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Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on August 27, 2025. 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 deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000- 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 proficiency testing (PT) desk review using the Centers for Medicare and Medicaid Services Casper report 155 and review of the laboratory's American 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 -- Association of Bioanalysts (AAB) reports, the laboratory failed to maintain overall satisfactory performance in the Specialty of Hematology resulting in a second subsequent unsuccessful occurrence for the analytes of Red Blood Cell (RBC) and hematocrit (HCT) in four out of five events. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 proficiency testing (PT) desk review using the Centers for Medicare and Medicaid Services Casper report 155 and review of the laboratory's PT reports, the laboratory failed to maintain overall satisfactory performance in the Specialty of Hematolgy resulting in a second subsequent unsuccessful occurrence for the analytes of Red Blood Cell (RBC) and hematocrit (HCT) in four out of five events (1st and 2nd event, 2024, and 1st and 2nd event, 2025). Findings: 1. Review of the CASPER 155 report revealed the following scores: a. RBC: 2024 Event 1 score 60% 2024 Event 2 score 0% 2025 Event 1 score 40% 2025 Event 2 score 60% b. HCT: 2024 Event 1 score 40% 2024 Event 2 score 0% 2025 Event 1 score 60% 2025 Event 2 score 60% 2. Desk review of the laboratory's PT reports from AAB confirms the laboratory scores for RBC and HCT and an overall score of (61%) in the Specialty of Hematology. 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: The laboratory director failed to provide overall management and direction of the laboratory to ensure successful participation in proficiency testing (PT) in the specialty of Hematology for the analytes of RBC and HCT. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: The laboratory director failed to ensure PT was tested as required under subpart H resulting in the unsuccessful occurrences in the Specialty of Hematology for the analytes of RBC and HCT. Refer to D2130 D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) -- 2 of 3 -- (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification Survey was completed on Jul y 24,2025. 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: D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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: A tour of the laboratory revealed that expired reagents were in use for patient testing and resulting. THE FINDINGS INCLUDE: 1. A tour of the Laboratory revealed the following expired reagents in use: a. COVID-19 IgG/M RAPID TEST CASSETTES: Expired 05/13/2022 b. eSWAB SPECIMEN COLLECTION SWABS: Expired 10/19 /2024 c. YELLOW TOP BROWN MICROTAINER COLLECTION TUBES: Expired 05/31/2024 & 04/30/2025 2. An exit interview with the Laboratory Director and the lab testing personnel, on July 24, 2025, at 1:30 pm, confirmed that expired reagents were in use for patient testing and resulting. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) (b)(1)(i) Establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(1)(ii) Perform and document the maintenance activities specified in paragraph b(1)(i) of this section. 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 -- This STANDARD is not met as evidenced by: A review of 2023 - 2025 Maintenance Records confirmed that the laboratory failed to document the manufacturers required maintenance for the CellDyne Emerald Hematology Analyzer. THE FINDINGS INCLUDE: 1. A review of 2023 - 2025 Maintenance Records confirmed that the required maintenance was not documented for the CellDyne Emerald Hematology Analyzer. 2. An exit interview, with the Laboratory Director and the laboratory staff, on July 24, 2025, at 1:30 pm confirmed that the laboratory failed to perform the maintenance as required by the manufacturer. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) (e)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: A review of 2023 - 2025 Personnel Records confirmed that the Laboratory Director failed to perform the required assessments of laboratory personnel to assure ongoing competencies in completing their assigned duties. THE FINDINGS INCLUDE: 1. A review of the 2023 - 2025 Personnel Records revealed that the testing personnel performed competencies on each other for the period of 2023 - July 2025. 2. An exit interview, with the Laboratory Director and the lab staff, on July 24, 2025, at 1:30 pm, confirmed that the Laboratory Director failed to perform the required assessments, of laboratory personnel, to assure ongoing competencies of assigned duties. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 16, 2025. 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 deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 CASPER 155 report and review of the American Association of Bioanalysts (AAB) reports, the laboratory failed to maintain satisfactory 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 -- proficiency testing (PT) participation for Red Blood Cell (RBC) and Hematocrit (HCT) in 2024 events 1 & 2 and 2025 event 1, resulting in the non- initial unsuccessful participation for RBC/HCT. Refer to D 2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of AAB reports, the laboratory failed to maintain satisfactory participation in three of four testing events ( 1st & 2nd events of 2024 and 1st event of 2025), resulting in the non-initial unsuccessful participation for RBC & HCT. Findings: 1. A review of Casper Report 155 revealed the laboratory failed RBC on the following: 2024 Event 1 Score 60% 2024 Event 2 Score 0% 2025 Event 1 Score 40% 2. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2024 Event 1 Score 40% 2024 Event 2 Score 0% 2025 Event 1 Score 60% 3. A review of the laboratory's AAB Reports confirmed the laboratory failed RBC & 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 AAB reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) 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 AAB 2024 events 1 & 2 & 2025 event 1 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in RBC & HCT in three out of four testing events ( 2024 events 1 &2 and 2025 event 1), resulting in the non-initial unsuccessful participation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on September 11, 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 deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 CASPER 155 report and review of the Medical Lavoratory Evaluation (MLE) reports, the laboratory failed to maintain satisfactory proficiency 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 -- testing (PT) participation for Erythrocyte (RBC) and Hematocrit (HCT), resulting in an initial unsuccessful participation for RBC & HCT. 