Carroll County Memorial Hospital Laboratory

Summary Statement of Deficiencies D0000 A recertification survey was initiated on 06/30/2026 and concluded on 07/01/2026. The facility was found to not be in compliance with the laboratory requirements of 42 CFR Part 493 with standard deficiencies cited. 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 review of Laboratory Policy, review of American Proficiency Institute (API) events for 2024/2025/2026, and confirmed in staff interview, the laboratory failed to have signed attestation forms for 10 of 25 Proficiency testing events. Findings include: Review of the Carroll County Memorial Hospital General Policy, Version 1.9 (director signature review 3/17/2026) titled "Proficiency Testing 1.9" stated: "The laboratory manager signs the attestation sheet of all proficiency testing performed. The medical director must also review and sign the attestation sheet for Transfusion Medicine proficiency testing." Review of the laboratory PT events revealed the following: 2024 Microbiology Kit Two 3rd Event - No Laboratory director or designee signature .2025 Chemistry Core 1st Event - No Laboratory director or designee signature 2025 Chemistry Core 2nd Event - No Laboratory director or designee signature 2025 Hematology/Coagulation 1st Event - No Laboratory director or designee signature 2025 Hematology/Coagulation 2nd Event -No Laboratory director or designee signature 2025 Hematology/Coagulation 3rd Event - No 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 -- Laboratory director or designee signature 2025 Immunology/Immunohematology 1st Event - No Laboratory director signature 2025 Immunology/Immunohematology 2nd Event - No Laboratory director signature 2025 Chemistry Miscellaneous 2nd Event - No Laboratory director or designee signature 2026 Immunology/Immunohematology 1st Event - No Laboratory director signature In an interview on 07/01/2026 at 10:50 AM in the conference room, the Technical Supervisor (TS) was asked if the attestation forms were signed for the PT events. The TS confirmed the attestation results were not signed for the PT events. This confirmed the findings. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) (e)(4)(iii) All proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratorys performance and to identify any problems that require

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing (PT) scores obtained from the national database and verified with the PT company. The laboratory was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 a proficiency testing (PT) desk review of the Certification and Survey 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 -- Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (2nd event) and 2025 records (1st event), the laboratory failed to successfully participate in a PT program. The laboratory failed to successfully participate in the specialty of Immunohematology for Unexpected Antibody Detection for 2 out of 3 consecutive testing events. Refer to D2172. D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (2nd event) and 2025 records (1st event), the laboratory failed to achieve an overall testing event score (100%) for the specialty of Immunohematology for Unexpected Antibody Detection for 2 out of 3 consecutive testing events. The findings include: 1. Review of the CASPER -0155 report revealed the following: Immunohematology 2024- 2nd Event The laboratory received an unsatisfactory score of 0% for Unexpected Antibody Detection. Immunohematology 2025- 1st Event The laboratory received an unsatisfactory score of 80% for Unexpected Antibody Detection. 2. A PT desk review from API 2024 and 2025 PT records confirmed the above findings. 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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute (API) 2024 records (2nd event) and 2025 records (1st event), the laboratory director failed to provide overall management and direction of the laboratory services to ensure successful PT participation of Unexpected Antibody Detection testing during 2 out of 3 consecutive testing events. Refer to D6089. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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 a proficiency testing (PT) desk review of the Certification and Survey Provider Enhanced Reporting (CASPER)-0155 and American Proficiency Institute -- 2 of 3 -- (API) 2024 records (2nd event) and 2025 records (1st event), the laboratory director failed to ensure that the PT samples were tested as required under Subpart H during 2 out of 3 consecutive testing events. Refer to D2172. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on 05/30/2024. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies cited. D2153 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(a) Failure to attain a score of at least 100 percent of acceptable responses for each analyte or test in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on policy review, document review, and confirmed in staff interview, the facility failed to score 100% for D (Rho) testing for 1 (2nd Event 2023) of 6 proficiency events reviewed. Findings included: Review of the facility's policy titled, "Proficiency Testing/Inspection/Accreditation 1.8," dated 12/2020, revealed, "Any proficiency testing failures will be researched as to possible cause and documented on the Unsatisfactory Proficiency Result Investigation form which will be filed in the Proficiency Test Binder located in the Lab office." Review of the American Proficiency Institute (API) "Performance Summary" for the immunology /immunohematology - 2nd Event for 2023, revealed D (RHO) Type was 80%. During an interview on 05/30/2024 at 1:15PM, the General Supervisor (GS) stated due to the transition period and the change in laboratory management, the failure was not identified, and no