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 lack of documentation and confirmation by the laboratory director, the laboratory failed to enroll in proficiency testing for the specialty of Hematology for 2019 testing. The laboratory did not enroll for the 1st and 2nd Hematology proficiency testing events. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on proficiency testing records review, lack of documentation, and interview with staff, the laboratory failed to retain proficiency testing attestation statements for 2 of 4 proficiency testing events reviewed from the 3rd American Proficiency Institute (API) event of 2017 through the 3rd event of 2018 (the last event participated in by the laboratory). Findings include: 1. The laboratory failed to retain the attesting 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 -- statement signed by the director and testing personnel from the 2nd and 3rd API Hematology events of 2018. 2. In an interview with staff on 08/22/2019 at approximately 11:30 A.M. staff confirmed the attestation statements signed by the director and testing personnel were not maintained for at least 2 years. 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 lack of documentation and confirmation by the laboratory director, the laboratory failed to ensure they had a quality assurance plan to monitor proficiency testing records to ensure enrollment in an approved proficiency testing program and that