Growing Kids Pediatrics, Llc

Summary Statement of Deficiencies D0000 A recertification survey was completed on 9/13/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.1250 Analytic Systems 42 CFR 493.1409 Technical Consultant - Moderate Complexity D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor and evaluate the overall quality of the analytic system and correct problems of quality control in the subspecialty Hematology. The laboratory failed to label controls with open date or updated expiration dates (Refer to D5415). The laboratory failed to ensure three of three control levels did not exceed the expiration dates (Refer to D5417). Finally, the laboratory failed to monitor quality control problems in their quality assessment for the analytic system (Refer to D5791). D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to label controls with open date or updated expiration date for three (EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X-TRA-H) of three controls used on analyzer Sysmex XP-300 (SN: B0623) from 9/07/2023 to the date of the survey and one (PT#7) of nine patients reviewed. Finding include(s): 1. On 9/13/23 at 4:33pm, during the laboratory tour, a Sysmex XP 300 (SN: BO623) was being used for hematology testing. A plastic container labeled "McKesson" with no dates contained 3 level controls (EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X- TRA-H) bottles inside. The individual bottles of controls did not have an open date or updated expiration date written on the bottle. 2. On 9/13/23 at 4:33 pm, Sp-3 (Testing Person) stated they do not put a date when they open the controls. Sp-3 confirmed all three controls were opened and in use. 3. Review of Sysmex product information for the EightCheck- 3 WP controls, revision date 7/2020, under "Storage and shelf life after first opening" read, "Open vials and vials which have been sampled by cap piercing will retain stability for 7 days if stored at 2-8 degrees Celsius." 4. Review of Quality Control Instrument printout revealed the three levels of controls without an open date was used on the analyzer Sysmex XP-300 (SN: B0623) prior to running patient PT#7's samples on 9/07/2023. Patient PT Sample Lot ID #/ (PT) Date(s) Control level w/ no date PT#7 9/07/2023 31640710/ Level 1 31640711/ Level 2 31640712/ Level 3 5. Annual Test volume for Hematology is approximately 3,618. 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 observation and record review, the laboratory failed to ensure three of three control levels (EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X- TRA-H) used on analyzer Sysmex XP-300 (SN: B0623) during 2/10/22 through 9/07 /23 did not exceed the expiration date for six (PT#1,PT#4,PT#5, PT#6, and PT#7) out of nine patients reviewed. Finding include(s): 1. Review of Quality Control Instrument printout for PT#1, PT#4, PT#5, PT#6, and PT#7 revealed three levels of expired controls were used on analyzer Sysmex XP-300(SN: B0623) prior to running patient samples from 2/10/2022 through 9/07/2023. 2. Patient PT Sample Expiration LOT ID #/ (PT) Date(s) Date(s) Control level PT#1 2/10/2022 2/09/2022 13060710/ level 1 13060711/ level 2 13060712/ level 3 PT#4 10/24/2022 10/19/2022 21930710/ level 1 21930711/ level 2 21930712/ level 3 PT#5 12/16/2022 10/19/2022 21930710/ level 1 21930711/ level 2 21930712/ level 3 PT#6 7/10/2023 6/28/2023 30800710/ level 1 30800711/ level 2 30800712/ level 3 PT#7 4/12/2023 1/11/2023 22770710/ level 1 22770711/ level 2 22770712/ level 3 3. Review of Sysmex product information for the EightCheck- 3 WP controls, revision date 7/2020, under "Storage and shelf life of unopened product" read, when stored at 2-8 degrees Celsius controls "are guaranteed stable until the expiration date stated on the package and vials." Under "Storage and shelf life of unopened product" reads, "Open vials and vials -- 2 of 6 -- which have been sampled by cap piercing will retain stability for 7 days if stored at 2- 8 degrees Celsius." 4. Annual Test volume for Hematology is approximately 3,618. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to monitor quality control expiration dates and failed to record open and expiration dates on quality control materials for three (EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X- TRA-H) of three controls used on analyzer Sysmex XP-300 (SN: B0623). Finding include(s): 1. The laboratory failed to document open and expiration dates for EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X-TRA-H controls. Refer to D5415. 2. The laboratory failed to ensure three control levels (EightCheck- 3WP Hematology controls: X-TRA-L, X-TRA-N, X-TRA-H)) did not exceed the expiration date. Refer to D5417 3. Review of "Quality Control Statement of facts" not signed by the laboratory director indicated the following guideline(s): I. General laboratory issues, number 7. General Lab system 95% of the time, we have total precision on overall control. 100% of the time, we do not report any patient results unless the controls work 100% of the time, the laboratory staff will review and take

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations(42 CFR 493, effective April 24, 2003). No deficiencies were cited. D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory failed to report SARS-Co-V- 2 test results as required for 269 of 269 test results and 139 days reviewed from December 2020 through September 28, 2021. Findings included: 1. SARS-Co-V-2 testing documentation "Rapid Antibody Testing" logs were reviewed from December 2020 through September 28, 2021. 2. SARS-Co-V-2 "Rapid Antibody Test" result reporting documentation was reviewed from December 2020 to date of survey. 3. Documentation revealed that SARS-CoV-2 test results were not reported as required for: Year/Month # Days tested # Positive #Negative 2020 December 20 18 38 2021 January 29 6 40 Year/Month # Days tested # Positive # Negative 2021 February 14 2 14 March 4 0 7 April 12 1 13 May 5 0 5 June 2 1 1 July 4 1 5 August 30 9 62 September 19 5 42 Total tests performed since 12/20: 269 Total tests reported: 0 4. 269 test results were not reported as required during the period of review. 5. The laboratory performed 269 SARS-Co-V-2 tests during the period of review. 6. In 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 -- interview on 9/28/21 at 12:10 p.m., SP1, Nurse Practitioner, confirmed SARS-Co-V-2 test results were not reported as required between December 2020 and September 28, 2021. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on observation and interview, the laboratory failed to have a written procedure for reporting positive and negative SARS-Co-V-2 patient test results to the State. Finding(s) included: 1. During a tour of the laboratory on 9/28/2021 at 11:45 am, the laboratory had the "Fastep COVID-19 IgG/IgM Rapid Test Device" available for SARS-Co-V-2 testing. 2. Upon request for apolicy and procedure to report SARS Co- V-2 test results to the State, on 9/28/2021 at 1:00 pm, SP#1 (Nurse Practitioner), acknowledged there was no written policy or procedure to report to the state. -- 2 of 2 --