Fort Bayard Medical Center

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 08/13/2025. The facility was found to be not in compliance with the following standard-level 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 laboratory personnel competency records and interview with the Technical Consultant (TC) the laboratory failed to establish and follow written policies and procedures to assess competency for one of one consultant. 1. A review of personnel competency records revealed there was no record of training or initial competency assessment for the TC. 2. During an interview conducted on 08/13/2025 at approximately 12:10 PM, the Technical Consultant confirmed the laboratory failed to establish written policies and procedures for competency assessment of the TC and there was no record of training or initial assessment for the TC. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test 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 -- reports. This STANDARD is not met as evidenced by: I. Based on laboratory tour observation, review of the BD Vacutainer package inserts, the laboratory temperature/humidity log and interview with the Technical Consultant (TC), the laboratory failed to ensure the room temperature acceptable range was within the manufacturer's storage specifications for four of four vacutainer types. Findings included: 1. During a laboratory tour on 08/13/2025 at approximately 2:45 PM, the following BD Vacutainer tubes were observed in storage in a cupboard in room F-43: 4 ml K2EDTA Lot Number: B240934K Expiration Date: 2026-01-01 Quantity = 12 Trays of 50 Tubes Storage Temperature Requirement on Label = 4-25C 5 ml Serum Sep Clot Activator Lot Number: B2412343 Expiration Date: 2026-04-02 Quantity = 8 Trays of 50 Tubes Storage Temperature Requirement on Label = 4-25C 3.5 ml Coagulation Sodium Citrate 3.2% High Altitude Lot Number: B25023C6 Expiration Date: 2026-02-05 Quantity = 1 Tray of 50 Tubes Storage Temperature Requirement on Label = 4-25C 4 ml Sodium Floride Potassium Oxalate Lot Number: A25033CS Expiration Date: 2026-07-07 Quantity = 1 Tray of 50 Tubes Storage Temperature Requirement on Label = 4-25C 2. A review of the BD Vacutainer package inserts for K2EDTA, Serum Sep Clot Activator, Coagulation Sodium Citrate, and Sodium Floride/Potassium Oxalate revealed a storage temperature requirement of 4-25C (39-77F). 3. A review of the laboratory temperature/humidity log for room F- 43 revealed an acceptable room temperature range of 18C to 30C with the following dates where the temperature exceeded 25C: Date Temperature 01/27/2025 25.4C 01/28 /2025 25.6C 01/29/2025 25.9C 01/30/2025 25.4C 01/31/2025 25.3C 4. In an interview on 08/13/2025 at approximately 3:00 PM, the TC confirmed the mentioned findings above. II. Based on laboratory tour observation, review of Chemistry reagent and Hematology Quality Control (QC) package inserts, the laboratory temperature /humidity log and interview with the Technical Consultant (TC), the laboratory failed to define and store reagents and QC material in temperatures consistent with the manufacturer's specifications for 43 out of 68 days. 1. During a tour of the laboratory, room F-43, on 08/13/2025 at approximately 1:20 PM, a refrigerator (State of NMDOH #19534) was observed storing the following items: Medica EasyRA Chemistry Test Reagents Alkaline Phosphatase (ALP), 2 boxes Alanine Aminotransferase (ALT), 2 boxes Aspartate Aminotransferase (AST), 2 boxes Blood Urea Nitrogen (BUN), 2 boxes Total Calcium (CA), 2 boxes Creatinine (CREA), 2 boxes Glucose-Hexokinase (GLU-H), 1 box Total Bilirubin (TBIL), 2 boxes Hematology Quality Control Cell-Dyn 22 Plus Control 2 Trays 2. A review of the manufacturer's package inserts for all the reagents and QC mentioned above revealed the following statements: Medica EasyRA test reagents, "Unopened reagent is stable until the expiration date listed on the label if stored at 2-8C. Cell-Dyn 22 Plus Control, "Cell-Dyn 22 Plus Control ... tightly capped and stored at 2-10C (36-50F). Protect containers from overheating and freezing." 3. A review of the laboratory temperature /humidity log for room F-43 revealed an acceptable temperature range for the refrigerator (State of NMDOH #19534) was 2C to 15C. A three-month random sample review of the refrigerator temperature recordings revealed the following dates when the temperature was outside the manufacturer's specified temperature ranges: Date Temperature 01/06/2024 1C and 8.7C 01/08-11/2024 1C 01/13/2024 1C 01/17- 20/2024 1C and 8.3C 01/22/2024 1C and 8.3C 01/23-24/2024 1C and 8.9C 01/26 /2024 1C 01/27/2024 1C, 8.3C, and 9.3C 01/29-31/2024 1C and 9.3C 01/06-07/2025 8.7C 01/10/2025 No Temperature Recorded 01/14-17/2025 9.4C 01/21/2025 9.4C 01 /22-24/2025 13.1C 01/28-29/2025 17.9C 01/30/2025 13.1C 01/31/2025 17.9C 05/01 /2025 1C 05/08-09/2025 1C 05/13-14/2025 1C 05/16/2025 1C 05/22-23/2025 No -- 2 of 4 -- Temperature Recorded 05/28-29/2025 15.0C 4. In an interview on 08/13/2025 at approximately 1:30 PM, the TC confirmed the mentioned findings above. D5785

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 2 -- Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 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 subspecialty of Routine Chemistry for the Sodium (Na) analyte. Refer to D2096. 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 the CASPER 0155 report and API 2025 proficiency testing records, the laboratory failed to achieve satisfactory performance (80% or greater) for the same analyte in two of two consecutive testing events (2025 Events 1 and 2) in the subspecialty of Routine Chemistry for the Sodium (Na) analyte. Findings included: 1. A review of the CASPER 0155 report revealed the following results: API 2025 - 1st Event The laboratory received an unsatisfactory score of 60% for Na. API 2025 - 2nd Event The laboratory received an unsatisfactory score of 0% for Na. 2. A review of API 2025 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 API 2025 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) (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 desk review of the CASPER 0155 report and API 2025 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 D2096. -- 2 of 2 --