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Guidelines for laboratory administration - part II.

IV. Test systems

A. Test selection is based on a number of criteria that vary with the demands on the individual laboratory and that sometimes may appear contradictory. Consider these factors in making a choice of tests to be offered by the laboratory:

1. The population to be served. This factor also influences work flow and specimen handling requirements. Test menus must reflect varying patient populations:

A. Hospital--inpatient or outpatient

b. Clinic--general or specialty care

c. Other populations, served through private practices, reference work for other laboratories, or local, regional, and national mail-order business

2. Volume and nature of workload. Factors like high or low volume, Stat testing versus large-scale batching, and distance required for specimen transport all indirectly influence test selection. A high-volume laboratory, for example, might place a premium on mass production, while a low-volume facility would seek to increase its batching capabilities--and both would look for the most economical, efficient methods to perform Stat testing.

3. Scope of services. Screening procedures are usually qualitative in nature, while definitive procedures are both qualitative and quantitative. Most tests that monitor analytes such as drugs and antibiotics are usually quantitative.

4. Ease of integration with existing lab services.

5. Personnel qualifications. With any ne procedure or technology, the laboratory has to provide additional training. It also may face an adverse impact on productivity.

6. Cost to the laboratory, its clients, and third-party payers.

7. Turnaround time

8. Effort required to validate procedures before adopting them.

B. Validation is the process of evaluating a method or test procedure to establish its reliability, i.e., precision, accuracy, sensitivity, and specificity. Every laboratory should validate each method or test before placing it into routine use. Evaluation should include, at the least:

1. An orientation phase, during which the method is used on control material and a standard operating procedure manual is developed. (See NCCLS Approved Guideline for Clinical Laboratory Procedure Manuals, GP2-A.)

2. Comparison of the test with one currently in use, a recognized standard test, or with the same procedure in use at another laborator. The extent of these comparisons will differ from lab to lab, but testing must be sufficient to provide laboratory users with an assessment of reliability, accuracy, and precision.

a. Run the test with a full range of controls and standards, with routine patient specimens, and with previously run and reported speciments including normals, abnormals, and borderline results.

b. Maintain validation study records as long as the test is in use.

c. Set acceptable limits for test performance.

d. Incorporate the protocol into the technical procedure manual.

3. Establishment of normal ranges with the test system for the population served. This requires use of validation data and comparison with national normal values, usually provided by manufcturers. For some tests, the laboratory may have to use published values.

4. Split-sample testing with another laboratory using the same method. This is a particularly good practice with new or developmental methods, for which no comparable experience exists.

5. Notification of new laboratory services to physicians and other affected members of the health care team.

a. Alert clinicians to any needed changes in patient management, preparation, and specimen collection.

b. Explain differences between old and new methods, including accuracy, precision, sensitivity, and specificity. Although not required, a statement about the test's false-positive or false-negative rate is useful.

c. Notification should include a listing of substances or conditions that interfere with the test.

C. Some variation may be expected in patient processing and management, depending on the population served--inpatient, outpatient, or a combination. For any group, consider these points when setting up administrative procedures:

1. Physician orders for testing--verbal, written, or standing

2. Patient handling considerations--identification, preadmission testing, transportation, and special problems like handicaps, acute illness, or communication barriers

3. Specimen requirements--for the patient (e.g., fasting), for the speciment (sterile), or for the collection time (1 hour postprandial, for example)

4. Specimen requisition identifiers--demographics, hospital room and accession numbers, tests ordered, phlebotomist identification, and routing codes

5. Payment, by type (cash, charge to patient or insurance carrier, discount, no charge, or special) and by routing (cashier, accounts receivable, or data processing)

6. Report handling

a. Routine--chart, file, and physician copies

b. Special--abnormal values, State report by phone, and reportable disease

c. Information request

7. Flow charts for outpatient and inpatient processing

V. Records and reports

A. Various workload recording systems have been developed for clinical laboratories. The system used most often is the College of American Pathologists' Laboratory Workload Recording Method. It was devised to provide accurate work measurement, reflecting both the volume of each kind of test (raw count) and the time consumed in completing one procedure (unit value). The products of these two numbers, for all kinds of tests, are the CAP workload record. Dividing the workload by total employee hours yields a productivity figure for the entire laboratory, or for various sections, shifts, or individuals. The system allows productivity monitoring and comparison with other labs.

B. Report forms serve to inform appropriate personnel of laboratory test results. Design them with these factors in mind:

1. Entry method--manual or computerized

2. Number of entries--single or cumulative

3. Use of form--request, report, or both

4. Purpose--report to physician, for hospital char, or duplicate for laboratory file

5. Size, color coding, and method of attachment to chart or record (shingling or other methods)

6. Heading--patient name, identification number, location in the hospital or the individual's address in the case of an outpatient, age, requesting physician, name and address of lab performing test, and name of laboratory director

7. Type of entry--numerical, descriptive, or diagnostic 8. Space for accession number

9. Normal range

10. Other information--time and date of specimen collection, specimen arrival in laboratory, and test completion, along with identification of person performing test

11. Number and distribution of copies--original for hospital chart, physician's copy, lab file copy, and others as needed

C. Procedure manuals should be comprehensive, detailed, and up to date.

1. Written procedures summarize the principle of each test; the specimen required; any special patient preparation; reagents, standards, controls, and media; and needed instrumentation.

2. They provide step-by-step directions for performing the test, including calibration (protocols and schedules) and calculations.

3. Other items that should be covered are tolerance of controls and corrective action; expected and critical values; method limitations, such as interfering substances; author; references; effective date; review schedule; and distribution of procedures.

D. Periodic review and updating of procedures are a necessity.

1. Assign authority to conduct a review. This assignment will vary with the labhs administrative structure. The director, associate director, doctoral section head, qualified superviors, or delegated committee are all possibilities.

2. Review each procedure at least once a year. At that time, decide if the procedure can be reappoved as currently written, needs revision, or is obsolete.

3. Review procedures after any change in methodology, instrumentation, reagents, and other key variables.

a. The procedure should conform to the guidelines described in Section IV.

b. It should also conform to current methodology and practice, and reflect actual test performance in the lab.

4. Document each review, signing and dating each procedure.

5. Review procedure manuals at least once a year. Do they contain all required material? Are all procedures current, with evidence of recent review? ARe bench manuals or card files current with the master manual?

VI. Personnel prctices

Personnel management policies are an individual matter, determined by each institution's administration. The following guidelines can be useful, however, in developing and organizing the laboratory managerhs approach to these policies.

A. Orientation procedures should be designed to inform the new employee of administrative policies, work rules, benefits, and day-to-day routine.

Upon confirmation of employment, the employee needs basic data such as assignment location, supervisor's name, reporting date, probationary period, and payroll schedule. Withholding forms, insurance applications, the institution's personnel policy handbook, and a work safety checklist round out this introductory pacakage, along with such miscellaneous items as a donor blood card and parking information.

B. The personnell handbook includes institutional and administrative goals and policies on equal employment opportunities; probation; and promotion; transfer; attendance, absenteeism, and tardiness; and performance appraisals. It should also be a reference for these related subjects:

1. Wages and salaries

2. Safety and health

3. Discipline; grievance procedure; termination of employment by resignation, retirement, or dismissal; and exit interviews

4. Work rules, including hours, payday, overtime, time cards, dress code, handling of confidential information, and use of facilities such as lockers or lunch room

5. Benefits, including sick leaves and other leaves of absense, personal days and holidays, disability and other insurance, pensions, educational opportunities, FICA and unemployment compensation, and any available dicounts, saving programs, or service awards

C. Job descriptions are a management tool whose importance cannot be overstated. They are essential guides to hiring competent personnel at realistic salaries. Without them, it is impossible to conduct a valid performance appraisal or make fair salary decisions.

