Primecare Pediatrics Pc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on May 31, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following Condition level deficiencies were cited: D2016, D6000 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory 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 -- failed to successfully participate in proficiency testing (PT) in 2 consecutive testing events for Red Blood Cell (RBC), Hematocrit (HCT), Hemoglobin (HGB) resulting in the initial unsuccessful participation for RBC, HCT, & HGB. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) 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 review of the CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for RBC, HBG, and HCT resulting in the initial unsuccessful participation for RBC, HGB, & HCT. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed RBC, HGB, & HCT on the following: RBC 2023 Event 3 Score 40% RBC 2024 Event 1 Score 40% HGB 2023 Event 3 Score 40% HGB 2024 Event 1 Score 60% HCT 2023 Event 3 Score 40% HCT 2024 Event 1 Score 60% 2. A review of the laboratory's API Reports confirmed the laboratory failed RBC, HGB, & HCT with the aforementioned scores. 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 CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to 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 review of the CMS CASPER Report 155 and the API PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 consecutive testing events. Refer to D 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on July 5, 2023. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the procedure manual (SOP), document review, and email from the lab director (LD), the laboratory failed to follow the written procedure for the Quality Assessment (QA) Plan. Findings: 1. Review of the QA plan revealed the laboratory was to perform monthly checklists with various monitors. 2. Review of the QA Plan page 2 of 2 revealed the plan was being reviewed 1 time per year, not monthly as written. 3. Review of the email sent by the LD on 7/6/23 at 11 AM, confirmed the lab was not following the monthly checklists as written. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on September 14, 2021. 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: D1002 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 lack of documentation and staff interview, the laboratory failed to report SARS-CoV-2 test results to the Georgia Department of Public Health (DPH) as required. Findings include: 1. The laboratory was unable to provide documentation of disease reporting to DPH at the time of the survey. 2. Interview with the office manager on 9/14/21 in her office at 12:29 PM, confirmed the laboratory was not reporting SARS-CoV-2 test results to DPH. 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 laboratory's routine methods. This STANDARD is not met as evidenced by: 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 -- Based on review of profiency test (PT) records and staff interview, the laboratory testing personnel and/or lab director failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of API 2020 Event #3 PT documents revealed the testing personnel failed to attest that PT samples were tested in the same manner as patient specimens. 2. Review of API 2021 Events #1 and #2 PT documents revealed no attestation documents were available at the time of the survey. 2. An interview with the practice manager on 09/14/21 at approximately 12:40 PM in the practice manager's office, confirmed the lack of attestation documents/ signatures. 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 American Proficiency Institute (API) proficiency documents and staff interview, the laboratory failed to maintain a copy of all records, including analyzer printouts, 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. Findings include: 1. Review of API 2021 Events #1 & #2 documents revealed the lab did not maintain copies of all required documents. 2. An interview with the practice manager on 09/14/21 at approximately 12:40 PM in the practice manager's office, confirmed the lack of the required documents. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of policy and procedures for Quality Assessment and subsequent staff interview, the laboratory failed to monitor and evaluate the overall quality of the general laboratory systems and correct identified problems for each specialty and subspecialty of testing performed as required. Findings include: For details refer to D5291 -- 2 of 4 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency results and staff interview, the laboratory failed to document review of the results obtained on proficiency testing. Findings include: 1. Review of API 2020 Event #3 result documents revealed the lab did not document review of the results obtained. 2. An interview with the practice manager on 09/14/21 at approximately 12:30 PM in the practice manager's office, confirmed the lack of documented review. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the lack of Quality Assessment (QA) policy and procedures or documents and staff interview, the lab failed to have and follow written policies and procedures to monitor, assess, and correct problems identified. Findings include: 1. Lack of written QA policies and procedures and lack of documentation of QA monitors revealed the laboratory did not have and follow written policies and procedures to monitor, assess, and correct problems identified. 2. An interview with the practice manager on 09/14/21 at approximately 12:15 PM in the practice manager's office, confirmed the QA policies or documentation there of were not available. ** This is a repeat deficiency ** 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 review of temperature (RT) and humidity (RH) logs and staff interview, the laboratory failed to document RT and RH each day of testing on the Medonic M hematology analyzer. Findings include: 1. Review of RT/RH logs for August 2019 revealed the lab failed to record RH 18 of 26 days. 2. Review of RT/RH logs for March 2020 revealed the lab failed to record RH 24 of 24 days and failed to record -- 3 of 4 -- RT 18 of 24 days. 3. Interview with the office manager on 9/14/21 in her office at approximately 12:25 PM confirmed the lack of the aforementioned missing data. D5781

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on May 8, 2019. 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: D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of Quality Assessment (QA) documents and staff interview, the lab failed to follow written policies and procedures to monitor, assess, and correct problems identified. Findings include: 1. Review of the QA binder revealed the lack of documentation for the written policies and procedures. No QA monitors followed or performed November 2017 to 2018 to date. 2. An interview with the practice manager on 5/8/19 at approximately 1 PM in the practice manager's office, confirmed the QA policies were not followed. ** This is a repeat deficiency ** 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) 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 -- (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 review of hematology calibration documents and staff interview, the laboratory failed to calibrate the Medonic M series analyzer at least once every 6 months. Findings include: 1. Review of the calibration documents revealed the facility calibrated the Medonic M analyzer on 04/14/17 and 6/18/18 (1 year 2 month span) 2. Interview with the practice manager on 05/08/19 at approximately 12:30 PM in the office of the practice manager, confirmed the analyzer was not calibrated at 6 months. ** Repeat Deficiency ** D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on quality control (QC) document review and staff interview, the lab failed to monitor over time the accuracy and precision of test performance ( long term monitoring (Levy-Jenning charts)). Findings include: 1. Review of the hematolgy QC documents revealed no long term monitoring (Levy-Jenning charts) was available for review. 2. Interview with the practice manager on 5/8/19 at approximately 1:00 PM in the office of the practice manager, confirmed the long term monitoring (Levy-Jenning charts) was not available to review. D5781