Haven Health Sky Harbor

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on January 8, 2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful Participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 review of the Certification and Survey Enhanced Reporting (CASPER) 155 report and the API-American Proficiency Institute, the laboratory failed to successfully participate in two out of three consecutive testing events for the regulated 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 -- analyte, PO2 Blood Gas, in 2022 and 2023, resulting in an initial unsuccessful performance. Refer to D2096. 1. The laboratory's PT performance was unsatisfactory for the second event of 2022 as indicated below: - PO2 Blood Gas - 0% 2. The laboratory's PT performance was unsatisfactory for the first event of 2023 as indicated below: - PO2 Blood Gas - 40% 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 review of the CASPER 155 report and the American Proficiency Institute (API) Proficiency Testing (PT) records from 2022 and 2023, the laboratory failed to achieve satisfactory performance (80% or greater) for two out of three consecutive testing events for the regulated analyte, PO2 Blood Gas. Findings include: 1. A review of the CASPER 155 report revealed the following unsatisfactory scores: 2022 event 2, PO2 Blood Gas 0% 2023 event 1, PO2 Blood Gas 40% 2. A review of the proficiency testing scores from API. (2022 and 2023) confirmed the above findings. 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 a proficiency testing desk review of the CASPER-0155 Individual Laboratory Report and the API-American Proficiency Institute 2022 and 2023 records, 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: Based on a proficiency testing desk review of the CASPER-0155 and the API- American Proficiency Institute 2022-2 and 2023-1 evaluation reports, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. -- 2 of 2 --

Summary Statement of Deficiencies D5301 TEST REQUEST CFR(s): 493.1241(a) The laboratory must have a written or electronic request for patient testing from an authorized person. This STANDARD is not met as evidenced by: Based on lack of test requisition documentation for review and interview with the facility personnel, the laboratory failed to have a written or electronic request for patient testing for two out of four patient records reviewed during the survey. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) testing and routine chemistry testing under the specialty of Chemistry, with an approximate annual test volume of 2,075. 2. No written or electronic request for ABG testing was presented for review for two of four patient records reviewed during the survey, patient# 315124 tested on 5/12/19 at 07:18 AM and patient# 315079 tested on 3/15/20 at 12:54 PM. 3. The laboratory's established policy reviewed during the survey conducted on May 26, 2021 titled, "Blood Gas-CG4+ or CG8+" stated, "A physician/provider must order a Blood Gas/CG4+ or CG8+ test and document it in the patient's records." 4. The facility personnel confirmed that the laboratory did not have an electronic or written test requisition for testing that was performed on the patients indicated above. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a 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 -- minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on lack of calibration verification documentation for blood gas testing and interview with the testing personnel, the laboratory failed to perform and document calibration verification procedures as required. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) testing on the I-Stat analyzer, with an approximate annual test volume of 2,075. 2. Review of the laboratory's established policy titled, "Calibration & Calibration Verification" during the survey conducted on May 26, 2021 stated, "Calibration verification is required every six months for Blood Gas cartridges." 3. No documentation was presented for review to indicate the laboratory performed a calibration verification for ABG testing at least once every six months during 2019, including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results. The laboratory performed a calibration verification on 11/08/18. A calibration verfiication was not performed again until 5/29/20. 4. The facility personnel acknowledged that a calibration verification was not performed every 6 months on the I-stat analyzer as required for ABG testing. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of patient test results in the laboratory's Electronic Medical Record (EMR), review of patient test records and interview with the facility personnel, the laboratory failed to ensure that test results are accurately and reliably sent from the point of data entry to the final report destination. Findings include: 1. The laboratory performs Arterial Blood Gas (ABG) testing on the I-Stat analyzer in the specialties of Chemistry and Hematology, with an approximate annual test volume of 2,075. 2. The laboratory utilizes an EMR, Point Click Care, as the final report destination for results -- 2 of 3 -- of laboratory testing. 3. The laboratory's established policy titled, "Blood Gas-CG4+ or CG8+" reviewed during the survey conducted on 5/26/21 stated, "Reports will be scanned into the patient's EHR." 4. Review of ABG test results for patient (MR# 315757) performed on 9/12/20 at 07:12 AM revealed the ABG test results were missing from the EMR. 5. The facility personnel confirmed the ABG test results indicated above were not reliably sent to the EMR. -- 3 of 3 --

