February 6, 2013

DOH ADMINISTRATIVE ORDER NO. 2013-0004

I. Rationale

Rabies, present in all continents and endemic in most African and Asian countries, is a fatal zoonotic viral disease, transmitted to humans through contact with infected animals, both domestic and wild. Rabies is estimated to cause at least 55,000 deaths per year worldwide, about 56% of which occur in Asia and 43.6% in Africa, particularly in rural areas on both continents. In the Philippines, although rabies is not among the leading causes of morbidity and mortality, rabies is still considered a significant public health problem for two reasons: it is one of the most acutely fatal infections and responsible for the death of 200-300 Filipinos annually.

The Department of Health continues to be committed to the fight against rabies and has set the goal of rabies elimination in 2020. An essential part of the strategy is the provision of post-exposure prophylaxis to bite victims and pre-exposure prophylaxis to high risk individuals as mandated by the

As part of our commitment to control and eliminate human rabies, the Department of Health (DOH) ensures all ABTCs and ABCs to provide adequate, appropriate, timely and quality post exposure prophylaxis (PEP) to all rabies exposures. With the recent proliferation of ABCs in government and private facilities, the Department must ensure that all ABTCs and ABCs shall provide affordable, quality and safe Post Exposure Prophylaxis (PEP) services to their patients.

To achieve this, the Department will set guidelines on how these ABTCs and ABCs will be certified. The guideline will facilitate the conduct of a stepwise process of certification by the Center for Health Development (CHD) to all Animal Bite Treatment Centers (ABTCs) and Animal Bite Clinics (ABCs) and ensure quality services are provided in accordance with DOH policies.

II. Objectives

A. General:

To prescribe guidelines and procedures in the conduct of National Rabies Prevention and Control Program (NRPCP) ABTC and ABC certification amongst public and private facilities, specifically for assessing the quality of the services provided to patients exposed to Rabies.

B. Specific:

1. To develop standards for improving certification process;

2. To establish systems and procedures for the certification of ABTC and ABC facilities.

III. Scope/Coverage

This Order shall encompass the certification process undertaken by the Department of Health through the CHDs, covering both ABTC (Public) and ABC (private) facilities.

IV. Definition of Terms

1. Certification refers to the process wherein the Centers for Health Development assesses and evaluates an ABTC/ABC facility, if it has met the standards for quality rabies exposure management.

2. Animal Bite Treatment Centers (ABTC) are health facilities owned and operated by either the National or Local Government Units (LGUs), providing Post-Exposure Prophylaxis (PEP) to rabies exposures in accordance with the DOH recommended management protocol. These facilities are provided by the National Rabies Prevention and Control Program with (Tissue Culture Vaccine) TCV and Rabies Immune Globulin (RIG) augmentation.

3. Animal Bite Centers (ABC) are health facilities owned and operated by either a private individual or company/corporation, providing Post-Exposure Prophylaxis (PEP) to rabies exposures in accordance with the DOH recommended management protocol. These include bite centers housed in government health facilities. These facilities are not provided by the National Rabies Prevention and Control Program with TCV and RIG augmentation.

4. Certified Bite Treatment Centers are ABTCs and/or ABCs that have satisfied all the criteria in section V (Procedural Guidelines) of this Administrative Order.

5. Self-assessment form (SAF) refers to the tool used to assess if the ABTC/ABC can provide quality PEP services that are consistent with the NRPCP policies.

V. Procedural Guidelines

The conduct of the certification process shall be based on a set of cycles to allow a regular fixed schedule for each step of the process. This is relevant to give ample time for the concerned public and private participants at the Center for Health Development/Provincial Health Office/City Health Office levels, in undertaking each step and to facilitate the processing of the ABTC/ABC Certificate. The cycles are divided into 4 parts namely:

A. Self-Assessment Cycle:

This is the cycle in which the facility head shall accomplish the Self-Assessment Form (SAF). It is the preliminary step of the certification process that provides an initial assessment of the quality of PEP services rendered by the ABTC/ABC. In this cycle, the facility shall internally assess its own PEP implementation, in accordance to the certification standards written in the SAF.

1. Phases

a. Self-Assessment Phase This is the phase when the staff of the ABTC/ABC headed by a trained physician shall undertake its own assessment based on the standards written in the SAF to facilitate its application for certification.

The SAF contains the following minimum standards:

i. The ABTC/ABC is adequately equipped to provide quality and safe PEP (refrigerator, vaccines, emergency drugs, water supply, waste disposal and recordings.)

ii. The ABTC/ABC provides for the privacy and comfort of its patients and staff.

iii. The ABTC/ABC is managed by trained doctors and nurses.

iv. Rabies exposures are accurately categorized and managed.

v. Patients have continuous access to safe and effective modern tissue culture vaccines and rabies immune globulin throughout the duration of their management.

vi. PEP is provided by a trained medical doctor and nurse.

vii. The training certificate from a DOH recognized training facility is posted prominently in the health facility.

viii. The ABTC maintain an updated rabies exposure registry.

b. Technical Assistance Phase This is the phase for provision of technical assistance to the ABTC/ABC by a TA Team composed of the Provincial or City NRPCP Coordinators and DOH Representatives. The Team shall assist the facility to fulfill the standards on ABTC certification and ensure the proper filling-up of the SAF to facilitate their application for ABTC/ABC certification.

