Nicklaus Children's Pediatric Specialists, Llc

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted from 12/04/2025 to 12/12 /2025 at NICKLAUS CHILDREN'S PEDIATRICS SPECIALISTS, LLC. The laboratory was not in compliance with 42 CFR Part 493, Requirement for Laboratories. The following Condition was cited: D6000 493.1403 - Moderate Complexity Laboratory Director D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to sign attestation for Proficiency Testing for for 1 out of 3 events reviewed in Chemistry and Hematology specialty in 2025. Findings included: 1. Review of American Proficiency Institute (API) Proficiency Testing (PT) records for 1st, 2nd and 3rd event for 2025, revealed that the laboratory failed to have attestation signed for Chemistry Core for the Neonatal Bilirubin test 3rd event and for the Hematology Specialty tests 3rd event: Erythrocyte count, Hematocrit, Hemoglobin, Leukocyte count, Platelet count, White Blood Cell Differential and Red Cell Distribution (RDW). 2. During an interview on 12/04/2025 at 12:00 PM, the Testing personnel #1 confirmed that the laboratory failed to sign attestations for the events of reference. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to retain daily Quality Control (QC) records for Bilirubin control level 1 for 23 out of 23 testing dates from 05/27/2025 to 08/11/2025. Findings included: 1. Review of manufacturer instructions (MI) for Quantimetrix Bilirubin - Pediatric Level 1 & 2, revealed that the lot number for the batch in use since 04/04/2025 was 211431 for level 1 and 241432 for level 2. 2. Review of QC records for level 1 and 2, revealed that the laboratory had no records for level 1 for 25 patients tested the following dates: 05/27/2025 (2 patients tested), 05/29/2025 (1 patient tested), 05/30/2025 (1 patient tested), 06/01/2025 (1 patient tested), 06/08/2025 (1 patient tested), 06/11/2025 (1 patient tested), 06/12 /2025 (1 patient tested), 06/13/2025 (1 patient tested), 06/15/2025 (1 patient tested), 06 /16/2025 (1 patient tested), 06/17/2025 (1 patient tested) , 06/18/2025 (1 patient tested), 06/19/2025 (1 patient tested), 06/22/2025 (1 patient tested), 06/26/2025 (1 patient tested), 06/30/2025 (1 patient tested), 07/01/2025 (1 patient tested), 07/07 /2025 (1 patient tested), 07/14/2025 (1 patient tested), 07/22/2025 (1 patient tested), 07 /27/2025 (1 patient tested), 07/29/2025 (1 patient tested), 08/05/2025 (1 patient tested) and 08/11/2025 (1 patient tested). 3. During an interview on 12/04/2025 at 1:35 PM, Testing Personnel #1 confirmed that the laboratory failed to have QC records for level 1 of Bilirubin for the period of 05/27/2024 to 08/11/2025. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to follow Manufacturer Instructions (MI) for daily and monthly maintenance of the Beckman Coulter Complete Blood Counter (CBC) DXH 500 during 2 out of 2 years reviewed. Findings included: 1. Review of the MI for CBC DXH 500, revealed that the user is required to do daily cleaning and monthly bleach cycle. 2. Review of DXH 500 Maintenance Checklist logs for 2024 and 2025 revealed the following: a) No documentation of the daily maintenance from 10/21/2024 to 10/25/2024, 04/14/2025 to 04/18/2025 and 10/08/2025 to 10/16/2025. b) No documentation of monthly bleach cycle on the following months: March 2024, April 2024, October 2024, January 2025, March 2025, May 2025, July 2025 and August 2025. 3. During an interview on 12/04 /2025 at 11:13 AM, Testing Personnel #1 confirmed that the laboratory failed to follow MI for maintenance of CBC analyzer DXH 500 during 2024 and 2025. 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. -- 2 of 4 -- This CONDITION is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to provide management of the laboratory's Proficiency Testing (PT) during 2025. Findings included: 1. The LD failed to ensure that the laboratory enrolled in PT during the first event of 2025 for Neonatal Bilirubin and Throat Culture tests. (See D6015). D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that-- This STANDARD is not met as evidenced by: Based on record review and staff interview, the Laboratory Director (LD) failed to ensure that the laboratory enrolled and participated in Proficiency Testing (PT) in the first event of 2025 for the Neonatal Bilirubin test and Throat Culture. Findings included: 1. Review of American Proficiency Institute (API) PT records for Chemistry (Neonatal Bilirubin) and Bacteriology (Throat Culture), revealed that the laboratory had no records for the 1st event of 2025. 2. Review of 2025 laboratory order revealed that the order was placed on 02/07/2025, and API notified the laboratory that they were not supplying the first event of Neonatal Bilirubin and no Throat Culture. 3. From 01/01/2025 to 04/30/2025 the laboratory tested 51 patients for Bilirubin and for Throat Culture the laboratory tested 214 patients from 01/01/2025 to 04/09/2025 when the laboratory ceased testing. 4. During an Interview on 12/04/2025 at 1:30 PM, Testing Personnel #1 confirmed that the LD failed to ensure the laboratory was enrolled in PT for Neonatal Bilirubin and Throat Culture for the 1st event of 2025. D6047 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b(8)(i) (b)(8)(i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; This STANDARD is not met as evidenced by: Based on record review and staff interview revealed that the Technical Consultant (TC) or a qualified designee failed to observe Patient testing during competency evaluation for four out of five Testing Personnel (TP) for one out of one year reviewed. Findings included: 1. Review of FORM CMS 209 signed by the Laboratory Director on 12/01/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Consultant for Hematology and Chemistry specialty and 4 TP (TP#1, TP#2, TP#3 and TP#4). 2. Review of personnel records revealed that competency for TP#1 (Lead Medical Assistant (Lead MA)) observed on 08/14/2025 by TP#2, TP#2 competency observed by TP#1 on 08/14/2025, TP#3 competency observed on 08/14/2025 by TP#1 and TP#4 observed on 09/19/2025 by TP#1. TP#1 did not meet the qualification of a Technical Consultant. 3. During an interview on 12/04/2025 at 12:50 PM, the TP#1 confirmed that the TC failed to observe patient testing observation during annual competency for TP#1, TP#2, TP#3 and TP#4. D6050 TECHNICAL CONSULTANT RESPONSIBILITIES -- 3 of 4 -- CFR(s): 493.1413(b)(8)(iv) (b)(8)(iv) Direct observation of performance of instrument maintenance and function checks; This STANDARD is not met as evidenced by: Based on record review and staff interview revealed that the Technical Consultant (TC) or a qualified designee failed to observe direct observation of instrument performance and function check during competency evaluation for four out of five Testing Personnel (TP) for one out of one year reviewed. Findings included: 1. Review of FORM CMS 209 signed by the Laboratory Director on 12/01/2025, revealed the following: Laboratory Director (LD) was also Clinical Consultant and Technical Consultant for Hematology and Chemistry specialty and 4 TP (TP#1, TP#2, TP#3 and TP#4). 2. Review of personnel records revealed that competency for TP#1 (Lead Medical Assistant (Lead MA)) observed by TP#2 on 08/14/2025, TP#2 competency overserved by TP#1 on 08/14/2025, TP#3 competency observed on 08/14 /2025 by TP#1 and TP#4 observed on 09/19/2025 by TP#1. TP#1 did not qualify for a peer review in competence. 3. During an interview on 08/20/2025 at 12:52 PM, the TP#1 confirmed that the TC failed to observe direct observation of performance of instrument and function check observation during annual competency for TP#1, TP#2, TP#3 and TP#4. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A recertification survey conducted from 09/27/2023 to 10/04/2023 found the NICKLAUS CHILDREN'S PEDIATRIC SPECIALISTS, LLC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on record review and interview, the Technical Consultant (TC) failed to document the review of the Quality Control records for Hematology Analyzer Beckman Coulter DXH 500, Bilirubin test with the Leica UNISTAT and for the Strep Throat Culture during 2022 and 2023. Findings included: -Review of "QUALITY ASSURANCE PLAN" revealed the following: "HEMATOLOGY QUALITY CONTROL SHEETS WILL BE CHECKED MONTHLY AND SIGNED BY LAB SUPERVISOR FOR PROPIER ENTRIES AND TECHNICIAN 'S SIGNATURE. CHEMISTRY Q.C. SHEETS FOR NEWBORN BILLIRUBIN TO BE CHECKED MONTHLY AND SIGNED BY LAB SUPERVISOR TO ASSURE ALL CONTROLS FALL WITHIN PROPER RANGE OF CURRENT ASSAY SHEET THROAT CULTURE DAILY ACCESION LOG SHEETS ARE CHECKED MONTHLY BY SUPERVISOR" -Review of Quality Control (QC) records revealed the following: a) Hematology: Review of Interlaboratory Quality Assessment Program for November 13, 2022 - December 2022 and April 14, 2023 - May 2023, revealed that there was no signature of the TC to document the review of the results. b) Bilirubin: Review of Leica Bilirubinometer Control Sheet for Control 1 with Lot # 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 -- 131651 and 186881 and for Control 2 with Lot # 13652 and 186882 for year 2023, revealed that there was no documentation that the TC reviewed the QC records. c) Throat Culture: Review of Throat Culture logs for November and December 2022 and July, August and September 2023, revealed that there was no documentation that the TC reviewed the log of reference. During an interview on 09/27/2023 at 01:30 PM, with testing Person A, she confirmed that the TC failed to sign the QC records of reference. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 09/28/2021-10/04/2021 found that the Atlantic Pediatric Partners clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least an 80% in Bacteriology for the 2nd proficiency testing (PT) event in 2021. Findings included: Review of Bacteriology American Proficiency Institute record revealed the following scores for the 2nd PT event in 2021: 40% in Bacteriology 40% in Throat Culture During an interview on 09/28/2021 at 3:10 PM, the office manager confirmed the laboratory failed to receive a passing score of at least 80% in Bacteriology for the 2nd PT event in 2021. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least an 80% in Routine Chemistry for the 2nd proficiency testing (PT) event in 2020. Findings included: Review of Routine Chemistry American Proficiency Institute record 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 -- revealed the following scores for the 2nd PT event in 2020: 60% in Routine Chemistry 60% in Total Bilirubin During an interview on 09/28/2021 at 3:09 PM, the office manager confirmed the laboratory failed to receive a passing score of at least 80% in Routine Chemistry for the 2nd PT event in 2020. 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 record review and interview, the laboratory failed to report 202 negative patient results for the COVID-19 Quickvue Sars-Antigen to the State of Florida from 05/17/2021 to 9/27/2021 Findings Included: Review of COVID-19 State of Florida ELR system revealed no documentation of COVID-19 negative patient results listed in the system for COVID-19 Quickvue Sars-Antigen testing. Review of patient records revealed 202 patients had been tested with the COVID-19 Quickvue Sars- Antigen and received a negative result for COVID-19 from 05/17/2021 to 9/27/2021. During an interview on 09/28/2021 at 3:11 PM, the laboratory manager and testing personnel confirmed that 202 negative COVID-19 patient results were not submitted to the state of Florida from 05/17/2021 to 9/27/2021. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to perform an initial competency assessment for 1 (TP#E) out of 5 testing personnel(TP). Findings Included: Review of Personnel Employee record revealed TP#E was a testing person hired in April 2021. Review of competency assessment records revealed that there was no documentation of an initial training competency assessment for TP#E in 2021. During an interview on 10/04/2021 at 10:21 AM, the office manager confirmed that there was no initial competency assessment for TP#E in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 09/28/2021-10/04/2021 found that the Atlantic Pediatric Partners clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least an 80% in Bacteriology for the 2nd proficiency testing (PT) event in 2021. Findings included: Review of Bacteriology American Proficiency Institute record revealed the following scores for the 2nd PT event in 2021: 40% in Bacteriology 40% in Throat Culture During an interview on 09/28/2021 at 3:10 PM, the office manager confirmed the laboratory failed to receive a passing score of at least 80% in Bacteriology for the 2nd PT event in 2021. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to score at least an 80% in Routine Chemistry for the 2nd proficiency testing (PT) event in 2020. Findings included: Review of Routine Chemistry American Proficiency Institute record 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 -- revealed the following scores for the 2nd PT event in 2020: 60% in Routine Chemistry 60% in Total Bilirubin During an interview on 09/28/2021 at 3:09 PM, the office manager confirmed the laboratory failed to receive a passing score of at least 80% in Routine Chemistry for the 2nd PT event in 2020. 