Welch Community Hospital

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Welch Community Hospital on July 29, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation is the second occurrence involving three of ten laboratory testing personnel 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 the College of American Pathologists (CAP), signed CAP PT Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- attestation records, and the laboratory personnel roster (CMS-209 from 7/30/25), the laboratory failed to achieve satisfactory performance for analyte #0415 glucose in three of three consecutive testing events in 2024 and 2025, and has sustained a subsequent occurrence of unsuccessful participation in PT involving three of 10 testing personnel. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, PT evaluations from College of American Pathologists (CAP), current personnel roster (CMS-209), and signed CAP attestation records, the laboratory failed to achieve satisfactory performance for the analyte #0415 glucose in three of three consecutive testing events and has sustained a second occurrence of unsuccessful participation in PT involving three of 10 testing personnel. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0415 glucose: 60% 2024 event 3 40% 2025 event 1 60% 2025 event 2 2. Review of CAP PT evaluation reports confirmed the unsatisfactory scores and second unsuccessful performance for analyte #0415 glucose in three of three consecutive testing events. 3. Review of laboratory personnel roster (CMS-209), from 7/30/2025, identified TP1, TP2, and TP3 as current testing personnel. 4. Review of signed CAP attestation records identified three of 10 testing personnel (TP) responsible for the testing events. 60% 2024 event 3 (performed by TP1, TP2, TP3) 40% 2025 event 1 (performed by TP1) 60% 2025 event 2 (performed by TP1) 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 the College of American Pathologists (CAP), signed CAP PT attestation records, and the current personnel roster (CMS-209), the laboratory director failed to ensure deficient practices leading to the initial unsuccessful participation in PT for analyte #0415 glucose were corrected, resulting in a subsequent occurrence of unsuccessful participation in three of three consecutive testing events, involving three of 10 testing personnel in 2024 and 2025. Refer to D6019. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) (e)(4)(iv) An approved

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Welch Community Hospital on July 25, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. 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 and PT evaluations from the College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for toxicology analyte #0610 acetaminophen in two 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 -- consecutive testing events, resulting in an initial occurrence of unsuccessful participation in PT. Refer to D2109. D2109 TOXICOLOGY CFR(s): 493.845(a) (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 CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from the College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for the toxicology analyte #0610 acetaminophen (serum) in two consecutive events of 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0610 acetaminophen (serum): 60% 2025 event 1 60% 2025 event 2 2. Review of 2025 CAP General Chemistry/Therapeutic Drugs PT evaluation reports confirmed the unsatisfactory scores for toxicology analyte #0610 acetaminophen (serum) in two consecutive PT events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Welch Community Hospital on May 2, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. 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 the College of American Pathologists (CAP), and confirming phone interview with testing personnel (TP1), the laboratory failed to achieve satisfactory 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 -- performance for analyte #0415 glucose in two consecutive testing events in 2024 and 2025, resulting in an initial occurrence of unsuccessful PT participation. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from the College of American Pathologists (CAP), and phone interview with testing personnel (TP1), the laboratory failed to achieve satisfactory performance for the analyte #0415 glucose in two consecutive testing events in 2024 and 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report identified the following unsatisfactory scores for analyte #0415 glucose:60% 2024 event 3 40% 2025 event 1 2. Review of CAP evaluation reports confirmed the unsatisfactory scores for the analyte #0415 glucose in the two consecutive testing events in 2024 and 2025. 3. A phone interview with TP1, 5/5/25 at 9:00 AM, verified the initial occurrence of unsuccessful participation in PT for analyte #0415 glucose in two consecutive testing events (2024 event 3 and 2025 event 1). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Welch Community Hospital, completed on April 16, 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. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on policies and procedures (P&P), personnel record review, and interview the laboratory failed to ensure 5 of 9 testing personnel (TP) had a documented competency evaluation for the performance of manual differential testing in 2023. Findings: 1. Review of laboratory general P&P revealed a process for assessing TP competency for all test methodologies at prescribed intervals. 2. Review of hematology competency assessment records for 2023 revealed documented evaluations of manual differential testing for 4 of 9 TP (TP6, TP7, TP8, TP9) in 2023. No documentation for the evaluation of manual differential testing in 2023 for 5 of 9 TP (TP1, TP2, TP3, TP4, TP5) could be located. 3. An interview with the general supervisor, 4/15/24 at 11:00 AM, confirmed that no documented competency for the performance of manual differentials could be located for 5 of 9 TP in 2023. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to perform external quality control (QC) each day of patient testing for moderate complexity Alere Triage Tox Drug Screen and Alere Triage BNP testing for 12 of 12 months in 2023. Findings: 1. Review of QC records (January thru December 2023) for Alere Triage Tox Drug Screen testing identified external QC documented monthly and with each new lot or shipment of test kits. 2. Review of QC records (January thru December 2023) for Alere Triage BNP testing identified external QC documented monthly and with each new lot or shipment of test kits. 3. No Individualized Quality Control Plan (IQCP) for Alere Triage Tox Drug Screen or Alere Triage BNP testing could be located. 4. An interview with testing personnel (TP1), 4/16/24 at 12:15 PM, confirmed no IQCP could be located and external QC was not being run each day of patient testing for Alere Triage Tox Drug Screen or BNP testing. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on policies and procedures (P&P), record review, and interview, the laboratory failed to establish a system for performing and evaluating comparison studies for test results between the two Coulter DxH 690T analyzers in hematology and between the two Siemens Dimension EXL 200 analyzers in chemistry. Findings: 1. Review of 2022 and 2023 records revealed comparisons were being performed monthly between the hematology analyzers and between the chemistry analyzers.. 2. No P&P could be located in the hematology, chemistry, or general laboratory procedure manuals that defined the process used to compare test results, criteria for evaluating the data, and the frequency of performance. 3. An interview with the testing personnel and general supervisor, 4/16/24 at 10:30 AM, confirmed that no P&P defining the frequency of the comparison between analyzers and the criteria for evaluation of the test results could be located. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Welch Community Hospital on March 1 and March 2 2022, 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. D3025 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(d) Investigation of transfusion reactions. The facility must have procedures for preventing transfusion reactions and when necessary, promptly identify, investigate, and report blood and blood product transfusion reactions to the laboratory and, as appropriate, to Federal and State authorities. This STANDARD is not met as evidenced by: Based on record review, review of policies and procedures (P&P), lack of documentation, and interview the facility failed to establish and define the specific criteria and parameters to promptly identify a blood or blood product transfusion reaction in 4 of 4 facility P&P reviewed. Findings: 1. Review of 2020 and 2021 laboratory blood bank transfusion records revealed no transfusion reactions identified in the two years. 2. Review of facility P&P related to blood product transfusions and transfusion reactions revealed no definition of the specific criteria and the parameters that indicate a possible transfusion reaction in all 4 reviewed. a. "Investigation of Adverse Transfusion Reactions" states all unfavorable events and adverse outcomes must be reported to the laboratory and names the different types of transfusion reactions. No specific criteria or defined parameters that indicate a transfusion reaction could be located. b. "Administration of Blood to Patients" states that the recipient must be closely observed for signs and symptoms of adverse reactions. No definition of the specific criteria and the parameters that indicate a possible transfusion reaction could be located. c. "Blood Administration" describes the process 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 -- of transfusing blood products and the time frame for taking recipient vital signs. No definition of the specific criteria and the parameters that indicate a possible transfusion reaction could be located. d. "Blood Reaction" details the process to take if a transfusion reaction is suspected. No definition of the specific criteria and the parameters that indicate a possible transfusion reaction could be located. 