Grant Memorial Hospital Respiratory

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Grant Memorial Hospital on June 29, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. 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 record review and interview the laboratory failed to ensure the acting laboratory director (LD) is qualified to fill the position. Findings: 1. Review of current personnel form CMS 209 identified a change in laboratory director. 2. The laboratory failure to notify the WV CLIA offcie of the laboratory director change resulted in no qualification process of the LD position for the laboratory until the date of survey. 3. Review of WV Board of Osteopathic Medicine primary verification identified the LD has a current medical license (DO). No documented training or experience in directing a laboratory or in supervising non-waived testing could be located. 4. An interview with the laboratory manager and the acting LD, 6/29/23 at approximately 8:35 AM, confirmed the lack of training and documented experience in directing a laboratory or supervising non-waived testing to meet the required qualifications. D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license 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 -- 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 on record review and interview the laboratory failed to ensure the acting technical consultant (TC) for the laboratory is qualified to fill the position. Findings: 1. Review of current CMS 209 personnel form identified a change in the TC. 2. Review of WV Board of Osteopathic Medicine primary source verification identified the TC has a current medical license (DO). No documented training or experience in directing a laboratory or in supervising non-waived testing could be located. 4. An interview with the laboratory manager and the acting TC, 6/29/23 at approximately 8: 35 AM, confirmed the lack of training and documented experience in directing a laboratory or in supervising non-waived testing to meet the qualification requirements for the position. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Grant Memorial Hospital Respiratory on July 14, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview the laboratory failed to enroll 4 of 4 CMS regulated Blood Gas analytes in an approved proficiency testing (PT) program for 2 of 3 2020 testing events. Findings: 1. Review of College of American Pathologists (CAP) PT records identified no enrollment for the analytes PH, PO2, PCO2, and HGB for the 1st 2020 and 2nd 2020 PT events. No other documentation of PT participation could be located. 2. An interview with the laboratory manager, 7/14/21 at approximately 1:30 PM, confirmed the findings. 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 D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the laboratory failed to take and document remedial action for unacceptable analyte scores in the College of American Pathologists (CAP) 3rd testing event of 2018. Findings: 1. A review of the 3rd testing event AQ-C of 2018 records revealed that no documentation of an investigation or remedial action regarding the unsuccessful analytes occurred. Specimen AQ-12 had unacceptable results for PH, PCO2, and PO2. 2. An interview with TP1, 7/17/19 at approximately 917 AM, confirmed that the CAP survey AQ-C 2018 had no investigation of unsuccessful analyte results and no remedial action was taken. 3. This is a repeat deficiency. On 5/02/17, the laboratory was cited the same D-Tag 2094. The