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: Based on review of personnel competency records for moderate complexity testing and interview with three (3) Medical Assistants (MA's) present during survey 01/19 /2021, the laboratory failed to ensure a qualified Technical Consultant (TC) was employed for ten (10) of twelve (12) months of 2020. Findings include: 1. Upon review of competency records for the MA's performing potassium hydroxide (KOH) mounts and parasite mounts, three (3) out of four (4) competency assessments were performed by unqualified individuals. 2. The three (3) MA's present and interviewed during survey 01/19/2021 confirmed each competency assessment was done by the unqualified individual who performed the competency assessments 02/18/2020. 3. The three (3) MA's present and interviewed during survey 01/19/2021 confirmed the former TC was not returning to work due to COVID related issues. 4. See D6034 and D6046. 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. 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 -- This STANDARD is not met as evidenced by: Based on review of the CMS 209 form submitted during survey and discussion with three (3) of four (4) Medical Assistants (MA's) present during survey on 01/19/2021, the laboratory failed to ensure a qualified Technical Consultant (TC) was available/on staff to perform competency assessment of MA's performing moderate complexity testing. Findings include: 1. During the survey 1/19/2021, three (3) MA's were interviewed during review of their competency assessment records for 2020 at approximately 1130 am. All three (3) confirmed the previously qualified TC was not returning to employment with this facility due to COVID related issues. 2. In an interview with the Office Manager at approximately 2 pm during survey 01/19/2021, she confirmed the previous TC was not returning to employment with this facility. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of competency records of the Medical Assistants (MA's) for the year 2020, the laboratory failed to ensure a qualified Technical Consultant (TC) was available to perform competency assessments on three (3) of four (4) MA's. Findings include: 1. Three (3) of four (4) competency assessments for performing potassium hydroxide (KOH) mounts and parasite examinations were performed by unqualified individuals. 2. The current competency evaluation form used by this laboratory lacks the six (6) competency criteria listed under 493.1413 Technical Consultant responsibilities. -- 2 of 2 --