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COCHISE REGIONAL HOSPITAL Maintenance Policies Policies and Procedures Relating to

the Maintenance Department POLICY The policies and procedures set forth in this manual are for the guidance of all employees of the Maintenance Department of COCHISE REGIONAL HOSPITAL so that the physical plant will be properly maintained to best serve our patients and communit

Reviewed Date: 11/14 Revised Date: 11/14

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Scope of Service POLICY Types of Customers § Patients § Employees § Vendors § Visitors § Suppliers § Contractors Procedures/Services Maintenance assumes responsibility for all utilities, planned maintenance, repairs and replacements. Additional responsibilities include readiness of all life support and safety systems, interim life, safety protocols when the facility is under construction, repair and maintenance of the facility grounds, supervision of service contracts for the building, support and exercises strict economy in the consumption of fuel, water, gas, electricity and all supplies. Hours of Operation The department is operational Monday - Friday, 7:00 AM – 5:30 PM. Maintenance staff is on call at all other times for emergency repair needs. Reviewed Date: 11/14 Revised Date: 11/14

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Staffing Plan POLICY The purpose of the Maintenance Department is to provide repairs and maintenance for all of the buildings, the grounds, the power plant and all associated mechanical equipment rooms, all heating, ventilating and air conditioning equipment, medical and surgical equipment, and all stretchers, carts and wheelchairs, and other rolling stock. Reviewed Date: 11/14 Revised Date: 11/14

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Plan to Improve Quality of Care

POLICY The main objectives of Maintenance Department will be to perform maintenance at a level that will keep the facilities and equipment in a safe and acceptable condition without over-maintaining or under-maintaining and to promote the most effective and efficient use of manpower and resources. Reviewed Date: 11/14 Revised Date: 11/14

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Additional Standards of Practice Adopted/Adapted by Department POLICY q Develop a better basis for determination of budgetary requirements and long-range planning projections. q Develop a better means of evaluating the maintenance effort being expanded in various departments/buildings. Reviewed Date: 11/14 Revised Date: 11/14

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Introduction to the Maintenance Department

POLICY To maintain and service utilities such as light, heat, air-conditioning and power to provide maintenance necessary for the care of hospital facilities, and to create a pleasant and comfortable physical environment and maintain facility in good repair. Responsibility Transmission of light, heat, service utilities, and power is the assigned function of the Maintenance Department. This function concerns preventive maintenance, repair, upkeep and minor renovation of buildings and grounds and the equipment not cared for by the using departments. Since plant operations and maintenance functions and responsibilities overlap to a considerable degree, these functions are combined under Maintenance. Plant operations functions include: advising the Administrator on matters pertaining to service utilities; establishing technical procedures and management functions pertaining to repairs and utilities; providing advice and assistance concerning improvements to the hospital, including landscaping, construction, and repairs; coordinating matters pertaining to major construction; establishing priority for repairs and utility projects, and planning, programming, and accomplishing maintenance, repair and improvement of buildings, grounds, drainage systems and utilities. Boilers, pumps, and other boiler room equipment are used to produce heat, cooling, hot water and steam for sterilizing equipment. The department maintains all electrical systems including refrigeration, air-conditioning, air-handling equipment, motors and wiring. This also includes maintaining and servicing the generating plant to provide emergency power. Maintenance of buildings, grounds, and equipment include the functions of carpentry, painting, electrical work, plumbing, air-conditioning, gardening, furniture repair, plastering/masonry, welding, and many others. A number of miscellaneous functions are assigned to this department. Some include refuse collection and disposal, insect and animal control, trucking, planning and supervision of plant protection in the form of security department and to head up energy conservation program.

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Authority The size and composition of the Maintenance staff varies according to the size and needs of the facility. The supervision of this department is the responsibility of the Department Head. The Department Head is under the direction of the administrator. Interrelationships The Department of Maintenance renders services essential to the operation of the facility, and it is necessary to establish responsibility for specific duties and to define clearly the lines of authority. This provides a guide for those related functions and encourages interdepartmental cooperation. The Maintenance Department services all departments in the facility. Scheduling of work and repairs must be established on a priority basis in cooperation with all departments. Reviewed Date: 11/14 Revised Date: 11/14

