Summary:
Summary Statement of Deficiencies D0000 The Peer Reviewer and QA coordinator were at the entrance conference conducted 02 /21/2019. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the Peer Reviewer and QA coordinator on 02/21/2019. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiency cited was discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Department of State Health Services, Health Facility Compliance Arlington Group. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure manual, patient test report and requisition, test volume records, and in interview with staff, the laboratory failed to establish and follow written policies for ongoing mechanism to monitor, assess, and when indicated, correct problems identified in preanalytic systems. Findings included: 1. Review of the laboratory's procedure manual did not include a review for ensuring all necessary information was obtained on patient test requisitions. 2. Review of all patient records in 2018 revealed 1 of 2 patient test requisitions did not include the collection date and time of the specimen, as follows: Patient #SA18-8729 final test report included "Taken: 09/13/2018," as the collection date; the patient test requisition included a "DATE AND TIME COLLECTED" space that had not been filled. The requisition did not solicit the date and time of collection. 3. According to records, the laboratory's annual volume was 2 tests. 4. During an interview on 02/21/2018 at 10:40 am, the QA coordinator reviewed the records for Patient #SA18-8729 and stated she 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 -- assumed the collection date was the "admission date" of the patient. The QA coordinator stated she was unable to find a "Problem/Resolution" report submitted to the client by Client Response Center for Patient #SA18-8729 (09/2018). The laboratory did not establish and follow written policies for ongoing mechanism to monitor, assess, and when indicated, correct problems identified in preanalytic systems. -- 2 of 2 --