Smg Bridgewater Internal Medicine

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Steward Medical Group - Whitman Lab laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 personnel competency record review and interview with the Technical Consultant (TC) on 6/30/2022, the TC failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that semiannual competency evaluations were not performed and documented for two (2) out of the two (2) newly hired testing persons (TP) in their first year of performing moderate complexity testing. The TC confirmed in an interview on 6/30/2022 at 9:56 AM that the TC failed to perform and document semiannual competency evaluations for two (2) newly hired TP's in their first year of performing moderate complexity testing. The laboratory performs 260,934 chemistry tests and 74,897 hematology tests annually. 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 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 -- annually, after the first year. This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with the Technical Consultant (TC) on 6/30/2022, the TC failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually, after the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the personnel competency records for review. The review revealed that annual competency evaluations were not performed and documented at least annually for one (1) out of the three (3) testing persons (TP) after the first year of performing moderate complexity testing. The TC confirmed in an interview on 6/30/2022 at 10:08 AM that the TC failed to perform and document annual competency evaluations for one (1) out of the three (3) TP's after the first year of performing moderate complexity testing. The laboratory performs 260,934 chemistry tests and 74,897 hematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Steward Medical Group - Whitman Lab pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. 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 proficiency testing (PT) review and interview with the Technical Consultant (TC) on 2/19/2020, the laboratory did not document and maintain a copy of all PT records as evidenced by the following: The surveyor reviewed American Proficiency Institute (API) PT records for calendar years 2018 and 2019 (16 total testing events). The review revealed that 14 out of 16 signed attestation statements provided by the PT program were not available for the following events: 1. API Chemistry Core 2018 Events 2 and 3. 2. API Hematology/Coagulation 2018 Events 2 and 3. 3. API Chemistry Miscellaneous 2018 Event 1 and 2. 4. API Chemistry Core 2019 Events 1, 2, and 3. 5. API Hematology/Coagulation 2019 Events 1, 2, and 3. 6. 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 -- API Chemistry Miscellaneous 2019 Event 1 and 2. The TC confirmed in an interview on 2/19/2020 at 10:45 AM that not all attestation statements were signed by the analyst and the laboratory director. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Steward Medica; Group - Whitman Laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to establish and maintain the accuracy of its testing procedures in accordance with 493.1236(c)(1). Findings include: 1. Review of proficiency testing records on 2/14/18 revealed that the laboratory failed to establish and maintain accuracy of Urinalysis tests. 2. Interview with the technical consultant on 2/14/18 at 9:45 AM confirmed that the laboratory failed to establish and maintain accuracy of Urinalysis tests. 3. The laboratory performs 2200 Urinalysis tests per year. 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 --