3. An interview with the general supervisor, 3/1/2022 at approximately 1:30 PM, confirmed that no defined parameters and specific criteria to identify a possible blood transfusion reaction could be located in the facility P&P. D3035 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(ii) In addition, the laboratory must retain immunohematology records, blood and blood product records, and transfusion records as specified in 21 CFR 606.160(b)(3)(ii), (b) (3)(iv), (b)(3)(v), and (d). This STANDARD is not met as evidenced by: Based on record review, lack of documentation, policies and procedures (P&P), and interview the laboratory failed to retain complete immunohematology records for 5 of 7 patient transfusion records reviewed. Findings: 1. Review of the 7 emergency release patient records from 2020 and 2021 identified the following 5 patient records with a lack of documentation : 3/23/2020 4 units documented on the emergency release form, no transfusion forms could be located for 2 of the 4 units 8/20/2020 2 units documented on emergency release form, no transfusion forms could be located for the 2 units 10/4/2020 2 units documented on emergency release form, no transfusion forms could be located for the 2 units 2 more units written in the transfusion log book, no transfusion forms could be located 1/7/2021 7 units listed on the emergency release form, no transfusion forms could be located for the 7 units 4 units of FFP written in the transfusion log book, no transfusion forms could be located 6/7/2021 1 unit documented on emergency release form, no transfusion form could be located 2 more units written in the transfusion log book, no transfusion form could be located for 1 of the 2 2. Review of P&P for the laboratory blood bank identified "Administration of Blood to Patients" which states a transfusion record must be completed for each unit of blood transfused. No written process for the completion and retention of patient transfusion records could be located. Refer to D5403. 3. An interview with the general supervisor, on 3/1/2022 at approximately 4:00 PM, confirmed the findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to verify the accuracy for three of three CMS unregulated analytes in 2020 and 2021. Findings: 1. Review of proficiency testing records revealed that KOH, Wet Prep, and DAT testing had no documentation of enrollment in a commercial proficiency testing program. 2. Review of Subpart I (regulated analytes) identified KOH, Wet Prep, and DAT testing are not classified by CMS as regulated analytes. 3. No documentation of -- 2 of 4 -- biannual accuracy verification of KOH, Wet Prep, and DAT testing could be located for 2020 and 2021. 4. An interview with the general supervisor, 3/1/22 at approximately 10:00 AM, confirmed that KOH, Wet Prep, and DAT testing had no commercial PT and verification of accuracy was not performed for 2020 and 2021. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a review of the laboratory College of American Pathologist (CAP) proficiency testing (PT) records and an interview with General Supervisor 1 (GS1), the laboratory failed to achieve satisfactory analyte performance for the analyte of bacteriology gram stain in the 2nd testing event of 2019. Findings: 1. A review of 2018 and 2019 CAP PT records identified the result for 2019 CAP D5-B 2nd testing event bacteriology as 60%. Specimens D5-06, D5-08, and D5-09 had unacceptable gram stain results by the laboratory. 2. An interview with GS1, on 01/06/2020 at approximately 12:25 PM, confirmed the findings. 3. A review of laboratory PT records revealed an appropriate investigation of the 2019 CAP D5-B unsatisfactory performance of 60% for bacteriology analyte gram stain documented. D2109 TOXICOLOGY CFR(s): 493.845(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 College of American Pathologist (CAP) proficiency testing (PT) records and an interview with General Supervisor 1 (GS1), the laboratory failed to achieve satisfactory analyte performance for the analyte alcohol in the 2nd testing event of 2019. Findings: 1. A review of 2018 and 2019 CAP 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 -- PT records identified the result for 2019 CAP AL2-B 2nd testing event alcohol as 60%. Specimens 09 and 10 had unacceptable alcohol results by the laboratory. 2. An interview with GS1, on 01/06/2020 at approximately 12:25 PM, confirmed the findings. 3. A review of laboratory PT records revealed an appropriate investigation of the 2019 CAP CGL-B unsatisfactory performance of 60% for alcohol documented. 