Fitzgibbon Hospital Resp Care

Summary Statement of Deficiencies D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(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 review of Rapid Point 500e blood gas analyzer quality control (QC) and interview with testing personnel (TP) #8, the laboratory director (LD) failed to ensure the Rapid Point 500e QC log included pertinent information to ensure the establishment and maintenance of acceptable levels of analytical performance. Findings: 1. Review of Rapid Point 500e blood gas analyzer QC log showed no documentation of QC lot numbers or expiration dates form June 29, 2022 to date February 22, 2024 2. Interview with TP #8 on February 22, 2024 at 10:15 AM confirmed the LD failed to ensure the Rapid Point 500e QC log included pertinent information to ensure the establishment and maintenance of acceptable levels of analytical performance. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on lack of procedures, performance specifications, blood gas quality control and interviews, the laboratory failed to meet the condition of analytic systems. The laboratory failed to provide procedures for the Siemens Rapid Point 500 blood gas analyzer (Refer to D5401); the laboratory failed to ensure verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population (Refer to D5421); and the laboratory failed to test one sample of control material every 8 hours of testing using a combination of control materials that include both low and high values on each day of patient testing (Refer to 5537). D5401 PROCEDURE MANUAL CFR(s): 493.1251(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: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- Based on the lack of laboratory procedures and interview with the laboratory manager, the laboratory failed to provide a written procedure manual for all tests performed by the laboratory. Findings: 1. The laboratory could not provide procedures for the Siemens Rapid Point 500 blood gas analyzer. 2. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed the laboratory failed to provide a written procedure manual for all tests performed by the laboratory. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on review of Siemens Rapid Point 500 blood gas analyzer performance specifications and interview with the laboratory manager, the laboratory failed to ensure accuracy, precision, reportable range of the test results and verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population. Findings: 1. Review of the Rapid Point 500 blood gas analyzer performance specifications showed no accuracy, precision, reportable range of the test results and verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population for the analytes: pH, pCO2, pO2, tHb, FO2Hb, FHHb and FCOHb since the start of patient testing in November 2021. 2. Interview with the laboratory manager on June 29, 2022 at 9:00 AM confirmed the laboratory failed to ensure accuracy, precision, reportable range of the test results and verification of the manufacturer's reference intervals (normal values) are appropriate for the laboratory's population. D5537 ROUTINE CHEMISTRY CFR(s): 493.1267(b)(d) For blood gas analyses, the laboratory must perform the following: (b) Test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. (d) Document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of Siemens Rapid Point 500 blood gas analyzer quality control (QC) and interview with the laboratory manager, the laboratory failed to test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. Findings: 1. Review of Siemens Rapid Point 500 blood gas analyzer QC showed no documentation of QC from November 1, 2021 to June 2, 2022. The laboratory performed 360 blood gas patients from November 1, 2021 to date June 29, 2022. 2. Review of previous blood gas analyzer Nova Prime Plus QC showed no documentation of QC from January 2020 to November 1, 2021. 3. Interview with the laboratory manager on June 29, -- 2 of 8 -- 2022 at 9:30 AM confirmed the laboratory failed to test one sample of control material each 8 hours of testing using a combination of control materials that include both low and high values on each day of testing. 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 review of the Siemens Rapid Point 500 blood gas analyzer verification procedures, quality control, testing personnel competencies, laboratory procedures and interviews, the laboratory failed to meet the condition of laboratory director (LD). The LD failed to ensure verification procedures are adequate to determine the accuracy, precision and other pertinent performance characteristics for the Rapid Point 500 blood gas analyzer (Refer to D6013); the LD failed to ensure a quality assessment program is established and maintained (Refer to D6021); the LD failed to ensure a quality control program is established and maintained to identify failures in quality as they occur (Refer to D6022); the LD failed to ensure the establishment and maintenance of acceptable levels of analytical performance (Refer to D6023); the LD failed to ensure a policy is established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure they are competent and maintain their competency (Refer to D6030); and the LD failed to ensure approved procedures are available to all testing personnel (Refer to D6031). D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on review of the Siemens Rapid Point 500 blood gas analyzer verification procedures and interview with the laboratory manager, the laboratory director (LD) failed to ensure verification procedures are adequate to determine the accuracy, precision and other pertinent performance characteristics for the Rapid Point 500 blood gas analyzer. Findings: 1. Review of the Siemens Rapid Point 500 blood gas analyzer verification procedures showed no LD review and approval before patient testing started in November 2021 for the analytes: pH, pCO2, pO2, tHb, FO2Hb, FHHb and FCOHb. The laboratory performed 360 blood gas patients from November 1, 2021 to date June 29, 2022. 2. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed, the LD failed to ensure verification procedures are adequate to determine the accuracy, precision, reportable range, and normal values for the Rapid Point 500 blood gas analyzer. -- 3 of 8 -- D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based of the lack of a quality assessment program and interview with the laboratory manager, the laboratory director (LD) failed to ensure a quality assessment program is established and maintained. Findings: 1. The laboratory could not provide documentation of a quality assessment program. 2. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed the LD failed to ensure a quality assessment program is established and maintained. D6022 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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)(5) Ensure that the quality control and quality assessment programs are established and maintained to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based of the lack of a quality control program and interview with the laboratory manager, the laboratory director (LD) failed to ensure a quality control program is established and maintained to identify failures in quality as they occur. Findings: 1. The laboratory could not provide documentation of a quality control program. The laboratory performed 360 blood gas patients from November 1, 2021 to date June 29, 2022. 2. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed the LD failed to ensure a quality control program is established and maintained to identify failures in quality as they occur. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) 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)(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 review of Siemens Rapid Point 500 blood gas analyzer quality control (QC) -- 4 of 8 -- and interview with the laboratory manager, the laboratory director (LD) failed to ensure the establishment and maintenance of acceptable levels of analytical performance. Findings: 1. Review of Siemens Rapid Point 500 blood gas analyzer QC showed no documentation of QC from November 2021 to June 2, 2022. The laboratory performed 360 blood gas patients from November 1, 2021 to date June 29, 2022. 2. Review of Nova Prime Plus blood gas analyzer QC showed no documentation of QC from January 2020 to November 2021. 3. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed the LD failed to ensure the establishment and maintenance of acceptable levels of analytical performance. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based of the lack of policies and interview with the laboratory manager, the laboratory director (LD) failed to ensure a policy is established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure they are competent and maintain their competency. Findings: 1. The laboratory could not provide a policy for competency. 2. Interview with the laboratory manager on June 29, 2022 at 9:30 AM confirmed the LD failed to ensure a policy is established for monitoring individuals who conduct preanalytical, analytical and postanalytical phases of testing to assure they are competent and maintain their competency. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based of the lack of procedures and interview with the laboratory manager, the laboratory director (LD) failed to ensure approved procedures for quality control, quality assessment, proficiency testing and competency are available to all personnel. Findings: 1. The laboratory could not provide approved procedures for quality control, quality assessment, proficiency testing and competency. 2. Interview with the -- 5 of 8 -- laboratory manager on June 29, 2022 at 9:30 AM confirmed the LD failed to ensure approved procedures are available to all personnel. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on review of testing personnel competencies, blood gas quality control (QC), training documents and interviews showed the laboratory failed to meet the condition of technical consultant. The technical consultant failed to ensure the technical and scientific oversight of the laboratory (Refer to D6036); the technical consultant failed to identify the training needs for eight testing personnel (TP) (Refer to D6045); the technical consultant failed to evaluate one semiannual evaluation in 2022 (Refer to D6053); and the technical consultant failed to evaluate and document annual competency (Refer to D6054). D6036 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413 The technical consultant is responsible for the technical and scientific oversight of the laboratory. This STANDARD is not met as evidenced by: Based on review of procedures, performance evaluations, testing personnel training, Siemens Rapid Point 500 blood gas quality control (QC,) and interview with the laboratory manager, the technical consultant (who is also the laboratory director) failed to ensure the technical and scientific oversight of the laboratory. Findings: 1. Review of procedures showed no laboratory procedures available. 2. Review of testing personnel performance evaluations showed no competencies for 2020, 2021, and to date June 29, 2022. 3. Review of testing personnel training showed no documentation of training for eight of eight testing personnel. 4. Review of blood gas QC showed no QC available from 2020 to June 2, 2022. The laboratory performed 360 blood gas patients from November 1, 2021 to date June 29, 2022. 5. Interview with the laboratory manager on June 29, 2022 at 9:30 AM, confirmed the technical consultant failed to ensure the technical and scientific oversight of the laboratory. 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 Siemens Rapid Point 500 blood gas training evaluations and -- 6 of 8 -- interview with the laboratory manager, the technical consultant (who is also the laboratory director) failed to identify the training needs for eight of eight testing personnel (TP). Findings: 1. Based on review of Siemens Rapid Point 500 blood gas training evaluations showed no documentation for TP #1, TP #2, TP #3, TP #4, TP #5, TP #6, TP #7 and TP #8. 