Kingman Healthcare Center

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 Centers for Medicare & Medicaid Services (CMS) Proficiency Testing (PT) Certification and Survey Provider Enhanced Reporting system (CASPER 0155D) and the American Proficiency Institute (API) PT summary reports, the laboratory failed to successfully participate in the CMS approved PT 2025 program under the specialty of Antibody Detection for the analyte: Unexpected antibody detection, for two of three testing events. Refer D2164. D2164 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(a) 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 -- (a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing (PT) on the Centers for Medicare & Medicaid Services (CMS) CASPER Reports 0153D and 0155D and the provider American Proficiency Institute (API) for Immunohematology, the laboratory failed to achieve an acceptable score of 100% for two of three testing events for the regulated analyte: 0855 Antibody Detection Findings: 1. Review of the API PT scores for 2025 Event 1 revealed a 80% performance score for 0855 Antibody Detection. 2. Review of the API PT scores for 2025 Event 3 revealed a 80% performance score for 0855 Antibody Detection. 3. A phone interview with the laboratory supervisor on February 4, 2026 at 10:40 a.m. and review of the CMS CASPER Reports 0153D and 0155D confirmed, the laboratory failed to achieve an acceptable score of 100% for two of three testing events for the regulated routine immunohematology analyte: 0855 Antibody Detection. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based upon direct observation during a tour of the laboratory, review of manufacturer's reagent labels and staff interview, the laboratory failed to ensure that reagents in use were not expired. Findings were: 1. During a tour of the lab the surveyor observed the Blood Bank Saline - Standard Solution, Stabilized Isotonic Saline, Azer Scientific Brand, lot # 13323 with unopened expiration date of 11/30 /2019 had an open date recorded on the box of 7/1/2018. The manufacture label on the box states, "Consume entire contents within 30 days of opening." Observation was made on 11/29/2018, which made the saline expired by 121 days. This Blood Bank Saline is used by Kingman Community Hospital to perform blood bank testing (i.e., ABO RH typing, washing red blood cells, and cross matching.) This was confirmed by interview with the Technical Consultant #2 at 11:41 am on November 29, 2018 in the laboratory. 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 --