North Clark Medical Group

Summary Statement of Deficiencies D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on record review, interview, and observation the laboratory failed to fulfill the Technical Supervisor responsibilities requirements found in 493.1451. The technical supervisor failed to validate one of one Laboratory Information System (LIS), for Free Thyroxine (FT4), implemented 8/14/24, and ran on the Roche Cobas 6000 e601 (Serial Number=1263-09) and three (Pt-12, Pt-13, Pt-14) of three patients reviewed on 12/09/24 and three (Pt-15, Pt-16, Pt-17) of eight patients reviewed on 12/10/24. (Refer to D6115) The technical supervisor failed resolve technical problems and ensure remedial actions were taken whenever test systems deviate from the laboratory's established performance specification by failing to ensure the laboratory successfully completed six-month Calibration Verification for two of two Calibration Verification for Testosterone non-regulated immunoassays ran on the Roche Cobas 6000 e601 (Serial Number=1263-09) and three (Pt-15, Pt-16, Pt-17) of eight patients reviewed on 12/10/24. (Refer to D6119) D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. 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 observation, record review and interview, the technical supervisor failed to validate one of one Laboratory Information System (LIS), for Free Thyroxine (FT4), implemented 8/14/24, and ran on the Roche Cobas 6000 e601 (Serial Number=1263- 09) and three (Pt-12, Pt-13, Pt-14) of three patients reviewed on 12/09/24 and three (Pt-15, Pt-16, Pt-17) of seven patients reviewed on 12/10/24. Findings included: 1. On 12/10/2024 at 11:16 am. review of FT4 results submitted for the College of American Pathologist (CAP) proficiency testing evaluation 11/1/2024, indicated results from the LIS results did not match the results observed coming from The Roche Cobas 6000 e601 for the same event: 9/24/24-CAP C-C 2024 LIS Cobas CAP, CHM11C FT4 IV=HIGH FT4 4=2.51 CAP, CHM12C FT4 IV=HIGH FT4 4=1.92 CAP, CHM13C FT4 IV=NORMAL FT4 4=0.91 CAP, CHM14C FT4 IV=HIGH FT4 4=1.67 CAP, CHM15C FT4 IV=HIGH FT4 4=2.2 2. On 12/09/2024 at 2:19 pm, SP-1 (Technical Supervisor) indicated that Roche had made changes in the FT4 reagent and validated the new FT4 4 on the Cobas 6000 e601 on 2/28/24, but the laboratory did not start using the new FT4 4 reagents until 8/14/24. 3. Review of medical records on 12/09/24 indicated: a) Pt-12- FT4 IV= NORMAL, tested on 9/26/2024 at 5:34 pm, Normal Range=0.9-1.7 ng/dL b) Pt-13 - FT4 IV =NORMAL, tested on 9/30/2024 at 4:07 pm, Normal Range= 0.9-1.7 ng/dL c) Pt-14- FT4 IV=NORMAL, tested on 09/24/2024 at 3:29 pm, Normal Range= 0.9-1.7 ng/dL 4. Review of medical records on 12/10/24 indicated: a) Pt-15- FT4 IV=1.6 ng/dL, tested on 10/02/2024 at 1:05 pm, No Normal Range b) Pt-16 - FT4 IV =1.33 ng/dL, tested on 10/04/2024 at 12:35 pm, No Normal Range c) Pt-17- FT4 IV=1.08 ng/dL, tested on 10/01/2024 at 3:39 pm, No Normal Range 5. In an interview on 12/10/24 at 1:00 pm, SP-1 (Technical Supervisor), confirmed that no LIS validation had been completed after the implementation of the new FT4 4 reagents on 8/14/24 before resuming patient testing. 6. Annual volume for Free Thyroxine (FT4) =3,100 D6119 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(6) The technical supervisor is responsible for ensuring that patient test results are not reported until all

Summary Statement of Deficiencies D0000 51197 A complaint survey was completed on 10/11/2024. The following condition level deficiencies existed: 42 C.F.R. 493.1250 Condition: Analytic Systems 42 C.F.R. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain one of one Individualized Quality Control Plan (IQCP), implemented in 2016, and currently in use, for 20 of 20 analytes run on the "BioFire Gastrointestinal Panel (GI) Kit", and 20 of 20 analytes run on the "FilmArray Respiratory Panel (RP) Kit" using the Biomerieux FilmArray, Microbiology/Virology analyzer, (Serial Number=FA3224) and two (Pt-1 and Pt-9) of eleven patients reviewed. Findings included: 1. In an interview on10/1/24 at 10:06 am, SP-1 (Technical Supervisor), confirmed that Biomerieux FilmArray testing is not being batched, and Quality Control (QC) is performed monthly, and with new reagent lots. At 2:09 pm, SP-1, affirmed, that an IQCP was implemented a year after they installed the Biofire, and was signed by SP-7 (Former Laboratory Director). 2. Review of the Procedure #: D6.1, signed by SP-2 (laboratory director) on 1/18/2024, identified the following viruses and bacteria were tested using the "FilmArray Respiratory Panel (RP) Kit": Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Human Metapneumovirus, Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtypeH1-2009, Influenza B, Parainfluenza Virus 1, Parainfluenza Virus 2, Parainfluenza Virus 3, Parainfluenza Virus 4, Human Rhinovirus/Enterovirus, 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 -- Bordetella pertussis, and Chlamydophila pneumonia. Page 4 of 16, 4. External controls C. required positive and negative controls to be run once a month when there is a test requisition and on new lots of reagent kits. The policy did not mention an Individualized Quality Control Plan or a risk assessment. 3. Review of the Procedure #: D6.2, signed by SP-2 on 1/18/2024, identified the following bacteria, parasites and viruses identified using the "BioFire Gastrointestinal (GI) Panel Kit": Campylobacter, Clostridium difficile toxin A/B, Plesiomonas shigelloides, Vibrio, including specific identification of Vibrio Cholerae, Yersinia enterocolitica ,Enteroaggregative Escherichia coli (EAEC), Enteropathogenic Escherichia coli (ETEC), Enteropathogenic Escherichia coli (ETEC) It/st, Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2(including specific identification of the E. coli 0157 serogroup withing STEC), Shigella/Enteroinvasive Escherichia coli (EIEC), Cryptoporidium, Cyclosporacayetanenis, Entamoebahistolytica, Giardia lamblia (also known as G. intestinalis and G. duodenalis) Adenovirus, Norovirus GI/GII, Rotavirus A, Sapovirus (Genogroups I, II, IV, and V). Page 4 of 16, 4. External controls C. required positive and negative controls to be run once a month when there is a test requisition and on new lots of reagent kits. The policy did not mention an Individualized Quality Control Plan or a risk assessment. 4. Review of document, 'IQCP Annual Quality Effectiveness Summary Biofire', signed by, SP-06, (Former Laboratory Director), dated 6/9/2017, stated that the IQCP plan was implemented 2016 and was signed by Laboratory Director. The document did not include the orginal Quality Control Plan or Risk Assessment. 5. Review of medical records indicated testing was performed on the Biomerieux FilmArray using the following panels: Respiratory panel- Not Detected on Pt-1 on 9/11/24 11:06 am, and GI panel Not Detected on Pt-9 on 7/9/24 at 1:06 pm. 6. In an interview on 10/2/24 at 12:30 pm, SP-1, confirmed the "BioFire Daily Quality Assurance" log has a line (6) marked Quality Control (QC), which is checked each day of testing, but this is the internal QC. External QC is performed monthly. SP-1 also confirmed they were unable to find any record of the IQCP, or any other records pertaining to the IQCP including the completed risk assessment. 7. Annual volume for microbiology/bacteriology is 300; Annual volume for microbiology /virology is 14,000. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Repeat Citation Based on record review and interview, the laboratory failed to perform twice annual accuracy verification on 16 of 64 (Amitriptyline, Desipramine, Imipramine, ortriptyline, Ritalinic Acid, Sertraline, Phenylcyclohexyl piperidine (PCP), Zaleplon, Pentazocine, Methlenedioxpyrovaleron, Delta-9- Carboxy Tetrahydrocannabinol (THC-COOH), Gabapentin, Buprenorphine, Morphine, Amphetamine, and Alpha-hyroxyalprazolam ) unregulated analytes performed on the Shimaszu LCMS 8030 (Serial Number=L20235154318) in 2023 and three (Pt-5, Pt-6, and Pt-7) of eleven patients reviewed. Findings included: 1. In an interview on 09/30 /2024 at 10:35 am, SP-1 (Technical Supervisor), confirmed enrollment in College of American Pathologist (CAP) for Proficiency Testing (PT) for drug testing performed on Shimaszu LCMS 8030. 2. Review of the list of drugs tested in the PT-CAP enrollment for 2023 indicated the following tests were missing from the review, but were included on Enclosure 1 as tests performed by the laboratory: Amitriptyline, -- 2 of 9 -- Desipramine, Imipramine, ortriptyline, Ritalinic Acid, Sertraline, PCP, Zaleplon, Pentazocine, Methlenedioxpyrovaleron. 3. Review of CAP Proficiency Testing for 2023, revealed the following tests failed one of the two PT events: a) DMPM-A 2023- mailed 2/7/2023, evaluated 4/6/2023: Delta-9-THC-COOH (unacceptable), Gabapentin (unacceptable), Buprenorphine (unacceptable). b) DMPM-B 2023- mailed 8/8/2023, evaluated 10/4/2023: Morphine (unacceptable), Amphetamine (unacceptable), Alpha-hyroxyalprazolam (unacceptable). 4. In an interview on 10/2 /24 at 12:45 pm, SP-1, indicated they were unaware that they were not enrolled with all of toxicology testing in CAP. They just ordered what had been previously ordered. SP-1 further confirmed no other verification for testing on the Shimaszu LCMS 8030 was completed in 2023. SP-1 acknowledged they did not know they needed to replace a failed Calibration Verification or Proficiency Testing failure on unregulated testing in order to have two verifications per year. 5. Review of medical records indicated the following patient tests: Pt-5, Pt-6, and Pt-7, had toxicology reports showing testing for Amitriptyline, Desipramine, Imipramine, Nortriptyline, Ritalinic Acid, Sertraline, PCP, Zaleplon, Pentazocine, Methlenedioxpyrovaleron, Amphetamines, Morphine, THC COOH, Alpha-hydroxyalprazolam, Gabapentin. a) Pt-5-ran on 10/6/23 at 3:22 pm: Amphetamines-Not detected, Morphine-Not detected, THC COOH-Positive >2000 nanograms/milliliters (mg/ml). Under Confirmation Results Summary the result for Amphetamines- Not Detected is inconsistent. Pt-5 prescribed: Adderall (Amphetamine) b) Pt-6 ran on 10/6/23 at 3:12 pm: Alpha-hydroxyalprazolam-Not detected, Gabapentin-Positive >20000 nanograms/milliliters (ng/mL). Under Confirmation Results Summary, Pt-6 was prescribed Xanax (Alprazolm) not Gabapentin the results of Alprazolam "Not Detected" and Gabapentin "Positive" were "Inconsistent". c) Pt-7 ran on 7/13/23 at 10:56 am: Buprenorphine- Postive (Pos) 71 nanograms/milliliters (ng/mL) 6. Annual volume for toxicology performed on Shimaszu LCMS 8030 is 384,000. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to meet the analytic system requirements found in 493.1251 through 493.1283. The laboratory failed to pass six-month Calibration Verification for 2 of 5 (Vitamin D (Vit D) and Vitamin B12 (Vit B12) non-regulated immunoassay ran on the Roche Cobas 6000 e601 Seral Number = 1263-09 (refer to D5439). The laboratory failed to successfully run two levels of quality control for Vitamin B12 (Vit B12) ran on the Roche Cobas 6000 e601, Seral Number = 1263-09 prior to running patients for three (Pt-2, Pt-10, and Pt- 11) of eleven patients reviewed (Refer to D5447). The laboratory failed to evaluate the effectiveness of the Individualized Quality Control Plan (IQCP) implemented in 2016, and currently in use on 10/3/2024, for 20 of 20 analytes run on the BioFire Gastrointestinal Panel (GI) kit and 20 of 20 analytes run on the FilmArray Respiratory -- 3 of 9 -- Pannel (RP) Kit tested on the on the Biomerieux FilmArray, Microbiology/Virology analyzer, (Serial Number=FA3224), for 2 of 2 years (2023 and 2024) and two (Pt-1 and Pt-9) of eleven patients reviewed (refer to D5739). D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to pass six-month Calibration Verification for two (Vitamin D (Vit D) and Vitamin B12 (Vit B12) of five non-regulated immunoassays run on the Roche Cobas 6000 e601 Seral Number=1263-09 and four (Pt-3, Pt-2, Pt-10, Pt-11) of eleven patients reviewed. Findings included: 1. The "LN5-A 2024 Ligand Calibration Verification/Linearity Vitamin B12 pg/mL Linearity Evaluation", mailed on 4/8/24 and evaluated on 5/8/24 indicated the following: a) on page 11 the Evaluation Result was "Imprecise (Poor repeatability and/or Fit)". b) on page 12 the documentation for investigation and corretive action, read, "entry error for sample." c) This is the only Calibration Verification/Linearity for Vit 12 available for 2024 review. 2. The "LN40-A 2024 Total 25-OH Vitamin D Calibration Verificaton/Linearity", mailed 4/29/2024 and evaluated on 5/24/24 indicated: the following: a) on page 3 the Evaluation Result was "Imprecise (Poor repeatability and/or Fit)". b) on page 4 the documentation for investigation and corretive action, read, "new lot installed with verified QC." c) This is the only Calibration Verification/Linearity for Vit D available for 2024 review. 3. In an interview on 10/1/2024 at 1:00 pm, SP-1 (Technical Supervisor), explained that the failed calibration verification was not repeated on VIT B12 and Vit D, and the Roch Cobas for Vit B12 and Vit D were not recalibrated. SP-1 indicted the only

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 9/4/2024. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1411 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: Repeat Deficiency Based on record review and interview, the laboratory failed to successfully participate in a proficiency testing program for four events for blood urea nitrogen and three events for Triiodothyronine in 2023 and 2024. The laboratory failed to successfully participate in four consecutive testing events in 2023 (event 2, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 2023 and event 3) and 2024 (event 1 and event 2) resulting in a score of 0 in Routine Chemistry for the analyte blood urea nitrogen (BUN) as reported by the College of American Pathologist (CAP) (Refer to D2089). The laboratory failed to achieve satisfactory performance of 80% or greater for three consecutive testing events in 2023 (event 3, 2023) and in 2024 (event 1 and event 2). Results for those events were 0% in for the analyte Triiodothyronine (T3) and 53% for event 3, 2023, 60% for event 1, 2024, and 66% for event 2, 2024 for the subspecialty of Endocrinology as reported by the CAP (Refer to D2107). D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Repeat Deficiency Based on record review and interview, the laboratory failed to successfully participate in a proficiency testing program. The laboratory failed to successfully participate in four consecutive testing events in 2023 (event 2 and event 3) and 2024 (event 1 and event 2) resulting in a score of 0 for four testing events in Routine Chemistry for the analyte blood urea nitrogen (BUN) as reported by the College of American Pathologist (CAP). Finding included: 1. Review of the "Casper Report 0155D," run date 12/18/2023 indicated a score of 0% for event 2 2023 and event 3 2023 for blood urea nitrogen (BUN) as reported by the CAP. 2. An email dated December 29, 2023 at 11:09 am, requesting confirmation of the 0% scores from urea nitrogen, SP-01 (Technical Supervisor) stated, "We don't test for urea nitrogen only uric acid." 3. Review of the "Casper Report 0155D," run date 8/20/2024 indicated a score of 0% for event 2 2023 and event 3 2023, 0% for event 1 2024 and 0% for event 2 2024 for blood urea nitrogen (BUN) as reported by the CAP. 4. In an email dated August 23, 2024 at 1:58 pm, upon request for confirmation of the 0% scores from urea nitrogen, SP-01 (Technical Supervisor) stated, "We have never stopped testing for BUN..." SP-1 further indicated they were unaware that BUN is reported for Urea Nitrogen. 5. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-B 2023 General Chemistry/Therapeutic Drugs" original evaluation: 7/11/2023 on page 9 of 11 indicated Urea Nitrogen for Proficiency Event 2023 2 had a score of 0/5 for 0%. On page 4 of 11, the grade for C-B 2023 (Event 2023 2) had a notation "See Note [42]". Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." 6. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-C2023 General Chemistry/Therapeutic Drugs" original evaluation: 10/31/2023 on page 9 of 11 indicated Urea Nitrogen for Proficiency Event 2023 2 and Event 2023 3 had a score of 0/5 for 0%. On page 5 of 11, the grade for C-C 2023 (Event 2023 3) had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes -- 2 of 5 -- appearing in this evaluation, "[42] = No credit assigned due to absence of response." 7. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-A 2024 General Chemistry /Therapeutic Drugs" page 9 of 11 original evaluation date 4 /10/2024 indicated Urea Nitrogen had scores of 0/5 for 0% for event 2, 2023, event 3, 2023 and event 1, 2024. On page 5 of 11 the grade for C-C 2023 (Event 2023 3) had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." 8. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-A 2024 General Chemistry /Therapeutic Drugs" page 9 of 11 original evaluation date 7/2 /2024 indicated Urea Nitrogen had scores of 0/5 0% for event 3, 2023, event 1, 2024 and event 2, 2024. On page 5 of 11 indicated Urea Nitrogen for Proficiency Event 2024 2 had a score of 0/5. The grade for Event 2024 2 had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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: Repeat Deficiency Based on record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for three consecutive testing events in 2023 (event 3, 2023) and in 2024 (event 1 and event 2). Results for those events were 0% in for the analyte Triiodothyronine (T3) and 53% for event 3, 2024, 60% for event 1, 2023, and 66% for event 2, 2024 for the subspecialty of Endocrinology as reported by the CAP. Findings included: 1. Review of "Casper Report 0155D," run date 8/20/2024 indicated a score of 0% for event 2 2023, event 1 2024 and event 2 2024, 0% for T3 as reported by the CAP. 2. In an email on 8/22 /2024 at 12:17 pm, SP-01 (Technical Supervisor) provided the PT results for for event 2 2023, event 1 2024 and event 2 2024 and confirmed 0% scores for T3. 3. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-C2023 General Chemistry/Therapeutic Drugs" original evaluation: 10/31/2023 on page 11 of 11 indicated Triiodothyronine (T3) had a score of 0/5 for 0% for Proficiency Event 2023 3. On page 7 of 11 the "Evaluation and Comparative Method Statistics" for "C-C 2023 General Chemistry /Therapeutic Drugs" showed five of five results provided by the laboratory for T3 were unacceptable. 4. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-C2023 General Chemistry/Therapeutic Drugs" original evaluation: 4/10/2024 on page 11 of 11 indicated Triiodothyronine (T3) had a score of 0/5 for 0% for Proficiency Event 2023 3 and Event 2024 1. On page 7 of 11 the "Evaluation and Comparative Method Statistics" showed five of five results provided by the laboratory for T3 were unacceptable. 5.Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-C2023 General Chemistry /Therapeutic Drugs" original evaluation: 7/2/2024 on page 11 of 11 indicated Triiodothyronine (T3) had a score of 0/5 for 0% for Proficiency Event 2023 3, Event -- 3 of 5 -- 2024 1, and Event 2024 2. On page 7 of 11 the "Evaluation and Comparative Method Statistics" showed five of five results provided by the laboratory for T3 were unacceptable. 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: Repeat Deficiency Based on record review and interview, the laboratory director failed to provide overall management and direction needed to ensure the laboratory successfully participated in a proficiency testing program for four of four testing event in 2023 (event 2 and event 3) and 2024 (event 1 and event 2) for blood urea nitrogen (BUN) and achieve a satisfactory performance for three of three consecutive testing events in 2023 (event 3, 2023) and in 2024 (event 1 and event 2) for Triiodothyronine (T3) and Endocrinology (Refer to D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Repeat Deficiency Based on record review and interview, the laboratory director failed to ensure the laboratory successfully participated in a proficiency testing program for four of four testing event in 2023 (event 2 and event 3) and 2024 (event 1 and event 2) for blood urea nitrogen (BUN); and failed to ensure the laboratory achieved a satisfactory performance for three of three consecutive testing events in 2023 (event 3, 2023) and in 2024 (event 1 and event 2) for Triiodothyronine (T3) and the subspecialty of Endocrinology. Findings included: 1. Review of "Casper Report 0155D," run date 12/18/2023 indicated a score of 0% for event 2 2023 and event 3 2023 for blood urea nitrogen (BUN) as reported by the CAP. 2. In email dated December 29, 2023 at 11:09 am, upon request for confirmation of the 0% scores from urea nitrogen, SP-01 (Technical Supervisor) stated, "We don't test for urea nitrogen only uric acid." 3. Review of "Casper Report 0155D," run date 8/20/2024 indicated a score of 0% for event 2 2023 and event 3 2023, 0% for event 1 2024 and 0% for event 2 2024 for blood urea nitrogen (BUN); and a score of 0% for event 2 2023, event 1 2024 and event 2 2024, 0% for T3 as reported by the CAP. 4. In an email dated August 23, 2024 at 1:58 pm, SP-01 (Technical Supervisor) confirmed the scores for BUN and T3 and further stated, "We have never stopped testing for BUN." SP-01 further indicated they were unaware that BUN should be reported for Urea Nitrogen. 5. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-B 2023 General Chemistry/Therapeutic Drugs" original evaluation: 7/11/2023 on page 9 of 11 indicated Urea Nitrogen for Proficiency Event 2023 2 had a score of 0/5 for 0%. On page 4 of 11, the grade for C-B 2023 (Event 2023 2) had a notation "See Note [42]". Page 1 of 11 had a legend for exception reason codes appearing in this -- 4 of 5 -- evaluation, "[42] = No credit assigned due to absence of response." 6. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-C2023 General Chemistry/Therapeutic Drugs" original evaluation: 10/31/2023 on page 9 of 11 indicated Urea Nitrogen for Proficiency Event 2023 2 and Event 2023 3 had a score of 0/5 for 0%; page 11 of 11 showed T3 had a score of 0/5 for 0% for Proficiency Event 2023 3. On page 5 of 11, the grade for C-C 2023 (Event 2023 3) had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." On page 7 of 11 the "Evaluation and Comparative Method Statistics" for "C-C 2023 General Chemistry /Therapeutic Drugs" showed five of five results provided by the laboratory for T3 were unacceptable. 7. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-A 2024 General Chemistry /Therapeutic Drugs" page 9 of 11 original evaluation date 4/10/2024 indicated Urea Nitrogen had scores of 0/5 for 0% for event 2, 2023, event 3, 2023 and event 1, 2024; page 11 of 11 showed T3 had a score of 0/5 for 0% for Proficiency Event 2023 3 and Event 2024 1. On page 5 of 11 the grade for C-C 2023 (Event 2023 3) had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." On page 7 of 11 the "Evaluation and Comparative Method Statistics" for "C-C 2023 General Chemistry /Therapeutic Drugs" showed five of five results provided by the laboratory for T3 were unacceptable. 8. Review of the CAP evaluation "CMS Performance Summary for Analytes Regulated under the Clinical Laboratory Improvement Amendment of 1988" for "C-A 2024 General Chemistry /Therapeutic Drugs" page 9 of 11 original evaluation date 7/2/2024 indicated Urea Nitrogen had scores of 0/5 0% for event 3, 2023, event 1, 2024 and event 2, 2024; page 11 of 11 showed T3 had a score of 0/5 for 0% for Proficiency Event 2023 3, Event 2024 1 and Event 2024 2. On page 5 of 11 indicated Urea Nitrogen for Proficiency Event 2024 2 had a score of 0/5. The grade for Event 2024 2 had a notation "See Note [42]." Page 1 of 11 had a legend for exception reason codes appearing in this evaluation, "[42] = No credit assigned due to absence of response." On page 7 of 11 the "Evaluation and Comparative Method Statistics" showed five of five results provided by the laboratory for T3 were unacceptable -- 5 of 5 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 1/4/2024. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1411 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: Repeat Deficiency Based on record review and interview, the laboratory failed to sucessfully participate in a proficiency testing program. The laboratory failed to participate in two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023) resulting in a score of 0 for both testing events in Hematology and for the following 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 -- analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). (Refer to D2123) The laboratory failed to achieve satisfactory performance of 80% or greater for two consecutive testing events in 2021 (event 2, 2021 and event 3, 2021) and two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023). Results for those events were 0% in Hematology and for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. (Refer to D2130) D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to participate in two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023) resulting in a score of 0 for both testing events in Hematology and for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 2023 and event 3 2023 for Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). 2) In email on 12/29/2023 at 10:13 am, SP-3 (Technical Supervisor) confirmed the laboratory is still performing hematology testing. 3) In email on 12/29/2023 at 11:09 am, SP-3 (Technical Supervisor) indicated the laboratory did not submit any results to AAB for event 2 and event 3 of 2023. SP- 3 further confirmed the laboratory did not perform proficiency testing for any proficiency testing program for event 2 or event 3 2023 for hematology and the analytes Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Repeat Deficiency Based on record review and interview, the laboratory failed to achieve satisfactory performance of 80% or greater for two consecutive testing events in 2021 (event 2, 2021 and event 3, 2021) and two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023). Results for those events were 0% in Hematology -- 2 of 4 -- and for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 2021 and event 3 2021 and 0% for event 2 2023 and event 3 2023 for Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. 3) In email on 12/29/2023 at 10:13 am, SP-3 (Technical Supervisor) confirmed the laboratory is still performing hematology testing. 4) In email on 12/29/2023 at 11:09 am, SP-3 (Technical Supervisor) indicated the laboratory did not submit any results to AAB for event 2 and event 3 of 2023. SP-3 further confirmed the laboratory did not perform proficiency testing for any proficiency testing program for event 2 or event 3 2023 for hematology and the analytes Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. 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: Repeat Deficiency. Based on document review and interview, the laboratory director failed to ensure the laboratory achieved satisfactory performance of 80% or greater for two consecutive testing events in 2021 (event 2, 2021 and event 3, 2021) and two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023). Results for those events were 0% in Hematology and for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. (Refer to D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Repeat Deficiency. Based on record review and interview, the laboratory director failed to ensure the laboratory achieved satisfactory performance of 80% or greater for two consecutive testing events in 2021 (event 2, 2021 and event 3, 2021) and two consecutive testing events in 2023 (event 2, 2023 and event 3, 2023). Results for those events were 0% in Hematology and for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 2021 and event 3 2021 and 0% for event 2 2023 and event 3 2023 for Cell Identification, Red Blood Cell, -- 3 of 4 -- Hematocrit, Hemoglobin, White Blood Cell, and Platelets as reported by the American Association of Bioanalysts (AAB). 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. 3) In email on 12/29/2023 at 10:13 am, SP-3 (Technical Supervisor) confirmed the laboratory is still performing hematology testing. 4) In email on 12/29/2023 at 11:09 am, SP-3 (Technical Supervisor) indicated the laboratory did not submit any results to AAB for event 2 and event 3 of 2023. SP-3 further confirmed the laboratory did not perform proficiency testing for any proficiency testing program for event 2 or event 3 2023 for hematology and the analytes Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey was completed on 8/30/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1411 Laboratory Director 42 CFR 493.1447 Technical Supervisor 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: Repeat deficiency. Based on record review and staff interview, the laboratory failed to successfully participate in American Association of Bioanalysts (AAB), proficiency testing (PT) in the subspecialty of Syphilis Serology for events (2/2021, 3/2021, 3 /2022 and 2/2023). (Refer to D2074). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- D2074 SYPHILIS SEROLOGY CFR(s): 493.835(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: Repeat deficiency. Based on record review and interview, the laboratory failed to achieve an overall testing event score of 80% in American Association of Bioanalysts (AAB) Proficiency testing (PT) for two consecutive testing events in 2021 (event 2, 2021, and event 3, 2021) and two out of three consecutive testing events in 2022/2023 (event 3, 2022 and event 2, 2023) in the specialty of Diagnostic Immunology for subspecialty of Syphilis Serology. Findings include: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores of Syphilis Serology Event 2 (2021) = 0%, Event 3 (2021) = 0%, Event 3 (2022) = 60%, and Event 2 (2023) = 0%. 2) In interview on 12/30/21 at 3:40 pm, SP-11 (laboratory manager) indicated they had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-11 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score. 3) Review of AAB results for Nonchemistry Q3 2022/ confirmed the 60% score for Syphilis Serology. 4) On 8/29 /23 at 2:03pm, an interview with SP-3 (Technical Supervisor) confirmed that the laboratory no longer wanted to use the AAB PT program, so the samples were not submitted for event #2 for 2023 for Syphilis (Serology) resulting in a score of 0%. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to verify the accuracy of 14 (metabolite of delta 9 tetrahydrocannabinol (THC), Buprenorphine, Hydrocodone, Hydromorphone, Norhydrocodone, Gabapentin, Tramadol, O-Desmethyltramadol, Methadone, Methadone Metabolite, Oxazepam, Codeine, Morphine, Pregabalin) out of 18 analytes in Drug Monitoring for Pain Management (DMPM) twice annually in 2022 for testing performed on one of one toxicology analyzer (Shimadzu LCMS- 8030, 8040 (SN: L20705161633)). Finding(s): 1) Review of College of America Pathologists (CAP) proficiency test (PT) document "DMPM-B 2022 Drug Monitoring for Pain Management", original evaluation: 10/18/2022, showed a grade of "Unacceptable" in Drug Monitoring for Pain Management (DMPM) for event: DMPM-B/2022 for the following specimens and analytes. PT Specimen Not verified analytes for 2022 DMPM-05 Delta-9-THC Buprenorphine Hydrocodone Hydromorphone Norhydrocodone Gabapentin DMPM-06 Tramadol O- Desmethyltramadol Methadone Methadone Metabolite Oxazepam DMPM-07 Codeine Morphine Pregabalin 2) Review of the policy "Quality Assurance" created 2012, revised and signed by laboratory director on 3/29/2023, read "5. Assessment for Non-Regulated Analytes/Alternative Proficiency A. When testing is performed on analytes that are not regulated, an alternative proficiency may be performed twice a year to validate the accuracy of the testing procedure." 3) Review of patients' records -- 2 of 12 -- indicated one of three patients' samples (PT-5) ran on analyzer Shimadzu LCMS- 8030, 8040 (SN: L20705161633) was tested during the submission of event DMPM-B /2022 and had results that were inconsistent with prescription. Patient (PT) Date Analyte(s) w/ Inconsistent Results PT-5 05/26/22 Buprenorphine (DMPM-05) Hydrocodone (DMPM-05) Norhydrocodone (DMPM-05) 4) On 8/29/23 at 1:15pm, Sp-3 (Technical Supervisor) acknowledged the above scores for DMPM-B/2022 and confirmed that a second verification of accuracy such as a split sample or blind sample had not been completed for 2022 after these failures. 5) Annual Test Volume for Toxicology is approximately 396,000. 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 document review and interview, the laboratory director failed to ensure the laboratory successfully participated in the AAB and CAP proficiency testing (PT) programs for Syphilis Serology. The laboratory failed to achieve an overall testing event score of 80% in AAB PT for two consecutive testing events in 2021 (event 2, 2021, and event 3, 2021) and two out of three consecutive testing events in 2022/2023 (event 3, 2022 and event 2, 2023) for subspecialty of Syphilis Serology. (Refer to D6089) D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory director failed to ensure the laboratory successfully participated in the AAB and CAP proficiency testing (PT) programs for Syphilis Serology. The laboratory also had unsatisfactory overall PT event testing scores (less than 80%) for two consecutive testing events in 2021 (event 2, 2021, and event 3, 2021) and two out of three consecutive testing events in 2022 /2023 (event 3, 2022 and event 2, 2023) for subspecialty of Syphilis Serology. Findings included: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores: a. Syphilis Serology submitted by AAB 1. Event 2 (2021) = 0%, 2. Event 3 (2021) = 0%, 3. Event 3 (2022) = 60%, and 4. Event 2 (2023) = 0%. 2) In interview on 12/30/21 at 3:40 pm, SP-11 (laboratory manager) indicated they had no documentation of proficiency testing being performed or submitted for event 2, 2021 for Syphilis Serology. SP-11 confirmed proficiency testing for event 3, 2021 were submitted past the due date resulting in a 0% score for the same tests. 3) Review of AAB results for Nonchemistry Q3 2022/ confirmed the 60% score for Syphilis Serology. 4) On 8/29/23 at 2:03pm, an interview with SP-3 (Technical Supervisor) confirmed that the laboratory no longer wanted to use the AAB PT program, so the samples were not submitted for event #2 for 2023 for Syphilis (Serology) resulting in a score of 0%. -- 3 of 12 -- D6108 LABORATORY TECHNICAL SUPERVISOR CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure three (SP-3, SP- 4, and SP-10) of nine personnel performing the duties of a technical supervisor (TS) meet qualification requirements, from January 2023 until August 2023. (Refer to D6111) The laboratory failed to ensure the technical supervisor evaluated competency for four (SP-3, SP-8, SP-9, SP-10) out of nine testing personnel. (Refer to D6120) D6111 TECHNICAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1449 (a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and (b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor-- (b)(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or Possesses qualifications that are equivalent to those required for such certification. (c) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, the individual functioning as the technical supervisor must-- (c)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (c)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (c)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (c)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (c)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of bacteriology; or (c)(5)(i) Have earned a bachelor's degree in a chemical, physical, or biological science or medical technology from an accredited institution; and (c)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum -- 4 of 12 -- of 6 months experience in high complexity testing within the subspecialty of bacteriology. (d) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycobacteriology, the individual functioning as the technical supervisor must-- (d)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (d) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology; or (d)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (d)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycobacteriology. (e) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of mycology, the individual functioning as the technical supervisor must-- (e)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (e)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (e) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (e)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (e)(3)(ii) Have at least 1 year of laboratory training or experience, or both in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(4) (i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (e)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology; or (e)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (e)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the -- 5 of 12 -- specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of mycology. (f) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of parasitology, the individual functioning as the technical supervisor must-- (f)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (f)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (f)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (f)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; (f)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (f)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (f)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology; or (f)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (f)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of parasitology. (g) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of virology, the individual functioning as the technical supervisor must-- (g)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (g)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (g) (2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (g)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (g)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (g)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology; or (g)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (g)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the -- 6 of 12 -- specialty of microbiology with a minimum of 6 months experience in high complexity testing within the subspecialty of virology. (h) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, the individual functioning as the technical supervisor must- (h)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (h)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (h)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (h)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (h)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of diagnostic immunology; or (h)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (h)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology; or (h)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (h)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of diagnostic immunology. (i) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of chemistry, the individual functioning as the technical supervisor must-- (i)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (i)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (i)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (i)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (i)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of chemistry; or (i) (4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (i)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry; or (i)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (i)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of chemistry. (j) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of hematology, the individual functioning as the technical supervisor must-- (j)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (j)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (j)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (j)(2)(ii) Have at least -- 7 of 12 -- one year of laboratory training or experience, or both, in high complexity testing for the specialty of hematology (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine); or (j) (3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (j)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of hematology; or (j)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (j)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology; or (j) (5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (j)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of hematology. (k)(1) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must-- (k)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (k)(1)(ii) Meet one of the following requirements-- (k)(1)(ii)(A) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (k)(1)(ii) (B) Be certified by the American Society of Cytology to practice cytopathology or possess qualifications that are equivalent to those required for such certification; (l) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must-- (l)(1) Meet one of the following requirements: (l)(1)(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (l)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; (l)(1)(ii) An individual qualified under 493.1449(b) or paragraph (l)(1) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (l)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens. (l)(2) For tests in dermatopathology, meet one of the following requirements: (l)(2)(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l) (2)(i)(B) Meet one of the following requirements: (l)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(i)(B) (3) Be certified in dermatology by the American Board of Dermatology or possess qualifications that are equivalent to those required for such certification; or (l)(2)(ii) An individual qualified under 493.1449(b) or paragraph (l)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens. (l) (3) For tests in ophthalmic pathology, meet one of the following requirements: (l)(3)(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (l)(3)(i)(B) Must meet one of the following requirements: (l)(3)(i)(B)(1) Be certified in anatomic pathology -- 8 of 12 -- by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (l)(3)(i)(B)(2) Be certified by the American Board of Ophthalmology or possess qualifications that are equivalent to those required for such certification and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or (l)(3)(ii) An individual qualified under 493.1449(b) or paragraph (1)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or (m) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements: (m)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located and-- (m)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (m)(2) Be certified in oral pathology by the American Board of Oral Pathology or possess qualifications for such certification; or (m)(3) An individual qualified under 493.1449(b) or paragraph (m)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraphs (b) or (m)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens. (n) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of radiobioassay, the individual functioning as the technical supervisor must-- (n)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (n)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (n)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (n)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(3)(i) Have an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution; and (n)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of radiobioassay; or (n)(4)(i) Have earned a master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (n)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay; or (n)(5)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (n)(5)(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the specialty of radiobioassay. (o) If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either-- (o)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (o)(1)(ii) Have training or experience that meets one of the following requirements: (o)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or (o)(2)(i) Have an earned doctoral -- 9 of 12 -- degree in a biological or clinical laboratory science from an accredited institution; and (o)(2)(ii) Have training or experience that meets one of the following requirements: (o) (2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or (o)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and (o)(2)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility. (p) If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must-- (p)(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (p)(1)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or (p)(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, or clinical laboratory science from an accredited institution; and (p)(2)(ii) Have 4 years of training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics. (q) If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of immunohematology, the individual functioning as the technical supervisor must-- (q)(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (q)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (q)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (q)(2)(ii) Have at least one year of laboratory training or experience, or both, in high complexity testing for the specialty of immunohematology. Note: The technical supervisor requirements for "laboratory training or experience, or both'' in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to ensure four (SP-3, SP- 4, and SP-10) of nine personnel performing the duties of a technical supervisor (TS) met qualification requirements, from November 2022 until August 2023. Findings: 1) Review of "Laboratory Personnel Report (CLIA)", signed by the laboratory director on 9/06/23 indicated the following: a) SP-3 is a technical supervisor b) SP-4 is a testing person. c) SP-11 is a testing person. d) SP-10 is a testing person 2) On 8/29/23 at 12:15pm, SP-3 (Technical Supervisor) confirmed their hire date was March 27, 2023. 3) Review of SP-3 (Technical Supervisor) personnel file indicated SP-3 has a Bachelor of Arts Degree with a resume (CV) listing prior work experience. 4) Review of personnel files for SP-4 indicated they had a hire date of 11/3/2015 and an associates degree in medical laboratory technology. 5) Review of personnel files for SP-10 indicated they had a hire date of 6/2021 and an associates degree in medical laboratory technology. 6) Review of document "Competency Assessment for Testing Personnel" and "LCMS Competency Assessment" for SP-3 revealed there was no signature or date for "Reviewer". The signature for the "Laboratory Director/Designee -- 10 of 12 -- Signature under "This individual demonstrates appropriate technique to run this test(s) /instrument(s) and report test results" was SP-3 and there was no date listed. The document was marked as the initial competency for SP-3 on analyzer Roche Cobas 8000/c502, e602 (SN: 18M3-03) and LCMS Shimadzu 8030 (SN: L20705161633). 7) Review of document "Competency Assessment for Testing Personnel" for SP-6 signed by SP-3 on 8/16/23 as the "Reviewer" on analyzers Roche Cobas 8000/c502, e602 (SN: 18M3-03), Roche Cobas 6000/c501, e601 (SN: 1263-09), and Sysmex XS 1000i (SN: C5158). Another document titled, "Filmarrray Respiratory Panel Training" for SP-6 on 7/27/23 was signed by SP-4 (testing personnel) as the "trainer" on analyzer: Biomerieux Film Array (SN: 2FA00388). 8) Review of document "Cobas Laboratory Competency" for SP-8 (testing personnel), not signed by SP -8 or SP-1 (laboratory director) revealed SP-11 (testing personnel) initialed under "Trainer initials" for competency on analyzers Roche Cobas 8000/c502, e602, SN: 18M3-03, Roche Cobas 6000/c501, e601 (SN: 1263-09) on "11/2022" with no specific date specified. 9) Review of document "Cobas Laboratory Competency" and "Laboratory Competency (Hematology)" for SP-11 (testing personnel) performed on 6/6/22 revealed SP-10 (testing personnel) initialed under "Trainer initials" for competency on analyzers Roche Cobas 8000/c502, e602, SN: 18M3-03, Roche Cobas 6000/c501, and Sysmex XS 1000i (SN: C5158). 10) Review of "Personnel Competency Assessment" Policy# A3, Subject: Quality Assurance, revised on 03/29/2023, under I. Summary and Explanation/ Intended Use, states, "technical supervisor is responsible for performing and documenting competency assessments". The requirements for assessment of competency for all personnel performing laboratory testing is ....1) Direct observations of routine patient test performance, specimen handling, processing, and testing, and 4) Direct observations of performance of instrument maintenance and function checks. 11) On 8/31/2023 at 12:14 pm, an email was sent to SP-3 (Technical Supervisor) requesting documentation for prior work experience to qualify SP-3 as a Technical Supervisor. 12) On 8/31/2023 at 12:40pm, SP-3 provided two documents, a job description for Technical Supervisor signed by SP-3 on December 20, 2021, and document, "Technical Supervisor Competency" form signed by SP-3 on December 20, 2022, from a previous employer (Laboratory B). The dates (12/20/21, 12/20/2022) from prior employment and start date (3/27/23) at current laboratory indicates 1 year and 3 months' work experience in the specialty of Chemistry and subspecialty of Toxicology. SP-3 did not provide additional documents of work experience to support 4 years of work experience needed to qualify as a Technical Supervisor for a High Complexity Laboratory. 13) Annual Test Volume for Routine Chemistry is approximately 782,000. 14) Annual Test Volume for Hematology is approximately 32,280. 15) Annual Test Volume for Microbiology is approximately 12,230. D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on record review and interview, the technical supervisor failed to evaluate -- 11 of 12 -- competency for four (SP-3, SP-8, SP-9, SP-10) out of nine testing personnel for performance on analyzer(s): Roche Cobas 8000/c502, e602 (SN: 18M3-03), Roche Cobas 6000/c501, e601 (SN: 1263-09), LCMS Shimadzu 8030 (SN: L20705161633), and Biomerieux Film Array (SN: 2FA00388). Findings: 1) Review of document "Competency Assessment for Testing Personnel" and "LCMS Competency Assessment" for SP-3 revealed there was no signature or date for "Reviewer". The signature for the "Laboratory Director/Designee Signature under "This individual demonstrates appropriate technique to run this test(s)/instrument(s) and report test results" was SP-3 and there was no date listed. The document was marked as the initial competency for SP-3 on analyzer Roche Cobas 8000/c502, e602 (SN: 18M3- 03) and LCMS Shimadzu 8030 (SN: L20705161633). 