ph9800002 regulatory control of radiation sources …

PH9800002

REGULATORY CONTROL OF RADIATION SOURCES IN THE PHILIPPINES

A paper presented during the IAEA Regional (RCA)Workshop on System of Notification, Registration,

Licensing, and Control of Radiation Sourcesand Installations, Jakarta, Indonesia,

24-28 April 1995

by

ROSITAR.DAROYSenior Science Research Specialist

Philippine Nuclear Research InstituteDiliman, Quezon City

ABSTRACT

This paper is concerned with the radiation protection and safety infrastructure providing

emphasis on the regulation and control of radiation sources in the Philippines. It deals with the

experiences of the Philippine Nuclear Research Institute, as a regulatory body, in the regulation

and control of radioactive materials in radiotherapy, nuclear medicine, industrial radiography,

industrial gauges, industrial irradiators, and well logging. This paper includes an inventory of

the sources and types of devices/equipment used by licensed users of radioactive materials in

the Philippines as a contribution to the data base being prepared by the IAEA. The problems

encountered by the regulatory body in the licensing and enforcement process, as well as the

lessons learned from incidents involving radioactive materials are discussed. Plans for improving

compliance to the regulations and enhancing the effectiveness of PNRTs regulatory functions

are presented.

I. INTRODUCTION

The Philippine Nuclear Research Institute (PNRI) is the government

agency designated to be the competent authority responsible for the regulation and

control of the uses of radioactive materials in the Philippines.

The main objective of PNRI as a regulatory body is to protect the health &

safety of radiation workers and the public from the radiological risks of ionizing

radiation. The agency is mandated by Republic Act 2067 as amended by RA 3589

and Republic Act 5207 as amended by RA 1484 to license and regulate atomic

energy facilities and the use of radioactive materials. To carry out its mandate, the

PNRI promulgates and issues specific regulations codified under the Code of PNRI

Regulations (CPR).

Another government agency, the Radiation Health Service (RHS) under

the Department of Health, was created in 1974 to promote the safe, efficient and

effective application of radiation technologies. It is mandated by Presidential

Decree No. 480 to regulate and control ionizing and non-ionizing radiation emitted

by electrical/electronic devices and consumer products. These include diagnostic

x-ray machines, industrial x-ray radiographic machines, and linear accelerators.

IL REGULATIONS

The Code of PNRI Regulations (CPR) sets the specific rules & regulations

to be followed in the acquisition, possession, use, transfer, import, export or sale of

radioactive materials for each field of application and for the licensing of atomic

energy facilities and materials. To name some of them:

CPRPart2

CPRPart3 -

CPRPart4 -

CPRPart6 -

CPR Part 7 -

CPR Part 8

CPRPart9 -

CPR Part 10 -

CPR Part 11 -

CPR Part 12 -

CPR Part 13 -

CPRPar t l4 -

CPR Part 15 -

Licensing of Radioactive Material (1990)

Standards for Protection Against Radiation (1976)

Safe Transport of Radioactive Materials in the

Philippines (1966)

Rule of Procedure for the Licensing of Atomic Energy

Facilities in the Philippines (1977)

Licensing of Atomic Energy Facilities (1974)

Atomic Energy Facility Operators' Licenses

(unpublished)

Physical Protection of Plants and Materials

(unpublished)

Financial Security and Government Indemnity

(unpublished)

Licenses for Industrial Radiography (1990)

Licenses for the Use of Sealed Radioactive Sources in

Teletherapy (1994)

Licenses for Medical Use of Radiopharmaceuticals

(1994)

Licenses for the Medical Use of Sealed Radioactive

Sources in Brachytherapy (1995)

Licenses for Industrial Gamma Irradiators (1993)

III. REGULATORY STAFF

Figure 1 shows the organizational chart of the Philippine Nuclear

Research Institute. The agency is mandated to advance and regulate the safe and

peaceful applications of nuclear science and technology in the Philippines. It

conducts research and development on the application of radiation and radioactive

materials, processes and techniques in agriculture, food, health, nutrition, medicine

and industrial enterprises. As a regulatory body, PNRI performs its role through the

Nuclear Regulations, Licensing and Safeguards Division (NRLSD). The internal

structure of this division consists of the following:

Standards Development Section - formulates the regulations and reviews

them regularly for amendment & revision to consider current standards & practices

and lessons learned. To supplement the regulations, the group establishes criteria and

develops regulatory bulletins which guide the licensees in complying with the

regulatory requirements.

Licensing Review & Evaluation Section - evaluates license applications

and recommends the issuance of licenses upon determining compliance with the

licensing requirements.

Inspection and Enforcement Section - conducts regulatory inspection

and audit of licensed activities to monitor compliance with regulations and license

conditions on a periodic basis or as needs arise.

Radiation Protection Section - provides radiation protection services such

as radiation surveys of facilities, leak tests of sealed sources & equipment, calibration

of equipment & monitoring instruments, and personnel monitoring to ensure that die

radiation levels in the facility and personnel exposures do not exceed the prescribed

limits, (transferred to another Division)

Radiological Impact Assessment Section - conducts actual observation

and monitoring in radiation facilities and operations to assess the radiological effects

to personnel & members of the public and the environment arising from the

licensees' activities.

Safeguards Section - is responsible for physical protection and accounting

of nuclear materials.

IV. REGULATORY PROCESSES

The regulatory control of radiation sources is exercised by PNRI through the

following processes:

A. Licensing

PNRI requires all persons who receive, acquire, possess, use, sell, import, or

export radioactive materials to acquire a license. An application is filed with the

licensing, Review, and Evaluation Section together with all the required

documentation for assessment. Upon determination of die acceptability of the

application and upon payment of the required licensing fee, a license is issued. The

license has a validity of one (1) year and is subject to amendment should there be

changes in the information provided in the license.

Figure 2 shows the percentage distribution of licensed radioisotope users in

the Philippines.

B. Inspection and Audit

PNRI conducts inspection and audit of the licensed facilities once a year to

ensure compliance with the regulations and specific license conditions. Following an

inspection, a preliminary report is given to the licensee and the inspectors discuss to

the licensee the results of the inspection conducted. Hie inspection findings are

evaluated in the office and an inspection report is formally transmitted to the licensee

citing the items of concern or items of noncompliances, if any, and requiring the

licensee to notify the Institute of the corrective actions taken. For violations that

represent a serious radiation hazard, the inspector may order immediate corrective

actions, or stop the use of radioactive material.

C. Enforcement

The PNRI imposes enforcement actions as appropriate to ensure compliance

with the regulations. The enforcement actions are limited to administrative sanctions

since it has no authority yet to impose monetary fines.

V. REGULATORY EXPERIENCES

A. Radiotherapy

A.1 Inventory of Radiation Sources and Equipment

1. Linear Accelerator

At present, there are only three (3) linear accelerators which are in

operation in the country. Table 1 shows the medical institutions which

operate these units and the specification of the units.

2. Teletherapy

At present, there are fifteen (15) medical facilities with Co-60

teletherapy units. Table 2 shows the names of these facilities, the type of

equipment possessed, and the respective activity of the sources. The total

number of Co-60 teletherapy units is 19, of which 13 are operational, 4 are

not operational and 2 units with sources disposed at PNRI.

3. Brachytherapy

There are ten (10) medical institutions with radiation sources for

brachytherapy procedures. Two (2) of these have high dose rate remote

afterloading brachytherapy unit using Ir-192 source, one (1) institution with

low dose rate remote afterloading brachytherapy unit using Cs-137 (not

operational), 3 institutions use manual afterloading techniques using Cs-

137 and Ra-226, and 4 institutions use Sr-90 sources for ophthalmic

applicators. Table 3 shows the list of the medical institutions and the type of

brachytherapy sources used.

A.2 Radiological Incidents:

1. The incident occurred while the service engineer from Nucletron BV was

replacing the defective column of the Selectron LDR remote afterloading

brachytherapy machine of the Jose R. Reyes Medical Center. When the

door of the safe was opened, the Cs-137 pellets were found scattered at

the back and bottom of the column. Radiation level was 2R/hrin contact

with the column. The inactive pellets were retrieved and placed in a porcelain

bowl while the active sources were placed in the transport container. Visual

inspection of the column revealed that the sorter column tube made of plastic

became discolored, brittle and broken.

Leak tests conducted by the NRLSD on the machine and on the

broken column tube showed no leak. It was recommended that the column

must be replaced every year.

2. It concerns an overexposure report from the Film Badge Monitoring

Service of the Radiation Protection Section of PNRI. The radiologic

technician trainee had the habit of hanging his laboratory gown with the film

badge inside the gown's pocket in the Co-60 treatment room after every office

hours. The film badge registered a reading of 5.7 mSv (S70 mR) for a period

of one (1) month. Investigation results revealed that the trainee was not

actually overexposed and the reading was attributed to the badge having

been placed in the gown hanged for one month at a distance of 2 meters away

from the source with dose reading of 5 uSv/hr.

The licensee came up with the following corrective actions to prevent

the recurrence:

a. Film badges when not in use will be placed only in the film badge

rack provided for, which is located at the console room.

b. The Medical Isotope Committe will come out with a scheme to

minimize entrance to the Co-60 room.

c. Certain disciplinary actions will be imposed on personnel not

following radiation protection measures, policies, and

procedures.

PNRI recommended strict implementation of the corrective actions as

presented and required the submission of the list of trainees, and the type and

duration of their training.

B. NUCLEAR MEDICINE

Nuclear Medicine started in the Philippines in the 1960's with scanning

procedures limited to scanning of the thyroid gland using 1-131 and scanning of the

liver using colloidal Au-198. In-vitro procedures using commercially available in-

vitro kits were introduced a few years later, giving rise to the use of gamma well

counters. The use of gamma cameras coupled with computers and Tc-99m

radiopharmaceuticals became established in 197S. It was in 1986 that the SPECT

system was first introduced in the country.

B. 1 Inventory of Equipment:

There are at present twenty (20) licensed nuclear medicine centers and three

(3) licensed individual physicians in the Philippines. Of these centers, nine (9) are

government hospitals and eleven are privately owned. Table 4 lists the different

nuclear medicine centers. The equipment presently available are as follows: twenty

six (26) gamma cameras (IS of which have SPECT capabilities); 5 rectilinear

scanners; 13 uptake probes; and 19 gamma well counters. By the end of 1995,

three (3) more gamma cameras with SPECT systems are expected to be added to the

total. Table 5 lists the nuclear medicine centers with SPECT systems.

Inventory of Radiopharmaceuticals:

The Philippine Nuclear Research Institute used to produce a number of

radiopharmaceuticals for clinical use but due to the on-going repairs and TRIGA

conversion of the Philippine Research Reactor-I, it has resorted to bulk importation

of 1-131 from Australia. An average total of 325 mCi of 1-131 (30 % of the demand)

are dispensed on a weekly basis by the PNRI and continuously provided to

various hospitals. 70% of the total amount of 1-131 being used and the other

radiopharmaceuticals like Tc-99m (generator), 1-125, Tl-201, C-14, Ga-67, Sr-89

and H-3 are ordered by users from foreign suppliers/ manufacturers through

licensed local representatives. The total activity reported as consumed for each

radioisotope and the total number of institutions using the radioisotopes are given in

Table 6.

B.2 Radiological Incident:

An incident occurred wherein the licensee failed to comply with the

notification and reporting requirements. A cancer patient treated with 1-131 left the

hospital unnoticed by the nurse on duty and was later located at his residence. The

following morning, the patient was found dead. The patient's household contacted

the mortuary who then contacted PNRI to inquire on the precautions in handling a

radioactive cadaver. It took two days before the hospital informed the PNRI about

the incident. By the nature of the incident and the events that transpired afterwards, it

showed the potential for subjecting the public to unnecessary exposure to radiation

from the "radioactive cadaver". To the effect, the NRLSD issued a Notice of

Violation to the licensee for its failure to comply with notification requirements. A

regulatory bulletin was issued on the handling of radioactive cadavers to guide

licensees on the actions to be taken in case the same incident happens.

C. INDUSTRIAL RADIOGRAPHY

C.I Inventory of Sources and Equipment:

There are at present 24 facilities in the Philippines which are licensed to

perform industrial radiography. Table 7 shows a listing of the different types of

radiographic equipment and sources used by these facilities. The radioactive

materials used are Ir-192 and Co-60. The most commonly used is Ir-192.

C.2 Summary of Industrial Radiography Incidents:

Table 8 lists a summary of incidents that occurred in industrial radiography.