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 record review and interview, the laboratory failed to report 202 negative patient results for the COVID-19 Quickvue Sars-Antigen to the State of Florida from 05/17/2021 to 9/27/2021 Findings Included: Review of COVID-19 State of Florida ELR system revealed no documentation of COVID-19 negative patient results listed in the system for COVID-19 Quickvue Sars-Antigen testing. Review of patient records revealed 202 patients had been tested with the COVID-19 Quickvue Sars- Antigen and received a negative result for COVID-19 from 05/17/2021 to 9/27/2021. During an interview on 09/28/2021 at 3:11 PM, the laboratory manager and testing personnel confirmed that 202 negative COVID-19 patient results were not submitted to the state of Florida from 05/17/2021 to 9/27/2021. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to perform an initial competency assessment for 1 (TP#E) out of 5 testing personnel(TP). Findings Included: Review of Personnel Employee record revealed TP#E was a testing person hired in April 2021. Review of competency assessment records revealed that there was no documentation of an initial training competency assessment for TP#E in 2021. During an interview on 10/04/2021 at 10:21 AM, the office manager confirmed that there was no initial competency assessment for TP#E in 2021. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A desk review survey of the laboratory's proficiency test results was performed on June 23, 2020 for South Florida Pediatric Partners. South Florida Pediatric Partners is not in compliance with Code of Federal Regulations (CFR), Part 493, Laboratory Requirements 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 review of the laboratory's proficiency testing records for 2019 and 2020, the laboratory did not have successful performance in proficiency testing for the specialty of bacteriology. Refer to D2028. Findings include: Review of the American Proficiency Institute (AAB\\PI) proficiency testing records and the review of the 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 -- Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports, on June 23, 2020 on or about 10:00 AM, showed that the laboratory had unsatisfactory testing scores for the specialty bacteriology for two consecutive testing events in 2019 and 2020. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on the review of the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports and the laboratory's proficiency testing records, the laboratory did not have successful performance in proficiency testing in the specialty of bacteriology. Findings include: On June 23, 2020, on or about 10:00 AM the American Proficiency Institute (API) proficiency testing records and the CMS 153 and 155 reports were reviewed. The review showed that the laboratory failed to achieve satisfactory performance for the specialty of bacteriology, as shown below. Event #3, 2019 bacteriology-20% Event #1, 2020 bacteriology-0% 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 the review of the laboratory's proficiency testing records, the laboratory director failed to ensure that the laboratory maintained a satisfactory score for proficiency testing in the specialty of routine bacteriology. Findings include: On June 23, 2020, on or about 10:00 AM, the American Proficiency Institute (API) proficiency records and the Centers for Medicare & Medicaid Service (CMS) 153 and 155 reports were reviewed. The review showed that the laboratory had unsatisfactory testing scores for two consecutive testing events for throat cultures in the specialty of bacteriology. The laboratory director is responsible for ensuring that the laboratory maintains successful participation in proficiency testing. Refer to D2028. 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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on the review of the laboratory's proficiency testing scores, the laboratory director failed to ensure that the laboratory performed proficiency testing in such a manner as to achieve and maintain successful participation in proficiency testing in the specialty of bacteriology. Findings Include: The review of the American Proficiency Institute (API) proficiency testing records and the Centers for Medicare & Medicaid Services (CMS) 153 and 155 reports on June 23, 2020 on or about 10:00 AM showed that the laboratory received unsatisfactory proficiency testing scores for the performance of throat cultures in the specialty of bacteriology, as shown below. Event #3, 2019 bacteriology-20% Event #1, 2020 bacteriology-0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 A recertification survey conducted on 10/03/2019 found that the South Florida Pediatric Partners clinical laboratory was not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following Condition was cited: D6063- Laboratory