Garden State Urology Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on November 10, 2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1445 Condition: Laboratories performing high complexity testing; laboratory director 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 an office review of the CASPER reports 153 and 155 and proficiency testing 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 -- provider reports, the laboratory failed to achieve 80% or more in two consecutive events for Mycobacteriology for the analyte Mycobacterium Tuberculosis Complex (MTBC), with the American Proficiency Institute (API). Refer to D2037 D2037 MYCOBACTERIOLOGY CFR(s): 493.825(e) (e) Failure to achieve an overall testing event score of satisfactory performance for 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 the CASPER 155 report and graded results from American Proficiency Institute (API). The laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive events in the subspecialty Mycobacteriology for the analyte Mycobacterium Tuberculosis Complex (MTBC) resulting in initial unsuccessful performance. The findings include: 1) A review of the CASPER 155 report revealed the following. a) The laboratory scored 40% for MTBC in event 1- 2025. b) The laboratory scored 60% for MTBC in event 2-2025. 2. A review of API graded results confirmed the laboratory failed two consecutive Proficiency Testing (PT) events. 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 review of the CASPER 155 report and graded results from the American Proficiency Institute (API). The Laboratory Director (LD) failed to provide overall management and direction to laboratory personnel to ensure that the Proficiency Testing (PT) surveys are performed satisfactorily and in compliance with Clinical Laboratory Improvement Amendments (CLIA) regulations. The findings include: 1. The LD failed to ensure PT surveys are performed satisfactorily and in compliance with CLIA regulations. Cross refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under subpart H of this part; This STANDARD is not met as evidenced by: Based on a review of the CASPER 155 report and graded results from American Proficiency Institute (API), the Laboratory Director (LD) failed to ensure successful participation in a Department of Health and Human Services (DHHS) approved -- 2 of 3 -- Proficiency Testing (PT) program for two consecutive PT events for the analyte Mycobacterium Tuberculosis Complex (MTBC), resulting in initial unsuccessful performance. Refer to D2037. -- 3 of 3 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to maintain the Work Records (WR) and Comparative Evaluation (CE) for Mycobacteriology and Urinary Tract Infection (UTI) panel performed with American Proficiency Institute (API) in the calendar years 2024 and 2025 1. There were no WR for all PT events in the calendar years 2024 and 2025. 2. There was no CE for events 1 of 2024 and 1 and 2 of 2025. 3. The GS confirmed on 11/5/25 at 11:00am the the WR for PT were not maintained. 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 surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to review and evaluate PT results obtained from the American Proficiency Institute (API) for Microbiology in the calendar year 2024 . The findings include: 1. The laboratory did not evaluate "Not Graded 11", "See Data Summary" responses from API in event 3, 2024 for the following: a. Resistance Gene: AmpC, Samples UTI-11, 13, 14. and 15. b. Resistance Gene: CTX-M , Samples UTI-11, 13, 14. and 15. c. Resistance Gene: CTX-M Group 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 -- 1 Samples UTI-11, 13, 14. and 15. d. Resistance Gene: CTX-M Group 2 Samples UTI- 11, 13, 14. and 15. e. Resistance Gene: dfrA Samples UTI-11, 13, 14. and 15. f. Resistance Gene: Emb Samples UTI-11, 13, 14. and 15. g. Resistance Gene: IMP Samples UTI-11, 13, 14. and 15. h. Resistance Gene: KPC Samples UTI-11, 13, 14. and 15. i. Resistance Gene: mecA Samples UTI-11, 12, 13, 14. and 15. j. Resistance Gene: qnrA Samples UTI-11, 13, 14. and 15. k. Resistance Gene: qnrS Samples UTI- 11, 13, 14. and 15. l. Resistance Gene: sul1 Samples UTI-11, 13, 14. and 15. m. Resistance Gene: sul2 Samples UTI-11, 13, 14. and 15. n. Resistance Gene: vanA Samples UTI-11, 13, and 14. o. Resistance Gene: vanB Samples UTI-11, 12, 13, and 14. p. Resistance Gene: VIM Samples UTI-11, 13, 14. and 15. q. Aerococcus urinae: Sample UTI-15. 2. The laboratory did not evaluate "Not Graded 3", "See Data Summary" responses from API in event 2, 2024 for the following: a) Rifampin resistance (molecular): Samples MTM-06 and 08 3. The GS confirmed on 11/5/25 at 10:30 am. the laboratory failed to evaluate the above mentioned coded results. Note: This was previously cited 10/18/23. 