Jefferson Community Health Center Inc

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's policy, observation of laboratory's patient blood tube samples, and interview with the laboratory supervisor, the laboratory failed to properly follow their written procedure on three out of three patient blood tube samples. 1. Review of the laboratory's "Collection of Blood Specimens" policy indicates to "Label each tube with patient's name, identification number, date and time of collection and collector's initials." 2. Observation of three patient blood tube samples located in the laboratory, revealed the three patient blood tubes were labeled with two letters. 3. Interview with the laboratory supervisor on 3/4 /2025 at 12:32 PM, confirmed the laboratory did not follow its "Collection of Blood Specimens" policy. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: 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 -- Based on surveyor review of manufacturer's instructions, blood bank preventative maintenance logs, and an interview with the laboratory supervisor, the laboratory failed to perform periodic dispenser volume verification checks from 1/1/2024 - 3/4 /2025. Findings are: 1. Manufacturer's instructions indicate to perform periodic dispenser volume verification checks. 2. Review of 2024 and 2025 blood bank preventative maintenance logs showed the laboratory did not perform periodic dispenser volume verification checks. 3. Interview with the laboratory supervisor on 3 /4/2025 at 12:21 PM, confirmed the laboratory did not perform periodic dispenser volume verification checks for blood bank from 1/1/2024 - 3/4/2025. -- 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 surveyor off-site desk review of 2022 immunohematology proficiency testing (PT) performance reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for the analyte compatibility testing. Refer to D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on surveyor off-site desk review of 2022 immunohematology proficiency testing (PT) performance reported to the CLIA database by the PT provider and phone interview with the laboratory manager, the laboratory failed to achieve satisfactory performance for two out of three consecutive testing events for the analyte compatibility testing. Findings are: 1. Desk review of the laboratory's 2022 PT records revealed the analyte, Compatibility Testing, scores of less than one hundred percent for the following events: 2022 first event, score 80% 2022 third event, score 20% 2. In a telephone interview with the laboratory manager on November 28, 2022 at 1:42 PM it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on surveyor review of the CMS 209, competency evaluations for 2019, and an interview with general supervisor, the laboratory failed to perform competency evaluations on three out of six high complexity testing personnel for 2019. Findings are: 1. The CMS 209 form completed by the laboratory revealed six high complexity testing personnel performing patient testing. 2. Review of competency evaluations for 2019 revealed three high complexity testing personnel had no annual competencies performed for 2019. Testing personnel labeled as TP #1, TP #2, and TP #4 on the CMS 209 form had no competencies performed for 2019. 3. Interview with the general supervisor at 1:50 PM on 6/30/2021, confirmed the competency evaluations for three high complexity testing personnel could not be presented at time of survey. 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 --