Gastonia Pediatric Associates Pa

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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 12/28/21, the laboratory failed to successfully participate in proficiency testing for Platelets in three of four 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 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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 12/28/21, the laboratory failed to achieve satisfactory performance for Platelets in three of four consecutive testing events, resulting in unsuccessful performance. Findings: 1. Desk review of CMS Casper report 155D and 2020 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2020 MLE 3rd event. 2. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate, resulting in a score of 0% for Platelets on the 2021 MLE 2nd event. 3. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2021 MLE 3rd 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 Medicate and Medicaid Services) Casper reports 153D and 155D and desk review of 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 12/28/21, 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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 12/28/21, 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 2020 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2020 MLE 3rd event. 2. Desk -- 2 of 3 -- review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate, resulting in a score of 0% for Platelets on the 2021 MLE 2nd event. 3. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2021 MLE 3rd event. 4. Desk review of CMS Casper reports 153D and 155D revealed the laboratory failed to achieve satisfactory performance for Platelets on three of four consecutive proficiency testing events, resulting in non-initial unsuccessful performance. -- 3 of 3 --

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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 8/3/21, the laboratory failed to successfully participate in proficiency testing for Platelets in two of three 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 and desk review of 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 8/3/21, the laboratory failed to achieve satisfactory performance for Platelets in two of three consecutive testing events, resulting in unsuccessful performance . Findings: 1. Desk review of CMS Casper report 155D and 2020 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2020 MLE 3rd event. 2. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate, resulting in a score of 0% for Platelets on the 2021 MLE 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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 8/3/21, 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 2020 and 2021 MLE(Medical Laboratory Evaluation) proficiency testing results 8/3/21, 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 2020 MLE proficiency testing results revealed the laboratory provided unacceptable responses for 2 of 5 samples, resulting in a score of 60% for Platelets on the 2020 MLE 3rd event. 2. Desk review of CMS Casper report 155D and 2021 MLE proficiency testing results revealed the laboratory failed to participate, resulting in a score of 0% for Platelets on the 2021 MLE 2nd event. -- 2 of 2 --

Summary Statement of Deficiencies D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of laboratory's procedures and IQCP(individualized quality control plan), review of quality control records, and interview with TC(technical consultant) on 3/17/21, the laboratory failed to establish the laboratory's IQCP for strep cultures when the laboratory changed to a different reagent media. Findings: Review of the laboratory's procedure and IQCP for strep cultures on 3/17/21 revealed the laboratory uses Health Link JEMBEC Strep Select Agar. The laboratory's IQCP states that as part of the manufacturer's media acceptability requirements the laboratory peels the lower portion of a product bag label(Quality control certificate) for the lot being accepted and affixes to the Quality control log sheet. Review of the laboratory's Quality control log sheets revealed the laboratory changed reagent manufacturer's from the Health Link JEMBEC Strep Select Agar to the Hardy Diagnostic Streplate media on 7/10/19 and changed again to Becton Dickinson BBL Group A select media on 3/5/21. There was no documentation the laboratory established an IQCP when the changes in reagent media occurred. During interview at approximately 4:15pm, the TC confirmed the laboratory had not established an IQCP for strep cultures when the laboratory changed media. He stated the laboratory switched because they were unable to obtain media from the manufacturer. 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 -- 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 the laboratory IQCP(individualized quality control plan) and review of laboratory quality control records 3/17/21, the laboratory failed to perform and document growth and sterility checks as required when the laboratory changed to a different reagent media for strep cultures. Findings: Review of laboratory IQCP records revealed the laboratory failed to establish an IQCP for strep cultures when new media was put into use. See D5445. Review of laboratory quality control records on 3/17/21 revealed the laboratory followed an IQCP for Health Link JEMBEC Strep Select Agar for strep cultures. When the laboratory changed to a different reagent media, there was no documentation to indicate the laboratory had performed growth and sterility checks as required for each lot or shipment of reagent media from 7/10/19 to 3/5/21 for the following lot numbers: 1. Hardy Diagnostics Streplate lot #439860, expiration date: 8/18/19; 2. Hardy Diagnostics Streplate lot #441161, expiration date: 9 /18/19; 3. Hardy Diagnostics Streplate lot #443130, expiration date: 10/18/19; 4. Hardy Diagnostics Streplate lot #444529, expiration date: 11/7/19; 5. Hardy Diagnostics Streplate lot # 447922, expiration date: 12/30/19; 6. Hardy Diagnostics Streplate lot #448105, expiration date: 1/7/20; 7. Hardy Diagnostics Streplate lot # 451824, expiration date: 3/1/20; 8. Hardy Diagnostics Streplate lot# 453604, expiration date: 4/8/20; 9. Hardy Diagnostics Streplate lot # 454999; expiration date: 4 /28/20; 10. Hardy Diagnostics Streplate lot # 460768, expiration date: 8/4/20; 11. Hardy Diagnostics Selective Strep lot # 131429, expiration date: 11/5/20; 12. Hardy Diagnostics Selective Strep lot # 468365, expiration date: 11/29/20; 13. Hardy Diagnostics Streplate lot # 474920, expiration date: 3/4/21; 14. BD BBL Group A Select lot # 1035650, expiration date: 6/18/21. D5785