Summary:
Summary Statement of Deficiencies 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 review of the laboratory's records and lack of proficiency testing documents, and interview with the laboratory testing personnel, it was determined that the laboratory failed to perform evaluation of proficiency testing performance for histopathology and cytology, and failed to ensure the accuracy, reliability, and timely of the patient testing result reports at least twice annually. The findings included: a. The laboratory is a pathology services laboratory and performed histopathology and non-gyn cytology which are not listed in the subpart I of 42 CFR part 493. b. The laboratory failed to perform evaluation of proficiency for histopathology and non-gyn cytology, at least twice annually for the years of 2020 and 2021 to ensure the accuracy and reliability of the patient test result reports. c. There were no documents of peer review by a qualified testing personnel available at the time of survey. d. The laboratory performed in approximately 192 patient samples annually. e. The laboratory testing personnel affirmed at the time of survey (3/15/22 @11:10 am) that the laboratory failed to perform evaluation of proficiency testing performance at least twice annually for the year of 2020 and 2021. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's records and lack of proficiency testing documents, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to ensure that the quality control programs were established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. The findings included: a. The laboratory is a pathology services laboratory and performed histopathology and non-gyn cytology which are not listed in the subpart I of 42 CFR part 493. b. The laboratory failed to perform evaluation of proficiency for histopathology and non-gyn cytology, at least twice annually for the years of 2020 and 2021 to ensure the accuracy and reliability of the patient test result reports, see D-5217. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the laboratory's records and lack of proficiency testing documents, and interview with the laboratory testing personnel, it was determined that the laboratory director failed to assure that the quality assessment programs were established and maintained to ensure the quality of laboratory services provided and to identify failures in quality as they occur, and to ensure the accuracy, reliability of the patient test result reports. The findings included: a. The laboratory is a pathology services laboratory and performed histopathology and non-gyn cytology which are not listed in the subpart I of 42 CFR part 493. b. The laboratory director failed to assure the quality assessment programs were established and maintained to ensure the quality of laboratory services provided, and to identify failures in quality as they occur, see D- 5217 . -- 2 of 2 --