Cook Hospital & Care Center

Summary Statement of Deficiencies D0000 The Cook Hospital & Care Center 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 which concluded on October 9, 2024. The following standard-level deficiencies were cited: 493.1256 Control Procedures 493.1271 Immunohematology 493.1291 Test Report . D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to document Hematology quality control procedures performed to evaluate stain for intended reactivity each day of use in 24 of 24 months from September 2022 through October 2024. Findings are as follows: 1. The laboratory performed manual differential blood smear testing under the specialty of Hematology as confirmed by the General Supervisor (GS) during a tour of the laboratory at 1:05 p. m. on 10/08/24. 2. Manual differential stains and an Olympus CH 30 microscope used to perform manual differentials were observed as present and available for use during the tour. 3. Direction to determine overall staining quality and direction to document this activity for manual differentials was not found in the Hematology Blood Smears (Wright Stain) procedure found in the Sysmex manual. 4. In an interview at 1:45 p.m on 10/09/24, the GS confirmed the above finding and stated the laboratory did not document the quality of staining when performing a manual differential. . 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 -- 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 nine of nine calendar quarters between September 2022 and September 2024. Findings are as follows: 1. The laboratory performed Immunohematology testing as confirmed by the General Supervisor during a tour of the laboratory at 1:05 p.m. on 10/08/24. 2. A blood product designated Jewett refrigerator with a temperature alarm system was observed as in use during the tour. 3. Quarterly blood product storage alarm check requirements were established in the Quarterly Blood Bank Temperature Check procedure located in the Blood Bank Procedure Manual. 4. Blood product storage alarm checks were not completed in the time period reviewed, September 2022 through September 2024, as indicated on service reports completed by vendor Agility. The last documented alarm check was performed in February 2022. 5. The laboratory performed approximately 156 Immunohematology tests annually as indicated on the Form CMS-116 provided by the laboratory on date of survey. 6. In an interview at 3: 10 p.m. on 10/09/24, the GS confirmed the above finding. . 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 observation, document review, and interview with laboratory personnel, the laboratory failed to ensure two of seven blood gas Chemistry reference intervals were consistent between a procedure and a patient test report in 2023. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS)) during a tour of the laboratory at 1:05 p.m. on 10/08/24. 2. An Abbott i-STAT blood analysis system was observed as present and available for use during the tour. The laboratory performed blood gas testing using this analyzer. 3. Two arterial blood gas reference intervals listed in the Arterial Blood Gas and Venous Blood Gas procedure, located in the I STAT manual, were not consistent with those included on a patient test report from 09/05/23 as indicated below. Analyte Procedure Report PO2 10-105 75-85 SO2 95-98 96-100 4. In an interview at 1:40 p.m. on 10/09 /24, the GS confirmed the above finding and indicated the reference range values in the procedure were correct. . -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate two unacceptable proficiency testing (PT) results in 2022. Findings are as follows: 1. The laboratory performed Bacteriology and Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/29/22. 2. The laboratory performed PT using the American Proficiency Institute (API) provider. 3. The laboratory received one unacceptable PT result of 10 Gram Stain testing challenges completed to date in 2022 and one unacceptable PT result of 10 Blood Urea Nitrogen(BUN) testing challenges completed to date in 2022 as indicated in API reports. See below. 2022 1st Microbiology event Test: Gram Stain Sample: GS-02 Laboratory Result: Gram Positive API expected result: Gram Negative 2022 1st Chemistry core event Test: BUN Sample: CH-05 Laboratory Result: 21 API expected result: 14-19 4. Investigation of unacceptable PT results was required as established in the laboratory's Proficiency Testing procedure located in the General Lab Policies manual. 5. Investigation of the unacceptable PT results was not found during review of laboratory records. The laboratory was unable to provide investigation documentation upon request. 6. In an interview at 12:15 p.m. on 09/29/22, the GS confirmed the above finding. . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without 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 -- analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of a non-graded proficiency testing (PT) result from a regulated Specialty when the PT program did not evaluate or score the result in one of two events reviewed from 2022. Findings are as follows: 1. The laboratory performed Microbiology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 09/29/22. 