testing Personnel 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 CMS 209 Laboratory Personnel Report, review of American Proficiency Institute (API) proficiency testing (PT) records and interview with Testing Personnel (TP) A. The laboratory failed to have all testing personnel (TP) rotate through the testing of PT for the Chemistry and Microbiology specialty for 1 out of 2 years (2018 - 2019) reviewed. Findings include: Review of CMS 209 signed and dated by the Laboratory Director (LD) on 10/02/2019 had 4 testing personnel listed (TPA, TP B, TP C and TP D). Review of API PT records found that TP B, C and D did not perform PT in Chemistry Specialty during 2018 and TP C and D did not participate in PT for Microbiology during 2018. During an interview on 10/03/2019 at 11:30 AM, TP A confirmed that TP B, C and D missed to participate in PT during the year of above-reference D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the 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 -- laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview with Testing Personnel # A (TPA), the laboratory failed to have an attestation signed for 1 out of 6 events reviewed (2017 3rd ; 2018 1st, 2nd and 3rd; 2019 1st and 2nd) for Chemistry and for 1 out of 6 events (2017 3rd ; 2018 1st, 2nd and 3rd; 2019 1st and 2nd) for Hematology Specialty reviewed . Findings include: Review of API proficiency records revealed that the laboratory failed to have a signed attestation for: -1st event of Hematology specialty of 2018 -3rd event of Chemistry specialty 2018 During an interview on 10/03/2019 at 11:30 AM, the TPA confirmed that the laboratory failed to have a signed attestation for the events of above-reference. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of API (American Proficiency Institute) proficiency testing (PT) records and interview with Testing Personnel # A (TPA), the laboratory failed 1 out of 3 events for Bacteriology during 2018. Findings include: Review of API proficiency records revealed that the laboratory failed the Bacteriology first event of 2018 with a 60 % score. During an interview on 10/03/2019 at 11:30 AM, the TPA confirmed that the laboratory failed the event of reference. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to ensure that the testing personnel wear gloves during testing process. Findings include: Surveyor 2 observed that TP # B, manipulated a urine sample without using gloves, and after finishing the sample processing did not wash her hands on 10/03/2019 at 9:30 am. Surveyor 1 observed TP # B, performed a strep A+B test without wearing gloves and after that proceed to work with documentation without using any sanitation procedure on 10/03/2019 at 11:00 am. During an interview on 10/03/19 at 12:00 pm, TP # A, confirmed that TP # B, performed the procedures of reference without wearing gloves. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to document semi- annual competencies assessment for 2 out of 4 testing personnel (TP) (# A, B, C and D) in 2018 Findings include: - A review of CMS-209 laboratory personnel signed and dated on 10/02/2019 by laboratory director (LD) revealed that the laboratory had 4 TP. - Review of employee records revealed that TP # B started on July 2017, TP # C started on November 2017, no records of 6 months assessment documented. During an interview on 10/03/19 at 11:30 am, TP # A, confirmed there was no documentation of semi-annual competencies assessment for the TP's of reference. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on review of CMS form 209, a review of Testing Personnel (TP) files and interview with Office Manager (OM), the laboratory failed to verify proof of education in 1(#A) out of 4 (#A-D) TP (See D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on record review and interview with staff, the laboratory failed to verify proof of education in 1 (# A) out of 4 (#A-D) testing personnel (TP). Findings include: A review of CMS form 209 Laboratory Personnel Report dated and signed by the Laboratory Director on 10/2/2019 revealed that there were 4 TP (TP # A-D). Review of TP files revealed that TP # A is a licensed practical nurse, but no proof of education was found. Without proof of education, the minimum education requirements could not be verified. During an interview on 10/3/2019 at 11:30 am with TP # A, she confirmed that she did not have proof of education, she state that she did her high school in a United Kingdom in 1963 and that she will contact them to obtain documentation. -- 3 of 3 --