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of Medical Laboratory Evaluation (MLE) reports, the laboratory failed to maintain satisfactory participation in two consecutive testing events ( 1st & 2nd events of 2024), resulting in an initial unsuccessful participation for RBC & HCT. Findings: 1. A review of Casper Report 155 revealed the laboratory failed HCT on the following: 2024 Event 1 Score 40% 2024 Event 2 Score 0% 2. A review of Casper Report 155 revealed the laboratory failed RBC on the following: 2024 Event 1 Score 60% 2024 Event 2 Score 0% 3. A review of the laboratory's MLE Reports confirmed the laboratory failed HCT & RBC 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 MLE reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing 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 MLE 2024 evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in RBC & HCT in 2 consecutive testing events (2024 events 1 & 2 ), resulting in the initial unsuccessful participation for RBC & HCT. Refer to 2130 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on August 20, 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 laboratory policy and procedure manual (SOP) review and staff interview, the laboratory failed to establish and follow the required 6-step criteria competency for 4 out of 4 Testing Personnel (TP). Findings include: 1. Competency document review revealed the laboratory was performing competency, but failed to follow the required 6-step CMS criteria policy and procedure for all Testing Personnel (TP) listed on the CMS-209 form. 2. During an interview with the Laboratory Director and Testing Personnel #1 (CMS-209) on July 20, 2023 at approximately 12:25 PM, in the conference room, confirmed that competency was performed for all Testing Personnel (TP), but the laboratory failed to follow the required 6-step criteria for competency. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 the American Academy of Family Physicians(AAFP) for 2021 and American Associates of Bioanalysts (AAB) Proficiency Testing (PT) documents for 2022 for Hematology, and staff interview, the laboratory failed to provide the evaluation documentation. The Findings include: 1. A review of the AAB-PT hematology overall score (80%) for the leukocytes, erythrocytes (80%), hemoglobin (80%), and hematocrit (80%) evaluation report for event Q1, the laboratory failed to provide

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 8, 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: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on the review of the calibration documents for the Emerald Hematology 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 -- analyzer, and staff interview, the laboratory failed to perform a calibration on the Emerald at least every 6 months. Findings: 1. Review of the calibration documents provided for the Emerald, the laboratory had documentation that the calibration was performed on the following dates: 2/12/2019 12/23/2019 - 10 months 6/10/2020 1/04 /2021 - 7 months 1/13/2021 6/14/2021 The laboratory did not document a calibration on the Emerald from 2/12/2019 and 12/23/2019, a period of 10 months. The laboratory did not document a calibration on the Everald from 6/10/2020 and 01/04 /2021 a period of 7 months. 2. Interview with the Laboratory Director (LD), on August 4, 2021, at approximately 3pm in the conference room, confirmed the aforementioned dates of calibrations on the Emerald Hematology Anaylzer. 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 review of the Quality Control (QC) documents, for the Abbott (Emerald) Hematology analyzer, for 2019, 2020, and 2021, the laboratory was not monitoring the QC to monitor over time the accuracy and precision of the performance that may be influenced by changes in test system performance, environmental conditions, or variance in operator performance. Findings: 1. Review of the QC documents for the Emerald analyzer, it was noted that no Levy Jennings(LJ) graphs had been printed for the years 2019 or 2020, there was one printed for 2021. LJ graphs allows the user to monitor the shifts and trends of the QC values to monitor errors before they actually occur. There was no documentation that this was being performed. 2. Interview with the Laboratory Director, on 08/04/2021,at approximately 2pm, confirmed the aforementioned statement. D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on review of the Quality Control(QC) documents, for the (Emerald) Hematology Analyzer for 2019, 2020, and 2021, as well as staff interview, the Laboratory Director failed to ensure that the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic phases, and postanalytic phases of testing. Findings: 1 Review of the QC documents, for the Emerald showed that there was no Levy Jennings charts printed for each lot number of QC ran on the Emerald for 2019, 2020, and 2021. The Levy Jennings charts demonstrate when QC results are drifting or trending above or below the calculated mean of the range. Monitoring the Levy Jennings charts allows the laboratory to correct errors in the QC before they are out of range. There was no documentation of QC February 16, 2021 thru February 24, 2021. 2 Interview with the Laboratory Director ,on August 8, 2021, in the conference room, in the facility, at approximately 2:30 pm, confirmed the aforementioned findings. 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 Employee training and competency documents for 2019, 2020, and 2021, as well as staff interview, the Laboratory Director fulfilling the Technical Consultant responsibilities failed to perform competency assessments following the six procedure minimal requirements for assessment of competency for all personnel performing laboratory testing. The six procedures are as follows: 1. Direct observation of routine patient test performance, including patient preparation, specimen handling, processing, and testing. 2. Monitoring the recording and reporting of test results 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 4. Direct observations of performance of instrument maintenance and function checks, 5. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples, and 6. Assessment of problem solving skills. Findings: 1. Review of the documents for 2019, 2020, and 2021, competency assessment consisted of a Check sheet with each test listed with a signature page for each procedure. 2. Interviw with the Laboratory Director, on 08/4 /2021, at approximately 2:20pm, in the conference room, confirmed the aforementioned statement. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on March 21, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was cited: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the American Academy of Family Physicians (AAFP) Proficiency Providor, and staff interview, the laboratory failed to document correction action taken for unsatisfactory scores. Findings: 1 Review of the AAFP evaluation report for 2018 event B, showed a score of 0% for the analyte Red Blood Cell,(RBC) and Hematocrit (HCT). There was no