Mea Primary Care - North

Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 4/20/2021, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of documentation of training, the Laboratory Director failed to ensure that prior to testing patients' specimens, Testing Personnel #1, #2, #3, #4, #5, and #7 received the appropriate training for moderate complexity testing and demonstrated performance of all testing operations reliably to provide and report accurate results. Findings include: Review of personnel records since the last survey on 4/20/2021, and the CMS 209 personnel form revealed the Laboratory Director failed to ensure that Testing Personnel #1, #2, #3, #4, #5, and #7 received appropriate training for performing moderate complexity testing prior to testing patients' specimens. There was no documentation of training available for Testing Personnel #1, #2, #3, #4, #5, and #7 listed on the CMS 209 personnel form on the day of the survey, 11/10/2022. Testing Personnel #1 (date of hire 5/16/2022) Testing Personnel #2 (date of hire 11/15/2021) Testing Personnel #3 (date of hire 9/3/2021) Testing Personnel #4 (date of hire 9/4 /2021) Testing Personnel #5 (date of hire 5/3/2021) Testing Personnel #7 (date of hire 6/20/2022) 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 -- D6049 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of laboratory records (including preventive maintenance, temperature logs, quality control, calibration, quality assurance) and interview with the current laboratory Technical Consultant (TC) listed on the CMS-209 form during the survey on 11/10/2022, there was no documented review of records by the previous TC for a period of 9 months. Findings include: 1) There was no review of records documented by the previous Technical Consultant (TC) after 3/14/2021. The new TC first documented review of records in January 2022. 2) All records from January 2022 through October 2022 were signed by the new TC. 3) The current TC confirmed in an interview on 11/10/2022 that there was no documented review of preventative maintenance, temperature logs, quality control, calibration and quality assurance for a period of 9 months from 3/14/2021 through 12/31/2021. 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. This STANDARD is not met as evidenced by: Based on review of the CMS 209 personnel form and personnel records since the last survey on 4/20/2021, the Technical Consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year these individuals tested patient specimens. Findings include: Review of the CMS 209 personnel form and personnel records since the last survey on 4/20/2021 revealed the Technical Consultant failed to evaluate and document the performance of the following testing personnel listed on the CMS 209 personnel form, at least semiannually during the first year these individuals tested patient specimens: Testing Personnel #2 (date of hire 11/15/2021) Testing Personnel #3 (date of hire 9/3/2021) Testing Personnel #4 (date of hire 9/4/2021) Testing Personnel #5 (date of hire 5/3/2021) Testing Personnel #6 (date of hire 1/31/2021) 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 review of personnel records since the last survey on 4/20/2021, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of -- 2 of 3 -- documentation of competency assessments, the Technical Consultant failed to evaluate and document the performance of Testing Personnel #3, #4, #5, and #6 at least annually. Findings include: Review of personnel records since the last survey on 4/20/2021 and the CMS 209 personnel form revealed the Technical Consultant failed to evaluate and document the performance of Testing Personnel #3, #4, #5, and #6, who were responsible for moderate complexity testing, at least annually since 4/20 /2021. -- 3 of 3 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/24/22, the laboratory has not successfully performed proficiency testing for WHITE BLOOD CELL COUNT (WBC) and WHITE BLOOD CELL DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL COUNT and WHITE BLOOD CELL DIFFERENTIAL (Lymphocyte, Granulocyte): PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians (AAFP) WHITE BLOOD CELL COUNT: Year 2021 3rd Event 0% Year 2022 2nd 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 60% WHITE BLOOD CELL DIFFERENTIAL: Year 2021 3rd Event 0% Year 2022 2nd Event 73% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 8/24/22, the laboratory has not successfully performed proficiency testing for WHITE BLOOD CELL COUNT (WBC) and WHITE BLOOD CELL DIFFERENTIAL. Findings include: Our records indicate the following proficiency testing scores for your laboratory for WHITE BLOOD CELL COUNT and WHITE BLOOD CELL DIFFERENTIAL (Lymphocyte, Granulocyte): PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians (AAFP) WHITE BLOOD CELL COUNT (WBC): Year 2021 3rd Event 0% Year 2022 2nd Event 60% WHITE BLOOD CELL DIFFERENTIAL: Year 2021 3rd Event 0% Year 2022 2nd Event 73% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/27/19, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY AND ERYTHROCYTE COUNT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY AND ERYTHROCYTE COUNT: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians HEMATOLOGY: Year 2019 2nd Event 78% Year 2019 3rd Event 5% ERYTHROCYTE COIUNT: Year 2019 2nd Event 60% Year 2019 3rd Event 0% 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 -- Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 11/27/19, the laboratory has not successfully participated in proficiency testing for HEMATOLOGY AND ERYTHROCYTE COUNT. Findings include: Our records indicate the following proficiency testing scores for your laboratory for HEMATOLOGY AND ERYTHROCYTE COUNT: PROFICIENCY TESTING PROVIDER: American Academy of Family Physicians HEMATOLOGY: Year 2019 2nd Event 78% Year 2019 3rd Event 5% ERYTHROCYTE COIUNT: Year 2019 2nd Event 60% Year 2019 3rd Event 0% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --