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 record review and an interview with Testing Personnel (TP), the laboratory failed to ensure TP attested to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods. Findings Include: 1. Review of five out of seven of the laboratory's 2016-2017 PT records provided on the date of the inspection, did not find TP signatures attesting to the routine integration of PT samples into the patient workload using the laboratory's routine methods on the following TP records: WSLH PT ID #2014020 June 22, 2016 MLE ID #014457 November 9, 2016 MLE ID #014457 February 24, 2017 MLE ID #014457 June 2, 2017 MLE ID #014457 September 29, 2017 2. TS#9 confirmed the TP did not provide signatures attesting to the routine integration of PT samples into the patient workload using the laboratory's routine methods and was unable to provide the requested documentation on the date of the inspection. The interview occurred on 01/17/2018 at 10:59 AM. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and 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 -- rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual and an interview, the laboratory failed to establish written policies and procedures for specimen rejection. Findings Include: 1. Review of the laboratory's procedure manual titled "Laboratory Procedure Manual North Office", did not find a policy and procedure for specimen rejections. 2. Testing Personel #9 confirmed that the laboratory's procedure manual did not have a specimen rejection procedure. The interview occurred 01/17/2018 at 11:18 AM. 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