Brio Primary Care

Summary Statement of Deficiencies D0000 An onsite CLIA recertification survey was conducted on January 24, 2025, at the clinical laboratory of Brio Primary Care - Greenville by the South Carolina Department of Public Health's (SC DPH) Bureau of Nursing Homes and Medical Services. The laboratory was found to be out of compliance with 42 CFR Part 493, CLIA Requirements for Laboratories. The following is a list of deficiencies identified during the CLIA survey: D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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 laboratory policy and procedure, direct observation, and staff interview, the laboratory failed to ensure materials were being stored as required. Findings included: 1. Review of the laboratory's Quality Assessment Plan reveals that the storage of materials and specimens must follow manufacturer's reecommendations. 2. During a tour of the laboratory on January 24, 2025 at 1:00pm, the surveyor observed collection tubes in the phlebotomy drawing room without a device to monitor the temperature and humidity. 3. Review of laboratory records reveals a lack of documentation for temperature and humidity of the phlebotomy drawing room. 4. In an interview with laboratory testing personnel (TP) on January 24, 2025, at 1:00pm in the laboratory, the 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 2 -- D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 laboratory policy and procedure, direct observation, and staff interview, the laboratory failed to ensure expired testing supplies were not available for use. Findings included: 1. Review of laboratory's Quality Assessment Plan reveals that the laboratory must follow manufacturer's recommendations for storage of supplies. 2. During a tour of the laboratory on January 24, 2025 at 1:00pm, the surveyor observed a temperature and humidity measuring device in use with a manufacturer's expiration date of April 19, 2019. 3. In an interview with laboratory TP on January 24, 2025, at 1: 00pm in the laboratory, the findings were confirmed. -- 2 of 2 --

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: Based on procedure manual review, proficiency testing record review, and testing personnel interview the laboratory failed to test proficiency testing samples in the same manner as patient specimens for 5 of 7 proficiency testing events reviewed from 2020 through 2022 (2020, Event 3, 2021, Events 2 and 3 and 2022, Events 1 and 2). Findings include: 1. The laboratory procedure manual stated that all CBCs with the following critical values should be verified by repeat analysis: a. Hemoglobin (Hgb) less than 7.0 g/dL or greater than 20.0 g/dL b. Hematocrit (Hct) less than 21.0% or greater than 64.0% 2. Review of proficiency testing records revealed the following CBC proficiency results which were reported with no repeat analysis documented: a. 2020, Event 3; specimen Hsy-14; Hgb- 6.4g/dL b. 2021, Event 2; specimen Hsy-08; Hgb- 6.6 g/dL c. 2021, Event 3; specimen Hsy-11; Hgb- 6.5 g/dL d. 2022, Event 1; specimen Hsy-02; Hgb 6.1 g/dL e. 2022, Event 2; specimen Hsy-06; Hgb 6.0 g/dL 3. Testing personnel confirmed during an onsite interview on 11/29/2022 at 3:49pm that the laboratory failed to test the reviewed proficiency testing samples in the same manner as patient specimens. D5401 PROCEDURE MANUAL 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 -- CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on laboratory procedure manual review, direct observation, and confirmation by the laboratory testing personnel, the laboratory failed to follow their written procedures for patient specimen labeling for 3 of 3 observed specimens. Findings include: 1. The laboratory procedure manual stated that all patient specimens would be labeled with the following information prior to testing; a. Initials of phlebotomist performing collection b. Date and time of collection. 2. During a laboratory walkthrough on 11/29/2022 at 03:33 pm, three patient specimens were observed on the testing rack. The specimens were not labeled with the date or time of collection. 3. Testing personnel confirmed during an onsite interview on 11/29/2022 at 03:49pm, that the laboratory had failed to follow their written procedures for labeling patient specimens prior to testing. 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 the Tosoh AIA 900 operators guide, laboratory room humidity record review, and testing personnel interview, it was determined that the laboratory failed to maintain acceptable room humidity levels for a total of 12 days between September 2022 through October 2022. Findings include: 1. Review of the Tosoh AIA 900 operators guide revealed that with each test run, the testing environment humidity should be verified to be between 40 and 80 percent. 2. Review of the laboratory's room humidity records revealed humidity levels were recorded as less than 40% for the following 12 days between September 2022 through October 2022. a. September 2022- 09/27/2022, 09/28/2022, 09/29/2022, 09/30/2022 b. October 2022- 10/05/2022, 10/06/2022, 10/14/2022, 10/18/2022, 10/19/2022, 10/20/2022, 10/21/2022, 10/24 /2022 There was no

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: During a proficiency testing desk review performed on 8/30/2018, based on review of CASPER report 155D and graded reports from American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the sub- specialty of routine chemistry, the analyte sodium, for two of three consecutive proficiency events (2017, Event 3 and 2018, Event 2). See D2087. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) 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 -- Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: During the proficiency testing desk review performed on 8/30/2018, based on review of CASPER report 155D and graded proficiency reports from API, the laboratory failed to attain a satisfactory score of at least 80% for sodium for two of three consecutive proficiency testing events. Findings include: 1. The CASPER 155D report revealed the following scores for your laboratory's total creatinine: a. 2017, Event 3: 60% b. 2018, Event 2: 0% 2. The scores were confirmed by review of the graded API results. Scores less than 80% for this analyte indicates unsatisfactory performance. A failure of this analyte for two consecutive or two out of three consecutive testing events is scored as unsuccessful. -- 2 of 2 --