Mid Jefferson Extended Care Hospital Beaumont

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a recertification survey completed on June 17, 2025. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies 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 CMS Report 209 Laboratory Personnel Report, personnel records and interview with laboratory staff, the Laboratory Director failed to provide overall management and direction to the laboratory. The laboratory Director failed to ensure the technical consultant met the minimum education requirements.( see D 6028) The laboratory director failed to ensure each testing person met the minimum education requirements and had received the appropriate training prior to testing patient specimens for blood gas analysis. (See D 6029) D6028 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(10) 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)(10) Employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests and report test results in accordance with the personnel responsibilities described in this subpart; 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 5 -- Based upon review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory director failed to ensure the individual identified as the technical consultant met the minimum education requirements to provide oversight for moderate complexity testing in Chemistry. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found one Technical Consultant identified. 2. Review of the credentials provided found a high school diploma with a graduation date of May 30, 1979 and a written delegation of duties for the Technical consultant dated 12/9/2022. 3. During interview of the laboratory director conducted July 6, 2023 at 9:28 AM, he confirmed the individual identified as the Technical Consultant on the CMS Report 209 Laboratory Personnel Report did not meet the minimum education requirements for the Technical Consultant. 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. This STANDARD is not met as evidenced by: Based upon review of the CMS 209 Laboratory Personnel Report, Personnel records, and interview of facility personnel, the laboratory director failed to ensure four of ten testing personnel had documentation of education and appropriate training prior testing patient specimens for Blood gasses using the Gem Premier blood gas analyzer. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory defined ten testing personnel performing moderate complexity testing. 2. Review of personnel files found no foreign credential evaluation of education received outside the United States for testing person seven (hired 10/11/2022). Records were requested but not provided. Continued review of laboratory personnel records found no documentation of training for four of ten testing personnel as follows: Testing person three (hire date 01/10/2022) Testing Person four (hire date 07/13/2022) Testing Person seven (hire date 10/11/2022) Testing person eight (hire date 01/10/2022) 3. During interview of testing person one conducted July 6, 2023 at 9:31 AM, she confirmed that no training records were available for review for the four testing personnel and the Laboratory Director confirmed at 9:37 AM that a foreign credential evaluation for testing person seven was necessary, but not available for review. 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. -- 2 of 5 -- This CONDITION is not met as evidenced by: Review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory failed to have a technical consultant to provide oversight of laboratory services that met the minimum education requirements. ( see D 6035) D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based upon review of the CMS Report 209 Laboratory Personnel Report, personnel records and interview of facility personnel found the laboratory failed to have a technical consultant to provide oversight for moderate complexity testing in Chemistry that met the minimum education requirements. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found one Technical Consultant identified. 2. Review of the credentials provided found a high school diploma with a graduation date of May 30, 1979 and a written delegation of duties for the Technical consultant dated 12/9/2022. 3. During interview of the laboratory -- 3 of 5 -- director conducted July 6, 2023 at 9:28 AM, he confirmed the individual identified as the Technical Consultant on the CMS Report 209 Laboratory Personnel Report did not meet the minimum education requirements for the Technical Consultant. 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: Based on a review of the Laboratory Personnel Report, personnel records and staff interview, it was revealed thatfour of ten testing personnel did not have the appropriate documented training and education required to perform moderate complexity testing (see D6065 and D6066). 