Select Reference Laboratories, Llc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with staff 1/14/25, the laboratory failed to follow written policies for evaluating the competency of personnel. Findings: Review of the laboratory's "General Policies and Procedures" revealed "SECTION 1 - PERSONNEL ... 1.2 Competency Assessment... Documented competency assessments will be performed on all persons that perform patient testing and/or report patient test results. At a minimum, this includes technical and clinical consultants, technical supervisors, general supervisors and testing personnel. The Technical Supervisor/Laboratory Director is responsible for performing and documenting competency assessments. ..." Review of personnel records revealed missing and incomplete competency evaluation documentation. Examples: 1. Review of personnel records revealed no documentation of 2023 and 2024 TP (testing personnel) competency evaluations for GS (general supervisor) #2 for testing performed on the IR 500 and IR 1200 chemistry analyzers. During interview at approximately 2:10 p.m., GS #2 confirmed she performs testing on these analyzers. 2. Review of personnel records revealed 2023 TS (technical supervisor), GS, and TP competency evaluations for TS #1 were not signed to indicate who performed the evaluations. In addition, there were no 2024 competency evaluations for TS #1 available for review. During interview at approximately 11:10 a. m., TS #1 and TS #3 confirmed that TS #1's 2023 competency evaluations were not signed, and they stated they were unable to locate any of her 2024 competency evaluations. 3. Review of personnel records revealed no documentation of semiannual or annual TP competency evaluations for TS #2 for testing performed on the 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 -- Thunderbolt in 2024. During interview at approximately 1:15 p.m., GS #1 stated there was no semiannual or annual Thunderbolt competency evaluation for TS #2 performed in 2024. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on tour of laboratory and interview with staff on 1/14/25 and 1/15/25, the laboratory failed to discard expired reagents. Findings: During a tour of the laboratory at approximately 3:15 p.m. on 1/14/25, the surveyor observed two bottles of expired Immulite TES Adjustor (Lot 134, expiration date 12/7/24), in the laboratory's American Biotech refrigerator, available for use. The bottles were in a closed container with previously tested proficiency samples, located on the right side of the refrigerator, on the second shelf from the top. There were no identifying marks on the storage container. During an interview at approximately 3:25 p.m., GS #1 stated that supplies are reviewed for expiration dates on a regular basis. He was unsure why the reagents and proficiency samples were left in the container. He stated that TS #2 might have further information, but TS #2 was unavailabe at that time. During an interview at approximately 9:00 a.m. on 1/15/25, TS #2 stated the Adjustor had been removed from its orginal kit and set aside for an unspecified purpose. She stated the expired Adjustor could not be used on patients since the Immulite analyzer would not allow it to be loaded. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment Chart/Computer Monitoring Form, review of patient test reports and corresponding analyzer printouts, and interview with the General Supervisor (GS #1) on 1/14/25, and interview with GS #1 on 1/16/25, the laboratory failed to follow their procedure to assess data, identify problems, and take

Summary Statement of Deficiencies 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 review of laboratory policies, review of 2021, 2022 and 2023 calibration records for Diazyme EZ Lite and Immulite 1000 analyzers and interview with general supervisor (GS) #1 on 3/29/23, the laboratory failed to retain at least 2 years of calibration records for testing performed on the Diazyme EZ Lite and Immulite 1000. Review of laboratory policy "General Policies and Procedures....Section 4...4.7 Record Retention..." revealed "Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities for at least 2 years.". 1. The laboratory failed to retain calibration records for the testing performed on the Diazyme EZ Lite analyzer since testing began in June of 2020. Findings: Review of laboratory policy "Diazyme DZ-Lite NT-proBNP Assay" revealed "2. Calibration procedure:...g. Review calibration results and store results electronically to Share Point.". Interview with GS #1 at approximately 1:45 p.m. confirmed calibration records for the Diazyme EZ Lite analyzer were not stored electronically to Share Point. He also confirmed the laboratory had not retained at least two years of calibration records for the testing performed on the Diazyme EZ Lite analyzer. 2. The laboratory failed to retain calibration records for the testing performed on the Immulite 1000 analyzer for at least 2 years. Findings: Review of Immulite 1000 calibration records, "adjustment reports", revealed the Immulite 1000 analyzer retained documentation of the last 2 or 3 three calibrations performed for each analyte. There was no documentation of calibrations, "adjustment reports" prior to the calibrations maintained on the analyzer, a period of approximately 2 years. Interview with GS #1 at approximately 1:45 p.m. 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 -- confirmed the Immulite 1000 retained the last 2 or 3 calibrations performed for each analyte. He stated "adjustment reports" for any prior calibrations were not retained by the analyzer or printed and retained elsewhere. He also stated that calibrations were required for each analyte with each new lot change and at 4 week intervals for most analytes. 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 review of the laboratory's policies and procedures, review of 2020, 2021, and 2022 American Association of Bioanalysts (AAB) and 2020 and 2021 College of American Pathologists (CAP) proficiency testing records, and interview with GS #1 on 3/30/23, the laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of the adiponectin and sdLDL (small dense low density lipoprotein) testing at least twice a year. Review of the "Alternate Proficiency Assessment Methods" procedure revealed "Intended Use: To make certain that the laboratory has processes and procedures to effectively ensure that all analytes are covered by Proficiency Testing either through a formal program or an equivalent substitute at least twice a year at six months interval. ..." Review of the "General Policies and Procedures, Section 3 - Quality Systems" procedures revealed "... 3.3 Proficiency Testing ... Non-regulated analytes may be evaluated by an external assessment twice yearly. ..." Review of 2020, 2021, and 2022 AAB and 2020 and 2021 CAP proficiency testing records revealed: 1. The laboratory did not participate in proficiency testing for adiponectin in 2020, 2021, and 2022. 2. The laboratory did not participate in proficiency testing for sdLDL in 2020, 2021, and 2022. The laboratory participated in one verification event for sdLDL in 2021 on 3/15/21. During interview at approximately 2:05 p.m., GS #1 confirmed that the laboratory was not enrolled in proficiency testing for adiponectin and sdLDL in 2020, 2021, or 2022. He stated the laboratory has not performed any patient adiponectin tests yet. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of laboratory quality assurance policies and procedures, and deficiencies cited at time of survey 3/28/23 through 3/30/23, the laboratory director failed to ensure quality assessment policies and procedures were either established or maintained to identify failures found at time of survey. 1. The laboratory's QA policies and procedures failed to identify calibration records for the testing performed on the Diazyme EZ Lite and Immulite 1000 analyzers were not retained for at least 2 years. Findings: See D3031. 2. The laboratory's QA policies and procedures failed to identify the laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of the adiponectin and sdLDL (small dense low density -- 2 of 3 -- lipoprotein) testing at least twice a year. Findings: See D5217. 3. The laboratory's QA policies and procedures failed to identify laboratory test reports failed to included the assay method of the PSA test and test results failed to include reference ranges for multiple tests performed. Findings: See D6098. Review of laboratory procedure "A5- LIS Verification Form" revealed "Patient final computer reports are checked for the following information...Reference ranges...". Review of laboratory procedure "A6- Chart Review" revealed "Quarterly Procedure: Randomly select five requisitions representing all areas of the laboratory. Obtain final result report corresponding to the requisitions. Reports must be checked for:...Reference Ranges...". D6098 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(8) The laboratory director must ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of laboratory procedure, review of random patient test reports and interview with GS #1 on 3/29/23, the laboratory director failed to ensure test results included the identity of the prostate specific antigen (PSA) assay and failed to ensure test results included reference ranges for the testing performed. 1. The laboratory director failed to ensure PSA test results included the assay method. Findings: Review of laboratory procedure "Third Generation PSA" revealed "The results reported by the laboratory to the physician must include the identity of the assay used.". Review of random patient test reports revealed the following: a. "Patient ID #: 768...Test Date: 3 /07/2023" revealed no assay method for the PSA test result. b. "Patient #: 776...Test Date: 3/20/2023" revealed no assay method for the PSA test result. 2. The laboratory director failed to ensure test results included reference ranges for the testing performed. Findings: Review of random patient test reports revealed the following examples; a. "Patient ID #: 768...Test Date: 3/07/2023" revealed no reference ranges for PSA, hemoglobin (HGB) and red blood cell count (RBC). b. "Patient ID #:270... Test Date:2/03/2023" revealed no reference ranges for HGB, RBC and Iron, Serum. c. "Patient #: 092204...Gender: Male...Run...on 9/29/2022...", revealed "Female Reference Range:...Ovulating...Post Menopausal...". The patient was male and the test report failed to include reference ranges for a male patient. The test report also failed to include reference ranges for Free Testosterone and Bioavailable Testosterone. d. "Patient #: 776...Test Date: 3/20/2023" revealed no reference ranges for HGB, RBC and PSA. The surveyor was unable to determine whether the patient was male or female. The reference range for the Testosterone was, "Female Reference Range:... Ovulating...Post Menopausal...". Interview with GS 3/29/23 at approximately 2:15 p. m. confirmed the test reports failed to include reference ranges for the testing performed and the PSA test result also failed to include the assay method. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 CAP (College of American Pathologists) and 2022 AAB (American Association of Bioanalysts) proficiency testing results 10/3/22, the laboratory failed to successfully participate in proficiency testing for sodium in four of seven consecutive test events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 desk review of CMS Casper reports 153D and 155D and desk review of 2020 and 2021 CAP and 2022 AAB proficiency testing records 10/3/22, the laboratory failed to achieve satisfactory performance for sodium in four of seven consecutive test events, resulting in unsuccessful participation. Findings: 1. Desk review of Casper reports 153D and 155D and 2020 CAP proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2020 C-B test event. 2. Desk review of Casper reports 153D and 155D and 2020 CAP proficiency testing results revealed the laboratory received a score of 60% for sodium on the 2020 C-C test event. 3. Desk review of Casper reports 153D and 155D and 2021 CAP proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2021 C-C test event. 4. Desk review of Casper reports 153D and 155D and 2022 AAB proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2022 Q2 Chemistry test event. 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 desk review of CMS Casper reports 153D and 155D and desk review of 2020 and 2021 CAP and 2022 AAB proficiency testing results 10/3/22, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS Casper reports 153D and 155D and desk review of 2020 and 2021 CAP and 2022 AAB proficiency testing records 10/3/22, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of Casper reports 153D and 155D and 2020 CAP proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2020 C-B test event. 2. Desk review of Casper reports 153D -- 2 of 3 -- and 155D and 2020 CAP proficiency testing results revealed the laboratory received a score of 60% for sodium on the 2020 C-C test event. 3. Desk review of Casper reports 153D and 155D and 2021 CAP proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2021 C-C test event. 4. Desk review of Casper reports 153D and 155D and 2022 AAB proficiency testing results revealed the laboratory received a score of 40% for sodium on the 2022 Q2 Chemistry test event. -- 3 of 3 --

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 CAP(College of American Pathologists) proficiency testing results 12/15/20, the laboratory failed to successfully participate for Sodium in two consecutive testing events. See the deficiency cited at D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 CAP(College of American Pathologists) proficiency testing results 12/15/20, the laboratory failed to achieve satisfactory performance for Sodium in two consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 CAP proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for Sodium on the C-B 2020 General Chemistry testing event. 2. Desk review of CMS Casper report 155D and 2020 CAP proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Sodium on the C-C 2020 General Chemistry testing event. 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 CAP(College of American Pathologists) proficiency testing results 12/15/20, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. See the deficiency cited at 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 desk review of CMS(Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 CAP(College of American Pathologists) proficiency testing results 12/15/20, the laboratory director failed to ensure successful participation as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2020 CAP proficiency testing results revealed the laboratory provided unacceptable responses for 3 of 5 samples, resulting in a score of 40% for Sodium on the C-B 2020 General Chemistry testing event. 2. Desk review of CMS Casper report 155D and 2020 CAP proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Sodium on the C-C 2020 General Chemistry testing event. -- 2 of 2 --

Summary Statement of Deficiencies 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 review of the laboratory's policies and procedures, review of 2017 and 2018 AAB (American Association of Bioanalysts) proficiency testing records, and interview with GS (general supervisor) #2 on 10/25/18, the laboratory failed to enroll in proficiency testing or establish a system to verify the accuracy of the free PSA (prostate specific antigen) and SHBG (sex hormone binding globulin) at least twice per year. The laboratory's "General Policies and Procedures" manual states on page 19- 20 "... 3.3 Proficiency Testing ... The laboratory will enroll and successfully participate in a proficiency testing program that includes each specialty and subspecialty where proficiency testing is required ... For analytes that do not require proficiency testing or analytes that are not regulated, the laboratory will verify the accuracy of the test procedure twice annually through external assessment programs or split sample comparisons with another laboratory's instrument/method. ..." Review of 2017 and 2018 AAB proficiency testing records revealed the laboratory was not enrolled in proficiency testing for free PSA and SHBG. During interview at approximately 2:20 p.m., GS #2 confirmed that the laboratory was not enrolled in proficiency testing and had not established a system to verify the accuracy of the free PSA and SHBG testing at least twice a year. 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, 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 -- 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)