Family Medicine Associates

Summary Statement of Deficiencies D0000 The recertification survey was performed on 01/19/2022 and 01/20/2022. The findings were reviewed with the laboratory supervisor at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory director or designee and testing person failed to sign proficiency testing attestation statements for two of 21 events. Findings include: (1) The surveyor reviewed 2020 and 2021 proficiency testing records and identified the following for two of 13 events: (a) Third Microbiology Event - The attestation statement had not been signed by the laboratory director or designee and by the person performing the test; (b) Third Hematology Event - The attestation statement had not been signed by the laboratory director or designee. (2) The surveyor reviewed the findings with the laboratory supervisor. The laboratory supervisor stated to the surveyor on 01/19/2022 at 11:30 am, the attestation statements had not been signed by the laboratory director or designee and the person performing the test as shown above. 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 -- D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to review and evaluate proficiency testing results for four of 21 events. Findings include: FAILURE (1) On 01/19/2022, the surveyor reviewed 2020 and 2021 proficiency testing records and identified the following failure: (a) Third 2020 Chemistry Event (i) Sodium - The laboratory failed the results for 1 of 5 samples (CH-15) (2) The surveyor could not locate evidence in the records proving the failure had been addressed; (3) The surveyor reviewed the records with the laboratory supervisor, and asked if

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database on 04/01/2020. 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 desk review of proficiency testing scores, the laboratory failed to successfully participate in a proficiency testing program for the subspecialty of Routine Chemistry. Findings include: (1) The laboratory failed to achieve satisfactory performance for two of three testing events for the analyte Chloride. Refer to D2094 and D2096. 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 -- 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 desk review of proficiency testing scores, the laboratory failed to achieve a successful performance for the analyte Chloride. Findings include: (1) The laboratory failed to achieve satisfactory performance on the third 2019 event and first 2020 events. NOTE: The only acceptable

Summary Statement of Deficiencies D0000 The recertification survey was performed on 09/18,19,20/19 The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: Analytic Systems 493.1403; D6000: Laboratory Director 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory director, senior partner, office manager, and laboratory supervisor during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory supervisor, the laboratory failed to ensure attestation statements were signed by the analyst(s) and failed to maintain a copy of all proficiency testing records for a minimum of two years for 5 of 18 events. Findings include: (1) On the first day of the survey, the surveyor reviewed 2018 and 2019 proficiency testing records, with the following identified: (a) First 2018 Chemistry Miscellaneous Event (i) The attestation statement had not been signed by the analyst(s); (ii) Copies of instrument printouts could not be located; (ii) A copy of the results form submitted to the proficiency testing program could not be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 18 -- located. (b) First 2018 Microbiology Event (i) The attestation statement had not been signed by the analyst(s). (c) Second 2018 Chemistry Core Event (i) The attestation statement had not been signed by the analyst(s); (ii) Copies of instrument printouts could not be located; (ii) A copy of the results form submitted to the proficiency testing program could not be located. (d) Second 2018 Microbiology Event (i) The attestation statement had not been signed by the analyst(s). (e) Third 2018 Chemistry Core Event (i) A copy of the results form submitted to the proficiency testing program could not be located. (2) The surveyor reviewed the records with the laboratory supervisor, who stated the attestation statements had not been signed by the the analyst (s) and the copies had not been maintained, as indicated above. 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 records and interview with the laboratory supervisor, the laboratory failed to take

Summary Statement of Deficiencies D0000 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --