PRESENTING                     (N.J. /Florida Program)

P.O.C. Consultants, LLC

Technical Consultant Program


493.1411 Technical Consultant Qualifications ( Federal Register, February 28, 1992).

The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical consultation.

INTRODUCTION

All moderate complexity labs must name a technical consultant. Many physicians do not have the time or expertise to perform the duties required of this position. Appendix A is a reprint of the qualifications for technical consultant. Before putting anyone's name down as technical consultant on your CLIA form, make sure you read and understand the responsibilities that go with the position. The cost of making a mistake will be high.

☞IMPORTANT☜ The technical consultant must meet the requirements of CLIA. The type of experience required under the regulation is clinical in nature. This means, examination and test performance on human specimens for the purpose of obtaining information for the diagnosis, treatment and monitoring of patients, or for providing that information to others who will be doing the diagnosing and treatment of the patient's condition. Patient or medically oriented experience, which is defined as the ordering of tests and interpreting and applying the results of these tests in diagnosing and treating a patient's illness is unacceptable to meet the requirement for laboratory training and experience. The term "laboratory training and experience" means that the technical consultant must have the training in and experience with the specialties or sub-specialties in which he/she is performing technical consultation.

The government's most recent "Survey Procedure and Interpretive Guidelines" requires a CLIA inspector to cite an office (fail inspection) if the position of technical consultant is not filled, or if the person serving in that capacity is not qualified, or does not perform all of the duties that the technical consultant is responsible for. Your inspection day is no time to find out that you are not in compliance with the law!

POC CONSULTANTS is New Jersey's most successful and respected company providing regulatory consulting services. Since May, 1990 (28 months before the CLIA regulations became law) we have helped over 1,500 offices deal with the increasing burden of government regulation. We are successful because we know what we are doing. We don't advertise. Almost all of our business comes from referrals from the health care industry, from county and the N.J. State Medical Societies or by word of mouth. A list of clients will be provided upon request. You probably know some of them. We are located at 2 Russ Farm Way, Delanco, N.J., 08075. Telephone (865) 824-0800.

We have qualified individuals to fill the role of technical consultant at a physician Laboratory. We will assume the responsibilities found in the Federal Register, as well as some additional services our company has added to ease the laboratory director's burden. Put a POC Consultant name on your CLIA form as technical consultant anddo it today!

PROGRAM OVERVIEW:

Technical maintenance will only be started once the laboratory is fully operational.

☞ Initial CLIA & OSHA quality assessment evaluation.

☞ A consultant will schedule 4-16 office visits per year as per contract. Each visit will be a minimum of 3-5 hours (dependent on size of lab), and will be confined to the tasks described. If you need help in areas outside of the scope of the duties of the technical consultant, then you must arrange for a separate consultation at our regular hourly rate.

☞ Phone assistance, as needed - up to 1/2 hour per month. Additional phone time will be charged at 75% of our normal hourly rate.

☞ Appointments must be canceled or rescheduled 24 hours in advance or a charge for the visit will be imposed.

☞ The monthly consultant maintenance fee will be based on laboratory specialties, volume, automation, computerization of reports, number of employees and travel distance/time from nearest consultant.

SERVICE SCHEDULE

All clients MUST complete the following services supplied by our company prior to starting technical maintenance:

} Processed CLIA registration, State license (if applicable) and COLA registration (if requested)

} CLIA /OSHA/ DEP consultation

} Laboratory procedure manual with procedures and quality assessment plan

} OSHA safety manual

} OSHA safety training for laboratory/medical staff (can be scheduled after start of services)

ALL VISITS ARE FOLLOWED-UP WITH A WRITTEN EVALUATION FOR THE STAFF AND LABORATORY DIRECTOR TO REVIEW. IT IS THE RESPONSIBILITY OF THE DIRECTOR TO ENSURE THAT THE LAB STAFF WILL CORRECT PROBLEMS NOTED IN REPORT PRIOR TO NEXT VISIT.

☞ IMPORTANT ☜ The laboratory staff is responsible for the performing all quality control, calibrations maintenance, validation studies and proficiency testing. The staff must providing all daily documentation in compliance with CLIA. Our role is to evaluate test and staff performance -not perform daily duties .

SERVICES WILL INCLUDE:

First 8 are required by the standard . Supplementary services are also provide as part of the program.

1. Evaluate and recommend appropriate test methods including reagents, supplies, and equipment which are cost effective and appropriate for the clinical use of the test results.

2. Establish procedures to evaluate the accuracy and precision of tests performed. This includes evaluation of reference intervals (normal ranges), reportable ranges, quality control data, analytical system performance, correlations and interpretations with other test data and clinical significance relative to patient status.

3. Evaluate and recommend a HHS approved proficiency testing program which is commensurate with the services offered.

4. Develop, implement, and monitor a quality control program which is appropriate for the testing performed and establishes the parameters for acceptable levels of analytic performance and ensures that these levels are maintained throughout the entire testing process from the initial receipt of the specimen through sample analysis and reporting of results. A report from this evaluation will be documented annually.

5. Resolve technical problems and ensure that remedial actions are taken whenever test systems deviate from the laboratory's established performance specifications.

6. Evaluate test requests and reporting system which ensures that patient test results are not reported until all corrective actions have been taken and the test system is functioning properly.

7. Identify training needs so that each individual performing tests receives training and education appropriate for the type of complexity of the laboratory services performed.

8. Evaluate competency of testing personnel so that staff can maintain their competency to perform test procedures and report test results promptly, accurately, and proficiently.

This written evaluation will include findings from:

a) Direct observation of procedures for patient identification, patient preparation, specimen collection, handling, processing and testing.

b) Monitoring of recording and reporting of test results.

c) Review of work sheets, quality control records, proficiency testing results, and preventive maintenance records.

d) Direct observation of performance of instrument maintenance and function checks.

e) Assessment of test performance, by proficiency testing samples or internal blind testing samples.

f) Assessment of problem solving skills

NOTE: All of the above must be documented twice in the first year and yearly thereafter or, as needed, if problems arise.

ADDITIONAL SERVICES INCLUDED IN PROGRAM:

9. Conduct lab staff meeting(s) to review quality assurance report.

10. Provide one office safety program (power point or lecture presentation)

11. Updating existing procedure manual as needed (this excludes producing new procedures).

12. Assistance in preparation of laboratory job descriptions for staff.

13. Review job application for laboratory positions (if requested).

14. Schedule one appointment to coincide with office performing proficiency testing (if requested).

15. Review of Proficiency Testing results document corrective actions, if needed.

FEE SCHEDULE FOR TECHNICAL CONSULTANT

Our fees are based on the CLIA’s "Schedule of Labs" and estimated hours needed to monitor compliance. This schedule is used by CLIA to determine the fees they charge for registration, certificates, and inspection surveys.

Schedule of Labs

# of Test/Year

# of Specialties

# of hours

Monthly Fee *

A - low volume

< 2,000

NOT DEFINED

3

$525

A

2,000 - 10,000

< 4

3

$550

B

< 10,000

> 3

3.5

$625

C

10,000 - 25,000

< 4

3.5

$650

D

10,000 - 25,000

> 3

4

$750

E

25,000 - 50,000

NOT DEFINED

4.5

$800 - up

* Fees for offices receiving less 12 visits per year will be adjusted upward to reflect additional time needed to review more than one month of laboratory data per visit.

A travel fee is added for offices >30 miles from consultant ($30), >60 miles ($60 ) and > 90miles ($90) .

A 10% discount will be offered for accounts paying 6 months in advance and 5% for using credit card.

APPENDIX A - QUALIFICATIONS FOR TECHNICAL CONSULTANT

(a) The technical consultant must possess a current license issued by the State in which the laboratory is located, if such a license is required.

(b) The technical consultant must -

(1)[i] Be a licensed doctor of medicine or osteopathy; and [ii] Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications equivalent to those required for such certification; or

(2)[i] Be a licensed doctor of medicine or osteopathy; and [ii] Have at least 1 year of laboratory training or experience, or both, in the designated specialty or sub-specialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or

(3)[i] Hold an earned Ph.D. or masters degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and [ii] Have at least 1 year of laboratory training experience, or both, in the designated specialty or sub-specialty areas for which the technical consultant is responsible,; or

(4)[i] Have earned a bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and [ii] Have at least 2 years of laboratory training experience, or both, in the designated specialty or sub-specialty areas for which the technical consultant is responsible.