Summary:
Summary Statement of Deficiencies D6115 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(2) The technical supervisor is responsible for verification of the test procedures performed and establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: Based on review of 417 gynecologic cases and corresponding final test reports from September through December 2017, and interview it was determined that the the Technical Supervisor failed to verify the accuracy of five gynecologic cytology test reports. Findings include: 1. TP17-200145 09/28/17 ThinPrep LABORATORY DIAGNOSIS: Satisfactory for Evaluation; Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity 2. TP17-316404 10/05/17 ThinPrep LABORATORY DIAGNOSIS: Satisfactory for Evaluation; Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity 3. TP17-316577 10/0517 ThinPrep Imaged LABORATORY DIAGNOSIS: Satisfactory for Evaluation; Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity 4. TP17-411219 10/18/17 SurePath FocalPoint LABORATORY DIAGNOSIS: Satisfactory for Evaluation; Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity 5. TP17-200181 12/27/17 Conventional LABORATORY DIAGNOSIS: Satisfactory for Evaluation; Negative for Intraepithelial Lesion or Malignancy SURVEY TEAM DIAGNOSIS: 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 -- Unsatisfactory for Evaluation; Scant Cellularity TECHNICAL SUPERVISOR DIAGNOSIS: Unsatisfactory for Evaluation; Scant Cellularity 6. The Technical Supervisor confirmed the Survey Team findings at 12:30 PM on January 10, 2018. D9999 By agreement between ASCT Services, Inc. and CMS, information provided for CMS's completion of CMS Form 670 are ASCT Services, Inc. averages only. This information is confidential and proprietary to ASCT Services, Inc., is exempt under the Freedom of Information Act (5 U.S.C. 552 et seq.), and shall be used for federal government purposes only. -- 2 of 2 --