Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) record review and an interview with the technical consultant, the laboratory director and the testing personnel failed to sign the College of American Pathologists (CAP) attestation statements for the complete blood counts (CBCs) performed during 2019 events 1 and 2. Findings: 1. A review of PT documents revealed the laboratory director and the testing person failed to sign the CAP attestation statements for the CBCs performed during events 1 and 2 in 2019. 2. An interview with the technical consultant on June 24, 2019 at 4:05 PM, confirmed the laboratory director and testing person failed to sign the CAP attestation statements in 2019. 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. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical consultant, the laboratory failed to verify the accuracy of microscopic urine sediment examinations at least twice annually since June 2018. Findings: 1. A record review of proficiency testing from the College of American Pathologists and laboratory documents, revealed the laboratory failed to document the accuracy of microscopic urine sediment analysis at least semiannually since the start of patient testing in June 2018. 2. The laboratory performed approximately 150 urine sediment examinations since June 2018. 3. An interview with the technical consultant on June 24, 2019 at 6:45 PM, confirmed the laboratory failed to document the accuracy of urine sediment exams at least semiannually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a record review and an interview with the technical consultant, the laboratory failed to state the acceptable refrigerator and room temperature ranges on the laboratory worksheet to record daily temperatures since June 29, 2019. Findings: 1. A review of laboratory documents revealed the laboratory failed to state the acceptable temperature ranges on the chart for the refrigerator where complete blood count quality control material was stored and the room temperature where patient specimens were tested. 2. A review of the temperature log worksheet revealed the laboratory failed to monitor and record the daily room temperature of the laboratory since the start of patient testing on June 29, 2018. 3. An interview with the technical consultant on June 24, 2019 at 6:45 PM, confirmed the laboratory failed to indicate the acceptable temperature ranges on the worksheet and record the daily room temperatures. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of quality control records, a review of patient test reports, and an interview with the technical consultant, the laboratory failed to test at least 2 levels of quality control materials for complete blood counts (CBCs) performed on the Emerald Cell-Dyn for each day of patient testing between February 28, 2019 and March 11, 2019. Findings: 1. A review of the quality control records for the Emerald Cell-Dyn hematology analyzer revealed the laboratory failed to test at least 2 levels of quality control materials each day of patient testing between February 28 and March 11, 2019. 2. A review of patient CBC reports between February 28 and March 11, 2019, revealed 7 patient CBC test results were reported. 3. An interview with the technical consultant on June 24, 2019 at 7:00 PM, confirmed the laboratory failed to test at least 2 levels of quality control materials prior to performing tests on patient specimens. D5781