Belen Branch Laboratory

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on July 8, 2026, at Belen Branch Laboratory found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on observation, interview with the technical consultant, review of the laboratory's Direct Observation of Employee Working at Different CLIA License Number Different from Parent CLIA License Location Form, the Technical Consultant failed to ensure competency assessments were completed for one of four testing personnel in 2024 through July 2026. Findings Included: 1. During a laboratory tour on 07/08/2026 at 10:05 am, it was observed testing personnel 4 (TP4), not previously listed on the laboratory's CMS (Centers for Medicaid and Medicare) 209 personnel form, was performing testing. 2. During an interview on 07/08/2026 at 10:30 am the technical consultant stated TP4 is a trainer and rotates to the different branch facilities to help with testing if needed. 3. The laboratory was asked to provide documentation of competency assessments being performed for TP4 for the onsite location. The laboratory provided a form titled "Direct Observation of Employee Working at Different CLIA License Number Different from Parent CLIA License Location Form - BL" 4. A review of the Direct Observation of Employee Working at Different CLIA License Number Different from Parent CLIA License Location Form revealed it did not include the 6-criterion required for competency assessment. 5. During an interview on 07/08/2026 at 11:15 am the technical consultant stated TP4 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 -- did have competency assessments completed at the "Home Location" for the testing personnel, but not at the onsite location. 6. The laboratory reported performing 4,876 tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The following deficiency was cited during a complaint survey completed on 03/11 /2021 for the federal requirements of 42 CFR Part 493 for Laboratories. Intake NM00047971 was substantiated. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based review of an email from the Technical Consultant, the laboratory website, and on interviews with laboratory staff, the laboratory failed to communicate information regarding patient care centers (locations where patients have blood or other body fluids collected) for SARS-CoV-2 (the strain of a coronavirus that causes COVID-19, a upper respiratory virus), positive patients with the public and ordering providers. Findings are: A. Review of a complaint dated 10/24/2020 indicated the laboratory refused to perform a blood draw on a SARS-CoV-2 positive patient. B. Review of the laboratory's corporate website on 10/28/2020 had no information for its clients regarding the availability of collection services for patients with SARS-CoV-2 infections. 1. "[Name of Facility] Update - 31 July 2020" and "[Name of Facility] Update - 10 September 2020" had information about updated hours and links to patient care center hours but no specific information to guide the public on which centers accept SARS-CoV-2 positive patients. 2. The list of patient care centers do not indicate which centers accept SARS-CoV-2 positive patients. C. During interview on 11/18/2020, the Technical Consultant stated the laboratory did not have a written policy for SARS-CoV-2 positive patients. The verbal policy was to send these patients to two patient care centers located in a nearby city (45 minute drive from this location). D. During interview on 03/11/2021 at 4:00 pm, 3 of 3 Testing Personnel 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 -- stated that the laboratory did not have a written policy at the time of the incident in October 2020 and still do not have one as of the day of the survey. E. Review of an email dated 10/22/2020 from the Technical Consultant to laboratory staff in response to the incident indicated, "[Patient Care Center] is the place to send them until they are declared negative by the State." -- 2 of 2 --