Summit Medical Group Dba Summit Health

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of the Maintenance Records (MR) for the Sysmex XS 1000 analyzer, Sysmex XS 1000 User Manual and interview with the General Supervisor (GS), the laboratory failed to perform and document monthly maintenance as specified by the manufacturer for the Sysmex XS 1000 used for Hematology tests in January, March and September of calendar year 2023. The findings include: 1. The User Manual states the monthly rinse sequence is to be performed monthly or every 1200 cycles. 2. There was no documented evidence monthly maintenance was performed in the months of January 2023, March 2023 and September 2023. 3. The GS confirmed on 3/19/24 at 12:15 pm there was no documented evidence monthly maintenance was performed and documented for the Sysmex XS 1000 in the above mentioned timeframe. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; 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 -- This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the General Supervisor (GS), the Laboratory Director (LD) failed to ensure that PS procedures for Chemistry tests performed on the Cobas analyzer were adequate from March 2022 to the date of survey. The findings include: 1. There were no raw data reports for the dilution study performed on the Cobas analyzer. 2. The GS confirmed on 3/20/24 at 11:00am, the PS were not adequate. -- 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 an office review of the CASPER reports 153 and 155 and Proficiency Testing (PT) provider reports, the laboratory failed to achieve a score of 80% or more for Endocrinology tests performed with the College or American Pathologists (CAP). The finding includes: 1) The laboratory scored 60% for Endocrinology in event 1- 2022 with the CAP. 2) The laboratory scored 60% for Endocrinology in event 2-2022 with the CAP. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on an office review of the proficecny testing provider reports and CASPER reports 153 and 155 and Proficiency Testing (PT), the laboratory failed to achieve a score of 80% or more in two out of three event for for Endocrinology tests performed with College of American Pathologists (CAP). The finding includes: 1) The laboratory scored 60% for Endocrinology in event 1-2022 with the CAP. 2) The laboratory scored 60% for Endocrinology in event 2-2022 with the CAP. 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 an office review of the laboratory's performance in Proficiency Testing (PT) surveys, the laboratory director failed to provide appropriate direction to the laboratory personnel to ensure that the PT surveys are performed satisfactorily and compliance with the CLIA regulations are maintained. -- 2 of 2 --