D Conrad Harper Md, Llc

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on November 19, 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 Bioanalyst (AAB) 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 Triglyceride (Trig) in 2024 event 3 and 2025 event 2, resulting in an initial unsuccessful participation for Trig. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in 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 Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of AAB reports, the laboratory failed to maintain satisfactory participation in two of three testing events ( 3rd event of 2024 and 2nd event of 2025), resulting in an initial unsuccessful participation for Trig. Findings: 1. A review of Casper Report 155 revealed the laboratory failed Trig on the following: 2024 Event 3 Trig Score 0% 2025 Event 2 Trig Score 0% 2. A review of the laboratory's AAB Reports confirmed the laboratory failed Trig 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 event 3 and 2025 event 2 PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Trig in two of three testing events (2024 event 3 and 2025 event 2), resulting in the initial unsuccessful participation for Trig. -- 2 of 2 --

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: D2096, 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 Association of Bioanalysts/Medical 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 -- Evaluation (AAB/MLE) reports, the laboratory failed to successfully participate in proficiency testing (PT) in 2 consecutive testing events for Blood Urea Nitrogen (BUN) resulting in the initial unsuccessful participation for BUN. Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 CMS CASPER 155 report and review of AAB/MLE PT reports, the laboratory failed to demonstrate satisfactory performance in 2 consecutive testing events for BUN resulting in the initial unsuccessful participation for BUN. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed BUN on the following: BUN 2023 Event 3 Score 40% BUN 2024 Event 1 Score 60% 2. A review of the laboratory's AAB/MLE Reports confirmed the laboratory failed BUN 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 AAB/MLE 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 AAB/MLE PT evaluation reports, the laboratory director failed to ensure successful PT participation in 2 consecutive testing events. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on September 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 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 review of the calibration documents for the Beckman/Coulter DH50, and 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 -- staff interview, the laboratory failed to perform calibration at every 6 months as required. Findings: 1. Review of the calibration documents for the Beckman Coulter DH50, the laboratory had calibration documents for November 2020 and August 2022. There were no documented calibrations between those dates. 2. Interview with staff #2 (CMS 209 Personnel Form) on 09/13/2022 at approximately 2pm in the breakroom, confirmed the aforementioned statement. An email received on 9/16/ 2022, at 12:13pm, confirmed the lack of documentation to support the required calibrations. D6005 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(c) 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. (c) The laboratory director must be accessible to the laboratory to provide onsite, telephone or electronic consultation as needed. This STANDARD is not met as evidenced by: Based on review of the calibration documents for the Beckman/Coulter DH50, and staff interview, the Laboratory Director failed to provide oversite for the laboratory. The laboratory failed to perform Calibration on the DH50 every 6 months as required. Findings: 1. Review of the calibration documents for the Beckman Coulter DH50, the laboratory had calibration documents for the following dates: November 2020, and August 2022. There were no documented calibrations between those dates. 2. Interview with staff #2 (CMS 209 Personnel Form) on 09/13/2022 at approximately 2pm in the breakroom, confirmed the aforementioned statement. An email was received on 9/16/ 2022 at 12:13pm confirmed the lack of oversight by the Laboratory Director to ensure completion of all required calibrations. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 29, 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 three consecutive events (1st, 2nd, and 3rd events of 2021), resulting 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 -- in the second unsuccessful occurrence for Total Bilirubin (T BIL) #305. Findings include: Refer to D 2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 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 three consecutive events (1st, 2nd, 3rd events of 2021), resulting in the second unsuccessful performance for T Bil, analyte # 305. Findings include: 1. The laboratory obtained an unsatisfactory score of 0% for the T Bili analyte in the first event of 2021. 2. The laboratory obtained an unsatisfactory score of 40% for the T Bili analyte in the second event of 2021. 3. The laboratory obtained an unsatisfactory score of 40% for the T Bili analyte in the third event of 2021. 4. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed T Bili on the aforementioned testing events resulting in the second 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 test 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 three consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the second unsuccessful occurrence for T Bili, analyte #305. 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 proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in three consecutive events (1st, 2nd, and 3rd events of 2021), resulting in the second unsuccessful occurrence for T Bili #305.. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #305, T Bili on event 1 of 2021 with a score of 0%, on event 2 of 2021 with a score of 40%, and event 3 of 2021 with a score of 40%. 2. Desk review of the laboratory's proficiency testing reports from Medical Laboratory Evaluation (MLE) confirmed the laboratory failed T Bili on the aforementioned testing events 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 October 8, 2020. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) Procedure, and staff interview, the Laboratory Director (LD) failed to ensure that quality assessment programs were monitored and maintained to assure the quality of laboratory services provided. Findings: 1. Review of the QA procedure, the LD failed to maintain and monitor the quality of the laboratory services that were being provided. There was no QA monitors, to monitor Quality Control, the

