Pediatric Care Center,The

Summary Statement of Deficiencies D6032 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(14) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(14) Specify, in writing, the responsibilities and duties of each consultant and each person, engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or results reporting, and whether consultant or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of the duties and responsibilities of the laboratory staff and interview with the testing person (TP) and laboratory director (LD), the LD did not ensure that the duties and responsibilities of the TP and technical consultant (TC) included instructions for the evaluation of laboratory quality control (QC) and quality assessment (QA) documentation to assure the quality of the laboratory services. Findings: During the survey on 11/22/24 at 12:45 PM, the TP and LD confirmed that duties and responsibilities did not include written instructions for the TP to submit QC and QA records at the beginning of the next month to the TC for review. The duties and responsibilities did not include written instructions for the TC to receive, evaluate, and submit follow up information to the TP and LD. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on procedure manual, laboratory reagent package insert, and patient log record review and interview with the laboratory director (LD), the laboratory did not follow the manufacturer's instructions for performing bacteriology testing. Findings: 1. The laboratory is performing presumptive identification of group A streptococcus on throat cultures, using Taxo A discs which are impregnated with low levels of Bacitracin. 2. During an interview at 10:30 AM on the day of the survey, the LD stated that the laboratory evaluates the culture plates at 24 and 48 hours after inoculation. This was confirmed with a review of the "Sophia 2 Strep A+ FIA Test and Culture Log" (patient log) from January to August, 2021. 3. The laboratory's "Throat Cultures For Diagnosis of Streptococcus Pyogenes (Group A Beta Hemolytic Streptococcus)" procedure states, "The sensitivity of the test can be increased by incubating all negative cultures for a total of 48 hours." 4. Review of the package insert for the "BD BBL Taxo A Discs" showed that culture plates must be incubated "at 35 to 37 degrees C for 18 to 24 hours" before being read or interpreted. 5. During an interview on 9/3/2021 at 1:00 PM the LD confirmed that the laboratory did not follow the manufacturer's instructions for performing throat cultures. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) record and patient sample log review and interview with the technical consultant (TC), the laboratory did not handle hematology and chemistry PT specimens in the same manner as patient samples. Findings: 1. All patient samples which enter the laboratory are recorded on a patient log. 2. A review of patient logs from January, 2017 to December, 2018 showed that hematology PT samples were not documented on the patient log along with patient specimens in 6 of 6 PT events; and 3. The chemistry PT specimen for the 1st event of 2017 was not logged on the bilirubin patient log. 4. During an interview on 1/4/19 at 2:15 PM, the TC confirmed that PT samples were not handled in the same manner as patient specimens. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods 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 proficiency testing (PT) record review and interview with the technical consultant (TC), the laboratory did not ensure that all the testing personnel who tested patient samples performed the PT. Findings: 1. The laboratory currently has 3 testing personnel listed on the "Laboratory Personnel Report (CMS-209)" who perform hematology and chemistry testing. 2. A review of hematology PT attestation worksheets from 2017 and 2018 showed that PT was performed by the same testing person in 4 of 6 events; and 3. A review of chemistry PT attestation worksheets from 2017 and 2018 showed that PT was performed by the same testing person in 5 of 6 events. 4. During an interview on 1/4/19 at 2:15 PM, the TC confirmed that PT samples were not tested each year by all the staff who perform patient testing to ensure accurate and reliable patient test results. -- 2 of 2 --