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 College of American Pathologists (CAP) proficiency testing (PT) records and an interview with General Supervisor 1 (GS1), the laboratory failed to achieve satisfactory analyte performance for the analyte fibrinogen in the 3rd testing event of 2019. Findings: 1. A review of 2018 and 2019 CAP PT records identified the result for 2019 CAP CGL-C 3rd testing event fibrinogen as 60%. Specimens 13 and 15 had unacceptable fibrinogen results by the laboratory. 2. An interview with GS1, on 01/06/2020 at approximately 12:45 PM, confirmed the findings. 3. A review of laboratory PT records revealed an appropriate investigation of the 2019 CAP CGL-C unsatisfactory analyte performance of 60% for fibrinogen documented. -- 2 of 2 --

Summary Statement of Deficiencies 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 College of American Pathologists (CAP) proficiency testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to achieve satisfactory performance for the analytes of Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, and Valproic Acid for PT event C-C 2016 General Chemistry/Therapeutic Drugs. The findings include: 1. Review of the C-C 2016 CAP proficiency testing records identified the results for Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, and Valproic Acid were 60%. 2. On 1 /23/18 at approximately 11:00 AM, the LM confirmed the findings. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the College of American Pathologists (CAP) proficiency testing (PT) records and interview with the Laboratory Manager (LM), the laboratory failed to achieve satisfactory performance for compatibility testing for J-A 2017 Transfusion Medicine(Comp). The findings include: 1. Review of the CAP proficiency testing records identified the result for J-A 2017 Transfusion Medicine(Comp) was 80%. 2. On 1/23/18 at approximately 11:00 AM, the LM 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 2 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, "QuickVue+ Strep A test" manufacturer's instructions, quality control records, "Strep A Internal and External Quality Control Log", "QuickVue+ Strep A test" patient records and interview with the Laboratory Manager (LM), the laboratory failed to perform and document a positive and negative control 308 of 346 days of patient testing in 2016 and 320 of 357 days of patient testing in 2017 for the "QuickVue+ Strep A test". Record review was from 1/1/16 to 12/31/17. The findings include: 1. Review of the laboratory's policy and procedure manual identified a policy "Quality Assessment- Waived Testing Kits", which states "As part of the laboratory's quality assurance plan, positive and negative external controls will be run with each shipment of a new lot number, with each shipment date or monthly on waived testing kits." 2. Review of the manufacturer's instructions for the "QuickVue+ Strep A test" identified the "QuickVue+ Strep A test" is "CLIA Complexity: Moderate". 3. On 1/23/18 at approximately 11:00 AM, the LM stated that she did not know the "QuickVue+ Strep A test" was "CLIA Complexity: Moderate". 4. Review of quality control records for the "QuickVue+ Strep A test" identified documentation of quality control for the following days in 2016: 1/1/16, 1/31/16, 2/1/16, 2/15/16, 2/25/16, 3/5/16, 3/13/16, 3 /18/16, 3/23/16, 3/28/16, 3/29/16, 3/30/16, 3/31/16, 4/2/16, 4/9/16, 4/10/16, 4/15/16, 4 /21/16, 4/23/16, 5/3/16, 5/8/16, 5/17/16, 5/24/16, 6/2/16, 6/16/16, 8/20/16, 9/3/16, 9/27 /16, 10/1/16, 11/10/16, 11/12/16, 11/21/16, 11/22/16, 12/7/16, 12/15/16, 12/19/16, and 12/26/16. 5. Review of quality control records for the "QuickVue+ Strep A test" identified documentation of quality control for the following days in 2017: 1/3/17, 1/9 /17, 1/14/17, 1/20/17, 1/25/17, 2/3/17, 2/4/17, 2/5/17, 2/7/17, 3/1/17, 3/16/17, 3/20/17, 3/25/17, 3/29/17, 4/13/17, 4/24/17, 5/11/17, 5/20/17, 5/23/17, 5/28/17, 6/5/17, 6/16 /17, 7/3/17, 8/13/17, 9/13/17, 9/30/17, 10/21/17, 11/2/17, 11/11/17, 11/16/17, 11/22 /17, 11/23/17, 11/28/17, 12/8/17, 12/12/17, and 12/18/17. 6. Review of the laboratory's ""QuickVue+ Strep A test" patient records identified patient testing was performed on the following days in 2016: 1/1/16 to 6/7/16, 6/9/16 to 6/30/16, 7/3/16 to 7/8/16, 7/11/16 to 7/15/18, 7/18/16, 7/20/16, 7/22/16, 7/24/16, 7/25/16, 7/27/16 to 7 /30/16, 8/1/16 to 8/10/16, 8/12/16, 8/14/16 to 8/19/16, 8/21/16 to 8/27/16, 8/29/16 to 8 /31/16, 9/2/16 to 9/16/16, 9/18/16 to 9/30/16, and 10/1/16 to 12/31/16. 7. Review of the laboratory's ""QuickVue+ Strep A test" patient records identified patient testing was performed on the following days in 2017: 1/1/17 to 1/5/17, 1/7/17 to 4/14/17, 4/16 /17 to 6/23/17, 6/25/17 to 8/1/17, 8/3/17 to 8/18/17, 8/20/17 to 8/22/17, 8/24/17 to 9/1 /17, 9/2/17, 9/4/17 to 9/30/17, and 10/1/17 to 12/31/17. 8. On 1/23/18 at approximately 11:00 AM, the LM confirmed the findings. -- 2 of 2 --