Columbus Regional Health Physicians

Summary Statement of Deficiencies D0000 A proficiency testing desk review survey was completed on 5/27/2025. The following condition-level deficiencies were found to be out of compliance: D2016- 42 C.F.R. 493.803 Condition: Successful participation (proficiency testing) D6000-42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologist (CAP) Evaluation Reports, Casper Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails 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 -- from the Back Office Lead (SP-1) on 05/23/2025, the laboratory failed to achieve satisfactory performance in two consecutive events (Event 3 of 2024 and Event 1 of 2025) resulting in unsuccessful participation for the sub-specialty of Routine Chemistry and the analyte Whole Blood Creatinine in 2024 and 2025. 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologist (CAP) Evaluation Reports, Casper Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Back Office Lead (SP-1) on 05/23/2025, the laboratory failed to achieve satisfactory performance in two consecutive events (Event 3 of 2024 and Event 1 of 2025) resulting in unsuccessful participation for the sub-specialty of Routine Chemistry and the analyte Whole Blood Creatinine in 2024 and 2025. Findings included: 1. Review of the "CASPER REPORT 0155D", run date 5/20/25 indicated a score of 60% for Event 3 2024, and 20% for Event 1 2025 for Routine Chemistry and Creatinine as reported by CAP. 2. On 05/23/2025 at 1:57, via email, SP-1 (Back Office Lead), confirmed that the scores, Event 3 2024-60% and Event 1 2025-20%, were correct for Routine Chemistry and Creatinine. 3. On 05/23/2025 at 11:58 pm, upon request, SP-1 (Back Office Lead) provided, via email, the CAP Original Evaluation and Performance Summary Proficiency Testing Reports for 2024 and 2025 for Creatinine. 4. Review of CAP Original Evaluation and Performance Summary Report for WBCR-C 2024 detailed the following: a.) Page 1 of 3, "Reviewed by" does not contain a signature. b.) Page 2 of 3 Original Evaluation 12/16/2024 Kit ID: 37426237 1.) Five samples were submitted: WBCR 11 through 15 2.) Two of the five samples were Unacceptable: WBCR-12 and WBCR-13 c.) Page 3 of 3 Performance Summary 1.) WBCR-C 2024 3/5 60% Unsatisfactory 5. Review of CAP Original Evaluation and Performance Summary Report for WBCR-A 2025 detailed the following: a.) Page 1 of 3, "Reviewed by" does not contain a signature. b.) Page 2 of 3 Original Evaluation 4/16/2025 Kit ID: 38918643 1.) Five samples were submitted: WBCR 01 through 05 2.) Four of the five samples were Unacceptable: WBCR-01 through WBCR-04 c.) Page 3 of 3 Performance Summary 1.) WBCR-C 2024 4/5 60% Unsatisfactory 2.) WBCR-A 2025 3/5 20% Unsatisfactory 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologist (CAP) Evaluation Reports, Casper Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails -- 2 of 3 -- from the Back Office Lead (SP-1) on 05/23/2025, the laboratory director failed to ensure that the laboratory successfully participated in two consecutive events (Event 3 of 2024 and Event 1 of 2025) resulting in unsuccessful participation for the sub- specialty of Routine Chemistry and the analyte Whole Blood Creatinine in 2024 and 2025. 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 surveyor proficiency testing (PT) desk review of the laboratory PT records, the College of American Pathologist (CAP) Evaluation Reports, Casper Report 0155D from the Centers for Medicare and Medicaid Services (CMS) data system, and emails from the Back Office Lead (SP-1) on 05/23/2025, the laboratory director failed to ensure that the laboratory successfully participated in an Health and Human Services (HHS) approved testing program for the sub-specialty of Routine Chemistry and the analyte Whole Blood Creatinine in 2024 and 2025. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An Initial CLIA Certification survey was completed on 10/12/2023. It was determined that the following condition-level deficiencies existed: 42 Code of Federal Regulation (CFR) 493.801 Enrollment and Testing of Samples D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to enroll in an approved Proficiency Testing (PT) program in 2023 for one (Creatinine) of one non-waived analyte tested using the Stat Sensor (SN: 02-0377-22271) for the subspecialty of Routine Chemistry from May 2023 to 10/12/2023 and for six (PT#1- PT#6) of six patients reviewed. Findings include: 1. On 10/12/23 at 11:16am, SP-2 (Practice Manager) confirmed the laboratory was not enrolled in a Proficiency Test (PT) Program. 2. On 10/12/23 at 2:00 pm, during the tour of the laboratory a Stat Sensor analyzer was observed to be available for use in the laboratory. 3. Review of document titled, "CLIA Moderate Complexity Laboratory Requirements", with no signature by the laboratory director or date of review, indicated the following guideline for "Proficiency Testing (PT)" on page 22 of 23: "The laboratory must enroll in an approved PT testing program that covers each test found in Subpart I of the February 28, 1992, regulations. The test listed in Subpart I are considered 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 -- "regulated analytes". 4. Review of medical records indicates the following patients were tested for Creatinine without PT being performed in 2023: PT# 1 on 05/16/23 - Result: Creatinine: 0.8 mg/dL PT# 2 on 05/25/23 - Result: Creatinine: 0.8 mg/dL PT# 3 on 08/22/23- Result: Creatinine: 1.22 mg/dL PT# 4 on 09/19/23- Result: Creatinine: 0.84 mg/dL PT# 5 on 10/03/23- Result: Creatinine: 0.84 mg/dL 5. Annual Test Volume for the subspecialty of Routine Chemistry is approximately 500. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory director failed to sign and date a procedure manual before use for creatinine testing on analyzer Stat Sensor (SN: 02- 0377-22271) for the subspecialty of Routine Chemistry from May 2023 to 10/12/2023 and for six (PT#1-PT#6) of six patients reviewed. Findings include: 1. Upon request for the laboratory's policy and procedure manual, on 10/12/23 at 12:18 pm, a binder was provided. The binder contained documents outlining "CLIA Moderate Complexity Laboratory Requirements". None of the documents provided had dates of initial use or signature of the laboratory director. 2. Review of document titled, "CLIA Moderate Complexity Laboratory Requirements", with no signature by the laboratory director or date of review, indicated the following three of eight guidelines for "Preparing the Procedure Manual" on page 15 of 23: 2) Manufacturer's literature (packet inserts/operator manuals) may be used, provided the instructions are followed in the unmodified form. When items are missing from the manufacturer, the laboratory must provide the information. 3) The date the procedure was put in place must be noted. 4) The current director must approve procedures and his/her signature, or designee's signature may be on the cover of the document. 3. Review of medical records indicates the following patients were tested for Creatinine without an approved procedure manual: PT# 1 on 05/16/23 - Result: Creatinine: 0.8 mg/dL PT# 2 on 05/25/23 - Result: Creatinine: 0.8 mg/dL PT# 3 on 08/22/23- Result: Creatinine: 1.22 mg/dL PT# 4 on 09/19/23- Result: Creatinine: 0.84 mg/dL PT# 5 on 10/03/23- Result: Creatinine: 0.84 mg/dL 4. Annual Test Volume for the subspecialty of Routine Chemistry is approximately 500. -- 2 of 2 --