Cary Pediatric Center

Summary Statement of Deficiencies 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 This STANDARD is not met as evidenced by: Based on review of 2021, 2022, 2023 and 2024 American Proficiency Institute (API) Bacteriology proficiency testing (PT) records, review of testing personnel (TP) training and competency records and interview TP #2, 3/28/24, the laboratory failed to ensure 2 of 6 TP participated in Bacteriology PT for urine and throat culture. Findings: Review of 2021, 2022, 2023 and 2024 Bacteriology API PT attestation records for urine and throat culture revealed TP #1 (laboratory director) failed to participate in 10 of 10 PT events reviewed. Review of TP #14 training and competency records revealed TP #14 began urine and throat culture testing in November of 2022. Review of 2023 and 2024 Bacteriology API PT attestation records for urine and throat culture revealed TP #14 failed to participate in 4 of 4 PT events reviewed. Interview with TP #2 at approximately 11:00 a.m. confirmed TP #1 failed to participate in 10 of 10 Bacteriology PT events and TP #14 failed to participate in 4 of 4 Bacteriology PT events. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are 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 -- reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 and desk review of 2021 and 2022 API(American Proficiency Institute) proficiency testing results 5/27/22, the laboratory failed to successfully participate for WBC(White blood cell) differential on two of three consecutive test 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 3 -- 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 and desk review of 2021 and 2022 API(American Proficiency Institute) proficiency testing results 5/27/22, the laboratory failed to successfully participate for WBC(white blood cell) differential on two out of three consecutive test events, resulting in unsuccessful performance. Findings: Desk review of CMS Casper report 155D and 2021 and 2022 API proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 5 of 5 Granulocytes, 5 of 5 Lymphocytes, 5 of 5 Monocytes, and received a 0% score for WBC Differential on the 2021 API 2nd Hematology test event. 2. The laboratory provided unacceptable responses for 5 of 5 Granulocytes, and 5 of 5 Monocytes, and received a 27% score for WBC Differential on the 2022 API 1st Hematology test event. 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 and desk review of 2021 and 2022 API(American Proficiency Institute) proficiency testing results 5/27/22, 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 and desk review of 2021 and 2022 API(American Proficiency Institute) proficiency testing results 5/27/22, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: Desk review of CMS Casper report 155D and 2021 and 2022 API proficiency testing results revealed: 1. The laboratory provided unacceptable responses for 5 of 5 Granulocytes, 5 of 5 Lymphocytes, 5 of 5 Monocytes, and received a 0% score for WBC Differential on the 2021 API 2nd Hematology test event. 2. The laboratory provided unacceptable responses for 5 of 5 Granulocytes, and 5 of 5 Monocytes, and -- 2 of 3 -- received a 27% score for WBC Differential on the 2022 API 1st Hematology test event. -- 3 of 3 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 review of 2020 and 2021 laboratory Uricult media quality control (QC) records, review of 2020 and 2021 patient testing logs and interview with testing personnel (TP #1) 1/6/22, the laboratory performed patient testing using expired Uricult media from 8/25/20 until 9/28/20, a period of approximately 30 days in which 16 patients were tested and from 8/27/21 until 11/15/21 a period of approximately 75 days in which 25 patients were tested. Findings: 1. Review of laboratory QC records, "Uricult QC Log", revealed on 3/17/20 the laboratory received Uricult media Lot #1892940, expiration 8/24/20. The laboratory received the next shipment of Uricult media, Lot #1897050, on 9/24/20 approximately 29 days after expiration of Lot #1892940. Review of QC records also revealed Lot #1897050 was put into use and QC performed on 9/28/20, a period of approximately 30 days in which expired Uricult media was in use. Review of patient logs revealed 16 patients were tested 8/24/20 through 9/28/20. Interview with TP #1 at approximately 4:00 p.m. confirmed 16 patients were tested using expired Uricult media from 8/24/20 through 9/28/20. 2. Review of laboratory QC records, "Uricult QC Log" revealed on 3/9/21, the laboratory received Uricult media Lot #1899021, expiration date 8/27/21. The laboratory received the next shipment of Uricult media, Lot #1902570, on 11/12/21 approximately 72 days after expiration of Lot #1899021. Review of QC records also revealed Lot #1902570 was put into use and QC performed on 11/15/21, a period of approximately 75 days in which expired Uricult media was in use. Review of patient 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 -- logs revealed 25 patients were tested 8/27/21 through 11/15/21. Interview with TP #1 at approximately 4:00 p.m. confirmed 25 patients were tested using expired Uricult media from 8/27/21 through 11/15/21. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory procedure manual, 2021 BBL Strep Select Agar (SSA) quality control (QC) records and interview with testing personnel (TP #1) 1/6/22, the laboratory failed to perform QC on each new lot number of SSA media as required. Approximately 10 patients were tested when QC was not performed as required. Findings: Review of laboratory procedure, "BBL Strep Plate Quality Control", revealed "1. Quality Control is performed on all new BBL plate lot numbers and shipments." Review of SSA media QC records, "BBL Strep Select Agar (SSA) QC Log", revealed the laboratory received ten plates of SSA media, Lot #126730, on 10/5 /21. Records also revealed QC was not performed on Lot # 126730 until 11/1/21, a period of approximately 29 days in which patient testing was performed. Interview with TP #1 at approximately 4:00 p.m. confirmed QC was not performed on SSA media, Lot #126730, as required. She also confirmed approximately 10 patients were tested prior to QC performance. -- 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 (Centers for Medicare and Medicaid Services) Casper reports 153D and 155D and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 9/8/20, the laboratory failed to successfully participate for WBC (White Blood Cell Count) in two out of three consecutive testing events, resulting in unsuccessful performance. 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 3 -- 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 and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 9/8/20, the laboratory failed to successfully participate in proficiency testing for WBC (white blood cell count) in two out of three consecutive testing events. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for WBC on the 2019 Hematology 3rd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for WBC on the 2020 Hematology 2nd event. 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 and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 9/8/20, 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 and desk review of 2019 and 2020 API (American Proficiency Institute) proficiency testing results 9/8/20, the laboratory director failed to ensure successful participation in proficiency testing as required in Subpart H. Findings: 1. Desk review of CMS Casper report 155D and 2019 API proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for WBC on the 2019 Hematology 3rd event. 2. Desk review of CMS Casper report 155D and 2020 API proficiency testing results -- 2 of 3 -- revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for WBC on the 2020 Hematology 2nd event. -- 3 of 3 --