Summary:
Summary Statement of Deficiencies D0000 A Complaint survey was performed at OLHS ST MARY PLACE MEDICAL CENTER LABORATORY, CLIA # 19D2181178, on August 23, 2023 through August 24, 2023. OLHS ST MARY PLACE MEDICAL CENTER LABORATORY was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.801 CONDITION: Enrollment and Testing of Samples 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 proficiency testing records and interview with personnel, the laboratory failed to ensure testing and reporting of proficiency samples of another CLIA laboratory did not occur. Findings: 1. The laboratory failed to ensure that no inter-laboratory communications occurred for Amniotic Fluid pH proficiency testing samples prior to the performance of testing and submission of results for five (5) of five (5) testing events reviewed from 2021-2023. Refer to D2011. 2. The laboratory failed to ensure the receipt of proficiency testing samples from another laboratory was reported to the Center of Medicaid & Medicare Services (CMS) for five (5) of five (5) consecutive proficiency testing events in 2021-2023. Refer to D2013. 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 -- D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of the laboratory's