Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on a review of the laboratory's submitted CMS 116 form, the laboratory's policies, and staff interview, the laboratory failed to establish a policy for verifying the accuracy of one of one non-regulated analyte (urine microscopic examinations). Findings include: 1. A review of the laboratory's submitted CMS 116 form revealed the laboratory estimated performing 21,000 urine microscopic examinations annually. 2. A review of the laboratory's policies revealed the laboratory failed to have a procedure for verifying the accuracy of the non-regulated analyte, urine microscopic examinations, at least twice annually. 3. In an interview on 2/28/24 at 14:31 p.m. in the conference room, after review of the records, testing person #1 (as indicated on the CMS 209 form) confirmed the above findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) 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 2 -- laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of the CMS 116 application, observations, review of policies and procedures and interview of facility personnel, the laboratory failed to define quality control procedures for microscopic urine sediment evaluations. The laboratory estimated an annual volume of 21,000 patients tested for urine sediment testing. The findings included: 1. Review of the CMS 116 application found the laboratory defined an annual volume of 21,000 patient specimens tested for urine sediment microscopic evaluation. 2. Review of the policy titled Routine Urinalysis Standard Operating Procedure (approved by the laboratory director on 1/3/2024) found no reference to quality control procedures under the heading Microscopic Evaluation of Urine. 3. Observations made during the tour of the lab conducted at 10:34 AM found no atlas of urinary sediment or pictographs available to testing personnel for reference. 4. During interview of the general supervisor conducted on February 28, 2024 at 10:46 AM he confirmed the laboratory had no defined quality control procedures in place for the microscopic urine sediment evaluation, and did not have an atlas of urinary sediment available to testing personnel. -- 2 of 2 --