Summary:
Summary Statement of Deficiencies D0000 A validation survey for the College of American Pathologists (CAP) was performed at United Hospital Center Resp Care on February 4, 2026, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderate complexity testing must-- (a) possess a current license issued by the State in which the laboratory is located, if such licensing is required; and This STANDARD is not met as evidenced by: Based on review of laboratory CMS 209 form, current test menu, WV LAB-PLUS license verification database, patient results from the EPIC laboratory information system (LIS), and interview with the laboratory manager, 33 of 40 testing personnel (TP) did not have a Clinical Laboratory Practitioner (CLP) license as required by the WV CLP Licensing and Certification Rule, 64 CSR 57. 31 of 33 unlicensed TP released chemistry results from 1/8/25 thru date of survey. Findings: 1. Review of the 2/2/2026 CMS 209 form revealed 40 listed TP for the respiratory therapy laboratory. 2. Review of current test menu, submitted by the laboratory pre-survey, identified respiratory therapy testing on IL Gem Premier 5000 analyzers for blood gas analytes (pH, PCO2, PO2), oximetry (carboxyhemoglobin, methemglobin, oxyhemoglobin, total hemoglobin), and chemistry analytes (sodium, potassium, chloride, ionized calcium, glucose, lactate). 3. Individuals licensed as Respiratory Therapists by the West Virginia Board of Respiratory Care are exempt from the CLP licensure rule under 57-1.6.c.3. if testing is limited to blood gases and oximetry. The chemistry analytes on the current test menu (sodium, potassium, chloride, ionized calcium, glucose, lactate) are not blood gases or oximetry analytes and TP must hold a valid 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 -- WV CLP license. 4. Review of WV LAB-PLUS license verification database identified 33 of 40 TP without the required current WV CLP license (TP1, TP2, TP3, TP4, TP5, TP6, TP7, TP8, TP9, TP10, TP11, TP12, TP13, TP14, TP15, TP16, TP17, TP18, TP19, TP20, TP21, TP22, TP23, TP24, TP25, TP26, TP27, TP28, TP29, TP30, TP31, TP32, TP33). 5. Review of EPIC LIS patient results for respiratory therapy testing (January 2025 thru date of survey) identified the following sodium, potassium, chloride, ionized calcium, glucose, or lactate patient results released without the required WV CLP license by 31 of the 33 unlicensed TP: 12/12/25: 1092255819 (TP3) sodium 11/19/25: 1090719871 (TP4) sodium 11/24/25: 1091412970 (TP5) sodium 02/03/26: 1094604514 (TP6) sodium 02/16/25: 1078259308 (TP7) lactate 09 /23/25: 1088487593 (TP8) sodium 12/20/25: 1092608568 (TP9) sodium 03/29/25: 1080216628 (TP10) sodium 06/23/25: 1084162793 (TP11) sodium 12/01/25: 1091726949 (TP12) sodium 12/10/25: 1092169293 (TP13) sodium 12/02/25: 1091773636 (TP14) sodium 02/04/26: 1094652492 (TP15) sodium 12/12/25: 1092283068 (TP16) lactate 11/21/25: 1091309865 (TP17) sodium 06/19/25: 1084055218 (TP18) sodium 10/19/25: 1089726826 (TP19) sodium 09/09/25: 1087796794 (TP20) sodium 06/21/25: 1084116014 (TP21) lactate 09/21/25: 1088373309 (TP22) sodium 12/23/25: 1092717548 (TP23) sodium 01/08/25: 1076497845 (TP24) sodium 11/29/25: 1091640738 (TP25) lactate 03/22/25: 1079888492 (TP26) sodium 11/19/25: 1091223607 (TP27) sodium 12/27/25: 1092870292 (TP28) sodium 06/16/25: 1083851606 (TP29) sodium 11/19/25: 1091223607 (TP30) sodium 11/20/25: 1091293349 (TP31) sodium 02/10/25: 1077991193 (TP32) ionized calcium 12/05/25: 1091938692 (TP33) sodium 6. During an interview, 2/4/26 at 10:00 AM, the laboratory manager verified the lack of required licensure for the 33 of 40 TP, release of patient results by 31 of 33 unlicensed TP, and stated the sodium, potassium, chloride, ionized calcium, glucose, and lactate testing on the IL Gem Premier 5000 analyzers would cease immediately and not resume until all TP had a current, valid WV CLP license. -- 2 of 2 --