Kelsey-Seybold Clinic / Memorial Villages Lab

Summary Statement of Deficiencies D0000 The laboratory was surveyed and found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, and recertification is recommended. Standard level deficiencies were cited. 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, surveyor observation, the laboratory's records, and staff interview, the laboratory failed to follow their policy for centrifuging patient samples for 42 of 42 urine microscopic examinations performed from October 1, 2024 to November 6, 2024. Findings include: 1. A review of the laboratory's policy titled 'Urinalysis Microscopic Examination' revealed the following: "Centrifuge for 5 minutes at 1500 rpm/450 rcf." 2. Surveyor observation of the laboratory on 11/6/24 at 12:40 p.m. revealed the laboratory staff used the following centrifuge for urine microscopic examinations: -Medline Model 642E Serial number (SN): 220913IG483 3. A review of the laboratory's Service Request Detail records for the Medline centrifuge (SN: 220913IG483) revealed the Revolutions per Minute (RPMs) and timing were tested on 8/29/24 with the following results: 3173 rpm 10 minutes 4. A review of the laboratory's records revealed the laboratory had performed 42 urine microscopic examinations using the Medline centrifuge (SN: 220913IG483) 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 -- from October 1, 2024 to November 6, 2024. 5. In an interview on 11/6/24 at 12:50 p. m. in the conference room, after review of the records, the laboratory compliance manager confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The laboratory was found out of compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found in compliance with applicable CLIA conditions, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the