2) Review of the document titled, "LCMS Competency Assessment" for SP-8 had no signature or date for "Reviewer" of competency on the LCMS Shimadzu 8030 (SN: L20705161633). 3) Review of personnel file for SP-9 (testing personnel) indicated there was no annual competency on the "Film array Respiratory Panel Training" on analyzer: Biomerieux Film Array (SN: 2FA00388). 4) Review of personnel file for SP-10 (testing personnel) indicated there was no annual competency for 2022 for the "Film array Respiratory Panel Training" on the analyzer: Biomerieux Film Array (SN: 2FA00388). 5) During personnel file review on 8/29/2023 at 12:15 pm, SP-3 confirmed there was no annual competency in 2022 for SP-8, SP-9 and SP-10. SP-3 confirmed that these testing personnel were still testing using the Biomerieux Film Array until the following dates: SP-8 - 4/2023, SP-9 -6/2023, and SP-10 - 5/2023. 6) Annual Test Volume for Routine Chemistry is approximately 782,000. 7) Annual Test Volume for Microbiology is approximately 12,230. 8) Annual Test volume for Toxicology is 396,000 -- 12 of 12 --

Summary Statement of Deficiencies D0000 A recertification/ proficiency testing review survey was completed on 8/29/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.803(a)(b)(c) Successful Participation 42 CFR 493.1411 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: Repeat deficiency. Based on record review and staff interview, the laboratory failed to successfully participate in the AAB and College of American Pathologist (CAP) PT for analyte creatine kinase (CK) Total in the subspecialty of Routine Chemistry for events (2/2021, 3/2021, 1/2023, and 2/2023). (Refer to D2096). 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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: Repeat deficiency. Based on document review and interview, the laboratory failed to achieve satisfactory performance of 80% of greater for two consecutive events in 2021 (event 2, 2021, event 3, 2021) and for two out of three consecutive events in 2023 (event 1. 2023 and event 2, 2023) for the analyte creatine kinase (CK) Total in the subspecialty of Routine Chemistry. Findings include: 1) Review of Oscar Report 155D (Individual Laboratory Profile) indicated the following unsatisfactory scores for CK Total: 0% for event 2, 2021, event 3, 2021, event 1, 2023, and event 2, 2023. 2) In interview on 12/30/21 at 3:40 pm, SP-11 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021 for CK total. SP-11 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for CK Total. 3) On 8/21/2023 at 2:45 pm, upon request for Proficiency Test Evaluation scores for 2023 for CK Total, none was provided by SP-3 (Technical Supervisor). SP-3 explained the laboratory had a Lot issue, and a Roche Cobas technician had to service the analyzer. 4) Review of "Cobas 6000 Quality Control Monthly Review" signed by SP-3 (Technical Supervisor) on 4/06/23 confirmed "issues w/ ranges" associated with reagents and QC, "Quality Control

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 record review and interview, the laboratory failed to successfully participate in proficiency testing (PT) for two out of three consecutive events (2/2021 and 3 /2021) in the sub-specialties; Syphilis Serology, General Immunology, Routine Chemistry, Endocrinology, and Hematology. Refer to D-2074, D-2084, D-2096, D- 2107, and D-2130. D2074 SYPHILIS SEROLOGY CFR(s): 493.835(e) 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 -- 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 record review and interview, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events (event 2, 2021 and event 3, 2021) for Syphilis Serology. Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 and event 3 in Syphilis Serology. 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated they had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(f) 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 record review and interview, the laboratory failed to achieve a satisfactory performance (0%) for the same analyte or test for two consecutive testing events (event 2, 2021 and event 3, 2021) in General Immunology for the following analytes; Anti-Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HBS- AG), Hepatitis B Core Antibodies (Anti-HBC), and Hepatitis B E Antigen (HBEAG). Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 and event 3 in 2021 for Anti-HIV, HBS AG, Anti-HBC, and HBEAG. 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 record review and interview, the laboratory failed to achieve a satisfactory performance (0%) for the same analyte or test for two consecutive testing events (event 2, 2021 and event 3, 2021) in Routine Chemistry for the following analytes; alanine transaminase (ALT), Albumin, Alkaline Phosphatase, aspartate aminotransferase (AST), Total Bilirubin, Total Calcium, Chloride, Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Total Creatinine Kinase, Creatine, Glucose, Total Iron, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Blood Urea Nitrogen (BUN), and Uric Acid. Findings include: 1) Review of "Casper -- 2 of 3 -- Report 0155D," indicated a score of 0% for event 2 and event 3 in 2021 for analytes; alanine transaminase (ALT), Albumin, Alkaline Phosphatase, aspartate aminotransferase (AST), Total Bilirubin, Total Calcium, Chloride, Total Cholesterol, High Density Lipoprotein (HDL) Cholesterol, Total Creatinine Kinase, Creatine, Glucose, Total Iron, Magnesium, Potassium, Sodium, Total Protein, Triglycerides, Blood Urea Nitrogen (BUN), and Uric Acid. 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) 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 record review and interview, the laboratory failed to achieve a satisfactory performance (0%) for the same analyte or test for two consecutive testing events (event 2, 2021 and event 3, 2021) in Endocrinology for the following analytes; Free Tyroxine, Tri-Iodothyronine, and Thyroid Stimulating Hormone. Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 and event 3 in 2021 for Free Tyroxine, Tri-Iodothyronine, and Thyroid Stimulating Hormone. 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to achieve a satisfactory performance (0%) for the same analyte or test for two consecutive testing events (event 2, 2021 and event 3, 2021) in Hematology for the following analytes; Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. Findings include: 1) Review of "Casper Report 0155D," indicated a score of 0% for event 2 and event 3 in 2021 for Cell Identification, Red Blood Cell, Hematocrit, Hemoglobin, White Blood Cell, and Platelets. 2) In interview on 12/30/21 at 3:40 pm, SP-1 (laboratory manager) indicated the laboratory had no documentation of proficiency testing being performed or submitted for event 2, 2021. SP-1 confirmed proficiency testing for event 3, 2021 was submitted past the due date resulting in a 0% score for the above analytes. -- 3 of 3 --