Daniel M. Baer, M.D., Richard E. Belsey, M.D.
Daniel M. Baer, M.D., Richard E. Belsey, M.D.
The quality of a laboratory's work depends exclusively on its employees. Good and bad laboratories use the same equipment, the same reagents, and the same supplies. The difference between them lies in the people who maintain the equipment and perform the tests.
Daniel M. Baer, M.D., Richard E. Belsey, M.D.
Who can do the testing in your laboratory depends on the complexity of the tests being analyzed. The Clinical Laboratory Improvement Act of 1988 (CLIA '88) allows a wide variety of individuals to perform tests for patient care. The laboratory director is responsible for permitting only those staff members having the necessary knowledge and skills to perform patient care testing. Even the simplest procedure can require compulsive attention to detail to produce consistently comparable results. The operator must follow instructions faithfully, not experiment with shortcuts, and understand any analytic pitfalls. In this chapter, we will discuss the criteria for selecting and evaluating the laboratory's staff.
Who May Perform Testing
Today, individuals with widely different backgrounds and training are doing tests in physicians' office laboratories. They range from employees with no medical or laboratory background to certified medical technologists who have studied the theory and practice of laboratory testing. Two studies of who does physicians' office testing showed that 30% are technologists or technicians, 30% have been educated on the job, and 40% have no formal training in laboratory medicine (1,2). In order to assign duties and responsibilities appropriately, the laboratory director should understand the differences in training and qualifications of office laboratory workers. Remember that the laboratory director is responsible for ensuring that the staff is appropriately trained for the tasks they perform and for the quality of the test results. (Personnel Regulations)
A medical technologist [MT(ASCP)] is someone who graduated from a baccalaureate-level medical technology program, including 1 full year of theoretical and practical training, and also passed a national certifying examination given by the Board of Registry of the American Society of Clinical Pathologists (ASCP). These technologists should be able to perform laboratory tests requiring considerable skill and independent judgment. After acquiring some experience they may become technical consultants or supervisors. The National Certifying Agency for Medical Laboratory Personnel (NCA) of the American Society of Clinical Laboratory Scientists (ASCLS) has a category known as clinical laboratory scientist (CLS). This is equivalent in training requirements to the MT(ASCP).
Several other organizations, such as the American Association of Bioanalysis (AAB), International Society for Clinical Laboratory Technology (ISCLT) and American Medical Technologists (AMT), also certify technologists. Except for the ASCP and ASCLS, however each of these organizations permits individuals without a bachelor's degree to qualify if they meet a combination of academic and experience requirements. This distinction may be important, because CLIA '88 requires a bachelor's degree in medical technology and 2 years of appropriate laboratory experience for technical consultants and certain levels of laboratory supervisor.
Medical Laboratory Technician
Medical laboratory technician [MLT(ASCP)] is a graduate of a 2 year associate degree program, of which 1 year is devoted to theory and practice. Certification requires passing a national examination, and these technicians can be expected to do many laboratory tests. Some regulatory agencies exclude them from doing tests that require independent judgment, such as microbiology tests and more advanced hematologic procedures requiring cell identification.
CLIA '88 allows this category of laboratory worker to perform highly complex testing as long as the worker is supervised by a qualified medical technologist. A medical laboratory technician is not expected to become a supervisor, nor is he or she qualified to act as a technical consultant. NCA, ISCLT, and AMT also have technician categories.
Certified Laboratory Assistant
Certified laboratory assistant [CLA(ASCP)] is a certification category that was granted by the ASCP from 1963 through 1980. A certified laboratory assistant is a graduate of a 1-year program, usually given in a hospital, that covers theory and practice of clinical laboratory procedures. In 1980, the CLA designation was altered to certificate level technician, or MLTC(ASCP). Several certifying organizations give examinations at this level, designating those who pass as technicians. They are not expected to perform tests requiring exercise of independent judgment. ASCP and AMT certify laboratory assistants.
Medical Office Assistant
Some medical assistant programs that last anywhere from 6 to 12 months may include laboratory training. A program at a community college may include 80 hours of theoretical and practical instruction in drawing blood and preparing specimens to be sent to other laboratories doing dipstick urinalyses and blood cell counting, plating bacteriology specimens, and performing Gram stains.
Nurse
Some nurses are proficient in venipuncture and skin puncture techniques, but few have been trained in the requirements and pitfalls of specimen collection. Formal training in doing basic laboratory tests is minimal in most nursing education programs.
Personnel in any of the above categories, and any high school graduate who has received training for the tests that he or she performs, were qualified under CLIA '88 rules to perform tests of any level of complexity until September 1, 1997. After that date, individuals who were performing highly complex tests prior to April 24, 1995 could continue such testing if the results they produce are reviewed by a qualified supervisor. Since September 1, 1997, other personnel performing highly complex tests are required to have an associate degree in laboratory science or a bachelor's degree in science.
Some states have laboratory licensing laws that require specific training or certification for office laboratory personnel, and CLIA '88 has more stringent requirements for laboratories doing highly complex testing. If your hospital permits test results from an office laboratory to be entered in the patient's hospital chart, the office technician may be subject to training or certification requirements determined by the institution.
Selecting Staff to Perform Testing
It may be difficult for you to assess an individual's ability to perform office laboratory testing. You might want to ask your technical consultant or your hospital's laboratory director to help you judge an applicant's level of training, skill, and experience. You could ask your technical consultant to actually assist in the selection of laboratory employees. The technical consultant is required by CLIA '88 to observe the new employee, training him or her in basic testing techniques, the use and care of equipment, quality assurance protocols, and the importance of careful and complete record-keeping.
When considering a prospective laboratory employee, the following qualities and skills should be assessed. The person should be:
A staff selection checklist can be used to help you evaluate candidates for positions that require doing laboratory procedures or current staff who you may ask to do laboratory work. The candidate with the highest number of total points may be more suitable than others to work in your laboratory, but, of course, there are other factors to consider, such as the candidate's ability to work with others and dependability. As should be done in the selection of other staff members in your office, it is a good idea to get references from former employers. If possible, speak directly to the applicant's supervisor or technical consultant. Ask about the items on the checklist
Since many analyses require visual color comparisons, anyone who does them should be tested to make sure he or she is not color blind and can discern subtle color changes A color-blind person may perform laboratory tests, but should not do those tests that require color perception. Results of color tests should be documented in the employee's personnel file, and may be requested by some laboratory accrediting agencies.
CLIA '88 requires a formal evaluation of each individual who performs laboratory tests on patient specimens. These documented evaluations must be performed within 6 months of hiring the individual or when a new testing procedure is initiated, and annually thereafter.
Exercise
Using the staff selection checklist, evaluate a member of your staff who performs laboratory tests. In addition to the checklist questions, use data from your quality control and proficiency testing programs.
Commentary
Data from your laboratory's quality control and proficiency testing programs should be used as part of the periodic evaluation of employees. Remember that each person performing patient tests should do quality control tests on those days that he or she tests any patient specimens. Although only one person's proficiency test results are sent in for scoring, it is a good idea to have each person who performs tests analyze the proficiency testing sample (but only after you have recorded and mailed the result for the program). In this way, you can collect objective data on the technical competency of each staff member.
Your technical consultant should be able to help you evaluate how much variability is acceptable for each kind of test. We suggest that you and the technical consultant review the quality control and proficiency testing data for each person who does testing. The technical consultant is responsible for performing such a review, and the laboratory director is responsible for ensuring that each person who performs tests is competent to do so.
Marian Schwabbauer, Ph.D., CLDir(NCA)*
Introduction
Physician office laboratories (POLs) perform more than half of all
laboratory tests. Poor laboratory results can place patients in
jeopardy. Physician office laboratory personnel are the critical
ingredient in achieving accurate, reliable laboratory data. CLIA '88
established minimum qualifications for personnel based upon the
complexity level of the testing being performed. In the process, new,
descriptive personnel categories or classifications using completely
revised nomenclature were defined that differ significantly from
other commonly used personnel certifications or
classifications. CLIA '88 (compared to previous HCFA and CLIA
regulations) moves the determination of physician office laboratory
competency from process review toward outcome measures. For example,
less stringent testing personnel standards are balanced by more
emphasis on proficiency testing; this is consistent with what is
occurring in other areas in society as well, i.e., value added
education.
Credentialing Terms
Accreditation refers to the process by which an agency
evaluates and recognizes an institution or program of study as
meeting certain predetermined standards. For example, the Joint
Commission on Accreditation of Health Organizations (JCAHO) accredits
hospitals including on site laboratories; the College of American
Pathologists (CAP) accredits clinical laboratories; and the National
Accrediting Committee for Clinical Laboratory for Clinical Laboratory
Sciences (NACCLS) accredits educational programs that prepare
clinical laboratory personnel.
Certification is the process by which a non governmental agency grants recognition to an individual who has met certain predetermined education qualifications and technical competencies; certification is voluntary. Certified laboratory personnel are entitled to use letters such as MLT, MT(ASCP); CLT, CLS (NCA), MT(AMT), depending upon the certification obtained, after their name.
Unfortunately the CLIA license is also called a certificate. However, CLIA only licenses or certifies the laboratory not the personnel who staff the laboratory, e.g., personnel who leave a CLIA licensed or certified laboratory to work in another laboratory are not CLIA certified nor is the second laboratory certified. The second laboratory must obtain its own license (certificate).
Competence denotes possession of the required abilities and qualities to perform a job or function; it generally requires both knowledge and skills.
Competency Testing refers to the measurement of individual's ability to perform a certain job; it is often accomplished by observing an individual perform a designated task. A checklist may be used to document performance. Other forms of competency testing may include examinations such as the HEW examination or performance on known samples (proficiency testing).
Continuing education (CE) refers to participation in any educational experience not normally leading to an academic degree, such as attending professional society meetings, taking classes, or completing self-study units.
Licensure is the process by which a governmental agency grants permission to persons meeting pre-determined qualifications to engage in a given occupation, or grants permission to institutions to perform certain functions; it is mandatory when it exists. States that currently license clinical laboratory personnel include California, Tennessee, and Florida. A number of other states have pending licensure legislation at varying stages of progress. You can determine whether or not licensure of clinical laboratory personnel is required in your state by contacting your state public health department.
Registration is the process by which a non governmental agency or association identifies an individual by maintaining (listing) his her name on a roster upon request of the individual; for example, the Board of Registry of the American Society for Clinical Pathology (ASCP) maintains a list or registry of all the individuals who have been certified by their organization. You can easily check a prospective employeeís credentials by calling the agency providing the credential.
Table 1. Summary of credentialing terms used in this course
Accreditation:
Certification
Competence:
Competency Testing:
Continuing Education:
Licensure:
Registration:
CLIA Personnel Requirements and Classifications
CLIA '88 establishes site neutral laboratory personnel requirements.
The regulations apply to all clinical laboratories, not just
physician office laboratories. Those clinical laboratories certified
to perform only waived tests have no personnel requirements imposed
by CLIA '88. However, only a few tests have been classified as
waived. Laboratory supply companies are attempting to design
instruments and procedures so that they meet the criteria for
classification as waived tests.
The remainder of this section will discuss the personnel requirements for moderate complexity laboratories. Laboratories who wish to perform any tests classified as moderate complexity must have the following four categories of personnel: laboratory director, technical consultant, clinical consultant, and testing personnel. All four categories can be covered by the same individual if s/he meets the qualifications for each category. For example, the laboratory director can qualify as the technical consultant only if he or she has the required hands on laboratory testing experience.
Laboratories certified to perform tests of high complexity must
have an individual classified as a technical
supervisor rather than the technical consultant, and a general
supervisor in addition to the laboratory director, clinical
consultant, and testing personnel required in the moderate complexity
laboratory. The qualifications and responsibilities specified for
testing personnel in the high complexity laboratory vary somewhat
from those listed for testing personnel in the moderate complexity
laboratory. Again one individual may meet the criteria for and
fulfill the requirement for more than one category of personnel. If a
laboratory engages in cytology testing it must also have the
following two categories of personnel: Cytology
general supervisor and Cytotechnologist,
who again may be the same person. b>Qualification Standards
CLIA personnel standards are designed to assure that laboratory
personnel have the appropriate training and experience to adequately
perform the level of tests that the laboratory offers. Only the
qualifications for those personnel categories required for the
moderate complexity laboratory will be described; similar information
about personnel requirements for the high complexity laboratory is
available.
Laboratories certified to perform moderate complexity tests must have personnel who meet the following specified qualifications.
Laboratory Director
There are five routes that will qualify an individual to fill the Laboratory
Director requirement.
1. Pathologist or 2. Licenced MD, DO or Doctor of Podiatry with: |
One year of experience directing/supervising non-waived tests; or |
Effective September 2, 1993, have at least 20 CME credit hours in laboratory practice commensurate with director duties; or laboratory training during residency equivalent to 20 CME rule above, or certification in hematology or hematology/oncology |
3. Doctorate in science with: |
1 year of full-time experience supervising non- waived testing; or |
clinical laboratory-related board certification |
4. Master in science with: |
1 year supervisory experience |
1 year laboratory training or experience; and |
5. Baccalaureate in science with : |
2 years of laboratory training or experience; and 2 years of supervisory experience |
|
The twenty hours of CME credit must cover preanalytic, analytic, and postanalytic phases of testing.It should provide information about the principles and theories of laboratory practice including: quality control and quality assurance; proficiency testing; patient test management and development; and implementation of personnel policy and procedures. It should include hands-on laboratory testing experience. Courses related to laboratory payment and CPT coding would not fulfill this requirement.
There are also two routes by which one can be "grandfathered" in as a laboratory director: if on February 28, 1992, they were previously qualified as a laboratory director under March 14, 1990 Medicare/CLIA '67 rules or were qualified under state law to direct a laboratory in that state.
Clinical Consultant
A Clinical
Consultant must be qualified as a laboratory director under #1,
#2, or #3 above; or be a licensed MD/DO.
Technical Consultant
The Technical
Consultant must meet one of the following four qualifications:
Testing Personnel
All Testing
Personnelmust meet
one of the following two qualifications:
The laboratory director is responsible for assuring and documenting that each person, regardless of education or experience, who performs a laboratory test is competent to perform that laboratory test. Responsibilities of Each Category of Laboratory Personnel Under CLIA '88 the responsibilities of each category of laboratory are clearly spelled out.
Laboratory
Director
The director is responsible for the overall operation and
administration of the laboratory, including hiring personnel who can
perform test procedures and to record and report test results
promptly, accurately, and proficiently. He or she is also
responsibile for compliance with CLIA regulations. The laboratory
director must be accessible but not necessarily on-site during
testing. Each individual director can direct no more than five
laboratories. Specifically, the laboratory director must ensure that:
Clinical
Consultant
Generally, the clinical consultant must be qualified to consult with
and render opinions to the laboratory's clients concerning the
diagnosis, treatment, and management of patient care. Specifically,
the clinical consultant must:
Technical
Consultant
The technical consultant is responsible for the technical and
scientific oversight of the laboratory. The technical consultant does
not have to be on-site but must be accessible to the laboratory to
provide on-site and telephone consultation as needed. Specifically,
the technical consultant is responsible for:
Testing
Personnel
Generally, testing personnel perform the actual testing process.
Specifically, testing personnel must:
B.maintain records that demonstrate that proficiency testing (PT) samples are tested in the same manner as patient samples.
This completes the first module on CLIA personnel regulations. The second module, CLIA Personnel Regulations II, will cover sources of personnel and continuing education. It will also address competency testing and other personnel related issues in the moderate complexity laboratory.
Daniel M. Baer, M.D., Richard E. Belsey, M.D.
Consultation in Medical Practice
Consultation plays an important part in the practice of modern medicine. Each practitioner is less than fully expert in some aspects of medical knowledge and practice. Consequently, when dealing with patient care problems, it is expected that physicians will seek consultation from an appropriate specialist when they reach the borders of their knowledge and competency. This tradition to ask for help allows the clinician to safely deal with a wide array of medical problems. Just as a practitioner may consult a surgeon, dermatologist, or radiologist for patient care problems, a physician can appropriately ask a pathologist, laboratory scientist, or medical technologist for assistance in dealing with technical and managerial issues of operating an office laboratory.
The requirements of the Clinical Laboratory Improvement Act of 1988 (CLIA '88) are based on the belief that written procedures and protocols for specimen handling, test analysis, equipment maintenance, proficiency testing, and quality control lead to test result quality that can confidently be used in patient care decisions. CLIA '88 dramatically changed the personnel standards of earlier laboratory regulation, which required trained technologists to perform most common laboratory tests, to a standard that allows nontechnically trained individuals to perform most of these test procedures. While individuals trained in medical technology understand and can apply the techniques required to produce consistently reliable test results, those without such training or experience are thought to require technical assistance to meet this standard of practice. A qualified laboratory technologist or laboratorian can help ensure that quality management procedures, required to ensure result reliability, are carried out appropriately in a physician's office laboratory.
The consultant can help the laboratory director improve a laboratory's design and develop analytic and quality management to satisfy licensing regulations.
CLIA '88 Requirements
CLIA '88 requires that laboratories without a licensed physician, such as those directed by chemists or microbiologists with doctorates, have a clinical consultant who can advise the laboratory's clients about diagnosis, treatment, and patient care management. Additionally, CLIA '88 states that laboratories without a trained laboratory director or a qualified medical technologist need to have a technical consultant to help the director and staff plan and supervise quality management activities, including the daily quality control program, verification of written procedures, and resolution of technical problems.
CLIA '88's rules (3) state the following:
The Consultant's Role
The office laboratory director is professionally responsible and liable for the reliability of laboratory results produced in the office, for quality assurance, for proper documentation of both laboratory results and quality assurance, and for other matters relating to licensure, accreditation, and satisfaction of fiscal intermediaries' requirements.
Management of an office laboratory involves selecting and training appropriate personnel; choosing tests, methods, and equipment; record-keeping; reporting results; and pricing. The director must choose the tests to be performed, the methods to be used, and the equipment on which to do these tests. The costs and benefits of performing tests in the office must be balanced against sending them to a referral laboratory. A price list must be established for tests processed in the office laboratory. In addition, the physician-director must establish a method of reporting and documenting test results.
Busy practitioners are generally unprepared to undertake all these roles and provide adequate supervision to the office laboratory staff. A knowledgeable technically proficient consultant can consequently be of great assistance to the office laboratory director in these areas. Although the consultant has a responsibility to select and recommend appropriate test methods, it is the laboratory director who is ultimately the decision maker and the one with final responsibility and authority.
The Laboratory Staff
Most personnel working in small office laboratories (serving 1-5 physicians) have had no formal training to prepare them for working in a laboratory. It is likely that the person doing the test analysis will have received instruction from manuals accompanying the test system or from another employee. Because health workers frequently have no background in basic laboratory technique or biological science, even the language used to describe a test method or instrument use may be unfamiliar. Instruction for a particular testing system given by a salesperson may focus primarily on system operation and casually cover quality management activities such as the need for standardization and for daily quality control. It is unlikely that salespeople will discuss the need for documentation of test and quality control data, basic record keeping requirements, or positive patient and specimen identification.
A typical characteristic of physicians' office laboratories is a high staff turnover rate; thus it is unlikely that salespeople will be able to provide adequate instruction for each new staff member. Consequently, there is a need for a technically competent individual who can train all new staff and provide continuing education to other laboratory staff.
Managing the Laboratory
There are a number of tasks that most physician-directors would rather delegate than manage themselves, for example, the economic and quality management of the laboratory. The volume and frequency of testing in physicians' office laboratories is very different from the hospital or independent laboratories. Depending on the size of the clinical practice and the physician's use of testing, the frequency of measuring particular analyses may be so low that reagent wastage can occur due to outdating of reagents that are sold in quantities greater than the laboratory needs. It may also be difficult for laboratory staff to maintain their proficiency in performing these very low-volume assays. An office laboratory consultant can help by managing the issues related to limited test volume and frequency. The consultant can also assist by keeping these issues in mind when making recommendations for the purchase of new analytic systems, reagents, and quality control materials.
Test and Equipment Selection
Selection of appropriate tests, test methods, instruments, and supplies are an important function for the consultant. In most cases the only other source of such information comes from the supplier, who has a financial interest in the choice made by the physician. The consultant can evaluate products in relation to the physician's needs, operational and capital costs, level of skill required to perform the test, and accuracy and precision of the test system. Once the system has been chosen, the consultant should be able to validate by comparison studies that the system operates acceptably. This validation is a common procedure in clinical laboratories and is required in the CLIA '88 regulations. The consultant may be able to perform equipment maintenance, arrange for repair services and provide documentation appropriate for these services. Sometimes a laboratory consultant can assist financially by providing group purchasing power to the physician's office laboratory or by providing leased equipment to the laboratory.
Quality Control
Of immediate importance, with the advent of CLIA '88, is the establishment of a quality assurance program. Laboratory professionals are highly indoctrinated in the requirements of such programs and the means for carrying them out. The consultant can assist in the design of a quality assurance program, indicating what procedures must be followed and the frequency with which they must be performed. Sometimes the consultant can provide quality control materials, usually at a cost much less than if the office laboratory had purchased them. The consultant can provide these materials in a reconstituted liquid form, thereby avoiding the variability caused by inexperienced technical people reconstituting freeze-dried materials. The consultant can also provide data from his or her laboratory that indicate the target values and variability that is acceptable in the physician's office laboratory.
Statistical analysis of quality control results is a complex matter for the uninitiated. The consultant can perform the statistical procedures and analyze and interpret the results. The consultant can assist in the documentation that is required for the regulatory agencies, provide proficiency tests samples, and perform parallel testing of specimens. This is especially important for procedures that do not lend themselves to other quality control methods.
Regulation and Reimbursement
There are constant changes in rules and regulations in the regulatory and reimbursement arena. Through their professional societies most pathologists and technologists are aware of these changes. The consultant can alert the physician to changes in rules, and advise the office practitioner about new regulations and the means for complying with them. Prior to licensing inspections, the consultant can inspect the practitioner's laboratory on an informal basis and provide advice about changes necessary to comply with regulations. In some cases, licensing procedures are complex; the professional laboratorian can assist the practitioner in preparing for licensure.
Troubleshooting
Professional laboratorians are able to assist the office staff in troubleshooting. The need for troubleshooting may be prompted by quality control data indicating loss of test accuracy or excessive variability, or it may be prompted by a request from the office staff who have noticed a problem with test results, reagents, or instrument operation. Troubleshooting may lead to identification and solution of the problem, but it should go further than that and include follow-up education. At times, troubleshooting leads to advice about changes in procedures, reagent systems, or instruments.
Training
Few of the individuals who work in physicians' office laboratories have either the basic or ongoing education that is important for providing quality test results. The consultant can provide both formal and informal training, which can take the form of informal one-to-one discussion of specific problems, formal educational programs support groups for personnel in several physicians' office laboratories, or newsletters for the office staff and physician.
Business Management
The consultant can provide valuable business and management advice. Laboratory results must be recorded in a manner that provides clarity, identification of patient, date and time of specimen collection, and test results. Although not required by CLIA '88, the consultant can advise the office physician about design of request and report forms, and methods of record-keeping for other essential laboratory records. The consultant should be able to assist in cost analysis and decision making concerning the relative merits of within-office testing vs testing at a referral laboratory. When the decision is made to test within the laboratory, the consultant can advise about testing fees and coding of tests so as to provide maximum appropriate reimbursement from insurers. If the consultant's own laboratory is computerized, he or she may be able to assist the physician by providing useful computer services for the office.
Characteristics of a Good Consultant
Technical consultation can be provided by a number of laboratory professionals, including pathologists, clinical scientists with doctorates such as chemists and microbiologists, and certified medical technologists. For many of the consultation tasks, a pathologist or clinical scientist might be too expensive. Medical technologists have been extensively trained at the technical level to understand test methods, equipment, result validation, and quality assurance needs and techniques. They have been thoroughly trained and experienced to understand sources of error in specimen collection and test analysis, and early warning signals of system failure. The office laboratory staff lacks this background and may have an unreasonable faith in the infallibility of the test system.
Nowhere in the medical technologist training has there been education for consultation or an understanding of how the physician office is staffed and how it operates. For the consultation process to be successful, the consultant must establish a common language and objectives with those for whom the consultation is made. This may require the consultant to gain an understanding of the physician's office routines and alter his or her way of speaking by using words that are clearly understood and are reduced to nontechnical terms. A successful consultant perceives what a client's needs are. The consultant must therefore be careful not to impose his or her own agenda.
The essence of a successful consultation consists of a number of steps. First, the consultant should listen to questions that arise and attempt to understand them within the context of the office practice. The consultant must be sensitive to the timeliness and reliability requirements of the physician and must be aware of the laboratory's resources, such as personnel, space, time, and capital funds. Next, the consultant should respond to the question in nontechnical language, verifying that the response is understood. The reply may bring forth other questions. If it does, the consultant should respond to these, keeping in mind that the scope and length of the consultation should be limited to the wishes of the consultee, and generally should be limited to the question or problem that was initially given to the consultant. The consultant should be sensitive to related problems. Depending on the circumstances, the consultant may wish to gently and tactfully mention other areas that might be appropriate for future consultation. The consultant should always keep in mind that the consultation is taking place in the physician's territory and that the consultee is free to accept or reject the consultant's recommendations.
An Effective Consultant's Tools
Effective communication skills are by far the most valuable tool of the consultant. To be able to hear and understand the problem and provide answers and training in language that is understood and in a manner and speed that will not overwhelm the office staff is essential. The consultant must constantly keep in mind that there is a vast difference in language and culture between him or her and the people being educated.
The consultant, of course, must have the technical knowledge and information to be able to advise about appropriate test systems. In providing advice to the physician, the office laboratory consultant needs to understand and appreciate the importance of timeliness of certain laboratory test results in caring for a patient in the office. Some office tests, although not economical for the physician to perform compared with sending them to a referral laboratory, may have great "time value" if the test results will lead to a therapeutic decision while the patient is still in the office. An effective consultant will try to understand how tests are used in the office setting before making a recommendation based solely on technical or economic grounds.
Exercise
Make a list of attributes that you and your office staff feel are important in the selection of a technical consultant.
Commentary
For the first few years following the implementation of CLIA '88, there were few experienced technical consultants available. Most were self-trained, but now some technologists have developed consultation businesses and have become highly experienced. Others consult only occasionally. Of greater importance that specific knowledge of the office laboratory are the willingness to learn, the ability to listen to a questions and problems, the ability to communicate in nontechnical language, and the willingness to look for information that is not immediately available. The consultation relationship should last for a long time. It is essential that the consultant and office laboratory staff feel comfortable with one another.
One way to evaluate consultant candidates is to invite each one for an interview. Ask each to review his or her qualifications for this role. The technical consultant should meet the following qualifications:
Ask the consultant candidate what CLIA '88 requires for quality control in your laboratory and how it should be set up. In evaluating the candidate's response pay particular attention to:
Use the Technical Consultant Checklist to rate the candidate or candidates. If there is only one candidate, and he or she does not meet your expectations in the interview, meet with one or more clinical or hospital lahoratory directors and review your requirements with them. Ask for their assistance in providing you with an acceptable consultant. CLIA '88 has created an opportunity for clinical and hospital laboratories to expand the scope of their services. Laboratory directors may need an incentive and some direction from potential clients to see the new opportunities.
Daniel M. Baer, M.D., Richard E. Belsey, M.D.
Daniel M. Baer, M.D., Richard E. Belsey, M.D.
Crawley RC, Belsey R, Brock D, Baer DM. Regulation of physicians' office laboratories: the Idaho experience. JAMA. 1986;255:374-382.
Fischer PM, Addison LA. The office laboratory director's guide. JAMA. 1985;254:2941-2945. Grayson RT. Effects of regulatory controls on the accuracy of clinical laboratory tests. JMed Tech. 1984; 1 :632-637.
Gwyther RE, Kirkman-Liff BL. Laboratory testing in the offices of family physicians. AmJMed Tech. 1982;48:697-702.
Kenney ML. Laboratory Performance and Regulatory Requirements: An Empirical Assessment of the Quality Assurance Effects of Selected Regulatory Requirements on the Performance of C'linical Laboratories. Atlanta, Ga: Technology, Evaluation, and Assistance Division, Laboratory Program Office, Centers for Disease Control, US Department of Health and Human Services; 1981.