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Selection of Employees POLICY All employees for the department are selected on the basis of their qualifications to fulfill established specifications for the job. General criteria include experience, ability to learn, physical ability and willingness to work in the job environment. No person is discriminated against in employment, placement, or promotion because of religion, race, citizenship, national origin, marital status, handicaps, or age. The personnel office screens applicants from both within and outside the organization. This screening includes review of a written application and resume, and a reference check. Candidates who meet qualifications outlined in the job description will be interviewed by the Department Head, who will make the final employment decision. Once this decision is made, the applicant is informed by the Department Head concerning salary range, personnel policies and the responsibilities of the position. In addition, the applicant may be asked to have a physical examination as part of the screening. Employees may be terminated for making false statements on the application or concealing information in any way. Department Orientation All new employees will go through a two part orientation procedure. The first being orientation to our organization, while the second is a specific orientation by the department's supervisory staff which will be conducted one hour a day, two days a week for three weeks. This is to acquaint new employees with our facility and department policies. All Employees Every employee will be given a copy of the Department Policy and Procedure Manual. He will be expected to read it in its entirety and sign a receipt slip acknowledging that he understands all policies and procedures. If an employee is illiterate or not able to understand a policy or procedure, it will be read and/or explained to him/her. Reviewed Date: 11/14 Revised Date: 11/14

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Illness, Call-In, and Overtime

POLICY To receive a personal paid day off, or overtime, the following procedure will be followed or the day will be leave without pay. § The call to report illness will be made not more than thirty (30) minutes before the

time you are to report to work. Failure to report to work will result in the following disciplinary action.

§ First Offense: Will result in a verbal warning. § Second Offense: Will result in a written warning. § Third Offense: Will result in a three day suspension. § Fourth Offense: Will result in termination.

§ All authority for overtime will be given by the Maintenance Department Head and

overtime is defined as any time worked over and above the normal 40 hours in one pay period.

Reviewed Date: 11/14 Revised Date: 11/14

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Work Schedules POLICY Work schedules for all Maintenance employees are from 7:00 AM to 5:30 PM with a thirty (30) minute lunch break. Lunch break will be from 12:30 PM to 13:00 PM. Coffee breaks will be from 10:00 AM until 10:15 AM. All persons in the department must realize that because of unforeseen or unavoidable circumstances, the schedule may be altered. Reviewed Date: 11/14 Revised Date: 11/14

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Work Schedule Changes POLICY No changes are to be made in the schedule without permission from the Maintenance Department Head. If an employee thinks there has been a mistake in his time or hours he is scheduled to work, he should check with the Maintenance Department Head. For any special requests, the Maintenance Department Head will be contacted. If the request is justified, effort will be made to accommodate the request. Reviewed Date: 11/14 Revised Date: 11/14

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Hours of Work POLICY Employees will be expected to work evenings, nights, holidays and weekends, as deemed necessary by the Maintenance Department Head. The normal workday will be eight (8) hours, not including a half-hour meal period. The normal work period will consist of ten (10) days. It is expected that employees work additional hours or days as required by absenteeism, etc., but only with the consent of the Department Head. The determination of the daily or weekly shift schedule is left to the Maintenance Department Head. It is expected that all employees follow the schedule as set forth. Any questions concerning being asked to work a different shift daily or weekly, the employee is free to contact the Maintenance Department Head. Starting Time A work day begins at sign in. Off-Duty Hours Employee must report for work no earlier than ten (10) minutes prior to the beginning of the work shift. Employee should leave the premises immediately on completing their work shift and not stay around in the building on off-duty time. Overtime All personnel are expected to work overtime, as needed, to provide necessary service. All overtime must have prior approval of the Maintenance Department Head. Reviewed Date: 11/14 Revised Date: 11/14

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Vacations and Holidays POLICY The vacation policy for the department will follow the general rules set forth in the Employee Handbook. In addition, the Maintenance Department will follow these specific guidelines: q All vacation requests will be made to the Department Head two weeks prior to start vacation. q Only one employee may be on vacation at any given time. In the event of two or more employees requesting the same time, the choice of vacation time will be granted to the employee with the longest length of service in the department. q If there are any conflicts or problems with the vacation time, the Maintenance

Department Head will intervene and that decision will be final. The holiday policy for the department will follow the guidelines set forth in the Employee Handbook. The Maintenance Department will also follow the following: q The Maintenance Department is closed all holidays. Holidays are: Thanksgiving Day,

Christmas Day, and New Year’s Day. The Maintenance Department Head may call employees to work holidays in emergencies.

