Summary:
Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review and surveyor interviews the laboratory failed to follow policies and procedures to determine the cause of discrepancies between the cytology diagnosis and the histopathology (refer to D5623); failed to follow policies and procedures to document the search for prior negative gynecologic specimens for patients with a current HSIL, adenocarcinoma, or other malignant neoplasm (refer to D5625); failed to follow policies and procedures for the evaluation and comparison of two of six laboratory statistics (refer to D5629) and failed to document procedures performed (refer to D5667). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on lack of records and interview it was determined that Facility A laboratory (CLIA 45D2080242) failed to ensure that records were available to show that Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- complaints were documented and investigated. Findings include: 1. The Survey Team requested, and Facility A laboratory failed to provide, records of complaints received from 2016 and 2017. 2. The Clinical Pathology Support Manager confirmed during an interview on 7/18/18 at 2:00 PM that these records were kept at the executive office and not at Facility A laboratory. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of records, and interview it was determined that Facility A laboratory failed to assess the competency of three of three Technical Supervisors who performed the microscopic evaluation of cytology specimens in 2016, 2017 and to the date of the survey in 2018. Findings include: 1. The policy titled "PATHOLOGISTS' COMPETENCY ASSESSMENTS" did not reference or describe the newly created form ("PATHOLOGIST COMPETENCY QA CHECKLIST") to document the competency for three of three Technical Supervisors. 2. The Survey Team requested, and the Facility A laboratory failed to provide, completed competency assessment records for three of three Technical Supervisors that performed the microscopic examination and reporting of cytology test results in 2016, 2017 and to the date of the survey in 2018. Laboratory Director/Technical Supervisor #1 Technical Supervisor #2 Technical Supervisor #3 3. The Clinical Pathology Support Manager confirmed these findings during an interview on 7/17/18 at 2:03 PM. 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 rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, lack of laboratory records, and interviews it was determined that the Facility A laboratory failed to follow policies or procedures to document the transportation of cytology slides from Facility A to Facility B (CLIA 45D0505003) for the years 2016, 2017 and to the date of the survey in July 2018. Findings include: 1. The policy "CYTOLOGICAL EXAMINATIONS" stated "5. Slides are tracked by (Facility B) at their main location. All slides sent to this laboratory (Facility A) for pathology review via (Facility B) courier." The policy referenced two Facility B procedures ("AUS250646SOP NON-GYN CASE ALLOCATION/DISTRIBUTION" and "AUS251461SOP GYN SLIDE TRACKING AND DISTRIBUTION") which were not followed. 2. The Survey Team requested, and Facility A laboratory failed to provide, transport records for slides received at -- 2 of 12 -- Facility A from Facility B for 2016, 2017 and to the date of the survey in July 2018. 3. During interviews with the Facility B Cytology Manager on 7/17/18 at 3:17 PM and again on 7/18/18 at 8:50 AM, the Survey Team requested slide transport records. a. During the interview on 7/18/18 at 8:50 AM, the Facility B Cytology Manager stated that the process of keeping slide transport records began in May and that Facility B stopped sending cytology slides to Facility A in May. Facility B Cytology Manager further stated that there were no slide transport records for May 2018 or for the previous months because Facility B was not keeping these records. 4. These findings were confirmed during an interview on 7/19/18 at 11:27 AM with the Facility A Laboratory Director/Technical Supervisor #1, the Clinical Pathology Support Manager and the Facility B Cytology Manager. D5393 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(b)(c) The preanalytic systems assessment must include a review of the effectiveness of