Gwinnett Pediatric Partners

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 19, 2023. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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. This STANDARD is not met as evidenced by: Based on the review of personnel records and competency assessment documents, it was determined that the Technical Consultant (TC) ,who is also the Laboratory Director, failed to perform competencies for 2022 and 2023 as required by CLIA. Findings; 1. Personnel documents review revealed the Laboratory Director, who is also the Technical Consultant (TC), did not perform annual competencies for TP #s (1 thru 10 on CMS 209) in 2022 and 2023 on the Horiba Micros 60 Analyzer in the Specialty of Hematology. 2. An interview with the office manager and lab lead (TP# 6 CMS 209) in the review room on 12/19/2023 at approximately 12:15 PM confirmed no competencies were performed in 2022 and 2023 by the laboratory director. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 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 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on documents review and interview with the office manager, the Lab Director (LD) failed to ensure that ALL Quality Assurance (QA) guidelines were followed to identify and fix problems in the laboratory in 2022 and 2023. Findings: 1. Standard Operating Procedures (SOP), QA, proficiency testing (PT) and maintenance logs ( Room Temperature, Refrigerator and QC) review revealed the Lab Director reviewed ALL of the above documents but forgot to perform annual competencies on (TP #s 1 to 10 CMS 209) in 2022 and 2023. 2. An interview with the laboratory's office manager and staff, in the break room, on 12/19/2023, at approximately 12:40 PM, confirmed the LD failed to ensure annual competencies on ALL testing personnel were performed in 2022 and 2023. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on March 1, 2022. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition and Standard deficiencies were cited: D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) documents, and staff interview, the laboratory was not performing the PT samples in the same manner as patient samples. Reference: D2006, D2015 D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally 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 -- require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on document review of the College of American Pathologist (CAP) Proficiency Testing (PT) documents for 2020, 2021 and 2022, in the Specialty of Hematology, the laboratory was not performing the testing on the PT samples in the same manner as the patient samples. Findings: 1. Review of the CAP PT attestation statements for Hematology for 2020, 2021, and 2022 showed the following: 2020 - Event A- there were six signatures on the attestation statement, with no PTspecimens assigned to personnel for testing - Event B- there were two signatures on the attestation statement, with no PT specimens assigned to personnel for testing - Event C - there was not an attestation statement available 2021 - Event A - there were four signatures on the attestation statement, with no PT specimens assigned to personnel for testing - Event B - there were five signatures on the attestation statement, with no PT specimens assigned to personnel for testing - Event C - there were three signatures on the attestation statement, with no PT specimens assigned to personnel for testing 2022 - Event A - there were six signatures on the attestation statement, with no specimens assigned to personnel 2. A phone interview with staff # 2(CMS 209 form), who was currently working at one of the other Gwinett Pediatric Partner offices. confirmed they were testing the samples in duplicate so all testing personnel could participate in PT performance. 3. Interview with staff #1(CMS 209 form) and the Office Manager, on March 1, 2022 at approximately 1pm in the breakroom, confirmed the above aforementioned statements. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologist (CAP) Proficiency Testing (PT) documents, and staff interview, the laboratory failed to retain all instrument printouts that were created during sampling of the PT specimens, in 2020, 2021, and 2022. Findings: 1. A review of the CAP PT documents confirmed that there was only one set of instrument printouts available, although samples were run several times, as shown on review of the attestation statements. 2. Interview with staff #1, (CMS 209 form) and the office manager, on March 1, 2022, at approximately 1:10 pm, in the breakroom confirmed the above afforementioned statement. -- 2 of 4 -- 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 activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on document review and staff interview, the laboratory was not retaining the instrument printouts from the Horiba Hematology analyzer (Horiba) for a minimum of two years. Findings: 1. The laboratory was not retaining the instrument printouts from the Horiba. A review of the College of American Pathologist (CAP) Proficiency Testing (PT) documents for 2020, 2021, and 2022, confirmed that there was only one copy of the PT results retained although the samples were ran several times. 2. Observation of laboratory documents confirmed that the laboratory utilized the Horiba printout and manually entered the results into the Electronic Medical Record (EMR), discarding the instrument printout. 3. Interview with staff #1 (CMS 209 form) and the office manager, on March 1, 2022, at approximately 1:25pm in the conference room confirmed the aforementioned statements. 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 review of the College of American Pathologist (CAP). Proficiency Testing documents (PT), Testing personnel (TP) training and competency documents, the Laboratory Director (LD) failed to provide overall management and direction as required. Reference: D6046, D6065 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Testing Personnel (TP) Competency documents, and staff interview, the Laboratory Director (LD) , acting as the Technical Consultant (TC), failed to provide training and competency documents for all TP staff for the years 2020, and 2021. Findings: 1. Review of the TP documents showed the following: TP #1 (CMS 209 form) - no competency documents to review TP #2 (CMS 209 form) - competencies for 2020, and 2021 TP #3 (CMS 209 form) - competencies for 2020, and a 6 month competency for 2021, no annual competency in 2021 TP #4 (CMS 209 -- 3 of 4 -- form) - no training documentation TP #5 (CMS 209 form) - an initial training in 2022 3. Interview with staff #1 and thre office manager on March 1, 2022, at approximately 1:30 pm, in the break room confirmed the above mentioned statement. 