Health Center.pdf

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ETHIOPIAN

STANDARD

Health Center - Requirements

ES 3611:2012

First edition

Tables of Contents

ACKNOWLEDGEMENT

SECTION ONE: GENERAL

1. Scope

2. Normative References

3. Terminologies and Definitions

SECTION TWO: LICENSURE

2.1. General

2.2. Application for licensure

2.3. Initial/ NEW Licensure

2.4. License Renewal Requirements

2.5. Removal Permits, Change of Operation and Forfeiture of License

2.6. Suspension and Revocation of a License

2.7. Right to Fair Hearing

2.8. Information to be Disclosed

Section 3: Governance

3.1. Managmenet committee or Governing Board

3.2. Head of the health center

3.3. advisory managment Committee

Section 4: Patient Rights and Responsibilities

4.1. Informed Consent

4.2. Patient Rights

4.3. Patient Responsibilities

Section 5: Human Resource Management

5.1. General Requirements

5.2. Staffing Plan

5.3. Job Description and Orientations

5.4. Staff Education:

5.5. Medical Staff

5.6. Employee’s Health

5.7. Dress Code and Employee identification badge

Section 6: Service Standards

6.1. General MEDICAL Services

6.2. Minor Surgical Services

6.3. Nursing Services

6.4. Emergency Services

6.5. Delivery and MCH Service

6.6. Laboratory services

6.7. Pharmaceutical Services

6.8. Patient Flow

6.9. Health Promotion Services

6.10. Medical Recording

6.11. Morgue Services

6.12. Infection Prevention

6.13. Sanitation and Waste Management

6.14. Housekeeping, Laundry and Maintenance Services

Section 7: Physical FACILITY STANDARDS

7.1. General

7.2. Site Selection Requirements

7.3. Construction Requirements

7.4. Building Space and Elements

7.5. Building Systems

7.6. Electrical System

7.7. Fire Protection System

7.8. Health Center Environment

7.9. Care and Treatment Areas

7.10. Ancillary areas

7.11. Bubble Diagrams

ACKNOWLEDGEMENT

Ethiopian Standard Agency, ESA would like to extend its special thanks to members of the technical working group organized by the Ethiopian Food, Medicine and

Healthcare Administration and Control Authority of Ethiopia, EFMHACA in developing the draft health facility standards. The members of the TWG were Dr.

Getahun Mengistu, Dr.Kidane Melles, Ato Yohannes Jorge, Dr Adefris Debalke, Dr.

Wondwossen Fantaye, Dr Faris Hussein, Dr Petros Mitiku, Dr David A.conteh, Dr

Ruth Lawson, Dr Birna Abdosh, Ato Liyusew Solomon, Ato Edmealem Ejigu, Dr

Solomon Tessema, Dr Endale Tefera, Ato Yihalem Tamiru, Dr Abyou Kiflie, Ato

K/mariam G/Michael, Sr Yeshialem Bekele, Ato Wondie Alemu, W/t Raey Yohannes, Ato Ayalew Adinew, Dr Zegeye Hailemariam, Dr. Tassew Tadesse, Dr Alem Michael, Dr. Aynalem Abraha, Dr. Mehrtu W/yes, Ato Zelalem mesele, Ato Salehunae, Dr

Daniel Admassie and Dr Tekle-ab Zaid.

In addition, the Agency would also thank all the workshop participants from the

Ministry of Health, Health Professional Associations, Universities, public and private hospitals, private clinics, non-governmental organizations and other governmental organizations for their commitment to enrich the draft document.

We are grateful to the USAID/PHSP-Ethiopia, MSH/SPS, Clinton Foundation and

Tulane University without whose support it would have been difficult to achieve the desired result.

The Agency would also like to express its appreciation to FMHACA for the commitment, effective coordination and overall leadership shown in the development of this standard.

FOREWORD

This Ethiopia Standard has been prepared under the direction of the Technical

Committee for Medical Care Practices (TC90) and published by the Ethiopian

Standards Agency (ESA).

The draft document (Working Draft, WD) has been submitted to the Secretariat by the Ethiopian Food, Medicine & Healthcare Administration and Control Authority

(FMHACA).

A Health center shall provide services in accordance with this standard and shall comply with the requirements. The standard shall enter into force starting from the day of approval as Ethiopian Standard. This standard is approved by the convention of ……….. made on…..Application of this standard is MANDATORY with the intention to ensure the quality and public safety of health services through standardized licensure and inspection procedures, to promote access to quality health services and encourage health investment.

The Ethiopian Standard Agency recommends fulfilling all the requirements stipulated under this document. It has to be noted that the fruition of fulfilling these requirements will ensure the quality and safety of public health services through availing appropriate infrastructure, deployment and retention of qualified and competent health professionals that deliver best practices and by generating innovative ideas and methodologies to solve healthcare problems.

Finally, acknowledgement is made to the EFMHACA, Technical Working Group, participants of national workshop and EFMHACA collaborators for their commitment and unreserved contribution to the effort of developing Ethiopian

Standards for Health Facilities.

Ato………………W/O…………Director General, Ethiopian Standard Agency

SECTION ONE: GENERAL

1. SCOPE

1.1. This Ethiopian standard shall be applicable for all health centers new and existing, governmental and non-governmental.

1.2. The standard covers the minimum requirements with respect to practices, premises, professionals and products or materials put into use for health centers.

1.3. Requirements of a health center are stipulated under section two to seven of this standard.

2. NORMATIVE REFERENCES

The latest editions of the following laws, regulations, directives and guidelines shall be taken as part and parcel of this Ethiopian Standard.

2.1. Ethiopian Food, medicine and Healthcare Administration and Control

Proclamation No. 661/2009

2.2. Ethiopian Food, Medicine and Healthcare Administration and Control

Regulation No. 189/2010

2.3. National Health Policy of the Transitional Government of Ethiopia, 1993

2.4. National Drug Policy of the Transitional Government of Ethiopia, November

2.5. Commercial Code of Ethiopia

2.6. Criminal Code of Ethiopia

2.7. Medicines Waste Management and Disposal Directive No 2/2011

2.8. Ethiopian National Guideline for Health Waste Management, 2008

2.9. Ethiopian Building Proclamation, No. 624/2009

3. TERMINOLOGIES AND DEFINITIONS

3.1

Appropriate Organ

Shall mean a state government organ authorized to implement food, medicine and healthcare administration and control activities at a state level;

3.2

Authority

Shall mean the Ethiopian Food, Medicine and Healthcare Administration and Control

Authority.

3.3

Proclamation

Shall mean the Ethiopian Food, Medicine and Healthcare Administration and Control proclamation No 661/2009.

3.4

Appropriate Law

Shall mean a law issued by a state to implement regulatory activities regarding food, medicine and healthcare.

3.5

Person

Shall mean any physical or juridical person

3.6

Authorized Person

Shall mean any health center staff who is responsible for a given service

3.7

Health center

Shall mean a health facility at primary level of the healthcare system which provides promotive, preventive, curative and rehabilitative outpatient care including basic laboratory and pharmacy services with the capacity of 10 beds for emergency and delivery services.

SECTION TWO: LICENSURE

2.1. GENERAL

2.1.1 This standard provides minimum requirements for the establishment and maintenance of health center in order to protect the public interest by promoting the health, welfare, and safety of individuals.

2.1.2 No health center shall be built or be functional by any person without prior permission of the appropriate organ.

2.1.3 The requirements set by this standard may not be waived unless otherwise for public interest and there is a substantial need for waiver. There shall be an assurance that the waiver will not create a hazard to the health and well- being of patients or others than the public interest.

2.2. APPLICATION FOR LICENSURE

2.2.1. No person shall operate a health center in Ethiopia, whether governmental, nongovernmental or private, without being licensed as required by appropriate law and this standard.

2.2.2. Any person desiring to operate a health center shall:

a) Apply to the appropriate organ on prescribed forms;

b) Pay the prescribed license fee and

c) Provide additional information or document upon written request by the appropriate organ.

2.2.3. A person desiring to operate a new health center shall consult the appropriate organ on the plant design conformity with this standard before starting construction or renovation work.

2.2.4. An application for the initial licensure of health center shall be submitted to the appropriate organ no later than forty five (45) days prior to the stated date of operation.

2.2.5. The first pre-licensing inspection shall be conducted by the appropriate organ upon application without service fee. In case of failure to comply with this standard during the first pre-licensing inspection, the applicant has the right to reapply not more than two times upon paying service fee.

If the applicant fails to comply with this standard for the third time, its application for licensure shall be suspended for three months.

