Cameron Memorial Community Hospital

Summary Statement of Deficiencies D5309 TEST REQUEST CFR(s): 493.1241(e) (e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to ensure patient information was entered accurately into the Laboratory Information System (LIS) for two (pt#7 and pt#12) of twelve medical records (MR) reviewed. Findings include: 1. The following patients (pt#7 and pt#12) had identification errors for the date(s) listed: pt #7 4-28-2025 ordered under wrong MRN pt #12 4-28-2025 No results in chart, ordered in error a) A test order, test requisition, and final test reports for blood draw date of 4-28-2025 for patient (pt#7) included three tests, Methicillin-resistant Staphylococcus aureus (MRSA), hemoglobin A1C(A1C), and Basic Metabolic w/ Total Calcium that include analytes: Glucose (GLU), Blood Urea Nitrogen (BUN), Creatinine (Crea), Sodium (NA), Potassium(K), Chloride (Cl), Carbon Dioxide (CO2), Hemoglobin A1C(A1C), (MRSA) and hemoglobin A1C(A1C). b) The order and results for pt#7 were entered into the LIS under pt#12 on 4-28-2025. The phlebotomist who entered the test results was SP-10 (phlebotomist). Labels on the test requisition, blood sample(s) and nasal swab printed on 4-28-2025 had pt#12's name, date of birth (DOB), and medical record number (MRN). c) A test requisition was entered for pt#7 on 5-07-2025 with a collection date/ time of 4-28-2025 at 9:17 am. Laboratory Identifiers (labels) with the correct patient's name and date of birth (DOB) were placed over the incorrect labels with the same draw date, testing person initials, and time. The incorrect labels for PT#12 were visible under the correct labels. d) The final test report for pt#7 indicated results were manually entered by SP-03 (Technical Supervisor) on 5-07-2025 at 10:16 am. e) The final test report for pt#12 indicated under "Results-Narrative" "wrong patient". Test results for pt#12 indicated test results 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 -- "inaccessible in MyChart" were not released into the patient's chart. The report did not contain any documentation on communication with the provider. 2. In an interview on 8-05-2025 at 9:07 am, SP-03 confirmed the phlebotomist SP-10 used the wrong medical record number (MRN) and ordered the laboratory (lab) tests under the wrong patient. SP-03 acknowledged no error report/quality assurance was issued for the clerical error regarding pt#7 and pt#12 or reported in error system (Midas). 3. Review of PolicyStat ID: 16305354 on pages 1 and 2 of 3, titled," Phlebotomy-Outpatient Identification " review/ approved on 07/2024 under Procedures (3-6) requires the following: 3. Laboratorian verify the orders match the paper order and/or Released Stored Orders (RSO). 4. Laboratorians will generate labels for samples being collected. 5. Prior to blood draw, the laboratorian will ask the patient to state their first and last name and date of birth (DOB). 6. After sample collection, phlebotomist will label sample(s) in the presence of the patient followed by the patient looking at each sample collected for accuracy. Procedure guidelines also included that "any identification errors noted prior to sample collection must be corrected before collecting the patient sample" and "any errors with sample labeling must be corrected prior to patient leaving the presence of their own samples. 4. Total test volume for chemistry is 395,498. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) (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 preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on record review, and interview, the laboratory failed to follow their policy on reviewing and documenting errors in reporting for two (pt#7 and pt#12) of twelve patients reviewed. Findings include: 1. The following patients (pt#7 and pt#12) had identification errors for the date(s) listed: pt #7 4-28-2025 ordered under wrong MRN pt #12 4-28-2025 No results in chart, ordered in error a) Final test reports for patient (pt#7) blood draw on 4-28-2025 included three tests, Methicillin-resistant Staphylococcus aureus (MRSA), hemoglobin A1C(A1C), and Basic Metabolic w/ Total Calcium that include analytes: Glucose (GLU), Blood Urea Nitrogen (BUN), Creatinine (Crea), Sodium (NA), Potassium(K), Chloride (Cl), Carbon Dioxide (CO2), Hemoglobin A1C(A1C), (MRSA) and hemoglobin A1C(A1C). b) The test results for pt#7 were entered into the medical record for pt#12 on 4-28-2025. The medical record for pt#12 contained the note "wrong patient" on 5-7-2025. The results for pt#7 were manually entered into the chart for pt#7 on 5-07-2025 by SP-3 (Technical Supervisor). (Refer to D5309) 2. In interview with Technical Supervisor (SP-03) on 8-05-2025 (Day 2) at 09:07 am, SP-03 confirmed the phlebotomist used the wrong medical record number (MRN) to order tests for pt #7. SP-03 confirmed they had "suppressed" the test results in "Orchard" to prevent the wrong information being transferred into "EPIC" system for pt#12. 3. In interview on 8-05-2025(Day 2) at 10:48 am SP#10 (phlebotomist) does not recall any incident regarding "wrong patient drawn or missing information on tubes" but if an error was made, the supervisor would inform them. 4. Review of PolicyStat ID: 16305354 on pages 1 and 2 of 3, titled," Phlebotomy-Outpatient Identification" review/ approved on 07/2024 under Procedures (3-6) requires the following: 3. Laboratorian verify the orders match the paper order and/or Released Stored Orders (RSO). 4. Laboratorians will generate labels for samples being collected. 5. Prior to drawing the patient, the laboratorian will -- 2 of 3 -- ask the patient to state their first and last name and date of birth (DOB). 6. After sample collection, phlebotomist will label sample(s) in the presence of the patient followed by the patient looking at each sample collected for accuracy. Procedure guidelines also included that "any identification errors noted prior to sample collection must be corrected before collecting the patient sample" and "any errors with sample labeling must be corrected prior to patient leaving the presence of their own samples." 5. Policy titled, "MLS-Detection of Analytical and Clerical Errors " PolicyStat ID: 16305250 signed and dated by the Laboratory Director on 7-2024 under Procedure stated the following guidelines: A. Computer Entry (Clerical Errors) 1. A bar code is utilized ...pulling up patients and the test needs results in the LIS to prevent clerical errors. 2. Analytical analyzers are interfaced with LIS to reduce transcription errors. 3. Results are matched to the accession number, patient name, and MRN number. B. Results Review (guidelines #1, 6, 8) 1. Any result that fails one of the rules requires a team member to review and manually release results. 2. All results are reviewed by a qualified team member before the result is verified and those who have completed the competency assessment for the assay. 3. Any errors discovered are brought to the attention of the technical supervisor. 6. Review of PolicyStat ID: 17940116 on page 2 of 6 titled, "Incident and Employee Injury Event Reporting (Patients, Visitors, and employees) review/ approved on 04/2025 stated "Follow up review and communications related to investigation are documented in MIDAS and kept confidential". 7. The error log for 4-08-2025 through survey date did not indicate any errors reported for dates 4-28-2025 and 5-07-2025 involving PT #7 and PT #12. 8. Total test volume for chemistry is 395,498. -- 3 of 3 --

Summary Statement of Deficiencies 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 lack of documentation, record review and interview, the laboratory failed to verify twice annually three of three body fluid cell count analytes (body fluid white blood cell count (WBC), body fluid red blood cell (RBC) and body fluid differential) not included in subpart I and tested in the specialty of hematology from January 1, 2023 to the date of the survey. Findings include: 1. Upon request for twice annual verification for body fluid cell count testing (WBC, RBC and differential) on 7-29- 2024 at 12:40 PM, SP-02 (testing personnel) stated, "I do not believe there is a twice annual verification is in place for body fluid counts". SP-01 (testing personnel) checked the American Proficiency Institute (API) participation sheet and could not confirm any enrollment in body fluid cell counts. They were not able to provide any other documentation of twice annual verification for body fluid cell count testing. 2. The policy "Laboratory- Proficiency Testing" reads on page 1, (1 of 14 pages), "...1. Alternate proficiency testing program is required, such as semi-annual in-house comparison of patient specimen test results or similar process to verify accuracy." 3. The following patients had testing performed when the twice annual verifications had not occurred. Patient date body fluid cell count PT# 1. 4-25-2024 WBC = 6.0, RBC = rare, Differential = 0% segs, 72% lymph, 28% mono. PT# 2. 6-24-2023 WBC =125, RBC = rare, Differential = 88% lymph, 12% mono. 4. Annual test volume for body fluid cell count is 20. 