Select Laboratories- Sc Llc

Summary Statement of Deficiencies D0000 An offsite Proficiency Testing Desk Review survey was conducted at Select Laboratories on October 7, 2025. The facility was found to be out of compliance with the conditions of 42 CFR Part 493 CLIA Laboratory Requirements. 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 desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and AAB-Medical Laboratory Evaluation (AAB-MLE) proficiency testing records, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the analyte Aspartate Aminotransferase {AST (SGOT)}, and Prolactin. Refer 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 a proficiency testing desk review of CASPER 0155 report and AAB- Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of three consecutive testing events in the subspecialty of Chemistry for the analyte Aspartate Aminotransferase (AST), and Prolactin. Findings included: 1. Review of the CAPSER 0155 report revealed the following results: Routine Chemistry 2024 2nd Event: The laboratory received an unsatisfactory score of 0% for Aspartate Aminotransferase (AST). Routine Chemistry 2025 1st Event: The laboratory received an unsatisfactory score of 60% for Aspartate Aminotransferase (AST), Routine Chemistry 2025 1st Event: The laboratory received an unsatisfactory score of 40% for Prolactin. Routine Chemistry 2025 2nd Event: The laboratory received an unsatisfactory score of 40% for Prolactin. 2. A review of the AAB- Medical Laboratory Evaluation 2024 and 2025 proficiency testing records (Chemistry AAB-MLE M2 2024, M3 2024, M1 2025 ) 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 CASPER 055 report and AAB-Medical Laboratory Evaluation 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 CASPER 0155 report and AAB- Medical Laboratory Evaluation 2024 and 2025 records, the laboratory director failed to ensure proficiency testing samples were as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite recertification survey was conducted at Select Laboratories-SC, LLC on October 23rd, 2024, by South Carolina Department of Public Health's (SCDPH), Bureau of Nursing Home and Medical Services. The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the standards of the CLIA program. The following STANDARD LEVEL DEFICIENCES were found to be out of compliance: D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: During an onsite recertification survey on 10/23/2024, based on procedure review, and staff interview, the laboratory failed to have a current client instructions manual with written information specified for specimen handling (e.g. collection, preservation, storage, transport, testing schedule times and how to obtain additional assistance for unusual circumstances). Findings include: 1) The surveyor reviewed client manual titled "Directory of Services", April 2017. The test menu was out of date. Lack current requirements to ensure client(s) have written instructions containing information on specimen handling. 2) During an interview with Vice President (VP), Compliance Officer (CO), general supervisor (GS) in the conference room on 10/23/2024@4:30 pm, the above findings were confirmed. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 -- storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of records, manufacturer's instructions, and interview with TS, the laboratory failed to monitor and evaluate the overall quality of analytic systems. Findings included: 1) During a 2nd tour of the laboratory on 10/23 /2024 at 4:13 pm, the surveyor observed the storage of the following items in the blood draw room: a. 1 pack of Becton Dickinson (BD) vacutainer K2E, Lavender Blood Collection Tubes, Lot#4166471, expiration (exp.) 10/31/2025 b. 1 pack of BD vacutainer SST, Serum Blood Collection Tubes, Lot#4236796, exp.07/31/2025. c. 1 pack of BD vacutainer SST, Serum Blood Collection Tubes, Lot#4194257, exp.06/30 /2026 d. 1 pack of BD vacutainer Sodium Citrate, Blue Collection Tubes, Lot#4073696, exp. 12/31/2024 e. 13 tubes, BD vacutainer Plain Red, Serum Blood Collection Tubes, Lot#3194576, exp. 07/31/2025 f. 3 each, Qiagen, Lot#575015683 g. 2 each, Qiagen, Lot#57802430 Review of manufacturer's label instructions reveal collection kits and supplies were to be stored between 4 to 25 degrees Celsius (a-g and o-t). The warehouse storage room contained the following items: h. Aptima Urine collection kit for males and females' urine specimens. 