Southernmed Pediatrics (Hillcrest)

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Southern Med Pediatrics on 06/13/2024 by the South Carolina Department of Environmental Control (SCDHEC). The laboratory was surveyed under 42 CFR Part 493 CLIA requirements. The facility was found to be out of compliance with the standards of the CLIA program. The following STANDARD LEVEL DEFICIENCES were found to be out of compliance: D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: During an onsite recertification survey on 06/13/2024, based on procedure manual review, proficiency testing Wisconsin State Laboratory of Hygiene (WSLH) PT 2023- HemeReg 1 record review, and testing personnel interview the laboratory failed to test proficiency testing samples in the same manner as patient samples for 5 of 5 samples in 2023. Findings included: 1. Review procedure titled "Proficiency Testing (PT)" reveal "step # 3 samples are tested in the identical manner, as patient samples would be." 2. Review of Heme Reg 1 proficiency testing records from WSLH revealed raw data for sample: a. PT23, one, sample ID AT 12023 ran at 8:31 am, 11:02 am; no panic value noted b. PT23, two, sample ID AT 22024 ran at 8:33 am, 8:36 am, 11:06 am, 11:09 am c. PT23, three, sample ID AT3205 ran at 8:38 am and 11:13 am d. PT23, four, sample ID AT 22026 ran 8:40 am and 8:43 am, 11:21 am, 11:23 am e. PT23, five, sample ID AT 22027 ran 8:45 am, 8:47am, 11:26 am, 11:28 am Samples 1 through 5 were ran multiple times and not handled like patient samples. 3. In an interview with testing personnel on 06/13/2024 at 2:00 pm the above findings were confirmed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of manufacturer's instructions, laboratory procedures, random laboratory environmental logs (January, February, March, April, November, December) 2022, and confirmed in staff interview, the laboratory failed to establish an acceptable room temperature range for 6 out of 6 months reviewed. Findings included: 1. During a tour of the laboratory on 06/13/2024 at 1:50 pm, the surveyor observed the following in the laboratory area: a. Non calibrated thermometer b. 1 pack, Tiger, BD Vacutainer tubes, Lot #4046196, exp. 1/31/2025 c. 1 pack, Purple, BD Vacutainer tubes, Lot#3318809 d. 10 tubes, 3.5 ml, Gold, BD Vacutainer tubes, Lot#3283885, exp. 10/31/2024 e. 14 tubes, 5.0 ml, Gold, BD Vacutainer tubes, Reference# 367986, exp. 02/28/2025 2. A review of the manufacturer's instruction label revealed room temperature requirement of 4-25C(39.2-77F). 3. Review of environmental records titled "temperature log" the room temperature (temp) range exceeded the upper limit of 25C for blood collection tubes. a. January 2022, room temp range (59-86F)/15-30C b. February 2022, room temp range (59-86F)/15-30C c. March 2022, room temp range (59-86F)/15-30C d. April 2022, room temp range (59- 86F)/15-30C e. November 2022, room temp range (59-86F)/15-30C f. December 2022, room temp range (59-86F)/15-30C 4. In an interview on 06/13/2024 at 1:55 pm in the laboratory with testing personnel, the above findings were confirmed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on direct observation, and staff interview for an onsite initial survey at SouthernMed Pediatrics-Orangeburg, revealed laboratory failed to label urine controls with open and expiration dates. Findings included: 1. During a tour of the laboratory on 06/13/2024 at 1:50 pm with testing personnel, the surveyor directly observed the following quality controls: a. Bio-Rad Liquichek Urine Level 1, Chemistry Control, Lot#98011, exp 11/30/2025 b. Bio-Rad Liquichek Urine Level 2, Chemistry Control, Lot#98012, exp. 11/30/2025 No documentation of open and or expiration dates written on bottle. 2. In an interview on 06/13/2024 at 1:55 pm in the laboratory with testing personnel, the above findings were confirmed. -- 2 of 4 -- D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, records review and interview it was determined that the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, asses correct problems identified in postanalytical systems. Findings included: 1. Review of laboratory policies and procedures titled "Proficiency Testing (PT)" under section "C. Proficiency Testing Assessment: Reference 493.1707 Proficiency testing results will be reviewed to determine the accuracy, compliance with regulations, completeness and remedial actions instituted in the event of a proficiency test failure." 2. Review of WSLH proficiency testing records for PT HemeReg, Event 2 revealed the following: a. Erythrocytes, score 40% b. Hematocrit, score 60% c. Hemoglobin, score 60% No

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: During an onsite recertification survey on 7/22/21, based on observing documentation and personnel interview, the laboratory failed to sign the attestation statement of the proficiency testing packet Findings include 1.Observation of the proficiency testing packet for hemetology showed that attestation statements for events B for 2021 weren't signed by lab director. 2. During an onsite interview with staff at 12:22pm, staff stated that the lab director had failed to sign the attestation statements. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on a policy and procedure manual review, lab record review and testing personnel interview, it was determined that the lab failed to document acceptable refrigerator readings for 1 of 36 months, reviewed from February 2019 through July 2021 (2020: December) Findings include: 1. A review of the laboratory policy and procedure manual on 07/22/21 revealed that the laboratory refrigerator should operate between 2 to 6 degrees Celsius. 2. A review of the lab temperature log on 07/22/21 revealed that the lab's refrigerator temperatures were below 2 degrees Celsius for the following months: a.December 2021 (1 days) -- 2 of 2 --