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on February 3 2020. 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 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 3 of 2019), resulting in the first 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 -- unsuccessful occurrence for NA (sodium) analyte #0475 in the specialty of Routine Chemistry. Findings include: Refer to D2096 D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 proficiency testing desk review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the laboratory's proficiency testing (PT) reports, the laboratory failed to maintain satisfactory performance in two out of three events (Events 1 & 3 of 2019), resulting in the first unsuccessful occurrence for NA (sodium) analyte #0475 in the specialty of Routine Chemistry. 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0475 NA, on Events 1 & 3 of 2019 with a score of 60% for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the Medical Laboratory Evaluation (MLE) confirmed the laboratory failed analyte #0475 NA for Events 1 and 3 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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 3 of 2019), resulting in the first unsuccessful occurrence for #0475 NA (Sodium) in the specialty of routine chemistry. The findings include: 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: -- 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 Medical Laboratory Evaluation (MLE) proficiency testing (PT) reports, the laboratory director failed to ensure the laboratory maintained satisfactory performance in two out of three consecutive events (Events 1 & 3 of 2019), resulting in the first unsuccessful occurrence for #0475 NA (Sodium) in the specialty of routine chemistry. The findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte #0475 NA, on Events 1 & 3 of 2019 with a score of 60% for both events. 2. The criteria for acceptable performance for the specialty of Routine Chemistry is 80%. 3. Desk review of the laboratory's proficiency testing reports from the Medical Laboratory Evaluation (MLE) confirmed the laboratory failed analyte #0475 NA for Events 1 and 3 of 2019 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 April 5, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following Condition level was 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 review of the facility's Proficiency Provider, Medical Laboratory Evaluation (MLE ) proficiency documents, 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 -- performance in two consecutive events ( 3rd event of 2017 and 1st event of 2018), resulting in the first unsuccessful occurrence for the analyte Albumin. Findings include: Refer to D2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 Proficiency Provider, Medical Laboratory Evaluation (MLE), documents for the year 2017 and 2018, and staff interview, the laboratory failed to achieve an overall testing event score of satisfactory performance for two consecutive testing events for the Speciality Chemistry, analyte Albumin. Findings: 1. Based on review of the MLE proficiency documents for the 3rd event in 2017, for the analyte Albumin, the laboratory received a score of 0 percent, for failure to participate. For the 1st event of 2018, for the analyte Albumin the laboratory received a score of 40 percent, for an unsuccessful performance for two consecutive testing events. 2. Interview with staff #1 testing personnel (CMS 209 form), on 04/05/2017 at 11:30am in the break room, confirmed that the laboratory failed to achieve a successful score on the MLE proficiency event #3, 2017 and event #1, 2018 on the analyte Albumin. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 2, 2018. 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 consecutive events (2nd and 3rd events of 2017), resulting in the 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 -- first unsuccessful occurrence for analyte # 285 amylase . Findings include: Refer to D 2097 D2097 ROUTINE CHEMISTRY CFR(s): 493.841(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 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 Medical Laboratory Evaluation (MLE), the laboratory failed to maintain satisfactory performance in two consecutive events (2nd and 3rd events of 2017), resulting in the first unsuccessful occurrence for analyte # 285, amylase. Findings include: 1. Desk review of Casper Reports 153 and 155 disclosed the laboratory failed analyte # 285 amylase on event 2 of 2017 with a score of 0% and event 3 of 2017 with a score of 0%. 2. Desk review of the laboratory's proficiency testing reports from MLE confirmed the laboratory failed amylase on events 2 and 3 of 2017 resulting in the first unsuccessful performance. -- 2 of 2 --