Family Medical Associates

Summary Statement of Deficiencies 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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with the Laboratory Director (LD), the laboratory failed to ensure the LD signed the attestation statements for four of twelve events from 2023 through 2024. The findings include: 1. A review of the API PT records revealed no signature by the Laboratory Director (or designee) on attestation statements for the following surveys: a) 2023 Hematology 2nd Event, b) 2023 Hematology 3rd Event, c) 2023 Chemistry 3rd Event. d) 2024 Chemistry 3rd Event. 2. During the exit interview on 11/5/2024, at 4:20 PM, the LD confirmed the above findings. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: 51319 Based on the review of the American Proficiency Institute Proficiency Testing 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 -- (PT) records, the laboratory failed to provide signed PT attestations forms, failed to ensure the preservation of CBC sample integrity, failed to ensure submission of PT results before the due dates, and failed to review and document

Summary Statement of Deficiencies 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report, and API (American Proficiency Institute) proficiency testing (PT) evaluations, the laboratory failed to successfully participate in Total Cholesterol testing for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER report, and API (American Proficiency Institute) proficiency testing (PT) evaluations, the laboratory failed to satisfactorily perform in Total Cholesterol testing for two consecutive testing events, Event #3, 2022 and Event #1, 2023. The findings include: 1. A review of the CASPER report revealed the following: a) Event #3, 2022 Total Cholesterol 60 % b) Event #1, 2023 Total Cholesterol 40 % 2. A review of the API PT evaluations confirmed the above noted findings. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Centers for Medicare and Medicaid Services CASPER Report 0153D, the American Proficiency Institute (API) 2022 Chemistry Performance Summary, and an interview with the Technical Consultant, the laboratory failed to achieve satisfactory performance for Sodium, (a regulated Chemistry analyte) on two consecutive proficiency testing (PT) surveys, Events #2 and #3 in 2022. These failures resulted in an initial unsuccessful PT participation in Sodium. The findings include: 1. A review of the CASPER Report 0153D and the API 2022 Chemistry Performance Summary revealed the following scores: A) Event #2, 2022: Sodium: 60 % B) Event #3, 2022: Sodium: 40 % 2. During an interview on 10/24/2022 at 1:20 PM, 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 -- Technical Consultant confirmed the above noted finding, and stated the Testing Personnel failed to follow the API's specimen handling instructions. . 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 a review of the Centers for Medicare and Medicaid Services CASPER 0153D Report, the American Proficiency Institute (API) 2022 Chemistry Performance Summary, and an interview with the Technical Consultant, the laboratory failed to achieve satisfactory performance in Sodium testing (a regulated Chemistry analyte) on two consecutive proficiency testing (PT)surveys, Events #2 and #3 in 2022. These failures resulted in initial unsuccessful PT participation for Sodium. The findings include: 1. A review of the CASPER 0153D Report and the API 2022 Chemistry Performance Summary revealed the following scores: A) 2022-Event #2: Sodium 60 % B) 2022-Event #3: Sodium 40 % 2. During a telephone interview on 10/24/2022 at 1:20 PM, the Technical Consultant confirmed the above findings, and stated the testing personnel failed to follow API's specimen handling instructions. SURVEYOR ID #32558 Licensure and certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute Proficiency Testing (PT) evaluations, the laboratory failed to successfully participate in Total Bilirubin (Chemistry) testing for two of three consecutive events, Event #3, 2021 and Event #2, 2022. The findings include: Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 a review of the Centers for Medicare and Medicaid Services CASPER reports and American Proficiency Institute (API) Proficiency Testing (PT) evaluations, the laboratory failed to satisfactorily perform in Total Bilirubin (Chemistry) testing for two of three consecutive events, Event #3, 2021 and Event #2, 2022. These failures resulted in an initial unsuccessful PT participation. The findings include: 1. A review of the CASPER reports revealed the following scores: Event #3, 2021, Total Bilirubin 40 % Event #2, 2022, Total Bilirubin 60 % 2. A review of the API PT Evaluations confirmed the above noted scores. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was conducted on 6/29/2022- 6/30/2022. An Immediate Jeopardy situation was determined based on failures in the analytical systems (493.1250) (refer to D5400). The facility was found to be NOT in compliance with the following Clinical Laboratory Improvement Amendments (CLIA) conditions: 42 CFR 493.1230 Condition: General Laboratory Systems. 42 CFR 493.1250 Condition: Analytic Systems 42 CFR 493.1403 Condition: Moderate Complexity Laboratory Director D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #1, the laboratory failed to review and evaluate PT results and implement

