Carolina Mountain Internal Medicine

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with laboratory staff on 08/12/2024, the laboratory failed to discard materials that had exceeded their expiration dates and were available for use in patient testing. Findings: 1. At approximately 3:30 P.M., the surveyor observed four (4) BD Vacutainer Red Top blood collection tubes with Lot Number 216938 and expiration date 2024-06-30 on the shelf above the sink in the Phlebotomy Collection Station inside the laboratory. 2. At approximately 3:30 P.M., the surveyor observed two (2) Black and Yellow Vacuette blood collection tubes with Lot Number B23023C3 and expiration date 2024-06-02 on the shelf above the sink in the Phlebotomy Collection Station inside the laboratory. 3. At approximately 3:30 P. M., the surveyor observed three (3) Green Aerobic Sterile Collection Swabs with Lot Number P2007450 and expiration date 2023-05-31 in a green basket on the desk in the Phlebotomy Collection Station inside the laboratory. 4. At approximately 3:30 P. M., the surveyor observed five (5) FLOQ Orange Top blood collection tubes with Lot Number 20242016313 and expiration date 2023-06-30 in a green basket on the desk in the Phlebotomy Collection Station inside the laboratory. 5. At approximately 3:30 P. M., the surveyor observed four (4) LabCorp Blood Collection Kits with Lot Number 23101301 and expiration date 07/31/2024 in a green basket on the desk in the Phlebotomy Collection Station inside the laboratory. The expired blood collection tubes and kits were given to laboratory staff who, during an interview at 3:30 P.M., confirmed the identified items had exceeded their expiration dates. The expired items were immediately discarded in the laboratory's biohazard container.Based on observation and interview with laboratory staff on 08/12/2024, the laboratory failed to 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 -- discard materials that had exceeded their expiration dates and were available for use in patient testing. Findings: . -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, review of manual test report form, and interview with office manager 11/16/21, the laboratory failed to include reference intervals on the manual test report form for urine microscopic testing. Findings: Review of the laboratory's procedure revealed the laboratory had established reference intervals for urine microscopy. For example, the "Urine Microscopy" procedure stated, "Normal results include: Red blood cells: 0-3/ hpf(high power field)(unless menstrual contamination) White blood cells: 0-5 /hpf Epithelial cells: 5-10 / hpf Casts: absent Bacteria: absent(on fresh specimens) Yeast: absent Parasites: absent Trichomonas: absent Mucous: not clinically significant" Review of a manual patient test report example showed the test report had a place to enter microscopic results under Urinalysis, but did not include reference intervals for the urine microscopic exam. At approximately 12 p.m., the office manager confirmed the laboratory is only using paper charts and they would give a copy of the manual test report to patients during physical exams for the Urinalysis and microscopic testing only. 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 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)