Summary:
Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: The laboratory failed to have a qualified technical consultant (TC) to oversee moderate complexity testing in routine chemistry. Refer to D6034. D6034 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation for each of the specialties and subspecialties of service in which the laboratory performs moderate complexity tests or procedures. The director of a laboratory performing moderate complexity testing may function as the technical consultant provided he or she meets the qualifications specified in this section. This STANDARD is not met as evidenced by: Based on the review of the form CMS-209, personnel qualifications, and interview with the quality manager, the laboratory failed to have an individual who qualified to perform the duties and responsibilities of the technical consultant (TC) for routine chemistry. Findings: 1. Review of the Form CMS-209 revealed two persons listed at the TC for routine chemistry. 2. Review of personal qualifications revealed the laboratory failed to have a qualified individual for the position of TC #1. 2. Interview with the quality manager on 6/18/24 at 10:45 a.m. confirmed, the laboratory failed to 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 -- have an individual who qualified to perform the duties and responsibilities of the TC for routine chemistry. -- 2 of 2 --