Kpc Promise Hospital Of Phoenix

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) records on September 6, 2023 at 2:20 PM and interview with the Testing Personnel (TP-1), the laboratory failed to successfully participate in a PT program for the specialty of Hematology, subspecialty of Routine Chemistry and for the following regulated analytes: Chloride, Potassium, Sodium, Hematocrit (HCT, Non-Waived) and Hemoglobin (HGB, Non-Waived). Findings include: 1. The laboratory's PT performance was unsatisfactory for the 2nd event of 2022 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 50% - Chloride - 0% - Potassium - 0% - Sodium - 0% - HCT, Non- Waived - 0% - HGB Non-Waived - 0% 2. *The laboratory's PT performance was Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- unsatisfactory for the 3rd event of 2022 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 46% - Chloride - 0% - Potassium - 0% - Sodium - 0% - HCT, Non-Waived - 0% - HGB Non-Waived - 0% 3. **The laboratory's PT performance was unsatisfactory for the 1st event of 2023 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 50% - Chloride - 0% - Potassium - 0% - Sodium - 0% - HCT, Non-Waived - 0% - HGB Non-Waived - 0% 4. **The laboratory's PT performance was unsatisfactory for the 2nd event of 2023 as indicated below: - Specialty of Hematology - 0% - Subspecialty of Chemistry - 50% - Chloride - 0% - Potassium - 0% - Sodium - 0% - HCT, Non-Waived - 0% - HGB Non- Waived - 0% 5. *Unsatisfactory participation in the second and third events of 2022 (two consecutive testing events) for the regulated analytes, Chloride, Potassium, Sodium, HCT (Non-Waived), and HGB (Non-Waived), and for the specialty of Hematology and sub-specialty of Routine Chemistry constitutes an initial unsuccessful PT performance. 6. **Unsatisfactory participation in the third event of 2022, first event of 2023 and second event of 2023 (three consecutive testing events) for the regulated analytes, Chloride, Potassium, Sodium, HCT (Non-Waived), and HGB (Non-Waived), and for the specialty of Hematology and sub-specialty of Routine Chemistry constitutes unsuccessful PT performance and a subsequent unsuccessful PT performance to the initial unsuccessful PT as outlined above in #5. 7. The TP-1 interviewed on September 6, 2023 at 11:50 AM confirmed the laboratory received unsuccessful PT results for the regulated analytes and specialty /subspecialties listed above during the 2nd and 3rd testing events of 2022 and 1st and 2nd testing events of 2023, resulting in subsequent unsuccessful PT performance. 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 2nd and 3rd events of 2022 and 1st and 2nd events of 2023 for the following regulated analytes: Chloride, Potassium, and Sodium, resulting in subsequent unsuccessful PT performance. See D2016 for findings. 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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the subspecialty of Routine Chemistry for the 2nd and 3rd events of 2022 and 1st and 2nd events of 2023, resulting in subsequent unsuccessful PT performance. See D2016 for findings. -- 2 of 13 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 2nd and 3rd events of 2022 and 1st and 2nd events of 2023 for the regulated analytes: Hematocrit (HCT, Non-Waived), and Hemoglobin (HGB, Non-Waived), resulting in subsequent unsuccessful PT performance. See D2016 for findings. D2131 HEMATOLOGY CFR(s): 493.851(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 information furnished to the State Agency by the Proficiency Testing (PT) provider, the laboratory failed to achieve an overall testing event score of satisfactory performance for the specialty of Hematology for the 2nd and 3rd events of 2022 and the 1st and 2nd events of 2023, resulting in subsequent unsuccessful performance. See D2016 for findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on review of i-Stat instrument printouts, patient's medical records and interview with the testing personnel (TP-1), the laboratory failed to ensure positive identification of the patient's specimen throughout the entire testing process for one out of four patient records reviewed; and the labortatory failed to establish policies and procedures to ensure positive identification of the patient's specimen from the time of collection through completion of testing and reporting of results. Findings include: 1. The laboratory began patient testing on the i-Stat analyzer in January 2022 in the subspecialty of Routine Chemistry, with an approximate annual test volume of 2,800. The laboratory utilizes three separate i-Stat analyzers and performs the CG4+ test (for Arterial Blood Gas). 2. It is the practice of the laboratory to manually enter the patients Medical Record (MR) number into the i-Stat analyzer prior to testing the specimen. The i-Stat instrument printout showing the test results is then affixed to a sheet of paper titled, Patient Blood Gas Report, and this form is maintained in the patients' medical chart (paper chart). The Patient Blood Gas Report is labeled with a -- 3 of 13 -- computer-generated barcode label containing the patient's full name, date of birth, MR#, account #, age, sex, room number, admission date and physician name. 3. One out of four medical charts reviewed during the survey for patient MR# 11189 contained a Patient Blood Gas Report form showing the barcode label for MR# 11189 and the i-Stat instrument printout for patient MR# 11290 (for testing performed on September 02, 2022 at 08:29). 4. The laboratory failed to ensure positive identification of the patient's specimen throughout the entire testing process as evidenced above. 5. The laboratory failed to establish written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. 