2. The laboratory performed PT using the American Proficiency Institute (API) PT provider. 3. The following PT result from the 2022 Microbiology first event was not graded by API as indicated in the API report: Test: Gram Stain Sample: GS-05 API instructed to See Data Summary 4. The API Data Summary for the 2022 Microbiology first event was not present in laboratory records. An evaluation of the non-graded result was not found in laboratory records. The laboratory was unable to provide an evaluation of the non-graded result upon request. 5. In an interview at 12:15 p.m. on 09/29/22, the GS confirmed the above finding. . -- 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 observation, document review and interview with laboratory personnel, the laboratory failed to ensure a Chemistry procedure (performance verification) was approved, signed, and dated by the laboratory director prior to use. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 01/14/21, at 8:05 a.m. 2. An Abbott Architect C4100 chemistry analyzer was observed as present and available for use during the tour of the laboratory. 3. Performance verification activities for the analyzer (a total of 38 analytes) were acceptable and the laboratory began patient specimen testing in August 2019 as indicated in laboratory records. 4. The laboratory director did not approve, sign, or date the performance verification documents prior to use of the analyzer. 5. In an interview on 1/15/21, at 8:30 a.m., the GS confirmed the above finding. . 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 observation, document review, and interview with laboratory personnel, 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 -- the laboratory failed to ensure a reference interval was consistent between a Coagulation procedure and a patient test report. Findings are as follows: 1. The laboratory performed Coagulation testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 01/14/21, at 8:05 a.m. 2. An ACL Elite Coagulation analyzer was observed as present and available for use during the tour. 3. The Prothrombin Time (PT) reference intervals listed in the Prothrombin Time (PT) / INR (International Normalized Ratio) procedure, located in the on-line Lab Manual, were not consistent with those included on a patient test report reviewed on date of survey, as indicated below. Patient - adult male, aged 80 yrs, tested on 11/25/20 Procedure Report 10.5 - 15.0 seconds 7.26 - 12.96 seconds 4. In an interview on 1/15 /21, at 8:30 a.m., the GS confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to evaluate an unacceptable proficiency testing (PT) result. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory on 08/23/18 at 8:10 a.m. 2. The laboratory performed PT using the American Proficiency Institute PT provider. 3. The laboratory received an unacceptable PT result from API in the second Chemistry event of 2017 for the analyte and sample listed below. Analyte - pO2 Sample ID Lab Result API expected IB-07 126 31-82 4. An evaluation of the unacceptable PT result was not found during review of laboratory records. The laboratory was unable to provide an evaluation upon request. 5. In an interview on 08/23/18 at 12:20 p.m., the GS confirmed a documented evaluation of the unacceptable result was not performed. D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the technical supervisor (TS) failed to ensure competency assessments included assessment of test 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 through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for all testing performed by the laboratory. Findings are as follows: 1. The laboratory performed Microbiology, General Immunology, Chemistry, Hematology and Immunohematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory 08/23/18 at 8:10 a.m. 2. Proficiency testing results for each of the following testing specialties /subspecialties were being used to evaluate testing personnel competency. This activity was documented on the Assessment of Proficiency Testing form. Specialty Instrument/test Microbiology (Micro) - BacT/Alert, Vitek2, Gram Stain Hematology (Heme) - Sysmex xs-100i, Excyte 10, Blood Cell ID Coagulation (Coag) - ACL Elite Chemistry (Chem) - Architect c4100, i-STAT Urinalysis (UA) - Drug Screen Endocrinology (Endo) - Serum HCG Immunohematology (BB) - Type, Antibody Screen, Crossmatch 3. The 2017 evaluations of proficiency testing did not include testing across all specialties/subspecialties for 5 of 5 testing personnel. The laboratory was unable to provide additional documented evaluations upon request. See below where "0" indicates proficiency testing evaluations were not complete. 2017 Testing Personnel 1 2 3 4 5 Micro 0 0 0 0 Heme 0 0 0 Coag 0 0 Chem 0 0 UA 0 0 0 Endo 0 0 0 BB 0 0 4. In an interview on 08/23/18 at 12:30 p.m., the GS confirmed the 2017 evaluations of proficiency testing did not include testing across all specialties /subspecialties. *This is a repeat finding - D6125 was cited during the 12/30/16 survey* -- 2 of 2 --