Northwood Deaconess Health Center - Northwood

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation, policy review, and staff interview, the laboratory failed to label 3 of 3 hematology staining containers (Fixative Solution, Solution I, Solution II) observed. The laboratory performed 64 patient hematology differentials since August 2024. Findings include: 1. Observation at 10:08 a.m. on 08/06/25 showed three filled containers in a sink at the hematology bench with no identifying information. 2. During interview at approximately 10:10 a.m. on 08/06/25, a technical consultant (#1) stated the containers in the hematology sink contained hematology staining solutions used for patient testing and confirmed the laboratory had not labeled these containers. 3. Reviewed on 08/06/25, the policy "Secondary Reagent Labeling," dated 12/15/07, stated, "Labels are required when hazardous/non-hazardous materials are transferred from their original containers and placed into secondary containers." 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 D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, staff interview, and policy review, the laboratory failed to verify the accuracy for 1 of 1 qualitative endocrinology test (serum pregnancy) implemented in 2019 before reporting patient results. The laboratory performed three serum pregnancy tests since implementation. Findings include: 1. Reviewed at 10:30 a. m. on 07/31/19, the laboratory's 2019 performance specification verification records for qualitative serum pregnancy lacked evidence the laboratory evaluated the accuracy data. 2. During interview at approximately 11:25 a.m. on 07/31/19, a technical consultant (#1) confirmed the laboratory began patient testing for serum pregnancy in June 2019, and the laboratory did not have evidence the laboratory director and/or technical consultant had evaluated and approved the accuracy verification data. 3. Reviewed at approximately 11:50 a.m. on 07/31/19, the policy "Validation Guidelines," effective 11/01/11, stated, "Purpose: To provide guidelines when validating a piece of equipment into operation; laboratory must verify the manufacturer's performance specification for each new test prior to reporting patient results. . . . Element [sic] involved in validations are: 1. Accuracy . . ." 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 --