Summary:
Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on a review of College of American Pathologist (CAP) Proficiency Test reports and an interview with the laboratory director and testing person, the laboratory failed to enroll in PT that meets the criteria in Subpart I and is approved by HHS. Finding Include: On December 13, 2018, at approximately 12:30 pm the laboratory director and testing person confirmed that the laboratory was in a throat culture PT challenge which offers 3 specimens to include a Strep antigen challenge. The laboratory needs to enrolled in a 5 specimens challenge. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of PT records from CAP, the laboratory failed to successfully Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- participate in a PT program approved by CMS for the test analyte Hematocrit (HCT) count for the first event of 2017 and the first event of 2018. No remediation was performed. The following scores were assigned: HCT 2017 first event = 60% 2018 first event = 20% This is considered unsatisfactory PT performance. D2122 HEMATOLOGY CFR(s): 493.851(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of CAP PT records and an interview with the laboratory director and testing person, the laboratory failed to participate and perform successfully in a PT program approved by CMS, for the specialty Hematology. The following score was assigned:Hematology 2018 first event = 77% This is considered unsatisfactory PT performance D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a review of lack of quality control (QC) records and an interview with the laboratory director and testing person, the laboratory failed to have a complete procedure manual, validation of new tests and QC for bacteriology testing for the last two years. Refer to: D5403, D5423, and D5477 D5006 MYCOLOGY CFR(s): 493.1203 If the laboratory provides services in the subspecialty of Mycology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1263, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a lack of records and confirmed an interivew by the laboratory director and testing person, the laboratory failed to perform QC for the DTM media for the last two years. Refer to: D5477 D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. -- 2 of 7 -- This STANDARD is not met as evidenced by: Based on a review of the proficiency test (PT) reports from College of American Pathologist (CAP), the laboratory failed to review and evaluate the PT scores that are less than 100%. Findings Include: On December 13, 2018 at approximately 12:30 pm, it was confirmed by the laboratory director and testing person that the laboratory failed to review and evaluate the following: 2017 third event Bacteriology = 89% 2018 second event HCT= 80% 2018 second event RBC = 80% D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)