Summary:
Summary Statement of Deficiencies D0000 An Initial/Complaint (LA 00056821) survey was performed at US Med Care, LLC- CLIA ID 19D1079189 on January 21, 2021 through January 25, 2021. US Med Care, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250 CONDITION: Analytic Systems 42 CFR 493.1290 CONDITION: Postanalytic Systems 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing, Laboratory Director 42 CFR 493.1409 CONDITION: Laboratories performing moderate complexity testing, Technical Consultant 42 CFR 493.1421 CONDITION: Laboratories performing moderate complexity testing, Testing Personnel 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 review of the laboratory's policy, CMS-209 form, the laboratory failed to establish written policies and procedures to assess competency of Testing Personnel. Findings: 1. Review of the laboratory's CMS- 209 (Laboratory Personnel Report) form received via email on January 25, 2021 revealed three (3) personnel listed as Testing Personnel. 2. Review of the laboratory's "Standard Operating Procedures" document received via email on January 25, 2021 under "Staff Training" section revealed "New hire laboratory training with return demonstrations & 6 month review. Yearly procedure manual review and laboratory in-service including blood borne pathogen training. Staff informed of any lab changes by memo or meeting." 3. Further review of the laboratory's "Standard Operating Procedures" revealed the laboratory did not include a written policy for competency of testing personnel that included frequency of performance as initial, semi-annual, and annual thereafter. The minimal Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 17 -- requirement of the following six (6) procedures was not included: a) Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling, processing and testing. b) Monitoring the recording and reporting or test results. c) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records. d) Direct observation of performance of instrument maintenance and function checks. e) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. f) Assessment of problem solving skills. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's procedures and interview with personnel, the laboratory failed to verify the accuracy of COVID-19 antigen IgG/IgM at least twice annually. Findings: 1. Review of the laboratory's "Standard Operating Procedures" document received via email on January 25, 2021 under "Proficiency Testing" section revealed "N/A." 2. In interview on January 21, 2021 at 10:47 am, the Testing Personnel (Owner) stated the laboratory does not perform proficiency testing. 3. The laboratory did not provide to the surveyor patient test records prior to January 2021 or the date the laboratory began performing COVID-19 patient testing. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation, record review, and interview with personnel, the laboratory failed to ensure the quality of testing within the analytic systems. Findings: 1. The laboratory failed to establish a complete policy and procedure manual. Refer to D5401. 2. The laboratory failed to establish a policy and procedure manual. Refer to D5403. 3. The laboratory failed to have the procedures approved and signed by the Laboratory Director. Refer to D5407. 4. The laboratory failed to monitor the room temperature of the laboratory where testing and supplies were stored per manufacturer requirements for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Refer to D5413. 5. The laboratory failed to perform performance verification studies that included accuracy and precision studies for COVID testing on the Healgen COVID- 19 IgG/IgM Rapid Test Cassette. Refer to D5421. 6. The laboratory failed to perform positive and negative controls for the Healgen COVID-19 IgG/IgM Rapid Test Cassette. Refer to D5449. 7. The laboratory failed to document the internal control results for the Healgen COVID-19 IgG/IgM Rapid Test Cassette testing for eighty -- 2 of 17 -- eight (88) of eighty eight (88) patients reviewed. Refer to D5481. 8. The laboratory failed to establish procedures to monitor, assess, and correct problems, identified with the analytic system. Refer to D5791. D5401 PROCEDURE MANUAL 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 review of the laboratory's procedures, the laboratory failed to establish a complete policy and procedure manual. Findings: 1. Review of the laboratory's "Standard Operating Procedures" document received via email on January 25, 2021 revealed the laboratory did not have written policies and procedures that included the following: a)