Summary:
Summary Statement of Deficiencies D0000 A complaint investigation (OK00083199) was performed on 07/18/2025. The complaint was substantiated. The laboratory was found out of compliance with the following CLIA Condition: 493.801; D2000: Enrollment and Testing of Samples The findings were reviewed with the quality and safety specialist on 07/23/2025. 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 a review of records, observation, and interview with the quality and safety specialist and lead technologist, the laboratory failed to ensure they followed Subpart H for one of two Chemistry Core proficiency testing events in 2025. Findings include: (1) The laboratory sent proficiency testing samples to another laboratory for one of two Chemistry Core events in 2025. Refer to D2013. D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) (b)(5) The laboratory must not send proficiency testing samples or portions of proficiency testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines 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 -- intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on a review of records, observation, and interview with the quality and safety specialist and lead technologist, the laboratory sent proficiency testing samples to another laboratory for one of two Chemistry Core events in 2025. Findings include: (1) The quality and safety specialist contacted the Oklahoma State Agency on 05/29 /2025 to self-report that five specimens from the API (American Proficiency Institute) Second 2025 Chemistry Core event had inadvertently been sent to their main hospital laboratory - SSM Health St Anthony- Oklahoma City- CLIA #37D0050352. The samples had been sent by courier on 05/27/2025 which was prior to the API submission cut-off date of 05/28/2025; (2) Interview with the quality and safety specialist and lead technologist on 07/18/2025 at 09:30 am provided the following information: (a) The main hospital laboratory courier picked up patient referral specimens at 10:00 am and 04:30 pm. Specimens for pickup were stored in plastic biohazard bags on the fourth shelf of the Thermoscientific refrigerator in the laboratory; (b) The second shift technologist prepared patient samples for the 04:30 pm courier pickup on 05/27/2025 by completing a packing list and placing the specimens from the fourth shelf into a large send-out testing bag which had been placed on the top shelf of the refrigerator. It was then noticed that a plastic biohazard bag containing specimens was sitting on the first shelf of the refrigerator and without looking in the bag, assumed the specimens were intended for the courier pickup, and they were placed into the send-out testing bag; (c) When the specimens were received at the main hospital laboratory, the evening processor at the main hospital laboratory identified the samples were not patient samples and immediately set them aside in the refrigerator with a note for the day shift lead technologist; (d) The day shift technologist identified the specimens in the biohazard bag were from the second 2025 Chemistry Core event, consisting of CH-07, ALC-07, HCG-07, NB-07, and IB-07 and immediately notified the laboratory. (3) The quality and safety specialist provided the following documents for review: (a) Copies of the proficiency testing records for the Second 2025 Chemistry Core event; (b) Copies of the API Submitted Results Form for the main hospital laboratory and the laboratory; (c) Copy of the Root Cause Analysis completed by the laboratory on 05/29/2025, outlining the investigation of the occurrence with the