Manchin Clinic Of Bridgeport

Summary Statement of Deficiencies D0000 An off site, proficiency testing (PT) desk review was conducted for Bridgeport Manchin Clinic on January 7, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. The identified unsuccessful participation is an initial occurrence and explained below. 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 CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and interview with testing 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 -- personnel (TP1), the laboratory failed to successfully participate in PT for the specialty 0760 Hematology in two consecutive testing events of 2024. Refer to D2123. D2123 HEMATOLOGY CFR(s): 493.851(c) (c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and interview with testing personnel (TP1), the laboratory failed to successfully participate in PT for 6 of 6 CMS regulated analytes in two consecutive testing events for 2024 resulting in unsuccessful participation for the specialty 0760 Hematology. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores in the specialty 0760 Hematology: Event 2 2024: 0765 WBC DIFF 0%, 0775 RBC 0%, 0785 HCT 0%, 0795 HGB 0%, 0805 WBC COUNT 0%, 0815 PLATELETS 0% Event 3 2024: 0765 WBC DIFF 0%, 0775 RBC 0%, 0785 HCT 0%, 0795 HGB 0%, 0805 WBC COUNT 0%, 0815 PLATELETS 0% 2. Review of API PT evaluations for 2024 confirmed the unsatisfactory performance of 6 of 6 regulated analytes and identified the unsatisfactory performance as "failure to participate" in Event 2 and Event 3 of 2024. 3. During a phone interview with TP1, 1/8/25 at 8:50 AM, TP1 stated the laboratory had performed the testing for the hematology PT events but had not been able to submit them to API. 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 CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), and interview with testing personnel (TP1), the laboratory director (LD) failed to ensure the laboratory successfully participated in a PT program for the specialty 0760 Hematology in two consecutive testing events of 2024. Refer to D2123. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An initial certification survey was performed at Bridgeport Manchin Clinic on June 19, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of laboratory policies and procedures (P&P), calibration records, lack of documentation, and an interview with the technical consultant (TC), the laboratory failed to perform and document calibration of the ACT2 Diff analyzer at the frequency determined by the laboratory in 2023. Findings: 1. A review of hematology P&P identified the frequency of calibration for the ACT2 Diff as every 6 months, as a step in the process of resolving QC issues, and after major maintenance. 2. A review of ACT2 Diff calibration records (2022 and 2023) identified a documented calibration performed on 10/27/2022. No documentation of calibration performed between 10/28/2022 and the analyzer being taken out of service in January 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 -- of 2024 could be located. 3. An interview with the TC, 6/19/24 at 9:00 AM, confirmed the lack of the required calibrations for the ACT2 Diff hematology analyzer from 10/28/2022 thru January 2024. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Manchin Clinic of Bridgeport on September 27, 2022, 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 are explained below. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to ensure that quality control (QC) materials used for hematology testing were not utilized beyond the expiration date for 22 of 47 days of patient testing. Findings: 1. QC record review (July 2022 thru date of survey) identified 47 days of patient testing. 2. QC record review revealed 22 of the 47 days had lots of expired QC materials documented on the analyzer printouts (8/15, 8/16, 8/17, 8/18, 8/19, 8/22, 8/23, 8/24, 8/25, 8/26, 8/29, 8 /30, 8/31, 9/1, 9/2, 9/7, 9/8, 9/9, 9/12, 9/13, 9/14, 9/15). 3. An interview with the technical consultant, 9/27/22 at approximately 11:00 AM, confirmed the findings. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to establish a system to monitor and assess the quality control (QC) system to ensure materials are not utilized beyond the expiration date for 22 of 47 days of patient testing. Findings: 1. QC record review (July 2022 thru date of survey) identified 47 days of patient testing. 2. QC record review revealed 22 of the 47 days had lots of expired QC materials documented on the analyzer printouts (8/15, 8/16, 8/17, 8/18, 8/19, 8/22, 8/23, 8/24, 8 /25, 8/26, 8/29, 8/30, 8/31, 9/1, 9/2, 9/7, 9/8, 9/9, 9/12, 9/13, 9/14, 9/15). 3. No documentation of