2.2.6. The application for a health center license shall state each services to be given in the health center and the number of beds allocated, and shall furnish other information as may be required by the appropriate organ including,

a) Health center location and address;

b) Name and address of the applicant (if the applicant is an authorized delegate, written delegation letter shall be submitted);

c) Previous owner, license number for existing health center;

d) Name, qualification and address of the licensee;

e) Total bed capacity;

f) Surrounding environment/ location;

g) Number, type, work experience and original release of all technical staffs;

h) Number of administrative staff;

i) Physical plant/ health center design and its description;

j) Proposed use of idle space;

k) Organization structure;

l) Owner of the building;

m) Professional license and registration certificate of the licensee and all other health professionals responsible for each service in the center;

n) Any other requirements set by the appropriate organ.

2.2.7. An application for a license or change in service shall be denied if the applicant cannot demonstrate that the premises, products, personnel and health care services are fit and adequate in accordance with this standard.

2.2.8. The appropriate organ shall consider an applicant's prior history in operating a health care facility in all the regions of the country in making licensure decision. Any evidence of licensure violations representing serious risk of harm to patients shall be considered by the appropriate organ, as well as any record of criminal convictions representing a risk of harm to the safety or welfare of patients.

2.3. INITIAL/ NEW LICENSURE

2.3.1. Every health center shall have a separate license. The appropriate organ shall issue each license in the name of the owner and chief clinical officer only for the premises and person named as applicant in the application and the license shall not be valid for use by any other person or at any place other than the designated in the license.

2.3.2. A health center license shall specify the following:

a) Name and address of the health center;

b) The name and professional license and registration number of the licensee;

c) Ownership of the health center;

d) Name of the owner;

e) License number, issuance and expiration dates of the license;

f) Signature and stamp of the appropriate organ and

g) Notices/reminders prepared by the appropriate organ.

2.3.3. Prior to initial licensure of the health center, the appropriate organ shall conduct an on-site inspection to determine compliance with the applicable laws and standards governing the health center.

2.3.4. The appropriate organ shall send a written report of the findings to the health center after the conclusion of the inspection. If the health center complies with the laws and standards, initial license valid for one year shall be issued to the applicant.

2.3.5. A health center with deficiencies shall correct them and submit written proof of correction of deficiencies.

2.3.6. The appropriate organ shall deny the application for licensure to a health center that has not corrected deficiencies. The applicant shall reapply for licensure when deficiencies are corrected.

2.3.7. The appropriate organ shall conduct an on-site inspection of the health center to assess the center's continued compliance with the laws and standards governing the center.

2.3.8. The appropriate organ shall issue a replacement license where the originally issued license has been lost or destroyed upon the application supported by affidavit.

2.3.9. The original license shall be posted in a conspicuous place at reception at all times.

2.4. LICENSE RENEWAL REQUIREMENTS

2.4.1. A license, unless suspended or revoked or under consideration in pending case, shall be renewable annually and the Health center shall submit an application for license renewal to the appropriate organ no later than sixty

(60) days before the expiration date of the current license.

2.4.2. Without prejudice to article 2.4.1;

(a) Subsequent to submitting renewal application, the owner shall pay the prescribed license fee

(b) License renewal shall be made during the first quarter of each fiscal year (Hamle 1 to Nehassie 30) based on routine inspection findings over the year

(c) In case of failure to renew license within the prescribed period, license may be renewed upon paying penalty (50% of renewal fee) within one month

(d) In case of failure to renew license as per article 2.4.2 (c), license shall be considered as cancelled

2.4.3. Every applicant who needs to renew a license shall:

(a) Apply to the appropriate organ in the prescribed form;

(b) Pay the prescribed license renewal fee and

(c) Provide additional information or document upon written request by the appropriate organ.

2.4.4. The appropriate organ may conduct background checks on the applicant or licensee to determine its suitability or capability to operate or to continue operating a health care facility. Background checks shall consist of, but not be limited to, the following:

(a) Verification of licensure status;

(b) Verification of educational credentials;

(c) Verification of residency status;

(d) Verification of solvency; and

(e) Contacts with federal and Regional State governments or within a regional state to determine outstanding warrants, complaints, criminal convictions, and records of malpractice actions.

2.4.5. The appropriate organ shall renew a license for a health center in substantial compliance with the applicable laws and this standard.

2.5. REMOVAL PERMITS, CHANGE OF OPERATION AND FORFEITURE

OF LICENSE

2.5.1. No health center or part thereof shall move from the premises for which a license has been issued to any other premises without first having obtained from the appropriate organ a permit to move to the premises not covered by the license issued to the health center.

2.5.2. Without the prejudice to article 2.5.1, permit in change of address shall indicate the special conditions governing the moving of the health center or part of it as the appropriate organ may find to be in the interest of the public health.

2.5.3. Without prior permission of the appropriate organ, change of owner and/or licensee shall not be made.

2.5.4. The health center shall inform the appropriate organ any change in operation and profession. Change of operation means any alteration of services that is different from that reported on the health center's most recent license application.

2.5.5. The license shall not be assignable or transferable to any other person or place without the prior approval of the appropriate organ and shall be immediately void if the health center ceases to operate, if its ownership or licensee changes, or if it is relocated to a different site.

2.5.6. When change of ownership of a health center is contemplated, the center shall notify the appropriate organ in writing and give the name and address of the proposed new owner.

2.6. SUSPENSION AND REVOCATION OF A LICENSE

2.6.1. The appropriate organ may suspend or revoke a license or order closure of a service/ unit within the health center or order removal of patients from the health center where it finds that there has been a substantial failure to comply with this standard.

2.6.2. Without prejudice to grounds of suspension provided under relevant laws, the appropriate organ shall suspend the license for 3 to 12 months in any of the following grounds:

a) Where the health center is legally suspended;

b) Where the health center fails to practice medical ethics;

c) Where the health center engages in rendering services which are outside the scope of the health center for which the license is obtained;

d) Where the health center fails to allow inspection pursuant to relevant law and this standard;

e) Where the head of the health center and key staff members are convicted of a serious offence involving the management or operation of the health center, or which is directly related to the integrity of the facility or the public health or safety;

f) Where the health center fails to implement or fulfill comments and corrections given by the appropriate organ;

g) Where the health center has shown any act which constitutes a threat to the public health or safety;

h) Where the health center allows a practitioner, who has been suspended by appropriate organ from practicing his profession;

i) Where the health center fails to observe laws relating to health services and this standard;

j) Where the health center fails to submit relevant information required under this standard.

2.6.3. Without prejudice to grounds of revocation provided under relevant laws, the appropriate organ shall revoke the health center license from one to two years on any of the following grounds:

a) Where the license is proved to have been obtained by submitting false information;

b) Allows a practitioner, who is not licensed pursuant to the appropriate law or who has been revoked by appropriate organ from practicing his profession;

c) Where any of its permanent health personnel is found registered/ employed as a permanent staff in any other facility;

d) Where the faults referred to in Article 2.6.2 have been committed for the second time;

e) Where the license is found transferred or rented to another person;

f) Where the health center changes types of services, name, address and the licensee without obtaining permission from the appropriate organ;

g) Where the license is not renewed in accordance with Section 2.4 of this standard;

h) Where the health center is legally closed or ceases operation;

i) Where the health center is found operating while suspended by appropriate organ;

j) Where the health center is found operating outside the scope of services stated under this standard;

2.6.4. At least 30 days prior to voluntary surrender of its license where approved by the appropriate organ, or order of revocation, refusal to renew, or suspension of license, the health center must notify each patient and the patient's direct attendant the intended closure.

2.6.5. Each license in the licensee's possession shall be the property of the appropriate organ and shall be returned to the appropriate organ immediately upon any of the following events:

a) Suspension or revocation of the license;

b) Refusal to renew the license;

c) Forfeiture of a license; or

d) Voluntary discontinuance of the operation by the licensee.

2.6.6. If the appropriate organ determines that operational or safety deficiencies exist, it may require that all admissions to the health center cease. This may be done simultaneously with, or in lieu of, action to revoke license and/or impose a fine. The appropriate organ shall notify to the health center in writing of such determination.

2.6.7. The appropriate organ shall order and ensure in collaboration with appropriate local health authorities the immediate removal of patients from the health center whenever it determines there is imminent danger to the patients’ health or safety.

2.6.8. The license shall be returned to the appropriate organ within five (5) working days from voluntary surrender, order of revocation, expiration, or suspension of license.

2.6.9. The appropriate organ shall issue to the health center a written notification on reasons for denial, suspension or revocation of the license.

2.7. RIGHT TO FAIR HEARING

2.7.1. Any applicant made subject to action by the appropriate organ for denial or suspension or revocation of license or who is assessed a fine under terms of this standard shall have the right to a fair hearing in accordance with relevant laws.

2.7.2. Fair hearing shall be provided/arranged by the appropriate organ whenever there is an official compliant submitted to this body.

2.8. INFORMATION TO BE DISCLOSED

2.8.1. Evidenced information received by the appropriate organ through inspection and other true sources about the health center shall be disclosed to the public in such a way to indicate the public a decision maker or self regulator for its own health.

2.8.2. Whenever public disclosure is necessary, the appropriate organ shall forward inspection reports to the health center at least 15 days prior to public disclosure.

2.8.3. Any citizen has the right to obtain information on the official profile of services of any licensed health center from the appropriate organ.

2.8.4. Anyone who is interested in establishing a health center shall have the right to be provided with information concerning the standards required by the appropriate organ at any working days.

SECTION 3: GOVERNANCE

3.1. MANAGMENET COMMITTEE OR GOVERNING BOARD

3.1.1. A health center shall have Management Committee or Governing Board, a head, an administrative head and necessary staffs indicated in this standard.

3.1.2. The Board of Management of non-governmental health center shall be deemed as Governing Board.

3.1.3. The Management Committee or Board shall have the authority and responsibility for the direction and policy of the health center.

3.1.4. The Management Committee or Board of the health center may issue its own rules and regulations of procedures.

3.1.5. Without prejudice to powers and duties provided by the relevant laws, the responsibilities of Management Committee or Board shall include:

(a) Formulate all policies and guidelines to be used in the health center;

(b) Maintaining the health center’s compliance with all applicable laws, its policies, procedures and plans of correction;

(c) Systems are in place for ensuring the quality of all services, care and treatment provided to patients;

(d) Designating and defining duties and responsibilities of the head of the health center;

(e) Notifying the appropriate organ in writing within thirty (30) working days when a vacancy in the head of the health center position occurs, including who will be responsible for the position until another person is appointed;

(f) Notifying the appropriate organ in writing within thirty (30) working days when the head of the health center vacancy is filled indicating effective date of the appointment and name of person appointed;

(g) At least once a year, reviewing the medical care provided and the utilization of the health center resources;

(h) Establishing a means for effective communication and coordination among the board, head of the health center and the staffs;

3.1.6. Minutes of the Management Committee or Board Meeting shall be recorded, signed, and retained in the health center as a permanent record.

3.1.7. There shall be an organizational chart of the health center and each service that shows lines of authority, responsibility, and communication between and within services.

3.1.8. The health center shall establish a mechanism for involving consumers in the formulation of policies and implementation of activities.

3.1.9. The health center shall develop and implement a complaint procedure for patients, families, visitors, and others.

3.2. HEAD OF THE HEALTH CENTER

3.2.1. The head of the health center shall be responsible for planning, organizing, directing and controlling the day to day operation of the health center. The head shall report and be directly responsible to the management committee or Board in all matters related to the maintenance, operation, and management of the center.

3.2.2. Without prejudice to powers and duties provided in relevant laws, the head of the health center shall be responsible for:

(a) Providing for the protection of patients’ safety and well- being;

(b) Maintaining staff appropriate to meet patient needs;

(c) Developing and implementing procedures on collecting and reporting information on abuse, neglect and exploitation;

(d) Ensuring that investigations of suspected abuse, neglect or exploitation are completed and that steps are taken to protect patients; and

(e) Ensuring appropriate response to reports from the appropriate organ other duties and responsibilities given by the management committee or Board;

3.3. ADVISORY MANAGMENT COMMITTEE

3.3.1. Any health center shall establish Advisory Management Committee consisting of heads of the medical and administrative departments. The head of the health center shall be the chairperson of the Committee.

3.3.2. The Committee shall be an advisor of the head of the health center.

3.3.3. The Committee shall meet upon regular basis. The minutes of the meeting shall be recorded and available to the appropriate organ upon request.

SECTION 4: PATIENT RIGHTS AND

RESPONSIBILITIES

4.1. INFORMED CONSENT

4.1.1. Each health center shall protect and promote each patient’s rights. This includes the establishment and implementation of written policies and procedures for the patient right.

