Orchard Hospital Cardiopulmonary

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 04/23/2025, 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]; and 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D and College of American Pathologists/EXCEL (CAP) report (for proficiency testing events: 2024-3 and 2025-1), the laboratory failed to successfully 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 -- participate in a proficiency testing program approved by HHS for each specialty, subspecialty and analyte or test in which the laboratory is certified under CLIA, the laboratory failed to successfully participate for the analyte - Potassium, resulting in a unsuccessful performance. Refer to D2096. 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and a CAP evaluation report, the laboratory failed to achieve satisfactory performance for two of three consecutive proficiency events in 2024 & 2025, for the analyte - Potassium (K). The findings include: 2024 third event, Potassium - 60%, 2025 first event, Potassium - 0%. A review of the 2023 and 2024 proficiency testing scores from CAP 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report CAP records for proficiency testing 2024-3 and 2025-1 events, the laboratory director failed to provide overall management and a 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 Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report CAP proficiency testing records for 2024-3 and 2025-1 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 2 of 2 --

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 Surveyor review of laboratory's policy & procedure and CAP proficiency testing (PT) records for the years of 2019, 2020 and 2021, and interview with the laboratory testing person #1 on September 29, 2021 at 11:35 am, the laboratory failed to attest the proficiency testing samples were integrated into the laboratory's routine workload. The findings include: 1. The laboratory successfully participated CAP proficiency testing program for the years of 2019, 2020 and 2021. However, it had no attested documentation showing that the testing person tested the PT samples by integration into the routine patient workload using the laboratory's routine method. The testing person #1 said that the PT samples were run by only the testing person #1 while there were 6 other testing persons performed patient sample testing. The samples must be tested with the laboratory ' s regular patient workload by personnel who routinely perform the testing in the laboratory. PT samples are to be tested in the same manner as patient specimens. Handling PT sample differently and with special care than the patient sample might have doubtful result of the patient sample reported. 2. The laboratory testing person #1 on September 29, 2021 at 11:35 am, affirmed that the laboratory did not have any records of PT sample testing attestation. 3. The laboratory's testing declaration form, signed by the laboratory Director on 9/29/2021, stated that the laboratory performs 220 tests in blood gases, annually. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 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 -- 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 Surveyor review of laboratory's policy & procedure, lack of competency assessment documents, and interview with the laboratory testing person #1 on September 29, 2021 at 11:05 am, the laboratory failed to establish and follow written policies and procedures to assess testing personnel competency resulting lack of competency evaluation for all 7 testing personnel. The findings include: 1. The laboratory performed blood gas analyses using ABL-90 Flex instrument. There were 7 testing persons in the laboratory. However, the laboratory did not have any documentation showing that it had evaluated competency of testing persons. The procedures for evaluation of the competency of the staff must include i) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing; ii) Monitoring the recording and reporting of test results; iii) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records; iv) Direct observation of performance of instrument maintenance and function checks; v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and vi) Assessment of problem solving skills. Testing of patient sample by incompetent testing persons might have incorrect results reported. 2. The laboratory testing person #1 on September 29, 2021 at 11:05 am, affirmed that the laboratory did not evaluate competency of its testing persons. 3. The laboratory's testing declaration form, signed by the laboratory Director on 9/29/2021, stated that the laboratory performs 220 tests in blood gases, annually. 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 required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, proficiency testing records for the years of 2019, 2020 and 2021, and interview with the laboratory testing person #1 on September 29, 2021 at 11:35 am, the laboratory director failed to assure that the proficiency testing samples were tested as in the same manner of patients' samples. The findings include: See D2009. 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 -- 2 of 3 -- 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. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy and procedure, lack of training and competency assessment records, and interview with the laboratory testing person #1 on September 29, 2021 at 11:05 am, the laboratory director failed to ensure laboratory staffs are performing the test methods as required for accurate and reliable results. The findings include: See D5209. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's policy & procedure, lack of competency assessment documents, and interview with the laboratory testing person #1 on September 29, 2021 at 11:05 am, the technical consultant failed to evaluate all 7 testing personnel competency. The findings include: 1. The laboratory performed blood gas analyses using ABL-90 Flex instrument. There were 7 testing persons in the laboratory. However, the laboratory did not have any documentation showing that it had evaluated competency of testing persons. Testing of patient sample by incompetent testing persons might have incorrect results reported. 2. The laboratory testing person #1 on September 29, 2021 at 11:05 am, affirmed that the technical consultant did not evaluate the competency of any testing person. 3. The laboratory's testing declaration form, signed by the laboratory Director on 9/29/2021, stated that the laboratory performs 220 tests in blood gases, annually. -- 3 of 3 --

