Santa Barbara Pulmonary Associate

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyor's observation during the laboratory tour, review of the laboratory's policy and procedure, and interviews with office manager (OM) and laboratory director (LD), the laboratory failed to establish safety procedures to ensure protection from physical, chemical, and biochemical materials. The findings include: 1. Based on the surveyor's review of policies and procedures on the day of the survey, August 6, 2025, at approximately 1:00 p.m. the laboratory failed to provide a written policy and procedure for laboratory safety. 2. Based on the surveyor's observations during the laboratory tour where processing and testing of samples took place, it was found that the laboratory lacked eye washing in the testing area. 3. The OM and LD affirmed by interviews August 6, 2025, at approximately 1:15 p.m. that the laboratory lacked safety procedures and eyewash in the sample processing and testing area. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 08/6/2025, the laboratory processed and reported annually approximately 3,000 patients' test samples. 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. 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 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality assessment (QA) policies and procedures, personnel competency documentation, five (5) randomly selected patient records, and an interview with the office manager (OM) as specified in the personnel requirements in subpart M, the laboratory failed to perform competency assessments for all testing personnel (TP) for the years 2023, 2024 and 2025. The findings include: 1. Based on the surveyor's review of documentation, the laboratory lacked competency documentation for testing personnel for the years 2023, 2024, and 2025. 2. None of the three (3) testing personnel listed in the CMS-209 form had complete records of competency assessment for the years 2023, 2024, and 2025 in Routine Chemistry including Respiratory Blood Gases, and Hematology testing performed in the laboratory. 3. The OM affirmed by interview on the day of the survey August 6, 2025, at approximately 12:00 p.m., of this deficient practice: all competency assessments performed for testing personnel for 2023, 2024, and 2025 were not performed. 4. According to the laboratory's annual testing declaration form submitted at the time of the survey, the laboratory reported and performed approximately 3,000 Chemistry, and Hematology specialties during the time competency assessments for all TP were not performed. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 the lack of laboratory written policies and procedures for the GEM 500 and interviews with the laboratory's office manager, the laboratory failed to have available and follow by all testing personnel written procedure for blood gasses and electrolytes tests performed in the laboratory. The findings included: 1. The laboratory uses on the daily basis the instrument GEM 500 for testing blood gases and electrolytes. 2. On the day of the survey on August 6, 2025, at approximately 12:15 p.m. the laboratory failed to provide written policies and procedures for the instrument GEM 500 to test patients' samples for blood gases and electrolytes performed daily in the laboratory. 3. The OM confirmed on 8/6/2025 at approximately 12:30 p.m. that the laboratory did not have written policies and procedures available for the blood gases and electrolytes test performed in the laboratory in the GEM 500 instrument. 4. Based on the laboratory's annual testing volume declaration signed by the laboratory director on 8/6 /2025, the laboratory processes and reports 1,500 Routine Chemistry, including blood gases, samples annually for which the laboratory did not have a written procedure approved by the laboratory director, available, and followed by all testing personnel. D5779

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was performed on 8/12/2024, 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]; 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 Collge of American Pathologists/EXCEL (CAP) records (2023-2, 2023-3, 2024-1, and 2024-2), the laboratory failed to successfully participate 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 -- 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 in the subspecialty of Routine Chemistry for the analyte Glucose resulting in subsequent unsuccessful performance. Refer to D2096. 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 Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile and CAP evaluation reports, the laboratory failed to achieve satisfactory performance for four proficiency events in 2023 and 2024 for the analyte Glucose. The findings include 1. The laboratory received the following scores: 0% on the 2023 Glucose second event; 0% on the 2023 Glucose third event; 0% on the 2024 Glucose first event; 0% on the 2024 Glucose second event. 2. A review of the 2023 and 2024 proficiency Testing scores from CAP confirmed the above scores. 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 0155D report and CAP records for 2023-2, 2023-3, 2024-1, and 2024-2 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) 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 proficiency testing desk review of CASPER 155 report CAP records for 2023-2, 2023-3, 2024-1, and 2024-2 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 D0000 A proficiency testing desk review survey was performed on 8/12/2024, 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 review of the Certification and Survey Provider Enhanced Reporting (CASPER) 0155D COLLEGE OF AMERICAN PATHOLOGISTS/EXCEL records (2023-3 and 2024-2), the laboratory failed to successfully participate in a proficiency 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 -- 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 in the specialty of Hematology for the analyte Hemoglobin (Hgb) resulting in unsuccessful performance. Refer to D2130 and D2131. 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 desk review of Certification and Survey Provider Enhanced Reporting (CASPER) Report 0155D Individual Laboratory Profile CAP evaluation reports, the Laboratory failed to achieve satisfactory performance for two of three proficiency event in 2023 and 2024 for analyte Hemoglobin (Hgb). The finding include: 1. The laboratory received the following Hgb scores: 0% on the 2023 Hgb third event, 0% on the 2024 Hgb second event. 2. A review of the 2023 and 2024 proficiency testing scores from CAP confirmed the above 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 desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) - 0155D report College of American Pathologists/Excel records (2023 and 2024); the laboratory failed to achieve satisfactory performance for the specialty of Hematology. The findings include: 1. 0% for the 2023 Hematology third testing event, 0% for the 2024 Hematology second test event. 2. A review of the 2023 and 2024 proficiency testing scores from CAP confirmed the above scores. 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 (for analyte and specialty of the CASPER 0155D CAP report for 2023-3 and 2024-2 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) -- 2 of 3 -- 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 proficiency testing desk review of CASPER 0155D report CAP records for 2023-3 and 2024-2 events, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2130 & D2131. . -- 3 of 3 --

Summary Statement of Deficiencies D2089 ROUTINE CHEMISTRY CFR(s): 493.841(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3)The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing (PT) records, and interview with the laboratory testing person on June 21, 2023, at 11:35 am, the laboratory failed to participate in the 1st event of proficiency testing program in 2023. The findings include: 1. The laboratory successfully participated in the CAP PT program for the year 2021 and 2022. However, it did not have any record showing that it had participated in the 1st event of 2023 PT program. Therefore, the accuracy of the patient test results reported by the laboratory during the PT event cannot be assured and might have harmed patients. 2. The laboratory testing person on June 21, 2023, at 11:35 am, affirmed that the laboratory did not have any documentation for the 1st event of 2023. 3. The laboratory's testing declaration form, signed by the laboratory director on 6/19/2023 stated that the laboratory performed approximately 6,300 tests, annually. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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 -- 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) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on Surveyor review of laboratory's proficiency testing records, and interview with the laboratory testing person on June 21, 2023, at 11:35 am, the laboratory director failed to ensure that the laboratory participated in the 1st event of proficiency testing program in 2023. The findings include: See D2089. -- 2 of 2 --