Providence Facey Medical Foundation-

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) documentation and interviews with the supervisor and technical consultant (TC) on August 7, 2026, the laboratory failed to attain at least 80 percent acceptable responses for the Troponin-I analyte for the first PT event of 2024 (Q1-2024) and the Chloride for the second event of 2024 (Q2-2024). The findings include: 1. The surveyor reviewed the laboratory's API PT documentation and found that the laboratory obtained unsatisfactory scores for the following: a. 60 percent for the Troponin-I analyte for the Q1-2024 event; b. 60 percent for the Chloride analyte for the Q2-2024 event. 2. During an interview on August 7, 2026, at approximately 10: 25 a.m., the supervisor and TC confirmed that the laboratory obtained the unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 1,765 patient samples annually for Chemistry specialty including the time when the laboratory obtained unsatisfactory scores for Troponin-I and Chloride analytes. . D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the American Proficiency Institute (API) proficiency testing (PT) documentation and interviews with the supervisor and technical consultant (TC) on August 7, 2026, the laboratory failed to attain at least 80 percent acceptable responses for the Red Blood Cell (RBC) analyte for the second event of 2023 (Q2-2023). The findings include: 1. The surveyor reviewed the laboratory's API PT documentation and found that the laboratory obtained an unsatisfactory score of 60 percent for the RBC analyte during the Q2-2023 event. 2. During an interview on August 7, 2026, at approximately 10:30 a.m., the supervisor and TC confirmed that the laboratory obtained the unsatisfactory scores as mentioned in statement #1. 3. According to the laboratory's testing declaration form (Lab-144) submitted at the time of survey, the laboratory performed and reported approximately 32,352 patient samples annually for Hematology specialty that included the RBC analyte during the time when the unsatisfactory score was obtained. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's competency assessment policy and procedure, ten randomly chosen patient records, lack of personnel competency documentation, and an interview with the supervisor and technical consultant on August 7, 2026, as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to follow the written personnel competency assessment policy and procedure. The findings include: 1. The laboratory did not follow its written and approved personnel competency assessment policy, which stated that: o Competency must be performed semi-annually during the first year of testing and annually thereafter. o Competency must assess performance across the preanalytic, analytic, and postanalytic phases of testing. o Personnel must receive competency at 6 months, 12 months, and annually thereafter. o The technical consultant is responsible for conducting, evaluating, and signing competency assessments. 2. Record review showed that the supervisor, a registered nurse who was unqualified under 493.1411, performed all competency assessments for moderate complexity testing personnel. No documentation showed that the technical consultant conducted or evaluated these assessments. 3. The laboratory failed to perform initial competency assessments for all testing personnel for the Sysmex XN430 in 2024. No

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey as performed on 07/15/2025, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful [proficiency testing] participation; and D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and American Proficiency Institute (API) records (202?-?, 202?- ?, and 202?-?), the laboratory failed to successfully participate in a proficiency 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 -- 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 analyte analyte name(s) resulting in unsuccessful performances. See D2118. 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and API - American Proficiency Institute (API) report, the laboratory failed to achieve satisfactory performance for two of three consecutive events (2025-1 and 2025-2) for the analyte Potassium (specialty Routine Chemistry: The finding include: Potassium 60% - 2025 first testing event; Potassium 40% - 2025 second testing event. A review of the 2025 scores from American Proficiency Institute (API) confirmed the above findings. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and (Proficiency Testing Programs) records for 2025-1 and 2025-2 events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(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 proficiency testing desk review of the CASPER 0155D report and API records for 2025-1 and 2025-2 events, the laboratory director failed to ensure successful participation in an HHS proficiency testing program. Refer to D2096 analyte deficiency/deficiencies. See D2096. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual and interview with the testing personnel (TP); it was determined that the laboratory failed to update protocols in place and the effective date and signature of approval by the laboratory director. The findings included: 1. On the day of the survey February 16, 2023, at approximately 12:45 p.m. the procedure manual in place had not been reviewed, approved, signed, and dated by the laboratory director. 2. The TP affirmed on February 16, 2023, that the laboratory failed to update protocols for the current testing performed in the laboratory and that the effective date and the laboratory director's signature were missing. 4. The laboratory's testing declaration form stated that the laboratory processes approximately 8,157 patients test annually. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced 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 -- Based on direct observation and interview with the laboratory testing personnel; it was determined that the laboratory director failed to ensure that a signed and dated approved written procedure manual is available at all times to all personnel responsible for any aspect of the testing process. See D5407. -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(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 surveyor's review of the American Proficiency Institute (API) proficiency testing records and interview with the testing personnel (TP) it was determined that the laboratory failed to ensure that the proficiency testing was performed with regular patient's samples workload by the laboratory personnel who routinely perform testing. Findings included: 1. Based on review of the laboratory's proficiency testing (PT) records, the PT samples testing had been performed by a laboratory staff who did not routinely performs laboratory testing instead of by the 15 testing personnel who routinely perform testing. 2. The TP affirmed on October 7, 2021 at approximately 12: 00 p.m., that the laboratory did not include proficiency testing samples in the regular patient workload during routine testing and that the testing was not performed by personnel who routinely perform the testing in the laboratory. 3. The laboratory testing declaration form signed by the laboratory director on 10/05/2021 indicates that the laboratory performed 6,663 tests annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. 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 -- This STANDARD is not met as evidenced by: Based on the lack of documentation, review of testing personnel competency assessment records, seven (7) randomly chosen patient records review, and interview with the testing personnel (TP) on October 7, 2021 as specified in the personnel requirements in subpart M, it was determined that the laboratory failed to establish and follow written policies and procedures to assess testing personnel competency. Findings include: 1. Based on review of the laboratory's policies and procedures, the laboratory failed to establish and follow written policies and procedures for competency assessment of the TP. 2. The laboratory listed in the CMS 209 Form 17 TP. 3. For 17 out of 17 TP from the laboratory personnel report Form CMS-209 and final test reports, the laboratory fail to provide documentation of training or competency assessment for the TP performing testing at the laboratory for the year 2020. 4. This deficient practice was affirmed by interview with the TP on October 7,2021 at approximately 1:00 p.m. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory's reagent materials and testing kits and interview with the laboratory's testing personnel (TP); it was determined that the laboratory failed to label reagents to indicate the opening, preparation, and expiration dates, when such reagents are used. The findings included: 1. Based on the surveyor's observation during the laboratory tour on October 7, 2021 at approximately 11:40 a. m., the TP indicated that no opening, preparation, or expiration date labels were documented as well as initials of the person preparing the reagents for all the reagents used in the laboratory. 2. The laboratory's TP affirmed in an interview conducted October 7, 2021 at approximately 12:00 p.m., that the reagents currently used to test patients samples were not labeled with opening, preparation, initials, and expiration dates. 3. Based on the laboratory's annual testing declaration submitted at the time of the survey, the laboratory analyzed approximately 19,364 samples annually. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on interview with laboratory testing personnel (TP) and review of two (2) randomly chosen patients' reports; it was determined that the laboratory failed to inform the authorized providers of the tests interpretation for the presence or absence of SARS-CoV-2 (Covid19) when samples testing results were reported. The findings included: 1. For two (2) out of two (2) positive and negative testing results for -- 2 of 4 -- Covid19 reviewed on October 7, 2021 at approximately 12:30 p.m. the report submitted to the authorized providers showed no interpretation of the results. 2. The TP affirmed that no interpretation of the results was provided to the sample submitters for Covid-19 in the final reports. 3. The laboratory tests and reports an unknown number of samples for the presence or absence of Covid-19. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require