Mena Regional Health System Respiratory Care

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based upon a review of the American Proficiency Testing Institute (API) proficiency test attestation records for three events in 2025 and two events in 2026, lack of documentation, and interviews with laboratory staff, it was determined that failed to obtain required signatures to attest to the routine integration of proficiency test samples in the patient workload on 5 of 5 events reviewed. Survey findings follow: A) Review of the attestation forms for API Chemistry Core proficiency test events, 1st event 2025, 2nd event 2025, 3rd event 2025, 1st event 2026, and 2nd event 2026 revealed that they were not signed by the lab director or designee or the testing personnel performing the test. B) In an interview, at 02:40 p.m.on 9/15/26, the laboratory staff member (number 1 on the form CMS 209) confirmed the API proficiency testing attestation forms identified above were not signed by the required personnel. 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: 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 -- Based upon a review of the CMS 209 form, review of laboratory documentation of competency assessment, lack of documentation and interview with laboratory staff the laboratory failed to assess clinical consultant competency on an annual basis for one of one clinical consultant listed on the form CMS 209. Findings follow: A) Review of the CMS 209 form revealed that the laboratory staff (number 12 on the form CMS 209) was acting as the clinical consultant for the laboratory. B) Review of competency assessment records revealed that the clinical consultant (number 12 on the CMS 209 form) had no record of competency evaluation. C) Upon request, the laboratory was unable to provide competency assessments for clinical consultant (number 12 on the CMS 209 form). D) In an interview on 9/15/26 at 2:30 p.m., the laboratory staff member (# 1 on the form CMS 209) confirmed that competency assessments for the clinical consultamt identified above were not performed. D5781

Summary Statement of Deficiencies 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: Through observation, review of the instrument manufacturer's operator manual, lack of documentation and interview it was determined that the laboratory failed to monitor humidity in one of one rooms in which an instrument with an operational humidity requirement is used to perform arterial blood gas analysis. Findings follow: 1. During a tour of the laboratory on 6/19/18 at approximately 12:30 PM, an ABL-800 FLEX arterial blood gas analyzer was observed. 2. Review of the instrument manufacturer's operator manual for the ABL-800 FLEX arterial blood gas analyzer revealed an operational humidity range requirement of 20% to 80%. 3. Upon request, the laboratory could not produce record of humidity level in the room in which the ABL- 800 FLEX blood gas analyzer is used. 4. In an interview on 6/19/18 at approximately 3:15 PM, the laboratory director, identified as number one on the CMS 209 form, confirmed that the ABL-800 FLEX analyzer is used to perform arterial blood gas analysis and the laboratory kept no record of the humidity level in the room in which the analyzer is used for the performance of arterial blood gas analysis. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --