Stephen E Chiarello Md Pa

Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 7/28/20 at Stephen E. Chiarello MD Pa, a clinical laboratory in Port Charlotte, Florida. Stephen E. Chiarello MD Pa was not in compliance with 42 Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories. 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 record review and interview with laboratory personnel, the laboratory did not verify the accuracy of potassium hydroxide (KOH) preps or scabies preps twice annually. The Findings included: Review of proficiency testing and quality assessment records for the last two years revealed that there was no documentation to indicate that any verification of accuracy was done for KOH or scabies preps. During an interview with the laboratory director at 10:45 a.m., on 7/28/20, he confirmed that proficiency testing had not been done for KOH or scabies preps over the past two years. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel, the laboratory did not have documentation to indicate that they checked the physical characteristics of each batch of media or that they checked each batch of media with control organisms. Findings include: Review of quality control records for fungal cultures on 04/11/18 revealed that there was no documentation that indicated that the physical characteristics of the media were not compromised or that a positive and a negative organism was used for each lot number to check it's ability to support growth and to produce the correct biochemical response. During an interview with the director at 10: 40 a.m. on 04/11/18, he confirmed that that information was not documented. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --