PGX testing Sample ID: 41220840303010 Sample ID: 41220840303120 Sample ID: 41220840303101 Sample ID: 41220840303152 Sample ID: 41220840303099 Sample ID: 41220840303100 Sample ID: 41220613310740 Sample ID: 41220840303154 Sample ID: 41220851703105 Sample ID: 41220840303153 Sample ID: 41220840303124 Sample ID: 41220840303098 Sample ID: 41220840303119 Sample ID: 41220840404020 Sample ID: 41220840303137 Sample ID: 41220840303139 Sample ID: 41220840303138 Sample ID: 41220840303033 Sample ID: 41220840303014 09/17/2024 7 PGX testing Sample ID: IGL240002214 Sample ID: IGL240002215 Sample ID: IGL240002216 Sample ID: IGL240002220 Sample ID: IGL240002225 Sample ID: IGL240002179 Sample ID: 41231150108154 09/19/2024 5 NGX testing Sample ID: 41231150108194 Sample ID: 41240350414343 Sample ID: 41240350414533 Sample ID: 41240350414621 Sample ID: 41231150108206 09/23/2024 3 PGX testing Sample ID: IGL240002215 Sample ID: IGL240002220 Sample ID: IGL240002225 7. An interview on 02/07/2025 at 10:50 am in the Inventory & QA room, the general -- 2 of 3 -- supervisor (as indicated on the CMS 209 form) confirmed the above finding. Key: C=Celcius F=Fahrenheit CMS=Center for Medicare and Medicaid Services D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on the review of CAP proficiency testing records in 2022, the laboratory's policy, and confirmed in an interview found the laboratory failed to have documentation of evaluating results returned as "Code 26: Educational Challenge" by the proficiency testing program for one of three SARS-CoV-2 Molecular events. The findings were: 1. Review of CAP Surveys and Anatomic Pathology Education Programs for SARS-CoV-2 Molecular COV2-A 2022 Participant Summary revealed "Code: 26. Exception Reason Code Description: Educational challenge. Action Required: Review participant summary for comparative results and document performance accordingly ..." 2. Review of the laboratory's policy titled Proficiency Testing (Document#: GEN-009) under Ungraded PT Challenges revealed "The laboratory assesses its performance on PT challenges that are not graded by performing and in-house comparison to the majority. PT Challenges are intended to be graded by CAP but were not due to the following reasons: ...Laboratory results were not graded due to lack of consensus." 3. Review of CAP proficiency testing in 2022 revealed the laboratory failed to have documentation of evaluating results returned as "Code 26: Educational Challenge" by the proficiency testing program for 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 -- one of three SARS-CoV-2 Molecular events. COV2-A 2022 Kit#1 Test: N Ct Value Specimen COV2-01 Your Result: 31.55 Specimen COV2-03 Your Result: 31.13 COV2-A 2022 Kit#2 Test: N Ct Value Specimen COV2-01 Your Result: 31.84 Specimen COV2-03 Your Result: 30.95 4. An interview with the general supervisor (GS) on 1/30/23 at 11:38 am in the conference room confirmed the above findings Key: CAP=College of American Pathologists -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed in response to complaint TX00370229 for compliance with CMS 42 CFR regulations. The laboratory failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780 resulting in the following IMMEDIATELY JEOPARDY findings: D5300 493.1240: Pre-Analytic Systems D6076 493.1441 Laboratory Director; high complexity The laboratory abated the immediate jeopardy and voluntarily started testing per the EUA approved manufacturer's instructions as evidenced by their letter dated 1/8/21. Complaint TX00370229 was substantiated with 2 of the 4 allegations with deficiencies cited. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the manufacturer's instructions, review of the laboratory's preanalytical studies, review of the laboratory policy, and review of patient records, the laboratory failed to meet the requirements for preanalytic systems, as evidenced by: 1. The laboratory failed to document preanalytical studies for the nasopharyngeal specimens for the qualitative detection of nucleic acid of SARS-CoV-2 using the non EUA approved thermocyler (Mic-PCR) with the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. Refer to D5311-I 2. The laboratory failed to analyze saliva specimens within the manufacturers specimen stability for the qualitative detection of 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 -- SARS-CoV using the FluidIGM Advanta Dx SARS-CoV-2 RT-PCR Assay. Refer to D5311-II 3. The laboratory failed to document a client service manual to include conditions of specimen transport and the specimen acceptability and rejection criteria for the nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit. Refer to D5317 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 the manufacturer's instructions, laboratory records, patient test records, and confirmed in interview, the laboratory failed to document preanalytical studies for the nasopharyngeal specimens for the qualitative detection of nucleic acid of SARS-CoV-2 using the non EUA approved thermocyler (Mic-PCR) with the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. Findings were: 1. Review of the laboratory records revealed the laboratory used the thermocycler Mic-PCR with the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit for the qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from individuals suspected of COVID-19. 