Summary:
Summary Statement of Deficiencies 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 record review and interview with the laboratory director (LD), the laboratory was not enrolled in proficiency testing (PT) for Rhesus factor (Rh) or serum human chorionic gonadotropin (hCG) testing while patient testing was being performed. Findings: 1. The laboratory began Rh and hCG testing in November 2024. During an interview on 03/28/2025 at 9:23 AM, the LD stated that the laboratory was not enrolled in PT for the specialties/subspecialties of endocrinology or immunohematology. 2. The CASPER report 0096D pulled on 04/03/2025 showed that the lab did not have any PT scores reported to the Center for Medicare and Medicaid Services. The cumulative effect of this deficiency has the potential to result in the laboratory's inability to ensure the accuracy and reliability of patient test results. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. 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 -- This CONDITION is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to meet the requirements specified in 493.1230 through 493.1256, 493.1271, and 493.1281 through 493.1299 (D5445). D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director (LD), the laboratory failed to have written procedures for performing proficiency testing (PT), quality control (QC), or quality assurance (QA). Findings: 1. Record review showed that the laboratory did not have written procedures for performing PT or what to do if PT results were unsatisfactory; for performing QC, including the frequency with which QC should be run and what to do if QC failed; or how the laboratory would perform QA, to identify failures and