Family Care Walk-In Clinic, Inc

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of the laboratory procedure manual, patient result review, lack of documentation, and staff interview, the laboratory failed to follow the procedure for flagged complete blood count with automated differential (CBC w/Diff) patient results (one of one reviewed) in 2024. The findings include: 1. A review of the laboratory procedure titled "Procedure: Emerald Cell Dyn Data Flag Review" revealed that the laboratory would repeat any CBC w/Diff results flagged with an "s" and document the flag review actions taken on the instrument printout. 2. A review of patient test records for patient A performed on 12/04/2024 at 10:08 am revealed that the CBC w/Diff instrument printout included an "s" flag for the Lymphocytes (LYM), Mid Cell (MID), Granulocytes (GRA), LYM %, MID %, and GRA % analytes. 3. Documentation that the laboratory performed a repeat test or took actions for the flag review was not available on the survey date (04/28/2025). 4. An interview with the laboratory technical consultant on 04/28/2025 at 11:30 am confirmed the survey findings. Word Key %- percent 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 --

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 a review of the Centers for Medicare and Medicaid Services (CMS) Casper report 0155D (CMS 155), the laboratory's American Proficiency Institute (API) proficiency testing (PT) records, and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events in 2024 for the White Blood Cell (WBC) Differential (WBC DIFF) analyte, resulting in initial unsuccessful PT performance. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- (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 review of the CMS 155, the laboratory's API PT records, and staff interview, the laboratory failed to maintain successful participation for two consecutive PT events in 2024 for the WBC DIFF analyte, resulting in initial unsuccessful PT performance. The findings include: 1. A review of the CMS 155 report revealed the following scores for the WBC DIFF analyte: 2024 Event Two- 0% 2024 Event Three- 33% 2. A review of the API PT performance evaluation reports revealed the following overall scores for the WBC DIFF analyte: 2024 Event Two- 0% 2024 Event Three- 33% 3. An electronic interview with the laboratory technical consultant on 01/07/2025 at 12:12 p.m. confirmed the survey findings. Word Key %- Percent -- 2 of 2 --

Summary Statement of Deficiencies D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

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 the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for the red blood cell (RBC) analyte resulting in the first unsuccessful PT occurrence for the RBC analyte. (See D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 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 desk review of the CMS 155 and the laboratory's 2022 and 2023 API PT evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the RBC analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory RBC scores: 2022 Event three 0% 2023 Event two 60% 2. Review of the API PT evaluation report for 2022 Event three revealed a 0% score for failure to participate for the RBC analyte. 3. Review of the API PT evaluation report for 2023 Event two revealed an overall score of 60% for the RBC analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: The laboratory failed to have a

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: The laboratory failed to maintain satisfactory participation for two out of three proficiency testing events for red blood cell (RBC) resulting in the first unsuccessful proficiency testing (PT) occurrence for the RBC analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(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. 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 a desk review of the Centers for Medicare and Medicaid Oscar Report 155 (CMS 155) and the laboratory's 2017 proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two out of three test events for the red blood cell (RBC) analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory RBC scores: 2017 event one 0%, 2017 event three 0%. 2. Review of the 2017 PT event one evaluation report revealed unacceptable scores for RBC for the following sample numbers: HEM-01, HEM-02, HEM-03, HEM-04, HEM-05. 3. Review of the 2017 PT event three evaluation report revealed unacceptable scores for RBC for the following sample numbers: HEM-11, HEM-12, HEM-13, HEM-15. -- 2 of 2 --