Reviewed Date: 11/14 Revised Date: 11/14

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Performance Evaluation

POLICY The Maintenance Department Head will be required to evaluate work performance prior to the end of six months of work and on each anniversary of employment thereafter. However, the Maintenance Department Head may decide to evaluate at any time. These evaluations are designed to help employees understand what is expected of them and how job performance can be improved. Each evaluation will be explained and the employee will be asked to sign the evaluation form. Reporting of Absence Daily attendance is vitally important in order for the department to provide complete and efficient service. Excessive absenteeism, for any reason, places a severe hardship on coworkers especially when a replacement must be called in. If it is necessary for an employee to be absent from duty, he must call the Maintenance Department Head giving the reason for the absence. This must be done each day until a return date is determined. Failure to report an absence will result in forfeiture of any benefits. An unreported absence for two consecutive scheduled days or two unreported absences within a six-month period will result in automatic termination of employment. Tardiness If for some reason an employee will be late for work, he must notify the Maintenance Department Head and advise what time he expects to arrive. Excessive tardiness will result in termination. Reviewed Date: 11/14 Revised Date: 11/14

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Work Orders Requests

POLICY The purpose of stating clearly all work order procedures in the Maintenance Department is to provide not only this department, but all other departments in the hospital, the proper procedure and overall concept on how maintenance is performed and controlled to provide service effectively. A significant portion of time spent on maintenance may be classified as inspection. This is prescribed to discover the need for additional work before it develops into more serious proportions. The Work Order Form is prescribed to report needed work that is discovered by and beyond the immediate scope of maintenance personnel. These forms are made available to all operating personnel, to those answering service calls and those assigned to preventive maintenance. Also, their use by guards, cleaning personnel, nursing stations, and all departments are encouraged since they will observe work that is needed while in pursuit of their assigned duties. Very little, if any, instruction is required to fill it out. The work order should be filled out, given to the supervisor and then sent to the Maintenance Department Head. A well organized work order system is necessary for the Maintenance Department Head to review, authorize, set priorities, schedule resources, assess unattended results and integrate into and take corrective action where needed. Reviewed Date: 11/14 Revised Date: 11/14

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Criteria for Established Priority on Maintenance Projects and Work Orders

POLICY Priority 1 § Involve areas or systems bearing on Direct Patient Care Activities. § Are required to correct unsafe or illegal conditions. (Comply with recommendations

of Fire Department, and other regulatory agencies.) § Enable improvement or advancement of a patient care service. Priority II § Improve departmental efficiency, particularly a patient or medical care service. § Improve appearance in patient units and other areas frequently visited by the public. § Improve employee comfort and convenience. Priority III § Any desirable changes in the building to enhance appearance or provide added

convenience but are unessential to primary goals of hospital or contribute to efficiency.

§ Involve painting or maintenance to non'public, isolated areas (incidental to appearnance or sanitation.)

Priority IV § Can be deferred until further planning and/or study can be made with initiation as to

necessity. § Can be deferred until financing can be assured. Note: Construction work on all projects is subject to interruption when maintenance personnel are called for emergency services. Reviewed Date: 11/14 Revised Date: 11/14

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Control and Follow-Up - Processing a Work Order

POLICY Work orders are received by mail or e-mail, delivered to the department, or in cases of emergency, filled out by the clerk when received over the telephone. All work orders must be submitted on the hospital Work Order Form. All work orders are received by the Maintenance Department Head, established priorities, and then logged in the Work Order Log Book, indicating what department intiated the work order and a brief description of work requested. A work order number is then given from the log book. Thereafter, the work order is assigned to a qualified technician to complete the job requested. The yellow copy of the Work Order Form is separated from the original and thereafter filed in the work order file which is situated in the foreman's office for follow-up. The original is then placed on the clipboard of the craftsman assigned. Each craftsman will check his board a minimum of every two (2) hours. Rush or emergency service calls are dispatched by paging the craftsman on the communication system. Craftsman completing the work order will record time spent, material used, and property control number on the work order and return same to the foreman's office. The foreman will then make an entry in the log book indictaing the job has been completed. The yellow copy is then removed from the follow-up file and destroyed. The original remains in the Maintenance Department for pricing and documentation on Preventive Maintenance Service Record. Reviewed Date: 11/14 Revised Date: 11/14

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Request for New Construction or Remodeling

POLICY This consists of any work which alters the shape of an area for furnishings within the area. It does include such items as new coverings on work tables and desk tops, new shelves, relocation of doorways, removal of partitions, new partitions, new bookcases, or any construction of any item that does not now exist. A request for this type of work will be made on the conventional work order form with attachment to outline the proposed change if necessary. The request must be signed by the Department Head of the department requesting the work. When this request is received by the Maintenance Department Head, a project estimate will be prepared and sent to the requesting department. The Department Head of the department requesting the work will sign the estimate indicating that the project estimate is satisfactory. The project estimate will then be sent to the administrator for signature indicating that funds are either available or not available for the project at this time. If funds are not available, the request will be sent back to the requesting department. If funds are available, the request will be returned to the Maintenance Department Head where a work order will be issued to the appropriate craftsman with a copy to the requesting department indicating the approximate starting and completion dates of the project. Any questions concerning availability of funds should be discussed with the administrator. Reviewed Date: 11/14 Revised Date: 11/14