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 surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to verify the accuracy of Microbiology test results obtained from the American Proficiency Institute (API) fro the 2nd and 3rd events of 2024. The findings include: 1. The PT program assigned an artificial score of 100%, results were reported with the comments "See data summary", "Not Graded 11", and "Not Graded 3" 2. The laboratory did not evaluate "Not Graded 11", "See Data Summary" responses from API in event 3, 2024 for the following: a. Resistance Gene: AmpC, Samples UTI-11, 13, 14. and 15. b. Resistance Gene: CTX-M , Samples UTI-11, 13, 14. and 15. c. Resistance Gene: CTX-M Group 1 Samples UTI-11, 13, 14. and 15. d. Resistance Gene: CTX-M Group 2 Samples UTI- 11, 13, 14. and 15. e. Resistance Gene: dfrA Samples UTI-11, 13, 14. and 15. f. Resistance Gene: Emb Samples UTI-11, 13, 14. and 15. g. Resistance Gene: IMP Samples UTI-11, 13, 14. and 15. h. Resistance Gene: KPC Samples UTI-11, 13, 14. and 15. i. Resistance Gene: mecA Samples UTI-11, 12, 13, 14. and 15. j. Resistance Gene: qnrA Samples UTI-11, 13, 14. and 15. k. Resistance Gene: qnrS Samples UTI- 11, 13, 14. and 15. l. Resistance Gene: sul1 Samples UTI-11, 13, 14. and 15. m. Resistance Gene: sul2 Samples UTI-11, 13, 14. and 15. n. Resistance Gene: vanA Samples UTI-11, 13, and 14. o. Resistance Gene: vanB Samples UTI-11, 12, 13, and 14. p. Resistance Gene: VIM Samples UTI-11, 13, 14. and 15. q. Aerococcus urinae: Sample UTI-15. 3. The laboratory did not evaluate "Not Graded 3", "See Data Summary" responses from API in event 2, 2024 for the following: a) Rifampin resistance (molecular): Samples MTM-06 and 08 4. The GS confirmed on 11/5/25 at 11:20 am that the accuracy of the PT results were not verified and the PT program assigned an artificial score of 100%. Note: This was previously cited 10/18/23 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT -- 2 of 4 -- CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation of reagents, review of the Procedure Manual (PM) and interview with the General Supervisor (GS) the laboratory failed to discard expired reagents used for Urinary Tract Infection Polymerase Chain Reaction (UTIPCR) testing from 10/19/23 to 11/5/25. The findings include: 1. The PM stated "All expired reagents, solutions, control materials and other supplies will be discarded and not used passed the expiration date." 2. Surveyor observation of the reagents revealed the following to be expired: a) One box of Taqman Master Mix lot 2791378 expired on 8 /31/24. b) One box of 20x SSC Lot 504627 expired on 9/30/24. c) One Quantstudio Digital PCR plate Lot 4619025 expired on 3/7/24. d) One box of Quantstudio 12k flex open array accessories kit lot 2211969 expired on 6/21/25. e) Two boxes of Quantstudio 12k flex open array accessories kit- starter lot 2208388 expired on 9/15 /23. f) Two boxes of Empty Array Card Kit-4pk lot 59313 expired on 7/23/22. 3. The GS stated "the reagents were kept but not used." 4. The GS confirmed on 11/5/25 at 1: 20 pm, the laboratory failed to discard expired reagents used for UTIPCR testing. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) (a)(2) Function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturers established limits before patient testing is conducted. (b) Equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer. The laboratory must do the following: This STANDARD is not met as evidenced by: A) Based on the lack of Maintenance Records (MR) for pipettes, observation of pipettes, review of the Procedure Manual (PM) and interview with the General Supervisor (GS), the laboratory failed to perform and document maintenance on pipettes used for specimen preparation for Urinary Tract Infection Polymerase Chain Reaction (UTIPCR) testing from 10/19/23 to 11/5/25. The findings include: 1. The PM stated " Maintenance checks of all equipment will be performed as defined by the manufacturer and with at least the frequency specified by the manufacturer." 2. Two Thermoscientific Pipettes had calibration stickers with due dates of 1/4/21 and 7/4/21. 3. Two Tacta Mechanical Pipettes did not have calibration dates on them. 4. The GS confirmed on 11/5/25 at 1:00 pm, the laboratory did not perform and document maintenance on the pipettes. B) Based on the lack of Maintenance Records (MR) for fume hoods, observation of fume hoods, review of the PM and interview with the General Supervisor (GS), the laboratory failed to perform and document maintenance on fume hoods used for specimen preparation for UTIPCR testing from 10/19/23 to 11 /5/25. The findings include: 1. The PM stated " The fume hoods are to be verified for function yearly. If the units use filters these are to be changed according to manufacturers guidance." 2. There were was do documented evidence the laboratory changed the filters on two Air Clean 600 fume hoods. 3. The GS confirmed on 11/5 -- 3 of 4 -- /25 at 1:05 pm, the laboratory did not perform and document maintenance on the two fume hoods. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Reports (TR) for Urine Cytology tests and interview with the General Supervisor (GS) the laboratory failed to have all the required information from 10/19/23 to 11/5/25. The findings include: 1. TR for Urine Cytology did not include the address of the laboratory where the technical component was being performed. 2. The GS confirmed on 11/5/25 at 1:30 pm, the laboratory did not have all the required information on Urine Cytology TR. -- 4 of 4 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supervisor (TS), the laboratory failed to establish and maintain the accuracy of Microbiology tests from 11/19/21 to the date of survey. This findings include. 1. The PT provider used by the laboratory American Proficiency Institute (API) did not include all analytes run on the Urinary Tract Infection (UTI) panel performed by the laboratory. 2. 1st event 2023 did not include C. Amalonaticus, C. trachomatis, CMV, E. aerogenes, HHV6, HBKV-VP2, G. Vaginalis, M. tuberculosis, N. gonorrhoeae, S. enterica, S. Haaemolytics, T. Gaginalis, U. parvum. 3. The TS confirmed on 10/18/23 at 12:45 pm not all analytes for microbiology PT were performed. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on surveyor observation of the laboratory reagents, reagent refrigerator and interview with the Technical Supervisor (TS), the laboratory failed to ensure Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- protection from chemical and physical hazards from 5/31/22 to the date of survey. The findings include: 1. All flammable and inhalation risk reagents were not kept in a flammable cabinet. 2. One case of 100% alcohol reagent and one case of 80% alcohol reagent were observed on a wire rack. 3. The laboratory stored a beverage in a refrigerator that was labeled No Food or Drink. 4. The TS confirmed on 10/18/23 at 12:00 pm that the laboratory did not ensure protection from chemical and physical hazards. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supwervisor (TS), the laboratory failed to review and evaluate PT results obtained from the American Proficiency Institute (API) for Microbiology in the calendar year 2023 . The findings include: 1. The laboratory did not evaluate "Not Graded 11", "See Data Summary" responses from API in event 1, 2023 for the following: a. Resistance Gene: CTX-M Group 1 Samples UTI-01,02,03 and 04. b. Resistance Gene: CTX-M Group 2 Samples UTI-03 and 04. c. Resistance Gene: Emb Samples UIT-01, and 05 d. Resistance Gene: IMP Samples UTI-01,03 and04. e. Resistance Gene: KPC Samples UTI-01,03 and 04. f. Resistance Gene: OXA Samples UTI-01,03 and 04. g. Resistance Gene: qnrA Samplse UTI-01,03 and 04. h. Resistance Gene: qnrS Samples UTI-01,03, and 04. i. Resistance Gene: vanA Samples UTI-01,02,03,04 and 05. j. Enterobacter Sample UIT-5. 2. The laboratory did not evaluate "Not Graded 11", "See Data Summary" responses from API in event 2, 2023 for the following: a.. Resistance Gene: AmpC, Samples UTI-07 and 09. b. Resistance Gene: CTX-M Samples UTI-07 and 09. c. Resistance Gene: CTX-M Group 1 Samples UTI-07 adn 09. d. Resistance Gene: CTX-M Group 2 Samples UIT-07 adn 09. e. Resistance Gene: dfrA Samples UIT-07 and 09. f. Resistance Gene: EmB Samples UTI-06,07, 09,a adn 10. g. Resistance Gene: IMP Samples UTI-07, and 09. h. Resistance Gene: OXA Samples UTI-07, and 09. i. Resistance Gene: qnr Samples UTI-07, and 09. j. Resistance Gene: qnrA Samples UTI-07, and 09. k. Resistance Gene: qnrS Samples UTI-07, 09 and 10. l .Resistance Gene: sul Samples UTI-07 and 09. m. Resistance Gene: sul1 Samples UTI-07 and 09. n. Resistance Gene: sul2 Samples UTI-07 and 09. o. Resistance Gene: vanA Samples UTI-06, 08, 09 and 10. p. Resistance Gene: vanB Samples UTI-06, 08, 09 and 10. 3. The TS confirmed on at 10: 30 am on 10/18/23 that the laboratory failed to evaluate the above mentioned coded results. 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). -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supervisor (TS), the laboratory failed to verify the accuracy of Microbiology test results obtained from the American Proficiency Institute (API) 2nd event of 2022 and 1st event 2023. The findings include: 1. The PT program assigned an artificial score of 100%, results were reported with the comments "See data summary", "Not Graded 11". 2. There was no documented evidence the laboratory verified the following for event 1st event 2023. a. Resistance Gene: CTX-M Group 1 Samples UTI-01,02,03 and 04. b. Resistance Gene: CTX-M Group 2 Samples UTI-03 and 04. c. Resistance Gene: Emb Samples UIT-01, and 05 d. Resistance Gene: IMP Samples UTI-01,03 and04. e. Resistance Gene: KPC Samples UTI-01,03 and 04. f. Resistance Gene: OXA Samples UTI-01,03 and 04. g. Resistance Gene: qnrA Samplse UTI-01,03 and 04. h. Resistance Gene: qnrS Samples UTI-01,03, and 04. i. Resistance Gene: vanA Samples UTI-01,02,03,04 and 05. j. Enterobacter Sample UIT- 5. 