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 Laboratory's Proficiency Testing (PT) records for 2016 and 2017, lack of director and testing personnel signatures on attestation statements and interview with Laboratory Technician, determined the laboratory failed to sign PT attestation statements for the two year period. The findings include: 1. Review of the 2016 and 2017 PT records. 2. Lack of director signature on attestation statements for 2016 and 2017. 3. Lack of personnel signatures on event B of 2017. 4. Interview with Laboratory Technician at approximately 12:00 p.m. February 13, 2018 confirmed that PT attestation statements had not been signed by laboratory director for 2016 and 2017 and for event B of 2017 by the testing personnel. ______________________________________ D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). 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 STANDARD is not met as evidenced by: ____________________________________ Based on review of 2 CBC (complete blood count) reports, lack of testing persons identification and interview with the Laboratory Technician, determined the laboratory failed to include identity of testing persons on CBC reports reviewed for April 2017 and January 2018. The findings include: 1. Review of 2 CBC reports, one for April 10, 2017 and one for January 25, 2018. 2. Lack of testing persons identification for 2 of 2 reports reviewed. 3. Interview with Laboratory Technician at approximately 12:00 p.m. February 13, 2018 confirmed the CBC reports reviewed did not contain testing persons identification. ______________________________________ D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(4)(iv) Ensure that an approved