2. Review of the Instructions of Use for the EUA approved test Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (PID-1048-02) under Material Required revealed 1 validated thermocycler CoDx Box (BMS, Bio Molecular Systems). There was no documentation that the Mic-PCR was a validated thermocyler under the EUA approved list. 3. Further review of the Instructions for Use for the EUA approved test Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (PID-1048-02) under Sample Collection, Transport, and Storage revealed "the sample selection, collection, storage, and handling play an essential part in the performance of nucleic acid assays. Thus, valuable information is presented here to help laboratories develop better procedures for the analysis of results and troubleshooting other problems...Nasopharyngeal swab AND oropharyngeal swab (NP /OP swab): use only synthetic fiber swabs with plastic shafts. Do not us D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: %TX_RTF32 14.0.520.503; Based on review of the laboratory policies and confirmed in interview, the laboratory failed to document a client service manual to include conditions of specimen transport and the specimen acceptability and rejection criteria for the nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart -- 2 of 7 -- Coronavirus Disease 2019 (Covid-19) kit. Findings were: 1. Review of the laboratory client service manual Specimen Collection and Handling for Laboratory Testing of Sars COVID 19 by PCR revealed no documentation of conditions of specimen transport and the specimen acceptability and rejection criteria for the nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit. 2. An interview with the technical supervisor on 1/5/21 at 1615 hours in the office confirmed the above findings. She stated that the laboratory used the client's instructions for their waived Covid-19 test BD VeritorTM System, but she confirmed that the laboratory had not established the specimen requirements for their clients for their test. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and staff interview, the laboratory's quality assurance program failed to detect problems in preanalytic systems. 1. The laboratory failed to document complete preanalytical studies for both nasopharyngeal and saliva specimens for SARS-CoV 2 testing. (Refer to D5311-I, II) 2. The laboratory failed to establish a complete client service manual to include nasopharyngeal specimens. (Refer to D5317) D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the laboratory records, manufacturer's instructions, review of the CDC (Centers for Disease Control and Prevention) website, surveyor observations, review of the patient test records from December 2020 and January 2021 and confirmed in interview, the laboratory failed to follow manufacturer's instructions for Covid-19 shipment of nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit. Findings were: 1. Review of the laboratory records revealed the laboratory performed SARS-CoV 2 testing testing using the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit starting in December 2020. 2. Review of the Instructions for Use for the Co- Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit (PID-1048-02) under Sample Shipping revealed "Specimens known to be, or suspected of, containing SARS-CoV-2 that require shipment by air should be shipped on dry ice as a Biological Substance Category B, UN3373. International regulations, as described in the WHO Guidance on Regulations for the Transport of Infectious Substances 2015- 2016, should be followed (CDC, 2020). If ground transportation is needed, the specimen should be shipped frozen overnight with enough ice to keep it frozen -- 3 of 7 -- throughout transit. After the collection of the sample and transfer to the clinical lab, the sample will receive an entry into the laboratory system." 3. Review of the CDC website under Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) under Specimen Packing and Shipping revealed "Pack and ship suspected and confirmed SARS-CoV-2 patient specimens, cultures, or isolates as UN 3373 Biological Substance, Category B, in accordance with the current edition of 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 a review of manufacturer's instructions, surveyor observation, and staff interview, it was revealed that the laboratory failed to have documentation of temperature monitoring in the supply room where laboratory supplies for patient testing were stored. Findings include: 1. A review of the manufacturer's instructions for the Gibco PBS 7.4 phosphate buffered saline (10010-031) revealed the storage requirements of 15 - 30C. 2. Surveyor observation, during a tour of the laboratory on 1 /5/21 at 1210 hours, found 146 bottles of Gibco PBS 7.4 phosphate buffered saline in the supply room with no means of temperature monitoring. The Gibco PBS 7.4 phosphate buffered saline is used for the Advanta Dx SARS-CoV-2 RT PCR test run on the Biomark HD System. 3. A review of the laboratory's testing records revealed the laboratory began testing the Advanta Dx SARS-CoV-2 RT PCR test on September 10, 2020 and estimated an annual test volume of 50,000. 4. An interview with technical supervisor #2 (as indicated on the CMS 209 form) on 1/5/21 at 12:35 p.m. in the supply room, stated that she was not aware that the temperature needed to be monitored in the supply room. This confirmed the above findings. D5423 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(2) Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: (2)(i) Accuracy. (2)(ii) Precision. (2)(iii) Analytical sensitivity. (2)(iv) Analytical specificity to include interfering substances. (2)(v) Reportable range of test results for the test system. (2)(vi) Reference intervals (normal values). (2)(vii) Any other performance characteristic required for test performance. This STANDARD is not met as evidenced by: -- 4 of 7 -- Based on review of the manufacturer's instructions, laboratory records, patient test records, and confirmed in interview, the laboratory failed to document complete establishment studies for the thermocyler (Mic-PCR) not validated for use for the EUA approved test Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. Findings were: 1. Review of the laboratory records revealed the laboratory used the thermocycler Mic-PCR with the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit for the qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from individuals suspected of COVID-19. 