Central Medical Associates

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; 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 a proficiency testing desk review of the Certification and Survey Provider 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 -- Enhanced Reporting (CASPER)-0155, Medical Laboratory Evaluation 2022 records (3RD event) and AAB- Medical Laboratory Evaluation 2023 records (1st event), the laboratory failed to successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the Potassium (K) analyte. (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 a proficiency testing desk review of the CASPER-0155 and Medical Laboratory Evaluation records 2022 (3rd event) and AAB- Medical Laboratory Evaluation 2023 (1st event), the laboratory failed to achieve satisfactory performance (80% or greater) for two (2) consecutive testing events in the specialty of Routine Chemistry for the Potassium (K) analyte. 1. A Review of the CASPER-0155 report revealed the following: Routine Chemistry 2022- 3rd Event The Laboratory received an unsatisfactory score of 0% for the Potassium analyte. Routine Chemistry 2023- 1st Event The Laboratory received an unsatisfactory score of 60% for the Potassium analyte. 2. A review of proficiency testing records from Medical Laboratory Evaluation 2022 and AAB-Medical Laboratory Evaluation 2023 confirmed the above findings. 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 proficiency testing desk review of the CASPER-0155 Individual Laboratory Report, Medical Laboratory Evaluation 2022 records (3rd event) and AAB- Medical Laboratory Evaluation 2023 records (1st event), the laboratory director failed to provide overall management and direction of the laboratory services. (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; -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER-0155, Medical Laboratory Evaluation 2022 records (3rd event) and AAB- Medical Laboratory Evaluation 2023 records (1st event), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. (Refer to 2096.) -- 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 desk review of Endocrinology proficiency testing results from the Medical Laboratory Evaluation (MLE) proficiency testing agency on 05/22/2020, the laboratory failed to successfully participate in the Free Thyroxine certified analyte in two of three testing events. See D2098 and D2107 D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte 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 -- in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on desk review of Endocrinology proficiency testing results from Medical Laboratory Evaluation proficiency testing agency on 05/22/2020, the laboratory failed to attain a successful score of at least eighty percent for the Free Thyroxine in two of three testing events. Findings include: 1. The laboratory scored sixty percent in the second testing event of 2019. 2. The laboratory scored sixty percent in the first testing event of 2020. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 desk review of Endocrinology proficiency testing results from Medical Laboratory Evaluation proficiency testing agency on 05/22/2020, the laboratory failed to successfully achieve satisfactory performance for the Free Thyroxine certified analyte in two of three consecutive testing events. Findings include: 1. The laboratory scored sixty percent in the second testing event of 2019. 2. The laboratory scored sixty percent in the first testing event of 2020. -- 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 review of the policy and procedure manual, review of proficiency testing results from the Medical Laboratory Evaluation (MLE) proficiency testing agency, and staff interview on 05/17/2019, the laboratory failed to ensure proficiency testing samples were tested by all testing personnel who routinely perform patient testing for testing events 2018 MLE-M1, 2018 MLE-M2, 2018 MLE-M3, and 2019 MLE-M1. Findings include: 1. Review of the policy and procedure manual revealed the Proficiency Testing Procedure stated "All testing personnel are to be rotated and take turns testing PT samples." 2. There was no evidence of Testing Personnel #2 listed on the CMS Form 209 testing proficiency samples for three testing events in 2018 and the first testing event in 2019. 3. Testing personnel acknowledged in an interview at 10:00 AM on 05/17/2019, the laboratory failed to have a system to ensure established policy was followed and proficiency testing samples were rotated among all testing personnel responsible for patient testing. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved