Stewart Memorial Community Hospital

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of American Proficiency Institute (API) proficiency testing (PT) records and confirmed by interview with technical supervisor #1 (TS #1) at 9:30 am on 01/28/2026, the laboratory failed to take and document

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on October 6, 2025. The laboratory was found to be out of compliance with the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R 493.803 Condition: Successful Participation D6000 - 42 C.F.R 493.1403 Condition: Laboratory Director, Moderate Complexity 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 Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two out of three consecutive 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 -- testing events for the analyte, anti-human immunodeficiency virus (HIV). The laboratory had unsatisfactory scores for 2024 event 3 and 2025 event 2. Refer to D2084. D2084 GENERAL IMMUNOLOGY CFR(s): 493.837(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 the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory failed to successfully participate in two out of three consecutive testing events for the analyte, anti-human immunodeficiency virus (anti-HIV). The findings include: 1. For 2024 event 3, the laboratory received an unsatisfactory performance score of 40% for the analyte, anti-HIV. 2. For 2025 event 2, the laboratory receive an unsatisfactory performance score of zero for the analyte, anti- HIV. 3. The CASPER 155 report and graded results from API confirm the findings listed above. 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 Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (2024 event 3 and 2025 event 2), the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the Certification and Survey Provider Enhanced Reporting (CASPER) 155 report and graded results from the American Proficiency Institute (API), the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2084. -- 2 of 2 --

Summary Statement of Deficiencies D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the blood bank procedures and temperature logs and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 12:12 pm on 2/29/2024, the laboratory failed to perform quarterly alarm checks for three out of four quarters from 1/1/2023 - 12/31/2023. The findings include: 1. The Blood Bank Alarm Check procedure states alarm checks will be performed quarterly. 2. The laboratory performed an alarm check on 6/13/2023. 3. The laboratory did not perform any other alarm checks in 2023. 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. This STANDARD is not met as evidenced by: Based on review of laboratory temperature logs and the blood bank refrigerator 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 -- temperature wheel and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 12:12 pm on 2/29/2024, the laboratory failed to correct problems identified with the blood bank refrigerator monitoring system for seven out of seven days from 12/24/2023 - 12/31/2023. The findings include: 1. The laboratory manually documented the following temperatures in Celsius (C) for the blood bank refrigerator: *12/24/23 Upper = 3.2 and Lower = 3.8 *12/25/23 Upper = 3. 2 and Lower = 3.7 *12/26/23 Upper = 3.1 and Lower = 3.7 *12/27/23 Upper = 3.2 and Lower = 3.8 *12/28/23 Upper = 3.2 and Lower = 3.7 *12/29/23 Upper = 3.2 and Lower = 3.7 *12/30/23 Upper = 3.2 and Lower = 3.7 *12/31/23 Upper = 3.2 and Lower = 3.7 2. The blood bank temperature wheel documented the temperature for the above dates as somewhere between 1 degree C and 4 degrees C. The temperature wheel recorded a thick line between 1 degree C and 4 degrees C, it did not record the exact temperatures. 3. At the time of the survey, the laboratory did not have documentation of

