Healthstar Physicians Pc

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and American Proficiency Institute (API) 2025 records, the laboratory failed to successfully participate in a proficiency testing program approved by Health and Human Services (HHS), for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Hematology for the Hematocrit analyte. Refer to D2130 D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and the American Proficiency Institute (API) 2025 records, the laboratory failed to achieve satisfactory performance (80% or better) for the same analyte in two consecutive testing events in the specialty of Hematology for the Hematocrit (HCT) analyte. Findings included: 1. Review of the CASPER 0155 report revealed the following results: *Hematology 2025-2nd Event: The laboratory received an unsatisfactory score of 40% for the HCT analyte. *Hematology 2025-3rd Event: The laboratory received an unsatisfactory score of 60% for the HCT analyte. 2. A review of the API proficiency testing records confirmed the laboratory received the above results. 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 a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure the overall quality of the laboratory services provided. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155 report and American Proficiency Institute (API) proficiency 2025 records, the laboratory director failed to ensure the overall quality of the laboratory services provided. The laboratory director failed to ensure successful participation in an HHS-approved proficiency testing program. Refer to D2130 -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Laboratory Personnel Report (CLIA) Form CMS 209 (Form CMS 209), review of laboratory procedures, and an interview with the technical consultant (TC), the laboratory failed to establish a competency assessment procedure that included the assessment of the regulatory responsibilities for the technical consultant (TC) on the survey date (10.01.2025). Findings Included: 1. A review of Form CMS 209, signed by the laboratory director on 10.01.2025, listed one TC for the laboratory. 2. A review of the laboratory procedures revealed no competency assessment procedure that included the assessment of the regulatory responsibilities for the TC was available for surveyor review. 3. An interview with the TC on 10.01.2025 at 11:00 a.m. confirmed the above findings. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or 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 -- she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's personnel records and staff interview, the laboratory director failed to delegate technical consultant (TC) responsibilities in writing and to perform competency assessments for the TC in 2023 and 2024. The findings include: 1. A review of the laboratory's personnel records revealed the following: -No written delegation from the laboratory director for the TC regulatory responsibilities was available for the surveyor's review. - No annual TC competency assessment documentation by the laboratory director was available for 2023 and 2024. 2. An interview with the TC on 10.01.2025 at 11:00 a.m. confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 07.17.2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCY: D2016 - 42 C.F.R. 493.803 Condition: Successful participation 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 review of the Centers for Medicare and Medicaid Services CASPER Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation 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 -- reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events in 2023 and 2024, resulting in initial unsuccessful participation for the Chloride analyte. (See D2096) D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in 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 a desk review of the CMS 155 and the laboratory's PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the Chloride (CL) analyte, resulting in an initial unsuccessful PT occurrence. The findings include: 1. A review of the CMS 155 report revealed the following unsatisfactory CL scores: - 2023 Event three: 0% - 2024 Event two: 0% 2. A review of the laboratory's American Proficiency Institute (API) PT evaluation report revealed the following unsatisfactory CL scores: - 2023 Event three: 0% - 2024 Event two: 0% -- 2 of 2 --

Summary Statement of Deficiencies D0000 ===================================== The Healthstar Physicians, DBA- Jefferson Family Physicians Laboratory was found to be in compliance with the requirements at 42 CFR, Part 493, 'Requirements for Laboratories' as a result of an onsite survey June 13, 2019. ===================================== 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 --