Powell Valley Healthcare

Summary Statement of Deficiencies 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 review of the CMS (Centers for Medicare and Medicaid Services) 209 Laboratory Personnel Report, review of personnel records, policy and procedure review, and staff interview, the laboratory failed to ensure the competency assessment for the technical supervisor (TS) and the general supervisor (GS) was completed for 1 of 2 years (2023) reviewed. The findings were: 1. Review of the CMS 209 Laboratory Personnel Report showed the laboratory employed one staff member which performed the duties of the TS and the GS. The following concerns were identified: a. Review of the personnel record for the TS/GS showed no evidence a competency assessment was completed in 2023. b. Interview with the TS on 1/9/24 at 10:55 AM confirmed the competency assessment for the duties of the technical supervisor and general supervisor was not completed in 2023. c. Review of the policy and procedure titled "Personnel Competency Review In the Lab" last reviewed by the laboratory director on 1/19/23 failed to include a procedure for assessing the competency of the technical supervisor and the general supervisor. . 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. 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 STANDARD is not met as evidenced by: . Based on observation and staff interview, the laboratory failed to ensure the Blood Agar/MacConkey Biplate (BAP/MAC) media used for the cultivation, isolation, and enumeration of all bacterial and yeast urinary pathogens was not used beyond its expiration date for 9 of 9 urine cultures performed between 1/3/24 and 1/9/24. This failure affected 9 of 9 patients (#1, #2, #3, #4, #5, #6, #7, #8, and #9). The findings were: 1. Observation on 1/9/24 at 12:50 PM of the bacteriology storage refrigerator showed the BAP/MAC media, lot #752139 with an expiration date of 1/2/24, was available for use. 2. Observation of the urine cultures currently in progress and the finalized cultures from 1/3/24 to 1/9/24 showed a urine specimen for patient #1 was inoculated on 1/3/24; patients #2, #4, and #3 were inoculated on 1/4/24; patients #5, #6 and #7 were inoculated on 1/5/24, patient #8 was inoculated on 1/8/24; and patient #9 was inoculated on 1/9/24. 3. Interview with the technical supervisor on 1/9/24 at 1: 03 PM confirmed the media in use was expired and should not have been used. -- 2 of 2 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of the new instrumentation and new test methodology verification studies, policy and procedure review, and staff interview, the laboratory failed to verify precision prior to testing patient samples for 2 of 4 new instrument and/or test methodology verification studies reviewed (Sysmex XN-550, Alcor miniiSED). The laboratory performed approximately 72,000 hematology tests annually and 130 erythocyte sedimentation rates from 8/30/21 through 1/20/22. The findings were: 1. Review of the Sysmex XN-550 new instrument verification study completed on 1/25 /21 showed an analysis of the performance specification of precision had not been performed prior to testing patient samples. 2. Review of the Alcor miniiSED new test methodology verification study completed on 8/30/21 showed the performance specification of precision had not been verified. In addition there was no evidence the laboratory director had reviewed the verification study documentation and approved the test procedure prior to testing patient samples. 3. Interview with the technical consultant on 1/20/22 at 12:15 PM confirmed the verification studies were incomplete. 4. Review of the "New Test, Method or Instrument Procedure" reviewed by the laboratory director on 1/18/22 showed "...When adding or replacing a test, method or instrument, PVHC laboratory shall verify the manufacturer's performance specifications regarding accuracy, precision and reportable ranges." 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 -- D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the Sysmex XN-550 new instrument and the Alcor miniiSED new test method verification documentation, policy and procedure review, and staff interview, the laboratory director failed to ensure the test verifications of accuracy, precision, analytic specificity, and analytic sensitivity was complete and met the laboratory's performance characteristics specified by the manufacturer. Refer to D5421. -- 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 direct observation, procedure manual review, and interview with staff, the laboratory failed to ensure the change to the blood bank specimen and unit labeling process was approved, signed and dated by the director. The laboratory performed approximately 3-6 compatibility tests per week. Findings include: 1. The laboratory changed the procedure for positive identification of blood recipient's specimens and tagging of crossmatched donor specimens in 2020. 2. The laboratory failed to change the established procedure and failed to have the director's signature and date of approval on the revised procedure. 3. In an interview conducted on 08/29/2020 at approximately 1:10 P.M., the laboratory manager confirmed the laboratory had not revised the procedure with the approval of the director by signature and date of approval. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 testing personnel competency evaluations reviewed, lack of documentation and confirmation by the laboratory manager, the technical supervisor failed to ensure seven of seven high complexity testing personnel were evaluated for competency in 4 of 5 specialties at least annually for 1 of 2 years of testing reviewed, 2019. Findings include: 1. The laboratory failed to document competency evaluations for Hematology, Chemistry, Microbiology, and General Immunology for the seven high complexity testing personnel in 2019. 2. In an interview conducted on 08/29/2020 at approximately 1:00 P.M., the laboratory manager confirmed competency was not documented for 2019 for specialties other than immunohematology. -- 2 of 2 --