Republic of the Philippines

Department of Health

BUREAU OF HEALTH DEVICES AND TECHNOLOGY

(former name: RADIATION HEALTH SERVICE) San Lazaro Cpd., Rizal Avenue Sta. Cruz, Manila, Philippines 1003 Telefax No. 711-6016 or 743-8301 loc. 3403 to 3406

Checklist of requirements of the Bureau of Health Devices and Technology that shall be fulfilled by the
Name of Facility Address Valid Until

located at
with x-ray license no.

1.0

PERSONNEL 1.1 The head of the x-ray facility who is the person-in-charge of the activities shall be the qualified physician as defined in Administrative Order No. 35, s. 1994 of the Department of Health
Name PRC No.

1.2 A fulltime x-ray/radiologic technologist who is registered with the Professional Regulation Commission (PRC) shall be hired for each machine.
Name PRC No.

1.3

The Radiation Safety Officer who is either the head of the facility, a medical physicist or a chief radiologic or x-ray technologist with at least ten years working experience who attended a course on radiation protection conducted by the RHS.
Name PRC No.

2.0

X-RAY MACHINE 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 The total filtration shall be indicated on the exterior source assembly at least 2.5 mm a1 equivalent. A set of cones or fixed diaphragms, or an adjustable collimator with light beam indication shall be provided. The cones or diaphragms shall be clearly marked with the following field sizes and distances: 14 x 17 at 72 inches, 10 x 12 at 72 inches, 14 x 17 and 8 x 10 at 36 inches. A visible mark on the exterior source assembly indicating the location of the focal spot shall be provided. The xray tube leakage shall be reduced to a value not greater than 1 mGy(100 mrad) in one hour at one meter from the focus. The control panel shall be provided with positive audible/or visible indication of the production of x-rays whenever the tube is energized. The control panel shall be provided with devices (labeled control dials, push buttons and/or meters) for setting and/or indicating physical factors (such as kVp, mA, exposure time, or mAs) used for exposure. The radiographic exposure switch of the dead-man or spring loaded type shall be provided. A device that automatically terminates the radiographic exposure at the preset time interval or exposure at the receptor shall be provided.

3.0

X-RAY EXAMINATION ROOM 3.1 X-ray room size shall satisfy the following specifications: 3.1.1 x-ray room not equipped with table shall have a room size of at least 2.5m x 3.0 m. For a transportable facility the width of the room shall be at least 2.0 m. 3.1.2 x-ray room equipped with stationary patient table shall have a room size of at least 3.5m x 4.0m. 3.1.3 x-ray room equipped with tilting patient table shall have a room size of at least 4.5m x 4.5m 3.1.4 for specialized facilities, the size of the x-ray examination room should be in accordance with the specification of the x-ray equipment manufacturer Door leading to the x-ray room must be lined with at least 1.5 mm(1/6 inch) thick lead sheet to a height of at least 2 meters from the floor/ground outside. The base of the examination room window/s shall be elevated to a height of at least 2 meters from the floor/ground outside the x-ray examination. A red warning light bulb that is automatically illuminated when the x-ray machine is switched on shall be

3.2 3.3 3.4

3.5

3.6 3.7 4.0

installed outside the x-ray examination room above the x-ray room door. A warning notice shall be put outside the x-ray examination room door. It shall be made up of a solid yellow equilateral triangle 180mm long on each side. At the center of the triangle is a black tre-foil sign for radiation. Under the triangle are the words X-RAY ROOM: DO NOT ENTER WHEN THE RED LIGHT IS ON. The warning notice shall be on a a 180 mm x 270 mm white background. Adequate ventilation shall be provided inside the x-ray examination room. The room shall be provided with adequate shielding from scattered and transmitted x-rays.

DARKROOM 4.1 4.2 4.3 Light leaks into the darkroom shall be corrected. A light tight air outlet with an exhaust fan should be installed inside the darkroom. For manual processing, processing tanks consisting of master tank two(2) insert tanks made of stainless steel or fiber glass shall be provided. 4.4 Separate paddles for the developer and fixer solutions shall be provided. 4.5 There should be an adequate supply of fresh water. 4.6 A luminous interval timer/digital timer shall be provided. 4.7 A darkroom thermometer or digital thermometer or alcohol thermometer shall be provided 4.8 A standard safelight with 10-15 watt light bulb shall be provided. 4.9 The safelight housing shall be provided wiht a safelight filter made of glass or hard plastic, tinted with amber or red and which does not fog a pre-exposed film within 45 seconds. 4.10 The safelight housing shall be installed not lower than 4 feet from the working table and the processing tanks. 4.11 Unprocessed films shall be properly shielded in a cool dry place protected from x-rays. Films shall be stored vertically on its end. This prevents marks on film because of pressure due to its weight. 4.12 Intensifying screens shall be kept clean or replaced when necessary.

