Fuquay Varina Pediatrics

Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of 2020 and 2021 American Proficiency Institute (API) proficiency testing (PT) records and interview with clinic manager (testing personnel (TP) #5 6/28 /22, the laboratory failed to review and evaluate unacceptable PT results for 3 of 6 API PT hematology/coagulation events. Findings: Review of APT PT records revealed the following 3 hematology/coagulation PT events had unacceptable results that were not reviewed or evaluated: 2020 API PT 3rd event - sample # HEM-13 2021 API PT 1st event - sample # HEM-02 2021 API PT 3rd event - sample # HEM-11 Interview with clinic manager (TP#5) at approximately 11:00 a.m. confirmed the laboratory failed to review and evaluate the unacceptable PT results. She stated they thought the evaluation was only necessary if API PT indicated a failure and they were unaware that all unacceptable results should be reviewed and evaluated. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as 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 -- specified in this section. This STANDARD is not met as evidenced by: Based on review of laboratory quality control (QC) records and interview with clinic manager (TP #5) 6/28/22, the laboratory failed to document QC for each new lot number of bacitracin (BC) disk, approximately 134 patients were tested during the period in which QC was not documented. Findings: Review of QC records for the BC disk revealed no documentation of QC performed for Lot # 9106825. QC records indicated the lot was received approximately 12/1/19. QC was not documented until the next lot number of BC disk was received, 1/14/20, approximately 1 and a half months later. Interview with TP #5 at approximately 1:00 p.m. confirmed the laboratory failed to document QC for BC disk Lot # 9106825. She also confirmed approximately 134 patients were tested 12/1/19 through 1/14/20. -- 2 of 2 --

Summary Statement of Deficiencies 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. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and review of 2018 API (American Proficiency Institute) proficiency testing results 2/5/19, the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential in two consecutive testing events. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and review of 2018 API (American Proficiency Institute) proficiency testing results 2/5/19, the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential in two consecutive testing events. Findings: Review of CMS Casper report 155D and review of 2018 API proficiency testing results revealed: 1. For the 2018 1st hematology testing event, the laboratory provided unacceptable responses for 1 of 5 lymphocytes %, 5 of 5 granulocytes %, and 5 of 5 monocytes % samples, resulting in a score of 27% for WBC Differential. 2. For the 2018 2nd hematology testing event, the laboratory provided unacceptable responses for 1 of 5 lymphocytes %, 4 of 5 monocytes %, and 5 of 5 granulocytes % samples, resulting in a score of 33% for WBC Differential. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and review of 2018 API (American Proficiency Institute) proficiency testing results 2/5/19, the laboratory director failed to ensure the laboratory achieved satisfactory performance for WBC (white blood cell) Differential in two consecutive testing events. See the deficiency cited at D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on desk review of CMS Casper reports 153D and 155D and review of 2017 and 2018 API (American Proficiency Institute) proficiency testing records 2/5/19, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: Review of CMS Casper report 155D and review of 2018 API proficiency testing results revealed the laboratory failed to achieve satisfactory performance for WBC (white blood cell) Differential in two consecutive testing events: 1. For the 2018 1st hematology testing event, the laboratory provided unacceptable responses for 1 of 5 lymphocytes %, 5 of 5 granulocytes %, and 5 of 5 monocytes % samples, resulting in a score of 27% for WBC Differential. 2. For the 2018 2nd hematology testing event, the laboratory provided unacceptable responses -- 2 of 3 -- for 1 of 5 lymphocytes %, 4 of 5 monocytes %, and 5 of 5 granulocytes % samples, resulting in a score of 33% for WBC Differential. -- 3 of 3 --