2. Review of the Instructions of Use for the EUA approved test Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (PID-1048-02) under Material Required But not Included with the Test revealed no documentation of the Mic-PCR as a validated thermocyler. 3. Review of the laboratory verification records revealed no documentation of the establishment studies for 1 of 1 Mic-PCR (S/N M0003857) to include the limit of detection, sensitivity, cross reactivity and preanalytical studies. Cross refer to D5311-I 4. Random review of the laboratory patient records from December 2020 to January 2021 revealed the laboratory performed the following 16 SARS-CoV-2 testing using the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit with the unapproved thermocylcer Mic-PCR. Date: 01/03/2021 STEAMEC0001096 STEAMEC0001112 STEAMEC0001113 STEAMEC0001097 date: 01/02/2021 STEAMEC0001086 STEAMEC0001090 Date: 01/04/2021 STEAMEC0001122 STEAMEC0001123 STEAMEC0001126 Date: 12/29/2020 STEAMEC0001024 D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of the laboratory records, surveyor observations, patient test records, and confirmed in interview, it was revealed the laboratory quality assessment failed to identify and correct problems in the analytic systems. Refer to D5411, D5423 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: TX_RTF32 14.0.520.503; Based on review of laboratory's policy, patient test records, and manufacturer's instructions, the laboratory director failed to provide overall management and direction, as evidenced by: 1. The laboratory director failed to ensure quality laboratory services for high complexity preanalytic and analytic -- 5 of 7 -- systems. Refer to D6082. 2. The laboratory director failed to ensure quality assessment programs were established and maintained to assure the quality of laboratory services. Refer to D6094. D6082 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(1) The laboratory director must ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing. This STANDARD is not met as evidenced by: Based on review of the manufacturer's instructions, laboratory's preanalytical studies, surveyor observation of specimens received by the facility, patient records, laboratory policy, laboratory establishment studies, and patient records, the laboratory director failed to ensure quality laboratory services for high complexity preanalytic and analytic systems, as evidenced by: 1. The laboratory failed to document preanalytical studies for the nasopharyngeal specimens for the qualitative detection of nucleic acid of SARS-CoV-2 using the non EUA approved thermocyler (Mic-PCR) with the Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. Refer to D5311-I 2. The laboratory failed to analyze saliva specimens within the manufacturers specimen stability for the qualitative detection of SARS-CoV using the FluidIGM Advanta Dx SARS-CoV-2 RT-PCR Assay. Refer to D5311-II 3. The laboratory failed to document a client service manual to include conditions of specimen transport and the specimen acceptability and rejection criteria for the nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit. Refer to D5317 4. The laboratory failed to follow manufacturer's instructions for Covid-19 shipment of nasopharyngeal specimens for testing with the Co-Diagnostics Logix Smart Coronavirus Disease 2019 (Covid-19) kit. Refer to D5411 5. The laboratory failed to document complete establishment studies for the thermocyler (Mic-PCR) not validated for use for the EUA approved test Logix Smart Coronavirus Disease 2019 (COVID-19) Kit. Refer to D5423 D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment 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 review of the manufacturer's instructions, laboratory's preanalytical studies, laboratory policies, surveyor observation of specimens received by the facility, patient records, the laboratory director failed to ensure quality assessment programs were established and maintained to assure the quality of laboratory services, as evidenced by: 1. The laboratory failed to establish and follow written policies/procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems. Refer to D5391. 2. The laboratory failed to -- 6 of 7 -- establish and follow written policies/procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems. Refer to D5791. D6174 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(a) Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a review of the submitted CMS 209 form, a review of the laboratory's personnel records, a review of the laboratory's testing records, and staff interview, it was revealed that the laboratory failed to ensure that 7 of 7 testing personnel performed tests authorized by the laboratory director. Findings include: 1. A review of the laboratory's policy titled 'Personnel SOP' revealed the following: "Each individual performs only those high complexity tests that are authorized by the laboratory director and require a degree of skill commensurate with the individual's education, training or experience, and technical abilities." 2. A review of the submitted CMS 209 form revealed the laboratory employed 7 testing personnel to perform the Advanta Dx SARS-CoV-2 RT PCR test run on the Biomark HD System (high complexity). 3. A review of the laboratory's personnel records revealed no documentation of the laboratory director's authorization to test for the 7 testing personnel. 4. A review of the laboratory's testing records revealed the laboratory began testing the Advanta Dx SARS-CoV-2 RT PCR test on September 10, 2020 and estimated an annual test volume of 50,000. 5. An interview with the laboratory director on 1/5/21 at 4:23 p.m. in the office, confirmed the above findings. -- 7 of 7 --