6. The TP-1 interviewed on September 6, 2023 at 3:10 PM confirmed the laboratory failed to ensure positive identification of the patient's specimen indicated above, and failed to establish policies and procedures to ensure positive patient identification throughout the entire testing process. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on lack of employee competency policies and procedures for review and interview with the testing personnel (TP-1), the laboratory failed to establish policies and procedures to assess the competency of the Technical Consultant. Findings include: 1. The CMS-209, Laboratory Personnel form submitted for review during the survey conducted on September 6, 2023 listed one Technical Consultant (TC) who provides technical oversight for testing performed in the specialty of Chemistry. 2. No documentation was presented for review to indicate the laboratory established policies and procedures to assess the competency of the Technical Consultant. 3. The TP-1 interviewed on 9/06/2023 at 12:35 PM confirmed the laboratory failed to establish policies and procedures to assess the competency of the TC indicated above. 4. The laboratory's reported annual test volume in the specialty of Chemistry is 2,800. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a lack of established quality assessment (QA) policies and procedures and interview with the testing personnel (TP-1), the laboratory failed to establish policies and procedures to monitor, assess and correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. Findings include: 1. No QA documentation was provided for review during the survey conducted on 09/06/2023 to indicate the laboratory established policies and procedures to monitor, assess and, when indicated, correct problems identified in the -- 4 of 13 -- general laboratory system requirements specified at 493.1231 through 493.1236, including but not limited to, Proficiency Testing policies and procedures. 2. The TP-1 interviewed on 09/06/23 at 4:00 PM confirmed the laboratory failed to provide documentation of an established QA policy and procedure to monitor, assess and correct problems identified in the general laboratory systems requirements. D5293 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(b)(c) (b) The general laboratory systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 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 blood gas testing on the Gem 4000 blood gas analyzer, with an approximate annual test volume of 3,200. 2. Review of the laboratory's established policy titled, "Laboratory Quality Control for the Gem 4000 Blood Analyzer" during the survey Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- conducted on May 10, 2021 stated, "PVP/Linearity studies will be run on the Gem 4000 every six months using control purchased from the Gem 4000 manufacturer." 3. No documentation was presented for review to indicate the laboratory performed a calibration verification for blood gas testing at least once every six months during 2020, 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 one PVP (Performance Verification Product) test in 2020 on 7/16/20. The PVP test was not performed again until 5/05/21. 4. The facility personnel acknowledged that the PVP test was not performed every 6 months as required. D5813 TEST REPORT CFR(s): 493.1291(g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of patient test results for Blood Gas testing and interview with the facility personnel, the laboratory failed to immediately alert the individual or entity requesting the test when the test result indicates an imminently life-threatening condition, or panic or alert values. Findings include: 1. Review of blood gas test results for patient ID# 1249 performed on 02/12/20 at 12:51pm indicated two critical low test results, PCO2 = 27 mmhg and Hct = 23 mmhg. The two critical test results were each noted with two down-arrow symbols, to indicate a panic or alert value. 2. Review of blood gas test results for patient ID# 74063 performed on 08/03/19 at 08: 46am indicated a critical high test result, PCO2 = 77 mmhg. The critical test result was noted with two up-arrow symbols, to indicate a panic or alert value. 3. The laboratory's established policy titled, "Arterial Blood Gas/Chemistry Critical Values" reviewed during the survey conducted on May 10, 2021 stated, "Notify the primary or consulting physician of the critical values. Document the notification contacts on the "Critical Values Verbal Report Sticker" and place on a Physician Progress Note in the patient chart." 4. No documentation was presented for review to indicate the laboratory notified the primary or consulting physician of the critical values and documented the notification for the critical values listed above for each patient as indicated in laboratory policy. 5. The facility personnel confirmed that the critical test results referenced above were not communicated and documented per laboratory policy. D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) 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)(11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on lack of education credentials and training documentation for testing personnel and interview with the facility personnel, (A) the laboratory director failed to ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience for the type and complexity of services offered and (B) the laboratory director failed to ensure that all testing personnel receive the appropriate training for the testing performed, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. Findings include: A1. No evidence of education credentials was presented for review for four out of four testing personnel who were hired as testing personnel in December 2019, January 2020, June 2020 and September 2020. A2. The facility personnel confirmed that the laboratory failed to provide a copy of the education credentials for the four testing personnel indicated above. B1. No documentation was presented for review to indicate four out of four testing personnel referenced above received the appropriate training for blood gas testing performed on the Gem 4000 analyzer prior to testing patient specimens. B2. The facility personnel confirmed that there was no documentation of initial training for four out of four testing personnel who performed testing on the Gem 4000 analyzer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on lack of performance evaluation documentation and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of one testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. No semiannual competency evaluation documentation was presented for review for four out of four testing personnel who began patient testing in October 2019, January 2020, September 2020 and June 2020. 2. The facility personnel confirmed that the laboratory did not have documentation of a semiannual competency evaluation for the four testing personnel indicated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on lack of competency evaluation documentation for review from 2019 and 2020 and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually. Findings include: 1. During the survey conducted on May 10, 2021, no annual competency evaluation documentation from 2019 was -- 3 of 4 -- presented for review for twelve out of twelve testing personnel who perform blood gas testing on the Gem 4000 analyzer. 2. No annual competency evaluation documentation from 2020 was presented for review for twelve out of twelve testing personnel who perform blood gas testing on the Gem 4000 analyzer. 3. The facility personnel confirmed that the laboratory failed to provide documentation of an annual competency evaluation from 2019 and 2020 for the testing personnel indicated above. -- 4 of 4 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records from 2017 and 2018 for testing performed in the specialties of Chemistry and Hematology and interview with the facility personnel, the laboratory director failed to sign the PT attestation statements. Findings include: 1. The laboratory performs Blood Gas testing in the specialties of Chemistry and Hematology, with an approximate annual test volume of 5,000. 2. The PT attestation statements presented for review for the second and third testing events of 2017 and the first and second testing events of 2018 lacked the current director's signature. 3. The PT attestation statements referenced above were signed and dated by individuals who were not listed on the CMS-209, Laboratory Personnel form presented for review during the survey. 4. The facility personnel confirmed that the PT attestation statements indicated above were not signed by the laboratory director. 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 review of the laboratory's policy and procedure manual and interview with the facility personnel, the laboratory failed to have the current laboratory director 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 -- approve, sign and date test procedures before use. Findings include: 1. The current laboratory director indicated in the CLIA Federal Database and assigned on the CMS- 209, Laboratory Personnel Form presented for review during the survey has been listed as laboratory director since 7/08/2014. 2. The policy and procedure manual presented for review during the survey conducted on August 29, 2018 was not approved, signed and dated by the current laboratory director. 3. The facility personnel confirmed that the policy and procedure manual indicated above was not approved, signed and dated by the current laboratory director before use. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of performance evaluation documentation and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of one testing personnel, at least semiannually during the first year the individual tested patient specimens. Findings include: 1. One out of one testing personnel was hired on May 2, 2017 to perform patient testing. 2. No evidence was presented for review to indicate a semiannual competency evaluation was performed for the testing personnel referenced above. The "Respiratory Department Laboratory Competency Assessment" form presented for review for this individual indicated the semi annual competency evaluation occurred on 7/08/16. 3. The facility personnel confirmed that the semiannual competency evaluation documentation for the testing personnel indicated above contained evaluation dates prior to this individual's date of employment. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of performance evaluation documentation and interview with the facility personnel, the technical consultant failed to evaluate and document the performance of one testing personnel, at least annually after the first year the individual tested patient specimens. Findings include: 1. One out of one testing personnel was hired on May 2, 2017 to perform patient testing. 2. No evidence was presented for review to indicate an annual competency evaluation was performed for the testing personnel referenced above. The "Respiratory Department Laboratory Competency Assessment" form presented for review for this individual indicated the annual competency evaluation occurred on 01/04/17. 3. The facility personnel confirmed that the annual competency evaluation documentation for the testing personnel indicated above contained evaluation dates prior to this individual's date of employment. -- 2 of 2 --