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The emerging role of the technical consultant.

Because of CLIA '88, as many as 30,000 POLs will have to hire experienced consultants. Are you missing a career opportunity?

FOR NEARLY 10 YEARS the authors have been publishing articles and presenting workshops to inform medical technologists and clinical pathologists about the need for and opportunities associated with providing consultative assistance to physicians' office laboratories (POLs).

With the publication of the final rules for CLIA '88 comes the requirement that certain laboratories engage a technical consultant. On board either full or part time, this person is responsible for important quality management issues that are assumed to be beyond the skill or training of the laboratory's staff, supervisors, or director (See "CLIA rules on the duties of the technical consultant," p. 29). This means that many POLs--those that use on-the-job trained staff and supervisors to perform moderately complex testing--will need to hire a consultant (See "Qualifications of the technical consultant," p. 30).

* How many consultants? The publication of the final CLIA rules prompted us to conduct a survey in an attempt to find out whether our efforts to help laboratorians become POL consultants had been successful. We also wanted to see what real-world office laboratory consultants were doing.

Before conducting the survey, it was our sense that although many individuals were interested in being laboratory consultants to testing sites without trained laboratory staff, few had actually ventured into such work and developed a consultation practice.

* Finding the population. We sent a questionnaire to approximately 700 attendees of workshops that we had given over a number of years for the American Society of Clinical Pathologists. We also sent the questionnaire to a group of laboratorians in Idaho who are registered with that state's Bureau of Laboratories, Laboratory Improvement Section, as technical consultants. (For several years, Idaho has required labs staffed by individuals without technical training to employ a qualified technical consultant).

In addition to these two sources, an informal registry of technical consultants has been developed by a medical technologist. We asked this MT to send our questionnaire to those on her registry list.

* Rate of return. From all of these sources, we received 75 responses, for a 10% return on the approximately 750 questionnaires mailed. This rate of return is fairly typical for a "cold" mailed survey. Since most of the respondents were active in consultation, it is difficult to know whether the non-respondents represented those without consulting careers or merely individuals who were not interested in participating in the survey.

* Services provided. The services provided by the 75 consultant-respondents are shown in Figure 1.

Most of the responding consultants provide services related to the constituents of a quality management program, including procedure manual preparation, organization and supervision of the QC program, and proficiency testing. Many also undertake the selection of methods, kits, and equipment, and the training of staff in their use. Far fewer are involved in the selection and evaluation of personnel despite the fact that these activities are part of the consultant's responsibility, according to CLIA.
Figure 1

Services provided by POL technical consultants

Service provided(*)

Write procedure manual 92%
Organize QC 90
Supervise PT 84
Train staff 79
Select methods 79
Supervise QC 78
Select kits and equipment 77
Calculate/interpret QC 73
Evaluate staff 47
Select staff 36
Provide lab supplies 34
Manage business 30
Train for safety 7
Maintain equipment 4

* Multiple responses were accepted.

Activities relating to the business management of lab testing, such as providing supplies, involved only about 30% of consultants. Business management and providing supplies are often overlooked income opportunities for consultants.

Absent from the activities list of most consultants were safety training and equipment maintenance. A small minority of respondents listed such services as assisting with licensing and staff certification; conducting mock inspections; developing reporting forms; designing lab facilities; providing reference or calibration materials; conducting OSHA training and mock safety inspections; disposing of hazardous or infectious waste; and reviewing reference laboratory contracts.

As technical consultants review the CLIA definition of their job description, they will find that their role should be expanded into the aforementioned areas.
Figure 2

Fees charged by POL consultants

Hourly fee Number

$15-20 2
25-35 8
50-60 9
75-85 5
150 1

* Fees charged. We found a wide range of fees among those consultants answering the questionnaire. Most survey respondents did not answer the question pertaining to fees, however, so the data may not be entirely representative.

A moderate number, mostly those consultants with only one or two clients, charge between $15 and $35 per hour. A few said that they do not charge at all or have a barter type of arrangement (such as a free physical exam) in exchange for consultation services. Those consultants with 15 or more clients generally charged in the $50 to $85 per hour range.

