Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 on review of proficiency testing (PT) records for testing performed in the specialty of Hematology and interview with the facility personnel, the laboratory director failed to sign the PT attestation statement. Findings include: 1. The laboratory performs Complete Blood Count (CBC) testing in the specialty of Hematology, with an approximate annual test volume of 52,000. 2. The PT attestation statement presented for review for the third event of 2019 for Hematology lacked the director's signature. 3. The PT attestation statement presented for review for the third event of 2020 for Hematology lacked the director's signature. 4. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) records, Proficiency Testing (PT) 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 -- records and interview with the facility personnel, the laboratory failed to document