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LabGuide 5
This LabGuide pertains to QSE Personnel and the General Phase of the Path of Workflow.

Finding a Laboratory Consultant

Technical laboratory consultants can provide expertise to help you provide
quality patient care; maintain Good Laboratory Practices; and identify,
investigate and correct problem areas in your laboratory.

Consultant Services
Your laboratory may need the expertise that a qualified and experienced laboratory
This LabGuide consultant can provide, or you may be required to engage the services of a qualified
provides technical consultant as part of your correction plan following an onsite inspection, or
suggestions to you may not have someone on staff that qualifies to hold the CLIA-required position
help you find the of technical consultant (for moderate complexity laboratories) or technical supervisor
right laboratory (for high complexity labs). If any of these situations apply to your laboratory, you can
consultant for hire an outside laboratory consultant.
your laboratory. The right laboratory consultant can provide many services, such as:
(p1) Consultant Assisting with new lab start-up or a change from waived to non-waived testing
Services
Creating written policy and procedure manuals
(p1) Finding Providing staff training, competency assessment, and continuing education
the Right
Consultant Aiding in evaluation and selection of instrumentation
Determining test menu feasibility and cost analysis
(p2) Professional
Organizations Offering training in proper billing practices and CPT coding
(p3) Qualifications Establishing a written quality control (QC) program

(p3) Fee Establishing and implementing a written quality assessment (QA) plan
Negotiations Assisting with OSHA training, safety audits, and the creation of a safety manual
(p3) Follow-up Aiding in selection and implementation of a laboratory information system (LIS)
Helping with the evaluation and selection of a proficiency testing (PT) program
Troubleshooting QC problems, PT failures, or technical issues
Assisting with preparation for onsite inspection and being present to
provide support during the inspection
Correcting deficiencies noted at an onsite survey / inspection in order to achieve
compliance

Finding the Right Consultant

To qualify as a technical consultant or a technical supervisor, the individual must
meet the CLIA education and experience requirements, and must also be able to
fulfill all the responsibilities of the position. These requirements and responsibilities
are described in LabGuide 4, titled Personnel for Non-waived Testing.

©COLA Last Updated: 04.08.2011 Next Scheduled Review: 04.05.2013

2 Comments? Feedback? Questions? Email us at info@cola.org or call us at 800 981-9883

To find a qualified consultant, you could always look for a recommendation from a
trusted colleague, but this type of personal referral may not be available to you.
Consider exploring the following resources to find a qualified laboratory consultant in
your area:
Your local hospital’s laboratory manager or supervisor
Your reference laboratory (they may provide consulting services)
Laboratories associated with physician’s offices in your area
The internet
Professional organizations are another possible source of qualified leads. They may
have members in your area who have expressed an interest in providing laboratory
consultation. Your state or regional CMS office may also keep a list of qualified
laboratory consultants. The following list provides contact information for a few of
the professional organizations.
There are several AAB — American Association of Bioanalysts (www.aab.org)
nationally known 906 Olive Street, Suite 1200 | St. Louis, MO 63101-1448
clinical laboratory Phone: (314) 241-1445
professional
organizations. AABB (www.aabb.org)
8101 Glenbrook Road | Bethesda, MD 20814-2749
Phone: (301) 907-6977

AACC — American Association for Clinical Chemistry (www.aacc.org)

1850 K Street NW, Suite 625 | Washington, DC 20006
Phone: (800) 892-1400

AMT — American Medical Technologists (www.amt1.com)

10700 West Higgins, Suite 150 | Rosemont, IL 60018
Phone: (847) 823-5169 or (800) 275-1268

ASCLS — American Society for Clinical Laboratory Science (www.ascls.org)

2025 M Street NW, Suite 800 | Washington, DC 20036
Phone: (202) 367-1174

ASCP — American Society for Clinical Pathology (www.ascp.org)

33 West Monroe Street, Suite 1600 | Chicago, IL 60603
Phone: (312) 541-4999

ASH — American Society of Hematology (www.hematology.org)

2021 L Street NW, Suite 900 | Washington, DC 20036
Phone: (202) 776-0544

ASM — American Society for Microbiology (www.asm.org)

1752 N Street NW | Washington, DC 20036-2904
Phone: (202) 737-3600

©COLA Last Updated: 04.08.2011 Next Scheduled Review: 04.05.2013

3 Comments? Feedback? Questions? Email us at info@cola.org or call us at 800 981-9883

Qualifications
Look for candidates that have the education and experience necessary to qualify
under CLIA as a technical consultant or a technical supervisor. This will help ensure
that the candidate has the expected level of knowledge of laboratory regulations,
processes and procedures. You may also wish to add national certification to your
list of desired qualifications. Conduct interviews with qualified potential candidates
to determine their:
Familiarity with your type and size of laboratory
Ability to communicate with personnel that have the education and experience
level of your employees
Problem-solving and customer service skills
Experience with your instruments and test procedures
Experience with laboratory information systems (LIS), if applicable
Availability to your staff
Schedule and other work commitments
Relationships with manufacturers or suppliers
Services offered and areas of expertise
Tell the consultant about your laboratory operations, your personnel, your test menu,
and your reasons for seeking an outside consultant. Always ask for personal and
professional references, and take the time to call them. Feedback from current cli-
ents will be of great help in determining if this is the right consultant for you.

Fee Negotiations
Consultants use various methods to charge for their services. Be sure to discuss
fees and payment methods with your chosen consultant. Various considerations
include: fee per service or per specialty of testing; hourly fees; retainer fees; and
travel Fees and expenses.
Always ask for a written proposal for consulting services that includes a full descrip-
tion of each service provided, the time commitment involved, and the itemized fees
for each service.

Follow-up
It is as essential to assess the competency of Technical Consultants as it is other
laboratory staff. One way to do this is to monitor their effectiveness in fulfilling their
contractual obligations. The following steps will help:
Inform all lab staff of the role you want the consultant to play.
Ensure that the consultant clearly understands your expectations.
Monitor the ongoing interaction between your staff and the consultant. Good
rapport between them will help ensure cooperation and a successful return on
your investment.
Stay informed about the consultant’s activities and progress in achieving the
desired outcomes.

The complete CLIA personnel requirements (Subpart M) can be found at:

www.cdc.gov/clia/regs/subpart_m.aspx

©COLA Last Updated: 04.08.2011 Next Scheduled Review: 04.05.2013