Analysis of the incidents revealed that the main causes are human error and

equipment failure.

The factors attributed to human error are:

1. inadequate training;

2. failure to conduct radiation survey;

3. failure to maintain and inspect the equipment; and

4. improper execution of operating and emergency procedures.

The main factors attributed to equipment failure are:

1. disconnection of the source from the drive cable;

2. stuck source in the guide tube; and

3. rupture of source pigtail assembly.

D. INDUSTRIAL IRRADIATORS

D. 1 Inventory of Radiation Sources and Equipment:

There are two irradiators the Philippines and they are located at the

Philippine Nuclear Research Institute. The first irradiator is a self-shielded dry-

source-storage Gamma Cell using Co-60 source mainly for research purposes in the

sterilization of tissue grafts (amnion), surgical gauze and surgical drapes. The second

irradiator is a panoramic wet-source-storage type using Co-60 source. It is used for

a) irradiating medical products such as rubber gloves, orthopedic implants (plastic

and metal), sutures, empty aluminum tubes for topical medicines in commercial

quantities; and b) decontamination of gelatin capsules, raw materials of cosmetics,

and food spices and flavors to reduce the viable organisms. Table 9 gives a

description of the irradiators.

D.2 Regulatory Experiences/Incidents:

The irradiators are regulated by the PNRI in accordance with CPR

Part 15, "Licenses for Large Irradiators". A Safety Committee was organized to

ensure the radiological safety in operating the facility. There had been no incident

that occurred since the irradiator facility started operation.

D.3 Plan for Improvement:

To increase the Co-60 activity to lessen the irradiation time, thereby

increasing the irradiated products.

D.4 Action Taken:

Instead of the turntable which rotates the materials to be irradiated, a

conveyor-type of mechanism located closer to the source than the turntable was used.

Rotation of the materials is done manually and with this method, the output was

increased and irradiation time shortened.

E. INDUSTRIAL GAUGES

E. 1 Inventory of Sources and Equipment:

Industrial gauges are widely used in the Philippines for level, moisture,

thickness and density measurements and control. Table 10 shows the number of

gauges licensed by PNRI according to the type of use. A large number of the gauges

are used in density and level measurements and control.

The industries that use these gauges and the number of licensees in each

industry are identified in Table 11. Most of the licensees are in road construction and

paper industry.

E.2 Regulatory Experience:

An incident of lost source due to inadequate management control during

dismantling of facility occurred in a mining which had stopped operation. The

abandoned thickness gauge containing Cs-137 was looted and sold to a junk shop

who had cannibalized the device. The source was still intact in the stainless

container and radiation measurements taken by the NRLSD team were not

significant. The recovered source was taken to the PNRI for storage.

F. DIAGNOSTIC RADIOLOGY

F. 1 Inventory of Sources and Equipment:

There are at present two thousand two hundred (2,200) i-ray machines for

industrial, dental, medical and veterinary use which are licensed in the country. The

number of licensed Computed Tomography (CT) scan units totaled twenty-five

and the number of Magnetic Resonance Imaging Equipment registered totaled four

(4).

F.2 Regulatory Control:

The field of diagnostic radiology is under the jurisdiction of the Radiation

Health Service (RHS) of the Department of Health. The RHS conducts an annual

inspection and radiation protection & survey evaluation of all licensed x-ray

facilities in the country. Inspection involves visual check on the physical plant

(includes building, shielding, and design), manpower, and equipment. An

acceptance testing is performed on all new x-ray units under the Department of

Health and only upon request on x-ray units which are privately owned.

F.3 Enforcement Actions:

1. The RHS imposes penalty of 50% surcharge on expired licenses.

2. The RHS denies the renewal of license to licensees who fail to correct

their noncompHances. As a consequence, these licensees cannot avail

of the medicare benefits granted by the Philippine Medical Care

Commission.

F.4 Plan for Improvement:

The RHS has initiated the formation of a network system such mat mere is a

tie-up among all licensing services of the Department of Health in order to speed up

the licensing process.

VI. LICENSEE VIOLATIONS AND REGULATORY POSITIONS

Some of the Common Licensee Violations :

1. Possession, ownership, storage, use and handling of radioactive

materials without a valid license.

2. Failure to conduct leak tests of sealed sources.

3. Failure to use properly calibrated instruments (i.e., survey meters and

pen dosimeters).

4. Failure to record radiation monitoring results.

5. Failure to report importable incidents promptly.

6. Failure to request for termination of expired licenses by licensed users

who have ceased operation but still possess the radioactive material.

7. Non-turnover of records and documents by Radiological Health

Officers (RHSOs) who had discontinued service in the company.

Plans for Future Improvements:

To hold an enforcement conference involving the licensee

management and RHSOs with PNRI regulatory staff in order to

discuss licensee's compliance with the regulatory requirements,

environmental problems, licensees' proposed corrective measures

and enforcement options available to the NRLSD.

To enforce the established criteria for determining regulatory

enforcement actions and severity levels of violations in order to

encourage the improvement of licensee's performance in complying

with the regulations, obtain prompt correction of non-compliance

and deter future violations by imposition of corresponding

enforcement actions.

VII. ENFORCEMENT ACTIONS

The PNRI is presently developing criteria for determining enforcement

actions against licensees who fail to comply with regulations and with license

conditions. The enforcement program emphasizes corrective actions, when

necessary, to assure that regulated activities meet applicable requirements and are

conducted with due regard of public health and safety, national interest, and

protection of the environment.

The enforcement actions available to the Institute in die exercise of its

regulatory responsibilities include the following:

1. Notice of Violation

2. Orders

a. Order to Cease and Desist

b. Order to Modify a License

c. Order to Suspend a License

d. Order to Revoke a License

3. Related Administrative Actions.

a. Enforcement Conferences

b. Bulletins and Circulars

VHI. TRANSPORT OF RADIOACTIVE MATERIALS

The transport of radioactive materials is in accordance with the provisions of

Part 4 of the CPR and with the IAEA Safety Series No. 6,1973 edition.

The transfer of radioactive materials to locations outside the confines of the

licensed facility requires a Certificate of Transport. In case of imported radioactive

material, the licensee has to secure, aside from a Certificate of Transport, a

Certificate of Release to be presented to the Bureau of Customs. The radioactive

consignment transported in the year 1994 are mostly Type A packages. A total of

160 Certificates of Release/Transport were issued in 1994.

An incident involving violation in the transport of radioactive material was

the return to the original supplier/manufacturer abroad of a depleted source

contained in a package declared "EMPTY" by the consignee. PNRI was notified

regarding this violation of international rule (IAT A) by the original supplier. As a

consequence, PNRI improved its procedures in ensuring that all packages for

transport abroad are properly declared, sealed, and labeled before a certificate of

transport can be issued.

IX. EMERGENCY PLANNING AND PREPAREDNESS

In radiological emergencies occurring in licensed facilities, the on-site

Radiological Health and Safety Officer (RHSO) coordinates with PNRI on remedial

measures and other radiation protection related activities mat have to be undertaken.

One of the requirements for issuance of a license is an Emergency Procedure

for the licensee to implement in case of a radiological incident which could threaten

the safety of the radiation workers or the public.

PNRI has considered emergency preparedness for the research reactor and

some large radiation facilities. It finds the need to upgrade its emergency planning

equipment and the reconstitution of PNRI emergency response team to small nuclear

incidents.

X. LOST SOURCES

Lost sources pose radiological hazards to the health and safety of radiation

workers and the public. The Code of PNRI Regulations has set a requirement mat

records showing the receipt, transfer and disposal of radiation sources shall be kept to

ensure their availability during inspection and audit of the facility. To ensure control

of radiation sources and avoid die consequence of getting lost, the following

regulatory requirements were imposed:

1. The licensee shall conduct a physical inventory of sources in his

possession and furnish the PNRI a copy of the inventory report.

Record of the same should be kept for inspection by the PNRI

inspectors.

2. The licensee shall ensure proper storage of the sources when no

longer in use, preparatory for transfer to a licensed user, for return to

the supplier, or for eventual disposal at the PNRI.

In the case of a lost source, the RHSO has to report the incident to PNRI by

telephone or similarly fast means of communication, makes an assessment of the

probable causes and consequences, initiates an investigation and radiological

hazards evaluation in the site where the source was lost and recommends measures to

be taken to correct the problem.

CONCLUSION

The system of licensing and control of radiation sources in the Philippines is

adequately sufficient, however, the regulatory body needs to strengthen the exercise

of its enforcement power to ensure licensees' prompt and strict compliance to the

regulations.

The regulatory and licensing experiences had been taken into consideration in

the licensing process through the establishment of regulatory criteria and regulatory

bulletins which guide the licensees on the corrective measures to be taken to deter the

occurrence of the same violation in the performance of their licensed activities.

The PNRI has plans of adopting the system of notification and registration for

radiation sources of exempt quantities and in products which are exempted firom

licensing as identified in Part 2 of the Code of PNRI Regulations.

ACKNOWLEDGMENT

The author wishes to extend her gratitude to the Licensing, Review, and

Evaluation Section staff for their unselfish cooperation in providing the data

needed for the Tables of this Paper. Thanks is also extended to the Standards

Development Section staff for their help and support, especially to Ms. Raquel

Espiritu for her untiring efforts in inputting the gathered data in the computer.

The valuable contributions of Mr. D. B. Domondon, Mr. O. L. Amparo,

Mr. A. J. Mateo, Ms. V. K. Parami, Ms. E. M. Valdezco, Mr. N. de Vera and

everyone who had made this Paper possible are greatly appreciated.

REFERENCES

Philippine Nuclear Research Institute. Licensing of Radioactive Materials.

Part 2 of the Code of PNRI Regulations. Official Gazette: Manila, Philippines; 1990.

Philippine Nuclear Research Institute. Standards for Protection Against

Radiation. Part 3 of the Code of PNRI Regulations. Official Gazette: Manila,

Philippines; 1976.

International Atomic Energy Agency. Regulations for the Safe Transport of

Radioactive Materials . IAEA Safety Series No 6: 1985.

Domingo B. Domondon. Nuclear Techniques in Industry in the Philippines

Presented during the IAEA Regional Seminar on Peaceful Applications of Radiation for

Asia and the Pacific, EDSA Plaza Hotel, Philippines; 1994.

Alan M. Borras. Radiological Incidents in Industrial Gamma Radiography in

the Philippines, 1979-1993. PNRI, Philippines; 1994.

Licensing, Review, and Evaluation Section. Licensees' Files. Philippine Nuclear

Research Institute, Philippines.

DEPARTMENT OF SCIENCE AND TECHNOLOGY

PHILIPPINE NUCLEAR RESEARCH INSTITUTE

[OFFICE OF THE DIRECTOR I I DEPUTY DIRECTOR [

TECHNICAL ASSISTANCE UNIT

INTERNAL CONTROL UNIT

ATOMIC RESEARCHDIVISION

NUCLEAR SERVICESAND TRAINING

DIVISION

STANDARDSDEVELOPMENT

LICENSING,REVIEW ANDEVALUATION

PLANNING

"1NUCLEAR

REGULATIONS,LICENSING AND

SAFEGUARDS DIVISION

FINANCE ANDADMINISTRATIVE

DIVISION

INSPECTION ANDENFORCEMENT

SAFEGUARDS RADIOLOGICAL.IMPACT

ASSESSMENT

ORGANIZATIONAL CHART OF PNRI

Figure, 2.

LICENSED RADIOISOTOPE USERS IN THE PHILIPPINES(As of December 1994)

23.2%

10.4% A

10.4%

41.1%

Commercial

Physician

Hospital

Ind'l Radiography

I Research/Education

Industry

TABLE 1. INVENTORY OF LINEAR ACCELERATORSIN THE PHILIPPINES(As of March 31, 1995)

NAME OF

LICENSEE

MakatiMedicalCenter

St.Luke'sMedicalCenter

LungCenterof thePhilip-pines

MANUFAC-TURER

SIEMENS

VARIANAsso-ciates

PHILIPS

MODEL

MD-2

CLINAC2100C

SL-75

SERIALNO.

2382

478

PHOTONBEAM

QUALITY(MV)

6, 15

6, 15

8

ELECTRONENERGY

(MeV)

5,7,9,

10,12 ,14

6,9,12,16,20

4, 14

DATEOF

INSTALLATION

Oct.1994

Dec.1993

1982

Table 2. INVENTORY of TELETHERAPY SOURCES and TELETHERAPY MACHINES in the PHILIPPINES(as of March 31 , 1995)

\.*r,~c of Licensee

1. W v r o C-ENEfiAL HOSPITAL

2. CM|; '-. i£ Gr.'.'f ":AL H O S P I T A L &

3. CV.VAO V-rOrjAL CENTER

4. EAST PVE.'iUE f-1".:OICAL CENTER

5. JOSE K Tsr-YES MEMORIAL

6. LEDESMA, DAN'ifL, M.O.

7. LUNG CENTER OF THE PHIL.

8. Cr;TAMEZ UNIVERSITYHOSPITAL

S. MAKATI J/^DICAL CENTER

TO. PHILIPPINE GENERAL HOSPiTAL

Sealed Radiation Source

Activity

1 1 . ST. LUKE'S MEDICAL CENTER

12. THE MEDICAL CITY GENERALHOSPITAL

13. VETERANS MEMORIALMEDICAL CENTER

14. VICENTE SOTTO MEMORIALM E D I A L CENTER

15. OSP.IAL NG MAYNILA

Co-GO

Co-50

Co-60

Co-60

Cc-60

Co 60

Co-60

Co-60

Co-60

Co-60

Co-60

Co-60

Co-50

CG-137

Co-60

Co-60

Co-60

CO-60

Co-60

Co-60

Manufacturer

AMESSHAM

AMERSHAMINTERNATIONAL,UK

1SS TBq as of 10/1/92

221.5 T8q as of March1937

1 59.4 TBq as of Feb.1991

| 135 TBq as of 5/1 9G2

14 TBq

307 TBq JTHERATRONICS, Canada(acquired in 1994)

3 TBq as of 1393

268 TBq as of March1990

43.6 TBq as Nov. 1989

Mode!No.

X4016

244 TBq as of 5/1991

229 TBq as of 9/1/89

229 TBq as of 3/1 /S9

97.6 TBq as of 11/1930

37 TBq as of May '62

333 TBq as of 11/18/91

246.8 TBq as of 7/1993

172 TBq as of 9/1/37

160.7 TBq as of10/19/89

195 TBq as of 5/1981

152 TBq as of April1974

THERATRONiCS-CANADA

AMERSHAM INT'L, UK

AMERSHAM INT'L, UK

X4016

X4015

F62001AP

SerialNo.

Equipment

Manufacturer

ISHIMADZU Corp., Japan

Atomic Energy,Canada,LTD.

04 59 ET SHIMADZU Corp., Japan! RTGS 20

PICKER C 4M/50

SHIMADZU Corp., Japjn

S-4467

O458ET

0458ET

A-2111

S3239

Mode! No.

RTGS 20

THERATRON 30

3347D

Serial No.

THERATR0N1CS (AECL) PHOENIX GS5A

SIEMENS

Atomic EnergyCanada,LTD

PICKER C-12

AECL, Canada

SHIMADZU, Corp.

SHIMADZU, Corp.

AECL

PICKER

ATC Medical Group,USA

General Eloctric-CGR

SHIMADZU Corp.

SIEMENS

AECL' Canada

TOSHIBA, Japan

G A MM AT RONS 60,0124

THERATRON780

THERATRON 80

RTGS-21

RTGS-20

ATC C/9

RTGS-20

GAMMATR0NS-65

THERATRON780

RCR1 2.003

237

203

23572

334000

43

096

DateAcquired

312

17033200

1972

DateInstalled

197b

Remarks

oporaiioriol

operational

197S

1369

1394

1S58

1990

1993

operational

not operational

disposed c.l PNfU(2.C'5,35)

operationp.l

-do-

-do-

not operational

operations!

•do-

Disposed at PNRi(5/18/93)

Disposed at PNRI(5/18/93)

operational

-do-

-do-

-do-

not operational

not operational

Table 3. INVENTORY of RADIOACTIVE MATERIALS used in BRACHYTHERAPY in the PHILIPPINES(as of March 3 1 , 1995)

Name of User

1. AFP-EENTSorvfce Dept.

2. JOSE RE-YES MEMORIAL MEDICALCENTER

3. LEDESMA, DANIEL, M.D.

4. LUNG CEU7ER of the PHIL.

5. MAKATI MEDICAL CENTER

6. PHILIPPINE GENERAL HOSPITAL

7. SMC- Mandaue Clinic

8. SLMC

9. UP-Dept. of Ophthalmology

10. Medical Center Manila

Sealed Radiation Source

Radionuclide

Sr-90

Cs-137

Ra-226

lr-192

Sr-90Date Acquired:

3/25/71

Cs-137Date Acquired:

5/20/68

Cs-137Date Acquired:

9/18/91

Ra-226 tubesRa-226 tubesCs-137 tubesCs-137 tube

Cs-137 in ColpoApplicator

Ra-226 tubesRa-226 NeedlesRa-226 tubesRa-226 flat

sourcesRa-226 Tappli-

catorRa-226

(attached to awire)

Sr-90

lr-192 (Wire)

Sr-90

Sr-90

No ofSources

i

18 pellets

29 needles

1 source/unit

2

10

4

102

1712

44873

1 •

1

1 source/unit

2 units

2 units

Activity

370 MBq

1.11 GBq/pellet as of 2/17/78

6.14 GBq

555 MBq

50.8 R eq. beta/sec as of 3/25/71*49.5 R eq. beta/sec as of 3/25/71

1.04 GBq1.06 GBq1.06 GBq1.03 GBq1.57 GBq1.56 GBq2.1 GBq2.1 GBq2.1 GBq2.1 GBq

2.1 GBq2.0 GBq

2.52 GBq2.6 GBq

5.55 GBq3.33 GBq9.62 GBq370 MBq1.11 GBq

740 MBq2.44 GBq2.8 GBq

740 MBq

740 MBq

740 MBq

370 MBq

555 MBq

407 MBq

407 MBq

Model No.

CDC H2CDC H2CDC H2CDC H2CDC H3CDC H3CDC H4CDC H4CDC H4CDC H4

6503650365046504

Serial No.

