Santa Fe County Adult Detention Facility

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on June 11, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and CAP (College of American Pathologists) - Medical Laboratory Evaluation 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 3 -- testing records for 2025 the laboratory failed to achieve satisfactory performance (80% or greater) for the hematology analyte red blood cells (RBC) for two out of three consecutive events resulting in unsuccessful performance. Refer to D2131 D2131 HEMATOLOGY CFR(s): 493.851(g) (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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and CAP (College of American Pathologists) - Medical Laboratory Evaluation proficiency testing records for 2025 the laboratory failed to achieve satisfactory performance (80% or greater) for the hematology analyte Red Blood Cells (RBC) for two out of three consecutive events resulting in unsuccessful performance. The findings included: 1. A PT desk review of the CASPER report 155 lists a score of "60%" for the analyte RBC for events 1 and 2 in 2025. 2. A proficiency testing desk review of the CAP- Medical Laboratory Evaluation proficiency testing records for 2025 confirmed that the laboratory received unsatisfactory scores for RBC for the 1st and 2nd events for 2025. 3. Laboratory reported performing 300 red blood cell tests annually. 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 (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and CAP (College of American Pathologists) - Medical Laboratory Evaluation proficiency testing records, the laboratory director failed to ensure successful PT participation for the hematology analyte red blood cells (RBC) in 2025. 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; This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and CAP (College of American Pathologists) - Medical Laboratory Evaluation -- 2 of 3 -- proficiency testing records, the laboratory director failed to ensure successful participation for the hematology analyte red blood cells (RBC) in 2025. The findings included: 1. A PT Desk review of the CASPER report 155 lists a score of "60%" for the analyte RBC for event 1 and 2 in 2025. 2. A proficiency testing desk review of the CAP- Medical Laboratory Evaluation proficiency testing records for 2025 confirmed that the laboratory received unsatisfactory scores for RBC for the 1st and 2nd events for 2025. 3. Laboratory reported performing 300 red blood cell tests annually. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An onsite initial survey conducted at Santa Fe County Adult Detention Facility on 03 /28/2024, found the laboratory to be out of compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with the following condition not met: D2000 - 493.801 Proficiency Testing enrollment and testing of samples D5400 - 493.1250 Analytic Systems D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the laboratory test menu and staff interview, the laboratory failed to enroll in a CMS-approved proficiency testing program (PT). Refer to D6015. 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 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 -- 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory records and staff interview, it was revealed that the laboratory failed to meet analytical requirements, as evidence by: 1. The laboratory failed to have any approved procedure manuals for any aspect of patient testing. Refer to D5401 2. The laboratory failed to have an approved quality assessment procedure. Refer to D5793 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 review of laboratory records and staff interview, the laboratory failed to provide approved procedure manuals for 1300 of 1300 patient tests in 2023. Findings included: 1. The laboratory was asked to provide approved procedure manuals available to staff for any aspect of the testing process. No procedures were provided. 2. A review of laboratory records revealed an annual volume of 1300 tests performed. 3. Interview on 03/28/2024 at 10:00 am with the technical consultant confirmed the findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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, laboratory temperature logs, and staff interview, the laboratory failed to monitor proper storage conditions of CELL-DYN Emerald 22 reagents for 3 of 3 months, from January 2024 through March 2024. Findings included: 1. During a tour of the laboratory on 03/28/2024 at 1:30 pm, the following reagents were stored at room temperature: a. CELL-DYN Emerald 22 Easy Cleaner Lot number 2314109815 Expiration date 05/21/2024 Manufacturer's storage requirements = 15 Celsius (C) - 30 C b. CELL-DYN Emerald 22 Lyse Lot number 2332 Expiration date 08/06/2025 Manufacturer's storage requirements = 2 Celsius (C) - 25 C 2. A request was made for documentation of room temperatures being monitored from January 2024 through March 2024. No documentation was provided. 3. During an interview on 03/23/2024 at 1:30 pm, after review of the above records, the Technical Consultant number 1 confirmed the findings. -- 2 of 5 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 direct observation, manufacturer's instructions, and interview, the laboratory failed to ensure laboratory supplies and reagents were not in use past expiration dates for 50 of 50 CAT Serum Sep Clot Activator tubes, 13 of 13 BD Vacutainer tubes, and 4 of 15 Piccolo Lipid Panel cartridges from April 2023 through March of 2024. Findings included: 1. During a tour of the laboratory area on 3/28/2024 at 1:40 pm the following expired items were found: - 50 CAT Serum Sep Clot Activator tubes: Lot number: B220333D, Expiration 09/10/2023 - 13 BD Vacutainer tubes: Lot number: 112315, Expiration 04/30/2023 - 4 Piccolo Lipid Panel cartridges: Lot number: 3122AA7, Expiration 03/14/2024 2. Interview on 03/28/2024 at 2:03 pm with the Technical Consultant number 1 confirmed the findings. 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 least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of the CELL-DYN Emerald 22 product user manual, Event Log Report, and interview, the laboratory failed to follow manufacturer's instructions for performing required weekly maintenance on the CELL-DYN Emerald 22 instrument for 14 of 16 weeks in 2023. Findings included: 1. Review of the CELL-DYN Emerald 22 product user manual under "Preventive Maintenance Schedule", listed bleach cleaning as a required weekly maintenance. 2. Review of the Event Log Report revealed the following weeks bleach cleaning was not performed: 1. 08/23/2023 - 08 /25/2023 2. 08/28/2023 - 09/01/2023 3. 09/04/2023 - 09/08/2023 4. 09/18/2023 - 09/22 /2023 5. 09/25/2023 - 09/29/2023 6. 10/02/2023 - 10/06/2023 7. 10/09/2023 - 10/13 /2023 8. 10/16/2023 - 10/20/2023 9. 10/23/2023 - 10/27/2023 10. 10/30/2023 - 11/03 /2023 11. 11/06/2023 - 11/10/2023 12. 11/13/2024 - 11/17/2023 13. 11/20/2023 - 11 /24/2023 14. 11/27/2023 - 12/01/2023 3. Interview on 03/28/2024 at 12:00 pm with the Technical Consultant number 1 confirmed the findings. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of