Palo Verde Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. 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 CMS proficiency testing (PT) records (i.e., CMS CASPER Report 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report", it was determined that the laboratory 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 -- failed to successfully participate in a PT program approved by CMS for each specialty and analyte in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte (Hemoglobin) and specialty (Hematology) in two out of three consecutive testing events constituting unsuccessful PT performances. (See D2096 & D2097) 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 desk review of CMS PT records CMS CASPER Report 0155D and the laboratory's College of American Pathologists/EXCEL records, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for Chemistry, analytes: Glucose (Non- Waived), Potassium, Sodium, and BUN, resulting in an "initial" (first) unsuccessful performances. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analytes, Glucose (Non- Waived), Potassium, Sodium, and BUN: 2024 Q3 2024 Q1 Glucose (Non-Waived) 0% 0% Potassium 0% 0% Sodium 0% 0% BUN 0% 0% Q1 = First Testing Event Q3 = Third Testing Event D2097 ROUTINE CHEMISTRY CFR(s): 493.841(g) Failure to achieve an overall testing event score of satisfactory performance for 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 desk review of CMS PT records: CMS CASPER Report 0155D and records, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the sub-specialty: Routine Chemistry resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with College of American Pathologists/EXCEL Proficiency Testing program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the sub-specialty of Routine Chemistry, as follows: 2024 Q3 2025 Q1 Routine Chemistry 0% 42% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve an overall Routine Chemistry testing in two of three consecutive testing events resulted in inital unsuccessful Proficiency performance for the subspecialty - Routine Chemistry. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 2 of 3 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the CASPER 0155D report and College of American Pathologists/EXCEL records for 2024-3 and 2025-1 proficiency events, the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: For the analyte Hgb and specialty Hematology, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte/specialty in two out of three consecutive testing events, resulting in unsuccessful PT Performances (D2096 and D2097) -- 3 of 3 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 12/19/2024, the laboratory was found not in compliance with the following CONDITION LEVEL DEFICIENCIES D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing]; D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; Laboratory Director. D2016 Based on review of the Certificate and Survey Provider Enhanced Reporting (CASPER) - 0155D and College of American Pathologists/EXCEL records (2024-3 and 2025-1), the laboratory failed to successfully participate in a proficiency testing program approved by HHS for each speciality, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate in: the subspecialty of Routine Chemistry; analytes:Glucose, Potassium, Sodium, and BUN resulting in initial unsuccessful performances. Refer to D2096 and D2097. D2096 Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D, it was determined that the laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT events for the analyte, Hemoglobin (Hgb), resulting in an "initial" (first) unsuccessful performance. The findings include: a. The laboratory failed to maintain successful performance with the PT program by failing to obtain a score of 80% of acceptable responses in two out of three consecutive PT events for the analyte, Hgb, as follows: 2024 Q2 2024 Q3 Hgb 0% 0% Q2 = Second Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performances for the same analyte or test in two out of three consecutive PT resulted in an unsuccessful performances for the analyte, Hgb. D2097 Based on desk review of CMS PT records (CMS CASPER Report 0155D and 0153D), it was determined that the laboratory failed to achieve satisfactory performance for the specialty of Hematology in two out of three consecutive PT events, resulting in an "Initial" (first) unsuccessful Hematology performance. The findings include: a. The laboratory failed to maintain successful performance with the 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 -- PT program by failing to obtasin a score of 80% of acceptable responses in two out of three consecutive PT events for the specialty, Hematology, as follows: 2024 Q2 2024 Q3 Hematology 50% 0% Q1 = First Testing Event Q2 = Second Testing Event b. Failure to achieve satisfactory performances for the same specialty, analyte or test in two out of three consecutive PT resulted in an unsuccessful performance for the specialty of Hematology. D6000 Based on the severity of the deficiencies cited herein, the Condition: Laboratories Performing Moderate Complexity Testing: Laboratory Director was not met. The Laboratory Director, moderate complexity testing, failed to ensure that PT samples were tested as required under Subpart H of this part. (See D6016) D6016 For the analyte Hgb and specialty Hematology, the laboratory repeatedly failed to achieve satisfactory performance for the same analyte/specialty in two out of three consecutive testing events, resulting in unsuccessful PT Performances (D2096 and D2097) -- 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: Based on Surveyor review of laboratory's proficiency testing (PT) results from CAP, and interview with the laboratory testing person on December 17, 2024, at 2:00 pm, the laboratory failed to successfully participate in the proficiency testing program for the blood gas, pO2 test. The findings include: 1. The laboratory participated in the CAP PT testing program for the blood gas in the specialty of chemistry in year 2023. However, it received an unsatisfactory score of 60% at the 2nd event and 0% at the 3rd event in 2023 for the pO2 test which resulted in an unsuccessful PT participation. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory testing person on December 17, 2024, 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 -- at 2:00 pm, affirmed that the laboratory did not receive a satisfactory score for the pO2 test at the 2nd and 3rd event in 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/17/2024, stated that the laboratory performs approximately 200 tests in blood gas, annually. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 Surveyor review of laboratory's proficiency testing (PT) results from CAP, and interview with the laboratory testing person on December 17, 2024, at 2:00 pm, the laboratory failed to achieve satisfactory performance for the pO2 test in two consecutive events. The findings include: 1. The laboratory participated in in the CAP PT testing program for the specialty of routine chemistry in 2023. However, it received an unsatisfactory score of 60% at the 2nd event and 0% at the 3rd event in 2023 for the pO2 test that resulted in an unsatisfactory analyte performance. Laboratory's failure to achieve satisfactory performance for the same analyte in two consecutive events resulted in an unsuccessful PT performance. Therefore, the accuracy of the patients' test results rendered by the laboratory during that time cannot be assured. 2. The laboratory testing person on December 17, 2024, at 2:00 pm, affirmed that the laboratory received an unsatisfactory score of 60% at the 2nd event and 0% at the 3rd event in 2023 for the pO2 test. 3. The laboratory's testing declaration form, signed by the laboratory director on 12/17/2024, stated that the laboratory performs approximately 200 tests in blood gas, annually. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory testing person during an onsite survey of the laboratory on December 17, 2024, at 2:00 pm, and the severity of deficiencies found and cited herein, it was determined that the laboratory director failed to provide effective direction over the operation of the laboratory, hence the Condition: Laboratories performing moderate complexity testing; laboratory director was not met. The laboratory director's failure to provide direction over the laboratory operation has a consequence of potential erroneous test result reporting and patient harm. The findings include: The laboratory director failed to ensure the maintenance of an acceptable levels of analytical performance for the pO2 test. (See D6023) D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) -- 2 of 3 -- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) results from CAP, and interview with the laboratory testing person on December 17, 2024, at 2:00 pm, the laboratory failed to achieve satisfactory performance for pO2 test in two consecutive PT events. The findings include: See D2096. -- 3 of 3 --