11921193

2142214321442145309430984048404640784084

04542046570148801501

SIA3, SIA5

Equipment

Manufacturer

Eye Applicator AMERSHAM SIA

Afterloading device NUCLETRON, SelectronLDR

El Dorado Gold Mining & Refining Ltd. Co.; TheRadium Co. of Colorado

MicroSELECTRON HDR Nucletron,Netherlands

Beta Ophthalmic ApplicatorFukwi Co., Ltd., 1968

MicroSelectron-HDR Remote after loader

Model No.

SEL-103

080-098

*

SI A1 882

Serial No.

117

9435

105185

Remarks

Ophthalmic Applicator

LDR

Manual afterloading

HDR

Manual afterloading

Manual afterloading


HDR


-do-

Table 4. Nuclear Medicine Centers in the Philippines(As of December 31, 1994)

*1. AFP Medical Center

2. Capitol Medical Center

3. Cebu Doctors Hospital

4. Chinese General Hospital

5. FEU-NMRP Hospital

6. John F. Cotton Hospital

*7. JRR Material Medical Center

*8. Lung Center of the Phils.

9. Makati Medical Center

10. Manila Doctors Hospital

11. Medical Center Manila

*12. Morong General Hospital

*13. National Kidney Institute

*14. Philippine General Hospital

*15. Philippine Heart Center

*16. Rizal Medical Center

17. Santo Tones Uhiversity Hospital

18. St. Luke's Medical Center

*19. Veterans Menorial Medical Center

20. Cardinal Santos Memorial Hospital

* Government Medical Institutions

Table 5. Nuclear Medicine Centers with SPECTin the Philippines

(As of December 31, 1994)

1. Cebu Doctors Hospital

2. Makati Medical Center

3. Manila Doctors Hospital

4. Philippine General Hospital

5. Philippine Heart Center

6. Santo Tonoas University Hospital

7. St. Luke's Medical Center

8. Chinese General Hospital

9. Lung Center of the Philippines

TABLE 6. RADIOISOTOPES USED IN NUCLEAR MEDICINECENTERS IN THE PHILIPPINES

(As of March 1995)

RADIOISOTOPE

T*99m1-1311-125

H-201C-14

Ga-67Sr-89H-3

TOTAL ACTIVITYREPORTED AS

CONSUMED

539 TBq1.53 TBq6.79 GBq

44.00 GBq1.15 GBq

196.00 MBq80.00 MBq

185.00 MBq

TOTAL NO. OFCENTERS USING

THERADIOISOTOPE

161917104311

TRBLE ?. INVENTORY OF SOURCES FIND EQUIPMENT USED IN INDUSTRIRL RRDIOGRRPHY IN THE PHILIPPINESCflS OF DECEMBER 31, 1994)

! LICENSEE

IFiG&P (HGNIRON>

1RG&P <HFD)

!RLC INDUSTRIES

1RCS

1 BMC

:BF CDRP.

:rsi

: CES

: ENER1 ECH

II1III

J

!TECH/OPS

;TECH/OPS:TECH/OPSilRIDITRON!IRIDIIRON

JIRIDITRON

:TECH/OPS:TECH/OPS!TECH/OPS!TECH/OPS!RMERTEST1RMERTEST! RMERTEST1 RMERTEST!RMERTEST1 TECH/DPS

:TECH/OPS:TECH/OPS!TECH/GPS!TECH/OPS!TECH/GPS

:TECH/OPS!TECH/OPS

ISfiMMRTRON

! RMERTEST

i TECH/GPS

: TECH/OPS! TECH/OPS

!TECH/GPS1l

JflMERTEST

CflMERR

660

660660520520

520

660660660660660660B660B660B660B683683900900900900670773

20 R

660 B

616616660

660

660~B .

3871

37294218725626

099

47624762559273753101165166616621669203-11222326156401

20-22

1462

452206267

C-337

BM&3

NUCLIDE

It-192

It—192-do--da--do-

Ir—192

Ir—192-do--do-~do--do--do--do--do--do--do--do--do--do--do-~do~

Co-60Cs-137

Co-60

It-192

It-192~d-o--do-

Ir-192'Co-60

! It- 192

MODEL

R-424-9

FI-424-9-do--do--do-

C-340

C-337R-424-9

-do-C-337

-do-R-424-9

—do—-do--do--do--do-

.2025

'R424-9

:R5S18-8• —do~

IR424-9

1R424-9

SOURCE

SERIRL !NO. 1

364 3 HW

3430 HW3429 HW1B29 HW1G30 HW

R031

R6864255 HW4256 HWR 844B 4544836 HW4837 HW4811 HW

3279•

3641 HW

4248

,1138

3f3&5 HW

RCTIVITY(Ci>

87.6

99.2799.2795. 4097.08

100

9553.153.2991055250100

-

0.1132

85

1003.0

102

DRTE IRCQUIRED !

10/12/92 !

9/25/92 !9/25/92 !11/20/91 I11/20/91 !

5/5/90 !

2/20/93 !1/28/93 !1/28/93 !3/30/92 ',1/18/93 !

4/28/93 I

!

11/30/82 i

! 1/1986 I

110/26/92 ;

i 3 ''9/8 3 !

:i/27/92 ;!7/5/76

!11/12/92

I LICENbEEE

FiLHOMLUB

I E.EI -CO*'.'-'.

