Wood Health Care Clinic P C

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Wood Health Care Clinic P C on October 21, 2025, 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. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with Testing Personnel 1 (TP1), the laboratory failed to accurately monitor the conditions essential for the proper storage of reagents and test system operation. Findings: 1. The temperature of the refrigerator the reagent storage refrigerator and the incubator were being monitored and documented from a NIST thermometer that had expired. 2. An interview with Testing Personnel 1 (TP1), on 8/6/19 at approximately 1130 AM, confirmed that the thermometers used to monitor the temperatures in the refrigerator and the incubator had expired calibrations. 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 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 proficiency testing records from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for each analyte on the CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER report 153D for failed proficiency testing results, found a PT failure for the laboratory for analyte #0365 (cholesterol, total). 2. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory scores for total cholesterol: a. 40% for 3rd event 2018 b. 60% for 1st event 2019 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records from the American Proficiency Institute (API), the laboratory produced unsatisfactory results for the same analyte in two consecutive testing events. Findings: 1. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory scores for total cholesterol: a. 40% for 3rd event 2018 b. 60% for 1st event 2019 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 proficiency testing records, the laboratory director failed to provide overall management and direction in accordance with the regulations. Findings: 1. Refer to citation at D6004 for details. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of proficiency testing records, the laboratory director failed to ensure satisfactory performance of proficiency testing. Findings: 1. Review of API Proficiency Testing evaluation scores for 3rd event 2018 and 1st event 2019 demonstrated unsatisfactory scores for total cholesterol, as follow: a. 40% for 3rd event 2018 b. 60% for 1st event 2019 -- 2 of 2 --

Summary Statement of Deficiencies 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 American Proficiency Institute (API) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile for Wood Health Care Clinic, the laboratory failed to successfully participate in a program approved by CMS for the Chemistry analyte of Sodium (NA) for the (2nd Event 2018, and 3rd Event 2018). The findings include: 1. Routine Chemistry - Sodium (NA) Event 2 (2018) - 0 % Event 3 (2018) - 20% D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile for Wood Health Care Clinic, the laboratory failed to receive satisfactory scores for the Routine Chemistry analyte of Sodium (NA) for the (2nd Event 2018, and 3rd Event 2018). The findings include: 1. The NA analyte received a score of 0% for the 2nd Routine Chemistry API proficiency testing of 2018. 2. The NA analyte received a score of 20% for the 3rd Routine Chemistry API proficiency testing event of 2018. 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 American Proficiency Institute (API) records and the CLIA 155 Individual Laboratory Profile, the laboratory director failed to ensure successful participation in a program approved by Centers for Medicare and Medicaid Services (CMS) for the analyte of sodium (NA) (2nd event 2018 and 3rd Event 2018). The findings include: 1. Refer to details outlined in standard D2087. 2. Refer to details outlined in standard D6004. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) records and the CLIA 155 Individual Laboratory Profile, the laboratory director failed to ensure compliance with the regulation requiring successful participation in PT testing (D2016) for the analyte of Sodium (NA) (2nd event 2018 and 3rd Event 2018). The findings include: 1. The Sodium (NA) analyte received a score of 0% for the 2nd Routine Chemistry API proficiency testing of 2018. 2. The Sodium (NA) analyte received a score of 20% for the 3rd Routine Chemistry API proficiency testing event of 2018. -- 2 of 2 --