Summary Statement of Deficiencies 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports for Proficiency Testing (PT), a review of API (American Proficiency Institute) PT evaluations, and a telephone interview on 11/12/2021 with the testing personnel, the surveyor determined the laboratory failed glucose testing for three of four consecutive events in 2020 - 2021. These failures result in an non-initial unsuccessful PT participation for the laboratory. This affected Events #3, 2020, #2 and #3 of 2021. The findings include: 1. A review of the CASPER reports revealed the laboratory failed glucose testing for three of four consecutive testing events: a) Glucose score of zero percent (0 %) for Event #3, 2020. b) Glucose score of 20 % for 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 -- Event #2, 2021. c) Glucose score of 0 % for Event #3, 2021. 2. A review of the API PT evaluations confirmed the above noted scores. 3. In a telephone interview on 11/12 /2021 at 2:36 PM, the surveyor inquired of the testing personnel if she was aware of the last score of zero percent on Event #3, 2021 for glucose. The testing personnel reviewed the API evaluation, while on the telephone with the surveyor, and confirmed the zero percent score. The testing personnel stated she had switched reagents and performed a remedial PT event, which all were within acceptable limits. However, the third event of 2021 PT specimens were analyzed, using the "old" reagent, resulting in a failing score. 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 a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed Glucose for three of four consecutive testing events (Event #3, 2020 and Event #2 and #3, 2021). These unsatisfactory performances of glucose testing resulted in a non-initial unsuccessful proficiency testing participation for the laboratory. The findings include: Refer to D2016. 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 a review of the CMS (Centers for Medicare and Medicaid Services) CASPER reports for Proficiency Testing (PT), a review of API (American Proficiency Institute) PT evaluations, and a telephone interview on 11/12/2021 with the testing personnel, the surveyor determined the Laboratory Director failed to ensure the laboratory staff performed remedial actions of glucose testing, after the initial unsuccessful PT participation to prevent further failures. A third failure within four consecutive testing events resulted in a non-initial unsuccessful PT participation. The findings include: Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies 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 a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed Glucose for two of three consecutive testing events (Event #3, 2020 and Event #2, 2021), and Total Protein for two consecutive testing events (Events #1 and #2, 2021). These failures resulted in an initial unsuccessful proficiency testing participation for the laboratory. The findings include: 1. A review of the Casper reports revealed the laboratory scored zero percent (0 %) on Glucose for Event #3, 2020 and 20 % for Event #2, 2021; and scored 40 % for Total Protein for Event #1, 2021 and 60 % for Event #2, 2021. These failures resulted in an 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 -- unsuccessful proficiency testing participation for the laboratory. 2. A review of the API proficiency testing evaluations confirmed the above noted failures. 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 a review of the CMS (Centers for Medicare and Medicaid Services) Casper reports and API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed Glucose for two of three consecutive testing events (Event #3, 2020 and Event #2, 2021), and Total Protein for two consecutive testing events (Events #1 and #2, 2021). These unsatisfactory performances resulted in an initial unsuccessful proficiency testing participation for the laboratory. Refer to D2016. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the API (American Proficiency Institute) proficiency testing (PT) records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed patient testing. This was noted on three out of four 2020 -2021 Chemistry Events and three out of three 2020 Hematology Events. The findings include: 1. A review of API attestation statements revealed Testing Personnel #1 had performed all the testing on three of four of the 2020 -2021 Chemistry surveys, and Testing Personnel #1 had performed all testing on three of three of the 2020 Hematology surveys. 2. During an interview on 04/27/2020 at 12:35 PM, Testing Personnel #1 confirmed Proficiency Testing was not rotated since 2020 1st Event Chemistry and 2019 3rd Event Hematology due to previous failures by Testing Personnel #2 and #3. Testing Personnel #2 and #3 have been testing patient samples during 2020 and 2021. 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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 a review of Proficiency Testing records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to successfully participate in Chemistry - Blood Urea Nitrogen (BUN) testing for two of three consecutive events (Event #2 of 2020 and Event #1 2021). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. A review of the proficiency testing revealed the laboratory scored twenty percent (20%) for Event #2 2020 and twenty percent (20%) for Event #1 2021 for Blood Urea Nitrogen (BUN) - Chemistry. 2. During an interview on 04/27/2021 at 12:30 PM, Testing Personnel #1 confirmed the laboratory failed to successfully participate in two of three consecutive events for BUN - Chemistry. 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 a review of Proficiency Testing records and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to successfully participate in Chemistry - Blood Urea Nitrogen (BUN) testing for two of three consecutive events (Event #2 of 2020 and Event #1 2021). The failures resulted in an initial unsuccessful participation for the laboratory. The findings include: 1. Refer to D2016. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing records and an interview with Testing Personnel #1, the Laboratory failed to verify the accuracy of D-Dimer that was not evaluated by American Proficiency Institute (API). This was noted on seven out of eight 2018 - 2020 Chemistry - Core Proficiency Testing Events. The findings include: -- 2 of 5 -- 1. A review of Proficiency Testing records revealed 2019, 2020 Events #1, #2, #3, and 2021 Event #1 results obtained on proficiency testing were not graded for D-Dimer and the laboratory failed to perform a self-evaluation of the results. 2. During an interview on 04/27/2021 at 12:30 PM, Testing Personnel #1 confirmed the above events were not graded by API and a self evaluation of the results were not performed. 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 a review of the PSA (Prostatic Specific Antigen) and FSH (Follicular Stimulating Hormone) calibration and calibration verification records for the Tosoh AIA-360, calibration verification records for the Biolis 24i, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to perform calibration verifications every six months. This was noted as missing opportunities for five out of six calibration verification from September 2018 to April 2021 for the Tosoh AIA-360 and four out of six calibration verification from September 2018 to April 2021 for the Biolis 24i. This is a repeat deficiency for the Tosoh AIA-360. The findings include: 1. A review of the records for the Tosoh revealed PSA and FSH each have a two-point calibration. Analytes calibrated with less than three calibrators must have a calibration verification performed every six months. 2. A review of the Chemistry records revealed a calibration verification was performed on 09/27/2018 for PSA and FSH and none thereafter. 3. A review of the calibration verification records for the Biolis 24i revealed the calibration verification was not performed in 2019. The calibration verification was performed on 09/24/2018, 01/29/2020, 08/05 /2020, and 04/19/2021. Not all analytes had calibration verification performed each time the calibration verification was performed. The following analytes were not performed for the following dates: a) 08/05/2020 - Triglyceride, Total Cholesterol, Creatinine, Glucose, Cholesterol HDL, Total Protein, Carbon Dioxide, and Uric Acid. b) 04/19/2021 - Triglyceride, Total Cholesterol, Creatinine, Glucose, Cholesterol HDL, Total Protein, Carbon Dioxide, and Uric Acid. 4. During an interview on 04/27 /2021 at 3:55 PM, Testing Personnel #1 confirmed no other calibration verifications -- 3 of 5 -- were performed for PSA and FSH after 09/27/2018 and confirmed the above findings for the calibration verification for Biolis 24i. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the surveyor determined the Technical Consultant (also the Laboratory Director) failed to evaluate and document the performance of individuals, failed to assure training for serum Human Chorionic Gonadotropin, and failed to review training/evaluations for individuals. This affected three of three testing personnel. This is a repeat deficiency. The findings include: 1. Refer to D6045. 2. Refer to D6053. 3. Refer to D6054. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to assure training and evaulations were performed for serum Human Chorionic Gonadotropin and failed to review the initial trainings and semiannual evaluation performed on employees. This was noted on three out of three employees since the previous survey. This is a repeat deficiency. The findings include: 1. A review of personnel evaluation records revealed the initial training/evaulations performed for Testing Personnel #1, #2, and #3 did not include serum Human Chorionic Gonadotropin and as evidenced by lack of Technical Consultant's signature. Testing Personnel #1's initial evaluation was performed on 08 /05/2018 and was performed/reviewed by previous Testing Personnel. Testing Personnel #2's semiannual evaluation was performed on 03/20/2018 and was performed/reviewed by previous Testing Personnel. Testing Personnel #3's initial evaluation was performed on 12/31/2019, and was performed/reviewed by Testing Personnel #1. 2. During an interview on 04/27/2021 at 12:20 PM, Testing Personnel #1 confirmed the above findings. D6053 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 semiannually during the first year the individual tests patient specimens. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate and document the performance of individuals at least semiannually during the first year of performing chemistry and hematology patient testing. This was noted on two out of two new employees since the previous survey. The findings include: 1. A review of personnel evaluation records revealed the semiannual performance was not evaluated or documented for Testing Personnel #1 and #3. Testing Personnel #1's initial training was performed on 08/05/2018 and Testing Personnel #3's initial training was performed on 12/31/2019. 2. During an interview on 04/27/2021 at 12:20 PM, Testing Personnel #1 confirmed the semiannual evaluations were not performed on the above testing personnel. 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. This STANDARD is not met as evidenced by: Based on a review of personnel evaluation records and an interview with Testing Personnel #1, the Technical Consultant failed to evaluate and document the performance of individuals at least annually after the first year of performing chemistry and hematology patient testing. This was noted on three out of three employees since the previous survey. This is a repeat deficiency. The findings include: 1. A review of personnel evaluation records revealed the annual performance was not evaluated or documented for Testing Personnel #1, #2, and #3. Testing Personnel #1's initial evaluation was performed on 08/05/2018, after the initial evaluation no other evaluations were performed and documented. Testing Personnel #2's semiannual evaluation was performed on 03/20/2018, after the semiannual evaluation no other evaluations were performed and documented. Testing Personnel #3's initial evaluation was performed on 12/31/2019, after the initial evaluation no other evaluations were performed and documented. 2. During an interview on 04/27 /2021 at 12:20 PM, Testing Personnel #1 confirmed the above findings. -- 5 of 5 --

Summary Statement of Deficiencies 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 a review of CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to successfully participate in Alkaline Phosphate testing for two of three consecutive testing events (Event #2, 2019 and Event #1 of 2020). The laboratory scored zero percent (0 %) for the Alkaline Phosphate for both events, resulting in an initial unsuccessful proficiency testing participation. The findings include: 1. A review of the CASPER reports revealed the laboratory scored zero percent for Alkaline Phosphate for Event #2, 2019 and Event #1, 2020. The failure of two of three consecutive testing events for 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 -- same analyte resulted in an initial unsuccessful proficiency participation. 2. A review of the API proficiency testing evaluations confirmed the above noted findings. 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 a review of CMS (Centers for Medicare and Medicaid) CASPER reports (#153 / #155), and a review of API (American Proficiency Institute) proficiency testing evaluations, the surveyor determined the laboratory failed to perform satisfactorily for Alkaline Phosphate (Chemistry testing) for two of three consecutive testing events (Event #2, 2019 and Event #1 of 2020). The laboratory scored zero percent (0 %) for the Alkaline Phosphate for both events, resulting in an initial unsuccessful proficiency testing participation. The findings include: Refer to D2016. -- 2 of 2 --