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 upon review of the CMS 209 Laboratory Personnel Report, Personnel records, and interview of facility personnel, one of ten testing personnel failed to have documentation of education appropriate to qualify for testing patient specimens for Blood gasses using the Gem Premier blood gas analyzer. The findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory defined ten testing personnel performing moderate complexity testing. 2. Review of personnel files found no foreign credential evaluation of education received outside the United States for testing person seven (hired 10/11/2022). Records were requested but not provided. 3. During interview of the Laboratory Director conducted July 6, 2023 at 9:37 AM, he confirmed that a foreign credential evaluation for testing person seven was necessary, but not available for review. D6066 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. -- 4 of 5 -- This STANDARD is not met as evidenced by: Based on review of the CMS 209 Laboratory Personnel Report, personnel records and interview of facility personnel found that four of ten testing personnel listed on the CMS Report 209 had no documentation of training prior to testing patient specimens using the Gem Premier 3500 blood gas analyzer. Findings included: 1. Review of the CMS Report 209 Laboratory Personnel Report found the laboratory listed 10 testing personnel performing blood gas analysis. 2. Review of laboratory personnel records found no documentation of training for four of ten testing personnel as follows: Testing person three (hire date 01/10/2022) Testing Person four (hire date 07/13 /2022) Testing Person seven (hire date 10/11/2022) Testing person eight (hire date 01 /10/2022) Training records were requested but not provided. 2. During Interview of testing person one on the CMS report 209 Laboratory Personnel Report conducted July 6, 2023 at 9:31 AM, she confirmed that no documented training records were available for review for testing persons three, four, seven and eight. -- 5 of 5 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of proficiency tests (PT) records from 2019 to 2021, CMS 155 report, and confirmed in an interview revealed the laboratory failed to retain attestation sheets for 1 of 6 PT events. The findings were: 1. Review of CMS155 report revealed the laboratory participated proficiency test (PT) in the following event: 2020 Event 3 for routine chemistry, including PH blood Gas, PCO2 blood gas, PCO2 blood gas, Glucose (non-waived), K, Na, Hematology, and Hct (non-waived) with a score of 100. 2. Review of proficiency tests records from 2019 to 2021 revealed 1 of 6 PT events had no documentation of attestation sheets. 2020 Event 3 for routine chemistry, including PH blood Gas, PCO2 blood gas, PCO2 blood gas, Glucose (non-waived), K, Na, Hematology, and Hct (non-waived) with a score of 100. 3. An interview with the laboratory director (LD) and testing personnel#1 (TP#1) on 6/1/21 at 1133 am in the conference room confirmed the above findings. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system 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 -- 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 the manufacturer's instructions, laboratory's performance verification studies, and confirmed in an interview, the laboratory failed to document reference range (normal range) verification studies for 3 of 3 analytes, pH, pCO2, and pO2 on the GEM Premier 3500 instrument. The findings were: 1. Review GEM Premier 3500 operation manual (Copyright @ January 2009 Instrument Laboratory) revealed the following reference ranges for arterial blood: pH 7.35 to 7.45 pCO2 35 to 48 mmHg (4.66 to 6.38 pKa) pO2 83 to 108 mmHg (11.04 to 14.36 pKa) 2. Review of the performance verification studies for the GEM Premier 3500 revealed the laboratory had no documentation of normal range verification studies for the reference ranges above. 3. Review CMS-116 signed by the laboratory director, the laboratory performed 1800 chemistry tests annually starting on 6/10/2019. 4. An interview with the laboratory director (LD) and testing personnel#1 (TP#1) on 6/1/21 at 1220 pm in the conference room confirmed the facility uses the manufacturer's reference range and did not perform a study to verify the normal ranges. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory and quality control test records from December 2020 to June 2021 and confirmed in interview, the laboratory failed to monitor over time 2 of 2 chemistry controls for the blood gas analysis (pH, pCO2, and pO2) on the GEM Premier 3500 instrument. Findings were: 1. Review of the laboratory quality control records from December 2020 to June 2021 revealed the laboratory used the following 2 controls for blood gas analysis (pH, pCO2, and pO2) on the GEM Premier 3500 instrument. CVP 1 lot 1840, exp 3/31/22 CVP 2 lot 2840, exp 3/31/22 2. Review of the laboratory records available revealed no documentation of the laboratory monitoring over time the accuracy and precision of the above quality controls. 3. Review of the CMS116 signed by the laboratory director on 6/1/21 revealed the laboratory performed 1800 chemistry tests annually. 4. An interview with the laboratory director on 6/1/21 at 1330 hours in the conference room confirmed the above findings. -- 2 of 2 --