2. Interview with the laboratory manager on June 29, 2022 at 9:00 AM confirmed the technical consultant failed to identify the training needs for eight TP. 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 competency/performance semiannual evaluations and interview with the laboratory manager, the technical consultant (whom is also the laboratory director) failed to evaluate one of one semiannual evaluations in 2022. Findings: 1. Review of semiannual competency/performance evaluations showed no semiannual evaluation for testing personnel #8 in 2022. 2. Interview with the laboratory manager on June 29, 2022 at 9:00 AM confirmed the technical consultant failed to evaluate one semiannual evaluation in 2022. 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 the lack of testing personnel (TP) competency/performance evaluations and interview with the laboratory manager, the technical consultant (who is also the laboratory director) failed to evaluate and document annual competency in 2020, 2021, and to date June 29, 2022 for four of eight TP. Findings: 1. Review of competency/performance evaluations showed a lack of TP competency/performance evaluations for TP #1, TP #2, TP #3 and TP #4 for 2020, 2021 and to date June 29, 2022. 2. Interview with the laboratory manager on June 29, 20222 at 10:00 AM confirmed the technical consultant failed to evaluate and document annual competency. D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: -- 7 of 8 -- Based on review of personnel records and interview with the laboratory manager, the laboratory failed to have academic credentials required to qualify one of eight testing personnel for the speciality of hematology for moderate complexity testing (Refer to D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of academic credentials and interview with the laboratory manager, the laboratory failed to provide academic credentials to qualify one of eight testing personnel. Findings: 1. The laboratory could not provide academic credentials to show testing personnel #2 was qualified to perform moderate complexity testing. 2. Interview with the laboratory manager on June 29, 2022 at 9:00 AM confirmed the academic credentials needed to qualify testing personnel #2 were not available for review. -- 8 of 8 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of blood gas proficiency testing (PT) records for 2019 and interview with technical consultant (TC) #1, the laboratory failed to obtain signed attestation documentation from the testing analyst (s) and laboratory director for one of three PT events to show PT samples were tested in the same manner as patient specimens. Findings: 1. No documentation was available to show the laboratory obtained signed attestation from the testing analyst(s) and laboratory director for first blood gas PT event of 2019. 2. Interview with TC #1 on December 30, 2019 at 11:30 AM confirmed the laboratory failed to have attestation documentation for the first PT event of 2019. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the quality assurance program, lack of competency documentation for seven of seven testing personnel for 2018/2019 and interview with technical consultant (TC) #1, the laboratory failed to follow written policies to assess competency of staff performing blood gas testing on the Optimedical CCA-TS2 and AVOXimeter 400 blood gas analyzers. Findings: 1. The "ABG (arterial blood gas) Lab Quality Assurance Program; Staff Competency" policy states," Newly hired employees and staff therapists will receive training on the ABG (Optimedical CC- TS2) and CO-OX (AVOXimeter 400) machines and be expected to complete an annual competency to maintain proficiency in the use of the machines and drawing and analyzing blood gases." 2. No documentation was available to show newly hired or staff therapists received initial training and annual competency evaluations specific for blood gas testing procedures on the Optimedical CCA-TS2 and AVOXimeter analyzers for 2018 and to date December 30, 2019. 3. Interview with TC # 1 on December 30, 2019 at 11:30 AM confirmed the laboratory failed to follow the written personnel competency policy. 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 proficiency testing and interview with technical consultant (TC) #1 the laboratory failed to verify the accuracy of non-regulated blood gas analytes performed on the AVOXimeter and Optimedical CCA-TS2 blood gas analyzers at least twice annually for 2018 and 2019. Findings: 1. No documentation was available to show the laboratory verified the accuracy for the following non-regulated blood gas analytes at least twice annually for 2018 and 2019: AVOXimeter 400 -oxyhemoglobin -carboxyhemoglobin -methemoglobin Optimedical CCA-TS2 -bicarbinate -total co2 - oxygen saturation 2. Interview with TC #1 on December 30, 2019 at 11:30 AM confirmed the laboratory failed to have a system to verify the accuracy of non- regulated blood gas analytes. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of patient blood gas reference intervals (normal values) included on laboratory information system (LIS) test reports, approved normal values included in the approved procedure manual and interview with technical consultant (TC) #1, the laboratory failed to ensure total carbon dioxide (TCO2) normal values as determined by the laboratory were available for interpretation. Findings: 1. The LIS patient test -- 2 of 4 -- reports included a TCO2 normal value of (24-30 mEq/L). 2. The approved procedure manual included a TCO2 normal value of (23-29 mEq/L). 3. Interview with TC #1 on December 30, 2019 at 11:30 AM confirmed the differences between TCO2 normal values included on LIS test reports and those included in the approved procedure manual. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) 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)(iv) Ensure that an approved

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --