Delgiacco Medical Llc

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of 2024 and 2025 American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) program attestation documentation and interview with the laboratory consultant, the laboratory testing personnel failed to sign the attestation for two of three events. Findings: 1. Review of AAB.-MLE M3 2024 and AAB.-MLE M1 2025 events showed no signature by the testing personnel analyzing the PT specimens. 2. Interview with the laboratory consultant on 8/25/2025 at 1:00 PM confirmed the individual testing the PT specimens failed to attest to the routine integration of the samples in the patient workload. 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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Based on observation, review of documentation, and interviews, the laboratory failed to ensure a step-by-step procedure for usage of sodium citrate tubes on the DxH 520 hematology analyzer for complete blood cell counts (Refer to D5403), failed to ensure the hematology controls were labeled with a preparation and expiration date (Refer to D5415); and failed to ensure hematology quality control were not used when they had exceeded their expiration date (Refer to D5417). D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2023, 2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hemoglobin (HGB) analyte resulting in a non-initial unsuccessful participation. Refer to D2130. 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE 2023, 2024 records, the laboratory failed to achieve satisfactory performance (80% or better) for two of two consecutive testing events in 2023 (Events 1 and 2) and two of two consecutive events in 2024 (Events 1 and 2) in the specialty of Hematology for the HGB analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2023-1st Event laboratory received an unsatisfactory score of 60% for HGB. Hematology 2023-2nd Event laboratory received an unsatisfactory score of 60 % for HGB. Hematology 2024- 1st Event laboratory received an unsatisfactory score of 0% for HGB. Hematology 2024- 2nd Event laboratory received an unsatisfactory score of 0% for HGB. 2. A review of AAB-MLE 2023 and 2024 proficiency testing records confirmed the laboratory received the above results D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2023, 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2023, 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity. testing; laboratory director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology and for the analytes WBC (White Blood Cell) and WBC Diff (Differential). Refer to D2130 and D2131. 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE 2024 records, the laboratory failed to achieve satisfactory performance (80% or better) for two of two consecutive testing events in the specialty of Hematology for the analytes WBC and WBC Diff. Findings included: 1. Review of the CASPER 0155 report revealed the following results: Hematology 2024-1st Event laboratory received an unsatisfactory score of 0% for WBC. Hematology 2024-1st Event laboratory received an unsatisfactory score of 64 % for WBC Diff. Hematology 2024- 2nd Event laboratory received an unsatisfactory score of 0% for WBC. Hematology 2024- 2nd Event laboratory received an unsatisfactory score of 76% for WBC Diff. 2. A review of AAB-MLE 2024 proficiency testing records confirmed the laboratory received the above results. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 a proficiency testing desk review of CASPER 0155 report and AAB-MLE 2024 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the specialty of Hematology for two of two consecutive testing events. Findings included: 1. A review of the CASPER 0155 report revealed the following results: Hematology 2024-1st Event the laboratory received an unsatisfactory score of 57% for overall Hematology. Hematology 2024-2nd Event the laboratory received an unsatisfactory score of 46% for overall Hematology. 2. A review of AAB-MLE 2024 proficiency testing records confirmed the laboratory received the above results D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. -- 2 of 3 -- This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and AAB- MLE 2024 proficiency testing records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 and D2131 -- 3 of 3 --

