Neutrophil Monitoring Laboratory

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 direct observation, a review of the laboratory's policies, and an interview with Technical Supervisor (TS) #2, the laboratory failed to label 2 of 2 pH meter buffer standards poured into secondary containers with their names, concentrations, storage requirements, or preparation and expiration dates. Findings Include: 1. During a laboratory tour on 08/11/2026 at 9:54 AM in room 106, 1 container with a yellow liquid and 1 container with a blue liquid were observed. No markings or labeling were on the containers. 2. A review of the laboratory's policy "Quality Control Plan for the Neutrophil Monitoring Laboratory", version 7, revealed, "All reagents, solutions, control materials, calibration materials, and other supplies must be labeled with the following information: Identity and, when significant, titer, strength, or concentration." 3. During an interview on 08/11/2026 at 9:54 AM, TC #2, as listed on the CMS-209, confirmed the containers were not labeled and stated that the pH meter was used the previous week, fresh standards would be poured before next use, but they keep the liquid in the containers to avoid cross-contamination. 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 D0000 A recertification survey was conducted on 06/27/2024. One standard level deficiency was cited. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedure, direct observation, review of assay request form, test requisition, and in interview with the technical supervisor-2 (TS-2), the laboratory failed to ensure an accurate specimen collection date and time for one of one specimen observed for dihydrohodamine test. Findings included: 1. Review of the laboratory's "Quality Control Plan for the Neutrophil Monitoring Laboratory" (Document ID: NMLQCP001) procedure stated, "Other reasons for sample rejection include incorrect tube or anticoagulant for requested testing, sample shipment in extreme temperatures, compromised sample integrity due to age of specimen (>48 hours) ..." 2. During a tour of the laboratory on 06/27/2024 at 11:34 am, two lavender 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 -- tubes for patient 70-60-05-01 were observed with an "Assay Request Form" and a "Universal Order Requisition." Review of the "Assay Request Form" included "Blood Draw Date: 06/27/2024" and "Blood Draw Time: 09:00 AM." Review of the "Universal Order Requisition" included a date/time stamp at the top left corner "06/27 /2024 07:28." 3. During an interview on 06/27/2024 at 12:00 pm, TS-2 stated the date /time of collection the laboratory used was from the "Universal Order Requisition" of "06/27/2024 07:28" not the "Assay Request Form" with "Blood Draw Date and Time." The laboratory failed to ensure an accurate specimen collection date and time to ensure the 48-hour stability. -- 2 of 2 --