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References & Links

Occupational Health and Safety Administration (OSHA)
www.osha.gov

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
www.jcaho.org

Federal Department of Transportation (DOT)
dms.dot.gov

Department of Health and Human Services (DHHS)
www.os.dhhs.gov

Environmental Protection Agency (EPA)
www.epa.gov

Patients coming to the occupational health clinic for services have expectations regarding their care. They expect to receive appropriate services by qualified staff members using equipment that is safe and functioning correctly. In order to deliver on that expectation, clinic management must have in place procedures to monitor the competency of the staff and the safety and accuracy of the equipment used in testing. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO), Occupational Safety and Health Administration (OSHA), Environmental Protection Agency, and Federal Department of Transportation have requirements regarding the maintenance and calibration of medical equipment used in the delivery of care in the occupational health clinic.

Each clinic should have policies in place that address these requirements and that are updated annually and whenever regulations change. The responsibility for the daily equipment monitoring should be delegated clearly. Often the responsibility falls to the individual who is also responsible for the daily calibration checks. If clinical engineering is available, as in a hospital department, that department may perform the annual safety reviews. In the case of audiometers, it is recommended that an agency with equipment that meets ANSI standards be utilized for the annual review. Review of established policies and associated training on procedures should be included in the orientation of new employees who will be performing testing services, as well as of management personnel.

The standards that address medical equipment are found in the Management of the Environment of Care function. The goal of these standards is to provide a safe, functional, and effective environment for patients, staff members, and other individuals in the Ambulatory Care setting. Specifically, Standard EC1.8 states a "management plan addresses medical equipment." This standard requires a plan that includes:

• Acquisition of equipment

• Evaluation and inventory of equipment

• Assessing and minimizing clinical and physical risks of equipment

• Monitoring and acting on equipment hazard notice recalls

• Monitoring and reporting incidents in which equipment is connected to a sentinel event

• Reporting and investigating equipment management problems, failures, and user errors

• Medical equipment orientation and education

• Emergency procedures

• Annual evaluation of the medical equipment management plan.

In addition, Standard EC2.13 states "Medical equipment is maintained, tested, and inspected." The intent of this standard is that the organization will maintain documentation of its inventory as well as the performance and safety testing of all equipment in the management plan prior to initial use and at least annually thereafter. This includes "new" equipment that may be acquired from another area of the system or hospital storage. A longer interval between safety checks may be justified, based on previous experience and authorization by the safety officer. Additionally, preventive maintenance and inspection should be scheduled based on manufacturer’s recommendations, industry standards, or current organization policy.

Spirometry: The maintenance and calibration of spirometry equipment are outlined in the Recommended Standardized Procedures for Pulmonary Function Testing, Federal Register, Vol. 43, Friday, June 23, 1978 (Ia, Ij, IIb, IVb,) pp. 58-59. The required procedures include:

• The spirometer must be properly calibrated daily

• Calibrate for volume and time or flow and time

• Calibrate before each shift with both spirometer and syringe at the same temperature

• Calibrate whenever the spirometer is transported

• Calibrate after every thirty tests or sooner (2-3 hours) under field conditions.

Audiology: The requirements for testing audiometers are stated in the OSHA Noise Standard, but are based on the American National Standards Institute (ANSI) standard (S3.6, 1969 or the revised ASA 81, 1989), which regulates the Audiometric Test Requirements. They include:

• Audiometric tests shall be conducted with audiometers (including microprocessors) that meet the specifications of, and are maintained and used in accordance with, the ANSI standard.

• Daily functional calibration of the audiometer using a bio-acoustic simulator and record of daily log. This is often referred to as a biological check. Deviation of 10dB or more in the audiometer’s desired output trigger the next stage of calibration.

• Acoustic calibration, performed by audiometer service companies, must be performed at least annually and include calibration results for intensity and linearity. The calibration results must be within the tolerances permitted by American Standard Specification for Audiometers, S3.5, 1969.

• Exhaustive calibration should be performed at least every two years.

These regulations address the use of Evidentiary Breath Alcohol Testing (EBT) equipment. Congress mandated testing for alcohol as well as controlled substances in 1991 in the Omnibus Transportation Employee Testing Act.

Clinics may use only evidential-grade EBT devices that are approved by the National Highway Transportation Safety Administration (NHTSA), are capable of testing blank air samples, and discriminate between alcohol and acetone (produced by diabetics when their condition is out of control).

The EBTs must have a quality assurance plan (QAP) developed by the manufacturer. If you have EBTs from different manufacturers, there must be a separate plan for each. The plan shall:

• Designate the method or methods to be used to perform external calibration checks of the device, using only calibration devices on the NHTSA "Conforming Products List of Calibrating Units for Breath Alcohol Tests".

• Specify the minimum intervals for performing external calibration checks of the device including frequency of use, environmental conditions, and contexts of operation.

• Specify the tolerances on an external calibration check within which the EBT is deemed properly calibrated.

• Specify inspection, maintenance, and calibration.

• Require a device be removed from service if any external calibration check results in a reading outside the tolerance level set in the QAP.

• Maintain a record of the external calibration checks of all EBTs.

The Environmental Protection Agency issues standards to limit human exposure to radiation and measures environmental levels of radiation.

The Center for Devices and Radiological Health (part of the Health and Human Services Food and Drug Administration) set the standards for x-ray machines. For the purposes of this article, we recommend that you follow your state’s guidelines for licensure and regulation.

Each clinic should have a policy that addresses the safety and maintenance of all equipment, but particularly the medical equipment used in patient care. In addition to the above regulations, the clinic manager must consider the manufacturer’s recommendations when writing procedures and educating staff on the use of equipment. Your policy should include:

• Inventory management

• Acquisition of new equipment

• Inspection of new equipment prior to putting into service

• Orientation of employees prior to using equipment

• Visual inspection of equipment prior to use

• Preventive maintenance of equipment

• Calibration procedures

• Procedure to follow in case of injury

• Action in case of recall

• Required signage

• Responsible party for management of the equipment.

Each clinic must determine who will be responsible and how required quality control checks will be maintained. Some clinic managers choose to delegate the responsibility to the technician and keep the documentation in the room where the procedures are performed. Logs can be transferred every three months to a central location.

Once your policy is in place, you can implement a plan to schedule all annual quality control monitoring. The annual inventory can be scheduled on the clinic manager’s schedule and reviewed for additions and deletions. The annual reviews can be scheduled with a time for completion set. This can then provide the basis for on-going annual reviews. Scheduling these maintenance tasks seasonally, when the clinic volume is lower, should allow you sufficient time to complete them thoroughly.

Adequately maintained equipment can prevent delays in delivery of clinic services due to malfunctioning equipment. Equipment that operates safely and accurately improves the completion of the tasks performed in your clinic and meets your patients’ expectations of quality care.