Centracare - Redwood

Summary Statement of Deficiencies D0000 The CentraCare - Redwood laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey performed on September 26, 2024. The following standard-level deficiencies were cited: 493.1271 Immunohematology 493.1445 Laboratory director responsibilities 493.1451 Technical supervisor responsibilities . 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 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 observation, document review, and interview with laboratory personnel, the laboratory failed to perform and document alarm system function checks for the blood storage refrigerator with the frequency defined by the laboratory in 7 of 24 months in 2022, 2023, and 2024. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the General Supervisor during a tour of the laboratory at 8:05 a.m. on 09/26/24. 2. A blood product designated refrigerator with a temperature alarm system was observed as in use during the tour. 3. Monthly blood product storage alarm check requirements and activities were established on the Blood Bank Maintenance Log and in the Alarm Activation Procedure provided by the laboratory. 4. Alarm checks were not completed on seven occasions in the time period reviewed, September 2022 through August 2024 as indicated on the Blood Bank Maintenance Log. See below. Months alarm checks were not performed 2022 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 -- December 2023 January February May November 2024 February August 5. The laboratory performed approximately 1057 Immunohematology results annually as indicated on the Form CMS-116 provided by the laboratory on date of survey. 6. In an interview at 4:00 p.m. on 09/26/24, the Technical Consultant confirmed the above finding. . D6103 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(13) The laboratory director must ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Laboratory Director failed to ensure 7 of 7 tenured testing personnel received comprehensive competency evaluations at least annually in 2023. Findings are as follows: 1. The laboratory was cited for incomplete annual competency evaluations during the previous survey conducted on 08/19/22. 2. Annual competency evaluations from 2023 were found incomplete on date of current survey, 09/26/24, for 7 of 7 tenured testing personnel. See D6128. 3. In an interview at 12:50 p.m. on 09/26/24, the Technical Consultant confirmed the above finding. . 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: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to complete comprehensive competency assessments at least annually for seven of seven tenured testing personnel (TP) in 2023. Findings are as follows: 1. The laboratory performed Microbiology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/26/24. 2. The following non-waived test systems, analyzers, devices, and test kits were in use in 2023 as indicated by the GS during the tour: Siemens Dimension EXL chemistry analyzer Quidel Triage Meter Pro chemistry analyzer MedToxScan toxicology analyzer Cell Dyn Ruby hematology analyzer Sysmex CA-660 coagulation analyzer Adeza TLiLQ system - Fetal Fibronectin BioRad Immunohematology test system Microscopes and stains for microscopic examinations Fungal exam (KOH) Vaginal preparation (VWP) Gram Stain Manual differential Body fluid cell counts Consult hCG Combo test kit 3. Annual competency assessments were required for all testing personnel as established in the Job Competency Verification for Testing Staff procedure provided by the -- 2 of 3 -- laboratory. 4. Annual competency assessment documentation for the above tests was incomplete on the 2023 competency evaluation forms for the following TP: TP1, TP2, TP3, TP4, TP8, TP9, and GS. See below. Required elements DO - Direct observation of test performance TR - Monitoring test result recording and reporting RV - Review of worksheets and records M - Direct observation of equipment maintenance B - Assessment using blind samples PS - Assessment of problem solving skills EXL TP9 - DO, TR, RV GS - DO Triage TP1 - B TP2 - B TP4 - B TP8 - TR MedToxScan GS - DO Cell Dyn Ruby TP1 - B TP2 - B TP3- B TP4 - B TP9 - B GS - M Sysmex CA- 660 TP1 - B TP2 - B TP3- B GS - M Adeza Ffn TP3 - B Immunohematology TP4 - B VWP/KOH TP1 - B, PS TP2 - M, B, PS TP3 - TR, M, B, PS TP4 - TR, M, B, PS TP8 - TR, M, B, PS TP9 - TR, M, B, PS GS - TR, M, B, PS Gram Stain TP1 - M, B TP2 - TR, M, B TP3 - TR, M TP4 - TR, M, B GS - TR, B Manual differential TP1 - M, PS TP3 - M, PS TP4 - M, B GS - B Body fluid cell count TP1 - DO, TR, B, PS TP3 - TR, M, PS TP4 - M, PS GS - DO, TR, B, PS Serum hCG TP4 - B TP8 - B 5. The laboratory was unable to provide additional documentation upon request. 6. In an interview at 12:50 p.m. on 09/26/24, the Technical Consultant confirmed the above finding. *This is a repeat deficiency. The issue was cited during the 08/19/22 survey. See D6103* . -- 3 of 3 --

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 observation, document review, and interview with laboratory personnel, the laboratory failed to complete a performance verification (PV) for one non-waived test implemented by the laboratory in 2021. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 08/19/22. 2. A MedTox Diagnostics MedToxScan Profile-V device was observed as present and available for use during the tour of the laboratory. Urine Drug Screens (UDS) were performed on this analyzer. 3. PV documentation for UDS on the MedToxScan Profile-V device was not found during review of laboratory records. The laboratory was unable to provide a PV upon request. 4. A PV procedure was not found during review of laboratory procedure manuals. 5. The GS stated the device was put into use in March 2021 and indicated a total of 953 UDS tests were performed on the MedToxScan Profile-V device from implementation to date of survey, 08/19/22. See below Year Number of tests 2021 650 2022 303 6. In an interview at 11:40 a.m. on 08/19/22, the GS confirmed the above finding. . D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) 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 -- (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to ensure comprehensive initial training for four of five new testing personnel was performed and documented in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 08/19/22. 2. The following tests were performed by the laboratory as indicated by the GS during the tour: Gram stain (GS) KOH microscopic examination (KOH) Vaginal wet preparation examination (VWP) Amnisure ROM (ROM) MedToxScan Profile-V urine drug screen (UDS) Manual differential (Diff) Manual cell count (CC) 3. Competency evaluation of all personnel was required as established in the Job Competence Verification procedure found in the Laboratory Policy Manual. 4. Initial training documentation was not found during review of personnel records for the following testing personnel (TP): TP3, TP4, TP5, TP7. See below Test TP missing training records GS TP4, TP7 KOH TP3, TP4, TP5, TP7 VWP TP3, TP4, TP5, TP7 ROM TP4UDS TP7Diff TP3, TP4, TP5CC TP3, TP4, TP5 5. The laboratory was unable to provide the missing training records upon request. 6. In an interview at 11:30 am., the GS confirmed the above finding. . D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to complete comprehensive competency assessments at least semi-annually during the first year of patient specimen testing for four of five testing personnel hired in 2021. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a. m. on 08/19/22. 2. The following non-waived test systems, analyzers, devices and test kits were present and available for use during the tour: Siemens Dimension EXL 200 chemistry analyzer Siemens EPOC blood gas analyzer MedTox Profile-V urine drug screen analyzer Abbott Cell-Dyn Ruby hematology analyzer Beckman Coulter ACT 5diff hematology analyzer Sysmex CA-600 coagulation analyzer Quidel Triage Meter Pro chemistry analyzer Adeza T-Li System chemistry analyzer Gram stain microbiology test system Bio-Rad Immunohematology test system Microscopes for microscopic examinations Amnisure ROM test kit Serum hCG test kit 3. Competency evaluation of all personnel was required as established in the Job Competence Verification procedure found in the Laboratory Policy Manual. 4. Initial training was -- 2 of 3 -- performed and documented for the following Testing Personnel (TP) as indicated in personnel records: TP Initial training dates TP3 January-March 2021 TP4 April- September 2021 TP5 May-August 2021 TP6 March-May 2021 5. Semi-annual competency assessment documentation was not found in personnel records as listed below: TP3 - Direct Observation of test performance was not found in the semi- annual competency assessment TP4 - No semi-annual competency assessment documentation was found TP5 - Direct Observation of test performance was not found in the semi-annual competency assessment TP6 - No semi-annual competency assessment documentation was found 6. The laboratory was unable to provide the missing documents upon request. 7. In an interview at 11:35 a.m. on 08/19/22, the GS confirmed the above finding. . 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: . Based on observation, document review, and interview with laboratory personnel, the Technical Supervisor failed to assess competency at least annually for three of three tenured Microbiology testing personnel in 2021. Findings are as follows: 1. 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 08/19/22. 2. KOH microscopic examination (KOH) and Vaginal wet preparation examination (VWP) was performed by the laboratory as indicated by the GS during the tour. An Olympus BX43 microscope was present and available for use during the tour. 3. Competency evaluation of all personnel was required as established in the Job Competence Verification procedure found in the Laboratory Policy Manual. 4. Annual competency assessment documentation for the above tests was not found during review of 2021 laboratory records for the following Testing Personnel (TP): GS, TP1, TP2. 5. The laboratory was unable to provide the missing records upon request. 6. In an interview at 11:35 am. on 08/19/22, the GS confirmed the above finding. . -- 3 of 3 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure microscopic examination proficiency testing samples were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology and Urinalysis microscopic examination testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:20 a.m. on 11/10/20. 2. The laboratory performed proficiency testing (PT) using the American Proficiency Institute proficiency provider. 3. The Proficiency Testing procedure located in the Lab Policy Manual annual indicated repetitive testing of PT samples would follow the laboratory's repeat policy. In addition, PT samples would not be used for correlations until results were reported to the proficiency provider. 4. Microscopic examination PT for Blood Cell Identification (BCI), Fecal Leucocytes (FW), Fern Test (FT), Nasal Smear (NE), Pinworm Preparation (PP), Sperm presence/absence (SPM), Urine Sediment (US), Vaginal Wet Preparation (VA), and Vaginal Wet Preparation KOH (VKP) was completed by multiple employees before the 2019 second event and 2019 third event submission deadlines as indicated on hand written result documents found in the PT document folders. See below. 2019 - 2nd event Submission deadline 07/26/20 Samples BCI-06 through BCI-10, FW-02, FT-02, NE-02, PP-02, SPM-02, US-03 and US-04, VA-02, VKP-02 Tested by Date TP1 07/25/19 TP2 07/25/19 TP3 07/25/19 GS 07/26/19 2019 - 3rd event Submission deadline 12/02/19 Samples BCI-11 through BCI-15, FW-03, FT-03, NE-03, PP-03, SPM-03, US-05 and US-06, VA-03, VKP-03 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 -- Tested by Date TP1 11/29/19 TP2 11/29/19 GS Nov 2019 5. In interviews at 10:50 a. m. and 11:10 a.m. on 11/10/20, the Technical Consultant confirmed the above finding and indicated patient specimens would not routinely be handled in this manner. -- 2 of 2 --