: INTEC

IMIRDC

IMIESCOR

10CERNEERIN6

IPflL

1SGS

1W1TCO

1WTL

II

1 CRMEERii

i

1 RfiERTEST 6601RMERTEST 660B1RMERTEST 6603

1 TECH/OPS 6601 TECH/OPS 6601 TECH/OPS 6601SPECT 2T

1 TECH/GPS 6601 TECH/OPS 9001 TECH/OPS 9001 TECH/OPS 900IRMERTEST 660 B

!TECH/OPS 684!TECH/OPS 684I TECH/OPS 900

IRMERTEST 6601RMERTEST 66031SPECT 2T!TECH/OPS 900

1 TECH/OPS 660I TECH/OPS 6601SPECT 2T

IGfiMMR CENTURY S

1SPECT 2T!TECH/OPS 660

1SPECT 2T!RMERTEST 660B

1 TECH/OPS 660 HSt!TECH/OPS 533IGULF NLICLEFlR 20 VIGflMMfl CENTURY SR!GRMMfl-CENTURY SR1GRMMR-CENTURY SRMJNITRGN 11ORB

5309Ell 156B1462

10145215C-131085

6832021291627

23926233

5311B1119112512

142014221132

2139

1142

1140B1401

i-2-8037CHI-358

1752636203920162445

NUCLIDE

Ir-192-do--do-

Ir—192-do--do-~do-

Ir—192-do--do--do--do-

Co-60-do-

Ir—192

Ir—192-do--do--do-

Ir-192-do--do-

Ir—192

Ir—192-do-

Ir—192-do-

lt—192-do--do--do-

. -do--do-

1 -do-

1 MGOEL

IR424-91 -do-1 -do-

1 C-337! C-3371 C-3371C-343

IR424-9It

II

SR424-15! -do-t

IFI424-91 -dc-IG-IT1 90013

1C-3371C-3371C-343

1FI-2-R

1C-343

1C-3431R424-9

1R424-9

1

1C-3591R-2--Rlfl-2-fl1R-2-FI

SOURCE

1 SERIRL1 NO.

13212 HW12723 HW13867 HW

1R-687IB-172IB-1371R-158

12578 HWi

I

I

I

11B78!1121 HO11189

13213 HW14527 HW1R21111195

1R8431B2691R166

1 E226

IR 172

IR 171

11481 HW1R1571RG35lfl-211 fl-871R-881C-762

FiCTIVITY(Ci)

100 Ci

101

1010

120

40506040

100100100

46

! 73

1 81.311 60.1171 * 52.51 88! 8b1 e61 1.42

1 DPTE 11RC0UISED 1

15/5/92 115/5/92 1112/10-"32 i

1 1( •

i 11 I

I I

14/1992 1t I1 i1 iI iI I) I

14/16/80 119/5/90 119/30/83 1

111/13/91 115/6/92 115/1/93 111/1987 1

13/30/92 1110/26/92 119/14/92 1

18/12/92 1

1 i

111/30/92 11 •I I

19/30/91 1112/10/87 117/28/92 117/28/92 1!2/22/88 112/22/88 117/1/86 !

LICENSEE?

PETRON - CORP.

PHELNICO

IIII

:PICOP

11

i f*' O M E~ O £-1

i y

i•

1 TECH/OPS 6841 TECH/OPS 684

1 TECH/OPS 684!TECH/OPS 684

IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IIRIDIUM 520IRMERTEST 660ISPECT 2TISPECT 2T

I TECH/OPS 684

255221

1641619

08270871029802790263003107340611517811241086

241

NUCLIDE

Co-60. -do-

Co-60-do-

Ir—192-do~-do--do~-do--do--do--do-—do—-do--do-

Co-60

1 MODELi

IR424-1S1 -do-

IR424-151 -da-

IC-340IR424-9IR424-9IC-340IT-51R424-9IR424-9IC-340IT-5IC-340IC-340

IR424-15

SOURCE

I SERIRLI NO.

12126 •11691

Il

II

IR54811574 HW10885 HW1RS90I29E0411573 HW11572 HWIR549129E03IR155IR159

I 1865

RCTIVITYVOX .*

1010

10087

78.53

798787948510095

I ORTEIRCQUIRED 1

16/6/88 I11978 1

I •I <

i •

t *

110/31/92 1110/21/91 116/17/91 1l I

i i

16/18/92 I110/21/91 I110/21/91 I110/31/91 116/18/92 117/28/92 I

- 18/17/92 1

l »

I

Table fi. Summary of Industrial Gamma Radiography Incidentsin the Philippines, 1979 - 1993

Case No. Date ofIncident

Oct. 1979

Source Activity

8 Ci lr-192

Dose (FilmBadge)

Aug. 1982 53 Ci lr-192 550mR185mR

June 1983 88 Ci lr-192

Nov. 1983 4.4 Ci lr-192 20mR35mR

Nature of Incident

The pigtail assembly of the camera wasdisconnected from the drive cable & gottrapped inside the guide tube. Retrieval ofthe source led to the exposure ofpersonnel.

The male connector of the drive cable wasbroken & the source pigtail assembly wasleft inside the guide tube.

The male connector of the drive cable wasbroken & the source pigtail assembly wasleft inside the guide tube. The guide tubecontaining the source pigtail wastransferred to another place. The retrievalwere carried out the following day aftersome occupants of the adjacent roomswas alarmed of high radiation dose rate intheir area.

During radiography operation, the radiationmonitoring showed that the survey meterreading is way beyond the normal readingwhen the source is in shielded position.The personnel involved was alarmed &immediately searched for the cause of thehigh radiation reading. It was found outthat the source was disconnected from thedrive cable. The retrieval operation wascarried out by PNRI personnel upon therequest of the company.

Probable Cause

a. Impropermaintenance

b. Violation ofemergency &operatingprocedures

a. Componentmalfunction

b. Impropermaintenance

a. Poor maintenance &inspection

b. Improper handling ofincident

Poor maintenance &inspection

Corrective Actions

a) Proper maintenance &inspection of equipment

b) Re-training of personnel



b) Prompt action duringemergencies


Feb. 1984 :i lr-192

Sept. 1985 Ci lr-192

July 1987 Ci lr-192



The radiographers left the camera at thebasement of the die sulphur diesel reactor.After 2 days of no work, the radiographerreturned to find that the source/camera ismissing. The source/camera was neverrecovered.

The source/camera was discoveredmissing from its permanent storage pit on24 Sept. 1985. The incident was reportedthe following day. The source wasrecovered on Oct. 7, 1985.

The male connector of the drive cable wasbroken & the source pigtail assembly wasleft inside the guide tube. Retrieval of thesource led to the overexposure ofpersonnel.

800 mR Four (4) personnel were exposed to5 Rem gamma radiation when the source pigtail5 Rem assembly was disconnected from the drive650 mR cable. One (1) personnel retrieved the

source using his bare hand.

650 mR A radiographer's assistant was exposed toradiation while setting the film at the otherside of the boiler. The transmission of theradio communicator was obstructed by theboiler. The incident was discovered onlyafter the film badge was processed.

a. Improper storageb. Violation of

operatingproceduresc. Violation of incident

reporting

a. Theftb. Poor storage of

facility

a. Impropermaintenance

b. Componentmalfunction due topoor inspection

c. Violation ofemergencyprocedures

a. Violation ofoperating &emergencyprocedures

b. Impropermaintenance

c. Improper handling


b. No proper radiationsurvey

a) Inventory of radioactivematerials

b) Proper storage ofradioactive materials

c) Prompt reporting >

a) Adequate safeguardingmeasures

b) Adequate storage facility


b) Re-training of personnelon emergency procedures

a) Re-training ofpersonnel

b) Proper maintenance & •inspection of equipment

c) Re-training in radiationsafety

a) Re-training of personnelb) Proper radiation area

monitoring

10 Feb. 1989 54 Ci lr-192 100 mR The source guide tube was disconnectedfrom the camera while cranking out thesource. The personnel involved retrievedthe source using his bare hands.

