Chris Burling Md, Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on June 11, 2025. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 laboratory policy, laboratory calibration verification documentation, and confirmed in interview, the laboratory failed to ensure calibration verification was performed every six months for two out of four calibration verifications performed on the Medonic M-Series Hematology Analyzer for records reviewed between March 2023 and January 2025. The findings included: 1. Review of the laboratory policy titled "Medonic M-Series hematology analyzer In House 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 -- Procedure Manual", section "Calibration" included the following information: "Calibration must be performed upon setup of the instrument and then at a minimum of every 6 months. Calibration must be performed more frequently than every 6 months if: - Major maintenance is performed that could affect calibration - Troubleshooting indicated a need for recalibration - The instrument is moved to another location" 2. Review of laboratory calibration verification for the Medonic M Series hematology analyzer, from 2023 to 2025, included the following two calibration verifications that elapsed a six-month period: September 2023: Calibration performed on: 9/18/2023. Next Calibration Due Date: 3/18/2024 May 2024: Calibration performed on 5/15/2024. Time elapsed since last calibration due date: 1 month and 27 days. Next Calibration Due Date: 11/15/2024 January 2025: Calibration performed on 1/8/2025. Time elapsed since calibration due date: 1 month and 24 days. 3. In an interview on 6/11/2025 at 12:20 hours, in the office, testing personnel (TP) 1 confirmed the laboratory had failed to ensure the calibration verification was performed every six months on the Medonic M Series hematology analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An onsite survey conducted 05/19/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. D5781

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records from 2020 to 2022 and confirmed in interview, the laboratory failed to follow the manufacturer's instructions and ensure four of four testing personnel were trained for Covid testing on the Abbott ID Now. The findings were: 1. Review of the package insert for the Abbott ID NOW (INI90000 Rev 4 2020/06) under conditions of authorization revealed "all operators using your product must be appropriately trained in performing and interpreting the results of your product." 2. Review of the laboratory's personnel records available revealed no documentation of training for the Covid testing on the Abbott ID Now per the manufacturer's instructions for four of four testing personnel (TP#1, TP #2, TP#3, TP#4) 3. Review of the CMS116 revealed the laboratory performed 7253 waived testing annually. 4. An interview with the laboratory director on 3/9/22 at 1345 hours in the break room confirmed the above findings. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- 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 review of laboratory procedure, maintenance records, and confirmed in interview, the laboratory failed to retain documentation of maintenance procedures for 2020 and 2021 for the Medonic M Series Hematology Analyzer. The findings include: 1. Review of the laboratory procedure 'Medonic M Series Hematology Analyzer' signed by the laboratory director 8/24/2012 section 'Maintenance' stated: "All maintenance should be documented (a maintenance log is recommended), and the documentation saved for a minimum of 2 years." 2. On 3/9/2022 at 14:45 hours in the laboratory, the surveyor queried for the maintenance records for 2020 and 2021, no such documentation was provided. 3. In an interview on 3/9/2022 at 14:45 hours in the laboratory, testing person 1 stated that they only started recording the maintenance on the maintenance log earlier that month, March 2022, and that there wasn't previous recorded maintenance documentation for the Medonic M Series Hematology analyzer. . 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 a review of the American Proficiency Institute (API) proficiency testing records from 2020 and 2021, laboratory records from 2020 to 2022 and confirmed in interview, the laboratory failed to establish quality assessment procedures to ensure the laboratory had a mechanism to monitor, assess, and correct problems in the general lab systems. (proficiency testing) Findings include: 1. A review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records for 2020 and 2021 revealed one of six events when the laboratory failed to attain an acceptable score (> 80%) for the analyte MPV 2021 API 2nd event 40% HSY-07: lab result 7.3 (acceptable range 7.5 - 9.4) HSY-09: lab result 9.1 (acceptable range 7.5 - 8.9) HSY-10: lab result 9.2 (acceptable range 7.5 - 8.9) 2. Review of the laboratory records revealed no documentation of the

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on September 15, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing nonwaived testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American 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 3 -- Institute proficiency testing records, the laboratory failed to successfully participate in three of three consecutive testing events for the analyte Platelet count, resulting in unsuccessful performance. Refer to D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory failed to participate successfully in three of three consecutive testing events for the analyte Platelet count, resulting in a non-initial proficiency testing failure in the specialty of Hematology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Platelet count in the specialty of Hematology in three of three consecutive events: 2020 API 3rd event- Platelets 0% 2021 API 1st event - Platelets 60% 2021 API 2nd event - Platelets 60% 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory failed to achieve satisfactory performance for the analyte Platelet count in three of three consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsuccessful performance for the analyte Platelet count in the specialty of Hematology in three of three consecutive events: 2020 API -- 2 of 3 -- 3rd event 0% 2021 API 1st event 60% 2021 API 2nd event 60% Failure to achieve satisfactory performance for the same analyte in two consecutive events or three out of three consecutive testing events is 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte Platelet count. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for analyte Platelet count in the specialty of Hematology. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on May 19, 2021, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D2017 - 42 C.F.R. 493.807 Condition: Reinstatement of laboratories performing nonwaived testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American 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 4 -- Institute proficiency testing records, the facility failed to achieve successful performance in three of three consecutive testing events for the analyte Platelet count, resulting in unsuccessful performance. Refer to D2121 and D2130. D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the facility failed to achieve successful performance in three of three consecutive testing events for the analyte Platelet count, resulting in a non-initial proficiency testing failure in the specialty of Hematology. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Platelet county in the specialty of Hematology in three of three consecutive events: 2020 API 3rd event- Platelets 0% 2021 API 1st event - Platelets 60% 2021 API 2nd event - Platelets 60% D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to attain a score of at least 80 percent for the analyte Platelet count in three of three consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsatisfactory scores (satisfactory is 80% or greater) for the analyte Platelet count in the specialty of Hematology in three of three -- 2 of 4 -- consecutive events: 2020 API 3rd event 0% 2021 API 1st event 60% 2021 API 2nd event 60% 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the facility failed to achieve satisfactory performance for the analyte Platelet count in three of three consecutive testing events in 2020 and 2021. The findings included: 1. Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the American Proficiency Institute (API) Comparative Evaluations, the laboratory received the following unsuccessful performance for the analyte Platelet count in the specialty of Hematology in three of three consecutive events: 2020 API 3rd event 0% 2021 API 1st event 60% 2021 API 2nd event 60% Failure to achieve satisfactory performance for the same analyte in two consecutive events or three out of three consecutive testing events is 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Platelet count. 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and American Proficiency -- 3 of 4 -- Institute (API) proficiency testing records, the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for analyte Platelet count in the specialty of Hematology. Refer to D2016 and D2017. -- 4 of 4 --