Providence Valdez Medical Center

Summary Statement of Deficiencies D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) (e)(14) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; and This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures and an interview with the laboratory director (LD), it was determined that the director did not approve 45 of 145 policies and procedures after assuming the role on December 26, 2025. Findings include: 1. A request was made to review the laboratory director's approval of the laboratory's polices and procedures and documentation could not be provided for 45 of 145 documents. 2. An on-site interview conducted on 7/9/25 at 14:45 PM with the LD, confirmed the laboratory did not have documentation of LD approval for 45 of 145 policies and procedures. 3. The laboratory reports performing approximately 52,700 tests annually. 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 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: Based on patient and quality control (QC) records, and an interview with the general supervisor, the laboratory failed to include a negative and positive control material each day patients were tested on the BioFire FilmArray Blood Culture Identification Panel 2 for one (1) of three (3) patients reviewed. Findings include: 1. A review of patient blood culture identification results and quality control records for May 2023, revealed the laboratory failed to perform positive and negative controls for patient sample 2315100082MM tested on 5/31/2023. 2. The General Supervisor confirmed quality control was not included each day of patient testing in an interview on June 20, 2023 at 12:00 PM. 3. The laboratory reports an annual test volume of 500 for the Specialty of Bacteriology. 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 D0000 The laboratory is in substantial compliance with the CMS Interim Final Rule (CMS- 3401-IFC) on Coronavirus Disease 2019 (COVID-19) Public Health Emergency (PHE) effective August 25, 2020. No deficiencies were cited. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) results and technical supervisor interview, the laboratory failed to document the acceptability of PT results when these results were not evaluated or scored by the PT provider for all non-scored analytes in the 2020 Hematology/Coagulation and Microbiology surveys. Findings include: 1. The laboratory subscribes to the American Proficiency Institute (API) for proficiency testing. 2. In the Hematology/Coagulation surveys the following samples were not scored and did not have documented review for acceptability: a. 2020 first event: Educational Blood Cell ID (DIF-01), Fecal Leukocytes (FW-01) b. 2020 second event: Educational Blood Cell ID (DIF-02, ECI-06, ECI-07, ECI-08, ECI-09, ECI-10) c. 2020 third event: Educational Blood Cell ID (DIF-03, ECI-11, ECI-12, ECI-13, ECI-14, ECI-15) and Urine Sediment (US-06) 3. In the Microbiology surveys the following samples were not scored and did not have documented review for acceptability: a. 2020 first event: Educational Susceptibility (ES-01), Blood Culture MIC/Interpretation (BL-01) b. 2020 second event Educational Susceptibility (ES-02), 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 -- Urine Culture MIC/Interpretation (UR-06) c. 2020 third event: Educational Susceptibility (ES-03), Urine Culture MIC/Interpretation (UR-11) 4. The technical consultant confirmed these findings on 4/6/21 at 11:00 am. 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 procedure review and technical supervisor interview the laboratory did not have a written procedure for the analysis of urine sediment. Findings include: 1. The laboratory performs approximately 350 urine sediment analyses annually. 2. The technical supervisor confirmed the laboratory did not have a written procedure for performing urine sediment analysis 4/6/2021 at 11:30 am. 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 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: Based on review of blood bank testing records and Technical Supervisor interview, the laboratory failed to perform ABO grouping and Rh typing on one of five (1/5) records reviewed for compatibility transfusion testing. Findings include: 1. The laboratory procedure titled "Compatibility Testing" states "Full forward and reverse ABO and Rh typing must be completed on the patient sample, containing two patient identifiers and blood bank ID ban number (BBID), and obtained within 72 hours of transfusion." 2. Patient record (MRN 1078519) did not have documentation of ABO and Rh testing on the sample used for compatibility testing. 3. The laboratory performs approximately 100 Immunohematology tests annually 4. The technical supervisor confirmed these finding on 4/6/21 at 11:00 am. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and -- 2 of 3 -- blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Immunohematology refrigerator temperature records and Technical Supervisor interview, the laboratory failed to check and document the immunohematology refrigerator alarm on a regular basis. Findings: 1. The laboratory stores blood, blood products, and reagents in the immunohematology refrigerator. 2. There was no documentation in 2019 or 2020 verifying the temperature at which the audible alarm system will alert or sound was checked. 3. The laboratory performs approximately 100 immunohematology tests annually. 4. The technical consultant confirmed these findings on 4/6/21 at 11:00 am. -- 3 of 3 --

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 an off-site desk review of the laboratory's 2020 American Proficiency Institute (API) proficiency testing (PT) records and telephone interview with the Laboratory Supervisor on February 22, 2021, it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Immunohematology Compatibility Testing in two (2) out of three (3) Immunohematology testing events resulting in unsuccessful PT performance. See 2181 D2181 COMPATIBILITY TESTING 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 -- CFR(s): 493.863(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 an off-site desk review of the laboratory's 2020 American Proficiency Institute (API) proficiency testing (PT) records, and telephone interview with the Laboratory Supervisor on February 22, 2021 it was determined that the laboratory failed to attain a score of at least eighty (80) percent of acceptable responses for Compatibility Testing in two (2) out of three (3) Immunohematology testing events. Findings include: 1. Desk review of the laboratory's 2020 API PT records revealed Compatibility Testing scores of less than eighty percent for the following Immunohematology events: 2020 first testing event -score of 60%, 2020 third testing event - score of 80% 2. ln a telephone interview with the Laboratory Supervisor on 2 /22/2021, it was confirmed that the laboratory was unsuccessful in the PT events listed above. -- 2 of 2 --

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on record review of microbiology culture documentation and testing person interview, the laboratory failed to record each step of work when performing microbiology cultures. Findings: 1. Review of microbiology culture testing on 2/21/19 at 13:00 pm showed no written or electronic documentation of the date, time, testing person, media type inoculated, culture or colony descriptions, and organism isolation for each microbiology culture. 2. The testing person confirmed that the Laboratory Information System used to capture this information but stopped doing so after a computer version upgrade within the past two years. 3. The laboratory performs approximately 250 routine microbiology cultures annually. 4. The general supervisor confirmed these findings on 2/21/19 at 15:00 pm. 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 --