11 Feb. 1990 76.36 Cilr-192

1.13 rem970 mR530 mR400 mR

During radiogr

12 March 1990 31.96 Cilr-192

485 mR

13 April 1990 30 Ci lr-192 945 mR

14 April 1991 2.4 Ci lr-192

15

16

April 1991

April 1992

20 Ci lr-192 695 mR

18.3 Ci lr-192 3 Rem

17 June 1992 70 Ci lr-192 730 mR845 mR

18 Jan. 1993 19 Ci lr-192 3 mR

19 April 1993 17 Ci lr-192

The radiographer's assistant was exposedto radiation when the source failed toretract to its shielded position.

The source pencil was disconnected fromthe drive cable & got stuck up inside theguide tube. This incident happened insidethe boiler. The personnel involved gotinside the boiler & brought out the camerawith the stuck-up source.

The two (2) radiographer's assistants & atrainee were exposed to radiation whenthe source jammed inside the guide tube &failed to retract to its shielded position.These three (3) personnel who are notauthorized to handle emergency situations,carried out the retrieval without thesupervision of a radiographer or a RHSO.

During source exchange operation, half ofthe source pigtail assembly went with thedrive cable when retracted, leaving theother half of the pigtail with theradioactive source inside the sourcechanger. The required written reportregarding the incident was submitted 2months after the incident.

The radiographer encountered somedifficulty in exposing the source duringradiography inspection of a 20" diameterpipe on a sloping terrain. The source pigtailwas broken into half leaving theradioactive source partly inside the guidetube when retracted. There was no recordof film badge results. However, calculated•••.••-ole body absorbed doses showed

a. Componentmalfunction due topoor inspection

a. Componentmalfunction due topoor inspection


b. Componentmalfunction due topoor inspection

a. Poor maintenance &inspection

b. Source pigtailmaterial deficiency

c. Violation of reportingrequirements

Poor maintenance &inspectionSource pigtailmaterial deficiencyNo use of personnelmonitoring device

a) Proper maintenance &inspection

a) Re-training of personnelb) Proper inspection

a) Re-training of personnelb) Proper inspection


b) Compliance to reportingrequirements

c) Query to supplier


b) Query to supplier

20 Dec. 1993 11.0 Ci lr-192

1.39 rem & 630 mR for each personnelinvolved in the retrieval operation.

The radiography trainee retracted thesource & immediately disconnected theguide tube from the camera without usingthe survey meter. The trainee noticed thatthe source was protruding thecamera/shielding approximately 112" fromthe exit port. The result of the film badgewhen processed & evaluated was nil.However, calculated absorbed doses in hishand & head showed 993 rem & 270 mR,respectively.

Violation ofoperatingproceduresUnauthorizedhandling ofradiographicequipment by trainee

a) Re-training of personnel inRT techniques & radiationsafety

b) Close supervision oftrainee by radiographer

TABLE 9 . USE OF GAht-iA IRRADIATORS IN THE PHILIPPINES(As of Decenfcer 31 , 1994)

IRRADIATOR

GAMMACELL220

INDUSTRIALIRRADIATOR

TYPE

Self-ShieldedDry-SourceStorage

PanoramicWat-SourceStorage

MODEL

GC220

GattinaBeam651PT

SERIALNUMBER

70

C188

SUPPLIER

AECL

NORDIONInterna-tional(AECL)

YEAROF

INSTAL-LATION

1971

Jan. 17,1989

SOURCE

TYPE

Co-60

Co-60

TOTALACTIVITYAS OFJAN.1995

367 Ci

50,574 Ci

DATEACQUIRED

Nov.1971

Aug. 9,1988

ACTIVITYWHEN

ACQUIRED

7770 Ci

9 Sources30,610 Ci.

7 Sources50,000 Ci

TABLE 10. USE OF INDUSTRIAL NUCLEAR GAUGESIN THE PHILIPPINES(Ai of December 31,1994)

TYPEThickness GaugeLevel GaugeDensity GaugeMoisture/Density GaugeMoisture GaugeX-ray Fluorescence Analyzer

(XRF)Total

NUMBER37

177185

194

21

443

TABLE 11. APPLICATION OF RADIOACTIVE SOURCESIN INDUSTRIES IN THE PHILIPPINES

(As of December 31,1994)

NatureBottlingCanningCementOil/Gas RefineryCigaretteSemi-ConductorsGlass ManufacturingOil/Gas ExplorationPaperPlastic FilmsSteelAluminumWood PreservationExplosivesRubber TireEnergy/PowerFertilizerMining (Minerals)ChemicalsElemental AnalysisRoad ConstructionWheat/Flour Mill

Total

Number of licensees101944834

1144211141822

123

99

TABLE 12. SEALED SOURCES USED IN INDUSTRY

Level gaugeThickness gaugeMoisture gaugeWeight gaugeDensity gaugeWell-loggingElectron captureDetectorBrachytherapyTeletherapyRadiographyIrradiation facilityX-ray fluorescence

Cs-137X

X

X

X

X

CO-60X

X

X

X

X

Am 241

X

X

X

X

X

X

Sr-90

X

X

X

Rfl-226

X

X

Ir-192

X

X

Fe-55

X

Pu-238

X

Nl-63

X

TABLE 12. SEALED SOURCES USED IN INDUSTRY

Level gaugeThickness gaugeMoisture gaugeWeight gaugeDensity gaugeWell-loggingElectron captureDetectorBrachytherapyTeletherapyRadiographyIrradiation facilityX-ray fluorescence

Cs^l37

X

X

X

X

X

CO-60

X

X

X

X

X

Am 241

X

X

X

X

X

X

Sr-90

X

X

X

Rfl-226

X

X

Ir-192

X

X

Fe-55

X

Pu-238

X

NI-«3

X

ph9800002 regulatory control of radiation sources …

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