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Manchin Clinic Bridgeport on October 14, 2020, 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. D2121 HEMATOLOGY CFR(s): 493.851(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 a review of the laboratory proficiency testing (PT) records from the American Proficiency Institute (API) and an interview with the technical consultant (TC), the laboratory failed to attain a score of at least 80 percent for each analyte in the API 2019 Hematology/Coagulation 1st testing event. Findings: 1. Review of API records identified unsatisfactory performance scores for leukocyte count, platelet count, and white blood cell differential for the 1st testing event of 2019. a. 60% for leukocyte count b. 60% for platelet count c. 73% for white blood cell differential 2. Review of 2019 1st testing event Hematology/Coagulation identified an investigation for the unsatisfactory performance scores. 3. During an interview with the TC, on 10 /14/2020 at approximately 8:50 AM, the TC stated the unsatisfactory scores of the 2019 1st testing event were due to testing personnel error. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the 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 -- manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of written laboratory policies and procedures (P&P), calibration records, quality control records, and an interview with the technical consultant (TC), the laboratory failed to document and perform calibration of the ACT2 Diff analyzer at the frequency specified by the manufacturer. Findings: 1. A review of written laboratory P&P identified the frequency of calibration for the ACT2 Diff as every 6 months, as a step in the process of resolving QC issues, and after major maintenance. 2. A review of 2019 ACT2 Diff calibration records identified a documented calibration performed on 8/29/2019. No calibration records of the ACT2 Diff could be located for 2020. The last documented calibration of the ACT2 Diff was 8/29/2019, surpassing the time frame of the manufacturer requirement for calibration every 6 months. 3. Review of quality control records identified no systemic issues with the 3 levels of QC ran each day of patient testing. 4. During an interview with the TC, on 10 /14/2020 at approximately 10:00 AM, the TC stated that no calibration documentation after the 8/29/2019 calibration could be located. The TC stated that calibrators will be ordered and the calibration will be performed on the ACT2 Diff before the laboratory returns to patient testing. Due to the loss of testing personnel the laboratory has not been performing patient testing. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of laboratory calibration records, quality control records, and an interview with the technical consultant (TC), the laboratory failed to meet the calibration verification requirements (b)(1) and (b)(3) for the ACT2 Diff analyzer. Findings: 1. Review of 2019 and 2020 calibration records identified a failure to follow manufacturer instructions for the calibration of the ACT2 Diff analyzer. Refer to D5437. 2. The lack of calibration every 6 months on the ACT2 Diff analyzer in 2020 is a failure to meet the calibration verification requirement for automated cell counters. 3. Review of quality control records identified no systemic issues with the 3 levels of QC ran each day of patient testing. 4. During an interview with the TC, on 10 /14/2020 at approximately 10:00 AM, the TC stated that no calibration documentation after the 8/29/2019 calibration could be located. The TC stated that calibrators will be ordered and the calibration will be performed on the ACT2 Diff before the laboratory returns to patient testing. Due to the loss of testing personnel the laboratory has not been performing patient testing. 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 a review of laboratory quality control records and an interview with the technical consultant (TC), the laboratory failed to (e) document all control procedures performed. Findings: 1. Review of the QC log for point of care testing identified no documentation of QC performed on the current lots in use for the Consult McKesson FLU A/B and Strep A test kits. Manufacturer instructions require external QC be performed once per kit. a. The last FLU A/B QC documented was lot 449A21A on 4 /02/2019. The lot 440A11, expiration 1/31/2022, of FLU A/B test kits were located in the laboratory. b. No documentation of QC for Strep A could be located. The lot STA9092021, expiration 9/30/2021, of Strep A test kits were located in the laboratory. 2. During an interview with the TC, on 10/14/2020 at approximately 10:15 AM, the TC stated that no documentation of calibrations performed after September 2019 could be located. The TC also stated that the documentation of the QC for FLU A/B and Strep A would have been documented in the log book the surveyor reviewed. D6020 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 -- 3 of 4 -- director must-- (e)(5) Ensure that the quality control program is established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on a review of laboratory quality control records and calibration records, the laboratory director failed to ensure that the quality control program of the laboratory was maintained. Findings: 1. A review of quality control records identified a lack of documentation of quality control for the McKesson FLU A/B and Strep A test kits. Refer to D5441. 2. A review of calibration records identified no documentation of calibration for the ACT2 Diff since September 2019. Refer to D5437 and D5439. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory calibration records for the ACT2 Diff hematology analyzer, quality control (QC) records for point of care testing, and an interview with the technical consultant (TC), testing personnel failed to document all quality control activities and instrument calibrations performed. Findings: 1. Review of the ACT2 Diff calibration records identified the last documented calibration as 8/29/2019. Adhering to the manufacturer instructions for calibration frequency, a calibration was due February 2020 and August 2020. No records of calibrations performed after September 2019 could be located. 2. Review of the QC log for point of care testing identified no documentation of QC performed on the current lots in use for the Consult McKesson FLU A/B and Strep A test kits. a. The last FLU A/B QC documented was lot 449A21A on 4/02/2019. The lot 440A11, expiration 1/31/2022, of FLU A/B test kits were located in the laboratory. b. No documentation of QC for Strep A could be located. The lot STA9092021, expiration 9/30/2021, of Strep A test kits were located in the laboratory. 3. During an interview with the TC, on 10/14/2020 at approximately 10:15 AM, the TC stated that no documentation of calibrations performed after September 2019 could be located. The TC also stated that the documentation of the QC for FLU A/B and Strep A would have been documented in the log book the surveyor reviewed. -- 4 of 4 --

Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess and, when indicated, correct problems identified in the postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on record review of the Hematology Reportable Range Policy and patient test report and interview with technical consultant, the laboratory did not properly follow the post analytic assessment plan regarding the patient test reports. Finding include: 1. A Reportable Range Policy for the ACT Diff 2 was found within the laboratory quality assessment manual. The policy stated the following: " the acceptable ranges have been established and/or validated by the facility. The results that are greater than the high end of the validated reportable range will be reported as greater than the high end of the reportable range". The validated reportable range for WBC's was determined to be 1.4 to 8.1. This policy was signed as approved by the director on 2/1 /17 and reviewed by the director on 2/1/18. 2. A random selection of Hematology Patient Test Reports were chosen for review from 12/13/17 to 7/27/18. They are as follows: A. Patient test report #1 WBC reported as 11.2 on 12/13/17 B. Patient test report # 2 WBC reported as 12.9 on 12/28/17 C. Patient test report # 3 WBC reported as 10.4 on 12/29/17 D Patient test report #4 WBC reported as 17.7 on 7/27/18 3. During the exit interview with technical consultant at approximately 3:30PM, the technical consultant stated the 8.1 value found in the policy was an error and would need corrected. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of 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 -- 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 on the record review of the Quality Assessment Plan and interview with the testing personnel and technical consultant, the laboratory director did not consistently assure the quality of the laboratory services. Findings include: 1. The laboratory had established a Quality Assessment Plan which covered all aspects of the laboratory quality systems. Part of the plan were QA Reviews performed on a monthly schedule. Each QA Review had a signature line for director review. The forms were completed with data supporting the monthly review. However, the laboratory director proof of review signature line was blank from April 2018 through July 2018. 2. The testing person stated at 11:00 AM and the technical consultant agreed that the director was behind on his monthly review. There was a folder with sticky notes as reminders for him to review. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. This STANDARD is not met as evidenced by: Based on review of the laboratories personnel records, quality assessment plan records and interview with testing personnel and technical consultant, the laboratory failed to ensure that testing personnel possessed a valid West Virginia Clinical Laboratory Practitioner Personnel license required by the state of West Virginia to be requested at the time the employee begins testing moderate complexity CLIA certified clinical testing. Findings Include: 1. The laboratory director did not ensure proper licensing of the only testing person conducting independent testing at the laboratory from Oct 2017 until July 2018. The WV Clinical Laboratory Personnel license initial application seeking a Point of Care Technicians license was dated April 11, 2018 with the Director signature date of July 17, 2018. The testing person was not issued the license until July 24, 2018. 2. The primary testing person performed patient testing from October 2017 until July 17, 2018 without a WV Clinical Laboratory Personnel License. 3. The technical consultant stated during an 11:45 AM interview that the primary testing person had been reminded to complete the application and supporting documentation should be found in the notes of the Monthly QA plan. However, review of the Oct through July QA plan items list pertaining to personnel showed no documentation to support the licensing reminder. The director did not sign off on the CLP application for the testing person until July, 2018. 4. The testing person stated at 10:30AM that she did not know that clincal laboratory personnel licensure was required to test specimens. 4. The WV Clinical Laboratory Practitioner Personnel Licensure Rule 64CSR 57 has a penalty section pertaining to expired licenses with a sliding fee scale. A copy of the fees needed to be submitted to the state for compliance with both CLIA and state CLP licensure are attached to this statement of deficiencies. -- 2 of 2 --