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 document review and interview, the laboratory failed to successfully participated in the American Proficiency Institute (API) proficiency testing (PT) program for compatibility testing. The laboratory had unsatisfactory overall PT event testing scores (less than 100%) for two out of three PT testing events in 2021 (Event 1, 2021 and Event 3, 2021) and 2019 (Event 1, 2019 and Event 3, 2019) (Refer to D2181). D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 -- Failure to achieve an overall testing event score of satisfactory for 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 document review and interview, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2021 (Event 1, 2021 and Event 3, 2021), resulting in unsuccessful performance. This is a repeat deficiency, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2019 (Event 1, 2019 and Event 3, 2019), resulting in unsuccessful performance. Findings included: 1. Review of email communication sent from SP1, technical supervisor, on 1/19/2022, indicated the laboratory received an 80% in compatibility for testing event 1, 2021 and testing event 3, 2021. 2. Review of the "Proficiency Testing Performance Evaluation" from the "American Proficiency Institute" (API) indicated the laboratory's overall PT score for compatibility testing was 80% for testing event 1, 2021 and testing event 3, 2021. 3. In interview on 1/21/2022 at 11:02 am, SP1, technical supervisor, confirmed the laboratory received an overall PT score of 80% for compatibility testing during testing event 1, 2021 and testing event 3, 2021. 4. This is a repeat deficiency, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2019 (Event 1, 2019 and Event 3, 2019), resulting in unsuccessful performance. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on document review and interview, the laboratory director failed to ensure the laboratory successfully participated in the American Proficiency Institute (API) proficiency testing (PT) program for compatibility testing. The laboratory had unsatisfactory overall PT event testing scores (less than 100%) for two out of three PT testing events in 2021 (Event 1, 2021 and Event 3, 2021) and 2019 (Event 1, 2019 and Event 3, 2019). (Refer to D6089). D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory director failed to ensure the laboratory achieved an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2021 (Event 1, -- 2 of 3 -- 2021 and Event 3, 2021), resulting in unsuccessful performance. This is a repeat deficiency, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2019 (Event 1, 2019 and Event 3, 2019), resulting in unsuccessful performance. Findings included: 1. Review of email communication sent from SP1, technical supervisor, on 1/19/2022, indicated the laboratory received an 80% in compatibility for testing event 1, 2021 and testing event 3, 2021. 2. Review of the "Proficiency Testing Performance Evaluation" from the "American Proficiency Institute" (API) indicated the laboratory's overall PT score for compatibility testing was 80% for testing event 1, 2021 and testing event 3, 2021. 3. In interview on 1/21/2022 at 11:02 am, SP1, technical supervisor, confirmed the laboratory received an overall PT score of 80% for compatibility testing during testing event 1, 2021 and testing event 3, 2021. 4. This is a repeat deficiency, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three testing events in 2019 (Event 1, 2019 and Event 3, 2019), resulting in unsuccessful performance. -- 3 of 3 --

Summary Statement of Deficiencies D0000 This visit was for a CLIA Proficiency Testing (PT) Desk Review Survey Facility #: 15D0034973 Survey Date(s): 01-07-2020 Condition Not Met: 1. 42 CFR 493.803: Successful Participation 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 document review and interview, the laboratory failed to successfully participate in the American Proficiency Institute (API) proficiency testing (PT) program for compatibility testing. The laboratory had unsatisfactory overall PT event testing scores (less than 100%) for two of three consecutive PT testing events (Event 1, 2019 and Event 3, 2019). (Refer to D2181). 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 -- D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 document review and interview, the laboratory failed to achieve an overall satisfactory proficiency testing (PT) event score of 100% in compatibility testing for two out of three consecutive testing events (Event 1, 2019 and Event 3, 2019), resulting in unsuccessful performance. Findings included: 1. Review of email communication sent from SP1, General Supervisor, indicated the laboratory received a score of 80% for "...2 out of the last 3 blood bank proficiencies..." 2. Review of the "Performance Summary" from the "American Proficiency Institute" (API) indicated the laboratory's overall PT score for compatibility testing was 80% for testing event 1, 2019 and testing event 3, 2019. 3. In interview on 1-7-2020 at 12:55 PM, SP1 confirmed the laboratory received an overall PT score of 80% for compatibility testing during testing event 1, 2019 and testing event 3, 2019. -- 2 of 2 --