5.0

ACCESSORIES 5.1 5.2 5.3 5.4 5.5 5.6 A set of contact gonad shields with a minimum lead equivalence of 1.5 mm lead shall be provided. An upright gonadal shield for chest examination with a minimum lead equivalence of 1.5 mm lead shall be provided. A lead rubber apron, with lead equivalence of 0.25 mm shall be provided. A pair of lead rubber gloves/lead hand protector with lead equivalence of at least 0.25 mm shall be provided. A caliper to measure the thickness of the patient shall be provided. A fixed/movable protective barrier to a height of at least 2 m from the floor shall be provided. For a fixed protective barrier it shall be made of 15.25cm (6 inches) poured concrete or 1.50mm thick lead sheets. For a movable protective barrier it shall be made of 1.50mm thick lead sheets. 5.6.1 The fixed/movable protective barrier shall be covered with a lead glass/acrylic viewing window with lead equivalence of at least 1.5 mm. 5.6.2 If the fixed/movable protective barrier in item 5.6 has no opening for a lead glass/acrylic viewing window then a mirror large enough and positioned in such a way that the operator can see the patient during the x-ray examination shall be provided.

6.0

ADMINISTRATIVE REQUIREMENTS 6.1 6.2 6.3 6.4 The owner/licensee shall ensure that the facility complies with the above requirements. The owner/licensee shall provide film badges or thermolumniscent dosemeter (TLD) badges to all radiation workers in the facility. The head of of the facility shall establish quality control program for the x-ray facility in accordance with the the Radiation Health Service of the Department of Health protocol on quality control. He shall ensure that no unlicensed person operates the x-ray equipment. The radiation safety officer shall be responsible for the conduct of radiation safety program in the facility. He/she shall keep record of occupational radiation doses received by the radiation workers in the facility. He/she shall ensure that no worker shall exceed the dose limit of 20 mSv per year averaged over a period of five (5) years.

7.0

OTHER IRREGULARITIES

7.1 7.2

Cleanliness and orderliness of the whole x-ray facility shall be observed. The following charts and tables, technical manuals, and records shall be made available to the RHS health physics team during the conduct of radiation protection survey and evaluation. 7.2.1 Radiographic technique charts per x-ray machine shall be provided. 7.2.2 X-ray tube rating and anode cooling charts must be kept. 7.2.3 Operation manuals and circuit diagrams must be kept. 7.2.4 Time-temperature chart shall be provided. 7.2.5 Records of maintenance and repair jobs of x-ray machine including mechanical and electircal safety programs must be kept. 7.2.6 Records of film spoilage/rejects must be kept. 7.2.7 Records of preventive maintenance of automatic processors and accessories must be kept. 7.2.8 Records of frequency of changing solutions or replenishment must be kept. 7.2.9 Files of written results signed by the qualified physician as defined in A.O. 35, s.1994 of the Department of Health must be kept. 7.2.10 Records of x-ray examinations performed with the corresponding written request must be kept.

8.0

GENERAL RECOMMENDATIONS

_____________________________________________________________________________________ ________________________________

____________________________________________________________________________________________________ ____________________________________________________________________________________________________ ____________________________________________________________________________________________________ ____________________________________________________________________________________________________ ____________________________________________________________________________________________________ Immediate processing of your license to operate an x-ray facility will be based upon your submission of the following documents: 1. 2. 3 4 5 6. 7. 8. 9. 10.
Name & Position Name & Position

duly accomplished x-ray license application form Notarized certificate of employment of radiologist and x-ray/radiologic technologist Certification of training of doctor if he/she is not a fellow/diplomate of the Philippine College/Board of Radiology (PCR) Photocopy of the PCR certificate of the radiologist (if diplomate or fellow) Photocopy of PRC license and certificate of the radiologist and x-ray/radiologic technologist Certificate of training in radiation protection of the radiologic/x-ray technologist if he/she acts as Radiation Safety Officer notarized certificate of compliance proof of compliance (pictures, receipts, logbooks, charts, etc.) with the above deficiencies license application fee(see attached) in the form of postal money order payable to the Radiation Health Service, Department of Health copy of business/mayors permit
Date

RHS health physics team that conducted the radiation protection survey and evaluation:

A copy of this report was received by:

Name & Position