Riverside Tangier Medical Center

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Riverside Tangier Medical Center on May 15, 2025 by the Virginia Department of Health's Office of Licensure and Certification. The inspection included an off-site exit interview with the laboratory director on 5/16/25. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes one Condition under 42 CFR part 493 CLIA Regulation: D6000 -42 CFR. 493.1403 Laboratory Director. D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing (PT) records, lack of documentation, and interviews, the laboratory failed to retain attestation statements signed by the laboratory director (LD) for ten (10) of fourteen (14) PT module events reviewed on the date of the inspection, May 15, 2025. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) PT documentation for fourteen event modules (2023 Event 3, 2024 Events 1-3, 2025 Event 1), revealed no signed LD attestation statements for: 2024 Chemistry Miscellaneous Event 1; 2024 Chemistry Miscellaneous Event 2; 2024 Chemistry Core Event 2; 2024 Chemistry Core Event 3; 2024 Hematology/Coagulation Event 1; 2024 Hematology/Coagulation Event 3; 2024 Microbiology Event 3; 2025 Chemistry Core Event 1; 2025 Hematology/Coagulation 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 -- Event 1; 2025 Microbiology Event 1. 10 of 14 tested module events lacked LD signed attestation records as noted on 5/15/25. 2. The inspector requested the LD attestation records. No documentation was available for the PT events outlined above. The inspector inquired of the policy for PT attestations, the LD stated on 5/16/25 at 4 PM, "We are to retain all attestations and we will improve this process". 3. Interviews with the lead testing personnel on 5/15/25 at 1:30 PM and LD on 5/16/25 at 4:00 PM confirmed the above findings. 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 a review of policies and procedures, hematology maintenance logs, monthly quality control (QC), proficiency testing (PT) records, Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, lack of documentation, and interviews, the laboratory director (LD) failed to: 1. ensure that the established quality assessment (QA) policy for monthly review of hematology QC and Levey Jennings charts was followed for nine of twenty- four months reviewed (CROSS REFERENCE D6020 A); 2. ensure that the laboratory followed QA policy for retention of attestation statements for ten of fourteen PT module events reviewed (CROSS REFERENCE D6020 B); and 3. ensure that the laboratory followed their established policy to document hematology and chemistry six month competency assessments for one new testing personnel during the twenty- four months reviewed (CROSS REFERENCE D6053). D6020 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: A. Based on a review of policies and procedures, hematology maintenance logs, monthly quality control (QC) records, and interviews, the laboratory director (LD) failed to ensure that the established quality assessment (QA) policy for monthly review of hematology QC and Levey Jennings (LJ) charts was followed for nine (9) of twenty-four (24) months reviewed (survey timeframe: May 27, 2023 to May 15, 2025). Findings include: 1. Review of the laboratory's policies and procedures revealed a QA policy that included LD to review monthly quality checklists. 2. Review of the laboratory's hematology maintenance protocols revealed instructions to "review of QC, review of Levy Jennings, and review of patient results to be checked as completed monthly". 3. Review of the laboratory's Sysmex pocH instrument maintenance logs for the survey timeframe of 5/27/23 to 5/15/25 revealed no documentation that the QA review of QC, review of LJ, and review of patient results was completed for the following months: January 2024 July 2024 October 2024 November 2024 December 2024 January 2025 February 2025 March 2025 April 2025 -- 2 of 3 -- A total of 9 of 24 months lacked required QA monitoring for hematology QC and patient review. 4. The inspector requested to review documentation of the hematology QC review for the months outlined above. No records were provided. 5. Interviews with the lead testing personnel on 5/15/25 at 1:30 PM and LD on 5/16/25 at 4:00 PM confirmed the above findings. B. Based on a review of the laboratory's proficiency testing (PT) records, lack of documentation, and interviews, the Laboratory Director failed to ensure that the laboratory followed their Quality Assurance (QA) policy for retention of attestation statements for ten of fourteen PT module events reviewed on the date of the inspection, May 15, 2025. Cross Reference D2014. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), laboratory personnel files, laboratory's policies and procedures, lack of documentation, and an interview, the technical consultant (TC) failed to follow established policy to perform/document semi annual hematology and chemistry competency assessments for one new testing personnel (TP) during the twenty-four months reviewed (survey timeframe: May 27, 2023 - May 15, 2025). Findings include: 1. Review of the CMS 209 personnel form revealed that the laboratory director (LD) also performs the duties of TC and identified two TP responsible for performing non-waived hematology Complete Blood Count (CBC) and iSTAT Chem8 during the review timeframe of May 27, 2023 to 5/15/25. 2. Review of the laboratory's personnel files revealed that TP A was hired and trained in June 2024 as a new TP. The inspector noted that the training was signed as completed /performed by the TC on 6/13/24. The inspector noted no other competency assessment records for TP A. (See Personnel Code Sheet.) 3. Review of the laboratory's policies and procedures revealed a protocol (titled: Competency Evaluation Program) that stated: "The competency evaluation program for Riverside Tangier Medical Center Laboratory has been designed to ensure that all staff members are trained and maintain their competency to perform all assigned tasks and is divided into three main areas: initial training, six month follow up competency, and annual review." The policy stated under heading Six Month Review, "Each employee will complete a six month competency review. Competency evaluations will be completed for each new employee. The checklist must be completed after six months of employment." 4. The inspector requested to review a semi annual competency Sysmex CBC and Abbott iSTAT chem8 assessments for TP A. No records were available for review. 5. Interviews with the lead testing personnel on 5/15/25 at 1:30 PM and LD on 5/16/25 at 4:00 PM confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Riverside Tangier Medical Center on May 25-26, 2023 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows and includes the Condition under 42 CFR part 493 CLIA Regulation: D5400 -42 CFR. 493.1250 Analytic Systems. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure Core Chemistry Module PT test results for Creatine Kinase (CK), Glycated Hemoglobin, Myoglobin, Troponin, Sodium (Na), Potassium (K), Chloride (Cl), ionized Calcium (iCa), Carbon Dioxide (CO2), Glucose, Urea Nitrogen (BUN), and Creatinine (Creat) were returned to American Proficiency Institute (API) within the program's deadline for one (1) of two (2) events in calendar year 2023. Findings include: 1. Review of the laboratory's 2023 API Core Chemistry PT documentation (Events 1-2) revealed that the laboratory failed to submit and received failure to participate scores for the following modules/analytes: 2023 Chemistry- Core Event 1: five of five challenges received zero percent (0%) scores for CK, Glycated Hemoglobin, Myoglobin, Troponin, Na, K, Cl, iCa, CO2, Glucose, BUN, and Creat for challenge samples 1B01-1B05. 2. An interview with the lab director on 5/25/23 at approximately 2:15 PM confirmed the above listed findings. D2127 HEMATOLOGY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure hematology Complete Blood Count (CBC) PT testing results were returned to American Proficiency Institute (API) within the program's deadline for one (1) of three (3) events in calendar year 2022. Findings include: 1. Review of the laboratory's 2022 API hematology PT documentation (Events 1-3) revealed that the laboratory failed to submit and received failure to participate scores for the following CBC module: API Hematology 2022-Event 3: Zero percent (0%) scores for five of five challenge samples for Cell Identification (Lymphocyte, Monocyte, Granulocyte), Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin, and Hematocrit. 2. An interview with the lab director on 5/25/23 at approximately 2:15 PM confirmed the above listed findings. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's Centers for Medicare and Medicaid Services CLIA Application Form (CMS 116), procedure manual, 2021 Centers for Medicare and Medicaid Services Statement of Deficiencies

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Riverside Tangier Medical Center on June 9, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The inspector noted that the laboratory performs SARS- CoV-2 (COVID-19) testing and was in compliance with the applicable COVID-19 reporting requirements. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiencies cited are as follows: D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), personnel records, proficiency testing (PT) documentation, and interviews, the laboratory failed to follow their PT policy to verify the accuracy of chemistry testing after receiving zero (0%) scores due to non participation for two (2) of three (3) events reviewed in calendar year 2020. **REPEAT DEFICIENCY Findings include: 1. Review of the CMS 209 form with the primary medical center provider on 6/9/21 at 11:40 AM revealed that three (3) testing personnel (TP A-C) performed non-waived hematology and patient microalbumin/creatinine chemistry testing during the twenty-four month review timeframe (June 2019 to June 2021). See Personnel Code Sheet. 2. Review of the laboratory's personnel records revealed the laboratory director (LD) utilized PT for competency assessment and verification of accuracy for chemistry urine microalbumin /creatinine. 3. Review of the laboratory's American Proficiency Institute (API) 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 -- records revealed failure to verify the accuracy of microalbumin/creatinine chemistry testing in 2020 due to non participation responses for the following Miscellaneous Chemistry Modules: 2020 Event 1 0% scores for Microalbumin and Creatinine; 2020 Event 2 0% scores for Microalbumin and Creatinine, long term unsuccessful noted by API; The inspector reviewed the PT records and noted instrument results and LD written comment for the two urine chemistries as: "Did not submit on time". The inspector requested to review self grade or additional accuracy evaluation documentation. No additional documentation was available for review. During an interview with the LD at approximately 5:30 PM, the LD stated "Yes, our PT is for accuracy verification of the chemistry tests but we have had continued issues with submitting the results on time which resulted in API reporting to us that we failed to participate. 2020 was a really hard year. I am working with our new tech to improve how we conduct the proficiency testing submissions. I will go back and document a self grade with the peer results". 4. An interview with the primary medical center provider on 06/09/21 at 2:30 PM and LD at 5:30 PM, confirmed the above listed findings. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory's hematology quality control (QC) records, interviews, and lack of documentation, the laboratory failed to perform an evaluation of statistical analysis to identify possible shifts and trends for Complete Blood Count (CBC) testing on the Sysmex pocHi-100i hematology instrument for nine (9) of the twelve (12) months reviewed in calendar year 2020. Findings include: 1. A review of the available records for the pocHi hematology instrument's Sysmex Eightcheck Tri Level QC materials (levels 1-3) revealed that the laboratory did not have documentation of performing statistical analysis for the parameters of CBC testing (white blood cell count WBC, red blood cell count RBC, Hemoglobin HGB, hematocrit HCT, Platelet PLT, Lymphoctye LYM%, Monocyte MXD%, Neutrophil NEUT%) in the following months of calendar year 2020: February, March, April, May, June, July, September, October, November. The inspector requested documentation. No documentation was available. The primary medical center provider on 06/09/21 at approximately 1:30 PM stated: "I would defer to our lab director for this issue. I am not sure why the Levey Jennings (LJ) charts are missing for those months." 2. During an interview with the LD at approximately 5:30 PM, the LD stated: "I do not have a QA

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Riverside Tangier Medical Center on May 15, 2019 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on a review of hematology proficiency testing (PT) documentation, and an interview, the laboratory failed to ensure complete blood count (CBC) PT testing results were returned to American Proficiency Institute (API) for one (1) of six (6) events reviewed from June 2017 to the date of the survey on May 15, 2018. Findings include: 1. Review of the laboratory's American Proficiency Institute (API) hematology PT documentation, a total of six (6) events, revealed that the laboratory failed to submit PT testing results and received a failure to participate score for the following CBC module: 2017 Hematology Event 3 - 0% scores for Cell Identification, Red Blood Cell, White Blood Cell, Platelet, Hemoglobin, and Hematocrit. 2. In an interview with the primary medical center provider at 1:30 PM, the above listed findings were confirmed. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance 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 -- (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report Form (CMS 209), proficiency testing (PT) documentation, and interviews, the laboratory failed to verify the accuracy of microalbumin/creatinine chemistry testing after receiving a zero (0%) score due to non participation for one (1) of two (2) events reviewed in 2018. Findings include: 1. Review of the CMS 209 form revealed that testing personnel A and B performed non-waived patient microalbumin /creatinine chemistry testing. (See Personnel Code Sheet) 2. Review of the laboratory's 2018 American Proficiency Institute (API) PT records revealed no verification of accuracy due to a non participation response for: 2018 Event 2 Miscellaneous Chemistry Module: 0% score for Microalbumin and Creatinine. The inspector requested to review accuracy evaluation documentation. No additional documentation was available for review. During an interview with the lab director (LD) at approximately 12:30 PM, the LD stated "Yes, we have had continued issues with submitting the results on time which resulted in API reporting to us that we failed to participate". 3. In an interview with the primary medical center provider at 1: 30 PM, the above listed findings were confirmed. 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 a review of microscopy test logs, proficiency testing (PT) records, and an interview, the laboratory failed to verify twice annual accuracy of Potassium Hydroxide Wet Preparation (KOH Wet Prep) testing in calendar year 2017. Findings include: 1. Review of microscopy patient test logs revealed that Testing Personnel C performed KOH Wet Prep microscopy examination in the laboratory. (See Testing Personnel Code Sheet) 2. Review of the laboratory's 2017 American Proficiency Institute (API) KOH Wet Prep PT records revealed: 2017 Event 1- 0% score; 2017 Event 3 - 0% score (failure to participate); resulting in unsuccessful performance for KOH Wet Prep PT in 2017. 3. In an interview with the primary medical center provider at 1:30 PM, the above listed findings were confirmed. -- 2 of 2 --