ANNEX D
GENERAL X-RAY FACILITY SELF ASSESMENT CHECKLIST
(Adapted from the current FDA-CDRRHR Radiation Protection Survey and Evaluation (RPSE) Checklists)
Name of Facility Date Accomplished
Facility Address X-ray Facility Level
I. MACHINE DETAILS (for those applied for initial authorization only)
Machine Manufacturer Name / Brand Serial Number
# Type Control Console Tube Control Console Tube
1
2
3
4
5
6
7
8
9
10
II. PERSONNEL REQUIREMENTS
(please check “yes” if complied, “no” if not complied, and N/A if not applicable)
REQUIREMENT (Based on DOH AO No. 35 s. 1994, AO No. 2-A s. 1996, and AO 149 s. 2004) YES NO N/A
1. The head of a diagnostic x-ray facility who is the person-in-charge of the
activities shall be a qualified physician as defined in DOH Administrative
Order No. 35 s. 1994
a. Diplomate or fellow of the Philippine Board of Radiology or the
Philippine College of Radiology.
b. Refer to section 4.1.1.2 to 8 of AO 35 s. 1994 if no physician with
the qualification above.
c. For Dental x-ray facilities, a PRC licensed dental practitioner with
appropriate training in dental x-ray work as per DOH AO no. 2-A
s. 1996.
2. A fulltime x-ray/radiologic technologist who is registered with the
Professional Regulation Commission (PRC) shall be hired for each machine.
a. Required only for dental x-ray machines in lieu of an available duly
qualified dental x-ray practitioner.
3. The facility shall have a Radiation Protection Officer (RPO) who is one of
the following:
a. Head of the facility
b. Medical Physicist
c. Chief Radiologic Technologist of x-ray technologist with at least
ten years working experience and attended a course on radiation
protection conducted by an organization recognized by the
CDRRHR.
d. Dental practitioner with appropriate training for dental x-ray
facilities.
Page 1 of 3
III. OPERATIONAL AND ADMINISTRATIVE REQUIREMENTS
(please check “yes” if complied, “no” if not complied, and N/A if not applicable)
REQUIREMENT (Based on DOH AO No. 35 s. 1994, AO No. 2-A s. 1996, and AO 149 s. 2004) YES NO N/A
1. The facility shall establish a quality assurance program to ensure continuous
compliance with the requirements set forth by the Department of Health under
which the following policies should be included:
a. The head of the facility shall establish a Quality Control (QC)
Program/Manual for the x-ray facility under which the following policies
should be included: (PROVIDE A SCANNED COPY)
i. List of individuals responsible for monitoring and maintenance.
ii. Classification of areas as to controlled and supervised areas for
occupational dose monitoring.
iii. List of parameters to be monitored and frequency of monitoring.
iv. Description of standards, criteria of quality, limits of acceptability for
every machine to be monitored.
v. Description of procedures to be done for every machine to be monitored.
vi. Records of preventive and corrective maintenance done per machine
including records of daily quality checks.
vii. Records of frequency of changing solutions for darkroom image
processing. (if applicable)
viii. Operation manuals and circuit diagrams including tube rating charts and
cooling diagrams.
b. The Radiation Protection Officer (RPO) shall establish and be responsible for
the conduct of a Radiation Protection/Safety Program under which the
following policies should be included:
(PROVIDE A SCANNED COPY)
i. Policy on dose monitoring for radiology personnel (including interns,
OJTs), patients, carers, pregnant personnel, etc.
ii. Policy on radiation protection/safety of pregnant women. (e.g. posting of
notices, risk communication, etc.)
iii. Records and analysis of personnel dose monitoring.
Service Provider: ____________________________________
Subscription period: __________________________________
Official Receipt No. __________________________________
No. of TLD/OSL: ____________________________________
iv. Records and policy on request and referral of x-ray examinations.
v. Procedures and practices to reduce dose of patients, workers, and the
public.
vi. Guidelines of appropriate action for personnel/patient that exceeded dose
limits. (action plan, corrective measures, risk communication, etc.)
vii. Process of reporting and notification in cases of exceeded doses.
c. All x-ray examinations should be justified by a qualified physician in which
a proper request and referral policy should be established.
d. Radiographic technique charts per x-ray machine posted near the control
console. (PROVIDE A SCANNED COPY)
e. Records and analysis of image reject/spoilage.
(IF APPLICABLE, PROVIDE PICTURE OF LOGBOOK)
f. Cleanliness and orderliness of the whole x-ray facility.
g. File of written results signed by qualified physician.
