Carolina Doctors Med Care

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 surveyor observation and testing personnel (TP) #1 interview 2/4/22, the laboratory failed to dispose of supplies and reagent that had exceeded their expiration date. Findings: Surveyor observed the following expired supplies in the laboratory cabinet drawers: 1. SteriPack Polyester Spun Swab - Lot #13516, expiration (exp.) 11 /3/21. Approximately 20 swabs. 2. Hologic Aptima Urine Specimen Collection Kit - Lot #34400H, exp. 1/31/21. Approximately 5 kits. 3. BD Vacutainer - Lot #7279807, exp. 4/30/19. Approximately 25 tubes. 4. BD Vacutainer - Lot #7097721, exp. 4/30 /19. Approximately 25 tubes. 5. BD Vacutainer - Lot # 0100314, exp. 4/30/21. Approximately 15 tubes. 6. BD Vacutainer - Lot #0003589, exp. 4/30/21. Approximately 50 tubes. Surveyor observed the following expired reagent in the laboratory cabinet: 1. Occult Blood Developer Consult Diagnostic - Lot #14-15- 551622, exp. 7/18. One bottle. Interview with TP #1 at approximately 2:00 p.m. confirmed the supplies and reagent were expired. She stated the BD Vacutainer tubes were being saved by a past employee for students and she did not realize they were in the drawers and not marked as "do not use". She also stated none of the reagent or supplies would have been used for patient testing or specimen collection. All expired supplies and reagent were disposed of at time of survey. . D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on review of Cell-Dyn Emerald operator's manual, review of 2019, 2020 and 2021 laboratory maintenance logs, review of Cell-Dyn Emerald on-board maintenance log and interview with TP #1 2/4/22, the laboratory failed to perform monthly maintenance on the Cell-Dyn Emerald analyzer 8 of 16 months reviewed. Findings: Review of Cell-Dyn Emerald operator's manual revealed under Section 9 "Preventive Maintenance Schedule...Monthly Maintenance...Bleach Cleaning...Cleaning the system with a bleach solution is performed monthly...". Review of 2019, 2020 and 2021 laboratory maintenance logs for the Cell-Dyn Emerald revealed no documentation the laboratory performed monthly maintenance in June and August of 2019, and January, April, May, June, August and September of 2020. Review of Cell- Dyn Emerald on-board maintenance logs revealed the logs could not be retrieved to determine monthly maintenance in 2019 and 2020. Interview with TP #1 at approximately 2:00 p.m. confirmed monthly maintenance was not performed. She stated she was sure it was performed but she may have not documented it. She also confirmed review of on-board maintenance records could not be retrieved to confirm all monthly maintenance in 2019 and 2020 was performed. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor record review and laboratory director (LD) interview 2/4/22, the LD failed to ensure the laboratory's approved

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of random patient test reports, and testing personnel (TP) interview 3 /21/2019, the laboratory failed to record the identity of the personnel who performed the complete blood cell (CBC) testing. The laboratory performs CBC testing on the Cell-Dyn Emerald analyzer. Test reports are printed directly from the analyzer, initialed by TP and then scanned into the patient's chart. Review of 7 random patient CBC test reports, patient identification numbers 31719, 27573, 20344, 8186, 31550, 32775, and 33059, revealed 3 of 7 test reports did not include the TP initials to indicate who performed the testing. During exit interview at approximately 1:30 p.m., TP #1 confirmed the 3 test reports did not include the TP initials. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on surveyor record review and testing personnel interview 3/21/19 the laboratory director failed to evaluate all unacceptable proficiency testing (PT) results and failed to ensure an approved,