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 review of Personnel Files for all testing personnel (TP) and staff interview, the laboratory failed to provide educational documents. Findings: 1. Review of the Personnel files for the five TP, listed on the CMS-209 personnel report, no educational records were available to review. 2. Interview with staff #1 (CMS 209 form) and the office manager, on March 1, 2022, at approximately 1:30 pm, in the break room, confirmed the above aforementioned statement. -- 4 of 4 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 10, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on observation and staff interview, the laboratory failed to label laboratory specimens with two unique identifiers as required. Findings include: 1. Observation during the laboratory tour on 9/10/2020 at approximately 12:00 p.m. in the hematology area revealed a patient specimen with only one unique identifier. 2. An interview with Staff #2 (CMS 209) in the laboratory on 9/10/2020 at approximately 12:15 p.m. confirmed a patient specimen label with only one unique identifier. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 calibration document review and staff interview, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems as required. Findings include: For details refer to D5437. 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 a review of the laboratory policy and procedure manual (SOP) and staff interview, the laboratory failed to establish an initial and six-month testing personnel (TP) competency policy and procedure as required. Findings include: 1. SOP review revealed the lack of an initial and six-month TP competency policy and procedure. 2. An interview with the Clinic Manager in the breakroom on 9/10/2020 at appoximately 10:30 a.m. confirmed the lack of the aforementioned policy and procedure. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on maintenance log review and staff interview, the laboratory failed to monitor and document temperature and humidity as required. Findings include: 1. Maintenance log review revealed the laboratory failed to monitor the laboratory temperature, as required for the Horiba hematology analyzer, for the following dates: 2017 -- November (15 out of 30 days) and December. 2. Maintenance log review revealed the laboratory failed to monitor the laboratory humidity, as required for the Horiba hematology analyzer, for the following dates: 2017 -- November and December 2017; 2020 -- January- August. 3. An interview with the Clinic Manager in the breakroom at approximately 11:30 a.m. on 9/10/2020 confirmed the failure to monitor and document laboratory temperature and humidity for the aforementioned dates. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE -- 2 of 5 -- CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on hematology document review and staff interview, the laboratory failed to verify all performance specifications as required. Findings include: 1. Horiba hematology analyzer validation document review revealed the facility failed to perform a correlation study upon receipt of the new analyzer on October 26, 2018. 2. An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 10:30 a..m. confirmed no correlation study was performed for the new Horiba hematology analyzer in 2018. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document 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 maintenance document review and staff interview, the laboratory failed to perform and document instrument maintenance as defined by the manufacturer and with the frequency specified by the manufacturer. Findings include: 1. Horiba hematology analyzer maintenance document review revealed there were no daily and weekly maintenance logs available at the time of survey for 2018 , 2019, and 2020 thus far. 2. An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 2:00 p.m. confirmed the lack of Horiba maintenance logs for the aforementioned dates. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on equipment maintenance log review and staff interview, the laboratory failed to perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Findings include: 1.. Equipment maintenance log review revealed the lack of eyewash maintenance logs available at the time of survey for 2017 (October - December), 2018, 2019, and 2020 thus far. 2. -- 3 of 5 -- An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 2 p.m. confirmed the lack of eyewash maintenance logs for the aforementioned dates. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on calibration document review and staff interview, the laboratory failed to perform instrument calibrations with required frequency. Findings include: 1. Horiba hematology analyzer calibration document review revealed there was no calibration documentation available at the time of survey between 10/26/2018 and 8/7/2020. The required calibration interval is every six months. 2. An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 10:45 a.m. confirmed the lack of calibration documentation for the aforementioned time period. REPEAT DEFICIENCY D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview the laboratory director/technical consultant (LD/TC) failed to ensure that, prior to testing patients' specimens, each TP receive required appropriate training for the type and complexity of the services offered. Findings include: 1. TP competency document review revealed the LD/TC failed to perform initial competencies in 2019 for Staff #1, Staff #2, Staff #3, and Staff #4 (CMS 209). 2, An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 11:00 a.m. confirmed the lack of 2019 initial competency performances for the aforementioned TP. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES -- 4 of 5 -- 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 testing personnel (TP) document review and staff interview, the technical consultant/laboratory director (TC/LD) failed to evaluate and document the performance of each TP responsible for moderate complexity testing semiannually during the first year of TP test performance as required. Findings include: 1. TP competency document review revealed the TC/LD failed to perform semiannual competencies in 2019 for Staff #1, Staff #2, and Staff #3 (CMS 209). 2, An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 11:00 a.m. confirmed the lack of 2019 annual competency performance for the aforementioned TP. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on testing personnel (TP) document review and staff interview the technical consultant/laboratory director (TC/LD) failed to evaluate and document the performance of each TP responsible for moderate complexity testing at least annually after the first year of TP test performance as required. Findings include: 1. TP competency document review revealed the TC/LD failed to perform a 2020 annual competency for Staff #1(CMS 209). 2, An interview with the Clinic Manager in the breakroom on 9/10/2020 at approximately 11:00 a.m. confirmed the lack of an 2019 annual competency performance for the aforementioned TP. -- 5 of 5 --