Wallowa Memorial Hospital Lab

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on review of the syphilis serology quality control and patient logs, and interview with the technical supervisor (TS), the laboratory failed to ensure that the needle use to deliver the syphilis antigen suspension was dispensing the correct volume: Findings include: 1. Review of the syphilis serology quality control and patient logs revealed there was no indication that the needle dispense accuracy check was performed. The procedural notes indicated that " the needle should deliver 60 drops plus or minus 2 of antigen suspension per milliliter when held in a vertical position. To perform accuracy check on the needle, attached the needle to a 1 or 3 ml syringe. Fill the syringe with antigen suspension and, holding the syringe in a vertical position count the number of drops delivered in 0.5 ml. The needle is considered satisfactory if 30 +/= 1 drops are obtained. The needle dispenses a 17 ul drop of antigen." 2. The laboratory uses the the Sure-Vue Rapid Plasma Reagin (RPR) test kit and performs 150 to 200 RPR per year. 3. Interview with the TS on 06/21/2023 at 3: 00 PM confirmed the laboratory failed to perform needle dispense accuracy check. 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. 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 review of the approved normal values in the laboratory procedure manual, two of two patients reports, and interview with the technical supervisor (TS), the laboratory failed to ensure the test report included pertinent normal ranges as determined by the laboratory. Two of 17 chemistry normal values listed on the laboratory information system (LIS) report differed from those in the approve procedure manual. Findings include: 1. Review of the patient report from the LIS system revealed Aspartate aminotransferase (AST) and Alanine transaminase (ALT) did not correctly match those reference ranges in the procedure manual. LIS patient report Procedure manual. AST 15-37 U/L 16-38 U/L ALT 30-65 U/L 18-63 U/L 2. Interview with the TS on 06/21/2023 at 2:00PM confirmed the laboratory failed to ensure correct reference ranges approved in the procedure manual were included on the LIS patient reports. -- 2 of 2 --

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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory had unsuccessful participation for two consecutive testing event 1st and 2nd event 2022 in the specialty Immunohematology. Refer to D2191. D2191 ANTIBODY IDENTIFICATION CFR(s): 493.865(f) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing showed the laboratory has had unsuccessful performance for two consecutive events for Antibody Identification in the specialty Immunohematology. Findings include: 1. 1st event 2022 Antibody Identification = 0% 2. 2nd event 2022 Antibody Identification = 0% -- 2 of 2 --

Summary Statement of Deficiencies D0000 A special survey of Wallowa Memorial Hospital Lab located in Enterprise, OR was conducted on May 25 & 26, 2021. The Laboratory was found to be in substantial compliance with the CLIA Condition-level regulation (42 CFR, Part 493.41) pertaining to COVID-19 reporting requirements. No deficiencies were cited. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of Microbiology Quality Control (QC) records and interview with the Technical Supervisor (TS), the laboratory failed to ensure end user QC was performed on each new lot of microbiological media received from outside vendors. Findings include: 1. Upon review of the QC logs for Microbiology, no record of end user QC could be found. 2. During an interview with the TS on 05/25/2021 at approximatelt 1500, she confirmed that end user QC was not being performed on purchased Microbiological media. D6106 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(14) The laboratory director must ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process. 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 review of several procedure manuals during the survey 05/25/2021 and 05 /26/2021, the Laboratory Director (LD) failed to sign off on several procedures. Findings include: 1. During review of the Blood Bank Quality Control (QC) manual, it was noted that the Daily Reagent QC procedure had not been signed off/approved by the current LD. 2. During review of the Chemistry Calibration manual, it was noted that the Calibration Verification for Chemistry Lab procedure had not been signed off/approved by the current LD. 3. During review of the Hematology Procedure manual, it was noted that four (4) out of nine (9) procedures reviewed had not been signed off/approved by the current LD. 4. The Technical Supervisor confirmed during interview that these procedures had not been approved by the current LD during interview at approximately 1400 on 05/26/2021. -- 2 of 2 --

Summary Statement of Deficiencies D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) shows the laboratory had unsuccessful participation in Immunohematology. Refer to D2191. D2191 ANTIBODY IDENTIFICATION CFR(s): 493.865(f) 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 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 -- performance. This STANDARD is not met as evidenced by: Review of the American Association of Bioanalyst shows unsatisfactory performance of two out of three consecutive testing events for Anibody Identification. Findings include: 1. 3rd Event of 2017 - Antibody Identification - 0% 2. 1st Event of 2018 - Antibody Identification - 80% 3. 2nd Event of 2018 - Antibody Identification - 0% -- 2 of 2 --

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: Proficiency Testing (PT) desk review of the American Association of Bioanalysts (AAB) proficiency testing (PT) shows the laboratory had unsuccessful participation for Compatibility Testing in Immunohematology. Refer to D2173. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. 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: PT desk review of the American Association of Bioanalyst (AAB) PT reveals that the laboratory failed to achieved a 100% for compatibility testing. Findings include: 1.. AAB PT 3rd event of 2017 Compatibility Testing - 80%. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --