Summary:
Summary Statement of Deficiencies D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records from API, and interview with the laboratory technical consultant on March 7, 2023, at 11:50 am, the laboratory failed to participate in the 3rd PT event of 2022. The findings include: 1. The laboratory participated in the API PT testing program in 2022 for its CT/GC test. However, the laboratory did not participate in the 3rd PT event. The technical consultant said that the laboratory lost the PT sample, probably was stolen. Therefore, the accuracy of the reported results during the 3rd PT event cannot be assured and may harmed patients. 2. The laboratory technical consultant on March 7, 2023, at 11: 50 am, affirmed that the laboratory did not participate in the PT testing for the 3rd event of 2022 and received a "0" score. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/6/2023 stated that the laboratory performs approximately 7,200 tests, annually. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, patients' test records, and interview with the laboratory technical consultant and testing person on March 7, 2023, at 11:30 am, it was determined that the laboratory did not meet the requirement under 493.1241, 493.1242 and 493.1249 to fulfil the preanalytic systems condition. The laboratory's failure to meet the condition may have potential to harm and affect patient care. The findings include: 1. The laboratory failed to have a written or electronic request for patient testing from an authorized person, see D5301. 2. The laboratory failed to follow specimen rejection policy and procedure, see D5311. 3. The laboratory failed to perform preanalytic systems quality assessment, see D5391. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/6 /2023 stated that the laboratory performs approximately 7,200 tests, annually. D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's patients test records, and interview with the laboratory technical consultant and testing person on March 7, 2023, at 11:30 am, the laboratory failed to have test request from an authorized person. The findings include: 1. The laboratory performed CT/GC molecular tests on urine samples with the GeneExpert instrument. It received the samples without any test request from an authorized person. The technical consultant informed that the lab received samples from their own clinic located at a different location. However, no test request documents were available. Therefore, it cannot be assured that an authorized person is requesting the test. 2. The laboratory technical consultant on March 7, 2023, at 11:30 am, affirmed that the laboratory did not have any test request documents. 3. The laboratory's testing declaration form, signed by the laboratory director on 3/6/2023 stated that the laboratory performs approximately 7,200 tests, annually. 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, and interview with the laboratory technical consultant and testing person on March 7, 2023, at 11:20 am, the laboratory failed to follow specimen rejection policy. The findings include: 1. The laboratory received urine sample for CT/GC test and rejected the sample. The testing person said that he rejected the sample due to low volume. However, it did not keep any documentation of the rejected sample and the