Primary Pediatrics, Pc

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on December 10, 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: 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. This STANDARD is not met as evidenced by: Based on Bacteriology quality control documents review and staff interview, the laboratory failed to perform and document quality control on Taxo Disc on days of patients testing and results release from November 2023 to December 2025. Findings: 1. A review of laboratory QC documents revealed that there was no QC data available to review on all days of patient testing in the specialty of Bacteriology for throat cultures. 2. An interview with the office manager in the breakroom on 12/10/2025 at approximately 1:00 PM confirmed Taxo disc controls were not performed on days of patients testing from November 2023 to December 2025. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(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 2 -- 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on documents review and interview with the office manager, the lab director failed to ensure that all Quality Assurance (QA) guidelines in the laboratory were followed to identify and fix problems from November 2023 to December 2025 as required by Clinical Laboratory Improvement Amendments (CLIA). Findings: 1. Monthly QA documents review revealed the lab director , who is also the technical consultant (TC) , did not ensure that Taxo disc quality controls (QC) were performed on throat cultures on days of patient testing from November 2023 to December 2025. 2. An interview with the office manager, in the break room, on 12/10/2025, at approximately 1:35 PM, confirmed the lab director failed to ensure QA oversight of the laboratory from November 2023 to December 2025. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 28, 2022. 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 deficiencies were cited: 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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 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 -- 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports from the American Proficiency Institute (API), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd event of 2020 and 1st events of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815 on event 2 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from API confirms the laboratory failed the aforementioned analytes on events 2 of 2020 and event 1 of 2021 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st events of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: Refer to D 6016 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 -- 2 of 3 -- 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2020 and 1st event of 2021), resulting in the first unsuccessful occurrence for Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Hematology # 760 including: cell ID or WBC differential (DIFF) # 765, red blood cell count (RBC) #775, hematocrit(HCT) # 785, hemoglobin (HGB) # 795, white blood cell count (WBC) # 805 and platelets (PLT) # 815 on event 2 of 2020 with a score of 0% and event 1 of 2021 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed the aforementioned analytes resulting in the first unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on January 13, 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 Level citations were cited: 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: Based on review of the American Proficiency Institute (API), Proficiency Testing (PT) documents, and staff interview, the laboratory failed to provide a signed Attestation Statement for the PT documents in 2020, and 2021. Findings: 1. Review of the PT documents for 2020, the laboratory did not have signed attestation statement for: Specialty- Chemistry, event 1 or 2 Specialty- Hematology, event 1, 2, or 3 Specialty- Microbiology, event 1, 2, and 3 2. Review of the PT document for 2021, the laboratory did not have signed attestation statements for: Specialty-Chemistry, event 1 Specialty-Hematology, event 1 and 3 Specialty-Microbiology, event 1,2 , and 3 3. Staff interview with the laboratory manager ,on January 13, 2022, at approximately 1:35 pm in the office/storage room, Confirmed the above aforementioned statements. 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 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 -- 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 American Proficiency Institute (API), Proficiency Testing (PT) provider documents, and staff interview the laboratory failed to successfully participate in PT for the year 2020, and 2021. Reference: D2028, D2131, 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events in Microbiology. Findings: 1. PT documents from 2020, for Microbiology, the laboratory scored 50% for event 1, and 50% for event 2. 2. Staff interview with the laboratory manager on January 13, 2022, at approximately 1:40 pm in the office/storage room, confirmed the aformentioned statement. D2131 HEMATOLOGY CFR(s): 493.851(g) 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 review of the American Proficiency Institute (API) Proficiency Testing (PT) documents, and staff interview, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events for Hematology, subspecialty Erythrocyte Sedimentation Rate (ESR). Findings: 1. Review of the PT documents for 2020, speciality Hematology, sub-specialty ESR, the laboratory received a score of 50% for event 1, and a score of 0% for event 2. 2. -- 2 of 4 -- Review of the PT documents for 2021, speciality Hematology, sub-specialty ESR, the laboratory received a score of 0% for event 1and a score of 50% for event 2. 3. Staff interview with the laboratoy manager, on January 13, 2022, at approximately 1:45 pm, in the office/storage room, confirmed the aformentioned statements. 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 review of the calibration documents for the Cell Dyn Emerald (Emerald), and staff interview, the laboratory failed to perform calibration every six months. Findings: 1. Review of the calibration documents, the laboratory performed calibration on the Emerald the following dates: 09/14/2021 and 05/17/2021. There was no documentation of calibrations in 2020. 2. Interview with the Lab Manager, on January 13, 2022 at approximately 1:30 pm in the office/storage room, confirmed the aforementioned documentation. 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 American Proficiency Institute, (API) Proficiency Testing (PT) Provider, the Laboratory Director failed to provide overall management and direction. This is a Condition Level Citation. Reference: D6018, D200 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) -- 3 of 4 -- 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on July 10, 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: D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's maintenance and Quality Assurance(QA) records and an interview with the clinic administrator, the Technical Consultant (TC) who is also the laboratory director failed to review and sign Monthly Quality Assurance report records from October 2017 to June 2019. Findings include: 1. Review of maintenance and Quality Assurance reports revealed QA logs were not reviewed and signed from October of 2017 to June 2019 by the (TC). 2. An interview with the clinic administrator on 07/10/2019 at approximately 12:45 pm in the review room confirmed that maintenance QA reports were not reviewed and signed by the (TC) from October 2017 to June 2019. 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. 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: Based on Personnel competency records review and an interview with the clinic administrator, the technical consultant (TC) who is also the laboratory director failed to perform annual competencies on all Testing Personnel (TP) in 2018 and 2019 as required. Findings include: 1. 2018 and 2019 competency records review revealed the TC did not perform annual competencies on (TP #s 4 - 10 CMS 209). The competencies were instead performed by the laboratory's lead tech. 2. An interview with the clinic administrator on July 10, 2019 in the review room at approximately 01: 42 p.m. confirmed annual competencies for the aforementioned testing personnel (TP) were not performed by the Technical Consultant. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on June 3, 2019. 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 deficiencies were cited: 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 desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (Event 2 of 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 -- 2018 and Event 1 of 2019), resulting in the first unsuccessful occurrence for Cell I.D. /WBC Diff #0765. The findings include: Refer to D2130 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two consecutive events (Event 2 of 2018 and Event 1 of 2019), resulting in the first unsuccessful occurrence for Cell I.D. /WBC Diff #0765. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte Cell I.D./WBC Diff #0765 on Event 2 of 2018 with a score of 0% and Event 1 of 2019 with a score of 0%. 2. The criteria for acceptable performance for the specialty of Hematology is a score of 80%. 2. Desk review of the laboratory's proficiency testing reports from American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on Events 2 of 2018 and Event 1 of 2019 resulting in the first unsuccessful performance. 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2018 and 1st event of 2019), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: Refer to D 6016 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: -- 2 of 3 -- Based on proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 155 and 153 and review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two of three consecutive events (2nd event of 2018 and 1st event of 2019), resulting in the first unsuccessful occurrence for Cell I.D./WBC Diff #0765. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed Cell I.D. /WBC Diff #0765 on Event 2 of 2018 with a score of 0% and Event 1 of 2019 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from the American Proficiency Institute (API) confirmed the laboratory failed Cell I.D./WBC Diff on event 2 of 2018 and event 1 of 2019 resulting in the first unsuccessful performance. -- 3 of 3 --