3. There was no documented evidence the laboratory verified the following for the 2st event of 2023. a.. Resistance Gene: AmpC, Samples UTI-07 and 09. b. Resistance Gene: CTX-M Samples UTI-07 and 09. c. Resistance Gene: CTX-M Group 1 Samples UTI-07 adn 09. d. Resistance Gene: CTX-M Group 2 Samples UIT-07 adn 09. e. Resistance Gene: dfrA Samples UIT-07 and 09. f. Resistance Gene: EmB Samples UTI-06,07, 09,a adn 10. g. Resistance Gene: IMP Samples UTI-07, and 09. h. Resistance Gene: OXA Samples UTI-07, and 09. i. Resistance Gene: qnr Samples UTI-07, and 09. j. Resistance Gene: qnrA Samples UTI-07, and 09. k. Resistance Gene: qnrS Samples UTI-07, 09 and 10. l .Resistance Gene: sul Samples UTI-07 and 09. m. Resistance Gene: sul1 Samples UTI-07 and 09. n. Resistance Gene: sul2 Samples UTI-07 and 09. o. Resistance Gene: vanA Samples UTI-06, 08, 09 and 10. p. Resistance Gene: vanB Samples UTI-06, 08, 09 and 10. 3. The TSD confirmed on 10 /18/23 at 11:20 am that the accuracy of the PT results were not verified and the PT program assigned an artificial score of 100%, 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 surveyor review of the Procedure Manual (PM) and interview with Technical Supervisor (TS) the laboratory failed to follow the procedure for "General QA Plan" from 5/31/22 to the date of survey. The findings include: 1. The PM states "Monthly the Medical Director (or his designee) is to review the following report: Monthly Quality Assessment Report (MQAR)." 2. There was no documented evidence the aforementioned report was reviewed. 3. The TS confirmed on 10/18/23 at 10:45 am the laboratory failed to follow the above mentioned procedure. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where -- 3 of 6 -- the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on surveyor review of the Test Reports (TR) for Bacteriology, Mycology, Parasitology and Virology tests performed on the Quantstudio 12 Flex Real- Time PCR System and interview with the Technical Supervisor (TS) the laboratory failed to ensure the TR included all the required information from May 2022 to the date of survey. The findings include: 1. 10 out of 10 TR did not indicate the address of the laboratory location where the test was performed. 2. 10 out of 10 TR did not indicate the specimen source. 3. 10 out of 10 TR did not include the required statement for tests that have not been FDA-cleared or approved, "The performance characteristics of this test were determined by Garden State Urology LLC." 4. The TS confirmed on 10/18/23 at 12:00 pm, the laboratory failed to ensure the TR included all the required information. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Techincal Supervisor (TS), the Laboratory Director (LD) failed to ensure that PT samples were tested for Microbiology tests in the calendar year 2022. The TS confirmed on 10/18/23 at 11:45 pm that the LD did not ensure PT Microbiology PT samples were tested. 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 a interview with the Techincal Supervisor (TS), the Laboratory Director (LD) failed to provide overall management and direction to the laboratory to ensure that laboratory testing is performed satisfactorily and in compliance with the CLIA regulations from May 2022 to the date of the survey. 1. The LD failed to ensure that PS were adequate . Cross refer to D6086. 2. The LD failed to ensure that Proficiency Testing results were reviewed and evaluated. Cross refer to D6091. 3. the LD failed to -- 4 of 6 -- ensure to specify in writing the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing. Cross refer to D6107. 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 surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the Laboratory Director (LD) failed to ensure that PS were adequate to perform Bacteriology, Virology, Mycology and parasitology tests performed on the Applied bioscience Quantstudio 12K Flex analyzer from May 2022 to the date of survey. The findings include: 1. There was no documented evidence a carryover study was performed. 2. There was no documented evidence of a stability study. 3. There were no Manufactures Packet Inserts (MPI) for any materials used to perform the PS. 4. There were no final reports for patients results used in the PS. 5. There were no original raw data reports with time and date. 6. There was no Comment for Sample P2317950 when the the validation run failed. 7. There was no Comment for Sample P2317027 when the validation run failed. 8. Clinical Validation Run Sample P2318014 Microbiology results were reported as S. agalactiae but the Original Run results and Validation run results reported A. Urinae. The Polymerase Chain Reaction (PCR) results did not match. 9. The TS confirmed on 10/18/23 at 12pm the LD failed to ensure that PS were adequate. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require