2. Procedures:

a. Any ABTC/ABC shall undergo self-assessment as the preliminary step in the certification process.

b. The facility shall request for technical support from the TA Team that is at the level of the Province/City. As TA providers, they shall verify the initial findings and validate the contents written by the facility in their SAF.

c. The self-assessment cycle is completed once the SAF is finally accomplished and is now ready for submission to the CHD.

d. The self-assessment cycle has no time limit and depends upon the readiness of the facility to conform to the standards of ABTC certification. The TA Team shall assess the readiness of the facility to achieve certification and accreditation.

B. Application Cycle (Application for Certification)

This is the step in which interested bite treatment facilities shall express their intention on certification, vis- -vis, agreeing to the conduct of an external assessment on the quality of their ABTC/ABC services. Application shall be made once the facility has finally completed the SAF; an indication also that the facility is now ready to be certified.

1. Procedures

a. Any ABTC/ABC facility can apply for certification. The Head of the bite treatment facility shall submit to the respective CHD NRPCP Coordinators a written Letter of Intention on Certification (LOIC) expressing their intention to be certified. Only the LOIC shall be submitted to the CHD. The SAF shall remain in the facility and shall be used upon the visit of the certifying team, during the certification proper.

b. The CHD NRPCP Coordinator/s shall file all the applications received to serve as bases for their coordination with the SS Staff, as invitation to their designated private representative and as itinerary to prioritize their travel.

C. Certification Cycle

This refers to the actual conduct of the certification process to be undertaken by the ABTC certifying team at the CHD level. In this cycle, the facility shall be externally assessed, based on the standards written in the SAF. The facility is either given the approval for ABTC certification or is recommended by the team for a re-assessment.

1. Phases

Preparatory Phase This consists of the necessary coordination with the other members of the certifying team, the logistical preparations and the schedule of visits or itinerary of travel. As head of the team, the CHD NRPCP Coordinators shall facilitate all the requirements for the certification proper. The CHD NRPCP Coordinators shall coordinate with the respective CHD Sentrong Sigla Staff concerned on ABTC certification, to synchronize their schedules for the actual certification visits.

a. Validation Phase this pertains to the actual visit of facilities by the CHD certifying team. The tool to be used by the team is also the SAF, in which they assess the facility's quality of Post Exposure Prophylaxis (PEP) services in accordance to the standards. They shall validate the findings in the SAF, deliberate and agree among themselves, the appropriate rating per criterion. The team shall also use the same rating scale stipulated in the SAF.

2. Procedures

a. The CHD NRPCP Coordinator shall be the head of the certifying team. The minimum composition of each team shall be three; maintaining an odd number to prevent a neutral decision.

b. For every facility visited, the team shall validate the findings written by the facility in their SAF. They shall then, give their corresponding rating after coming up with a consensus. The overall decision of whether the facility is certified or for re-assessment shall be made once the entire certification visit is already completed.

c. The team shall furnish each facility a written response of their final decision about the certification process conducted. They shall provide the facility the "Summary Report on ABTC/ABC Certification" that shall briefly describe the visit, the team's rating per standard; and, shall indicate whether the facility is certified or needs re-assessment. The certification of the ABTC/ABC facility will be valid for two years.

d. The decision of the CHD certifying team shall remain final and official. This shall also serve as the basis of approval for the facility's certification.

e. For those facilities that need re-assessment, the TA Team shall be notified by the certifying team for the same purpose. The CHD NRPCP Coordinator can also be requested to provide technical assistance and be part of the TA team. However, in his/her capacity to provide technical assistance, the latter shall now abstain from participating in the actual conduct of the re-assessment process, to prevent bias. The facility shall be encouraged to re-apply the soonest possible time.

f. If a facility is still found to be unfit for certification on three consecutive occasions, a joint monitoring composed of the central, CHD, provincial/city levels shall be scheduled to assist the facility in their certification.

g. For those facilities that need to be re-certified, upon expiration of their ABTC certificate, the same process/step shall also be undertaken.

D. Registration and Issuance Cycle

The registration and issuance cycle covers the period where the ABTCs, both certified and those for re-assessment are registered in the central registry at the CHD. This cycle is also the time allotted for the preparation of the official ABTC Certificate intended for those qualified facilities. The cycle involves mainly the role of the CHD in the certification process. Registration and issuance of ABTC/ABC certificates are done upon receipt of the summary report from the various CHDs.

1. Procedures

a. Upon receipt of the summary reports from the CHDs, the NRPCP coordinator shall register the various facilities (whether certified or for re-assessment) in the central registry on ABTC certification. Each facility registered shall be assigned a registration number to easily track their certification status. However, a certification number is assigned only to those facilities that qualify in the ABTC certification. The registry is maintained at the National Center for Disease Prevention and Control (NCDPC), DOH.

b. For those certified facilities, the CHD shall automatically issue the official quality certificate or the, "Certificate of Quality Service on Post Exposure Prophylaxis", duly signed by the CHD Director and dry sealed for authenticity. Likewise, a congratulatory note is attached to encourage the facility in their application for accreditation.

c. The effectivity of the ABTC certificate shall be for two (2) years upon date of issuance. However, regular monitoring of ABTC implementation and performance shall still be continued in-between, to sustain and safeguard the good quality of PEP services.

VI. Implementing Mechanisms

A. Roles and Responsibilities

The participating agencies in the ABTC certification process are representatives of both public and private sectors. This ensures impartiality in as much as both sectors are represented during the actual certification process. Likewise, there is provision of technical assistance prior to the conduct of certification proper, to facilitate the needs of the facility for compliance with the standards, including those requirements for the availment of the PHIC Animal Bite OPD Benefit Package. The key players and their respective role are as follows:

1. DOH

a. The National Center for Disease Prevention and Control (NCDPC)

The NCDPC shall:

a.1. Register all certified ABTCs forwarded by the CHDs. NCDPC shall maintain this official registry of all certified ABTCs, both public and private. They shall be responsible to assign the respective certification number per certified ABTC on a chronological basis. Those facilities that did not qualify but are recommended by the CHD certifying team for re-assessment shall also be registered.

a.2. Prioritize in their monitoring visits those facilities that need re-assessment. This shall be done in joint cooperation with the CHD/PHO/CHO, to analyze the reasons for non-qualification and provide recommendations to improve PEP implementation.

b. Center for Health Development (CHD)

The CHD shall:

b.1. Validate the findings of the facility as stipulated in the SAF. When possible, this shall be done in joint participation of the Sentrong Sigla certifiers/assessors, trained on ABTC certification. The CHD NRPCP Coordinators shall be the overall leaders of the certifying team.

b.2. Exercise impartiality during the certification proper. Since their role is critical in the certification process, they shall function with objectivity at all times and in all ABTCs.

b.3. Ensure that feedback of the results of the certification process is provided to the respective technical assistance team, particularly, among those facilities that need to be re-assessed. This feedback is important to strengthen the technical assistance that a facility needs, in order to be certified during the re-assessment.

b.4. Issue the "Certificate of Quality Service on PEP" duly signed by the Regional Director and dry sealed for authenticity.

b.5. Quarterly submit to NCDPC an updated list of newly of Certified ABTC/ABC duly signed by the CHD Director. The list shall also include recently delisted ABTCs and ABCs.

c. DOH Representatives

The DOH Representatives shall:

c.1. Facilitate the submission of all pertinent documents to the Province/City. CHD and vice-versa, in accordance with the set time frame.

c.2. Participate in the provision of technical assistance together with the Provincial/City NRPCP Coordinators. As members of the technical assistance team, they shall support the areas they represent. However, due to limited Staff at the CHD, they shall also function as certifiers in areas outside their responsibility, or in areas where they did not provide technical assistance.

c.3. Ensure that the re-assessment be undertaken jointly with the technical assistance team in the event that the facility needs to be re-assessed.

2. Local Government Units (LGU)

a. Provincial/City NRPCP Coordinators

The Provincial/City Coordinator shall:

a.1. Provide technical assistance to the ABTCs/ABCs. This covers technical support to the facility in order to cope with the required standards and eventually, be certified. They shall also assist in the proper completion of the SAF, prior to submission to the CHD certifiers that shall serve as the basis for the latter's validation of the ABTC/ABC performance. As the local experts on NRPCP, they shall head the technical assistance team.

B. Funding

All expenses to be incurred in the performance of the NRPCP-ABTC certification activity of the public sector shall be borne by the respective CHDs.

VII. Monitoring and Evaluation

Certified bite treatment facilities shall be monitored at least once a year by the CHD to keep track of the overall progress of the NRPCP-ABTC certification at the LGU levels. This shall ensure that certified bite treatment facilities continuously comply with the standards set the program even after receiving the certification. The CHD monitoring team shall recommend to the CHD Director the suspension or revocation of the certification depending on the gravity of the deficiencies noted during the monitoring visit/s.

VIII. Effectivity

This Order shall take effect immediately.

(SGD.) ENRIQUE T. ONA, M.D., FPCS, FACS
Secretary of Health