Texas Children's Pediatrics Lone Star

Summary Statement of Deficiencies D0000 Noted deficiencies were discussed with the laboratory representative at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the manufacturer's instructions, laboratory policy and procedure, patient test reports, interview, and pre-survey paperwork, the laboratory failed to redact or verify flagged indices on the CBC test report using the Medonic M-Series for two out of four flagged patient test reports reviewed. A. Review of the Medonic M- Series User's Manual under 9.2 System Information Messages starting on page 71 stated, "the system software monitors a number of analytical and system functions and will display information that indicates the possible attention of the operator. This information will alert the operator to check the system or sample, or institute selected troubleshooting procedures... System Information Messages... 1. Indicator Message OM WBC Diff: Only one WBC population found; slide review advised. Description There was only one mode in the WBC distribution between the LYM-L and GRAN - H settings. Often in pathological samples with granulotcytosis or lymphocytosis a blood smear is recommended. Action Blood sample too old or pathological sample. Follow laboratory's protocol for verification of results. 2. Indicator Message TM WBC Diff: Too many WBC population found; slide review advised. Description There were more than two modes in the WBC distribution between the LYM-L and GRAN -H settings. Action Blood sample too old or pathological sample. Follow 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 -- laboratory's protocol for verification of results". B. Review of the laboratory's policy and procedure titled CBC Medonic M-Series, revision 08/16, under Procedure Patient Testing- Capillary Draws stated, "7. Report patient testing results. a. It is the responsibility of the Provider to correlate instrument results (including flagged parameters) with clinical findings. See the User's manual (pages 71-76) for system information message descriptions. The Diff flags (BD, NM, OM, and TM) indicate a possible problem with the accuracy of the results. Performing a slide review by a reference lab (as recommended by the manufacturer) or further will be performed as requested by the attending Provider. Don't Report in EMR and mark out with dark line on original." C. Review of 7 patient reports, showed 4 had flagged indices. Of the 4 test reports with flagged indices, 2 had been reported (not redacted). 1. On 12/15 /2021, sample at sequence #4432 was flagged with OM for the LYM, MID, GRAN, LYM%, MID%, GRA% and reported. 2. On 12/16/2021, sample at sequence #4442 was flagged with TM for the LYM, MID, GRAN, LYM%, MID%, GRA% and reported. D. Interview with the technical consultant on June 16, 2022 at 1100 hours confirmed testing personnel were not following the procedure and indices with flags were reported. E. Review of pre-survey paperwork showed the annual test volume was 3828. KEY: CBC = Complete Blood Count EMR = Electronic Medical Record LYM = absolute Lymphocytes MID = absolute Monocytes, mixed GRAN = absolute granulocytes LYM% = percent Lymphocytes MID% = percent Monocytes, mixed GRA% = percent Granulocytes -- 2 of 2 --

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) 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 review of proficiency testing records for 2016, 2017 and 2018, and interview of facility personnel, the laboratory failed to participate in 1 of 6 proficiency testing events for the specialty of hematology. The findings include: 1. A review of the American Proficiency Institute (API) proficiency testing records found the laboratory failed to submit the results in the time frame specified by the program for the 2017 Hematology 3rd testing event. a. Review of the 2017 Hematology 3rd event proficiency testing instructions found that the Proficiency online and postmark due date as Friday, 12/1/2017 11:59 PM b. Review of the 2017 Hematology 3rd event Performance Summary found no scores for the analytes Erythrocytes, Hematocrit, Hemoglobin, Leukocyte Count, MCH, MCHC, MCV, Platelet count, RDW, and White Blood Cell Differential. c. Review of the 2017 Hematology 3rd event Performance Evaluation found a handwritten notation " deadline missed for online reporting. Spoke with API, recommended self grading of scores. 100% for all analytes." 2. Interview of the Technical Consultant conducted on July 18, 2018 at 10: 06 AM confirmed that the laboratory failed to test specimens and submit results to the proficiency testing agency before the submission deadline. She confirmed that the 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 -- specimens were not tested until December 19, 2017 and self graded on January 25, 2018. D6017 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(ii) 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)(4)(ii) Ensure that results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on review of the laboratory's proficiency testing records from 2016, 2017 and 2018 and staff interview, found the laboratory director failed to ensure proficiency test results were returned prior to the submission deadline in one of six events. (refer toD2123). -- 2 of 2 --