North Carolina Pediatric Associates

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor observation and interview with technical consultant (TC) and testing personnel (TP #1) 03/05/26, the laboratory failed to discard 82 purple top Ethylenediaminetetraacetic acid (EDTA) blood collection tubes that had exceeded their expiration date. It is unknown at time of survey if patients were affected. Findings: At approximately 11:15 a.m. surveyor observed the following expired blood collection tubes on a shelf in a open cupboard of the room in which surveyor was reviewing records: 1 unopened pack of 50 purple top EDTA blood collection tubes - Lot # B240933K - Expiration date 01/01/26. 1 open pack of 32 purple top EDTA blood collection tubes - Lot # B240933K - Expiration date 01/01/26. Interview with TC and TP #1 at approximately 11:30 a.m. confirmed the 82 EDTA blood collection tubes had exceeded their expiration date. They stated that the laboratory seldom utilizes this type of blood collection tube unless the physician specifically requests a test that would need to be sent out to a reference laboratory. The TC stated them would have to research the laboratory send out records to determine if any tubes were used for patient testing. 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 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory failed to successfully participate in proficiency testing for RBC (erythrocyte count) in two consecutive testing events. See the deficiency cited at D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- 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 desk review of CMS (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory failed to achieve satisfactory performance for RBC (erythrocyte count) in 2 consecutive testing events. Findings: Review of CMS Casper report 155D and review of 2018 and 2019 API proficiency testing results revealed: 1. For the 2018 3rd hematology testing event, the laboratory provided unacceptable responses for 3 of 5 RBC samples and received a score of 40% for RBC. 2. For the 2019 1st hematology testing event, the laboratory provided unacceptable responses for 2 of 5 RBC samples and received a score of 60% for RBC. 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, the laboratory director failed to provide overall management and direction to ensure successful proficiency testing participation. 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D 6/23/19 and desk review of 2018 and 2019 API (American Proficiency Institute) proficiency testing results 7/5/19, 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 and 2019 API proficiency testing results revealed: 1. For the 2018 3rd hematology testing event, the laboratory provided unacceptable responses for 3 of 5 RBC (erythrocyte count) samples and received a score of 40% for RBC. 2. For the 2019 1st hematology testing event, the laboratory provided unacceptable responses for 2 of 5 RBC samples and received a score of 60% for RBC. -- 2 of 2 --