Clinical Pediatric Assoc Of North Texas

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. 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 manufacturer's instructions, laboratory policy, patient test reports, and confirmed in staff interview, the laboratory failed to follow manufacturer's instructions for flags on the Cell-Dyn Emerald hematology analyzer for 1 of 19 patients reviewed in January 2023. Findings included: 1. Review of Cell-Dyn Emerald Operator's Manual page 3-13 revealed: "WBC Measurand Flags An asterisk (*) for count invalidation or (s) suspect measureand [sic] flags are displayed with the corresponding results. These flags are generated after the instrument evaluates the measured data for a particular measurand or group of measurands. The result may be suspect due to interfering substances or the inability of the instrument to measure a particular measurand due to a sample abnormality. The name of each flag, how it is displayed, the cause of the flag, and the action to be taken are given in the following explanations. NOTE: Count Invalidation (*) flags will supersede Suspect Measureand [sic] (s) flags if generated at the same time." Page 13-4 revealed Table 3.4 WBC Flags ... Measurand: Differential Result Flag: s Text in Flags Box: L2 (white text) Result Displayed: XXXXX Cause: May indicate the presence of myelocytes, lymphoblasts, or basophils. Action: Check the specimen for clots or agglutination. Follow your laboratory's review criteria or review a stained smear to confirm the differential results. Redraw and retest the specimen as required. 2. Review of the laboratory's 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 -- "CBC Flag Protocol" policy revealed: "WBC Flags for CELL-DYN Emerald Flags indicate a problem with the testing. An asterisk invalidates the result. An (s) indicates a suspect result. Any flagged result should not be recorded in the patient's chart. All flagged results will be blacked out by testing personnel so that providers will not see or use these results. Compliance will be monitored on quarterly audit. Any flagged or suspect result should be brought to the ordering provider's attention for instruction whether to redraw, redraw and send to a reference lab or cancel the test depending on the clinical situation. Refer to June 2010 section of the operator's manual attached for possible causes of the flagging. All redraws will be at the discretion of the ordering provider." 3. Review of patient Cell-Dyn Emerald hematology analyzer test reports revealed patient test results with flags were reported in January 2023. The following flagged results were reported: 01/26/2023 Patient ID: 61362 Parameter: LYM; Result: 5.9 10*3 u/L; Flag: s Parameter: MID; Result: 2.0 10*3 u/L; Flag: s Parameter: GRA; Result: 7.0 10*3 u/L; Flag: s Parameter: LYM%; Result: 39.7%; Flag: s Parameter: MID%; Result: 13.6%; Flag: s Parameter: GRA%; Result: 46.7%; Flag: s 4. During an interview on 04/11/2023 at 12:10 pm, Testing Person-1 after review of records, confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An entrance conference was held on 07/31/2019 with Testing Person-1. The survey process was discussed. An opportunity for questions and comments was given. Based upon the onsite survey conducted 07/31/2019, this facility was found NOT to be compliance with CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed. 493.803(a)(b)(c) Successful Participation 493.1403 Moderate Compexity Lab Director An exit conference was held on 07/31/2019 with Testing Person-1, Administrator and the Laboratory Director. The exit conference attendees were advised the laboratory was out of compliance and advised of conditions and deficiencies found during the survey. An opportunity for questions and comments was provided. CMS form 2567 will be emailed from the Texas Department of State Health Services, Health Facility Compliance Arlington Group. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 9 -- This CONDITION is not met as evidenced by: Based on a review of Centers for Medicare & Medicaid Services (CMS) 155 report, College of American Pathologists (CAP) proficiency testing records and staff interview, the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory did not successfully participate for the analyte of red blood cell (RBC). Refer to D2130. 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 review of the Centers for Medicare & Medicaid Services (CMS) 155 report, College of American Pathologists (CAP) proficiency testing (PT) records, and staff interview, the laboratory failed to attain an overall testing event score of at least 80% for the analyte of red blood cell (RBC) resulting in unsatisfactory performance in 2018 (FH1-C) and 2019 (FH1-B). Findings: 1. Review of the CMS-155 report revealed the following scores in hematology for the RBC analyte for 2018 FH1-C and 2019 FH1-B: 2018 FH1-C: RBC 40% 2019 FH1-B: RBC 40% The laboratory failed to achieve passing scores of at least 80% for the above events. 2. Review of the CAP PT records revealed the following scores for the RBC analyte tested on the Cell-Dyn Emerald analyzer: 2018 FH1-C: RBC 40% 2019 FH1-B: RBC 40% 3. During the exit interview on 07/31/19 at 3:15 pm, the laboratory director and testing person-1 confirmed the above findings. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare & Medicaid Services (CMS) 155 report, College of American Pathologists (CAP) proficiency testing (PT) records, and staff interview, the laboratory failed to achieve satisfactory performance (80% or higher) for the red blood cell (RBC) analyte in two out of three consecutive testing events resulting in unsatisfactory performance in 2018 (FH1-C) and 2019 (FH1-B). Findings: 1. Review of the CMS-155 report revealed the following scores in bacteriology for 2018 (FH1-C) and 2019 (FH1-B). 2018 FH1-C: RBC 40% 2019 FH1-B: RBC 40% The laboratory failed to achieve a passing testing event score of 80% or higher for two out of three consecutive events for the RBC analyte. 2. Review of the CAP PT records revealed the following scores for the RBC analyte tested on the Cell-Dyn Emerald analyzer: 2018 FH1-C: RBC 40% 2019 FH1-B: RBC 40% 3. During the exit interview on 07/31/19 at 3:15 pm, the laboratory director and testing person-1 confirmed the above findings. -- 2 of 9 -- 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)