White River Medical Center

Summary Statement of Deficiencies D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based upon a review of laboratory policy and procedure " H&E/Diff Quick Stain QC" , lack of documentation, a review of patient test records for 2022 and interviews with laboratory staff, the laboratory failed to document stain quality on twenty-seven of twenty-seven performances of frozen section examinations in which patient histopathology slides were stained and examined. Survey finding include: A) A review of the laboratory's policy and procedure "H&E/Diff Quick Stain QC" revealed "evaluation will be performed on each day of use by the interpreting pathologist and documented on the attached form". B) The laboratory provided reports of twenty- seven frozen section examinations that were performed on patients in 2024 (identified as numbers one through twenty-seven on a separate patient identification list) . C) Upon request, the laboratory was unable to provide H&E quality control (QC) documentation for the days when the frozen sections were performed on the patients identified above D) In an interview, at 2:00 p.m. on 9/29/25, laboratory staff member ( #1, as listed on form CMS 209), confirmed that stain quality was not documented and "it is possible that it has fallen by the wayside".. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the 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 -- staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based upon a review of personnel records for eleven testing personnel listed on the form CMS-209, and through interviews with laboratory staff, the technical consultant failed to perform competency assessments using the six required methods for eleven of twenty-seven testing personnel reviewed. Survey findings include: A) Review of personnel records for eleven testing personnel ( Numbers 36, 37, 38, 39, 40, 43, 45, 46 47, 49, 60 on Form CMS 209) revealed competencies were documented by a check mark placed next to a statement of duty elements without an indication of any of the six required methods for assessing personnel competency identified. B) During an interview, at 1:45 p.m. on 5/29/25, laboratory staff members ( numbers #2, 3, 4, 5, 6 on form CMS 209) confirmed the methods of competency assessment were not documented on personnel competency records identified above. 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 upon review of personnel competency records for 27 employees listed on the CMS 209 form, authorizations to perform tests, and interview the laboratory did not assess the competency of one employee semiannually during the first year of employment. Findings follow: A) Review of personnel records of testing personnel, ( number 39 on the CMS 209 form), indicated that the employee was hired in January 2024 and authorized by the laboratory director to perform moderately complex testing without direct supervision in January 2024. B) Upon review of personnel records of testing personnel ( number 39 on the CMS 209 form) only one instance of competency evaluation was found dated in October 2024. C) In an interview on 5/28 /25 3:30 p.m., the laboratory staff member ( # 34 on the CMS 209 form) confirmed that only one competency evaluation was present in the personnel file of the testing personnel ( number 39 on the CMS 209 form). D6107 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(15) (e)(15) Specify, in writing, the responsibilities and duties of each consultant and each supervisor, as well as each person engaged in the performance of the preanalytic, analytic, and postanalytic phases of testing, that identifies which examinations and procedures each individual is authorized to perform, whether supervision is required for specimen processing, test performance or result reporting and whether supervisory or director review is required prior to reporting patient test results. This STANDARD is not met as evidenced by: . Based upon a review of personnel records of twenty-seven testing personnel performing moderately complex laboratory assays, and interviews with laboratory staff, the laboratory director failed to give written authorization for one of twenty- -- 2 of 3 -- seven testing personnel reviewed to perform moderately complex procedures without direct supervision. Survey findings follow: A) A review of personnel records of twenty-seven randomly selected testing personnel, who have completed training for performing moderately complex procedures, revealed that one (#38, as listed on the form CMS-209) failed to have the laboratory director's written authorization to perform moderately complex testing without supervision. B) In an interview, at 3:57 p. m. on 5/28/25, laboratory employee (#34 as listed on the form CMS-209) confirmed the lack of written authorizations for the laboratory staff member ( # 38 on form CMS 209) and that they performed moderately complex testing for Arterial Blood Gas on 4 /25/25 at 3:43 a.m. . -- 3 of 3 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of policy and procedure manuals, manufacturer's instruction, temperature logs, and interview with staff, the laboratory failed to follow manufacturer's instructions for operational environment relative humidity for Sysmex XN-2000 and Stago Compact Max. Findings follow: A) Review of the Sysmex XN- 2000 Instruction for use revealed the operating environment for relative humidity is "20 to 85% ". B) Review of the Stago Compact Max reference manual revealed the operation conditions is "Relative humidity: 20% to 80% without condensation ". C) Review of the Chemistry Refrigerator/Freezer Temperature Check Sheet log for July 2023 through May 2022 revealed 24 days out 426 days humidity below 20%. D) During an interview on 8/17/2023 at 11:15 a.m. the laboratory staff member General Supervisor - 2 (GS-2) confirmed the 24 days below 20% hunidity. 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 D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on the lack of laboratory policies and procedures, record review, observation and interviews it was determined the laboratory failed to establish written policies and procedures to ensure positive identification of patient specimens (refer to D5203); failed to establish written policies and procedures to assess the competency of seven of seven Technical Supervisors (refer to D5209); failed to establish written policies and procedures to describe how nongynecologic specimens were collected, labeled, stored, preserved and transported (refer to D5311); failed to have a procedures manual available to personnel (refer to D5401); failed to establish written policies and procedures for any laboratory test processes (refer to D5403); failed to test staining materials for intended reactivity (refer to D5473); failed to establish written policies and procedures for the evaluation and comparison of three of three required nongynecologic statistics (refer to D5629); failed to establish written policies and procedures to ensure unsatisfactory nongynecologic cytology slide preparations were identified and reported as unsatisfactory (refer to D5655); failed to establish written policies and procedures for the system of narrative descriptive nomenclature used by the laboratory to report nongynecologic cytology test results (refer to D5657); and failed to establish written policies and procedures to ensure corrected reports indicated the basis for the correction on the report (refer to D5659). D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures, observation and interview it was determined the laboratory failed to establish written policies and procedures to ensure positive patient identification during all phases of nongynecologic specimen testing. The laboratory failed to label two of two specimen slides with a unique identifier during nongynecologic testing. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to ensure positive patient identification during all phases of nongynecologic testing. 2. The Survey Team observed incomplete patient identifier accession numbers on 26 of 26 glass specimen slides associated with two specimens on 06/16/2021. Specimens include: Accession #: # Written on Specimen Slides: -WM21-177 177 -WM21-179 179 3. During an interview on 02/15/2022 at 3:00 PM, the Laboratory Director /Technical Supervisor A confirmed these findings. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures, lack of laboratory records and interview it was determined that the laboratory failed to establish written policies and procedures to assess the competency of Technical Supervisors. The laboratory failed to assess the competency of seven of seven Technical Supervisors in 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing the competency of Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for seven of seven Technical Supervisors in 2021 and to the date of the survey in 2022. Technical Supervisors include: - Laboratory Director /Technical Supervisor A - Technical Supervisor B - Technical Supervisor C - Technical Supervisor D - Technical Supervisor E - Technical Supervisor F - Technical Supervisor G 3. During an interview on 02/14/2022 at 11:30 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. -- 2 of 8 -- This STANDARD is not met as evidenced by: Based on the lack of laboratory policies and procedures and interview it was determined that the laboratory failed to establish written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the collection, labeling, storage and preservation, and transportation of nongynecologic specimens. 2. The Survey Team requested and the laboratory failed to provide written policies and procedures to detail the process for packing and shipment of nongynecologic cytology specimens to Facility B for processing and preliminary diagnostic review and for the receipt of prepared specimen slides from Facility B. 3. During an interview on 02/15 /2022 at 10:00 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on the lack of written policies and procedures and interview it was determined that the laboratory failed to have a procedures manual available to laboratory personnel during 2021 and to the date of the survey in 2022. Findings include: 1. The Survey Team requested and the laboratory failed to provide a written procedures manual for all cytology tests and examinations performed at the laboratory. 2. During an interview on 02/14/2022 at 11:00 AM, the Laboratory Director/Technical Supervisor A confirmed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)