Samaritan Hospital

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 desk review of proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report and College of American Pathologists (CAP) 2025 proficiency records and phone interview with the laboratory manager on August 5, 2025 at 3:00 PM, the laboratory failed to successfully participate in a proficiency testing program approved by 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 speciality of routine chemistry for the analytes total bilirubin and creatine kinase. Refer to D2096. 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 -- D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 proficiency testing (PT) records from the Certification and Survey Provider Enhanced Reporting (CASPER) 0155 report, review of College of American Pathologists (CAP) 2025 proficiency records and phone interview with the laboratory manager on August 5, 2025, at 3:00 PM, the laboratory failed to achieve satisfactory performance for total bilirubin and creatine kinase in two out of two consecutive proficiency testing events. Findings: 1. Review of the CASPER 0155 report showed the following results: Routine chemistry 2025 1st event the laboratory received an unsatisfactory score of 60 percent for the analyte total bilirubin and an unsatisfactory score of 20 percent for the analyte creatine kinase. Routine chemistry 2025 2nd event the laboratory received an unsatisfactory score of 40 percent for the analyte total bilirubin and an unsatisfactory score of 60 percent for the analyte creatine kinase. 2. Review of the College of American Pathologists (CAP) 2025 proficiency records confirmed the CASPER 0155 report results. 3. Phone interview with the laboratory manager on August 5, 2025, at 3:00 PM confirmed the laboratory failed to achieve satisfactory performance for total bilirubin and creatine kinase in two out of two consecutive proficiency testing events. -- 2 of 2 --

Summary Statement of Deficiencies D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of blood bank procedures, blood bank quality control (QC) logs, blood bank patient records/logs, and interviews, the laboratory failed to meet the requirements for the specialty of immunohematology. The laboratory failed to provide a procedure for checking patient history in blood bank and for confirmation retying patient blood types (Refer for D5401); the laboratory failed to document quality control (QC) for nine blood bank testing days from January 1, 2022 to date December 14, 2022 (Refer to D5551); and the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the post-analytic systems (Refer to D5891). D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 review of blood bank procedures, and interview with the general supervisor (GS) #1, the laboratory failed to provide a procedure for checking patient history in Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- blood bank and for confirmation retying patient blood types. Findings: 1. Review of blood bank procedures showed no procedure for checking patient history prior to performing blood bank procedures and no procedure for performing a confirmation retype of the patient blood type. 2. Interview with the GS #1 on December 14, 2022 at 11:30 AM confirmed the laboratory failed to provide a blood bank procedure for checking patient history and for confirmation retying patient blood types. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency and laboratory correlation records for 2017, 2018 and interview with the general supervisor, the laboratory failed to establish a means to verify the accuracy of wet mount testing twice a year. Findings: 1. Review of proficiency records for 2017 and 2018 revealed the laboratory failed to enroll to prove accuracy on the nonregulated analyte, wet mounts. 2. Review of correlation records for 2017 and 2018 revealed a lack of documentation to prove accuracy 2 times a year for wet mounts. 3. Interview with the general supervisor on August 28, 2018 at 12:30 PM confirmed the laboratory failed to verify the accuracy of the nonregulated wet mount testing twice annually for 2017 and to date 2018. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)