Summary Statement of Deficiencies D0000 An off-site CLIA proficiency testing (PT) desk review for Delgiacco Medical LLC dba St. Thomas Cancer Specialists was conducted on August 15, 2023 by a federal surveyor from the Centers for Medicare and Medicaid Services, CLIA New York Operation Branch. The laboratory was inspected under 42 CFR Part 493 CLIA regulations. The laboratory was found to be out of compliance with the following Condition level deficiency: Successful participation (proficiency testing) on August 15, 2023. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on an off-site review of the CASPER 0153D report (Unsuccessful proficiency Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- testing report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing (PT) organization American Association of Bioanalysts (AAB) - Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory performance of at least 80% for two out of three (first and second) consecutive events for the analyte Hemoglobin (HGB) which is in the specialty of Hematology in 2023. Findings include: Please refer to D2130. 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 an off-site review of the CASPER 0153D report (Unsuccessful proficiency testing report), CASPER 0155D report (Individual Laboratory Profile the laboratory) and performance evaluations from the proficiency testing (PT) organization American Association of Bioanalysts (AAB) - Medical Laboratory Evaluation (MLE), the laboratory failed to achieve satisfactory performance of at least 80% for two out of three (first and second) consecutive events for the analyte Hemoglobin (HGB) which is in the specialty of Hematology in 2023. Findings include: 1. Based on an offsite PT desk review performed on August 15, 2021, at 10:30 am and review of the CASPER 0153D, 0155D, and AAB-MLE PT evaluation reports, the laboratory failed to achieve satisfactory scores for the following two out of three consecutive events in 2023: Analyte: 0795 HGB: AAB-MLE 2023 - 1st event - 60%. AAB-MLE 2023 - 2nd event - 60%. 2. The above results were confirmed by email with AAB-MLE on August 15, 2023 at 11:04 am. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The Centers for Medicare & Medicaid Services (CMS) federal surveyor conducted an announced CLIA recertification survey at DelGiacco Medical LLC on June 14, 2023. The laboratory was surveyed under 42 CFR part 493 CLIA requirements. The findings were reviewed with the Laboratory Director and Testing Person #1 at the conclusion of the survey. The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: Analytic Systems 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, written policies and procedures, and interview with the Laboratory Director and Testing Person #1, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings include: 1. The laboratory failed to follow written policy and procedure for patient hematology testing using the Beckman Coulter AcT Diff analyzer for three of three days of patient testing. Refer to D5401. 2. The laboratory failed to ensure the humidity was maintained as required by the manufacturer for the Beckman Coulter AcT Diff analyzer for two of two months. Refer to D5413. 3. The laboratory failed to demonstrate performance specifications prior to patient testing after the relocation for one of one analyzer. Refer to D5421. 4. The laboratory failed to perform two levels of control materials each day of patient hematology testing using the Beckman Coulter AcT Diff analyzer for three of three days of patient testing. Refer to D5447 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 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review, written policy and procedure manual, and interview with Testing Person #1 (TP#1) and Laboratory Director (LD), the laboratory failed to follow written procedures for CBC (Complete Blood Count) testing for three of three days of patient testing. Findings include: 1. Interview with TP#1 on 06/14/2023 at 09: 40 AM confirmed the laboratory performed Complete Blood Count (CBC) testing using the Beckman Coulter AcT Diff Analyzer. 2. Review of the laboratory's written policy and procedures titled, "Lab Procedure Manual and Quality Assessment Plan" section "Machine StartUp and Daily Controls" stated: a. "Three levels of cell control material (low, normal, and high) are to be analyzed on a daily basis". b. "Review the control results to ensure they are within the acceptable ranges before analyzing patient samples". 3. Review of Quality Control (QC) records (AcT 5 Diff Control Plus Low Lot# 360523, Normal Lot# 370523, and High Lot# 380523) and patient testing records from 06/01/2023 through 06/06/2023 revealed the laboratory failed to follow written procedures for three of three days of patient testing. a. Low Control Lot# 360523 for Red Blood Cells (RBC) tested on 06/01/2023 at 09:00 AM failed with no documented

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to sign the attestation for five of seven hematology proficiency testing events reviewed. Findings: 1. Review of proficiency testing events 2020-2, 2020-3, 2021-1, 2021-2, and 2021-3 for hematology revealed no laboratory signature on the proficiency testing attestation statement. 2. In interview on September 24, 2021 at approximately 12:30 PM, Testing Personnel #1 confirmed that the laboratory director did not sign the proficiency testing attestation statements. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain hematology daily quality control records for five of seven days reviewed and daily background counts for six of seven days reviewed. Findings: 1. Quality control and background count records were reviewed for the following dates patient testing was performed: 07/20/2021, 05/10/2021, 04/08/2021, 03/25/2021, 02/23/2021, 09/15 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 -- /2020, and 06/23/2020. 2. Quality control records were not available for 05/10/2021, 04/08/2021, 03/25/2021, 02/23/2021, and 09/15/2020. Daily background counts for the hematology instrument were not available for 05/10/2021, 04/08/2021, 03/25 /2021, 02/23/2021, 09/15/2020, and 06/23/2020. 3. In interview on September 21, 2021 at approximately 01:35 PM, Testing Personnel #1 confirmed that the quality control records and instrument background counts were not retained. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview, the laboratory failed to retain instrument printouts for four of seven hematology proficiency testing events reviewed. Findings: 1. Review of proficiency testing events 2019-3, 2020-1, 2020-2, 2020-3, 2021-1, 2021-2, and 2021-3 for hematology revealed no instrument printouts for events 2020-3, 2021-1, 2021-2, and 2021-3. 2. In interview on September 21, 2021 at approximately 12:24 PM, testing personnel #1 (TP1) confirmed that there was no documentation of testing records for event 2020-2. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to review and evaluate unacceptable results obtained for two of six hematology proficiency testing events reviewed. Findings: 1. Review of proficiency testing events 2021-1 and 2019-3 for hematology revealed no evidence of review or evaluation of unacceptable results for percent Eosinophils. 2. In interview on September 21, 2021 at approximately 12:30 AM, Testing Personnel #1 confirmed there was no documentation of review or evaluation of the unacceptable results for the two proficiency testing events. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies 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 interview with and confirmation by the laboratory director and lack of records, the laboratory failed to participate in the second and third events of fiscal year 2018. The laboratory director stated at around 11 am that due to changing testing personnel during th recovery period of natural disasters in 2017, the performance of PT testing was inadvertently not done. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on review interview with and confirmation by the testing personnel at around 10:45 am and review of Tek-Pro electronic testing records, the laboratory failed to document the identify of the current testing personnel. -- 2 of 2 --