1 kit (50 swabs), Lot#898300V, exp. 03/31/2026 i. Aptima Multi-test Swab, specimen collection, 2 kits (50 swabs per kit), Lot#88924V j. Aptima Multi-test Swab, specimen collection, 2 kits (50 swabs per kit), Lot#89305V k. 10 boxes , Plylo Plus+, manufactured by ARJ Medical , Inc. Oldsmar, FL 34677 l. 5 boxes (50 tubes in each), QuantiFeron TB Gold Plus (QFT- Plus) Review of manufacturer's label instructions reveal kits temperature requirements are 15 to 30 degrees Celsius (h-l). m. 2 each, Urethral swabs, ref# 99-08C14-VCF, Lot #248516, exp. 01/05/2025 Diagnostic Hybrids, Inc. n. 7 each, Nasopharyngeal swabs, ref# 99-08015-VCF,Lot#247310, exp. 12/27/2024, Diagnostic Hybrids, Inc. Review of manufacturer's label instructions reveal kit temperature requirements are 2 to 25 degrees Celsius (m,n). o. 4 packs (100 per pack) BD vacutainer K2E, Lavender Blood Collection Tubes, Lot#4198187, exp. 11/30/2025. p. 4 packs BD vacutainer, SST Tiger Serum Blood Collection Tubes, Lot#4135886, exp. 04/30/2025 q. 6 packs BD vacutainer, Plain Red Blood Collection Tubes, Lot#4194257, exp. 06/30/2024 r. 2 cases (1,000 per case) BD vacutainer Lavender Blood Collection Tubes s. 9 packs(100 per pack) + 1 case (1,000) BD vacutainer, SST Tiger Serum Blood Collection Tubes, t. 2 packs (100 per pack) + 2 cases (1,000) BD vacutainer, Blue Top Blood Collection Tubes, Lot# 4073696, exp. 12/31/2024 2) The surveyor observed no temperature monitoring devices in the blood draw room, or laboratory storage area. 3) Review of environmental temperature logs for chemistry reveals the laboratory failed to define temperature criteria/range for proper storage of reagents and specimens. 4) The laboratory failed to ensure materials had been stored as required. 5) In an interview on 10/23/2024 at 4:30 pm with VP, CO, and GS in the conference room, the above findings were confirmed. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at -- 2 of 3 -- least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on direct observation and staff interviews, the laboratory failed to define functional check protocol that ensures equipment performance that is necessary for accurate and reliable test results and test result reporting. Findings include: 1) During an onsite recertificate visit on 10/23/2024 at 11:00am, the surveyor directly observed that no function checks were performed on microscopes. The following microscopes were in the laboratory at Select Laboratories: a. Microscope in UA, tag HCA Biomedical Services 007280, no service/maintenance tag. b. Olympus BX41, Calib Photoelectric Tech, Service Tag date 02/15/2022. c. Olympus BX40, No service /maintenance tag. 2) In an interview on 10/23/2024 at 4:30 pm in the conference room with TS the above findings were confirmed. -- 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: During a proficiency testing desk review performed on 08/29/2019, based on review of CASPER report 155D and graded reports from American Association of Bioanalysts (AAB), it was determined that the laboratory failed to successfully participate in proficiency testing for the specialty of chemistry, the analyte total lactic acid dehydrogenase (Total LDH) for two consecutive proficiency testing events reviewed (2019, Event 1 and 2019, Event 2). See D2087, D2096 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During the proficiency testing desk review performed on 08/29/2019, based on review of CASPER report 155D and graded proficiency reports from AA8, it was determined that the laboratory failed to attain a satisfactory score of at least 80% for total lactic acid dehydrogenase (Total LDH) on two consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's Total LDH: a. 2019, Event 1: 0% b. 2019, Event 2: 0% 2. The scores were confirmed by review of the graded AAB results. Scores less than 80% for these analytes indicate failure or unsatisfactory performance. A failure of the analytes for two consecutive or two out of three testing events is scored as unsuccessful. A failure of the analyte for three consecutive or three out of four/five events is scored as a repeat unsuccessful. 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: During a proficiency testing desk review performed on 08/29/2019, based on review of the CASPER 155D report and graded report from AAB, it was determined that the laboratory failed to achieve satisfactory performance for total lactic acid dehydrogenase (Total LDH) in two consecutive testing events (2019, Event 1 and 2019, Event 2). See D2087. -- 2 of 2 --