Browne Medical, Llc

Summary Statement of Deficiencies D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor review of Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to retain graded results received from the American Proficiency Institute for event 1-2019. The TC #2 listed on CMS form 209 confirmed on 12/5/19 at 12:45 pm that all PT records were not retained. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the Technical Consultant (TC), the laboratory failed to review and evaluate results when they received an unacceptable score in Hematology tests performed with the American Proficiency Institute for the first event in the calendar year 2019. The findings include: 1. The laboratory received an 80% Grade for Erythrocyte Count, Hematocrit, Hemoglobin, and Leukocyte Count for 2019 event 1. 2. There was no documented evidence that the laboratory investigated the failures. 3. The TC #2 listed on CMS form 209 confirmed on 12/5/19 at 1:10 pm that the laboratory did not review and document an evaluation of unacceptable PT results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(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 -- 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 surveyor review of the Procedure Manual (PM), Quality Control records and interview with the Technical Consultant (TC), the laboratory failed to follow their PM policy for "

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor review of the Competency Assessment (CA) records and interview with the Technical Consultant (TC), the laboratory failed to perform CA correctly on nine out of nine TP in 2017. The findings include: 1. The laboratory did not document what records were reviewed and how CA was assessed. 2. The laboratory did not document assessment was for which tests. 3. The TC confirmed on 5/22/18 at 1:00 pm that CA was not performed correctly. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material, review of the Manufacturer Package Insert and interview with the Technical Consultant (TC), the laboratory failed to follow the MPI instructions for hematology Boule Con-Diff Tri- level controls on the day survey. The findings include: 1. The MPI stated "Open QC vial stability 14 days after opening". a. The laboratory did not record new expiration 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 -- date on vials. 2. The TC confirmed on 5/22/18 at 1:10 pm the laboratory failed to follow the MPI instructions. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on surveyor review of Temperature Records (TR) and interview with the Technical Consultant (TC), the laboratory failed to records room and refrigerator temperature accurately in April 2018. The findings include: 1. A review of TR revealed that refrigerator temperature was recorded in freezer column and vise versa but the Quality assurance reviewer did not noticed and signed off on it. 2. The TC confirmed on 5/22/18 at 2:00 pm that room and refrigerator temperatures was not recorded accurately. -- 2 of 2 --