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 review of Proficiency Testing (PT) reports for 2019 and 2020 sent to the State Agency by the PT provider, the laboratory failed to successfully participate in a PT program for the regulated analyte, PCO2, under the specialty of Chemistry. Findings include: 1. The laboratory's PT performance was unsatisfactory for the 3rd event of 2019 for the regulated analyte, PCO2, with a score of 0%. 2. The laboratory's PT performance was unsatisfactory for the 1st event of 2020 for the regulated analyte, PCO2, with a score of 60%. D2094 ROUTINE 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 3 -- CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on the information furnished to the State Agency by the Proficiency Testing (PT) provider, it could not be determined if the laboratory underwent training and technical assistance and if remedial action was taken to correct the PT failure for the analyte, PCO2, for the 3rd testing event of 2019 and 1st testing event of 2020. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve satisfactory performance for the regulated analyte, PCO2, for the 3rd event of 2019 and 1st event of 2020 resulting in unsuccessful PT performance. See D2016 for findings. 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: The Condition of Laboratory Director was found to be not met based on the failure to provide overall management and direction as evidenced by D6016 - ensuring that the proficiency testing samples are tested as required under Subpart H. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as -- 2 of 3 -- required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on information furnished to the State Agency by the Proficiency Testing (PT) provider, it was determined that the laboratory director failed to ensure that PT samples are tested in a manner that results in successful participation in a proficiency testing program for the regulated analyte, PCO2. See D2016 and D6000 for findings. -- 3 of 3 --

Summary Statement of Deficiencies D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on review of of four laboratory report forms for blood gas testing and interview with the technical consultant, the laboratory failed to provide evidence of acceptable test performance dates and times within the limits of the blood draw dates and times indicated on 3 out of the 4 laboratory reports reviewed. Findings include: 1. The laboratory's policy regarding blood gas testing indicated that specimens should be tested immediately, and must be tested within 10 minutes of collection. 2. Patient #314686 was drawn on 10/24/2018 at 13:10, and the i-Stat test result tape indicated the test was performed on 10/25/18 at 04:15. Patient #314743 was drawn on 01/12 /2019 at 06:55, and the i-Stat result tape indicated the test was performed on 01/12 /2019 at 21:58. Patient #315007 was drawn on 02/09/2019 at 11:15, and the i-Stat result tape indicated the test was performed on 02/10/2019 at 02:25. 3. The technical consultant acknowledged that the information regarding the blood draw dates and times was inconsistent with the respective test performance dates and times. D5819 TEST REPORT CFR(s): 493.1291(j) 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 -- All test reports or records of the information on the test reports must be maintained by the laboratory in a manner that permits ready identification and timely accessibility. This STANDARD is not met as evidenced by: Based on review of 4 hard copy patient test reports and interview with the testing personnel, the laboratory failed to scan 4 out of 4 hard copy reports into each patient's respective electronic health record (EHR) as directed by the laboratory's policy. Findings include: 1. The testing personnel was unable to retrieve any of the 4 test reports (Pt #314686, Pt #314743, Pt #315007, Pt #315041) in the EHR system. 2. The testing personnel acknowledged that the reports were not scanned into the EHR system. D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on inconsistencies in the laboratory's test reports and lack of scanned test reports in the electronic health record (EHR), the laboratory failed to have an adequate post analytic quality assessment in place that monitored and assessed the accuracy of all the information on the patient test reports and the consistant scanning of hard copy reports into each patient's EHR. See D5801 and D5819 for findings. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (b)(7) 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; This STANDARD is not met as evidenced by: Based on review of training records for the laboratory's testing personnel and interview with the testing personnel, the laboratory failed to provide evidence of initial training for blood gas testing using the i-Stat instrument for 1 out of 22 testing personnel training and competency records reviewed. Findings include: 1. The testing personnel did have a six month competency assessment, but the initial training documentation was not presented for review. 2. The testing personnel acknowledged that the documentation of the initial training was missing. -- 2 of 2 --