Bh Services Southeast 1, Pc

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 the laboratory's proficiency testing records and interview with the lead testing personnel, the laboratory director failed to sign four of five proficiency testing attestation statements in 2018 and 2019. The findings include: 1) Review of the laboratory's proficiency testing records revealed Hematology/Coagulation proficiency testing attestation statements that had not been signed by the laboratory director for 2018 events two and three, and 2019 events one and two. 2) Interview with the lead testing personnel on February 4, 2020 at 11:30 a.m. confirmed the laboratory director failed to sign four of five proficiency testing attestation statements in 2018 and 2019. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the 2018 complete blood count (CBC) quality control (QC) records, three patient records, the February 2018 quality assessment (QA) records and interview with testing personnel number one, the laboratory director failed to ensure the quality assessment (QA) review was effective, with no