Chi St Vincent Medical Group Hot Springs

Summary Statement of Deficiencies D0000 A proficency testing desk review was performed January 14th, 2026 and the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 Code of Federal Regulations (C.F.R.) 493.803 Condition: Successful participation (proficiency testing) D6076 - 42 C.F.R. 493.1403 Condition: Laboratories performing high complexity testing; laboratory director. The following acronyms will be utilized in this report: API - American Proficiency Institute CASPER - Certification and Survey Provider Enhanced Reporting CLIA - Clinical Laboratory Improvement Act CMS - Centers for Medicare and Medicaid Services HHS - Department of Health and Human Services 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. 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 CONDITION is not met as evidenced by: Based on review of the 2025 CMS CASPER Reports 0155D, and API records (2025- 2nd and 2025-3rd), the laboratory failed to achieve satisfactory performance in a proficiency program approved by the HHS for each specialty, subspecialty, and analyte or test in which the laboratory is certified under the CLIA. The laboratory failed to successfully participate in the subspecialty of Immunohematology for the analyte Unexpected Antibody Detection. Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events is unsuccessful performance as cited at D2172. D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory 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 the CMS CASPER Reports 0155D and API proficiency testing results, the laboratory failed to achieve satisfactory performance for two consecutive testing events (2025-2 and 2025-3) proficiency testing for the analyte unexpected antibody detection. Survey Findings follow: A. A review of CASPER 0155D reports revealed the following results for two of two testing events for compatibility testing: 2025-2:80% 2025-3:80% B. API reports confirmed the findings. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of CMS 0155D and API proficiency testing results for 2025, the laboratory director failed to provide overall management and direction of the laboratory services. The laboratory director failed to ensure that the proficiency testing samples are tested as required under Subpart H of this part. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 review of the 2025 Casper CMS 0155D and API proficency testing event results, the laboratory director failed to ensure the laboratory successfully participated in proficiency testing in an HHS approved proficiency testing program for unexpected antibody detection. Refer to D2172. -- 2 of 2 --

Summary Statement of Deficiencies D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Through a review of laboratory policy and procedures manual, quality control data, patient testing logs, lack of documentation, as well as interview with staff, it was determined the laboratory failed to perform positive and negative controls on days when patients were analyzed. As evidence by: A. A review of the laboratory quality control policy for Stanibo True Serum Pregnancy test revealed "positive and negative controls should be run each day of patient testing. B. A review of quality control data for March, June and July of 2018 revealed on one of sixteen days in June of 2018, the laboratory had no documentation of quality control. C. A review of the Stanibo Serum Pregnancy patient log revealed patient #1402641696 had a serum pregnancy test performed and resulted on 6/22/2018 without documentation of quality controls. D. In an interview on 8/28/2018 at 1330, laboratory personnel #3 (as listed on form CMS 209) confirmed patients were test without documentation of quality controls. D5551 IMMUNOHEMATOLOGY CFR(s): 493.1271(a)(f) (a) Patient testing. (a)(1) The laboratory must perform ABO grouping, D (Rho) typing, unexpected antibody detection, antibody identification, and compatibility testing by following the manufacturer's instructions, if provided, and as applicable, 21 CFR 606.151(a) through (e). (a)(2) The laboratory must determine ABO group 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 -- concurrently testing unknown red cells with, at a minimum, anti-A and anti-B grouping reagents. For confirmation of ABO group, the unknown serum must be tested with known A1 and B red cells. (a)(3) The laboratory must determine the D (Rho) type by testing unknown red cells with anti-D (anti-Rho) blood typing reagent. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Through a review of laboratory policy and procedure manual, Immunohematology quality control records, patient testing logs, lack of documentation, as well as interviews with laboratory staff, it was determined the laboratory failed to perform and document quality control for Immunohematology testing on each day of patient testing. As evidenced by: A. A review of the laboratory Immunohematology quality control policy (QC) revealed " QC will be performed with each run of patient samples." B. A review of quality control data for March, June, and July of 2018 revealed on one of twenty-five days in June 2018, the laboratory had no documentation of quality control. C. A review of the Immunohematology patient log revealed patient #29513514 had an Type and Screen performed and resulted on 6/04 /2018 without documentation of quality controls. D. In an interview on 8/28/2018 at 1130, laboratory personnel #3 (as listed on form CMS 209) confirmed the lack of documented quality control on the day of Immunohematology patient testing. -- 2 of 2 --