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Infection Control Policies and Procedures POLICY The Maintenance Department provides a hygienically clean environment for systemic inspection and preventive maintenance of all equipment, by established routines for emergency repairs, and by proper care of the entire physical structure and its movable and fixed equipment. Personnel Employee Health All buildings, grounds, and personnel shall be free of infectious diseases, colds, boils, pneumonia, gastritis, or skin infections when coming in contact with patients. Dress Code Clothing and shoes shall be changed when they become contaminated. Heavy boots and coveralls shall be worn when personnel are exposed to gross contaminated waste such as broken sewer lines and sewer stops. Surgical Suite § Do not enter without prior permission of nurse on duty. § Before entering room, wipe tools, carts, electrical cords, etc. with appropriate

disinfectant. § Thorough hand washing for at least 15 seconds with soap and running water before

entering area. § Attire

§ A scrub suit must be worn. § A surgical cap shall be worn making sure that all head and facial hair is covered. § Shoe covers shall be worn over regular work shoes.

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In-Service Education § Specific educational programs regarding infectious diseases, their prevention, and

communicability shall be made available and documented. § Guidelines on infection control of contaminated articles and equipment in isolation

rooms shall be made available. § Instruction shall be given on environmental control in the prevention of nosocomial

infections and the maintenance employee's role in it. Isolation Procedures Do not enter isolation rooms without the permission of the nurse on duty. Check patient's door for color-coded card which described precautions necessary to take before entering rooms. Wipe all tools with appropriate disinfectant before entering and departure from the rooms. Since it is necessary to regown, mask, and wash hands before each entry into room, it is essential to assemble all anticipated equipment prior to entering. Handwashing § Hands must be washed with antiseptic soap or detergent and water on entering and

leaving the room. Vigorous scrubbing for at least 15 seconds and thorough rinsing are essential for handwashing to be effective.

A gown must be worn over the usual work clothes, follow technique prescribed in the hospital's procedure manual. Garbage Storage and Collection All normal landfill and waste is collected by Environmental Services and deposited in collection dumpsters about the facility. This waste is picked up by a contract service. Infectious and hazardous waster is double bagged at its origin; it is then retained in watertight receptacles of impervious material with tight fitting lids that will protect the contents from flies,

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Insects, rodents, and other animals. This waste is picked up by a contract company. Equipment Water Supply Hospital water supply system shall not be connected with other piping systems or with fixtures that could allow contamination. Water supplies shall be protected from contamination by the installation of vacuum breakers. A reserve of portable water shall be kept available. Indirect waste vents: § Traps shall be installed in liquid waste plumbing in accordance with building codes

and shall be checked frequently for stoppage. Water traps shall be filled at all times. Maintenance of Buildings All surfaces, floors, walls, and ceilings require constant inspection and immediate repair, when necessary, in order to maintain smooth, dry and cleanable surfaces. Any openings or breaks in walls, foundations, window panes, etc. require immediate repair in order to preserve a clean environment. Acoustical surfaces, walls, or ceilings shall not be used in the surgical suites, kitchen, and treatment rooms where cleaning problems are most important.

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Carpets: § Must be extremely tough to withstand astringent cleaning routine such as rotary

scrubbing. § Shall be water and rot proof and provide no nourishment for bacteria. § Pile shall be non-absorbent so spills of blood, urine, feces, food and drink will not

stain. § Pile shall be resistant to shedding or linting because resulting fluff harbors bacteria. § Carpet shall be flame and static resistant. § Bacterial count on carpets will increase only when the carpet is damp for a long

period of time. Ventilation Air Intake and Outlet Discharge and exhaust air openings and recirculating air intakes shall be located at least three (3) inches above the floor. When located less than seven (7) feet above the floor, intake and outlet openings shall be protected by a grill or screen with openings no larger than half-inch mesh. All fans serving exhaust systems are to be located at discharge end of the system. All air supplied to sensitive areas, such as surgical suites, will be delievered at or near the ceilings. All air exhausted shall be removed at or near the floor level. § At least two (2) exhaust outlets shall be used in all surgical suites. § This air can be supplied directly from the outside with all air being exhausted directly

outdoors; therefore, there is no recirculation. Without recirculation, fifteen (15) fresh air exchanges per hour shall be suplied to operating rooms. With recirculation, operating room areas shall receive twenty-five (25) air exchanges per hour with five (5) fresh air exchanges per hour. Recirculation for Recovery Rooms shall be six (6) total exchanges per hour with two (2) fresh air exchanges.

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Air Filters on Air Conditioners and Air Handling Units § Clean or replace unit filters when their resistance to air flow has increased to two (2)

times the original resistance. § Disposables shall not be cleaned and reused. § Ventilating systems in operating rooms and other sensitive areas including isolation

rooms and laboratory sterile room shall incorporate air filters with the efficiency of no less than 90%

Preventive Maintenance The filters of all air handling units shall have routine six month inspection, cleaning and replacement when necessary. Air conditioning coils and drip pans shall be maintained at least monthly to prevent algae and bacterial growth. Routine cleaning and sterilization of humidification aerosol generators are required to prevent bacterial growth in air conditioning equipment. The food serving units using refrigeration or hot service elements shall be checked for operation and proper temperature. The food serving and preparation equipment shall be kept clean at all times. Vacuum breakers shall be installed in the water supply lines and shall be inspected annually to ensure proper operation, or more frequently if so dictated by local authorities. Clean sterilizer drain screens routinely. Calibrate sterilizer, thermometer and maintain efficiency of recording devices. Check sterilizer valves and regulate equipment to ensure proper operation. Controls in System Written routine procedures and schedules for the evaluation of the quality of the ventilating system, water supplies, ice machines, and piped in gases are formulated according to the manufacturer's recommendations. Reviewed Date: 11/14 Revised Date: 11/14

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Disposal of Syringes and Needles

POLICY It is the responsibility of Environmental Services personnel to retrieve all full and used needles and syringe storage boxes from all hospital areas. These same personnel will then transport the storage boxes using extreme care and caution to the refuse cage located west of the North Wing area and deposit it in red barrels. These containers shall be removed by an outside contractor. Reviewed Date: 11/14 Revised Date: 11/14

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Terminal Cleaning of Isolation Room

POLICY The cleaning of an Isolation Room will be carried out as outlined in the Infection Control Policy. However, the Maintenance Department will be called in by the nursing supervisor to clean and disinfect the fan coil unit. Before entering the room, the person designated to clean the room will wash his hands, wrists, and forearms thoroughly with germicidal soap and will put on a mask, gown, and gloves as indicated. The filter in the fan coil unit should be taken out and same will be "red bagged" in the room, ready for destruction. The whole unit shall then be disinfected and the disinfectant used for the job shall be obtained from the Environmental Services Department. Once the unit has been properly disinfected, the new filters should be installed and the unit put back together. The fan will not be turned on until the room in question is again occupied by a new patient. When the job has been completed, the gown, mask, and gloves are to be removed and deposited in the final trash bag. Wash hands, wrists, and forearms thoroughly with germicidal solution and advise nursing supervisor that the job has been completed. Reviewed Date: 1114 Revised Date: 11/14

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Disinfecting of Tools Carried by Maintenance Personnel

Before Entering High Risk Areas

POLICY Personnel from the Maintenance Department having to enter into high risk areas which include surgery for assigned tasks should ensure that apart from adhering to procedures already specified, they will also clean their tools and anything else which they might be carrying with a germicidal solution. Only the tools needed for the particular job shall be carried. Reviewed Date: 1114 Revised Date: 11/14

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Ventilation and Air Control POLICY Ventilation in administrative areas shall be controlled by multi-zone air handlers delivering 20% fresh air make-up, which is being filtered by a final filter of 40% efficiency and pre-filtered by 30% efficient filters. Laboratory area shall be controlled by an air handler with a final filter of 95% efficiency. Surgery shall be controlled by an air handler with 100% fresh air make-up being filtered with a Hepa type filter with 95% efficiency. The air handler provides a minimum of 12.8 changes of air per hour. All pre filters should be checked monthly. Documentation shall be kept in Maintenance filter log. Patient rooms shall be controlled by fan coil units with a 10% fresh air make-up being filtered by polyester media. Patient room filters shall be checked monthly. Isolation rooms shall be controlled the same as patient rooms. Reviewed Date: 11/14 Revised Date: 11/14

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Oxygen and Vacuum Testing

POLICY It is the policy of COCHISE REGIONAL HOSPITAL that the Oxygen and Vaccum Testing will be accomplished by the Maintenance Department Head on a monthly basis and an outside contractor on a yearly basis. Reviewed Date: 11/14 Revised Date: 11//14

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Inspection Procedure for Portable Fire Extinguishers

POLICY The Safety Officer (Maintenance Department Head) will inspect all portable fire extinguishers located throughout the hospital once each month and complete a "Fire Extinguisher Report or Log". The log is to be kept in the Maintenance Department. The following checklist is to be followed for completion of the inspection once each quarter and inspection is by an outside contractor. PURPOSE To ensure that operable fire extinguishers be available in the event of a fire incident. Pressure or Weight Pressurized water and dry chemical extinguishers have a pressure gauge indicating the amount of stored pressure used for expelling the extinguishing agent. On these units, the gauge pointer must be in the proper pressure range marked on the dial face. The gauge should be tapped gently to assure a movement of the gauge needle as a check that the needle is not stuck. The extinguisher should be lifted to ensure it is full. Safety Seal The safety seal is a lead or plastic seal on the valve safety pin. A broken or missing seal indicates that the extinguisher has been tampered with. If this is the case, the extinguisher should be carefully checked as to charge level, recharged if necessary, and resealed. Access Is the extinguisher visible? Has someone covered up the extinguisher with something or placed a cart, cabinet, etc. in front of it restricting its access and/or visibility? Obstructions must be removed. Hose and Nozzle Conditions Check the hose to determine if it has been cut or is cracked or worn. The nozzle or hose should be checked for plugged opening and any damage or deformity.

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Shell Condition Check for corrosion, mechanical damage, (broken hanger, door latch and hinges) and point condition. Reviewed Date: 1114 Revised Date: 11/14

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Incoming Equipment Policy and Procedure

POLICY It is the policy of COCHISE REGIONAL HOSPITAL to process all incoming equipment. All equipment, regardless of age or ownership, must be subjected to certain electrical and mechanical tests before it may be used in the hospital. The results of these examinations must be recorded. The item must also receive periodic re-examination. For this reason, the following procedures must be followed for any incoming equipment. PROCEDURE Upon arrival of the equipment, maintenance must be notified. Maintenance will obtain all available information including the model, type, serial number, purchase price, shipping information, department and location where the item will be used, any electrical and mechanical data. All service manuals will be kept on file in the Maintenance Department. All incoming equipment will be evaluated as to its function. All patient care equipment will be included in the preventive maintenance program. Maintenance will enter this information into the computer. A control number will be assigned to and placed on the item. He will perform the necessary testing and record the results. A maintenance schedule will be set up and entered into the computer. The Maintenance Department keeps a copy of the pertinent information and control number. Finally, maintenance will deliver the item to its location of intended use. Reviewed Date: 11/14 Revised Date: 11/14

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Hospital Preventive Maintenance

POLICY Preventative maintenance is provided through a contract company. Reviewed Date: 11/14 Revised Date: 11/14

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Reporting, Isolating and Removing Recalled Equipment and Supplies

POLICY The Safety Officer (Maintenance Department Head) shall be designated as the hospital individual to receive any manufacturer recall notices. Definition: A "recall" as defined by the Food and Drug Administration (FDA) is a "Firm's removal or correction of distributed products that in the judgment of the FDA are subject to legal action under laws administered by the FDA". Recalls are classified by the FDA as: Class I (Urgent, life threatening) - a situation in which there is reasonable

probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.

Class II (Serious, corrective action required) - a situation in which the use of or

exposure to a volatile product may cause health consequences, or where the probability of serious adverse health consequences are remote.

Class III (Advisory) - a situation in which the use of or exposure to a volatile

product is not likely to cause adverse health conditions. Immediate action shall be taken in the reporting, isolating and removing recalled supplies and equipment from the hospital. Manufacturers of medical supplies and devices are required by the FDA Medical Devices Amendments of 1976 to advise users of any product hazards. Notification should be made by telephone, mail-gram, certified mail or registered mail. Manufacturers involved in distributing materials that are recalled shall rectify such matters by repairing the defective item, replacing it, or refunding all or part of the purchase price. An in-house recall system shall be implemented and coordinated by the Safety Officer. PURPOSE To establish a system of reporting, isolating, and removing recalled equipment and supplies from the hospital to ensure that such items do not cause harm to users.

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O: 5/91 PROCEDURE All notification concerning equipment or supply recalls shall be forwarded to the Maintenance Department Head. Class I recalls shall have priority. If a Class I recall is in effect, all in-house users of such products shall be notified to isolate the materials in question. § Written follow-up verification of the items recalled shall be sent to all appropriate

department managers or supervisors by the Safety Officer. Disposal of recalled items in the hospital shall be coordinated with the Safety Officer.

§ A copy of the "Equipment/Material Recall Notification" letter, detailing the recall

specifics, shall be sent to the Risk Management/Safety Committee. § Upon notification by the Safety Officer of recalled items, all recalled items shall be

isolated from other inventories pending disposal instructions. § Adequate replacements shall be acquired, at once, by the Central Supply

Department. § Maintenance Department personnel shall repair or replace parts on recalled

equipment that are within the scope of the department's capability. The cost of repair or replacement parts of recalled items shall be levied against the manufacturer by the Central Supply Department Head when appropriate. The Maintenance Department Head shall indicate recalled items that are repaired or parts replaced in its departmental records.

