Stark Family Health Center Inc

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: Based on record review and an interview with the Laboratory Director (LD), the laboratory failed to monitor and evaluate the overall quality of the analytic systems and correct identified problems with the moderately complex testing procedures in the subspecialties of Routine Chemistry, Toxicology and Endocrinology. This deficient practice had the potential to affect all patient testing procedures performed in this laboratory between 03/14/2025 through 03/18/2025. Findings Include: 1. The laboratory failed to ensure that the laboratory's reagents were not used when they had exceeded their expiration dates. (Refer to D5417) 2. The laboratory failed to perform and document maintenance protocol which was necessary for accurate and reliable test results and test result reporting in the subspecialties of Routine Chemistry, Endocrinology and Toxicology (Refer to D5429) 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and an interview with the sole Testing Personnel (TP), the laboratory failed to test the proficiency test samples with the regular patient workload. This deficient practice had the potential to affect 544 out of 544 patients tested under the subspecialty of Routine Chemistry from 09/24/2023 through 02/01/2024. Findings Include: 1. Review of the laboratory's policy and procedure titled "5.1 Proficiency Testing Compliance" approved via signature and date by the Laboratory Director on 06/03/2024, and provided on the date of inspection, revealed the following statement: "Test PT samples with the regular patient workload using routine methods and rotating testing among all testing personnel as staffing allows." 2. Review of the American Proficiency Institute's 2024 Chemistry Core 1st event "Performance Review and

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interviews with the Technical Consultant (TC) and the Testing Personnel (TP), the Laboratory Director (LD) failed to attest to the routine integration of proficiency testing (PT) samples into the patient workload using the laboratory's routine methods for one out of five of the reviewed American Proficiency Institute (API) PT events. All patient testing performed in this laboratory between the third testing event, due 10/27/2021, and the second testing event due, 06/08/2022, in the subspecialties of Immunology, Routine Chemistry, Endocrinology and Toxicology had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's "SOP & QC CORR", policy and procedure manual, provided for the inspection, did not find any letter from the LD delegating the PT attestation to the TC. 2. Further review of the laboratory's "Delegated Responsibilities" document revealed only the following PT statements: "4. Testing of proficiency samples are in accordance with CLIA requirements. 5. Review of proficiency testing performance, including recommendations on

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 record review and interviews with Testing Personnel (TP) and an American Proficiency Institute (API) proficiency testing (PT) representative, the laboratory failed to successfully participate in a PT program for the non-waived calcium (Ca) testing performed under the subspecialty of Routine Chemistry. All patients who had Ca tested in this laboratory from the third API PT event of 2019 to current had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to achieve satisfactory PT performance for the analyte calcium, total (Ca) in two out of three consecutive PT testing events in 2019 and 2020 which resulted in a subsequent unsuccessful analyte performance. All patient Ca specimens tested from 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 -- the third API PT event of 2019 to current had the potential to be affected by this deficient practice. (Refer to 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 record review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and interviews with Testing Personnel (TP) and an American Proficiency Institute (API) proficiency testing (PT) representative, the laboratory failed to achieve satisfactory PT performance for the analyte calcium, total (Ca) in two out of three consecutive PT testing events in 2019 and 2020 which resulted in a subsequent unsuccessful analyte performance. All patient Ca specimens tested from the third API PT event of 2019 to current had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's 2019 and 2020 API PT documentation revealed a Ca analyte score of 0% for the second PT event of 2019 and Ca analyte score of 40% for the first testing event of 2020. %; percent 2. A prior unsuccessful PT review, on 08/12/2019, of the laboratory's 2018 and 2019 API PT documentation, provided on 08/02/2019 via electronic mail (email), revealed a Ca analyte score of 60% for the third testing event of 2018 and a Ca analyte score of 0% for the 2nd testing event of 2019. A CMS-2567 was issued for this initial unsuccessful PT performance with an acceptable

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 record review and interviews with Testing Personnel (TP) and an American Proficiency Institute (API) proficiency testing (PT) representative, the laboratory failed to successfully participate in a PT program for the non-waived testing performed under the subspecialty of Routine Chemistry. All patients who had Routine Chemistry analytes tested in this laboratory from the 2nd PT event of 2018 to current had the potential to be affected by this deficient practice. Findings Include: 1. The laboratory failed to return 22 out of 22 Routine Chemistry PT results to the PT provider within the timeframe specified which resulted in an unsuccessful score of 0% (percent) for the 2nd testing event in 2019. (Refer to D2093) 2. The laboratory failed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- to achieve satisfactory PT performance for the analytes, calcium, total (Ca), cholesterol, high density lipoprotein (CHOL, HDL), iron (Fe), magnesium (Mg) and sodium (Na), in two out of three consecutive PT testing events in 2018 and 2019 which resulted in unsuccessful analyte performance. All patients who had the above mentioned analytes tested from the 2nd PT event of 2018 to current had the potential to be affected by this deficient practice. (Refer to D2096) D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review of the American Proficiency Institute (API) proficiency testing (PT) documentation and interviews with a Testing Personnel (TP) and an API representative, the laboratory failed to return 22 out of 22 Routine Chemistry PT results to the PT provider within the timeframe specified which resulted in an unsuccessful score of 0% (percent) for the 2nd testing event in 2019. Findings Include: 1. Review of the 2019 API PT documentation found the laboratory received the following unsatisfactory PT scores: 2nd testing event of 2019: ALT 0% ALB 0% Alk Phos 0% AST 0% TBIL 0% CA, total 0% Cl 0% CHOL, total 0% CHOL, HDL 0% CK, total 0% Creat 0% Glu 0% Fe 0% MG 0% K 0% Na 0% Prot, total 0% TRIG 0% BUN 0% Uric Acid 0% Free Thyroxine 0% TSH 0% 2. The TP stated the 0% scores for the analytes listed above were due to a missed submission deadline. The TP further stated they contacted API, immediately purchased/conducted an off cycle PT testing event and performed acceptable self-evaluations for both testing events. The interviews occurred via electronic mail (email) on 08/01/2019 at 11:31 AM. 3. The API PT provider, on 08/12/2019 at 3:25 PM, verified the laboratory's lack of PT result submission by the due date which resulted in the unsuccessful 0% PT scores. 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 record review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) documentation and an interview with a Testing Personnel (TP), the laboratory failed to achieve satisfactory PT performance for the analytes, calcium, total (Ca), cholesterol, high density lipoprotein (CHOL, HDL), iron (Fe), magnesium (Mg) and sodium (Na), in two out of three consecutive PT testing events in 2018 and 2019 which resulted in unsuccessful analyte performance. All patients who had the above mentioned analytes tested from the 2nd PT event of 2018 to current had the potential to be affected by this deficient practice. Findings Include: 1. Review of the laboratory's 2018 and 2019 API PT documentation, provided on 08/02 /2019 via electronic mail (email), revealed Ca, Fe and Mg analyte scores of 60% and a CHOL, HDL analyte score of 0% for the third testing event of 2018, a Na analyte -- 2 of 3 -- score of 60% for the first testing event of 2019 and Ca, Fe, Mg, CHOL, HDL and Na analyte scores of 0% for the 2nd testing event of 2019. 2. The TP confirmed, via an email on 08/02/2019 at 11:31 AM, that the laboratory did not achieve satisfactory PT performance for the analytes Ca, CHOL, HDL, Fe, Mg and Na in two out of three consecutive testing events in 2018 and 2019. -- 3 of 3 --