Guidelines for laboratory administration - Part III.
A. A budger program has several basic objectives:
1. To provide a quantitative written expression of the organization's objectives, policies, and plans
2. To provide the information needed by management to insure financial viability
3. To serve as a basis for evaluating financial performance in accordance with a stated plan
4. To provide a useful tool for cost control
5. To create cost awareness throughout the organization
6. To achieve maximum utilization of available funds
B. Various budgeting techniques can be used to develop the program.
1. The traditional budget, also called the incremental or fixed budget, is based upon one level of operations (such as projected laboratory test volume). Past spending levels, inflation, an new services are major factors.
2. The flexible budget is based on varying levels of operations or volume ranges. In this system, costs vary with volume assumptions.
3. Program budgeting is based on projected expenditures and income for various projects and programs, rather than on functional items of expenditure. This method, a forerunner of zero-based budgeting, is generally used by government agencies.
4. The zero-based budget justifies all expenses annually based upon function, at various levels of operation from minimum subsistence to maximum. It also provides management with ranked decision packages showing the projected impact of proposed activities on the bottom line.
5. Budgeting by patient diagnosis is based upon the level of acuity and volume--for instance, calculating revenues and expenditures by DRG.
C. Budgeting can be performed in several time frameworks, either short range (every 12 months or fiscal year) or long range (over a three- to five-year period).
D. Budgeting requires these forms of input:
1. Test cost or workload statistics (past, present, and projected)
2. Income or revenue (past, present, projected)
3. Cost of capital equipment (initial cost, life expectancy, and yearly depreciation)
4. Operating expenses for reagents, expendables, service contracts, and other items
5. Personnel (present and projected)
E. Test cost analysis is an essential part of budgeting. While the details of such an analysis will vary among different laboratories, the sample form shown in Figure I contains the basic elements of the process. IX. Safety
Every laboratory needs an organized program covering all aspects of on-the-job safety and health.
Written descriptions of standards and procedures, usually in the form of a laboratory safety manual, should be available for use in performing and documenting educational and inspection activities.
Written procedures should deal with fire, electrical, chemical, and radiation safety, and the handling and disposal of toxic or hazardous materials. Include samples of all forms and checklists used, along with relevant Federal, state, and local safety laws. The manual should also identify individuals or groups responsible for implementing and enforcing safety policies.
A. Here are the elements of a basic general safety plan:
1. Develop a formal system to report and investigate all accidents and property losses.
2. Document violations and follow-up actions.
3. Train all employees in first aid, cardiopulmonary resuscitation (CPR), and safety procedures (such as use of fire extinguisher).
4. Post and enforce workplace rules on protective gear and clothing; designated eating, smoking, and recreation areas; cleanliness and housekeeping requirements; unauthorized experiments; and the safety and security of individuals working alone.
5. Schedule periodic inspections, using a checklist. Promptly review inspection results and document follow-up steps.
6. Post emergency procedures and telephone in prominent places.
7. Provide deluge showers and eye wash fountains in well-marked and unobstructed locations near work stations.
8. Appoint and train area safety monitors for adequate coverage of the facility.
9. Set safety policies for laboratory visitors.
B. Establish fire protection and emergency practices.
1. Schedule fire drills on planned escape and assembly routes and evacuation checks.
2. Train staff to use the emergency alert system. Post instructions and maintain operational alarms and telephones.
3. Consider all relevant environmental factors in making emergency plans:
a. Identify areas where radiation, biohazards, or toxic or explosive vapors are present, or where gas cylinders or flammables are stored or used.
b. Clearly mark exits, doors opening from the inside, and fire doors that close automatically.
c. Maintain unobstructed escape routes, with clear aisles and doorways, unlocked doors, and no "blind" rooms or corridors.
d. Assure structural protection through use of fire-retardant materials.
e. Clearly designate smoking and no-smoking areas.
f. Keep fire-fighting and protective equipment readily available.
g. Use fire- and explosion-proof storage cabinets and containers as required by law and regulations.
4. Schedule inspections using a fire safety checklist, and document inspections, violations, and corrective action.
5. Train staff in proper use of fire-fighting and personal safety equipment:
a. Class, type, and location of portable extinguishers
b. Automatic sprinkler systems
c. Fire blankets, portable breathing equipment, and gas masks.
6. Document completion of lab safety training programs on employee records.
C. Develop written electrical safety practices and make them part of the general safety inspection. Assign responsibility for verifying instrument and equipment safety and document these activities.
1. Safety practices should include proper use of outlets and extension cords; protection of electrical devices from spills or leakage of conductive fluids; proper grounding of equipment; protection from static charge; and precautions against unprotected wiring, connectors, or contacts. Describe use of voltage regulators and power supplies where appropriate.
2. List emergency power requirements and outlets so that essential instrumentation and alarm systems will function in electrical emergencies.
3. Instrument and equipment safety should be documented by the facility's own biomedical engineering or technical group or by a contracted outside service organization.
a. List Items requiring regular testing, plus method and specifications where appropriate. List separately any unscheduled items to be tested or recertified after repairs. File results with the apparatus log book or in a central maintenance file.
b. Instrument and equipment safety testing may include measuring chassis current leakage; checking for electromagnetic emissions or interferences (ionizing and non-ionizing radiation); testing hospital outlets for ground safety and service lines for isolation or peak load; and checking for adequate overload protection and fluctuations in voltage and current.
D. The safety manual should describe standards and checking methods for fire- and explosion-proof environments. Mark all such rooms and equipment clearly and document periodic inspections.
1. Large, easily visible warning signs should mark designated areas, safety hoods, cabinets, glove boxes, and other such equipment. All data plate information and exhaust requirements should be clearly readable. Post inspection records in the immediate area or on equipment itself.
2. Because of the explosion hazard involved with caustic acid hoods, written safety protocols should include compliance with such current standards as National Fire Protection Association (NFPA) Code 56-C (part 3-3.5.3) and VS-205 (American Conference of Government and Industrial Hygienists).
E. Biohazardous materials should be classified and handled in accordance with the National Institutes of Health "Biohazards Safety Guide" (1974). Maintain specific hazard containment procedures and verify their use. These include;
1. Personnel training in aseptic technique and decontamination procedures
2. Protection against aerosol hazards from centrifugation and other sources.
3. Use and limits of protective clothing and equipment (pipetting devices, face masks, safety cabinets)
F. To avoid radiation hazards, comply as required with Nuclear Regulatory Commission (NRC) regulations under various sections of Title 10, Code of Federal Regulations (10 CFR). Adhere to occupational exposure limits, as defined in millirems (mrem) per year, by minimizing lab exposure.
1. External exposure control includes policy and procedure on use of safety equipment, badges, and survey meters; shielding and storage of stock materials; and a system to report and review accidental exposures.
2. Internal exposure control covers means of preventing ingestion, inhalation, or skin absorbtion of radioactive materials.
3. Policies must also provide protection for visitors, custodial personnel, and others untrained in radiation safety.
G. Provide written instructions on proper methods of shipping, receiving, and handling potentially hazardous specimens. Follow Department of Transportation and postal regulations on proper packaging materials, and make provision for appropriate decontamination and disposal.
1. Receive and open specimen containers in a controlled area where food, beverages, and smoking are prohibited. Make safety equipment and materials available and train personnel to use them. Procedures for handling damaged containers and spills should be understood and followed. Flag or mark specimens where etiologic agents are known or suspected.
2. Provide a staff treatment or prophylactic program for accidental exposure (cuts, ingestion, or inhalation) to hazardous or etiologic agents--for example, testing employees for hepatitis and administering gamma globulin. Report laboratory accidents immediately to the safety officer or responsible member of management.
H. Waste disposal also requires systematic handling. Maintain written spill control procedures and instructions for final disposal of all chemical and hazardous wastes. Keep materials on hand to absorb, neutralize, decontaminate, and contain such wastes for removal, and train lab personnel to use them. Available reference sources should cover hazardous waste preparation and disposal, required safety equipment, and any special precautions.
1. Label and identify dangerous waste material from the time of collection and storage through final disposal.
2. Provide a means for collecting and storing organic solvent wastes.
a. When volumes in safety cans exceed established safe quantities, use outdoor storage tanks.
B. Store ether and chlorinated solvents separately and never mix them with other solvents.
c. Incinerate in licensed burners that comply with local, state, and Federal regulations.
3. For solid and liquid chemical wastes:
a. Have material available to neutralize and absorb acids, bases, or strong oxidizers, rendering them noncombustible and noncorrosive.
b. Distinguish wastes that may be safely diluted with water and flushed into the sewer system from those that cannot.
c. Describe spatter-proof dilution protocols, and special precautions for explosive chemical hazards and gases from mercury, sodium azide, and other wastes.
d. Segregate all chemical wastes from general trash destined for incineration or compacting.
e. Train personnel in principles and practice of safe chemical waste disposal.
4. Toxic and carcinogenic wastes cannot usually be rendered "neutral" by practical means. Place such wastes in clearly marked containers for removal by a licensed commercial waste disposal agency. Incineration or burial should be done only by a facility licensed to handle these materials.
While most hospital laboratory materials can be diluted and released safely into most sewer systems, this practice in general should be discouraged. Keep records of the quantity, type, and mix of such hazardous wastes in conformance with applicable state and Federal laws.
5. Sterilize all biological materials (both specimen and reagent substances) and their containers before final disposition. Autoclaves, ovens, and incinerators (where allowed) must meet required standards for decontaminating infectious materials.
a. Identify sterilized liquid waste that cannot be safely poured into the sewer system. Develop, disposal procedures for these materials, along with a documented system to assure sterility of solid waste to be compacted and hauled away with general rubbish.
6. Both tracer and RIA labs need a written disposal program for radioactive wastes.
a. Shielding may not be necessary for storage of short half-life wastes.
b. Know restrictions on effluent concentrations from incineration or sewer disposal, and follow them per Nuclear Regulatory Commission regulations in Title 10, Code of Federal Regulations. c. Base normal trashing policy for radioactive wastes (empty vials, paper, gloves, disposable glassware) on license conditions. X. Disaster plans
Every clinical laboratory, regardless of size, requires a contingency plan and a well-rehearsed protocol in case of an institutional disaster that would put a strain on the laboratory's normal functioning. Such a plan should not be developed when immediately needed--it should be a management practice, monitored and refined by the supervisory staff.
A. Establish a disaster manual in an easily amended format. B. Develop a simple and flexible master plan, and review it annually for needed modifications.
C. Categorize this plan as to type of disaster and number of people involved. For example: Plan I covers major emergencies involving large numbers of people during an external disaster; Plan II, medical or sturgical emergencies involving 15 people or less; and Plan III, major emergencies due to an internal disaster.
D. When the institution has been placed on disaster status or alert, a prescribed communication network or call list should notify the laboratory director or manager, who in turn initiates appropriate action.
E. Form disaster teams within the laboratory to provide the following services: blood donor telephone notification, screening and physicals, drawing, and processing; hemoglobin determinations: crossmatching and other blood bank tests; hospital blood collection: and other emergency lab, service if required.
F. EStablish a laboratory disaster committee with representatives from administrative and technical staffs.
1. After actual disasters or drills, this committee should meet to review effectiveness of the communication network and emergency protocols, and make any necessary revisions.
G. Hold disaster drills at least semiannually to cover all categories mentioned above.