A complete and accuracte job description must include the following items:

1. Identifiers--job title, shift and department hours, supervisor, and data prepared

2. A brief summary of the job and its scope of responsibility

3. Probation period

4. Technical and administrative duties

5. Performance standards

6. Requirements in education and training, work experience, knowledge and skills

7. Chain of command

8. Working conditions--physical demands and potential hazards

9. Annual review of job description, dated and signed

D. Performance appraisals can be formal or informal. The informal evaluation, sometimes called coaching, is usually conducted at bench level as needed. The formal appraisal is used to set longer-range goals and improve overall performance. It should take place at least once a year, more often if necessary.

1. Schedule appraisals at regular intervals. New employees should be appraised after probation, and all employees should undergo periodic appraisals.

2. Set evaluation parameters.

a. For nonsupervisory personnel, these include quality and quantity of work, absenteeism, job behavior, and development of skills and knowledge.

b. For supervisory personnel, they cover organization and planning; communication with employees, peers, and the public; development of employees delegation; problem solving and ability to innovate; financial management; and continuing education.

3. Employees at all level should also conduct a self-evaluation, to use as a basis for discussion during their formal appraisal. Self-evaluation should cover working relationhips with supervisors, co-workers, and patients; views on corrective counseling; personal goals; and an assessment of job quality in terms of work assignments, hours, and facilites.

E. Continuing education serves two purposes: to enhance job competence and to provide job enrichment. These are the basic components of human resource development.

1. Set eligibility guidelines for supervisory and nonsupervisory staff, and reimbursement policies for paid time off, travel costs, registration fees, tuition, and outside remuneration.

2. Personnel files should document such activities as attendance at college courses, workshops, seminars, professional meetings, and in-house presentations; lectures given; and articles reviewed or published.

3. In-service education guidelines are also needed to define maximum time allowed for attendance and minimum time mandated.

4. Participation in professional societies should be considered a form of continuing education.

F. Procedure manuals should include a copy of all personnel records and forms, with full instructions for their use.

As a rule, necessary files include the following:

1. Request for time off or leave of absence, and report of absence

2. Pay rate adjustment (scheduled increase or status change)

3. Probationary and termination reports

4. Change in shift or department, full- or part-time status, or job category

5. Injury report

6. Receipt of policy handbook

7. Corrective counseling, disciplinary warnings, and suspensions

8. Personnel requisition forms for new or vacated positions

9. Chance in personnel/payroll data--name, address, telephone, insurance, and withholding information.

10. Request for continuing education attendance or reimbursement, proof of attendance, and report of meeting

G. Managers must establish and maintain a personnel data file for each employee, documenting application and entry salary; educational information and other, credientials; signed orientation checklist; health records; current job description; continuing edcuation; salary adjustments; performance appraisals; counseling and corrective action; vacation and sick days accumulated and used; payroll deductions; and letters of reference.

VII. Regulations

A. Administrators, managers, and technical supervisory staff are responsible for maintaining professional standards and knowing local, state, and Federal laws and regulations that apply to their services.

1. Ethical standards are too difficult and complex a topic for easy generalizations. It is not within the range of these guidelines to suggest or establish a standard code of laboratory practice. Rather, the guidelines can provide an opportunity to review and rethink ethical standards.

Each laboratory should establish and enforce a code of employee conduct that takes these areas into consideration:

a. Protection of patient privacy

b. Recognition of patient and client rights

c. Integrity in speciment handling, quality control practices, and result reporting

d. Adoption of policies and procedures that will minimize technical errors and allegations of negligence

e. Awareness of legal responsibilities and limitations

2. Legal requirements are also too broad for detailed coverage, because of widely varying state and local laws. However, each laboratory administrator must be aware of all applicable regulations, and familiar with agencies that regulate laboratory operations at the Federal level as well.

a. Most local requirements are business regulations, such as building codes, use permits, insurance requirements, and rules covering fire, safety, and storage and disposal of hazardous substances, (More on this topic in the final section of the guidelines.)

b. For state requirements, the best information sources is usually the director of the state public health laboratory. More than a dozen states have laboratory licensure laws; still more demand some form of personnel licensure, registration, or certification. All states have requirements governing fair employment practices, unemployment compensation, and industrial disability.

c. Numerous Federal agencies participate, directly or indirectly, in lab regulation. They include:

1. The Alcohol, Tobacco, and Firearms Bureau of the U.S. Treasury Department, which issues permits for tax-free alcohol used by laboratories

2. The Centers for Disease Control, which serves as technical consultant to the Health Care Financing Administration and state laboratories

3. The Food and Drug Administration, wich regulates medical devices, reagents, and blood banks

4. The Health Care Financing Administration, which certifies laboratories in the Medical program and licenses labs involved in interstate commerce as required by the Clinical Laboratory Improvement Act of 1967

5. The Nuclear Regulatory Commission, which controls use of radioactive materials

6. The Occupational Safety and Health Administration, which overseas safety in the workplace

7. The Department of Transportation, the U.S. Postal Service, the Public Health Service, and other agencies that regulate shipment of biohazardous materials

8. The Environmental Protection Agency (pollution control)

B. Accreditation and certification are processes to recognize that a laboratory or lab professional has met certain standards. Strictly defined, accreditation applies to institutions, whereas certification is restricted to individuals.

1. A number of organizations sponsor voluntary laboratory accreditation programs, including the American Association of Blood Banks and the College of American Pathologists.

Note: The Joint Commission on Accreditation of Hospitals inspects hospital laboratories as part of its overall facilites accreditation process, but it does not accredit them as separate entities.

2. Certification usually refers to the process of verifying an individual's credentials. At least 26 national certifying boards, registries, and other associations certify personnel or certification programs. The National Commission for Heath Certifying Agencies is composed of various organizations attempting to consolidate and standardize laboratory credentialing.

Almost 70 national and regional organizations claim a significant membership of laboratories, both generalists and specialists. The American Public Health Association's book, "Quality Assurance Practices for Health Laboratories," lists most of them.

a. The Health Care Financing Administration "certifies," or authorizes, laboratories for payment of services under Medicare and Medicaid. Procedures vary, depending on the laboratory's classification:

Hospital laboratories qualify through "deemed status" if the hospital is accredited by JCAH or the American Osteopathic Association.

Non-JCAH accredited hospitals must meet federal quality control standards and satisfactorily participate in a state-offered or approved proficiency testing program.

No formal HCFA regulations apply to personnel in hospital-based laboratories.

b. Independent Medicare and Medicaid laboratories are surveyed by state agencies under contract to HCFA. Surveys determine compliance with Federal regulations on personnel qualifications, from technician to director; on quality control; and on demonstration of proficiency testing. The CDC conducts spot checks of labs already visited by state inspectors, as well as JCAH- and CAP-accredited facilities, since HCFA accepts such accreditation as assurance of compliance.

C. Licensure is the process by which a governmental agency permits an individual or business to engage in a particular occupation or perform specified functions. Licensure standards are specified by law and regulation.

The Federal licensure law with the greatest impact on clinical labs is CLIA '67. CLIA personnel and quality control requirements apply to all laboratories, hospital-based or independent, that engage in interstate commerce as defined by law.

1. All CLIA-licensed laboratories must demonstrate satisfactory participation in CDC proficiency testing.

2. Exemptions from licensure may be granted if a laboratory performs fewer than 100 tests annually per test category for interstate commerce; if it is accredited by the CAP's interstate program; or if it is licensed by the State of New York.
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Author:Bender, James L.
Publication:Medical Laboratory Observer
Date:Jul 1, 1984
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Next Article:Developing cost awareness at the bench.

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