Page 2 of 3
IV. GENERAL PHYSICAL PLANT REQUIREMENTS
(please check “yes” if complied, “no” if not complied, and N/A if not applicable) refer to individual machine checklist for
physical plant requirements specific to an x-ray machine
REQUIREMENT (Based on DOH AO No. 35 s. 1994, AO No. 2-A s. 1996, and AO 149 s. 2004) YES NO N/A
(PROVIDE DIGITAL/SCANNED COPY OF FACILITY FLOOR PLAN/LAYOUT)
1. For automatic/manual processing (Dark room processing)
a. Adequate space (2.0 m x 1.5m)
b. Processing tanks (for manual processing only)
c. Separate paddles for processing tanks (for manual processing
only)
Light tight
d.
Well ventilated (with exhaust fan)
e.
Tinted standard safelight (>1.3 m from working table)
f.
Proper storage of unprocessed films
g.
Well-maintained intensifying screens
h.
Luminous timer/digital timer (for manual processing only)
i.
Non-mercurial thermometer (for manual processing only)
j.
2. For digital/computed radiography processing (DR/CR)
a. Designated area for processing/viewing machine
3. Waiting area for patients (provision/designated area)
4. Film storage and/or reading area (where applicable)
a. 1 m x 2 m for level one (1) x-ray facility
b. 3 m x 3.5 m for level two (2) and three (3) x-ray facility
V. INDIVIDUAL MACHINE REQUIREMENTS
Accomplish and attach applicable individual machine checklist (Annex C-I to IV)
I hereby declare that this application has been accomplished by me, and that the
foregoing information and attached documents required for the authorization are true and corre
PREPARED AND ACCOMPLISHED BY:
Name: Designation/Position: Date:
ATTESTED BY (FACILITY HEAD/MANAGER)
Name: Designation/Position: Date:
Page 3 of 3
INDIVIDUAL X-RAY MACHINE CHECKLIST ANNEX D - II
Name of Facility
Facility Address
COMPUTED TOMOGRAPHY X-RAY MACHINE REQUIREMENTS
(use additional sheets if necessary)
Machine # Applicable Type of Machines
(based on Computed Tomography Machines CT Simulator Machine for Radiation Therapy
Section I of PET CT Machines
the Annex C) SPECT Machines
REQUIREMENT (please check “yes” if complied, “no” if not complied, and N/A if not applicable) YES NO N/A
1. CT unit assembly properly installed, operational, and duly accepted by the
licensee with appropriate documents signed by installer/supplier and received
by licensee representative/owner. (provide pictures/proof of installation)
2. Undergone and passed performance testing conducted by PLSD-CSL or by
DTI-PAB accredited testing laboratory (attach report of service provider)
(BO 220 s. 2002)
3. Adequate x-ray room size (manufacturers specifications) (AO 35 s. 1995 sec. 6.1.4)
4. Adequate shielding for the x-ray room (doors, walls, etc.) (AO 35 s. 1995 sec. 6.2)
a. At least 6 inches thick poured concrete with a density of 2.35 g/cm 3
b. At least 1/6 in (1.5 mm) thick lead sheet glued onto and sandwich
between wooden panels without any punctures during installation.
5. Fixed/ Movable Protective barrier with means of viewing patient (glass/acrylic
with 1.5 mm lead equivalence) and with adequate shielding from x-rays similar
to room shielding requirements. (AO 35 s. 1995 sec. 6.4)
(provide pictures/proof of installation)
6. If windows are present, it should be elevated to height of at least 2 m from
ground. (provide pictures) (AO 35 s. 1995 sec. 6.6)
7. With red warning light bulb (provide pictures) (AO 35 s. 1995 sec. 6.7)
8. Dressing Area (provide pictures) (AO 35 s. 1995 sec. 6.18)
9. With appropriate warning notice outside x-ray examination room door. It shall
be made up of a solid yellow equilateral triangle 180 mm 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 180 mm x 270 mm
white background. (provide pictures) (AO 35 s. 1995 sec. 6.8)
10. With adequate ventilation (provide pictures) (AO 35 s. 1995 sec. 6.1)
11. Toilet with door opening directly to x-ray room if examinations using contrast
media will be performed (provide pictures) (AO 35 s. 1995 sec. 6.19)
12. Radiological accessories (provide pictures/proof of purchase)
(AO 35 s. 1995 sec. 6.20)
a. Lead equivalent gloves (>0.25 mm Pb equivalent)
b. Lead equivalent apron (>0.25 mm Pb equivalent)
c. Quality control phantom (AO 35 s. 1995 sec. 5.7.9)