Desert View Hospital

Summary Statement of Deficiencies D0000 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on an interview with the laboratory manager, a review of the director approved procedure for emergency release of blood products, and the American Association of Blood Banks (AABB) Technical Manual (13th Edition), the laboratory failed to ensure that the director approved procedure for pre-transfusion testing was followed in the event of emergency release of blood products during the survey on February 27, 2024 between approximately 9:00 AM and 4:00 PM, and email correspondence received from the laboratory on February 29, 2024 at 5:29 PM. Findings include: 1. The laboratory manager stated during an interview on February 27, 2024 at approximately 10:30 AM that the laboratory had started performing emergency release of blood products for all patients, beginning January 1, 2024, without completing a crossmatch after release of the blood products. 2. The laboratory manager elaborated that the reasoning for completing only the antibody screen and not the crossmatch was because the laboratory implemented use of the Galileo Echo for the performance of ABO, Rh, Antibody Screen, and compatibility testing. The Echo did not have the capability of performing the immediate spin crossmatch, and the laboratory does not have the capability to perform an electronic crossmatch. 3. The older model of the Ortho MTS centrifuge and incubator for use with the Ortho MTS gel system previously in use was slated for revocation of FDA approval, effective January 1, 2024, forcing the facility to discontinue use of the instrumentation at that 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 -- time. 4. There was no back up method established by the laboratory for the Ortho MTS gel system at the time that it was discontinued which would have allowed the performance of the immediate spin crossmatch when the use of the Echo was implemented. 5. These findings were confirmed via email correspondence received from the laboratory on February 29, 2024 at 5:29 PM. 6. The director approved procedure entitled, "Emergency Release or Special Issue of Components" stated in step 4, "Begin pre-transfusion testing IMMEDIATELY when the patient sample arrives (preferably collected before transfusion). 7. In the AABB Technical Manual (13th Edition), on page 386, under the section entitled, "Bood Administered in Urgent Situations," in the sub-section entitled, "Required Procedures" it states in step 3, "Begin compatibility tests and complete them promptly. If incompatibility is detected at any stage of testing, the patient's physician and the transfusion service physician should be notified immediately. Standard compatibility tests should be completed promptly for those units issued for initial replacement of patient's blood volume." The laboratory performs approximately 775 immunohematology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site CLIA recertification survey conducted at your facility on April 19, 2022. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) 2021 Chemistry Core Test Event Three, a review of the API PT 2022 Chemistry Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- Core Test Event One, and an interview with the Lead Medical Technologist, and the Laboratory director, the laboratory failed to successfully participate in the proficiency testing program for Creatine Kinase and Quantitative human Chorionic Gonadotropin (hCG). (Refer to D2096 and D2107). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) 2021 Chemistry Core Test Event Three, a review of the API PT 2022 Chemistry Core Test Event One, and an interview with the Lead Medical Technologist, and the Laboratory director, the laboratory failed to achieve successful performance in two consecutive testing events for Creatine Kinase (CK). Findings include: 1. The laboratory failed to submit the 2021 API PT Chemistry Core Test Event Three results to API by the deadline established by the proficiency testing program, resulting in a score of zero for the test event. 2. For the 2022 API PT Chemistry Core Test Event One, the laboratory achieved a score of 60% for the Creatine Kinase test. Specimen numbers CH-01 and CH-02 were each outside the acceptable range established by the proficiency testing program. 3. The findings were confirmed during an interview with the Laboratory Director and the Lead Medical Technologist that was conducted on April 19, 2022 at approximately 10:00 AM. The laboratory performs approximately 260,402 Chemistry tests annually. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 a review of the American Proficiency Institute (API) Proficiency Testing (PT) 2021 Chemistry Core Test Event Three, a review of the API PT 2022 Chemistry Core Test Event One, and an interview with the Lead Medical Technologist, and the Laboratory director, the laboratory failed to achieve successful performance in two consecutive testing events for Quantitative Human Chorionic Gonadotropin (hCG). Findings include: 1. The laboratory failed to submit the 2021 API PT Chemistry Core Test Event Three results to API by the deadline established by the proficiency testing program, resulting in a score of zero for the test event. 2. For the 2022 API PT Chemistry Core Test Event One, the laboratory achieved a score of 60% for the Quantitative hCG test. Specimen numbers HCG-01 and HCG-04 were each outside the acceptable range established by the proficiency testing program. 3. The findings were confirmed during an interview with the Laboratory Director and the Lead Medical Technologist that was conducted on April 19, 2022 at approximately 10:00 AM. The laboratory performs approximately 260,402 Chemistry tests annually. -- 2 of 11 -- D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the American Proficiency Institute (API) Proficiency Testing (PT) 2020 Hematology/Coagulation Test Event Three, and the API 2021 Hematology /Coagulation Test Event Two records, and an interview with the Laboratory Director and the Lead Medical Technologist, the laboratory failed to document review of the data summary to evaluate results that were not graded due to lack of consensus, or results that were designated as educational challenges for acceptability. Findings include: 1. There was no documentation of a review of the data summary for the API PT 2020 Hematology/Coagulation test event three for the blood cell identification of Specimen BCI-11, which was ungraded due to lack of consensus. 2. There was no documentation of a review for the API PT 2020 Hematology/Coagulation test event three of the ungraded Educational Blood Cell Identification samples ECI-11, ECI-12, ECI-13. ECI-14 and ECI-15. 3. There was no documentation of a review of the data summary for the API PT 2020 Hematology/Coagulation test event for the urine sediment result for specimen number US-06, which was ungraded due to lack of consensus. 4. There was no documentation of a review of the data summary for the API PT 2021 Hematology/Coagulation test event for the blood cell identification of Specimen BCI-07, which was ungraded due to lack of consensus. 5. There was no documentation of a review for the API PT 2021 Hematology/Coagulation test event two of the ungraded Educational Blood Cell Identification samples ECI-06, ECI-07, ECI-08, ECI-09, and ECI-10. 6. The findings were confirmed during an interview conducted with the Laboratory Director and the Lead Medical Technologist on April 19, 2022 at approximately 10:30 AM. The laboratory performs approximately 163,410 hematology tests annually. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on a review of the 2020, 2021, and 2022 American Proficiency Institute (API) Proficiency Testing (PT) records, and an interview with the Laboratory Director and the Lead Medical Technologist, the laboratory failed to ensure that all proficiency testing evaluation and verification activities, including

Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the CLIA proficiency testing desk review conducted off-site for your laboratory on 1/22/2021. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state, or local laws. 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 desk review of federal database CASPER Report 155D, American Proficiency Institute (API) proficiency testing (PT) evaluation forms, and review of 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 -- the laboratory's Performance Review and

Summary Statement of Deficiencies D0000 This statement of deficiencies was generated as a result of the on-site CLIA recertification survey conducted at your facility on January 9, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state or local laws. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random audit of patient laboratory tests performed by the laboratory from January 9, 2016 to October 18, 2017, a review of the quality control performed for the laboratory tests, a review of the director approved policy and procedure manual that refers to quality control and an interview with the laboratory manager, the laboratory failed to perform two levels of quality control every day of patient testing or evaluate and establish a process to reduce the frequency of quality control performed for each test system. Findings include: 1. The laboratory failed to perform two levels of external quality control every day of patient testing for Serum HCG and for Clostridium Difficile testing. 2. There was no director approved policy and procedure established for the reduced frequency of quality control for the performance of Serum 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 -- HCG and for Clostridium Difficile patient testing. This was confirmed by the laboratory manager on January 9, 2018 at approximately 2:30 PM. The laboratory performs approximately 203 bacteriology tests annually. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a review of the director approved policy and procedure manual for quality assessment, a review of the documentation of laboratory quality assessment for testing performed in 2016 and 2017 and an interview with the laboratory manager, the laboratory failed to follow the quality assessment policy of documenting assessment of the laboratory services provided to assess and identify failures in quality as they may occur. Findings include: 1. The laboratory failed to provide documentation of monthly quality assessment from February 2017 through July 2017 as defined in the director approved policy and procedure manual. 2. There was no documentation of monthly quality assessment for the performance of blood gas testing. 3. There was no documentation of review of the returned blood bank patient transfusion records to evaluate any issues that could arise from the transfusion of patients with donor blood products. 4. There was irregular documentation of the review of the blood bank log book for the evaluation of any discrepancies that may arise by testing personnel. This was confirmed by the laboratory manager on January 9, 2018 at approximately 6:00 PM. The laboratory performs approximately 397,869 patient laboratory tests annually. -- 2 of 2 --