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 surveyor's review of laboratory policies and procedures, laboratory records and confirmed in an interview with the pathologist/laboratory director, the laboratory failed to establish, reassess and document a workload limit for the laboratory director /technical supervisor (refer to D5631, D5633, D5637, D5639, D5645 and D5647). 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. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor's review of the twice year verification records for histology, cytology and an interview with the pathologist/laboratory director/technical supervisor, the laboratory failed to verify the accuracy for the Fluorescence In Situ Hybridization (FISH) images from January 1, 2020 through September 3, 2021. FINDINGS: The pathologist/laboratory director/technical supervisor confirmed on September 3, 2021 at approximately 10:30 AM that the laboratory failed to verify the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- accuracy for the urine FISH images from January 1, 2020 through September 3, 2021. a. Approximately 5 patients were tested and reported for FISH. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's Quality Assessment (QA) policy, lack of QA review records for the calendar year 2020 and an interview with the pathologist /laboratory director/technical supervisor, the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. FINDINGS: 1. The pathologist /laboratory director/technical supervisor confirmed on September 3, 2021 at approximately 10:15 AM, that the laboratory failed to follow their established QA policy for an ongoing mechanism to monitor, assess and correct problems identified in the general laboratory systems. 2. The laboratory's QA policy requires an annual review of all phases of laboratory's histology and cytology testing. a. the laboratory failed to perform and document the QA review for the calendar year 2020. 3. The laboratory failed to identify and take