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of coagulation reagent study records, direct observation, and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:10 am on 02/16/2022, the laboratory failed to retain records used to establish the normal patient mean for one out of one lot number of thromboplastin reagent (lot 549763, expiration 11/28/2022). The findings include: 1. The laboratory established a normal patient mean of 10.8 seconds for thromboplastin lot 549763 (expiration 11/28/2022) in November 2021. 2. The coagulation reagent study records for lot 549763 (expiration 11/28/2022) did not include the patient test results and records used to establish the normal patient mean. 3. Observation of the thromboplastin reagent in the laboratory's refrigerator confirmed current use of lot 549763 (expiration 11/28/2022). 4. At the time of the survey, personnel identifier #2 confirmed that the laboratory did not retain the patient test results and records used to establish the normal patient mean for thromboplastin lot 549763 (expiration 11/28 /2022). D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) 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 -- (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on lack of performance specification records and confirmed by Laboratory Personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3: 25 pm on 02/16/2022, the laboratory failed to verify the performance specifications of accuracy and precision for the Alere QuikDiff Complete Clostridium difficile antigen /toxin test system. The findings include: 1. The laboratory began using the Alere QuikDiff Complete Clostridium difficile antigen/toxin test system in May 2020. 2. At the time of the survey, the laboratory did not have performance specification records for this test system. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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: A. Based on lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 02/16/2022, the laboratory failed to perform a positive and negative control each day of patient testing for the following test systems: ActimProm rupture of membranes (ROM), Alere QuikDiff Complete clostridium difficile, Alere Determine human immunodeficiency virus (HIV) 1/2 antibody/antigen, and Quidel Solana (Streptococcus A and SARS CoV-2). The findings include: 1. The laboratory performed controls with each new lot and shipment of tests for the following test systems: ActimProm ROM, Alere QuikDiff Complete clostridium difficile, and Alere Determine HIV 1/2 antibody/antigen. 2. The laboratory performed controls with each new lot and shipment of tests and monthly for the Quidel Solana (Streptococcus A and SARS CoV-2) test system. 3. Laboratory personnel identifier #2 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 4. At the time of the survey, the laboratory did not have an IQCP for the ActimProm ROM, Alere QuikDiff Complete clostridium difficile, Alere Determine HIV 1/2 antibody /antigen, and Quidel Solana test systems. B. Based on lack of Individualized Quality Control Plan (IQCP) records, review of quality control (QC) records, and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3:00 pm on 02/16/2022, the laboratory failed to perform two levels of QC each day of patient testing for the Opti CCA-TS2 test system. The findings include: 1. The laboratory performed QC with each new lot and shipment of test cartridges and monthly. 2. Laboratory personnel identifier #2 indicated that the laboratory intended to follow manufacturer's instructions for performing QC. 3. At the -- 2 of 4 -- time of the survey, the laboratory did not have an IQCP for the Opti CCA-TS2 test system. C. Based on review of the laboratory's Individualized Quality Control Plan (IQCP) and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 02/16/2022, the laboratory failed to include a risk assessment as part of the IQCP for the BioFire FilmArray (gastrointestinal and respiratory panels) test system. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Test List and Annual Volume form, lack of media quality control (QC) records, lack of an Individualized Quality Control Plan (IQCP), and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 3:30 pm on 02/16/2022, the laboratory failed to check each lot of Cary Blair transport media for sterility, ability to support growth, and ability to select or inhibit specific organisms or produce a biochemical response, as appropriate, from the last survey on 12/12/2019 to the time of the survey on 02/16/2022. The findings include: 1. Review of the Test List and Annual Volume form indicated that the laboratory uses the BioFire FilmArray test system to perform gastrointestinal (GI) panel testing. 2. The laboratory's BioFire GI Panel Testing procedure indicated that stool specimens must be placed in Cary Blair transport media prior to testing. 3. Personnel identifier #2 indicated that the laboratory intended to retain the manufacturer's QC certificates and not perform additional QC. 3. At the time of the survey, the laboratory did not retain the manufacturer's QC certificates and did not have an IQCP. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 8:20 am on 02/16/2022, the technical supervisor failed to assess and document the competency of individuals performing high complexity testing at least annually for three out of 11 testing personnel and three out of three years from 2019- 2021. The findings include: 1. Review of personnel records indicated that personnel identifier #7 did not have a -- 3 of 4 -- competency evaluation completed in 2019. 2. Review of personnel records indicated that personnel identifiers #6, #7, and #12 did not have competency evaluations completed in 2020. 3. Review of personnel records indicated that personnel identifiers #7 and #12 did not have competency evaluations completed in 2021. 4. At the time of the survey, personnel identifier #2 confirmed that competency evaluations were not completed for personnel identifiers #6, #7, and #12 for the years listed above. -- 4 of 4 --

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 proficiency records and reports, the laboratory failed to successfully participate in a proficiency testing program for the analyte, alanine aminotransferase (ALT) for three out of four consecutive proficiency testing events: 2019 event 3 and 2020 events 1 and 3. (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory failed to achieve satisfactory performance for the analyte, alanine aminotransferase (ALT), for three out of four testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2019 testing event 3, 60% for 2020 testing event 1, and zero for 2020 testing event 3. -- 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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, automated white blood cell (WBC) differential, for two consecutive testing events: 2020 events 1 and 2 (refer to D2130). D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 -- events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) reports and records, the laboratory fails to achieve satisfactory performance for the analyte, automated white blood cell (WBC) differential, for two consecutive PT events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2020 testing event 1 and 24% for 2020 testing event 2. -- 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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, alanine aminotransferase (ALT), for two consecutive proficiency testing events: 2019 event 3 and 2020 event 1 (refer to D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test 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 or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, alanine aminotransferase (ALT), for two consecutive testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 60% for 2019 testing event 3 and 2020 testing event 1. -- 2 of 2 --

Summary Statement of Deficiencies No Tags No deficiency details available. 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 proficiency records and reports, the laboratory fails to successfully participate in a proficiency testing program for the analyte, compatibility testing, for three out of four consecutive testing events: 2017 events 1 and 2 and 2018 event 1(refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 -- 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 proficiency testing reports and records, the laboratory fails to achieve satisfactory performance for the analyte, compatibility testing, for three out of four testing events for unsuccessful participation. The laboratory received unsatisfactory performance scores of 40% for 2017 testing event 1, 80% for 2017 testing event 2, and 80% for 2018 testing event 1. -- 2 of 2 --