Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on 03/13/2024. The laboratory was found to be out of compliance with the following condition: 493.801 Enrollment and Testing of Samples. 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 laboratory policy, document review, and confirmed in staff interview, the laboratory failed to enroll in a Centers for Medicare and Medicaid Services (CMS) approved proficiency testing (PT) program as required by Clinical Laboratory Improvement Amendments (CLIA) for the specialty of hematology for 5 of 7 events. Findings included: The laboratory policy, signed by the Laboratory Director (LD) on 08/29/2023, included "Proficiency Testing Instructions" that revealed, "11. This laboratory will abide by all rules of the proficiency testing agency and all rules under CLIA '88 [1988] regarding successful participation in, and sanctions resulting from any failure of proficiency testing, as deemed by HCFA [health care financing administration] or any other government, or accrediting agency." Review of the untitled document signed by the LD, undated, revealed, "This is being written to disclose our failure to promptly enroll in proficiency testing during the opening of [name of laboratory] in July of 2022 and to serve as a plan of action to Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- correct the error. On April 24, 2023 our purchasing director sent out an email to the administration inquiring about the purchase of the API-PT testing. At that time, it was recognized that the clinic had failed to be enrolled in the API-PT testing. The emails are included in the action plan to show the quick response and attempt to correct the error. The clinic was enrolled in API-PT testing the next day on April 25, 2023. Due to clinical staffing issues in those first few months after the clinic opened it was not evidence that the proficiency testing was absent from our normal clinical standards. Once the error was realized the order was placed and the first shipment was set up to be delivered. Now that our clinic is enrolled in the API-PT testing the account will auto re-new with no concern for further missed cycles. To disclose we did miss the October 2022 event and March 2023 event. The API-PT testing was delivered in July 2023 for the second event of the year. Missing API-PT testing should never be a problem in the future from here on out." In an interview on 03/13/2024 at 12:15PM, the Regional Director (RD) acknowledged the laboratory did not enroll in proficiency testing (PT) when the laboratory first opened. Per the RD, the oversight was first discovered in April of 2023. The RD stated the laboratory enrolled in PT on 04/23 /2023 and missed the third event of 2022, and the first event of 2023. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)