Esse Health

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation of laboratory refrigerator and interview with the technical consultant (TC), the laboratory failed to ensure patient protection from biohazardous materials. Findings: 1. Observation of the laboratory refrigerator showed children's liquid oral Tylenol and children's liquid oral Benadryl stored with the laboratory's positive and negative streptococci microbiology quality control swabs. 2. Interview with the TC on August 30, 2023 at 10:30 AM confirmed the laboratory failed to ensure protection from from biohazardous materials. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on observation of the "BD BBL Taxo A Discs" reagent vial, review of the "BD BBL Taxo A Discs" package insert and interviews with the clinic staff and the technical consultant (TC), the laboratory failed to follow manufacturer's instructions for reagent storage. Findings: 1. Observation of "BD BBL Taxo A Discs" reagent vial, 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 -- lot # 3058506 expiation date September 30, 2024 showed the reagent vial stored on the laboratory counter at room temperature. 2. Review of the "BD BBL Taxo A Discs" package insert states "After use, store vial or cartridge to protect product integrity at 2 to 8 degrees C" and "Vials and cartridges from which discs have been frequently removed during one week and disc left out overnight in the laboratory should be discarded or the discs should be tested for performance with control organisms prior to continued use." 3. Interview with the medical assistant on August 30, 2023 at 10:15 AM, the medical assistant stated that "those were left out over- night." 4. Interview with the TC on August 30, 2023 at 11:00 AM, confirmed the laboratory failed to follow manufacturer's instructions for reagent storage. -- 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 review of bacteriology proficiency testing (PT) results for 2020 reported to the CLIA database by the PT provider and phone interview with the laboratory (office) manager, the laboratory failed to successfully participate in PT. See D-tag 2028, unsatisfactory performance in two out of three consecutive bacteriology PT events. D2028 BACTERIOLOGY CFR(s): 493.823(e) 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 achieve an overall testing event score of satisfactory performance for 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 review of 2020 bacteriology proficiency testing (PT) performance reported to the CLIA database by the PT provider, and phone interview with the laboratory (office) manager the laboratory failed to achieve satisfactory performance for the subspecialty of bacteriology in two out of three consecutive testing events. Findings: 1. The laboratory obtained an unsatisfactory score of 40 percent for the subspecialty of bacteriology in the first testing event of 2020. 2. The laboratory obtained an unsatisfactory score of 60 percent for the subspecialty of bacteriology in the third testing event of 2020. 3. Phone interview with the laboratory (office) manager on December 10, 2020 at 10:00 AM confirmed the laboratory failed to achieve satisfactory performance for the subspecialty of bacteriology in the first and third testing events of 2020. -- 2 of 2 --