§ The Central Supply Department Head shall notify the manufacturer of the recalled

equipment or supplies after the recalled items are isolated and quantities totaled. All questions concerning the recall of equipment or supplies should be forwarded to the Safety Officer (Maintenance Department Head). Reviewed Date: 11/14 Revised Date: 11/14

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Emergency Generator Testing

POLICY It is the responsibility of the Maintenance Department Head to ensure that the emergency generator is started up and operated once per week and once per month for at least one-half hour under load conditions. The procedure for testing the emergency generator is as follows: Inform Administration, Director of Nursing, Surgery Supervisor, and Laboratory Department Head that the test is to begin. The Maintenance Department Head or his designee will ensure that one person from his unit is with him while testing in the transfer switch area. He will activate the test switch which in turn activates the generator and transfers the load from A.P.S. Public Utility side to emergency side. The Maintenance Department Head or his designee should record in the Emergency Generator Log Book the following data: § Date § Time § Elapsed Time Recording § Cycles § AC Amps § AC Volts § Engine Water Temperature § Engine Fuel Pressure § Engine Oil Pressure § Amount of Fuel on Hand § At the bottom of the page in the log book, the Maintenance Department Head or his

designee should sign his name. If any abnormalities occurred during the time of the test, it is imperative that the Maintenance Department Head be contacted immediately. It should be understood that any time normal service to the hospital is interrupted, persons noted above should be contacted to confirm that emergency power has been furnished (this includes

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Tests). Items 2, 3, and 4 above should also be followed to indicate and record the time of power interruption as well as the time when normal power is restored to the hospital. Any time service is interrupted, the Maintenance Department Head should be informed immediately. Reviewed Date: 11/14 Revised Date: 11/14

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Extension Cords

POLICY Use of extension cords in the hospital is forbidden except in an emergency or on a temporary basis. NO person in the Maintenance Department is permitted to issue an extension cord of any length without first checking with the Safety Officer. The Safety Officer will then record the department, room number, etc. who is receiving the extension cord and this record will be kept in the Maintenance Department. The Safety Officer will inspect the condition of the extension cord prior to and after use. It will be the responsibility of the Safety Officer to review this list daily. If an extension cord has not been turned in within four (4) days, the Safety Officer will take appropriate action. Reviewed Date: 11/14 Revised Date: 11/14

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Illness/Injury Reporting

POLICY In compliance with the Safe Medical Devices Act of 1990, it is the policy of COCHISE REGIONAL HOSPITAL to report all deaths, serious illnesses, or injuries to either the Food and Drug Administration (FDA) or the manufacturer that are sustained by the patient at COCHISE REGIONAL HOSPITAL and are caused or suspected to be caused by a medical device in accordance with the procedure below. SCOPE This policy applies to any medical personnel who discover, witness, or are notified of a suspected medical device occurrence. Included within the scope of this policy are personnel who use or operate a medical device, including physicians, nurses, technicians and therapists, or other medical personnel. DEFINITIONS Serious Illness or Injury: A serious illness or injury as defined by the act is an illness or injury that is life threatening or that either results in permanent impairment of a bodily function or permanent damage to a bodily structure or necessitated immediate medical or surgical intervention to preclude permanent impairment of a bodily function or permanent damage to a bodily structure. Medical Device: FDA defines a medical device as any instrument, apparatus, or other article that is used to prevent, diagnose, mitigate, or treat a disease or to affect the structure or function of the body, with the exception of drugs. For example, a medical device includes but is not limited to ventilators, monitors, dialyzer, and any other electronic equipment, implants, thermometers, patient restraints, syringes, infusion pumps, hospital beds, defibrillator, pacemakers, tampons, wheelchairs, catheters, in vitro diagnostic test kits and reagents, disposable, components, parts, accessories, and related software. STATEMENT POLICY General Reporting Requirements

Any medical personnel who discover, witness, or are notified of a medical device occurrence that

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he or she suspects may have caused a death, serious illness, or injury to a patient under treatment, shall immediately notify the attending physician, the Bio-Medical Equipment Technician, and the hospital Risk Manager. To ensure proper follow-up and investigation of the occurrence, the medical personnel who report the adverse medical device occurrence shall inform the Bio-Medical Equipment Technician and the hospital Risk Manager by telephone of the following: § Patient's Name § Room and Bed Number § Name of Attending Physician Notified § Location of the Product § Product Name § Model Number § Serial Number of the Product § Name of the Manufacturer, if known § Brief Description of the Occurrence Within twenty-four (24) hours of the suspected adverse medical device occurrence, the medical personnel who reported the incident shall complete an occurrence report and forward the occurrence report to the hospital Risk Manager. The hospital Risk Manager will forward a copy of the report to the Bio-Medical Equipment Technician. Responsibility of Attending Physician The attending physician who is informed of a medical device occurrence shall examine the patient, evaluate the severity of the patient's illness or injury related to the occurrence, record the patient's physical findings, and document in the patient's progress note the occurrence of the suspected adverse medical device occurrence and any actions taken based on the examination. Investigation of the Medical Device Occurrence Within twenty-four (24) hours of being notified of a suspected medical device occurrence, the hospital Risk Manager in conjunction with the Bio-Medical Equipment Technician will conduct an investigation and determine whether the medical device should be impounded or similar equipment taken out of service.

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At the conclusion of the investigation, the Bio-Medical Equipment Technician will complete the Medical Device Occurrence Investigation Report and send a copy to the hospital Risk Manager. Any corrective action that the Bio-Medical Equipment Technician believes is appropriate should be noted in the investigation conclusions section of the Medical Device Occurrence Investigation report. Corrective action will be initiated by the Bio-Medical Equipment Technician with the hospital Risk Manager and conveyed to the medical device user and hospital administration. Corrective action might include, for example, improved orientation, counseling, supervision, new policies or procedures, or system changes. Bio-Medical Equipment Technician Responsibilities The Bio-Medical Equipment Technician shall play a key role in maintaining the medical device reporting program, investigating occurrences, and evaluating the safety of devices. The Bio-Medical Equipment Technician shall obtain relevant information regarding previously reported hazards, recalls, and problems with respect to occurrence-related devices through contact with FDA and/or ECRI. All such information shall be shared with the Risk Manager. The Bio-Medical Equipment Technician shall assist the Risk Manager with collecting the device information, service and history information, and other information required. The Bio-Medical Equipment Technician shall assist in conducting an investigation of the device-related occurrence, evaluate the safety of the device, and determine whether the device along with the relevant supplies, accessories, and packaging should be impounded, repaired or returned to service. Submission of Adverse Medical Device Occurrence Reports Deaths When a death of a patient under treatment has occurred and the Bio-Medical Equipment Technician has information that reasonably suggests the probability of a device causing or contributing to that death, the occurrence must be reported to the FDA with a copy sent to the manufacturer, if known. Reports will be submitted by the Bio-Medical Equipment Technician no later than ten (10) working days after medical personnel (including physician) receive or become aware of the information in the course of their duties.

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Serious Illness or Injury When the Bio-Medical Equipment Technician has information that reasonably suggests the probability that a device has caused or contributed to the serious injury or illness of a patient, the Bio-Medical Equipment Technician must report the occurrence to the manufacturer. If the manufacturer is not known, the occurrence shall be reported to the FDA. This report must also be submitted within ten (10) working days. Semi-annual Reports On January 1 and July 1 of each year, COCHISE REGIONAL HOSPITAL is required to send FDA a semi-annual summary of all adverse medical device reports. These summaries shall be prepared by the Bio-Medical Equipment Technician and sent to the hospital Risk Manager for review and submission to the FDA. All reports shall contain the following information: § Name of COCHISE REGIONAL HOSPITAL § Serial number of the device § Model number of the device § Manufacturer's name and address § Brief description of the event reported to the manufacturer. To protect the confidentiality of information disclosed to FDA or manufacturers, any report or semi-annual summary shall contain an appropriate disclaimer. The hospital Risk Manager in conjunction with the Bio-Medical Equipment Technician shall develop, publish, and maintain the forms, instructions, and procedures necessary for the implementation and consistent application of this policy. Review This statement of policy shall be reviewed upon the publication of final regulations implementing the Safe Medical Devices Act of 1990. Thereafter, the policy shall be reviewed annually and presented to the Risk Management Committee for repeal or amendment as appropriate. Reviewed Date: 11/14 Revised Date: 11/14

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Plan for Removal of Bees

POLICY This policy describes how bee colonies will be removed at COCHISE REGIONAL HOSPITAL. The Safety Office (Maintenance Department Head) will be notified when bee colonies are discovered and he will determine the mode of removal based on the following after inspecting the area: § If the bees present an immediate hazard or danger to patients, families, or staff, the

bees and hive will be removed immediately by the exterminator or Pirtleville Fire Department. The area will be roped off and personnel will stand by, not allowing anyone into the area until the hazard is removed.

§ If the bees do not pose immediate danger, the area will be roped off and the

exterminator will come in the evening to remove and follow-up as necessary. Reviewed Date: 11/14 Revised Date: 11/14