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory patient test result reports, lack of evaluation of proficiency testing (PT) persofrmance documents, and interview with the testing personnel (TP), it was determined that the laboratory failed to verify at least twice annually, the accuracy of any test or procedure it performed and reported that is not included in subpart I of 42 CFR part 493. The findings included: a. The laboratory performed ABG (arterial blood gases) and report the test results including pH, pCO2, pO2, HCO3, O2 Saturation, TCO2 in the patient final report. b. The laboratory enrolled its pH, pCO2, and pO2 testing analyte which are in the list of subpart I with CAP (College of American Pathologists) PT programs approved by CMS CLIA programs. c. The patient tests report including HCO3, O2 Saturation and TCO2 are not included in subpart I of 42 CFR part 493. d. The laboratory must verify, but failed to, at least twice annually, the accuracy of the test or procedure listed in (c) mentioned above which are NOT included in subpart I of 42 CFR part 493. d. The laboratory may enroll in a PT program or another alternative way to verify the accuracy of their test or procedure, at least twice annually. 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 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 -- 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 the laboratory reports and instrument print-out, and interview with the testing personnel (TP), it was determined that the laboratory failed to have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination including results and patient-specific data electronically reported to network or interfaced systems., The findings included: a. The laboratory implemented a new hospital computer system, Evidence, to provide EMR (electronic medical records) in June 2018, and interfaced with the laboratory instrument, ABL 80 flex Radiometer, a arterial blood gases instrument. b. Interviewed with the testing personnel and requested the TP to provide evidences how the tests results and other patient-specific data were accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination. c. The TP was not able to provide the acceptable evidences or print-out in a timely manners. d. of the patient the print out, to show how the instrument testing results were accurately and correctly interfaced/transmitted to the Evidence for EMR purpose. e. Review of a instrument print-out data indicated ID # "27862" and a patient report identified by the name of MidwXXX, ClaXX were provided without evidence how this ID # 27862 is from the sample of the patient's name identified on the report. f. The surveyor requested the evidences to provide the linkage between "27862" and MidwXXX, ClaXX. g. At the time of survey (10/24/18 @ 15:15) the TP was not able to print out and provide the acceptable linkage evidences between ID # and the patient's name on the final report. h. The TP called someone in IT (information system) for help, but failed before the surveyor left and no print out. i. Day later 10/25/18, the TP faxed to our LA office, copies of designated "Machine results that print out" with a patient information of "27862" and patient test result reports ("Ugly" report print to us, also in computer, "Pretty" report goes to doctor), which were identical at the time the surveyor reviewed. j. No NEW evidences to provide the linkage of "27862" results accurately interfaced to the patient final report, name of MidwXXX, ClaXX (purposely not to disclose full name). D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's records, and interview with the testing personnel -- 2 of 3 -- (TP), it was determined that the laboratory director failed to be 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 for assuring compliance with the applicable regulations. A qualified laboratory director may perform the duties of the technical consultant, clinical consultant, and testing personnel. The findings included: See D-5217, D-5801, D-6018, and D-6045 D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) 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)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 desk review of CMS proficiency testing (PT) records (i.e. CMS CASPER Reports 0155D entitled, "Individual Laboratory Profile" and CMS CASPER Report 0153D entitled, "Unsuccessful (2 of 3) Report"), it was determined that the laboratory failed to successfully participate in a PT program approved by CMS for each analyte or test in which the laboratory is certified under CLIA. The findings included: The laboratory failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events in the subspecialty of Routine Chemistry constituting unsuccessful PT performance. (See D2096) 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 -- 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 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 analytes, PH Blood Gas (BG); PO2 (BG); and PCO2 (BG), 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 analytes, PH (BG); PO2 (BG); and PCO2 (BG), as follows: 2017 Q3 2018 Q1 PH (BG) 0% 0% PO2 (BG) 0% 0% PCO2 (BG) 0% 0% Q1 = First Testing Event Q3 = Third Testing Event b. Failure to achieve satisfactory performance for the same analyte or test in two out of three consecutive PT resulted in an initial unsuccessful performance for the analyte, PH (BG); PO2 (BG); and PCO2 (BG). 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 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 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 required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a desk review of CMS PT records, it was determined the laboratory director, moderate complexity testing, failed to ensure that PT samples were tested as required under subpart H. of this part. The findings included: For the analytes, PH (BG); PO2 -- 2 of 3 -- (BG); and PCO2 (BG), the laboratory repeatedly failed to achieve satisfactory performance for the same analyte or test in two out of three consecutive testing events, resulting in unsuccessful PT performance. (See D2016 and D2096) -- 3 of 3 --