Summary:
Summary Statement of Deficiencies D0000 A Validation survey was performed at Freedman Clinic of Internal Medicine, CLIA ID #19D0464721 on August 6, 2025. Freedman Clinic of Internal Medicine was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1250: CONDITION: Analytic 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 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 policies, CMS-209 (Laboratory Personnel Report) form, and personnel records; as well as interview with personnel, the laboratory failed to establish written policies and procedures to assess competency of the Technical Consultant. Findings: 1. Review of the laboratory's policy and procedure manual revealed the laboratory did not include a policy for competency assessment of the Technical Consultant to include, but not limited to, frequency of performance. 2. Review of the laboratory's CMS-209 form revealed Personnel 2 served as Technical Consultant. 3. In interview on August 6, 2025 at 10:58 a.m., the Technical Consultant confirmed the laboratory did not have a policy for competency assessment of the Technical Consultant. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and proficiency testing (PT) records as well as interview with personnel, the laboratory failed to perform assessment activities for unacceptable PT results for two (2) of ten (10) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing Policy" revealed "All unacceptable PT results will be investigated, consultation will be obtained where indicated and remedial education will be performed, as appropriate...Any results given a passing score of less than 100% will be evaluated." 2. Review of the laboratory's American Proficiency Institute (API) PT records revealed the laboratory did not assess unacceptable results for the following events: a) 2024 Chemistry - Core - 1st Event: * Bilirubin, Direct - Sample CH-02 Unacceptable * Phosphorous - Sample CH-05 Unacceptable b) 2024 Chemistry - Core - 2nd Event * Cholesterol, HDL - Sample CH- 07 Unacceptable 3. In interview on August 6, 2025 at 11:17 a.m., Testing Personnel 1 confirmed the laboratory did not assess the unacceptable results identified above. 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 observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure quality of testing within the analytic systems. Findings: 1. The laboratory failed to define acceptable room temperature limits within the manufacturer's required range for blood collection supplies stored in one (1) of one (1) rooms in the laboratory. Refer to D5413. 2. The laboratory failed to document the open expiration date for Hematology and Chemistry quality control materials. Refer to D5415. 3. The laboratory failed to ensure microbiology specimen collection supplies did not exceed their expiration dates in one (1) of one (1) rooms where supplies are stored. Refer to D5417. 4. The laboratory failed to verify complete performance specifications for microalbumin and urine creatinine testing on the DCA Vantage analyzer. Refer to D5421. 5. The laboratory failed to perform maintenance on the DCA Vantage analyzer as required by the manufacturer for twelve (12) of twelve (12) months reviewed. Refer to D5429. 6. The laboratory failed to establish their own means and ranges for QC material utilized for erythrocyte sedimentation rate (ESR) testing. Refer to D5469. 7. The laboratory failed to follow their