Hourly fees are not the only method of charging. Some consultants have fees for specific services, such as procedure manual preparation. Others provide service on a yearly contract, charging $200 to $500 per month for one or two visits per month to the lab. Of the four pathologists who answered this question, two have such arrangements, while one sends a consulting technologist in his place and charges the cost of that person's salary. The fourth charges by the hour.

* Client profile. About half of the consultants have five or fewer clients, while one-quarter have but one or two. Eight reported between 40 and 200 clients. Consultants associated with referral labs are most likely to have between 10 and 40 clients.

Most consultants were sought out by their clients. Over one-third of consultants (37%) obtained clients through the clients' association with the consultant's reference lab. Only a few consultants found clients by advertising for them.

Most of the consultants visit their clients quarterly. Almost all of the others make monthly visits. A few make daily or weekly visits.
Figure 3

A profile of clients

Number of clients

 Number of
Clients consultants

1-2 12
3-5 13
6-10 8
11-20 9
|greater than~ 20 13

Source of clients(*)

Clients sought out consultant 79%
Clients of consultant's referral lab 37
Consultant advertised 15

* Multiple responses were accepted.
Frequency of visits to client's lab


Weekly 5
Monthly 15
Quarterly 23
Yearly 3

* Writing contracts. Sixty percent of all respondents have contracts with clients.

Of the 32 consultants who have five or more clients, 22 (69%) have contracts with them. Of the 36 consultants who have fewer than five clients, however, only 10 (28%) drew up contracts.

Nearly all (91%) contracts delineate the scope of services; 98% set fees. More than half (56%) of the contracts limit the consultant's liability, holding him or her harmless if the client does not follow advice. Thirty-three percent hold the consultant harmless if an inspector finds deficiencies at the lab. An attorney was consulted in drawing up more than half (58%) of the agreements.

* Learning how. We were interested in how consultants obtained the information and skills to successfully assist physicians in operating their labs. Those who answered this question often listed several sources of information.

Thirty of the consultants said that they attended workshops on the subject. Twenty-three read MLO and other journals as well as books to garner information. The consultant's library is an extensive one. Included is our book, The Physician's Office Laboratory, as well as works by other authors (See "A basic bookshelf for the technical consultant," p. 31). A few consultants told of reading the Federal Register. Eight cited experience as the way they obtained their information. Several of the consultants from Idaho indicated that they had been trained by that state's Bureau of Laboratory Improvement.
Figure 4

Resources used in learning to be a POL consultant(*)

 Number of
Resource consultants using

ASCP and CLMA 30

Reading MLO and 23
other journals and books

Lab experience 13

Reading CLIA and 8
state regulations

NCCLS and other manuals 6

Other 14

* Multiple responses were accepted.

* Who is consulting? The vast majority of laboratorians working as POL consultants are MT(ASCP) or CLS(NCA) technologists, but three were CLAs. Six pathologists (some of them retired) and one Ph.D. clinical chemist also are consultants.

Twenty-two of the 75 respondents work in hospital labs; 12 hail from independent labs. Many of those from hospitals also appear to do referral work for the physicians' office labs for which they consult.

Twenty-three consultants come from a variety of other settings. Eleven work in a physician's office, group practice, or clinic lab. Eight listed themselves as unaffiliated POL consultants. A few are with public health laboratories, probably doing consultancy as part of their official laboratory improvement duties. Two work at academic institutions. Thirty-seven of the consultants--nearly half the total number of respondents--said that consulting is part of their regular duties and not moonlighting.

* Opportunity beckons. The role of the technical consultant has been defined in the CLIA rules, and physicians' office lab directors are or soon will be looking for qualified individuals to help them comply with the massive regulations.

As things stand, too few technologists are providing the needed consultation services, and no clear patterns of practice have emerged. Is the supply of qualified medical technologists adequate to meet the need for technical consultants? Figure 5 shows the estimated number of physicians' office labs and "other labs" (such non-POLs as family planning centers, student health facilities, dialysis centers, and home health agencies).

In all, according to CLIA, between 25,000 and 30,000 POLs must hire technical consultants. Here is an opportunity that many qualified technologists are seeming to ignore.

CLIA rules on the duties of the technical consultant

CLIA '88 requires that labs without a licensed physician, such as those directed by Ph.D. chemists or microbiologists, have a clinical consultant who can advise the lab's clients about diagnosis, treatment, and patient care management. Conversely, CLIA requires labs that don't employ a trained laboratory director or a qualified medical technologist to hire a technical consultant to help the director and staff plan and supervise quality management activities, including the daily quality control (QC) program, the verification of written procedures, and the resolution of technical problems.

The responsibilities of the technical consultant, as defined by CLIA are:

* Selecting test methodology appropriate to the clinical use of the results.

* Verifying precision and accuracy and other performance characteristics of tests performed.

* Enrolling the lab in an approved proficiency testing (PT) program commensurate with the services offered.

* Establishing a QC program appropriate for the testing performed.

* Establishing parameters for acceptable levels of analytic performance.

* Maintaining acceptable levels of performance throughout the entire testing process, from receipt of the specimen through analysis and reporting of results.

* Resolving technical problems and ensuring that remedial actions are taken whenever test systems deviate from established performance criteria.

* Ensuring that patient test results are not reported until all corrective action has been taken and the test system is functioning properly.

* Identifying staff training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed.

* 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.

* Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual performs patient care testing. Such persons must be reevaluated and redocumented at least annually after the first year, and must be reevaluated to include the use of new methodology or instrumentation, if they change, prior to reporting patient care results.

The procedures for evaluating the competency of staff must, according to the CLIA '88 rules, include but are not limited to:

* Direct observation of routine patient care test performance, including patient preparation (if applicable), specimen handling, processing, and testing.

* Monitoring the recording and reporting of results.

* Reviewing intermediate test results or worksheets, QC records, PT results, and preventive maintenance records.

* Directly observing instrument maintenance and function checks.

* Assessing test performance through testing of previously analyzed specimens, internal blind testing samples, or external PT samples.

* Assessing problem-solving skills.

Source: Medicare, Medicaid, and CLIA Programs. Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Department of Health and Human Services, Health Care Financing Administration. Federal Register. Feb. 28, 1992. 57: 7,174.

Qualifications of the technical consultant

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 a technical consultant provided he or she is qualified by the criteria of the regulations.

According to CLIA '88, the technical consultant must meet one of the following requirements:

* Possess a current license issued by the state in which the laboratory is located, if such licensing is required.

* Be a licensed physician certified in anatomic or clinical pathology or both, or possess equivalent qualifications.

* Be a licensed physician who has had 1 year of laboratory training or experience in the designated specialty or subspecialty areas of service for which the designated technical consultant is responsible.

* Hold an earned doctoral or master's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution and have 1 year of laboratory training or experience or both, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

* Have earned a bachelor's degree in a chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution and have 2 years of laboratory training or experience or both, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible.

A basic bookshelf for the technical consultant


Addison LA, Fischer PM. The Office Laboratory. 2nd ed. Norwalk, Conn: Appleton and Lange; 1990.

American Society of Clinical Pathologists. LabWork: A Self-Study Course on the Management of the Physician's Office Lab for Lab Directors, the Lab Staff and Technical Consultant. Chicago, Ill: ASCP Press; 1993.

Baisden CR. The Office Practice Laboratory. Rockville, Md: Aspin System Corp.; 1985.

Belsey RE, Baer DM, Statland B, Sewell D. The Physician's Office Laboratory. 2nd ed. Los Angeles, Calif: Practice Management Information Corp.; 1993.

Belsey RE, Skeels MR, Baer DM, Koneman EW. Basic Office Microbiology. Los Angeles, Calif: Practice Management Information Corp.; 1990.

Crowley JR, ed. Consultant's Handbook. 2nd ed. Dubuque, Iowa: Kendall-Hunt Publishing Co.; 1991.

Fischer PM, Addison LA. Office Laboratory Testing: Primary Care Clinics in Office Practice. Philadelphia, Pa: W.B. Saunders; 1986; 13: 605-796.

Speicher CE. The Right Test. Philadelphia, Pa: W.B. Saunders; 1990.

Handbooks and manuals

International Society for Clinical Laboratory Technology. Physician Office Laboratory Technician Handbook. St. Louis, Mo: ISCLT; 1990.

Spencer CL, Gross MA. How to Avoid Mistakes in a Physician's Office Laboratory. Bethesda, Md: R.C. Butler Health and Education Resources; 1989.

Physician's Office Laboratory Guidelines, Procedure Manual, and CLIA/NCCLS POL Index. 2nd ed. NCCLS Document POL1/2-T2. Villanova, Pa: NCCLS; 1992.

Medicare, Medicaid, and CLIA Programs; Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Department of Health and Human Services, Health Care Financing Administration. Federal Register. Feb. 28, 1992; 57: 7,001-7,288.

CLIA final rule corrections. Federal Register. Jan. 19, 1993; 58: 5,212-5,237.


The premier issue of POL Adviser:

Baer DM, Belsey RE. Coping with CLIA: A guide for POLs. POL Adviser. October 1993; 1(1): 1, 9-11, 21.

Krienitz D. CLIA accreditation: Go with HCFA or COLA? POL Adviser. October 1993; 1(1): 19-21.

Pontius CA. Proficiency testing for the POL. POL Adviser. October 1993; 1(1): 1, 14, 15, 18, 25.

The MLO series on off-site testing:

Belsey RE, Baer DM. The technologist's role in quality management of off-site testing. MLO. Part 1, September 1987, 19(9): 28-32; Part 2, October 1987, 19(10): 45-53; Part 3, November 1987, 19(11): 41-54; Part 4, December 1987, 19(12): 53-59.

The JAMA series on the office laboratory:

Fischer PM, Addison LA. The office laboratory director's guide. JAMA. 1985; 254: 2,941-2,945.

Belsey RE, Baer DM, Sewell DL. Laboratory test analysis near the patient. JAMA. 1986; 255: 775-786.

Fischer PM, Addison LA. Education and the office laboratory. JAMA. 1986; 255: 1,464-1,467.

Wildermann RF, Schneider KA. Regulatory and legal influence in physician office laboratories. JAMA. 1986; 256: 252-253.

Belsey RE, Greene M, Baer DM. Managing the liability risk in the office laboratory. JAMA. 1986; 256: 1,338-1,341.

Other articles

Baer DM, Belsey RE. Assessing an office chemistry instrument. Primary Care. 1986; 13: 699-711.

Baer DM, Belsey RE. Professional consultation for physician's office laboratories. Lab Med. 1986; 17: 330-334.

POL workshops

ASCP half-day workshops for laboratorians providing consultation services to POLs are held at the spring and fall national meetings, and during some regional workshops. For information, call (312) 738-1336.

The San Diego State University Student Health Service Physician's Office Laboratory Conference is presented twice a year in San Diego, Calif. This 3-day course is a comprehensive review of lab topics for physicians with labs, but is also useful for technical consultants and testing personnel. For information, call Kimberly Johnson at (619) 594-7359.

Bowman Gray School of Medicine Physician's Assistant Program and Physicians' Office Laboratory Conference. Similar in organization and content to the San Diego conference, this course is given twice a year in Winston-Salem, N.C. For information, call: Course director Nancy Dennis at (919) 716-2031, or the Division of Continuing Education at (800) 277-7654.

Dr. Baer, a member of MLO's Editorial Advisory Board, is chief of laboratory service, VA Medical Center, and professor of pathology, Oregon Health Sciences University, Portland, Ore. Dr. Belsey is professor emeritus of pathology at Oregon Health Sciences University.
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Title Annotation:includes related articles
Author:Baer, Daniel M.
Publication:Medical Laboratory Observer
Article Type:Cover Story
Date:Oct 1, 1993
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