4.1.2. For undertaking any type of procedures and treatments an informed consent shall be required from the patient or patient’s next of kin or guardian.

4.1.3. An informed consent may not be required during emergency cases or life threatening situations where the patient is not capable of giving an informed consent and his or her next of kin or guardian is not available.

4.1.4. Unless provided by the law or this standard or by the health center policies and procedures that an informed consent shall be given in written form, an informed consent of the patient can be given orally or inferred from an act. A written consent shall be needed at least for the following:

(a) Minor surgery procedures;

(b) Blood transfusion.

4.1.5. The health center shall comply with relevant laws, national codes of ethics in the cases of vulnerable groups like children, women, geriatric patients etc when someone other than the patient can give consent.

4.1.6. Patient consent forms shall be available in all applicable locations like areas where minor surgery procedures are done

4.1.7. No photographic, audio, video or other similar identifiable recording is made of without prior informed consent of a patient.

4.1.8. A health center shall establish and implement a process to provide patients and/or their designee an appropriate education to assist in understanding the identified condition and the necessary care and treatment and shall document its assessment of each patient's ability to understand the scope and nature of the diagnosis and treatment needed.

4.2. PATIENT RIGHTS

Every patient shall at least have the following rights,

4.2.1. To receive reasonable, respectful and safe access to health services by competent personnel that the health center is required to provide according to this standard;

4.2.2. To receive treatment and medical services without discrimination based on race, age, color, religion, ethnicity, national or social origin, sex, disabilities, diagnosis, source of payment or other status;

4.2.3. To retain and exercise to the fullest extent possible all the constitutional and legal rights to which the patient is entitled by law;

4.2.4. To be informed of the names and functions of all clinical practitioners who are providing direct care to the patient. These people shall identify themselves by introduction or by wearing a name tag;

4.2.5. To receive, to the extent possible, the services of a translator or interpreter, if any, to facilitate communication between the patient and the center's health care personnel if the patient cannot understand the working language;

4.2.6. To receive from the patient's clinical practitioner(s) an explanation of his or her complete medical condition, recommended treatment, risk(s) of the treatment, expected results and reasonable medical alternatives in terms that the patient understands. If this information shall be detrimental to the patient's health, or if the patient is not capable of understanding the information, the explanation shall be provided to his or her next of kin or guardian and be documented in the patient's personal medical record;

4.2.7. To refuse medication and treatment and to be informed of the medical consequences of refusing treatment provided that he/she is mentally clear except conditions which are threatening the public health. The health center shall develop a procedure on the management of the cases of patients who refuse treatment.

4.2.8. To be informed if the health center has authorized other health care and educational institutions to participate in the patient's treatment. The patient also shall have a right to know the identity and function of these institutions, and may refuse to allow their participation in the patient's treatment;

4.2.9. To be informed by the attending clinical practitioner about any continuing health care requirements after the patient's discharge from the health center.

4.2.10. To be transferred to another health facility only for one of the following reasons, with the reason recorded in the patient's medical record:

(a) The transferring health center is unable to provide the type or level of medical care appropriate for the patient's needs.

(b) The transfer is requested by the patient, or by the patient's next of kin or guardian when the patient is mentally incapacitated or incompetent;

4.2.11. To be treated with courtesy, consideration, and respect for the patient's dignity and individuality i.e. the right to care that respects the patient’s personal values and beliefs;

4.2.12. To be free from physical and mental abuse, neglect, sexual harassment, violence and exploitation;

4.2.13. To have personal and physical privacy during medical treatment and personal hygiene functions, such as bathing and using the toilet, unless the patient needs assistance for his or her own safety. The patient's privacy shall also be respected during other health care procedures and when clinical personnel are discussing with the patient;

4.2.14. To get confidential treatment. Information in the patient's records shall not be released to anyone outside the health center except the followings;

(a) If the patient has approved the request,

(b) If another health care facility to which the patient was transferred requires the information,

(c) If the release of the information is required and permitted by law.

(d) If the patient's identity is masked

4.2.15. To know the price of services and procedures,

4.2.16. To have prompt access to the information contained in the patient's medical record as per the medical record section stated under this standard, unless the clinical practitioner prohibits such access as detrimental to the patient's health, and explains the reason in the medical record. In that instance, the patient's next of kin or guardian shall have a right to see the record. This right continues after the patient is discharged from the health center for as long as a copy of the record is kept;

4.2.17. To obtain a copy of the patient's medical record, as per the standards set under the medical record section of this standard.

4.2.18. To receive a medical certificate in English or Amharic or in a working language of the place where the health center is located;

4.2.19. To present his or her suggestion or grievances, without fear of retribution, to the health center staff member designated by the center to respond to questions or grievances about patient rights and to receive an answer to those grievances within a reasonable period of time without discrimination.

4.2.20. To be informed and participate in decisions relating to their care and participates in the development and implementation of a plan of care and any changes.

4.3. PATIENT RESPONSIBILITIES

4.3.1. Every patient shall have the following responsibilities:

(a) To provide, to the best of the patient’s knowledge, accurate and complete information regarding past medical history and issues related to the patient’s health, including unexpected changes, to the health professional responsible for the patient’s care;

(b) To follow the course of treatment and instructions proposed by the attending clinical practitioner or to accept the consequences if treatment instructions is refused;

(c) To report any changes in his/her condition or anything that appears unsafe to the responsible health professional;

(d) To be considerate of the rights of other patients and to respect their privacy;

(e) To respect their caregivers;

(f) To fulfill the financial obligations as promptly as possible;

(g) To keep all appointments and notify health center or the appropriate person when unable to do so;

(h) To observe the health center policies and procedures, including those on smoking, alcohol or drug addiction, cellular phones, noise and visitors;

(i) Be considerate of the health center facilities and equipment and to use them in such a manner so as not to abuse them;

(j) Not to litter the health center premises.

(k) To sign on “Against Medical Advice Notice” if he / she refuses the recommended treatment or intervention.

4.3.2. The list of a patient’s rights and responsibilities shall be posted at various places of the health enter premises.

SECTION 5: HUMAN RESOURCE MANAGEMENT

5.1. GENERAL REQUIREMENTS

5.1.1. The health center shall have a unit or focal person who carries out the major functions of Human Resource Management (HRM).

5.1.2. Each service units of the health center shall maintain a sufficient number of staff with the qualifications, training and skills necessary to meet patient needs as per this standard.

5.1.3. All recruitment and selection shall follow consistent approach using the recruitment and selection manual approved by the health center management/ governing board.

5.1.4. No health professional shall practice his/her profession in the health center without having professional license from the appropriate organ.

The health center shall ensure that all health professionals recruited by the health center are licensed as per the registration and licensing requirement of the appropriate organ.

5.1.5. Each health center shall ensure and maintain evidence of current active licensure, registration, certification or other credentials for employees and contract staff prior to staff assuming job responsibilities and shall have procedures for verifying that the current status is maintained.

5.1.6. Whenever a licensed health-care professional is terminated as a result of a job-related incident, the health center shall refer a report of the incident to the appropriate organ.

5.1.7. Every health professional shall report to the health center whenever he/she is infected with contagious diseases. The health center shall also establish a mechanism for screening health professionals with contagious diseases. The health professional shall not practice his/her profession during the period of such infection and his/her rights provided under the relevant employment law and the health center’s HR manual shall be respected.

5.1.8. Each person involved in direct patient care shall have an occupational health screening by a physician or other qualified health professional prior to entering active status and at least once every five (5) years thereafter. A health professional shall not conduct health examination for himself/ herself.

5.1.9. Each health screening shall include a medical history, physical examination, and any indicated laboratory work and investigations.

5.1.10. A report, signed by an examining physician or other qualified health professional, shall be made of each examination.

5.1.11. The report of each examination shall be kept on file in the health center and shall be open to inspection by the appropriate organ.

5.1.12. Each person who is involved in direct patient care and who acquires notifiable illness shall, prior to returning to duty, obtain certificate of fitness, as provided in the health center's policies, that he or she may return to duty without apparent danger to any patient.

5.1.13. Immunization against communicable disease shall be required of all employees and all other persons who routinely come in contact with patients or patient areas. Immunizations shall be in accordance with current national immunization guidelines.

5.1.14. Each health center shall maintain a current employment record for each staff. The record shall contain, at a minimum, information on credentials, health examination (fitness for duty), work history, current job description, and evidence of orientation, in-service education/training and copies of annual evaluation.

5.1.15. All health professionals shall abide with health professionals Code of conduct and respective scope of practice.

5.1.16. There shall be a policy or procedures for all health professionals to report any suggestive signs of child abuse, substance abuse and /or abnormal psychiatric manifestations by the patients under their care.

5.2. STAFFING PLAN

5.2.1. The health center shall avail as a minimum the staff requirement stated under this standard.

5.2.2. A staffing plan shall be developed collaboratively by the different service units and management, which identifies the number and types of the staff

5.2.3. The planning process shall use recognizable process for estimating the staffing need like Workload Indicator for Staffing Need (WISN) method.

5.2.4. The staffing plan shall be reviewed on an ongoing basis and updated as necessary.

5.2.5. The staffing plan shall define the following elements:

(a) The total number and types of staff needed for the health center as a whole and for each service unit,

(b) The total number and types of staff currently available for the health center as a whole and each service unit,

(c) The required education, skills, knowledge, and experience required for each position,

(d) The process and time period for reviewing and updating the plan shall be indicated. (The plan is periodically reviewed and updated as required, but it shall be done at least every two years.)

(e) Expected workload.

5.2.6. The health center shall have at least the following summary of professionals:

Professionals required Minimum number required

Health Officer 2

General Practitioner (optional) 1

Midwife 3

Nurse 5

Ophthalmic nurse 1

Psychiatry nurse 1

Environmental Health professional 1

Laboratory technician or technologist 2

Pharmacist or pharmacy technician 3

Cleaners 5

Archive workers 6

Maintenance officer 1

Morgue attendant 1

5.3. JOB DESCRIPTION AND ORIENTATIONS

5.3.1. All staffs shall be provided with current written job descriptions and be oriented to their specific job responsibilities at appointment.

5.3.2. The job description shall include the title and grade of the position, specific function of the job, job requirement, reporting mechanism, evaluation criteria and description of job site and work environment.

5.3.3. The orientation program for all employees shall include three levels of orientation: health center wide, service unit and job specific.

5.3.4. Orientation to health center structure and administration shall be provided by health center management.

5.3.5. Orientation to health center policies, including all environmental safety programs, infection control, and quality improvement shall be provided

5.3.6. Staff members who are not licensed to independently practice shall have their responsibilities defined in a current job description.

5.3.7. Each health center shall provide and maintain evidence of an orientation program for all new staff and, as needed, for existing staff who are given new assignments. The orientation program shall include:

(a) Job duties and responsibilities;

(b) Health center's sanitation and infection control programs;

(c) Organizational structure within the health center;

(d) Patient rights;

(e) Patient care policies and procedures relevant to the job;

(f) Personnel policies and procedures;

(g) Emergency procedures;

(h) The Disaster preparedness plan; and

(i) Reporting requirements for abuse, neglect or exploitation.

5.4. STAFF EDUCATION:

5.4.1. The health center shall ensure that staffs receive training in order to perform assigned job responsibilities.

5.4.2. Each staff member shall receive ongoing Continuing Professional Development (CPD) to maintain or advance his or her skills and knowledge

5.4.3. The CPD shall be relevant to the setting in which they work as well as to the continuing advancement of the health center.

5.4.4. The health center shall decide the type and level of training for staff in accordance with National CPD guideline and then carry out and document a program for this training and education.

5.4.5. The health center shall provide and maintain evidence of CPD for staff. A record shall be maintained including dates, topics, CPD providing institute and participants.

5.4.6. The health center shall periodically tests staff knowledge, skill and attitude through demonstration, mock events and other suitable methods.

This testing is then documented.

5.5. MEDICAL STAFF

5.5.1. The medical staff shall be responsible to the governing authority for medical care and treatment provided in the health center in accordance with the standards stipulated under the health center administration and shall:

(a) Participate in a Quality Assurance/Performance Improvement program to determine the status of patient care and treatment;

(b) Abide by health center and medical staff policies;

(c) Establish a disciplinary process for infraction of the policies;

5.5.2. The medical staff shall see that there is adequate documentation of medical events and shall also insure that medical records meet the required standards of completeness, clinical pertinence and promptness or completion of following discharge.

5.5.3. The medical staff shall actively participate in the study of health center associated infections and infection potentials and must promote preventive and corrective programs designed to minimize their hazards.

5.5.4. There shall be regular medical staff meetings to review the clinical works of the members and to complete medical staff administrative duties.

5.6. EMPLOYEE’S HEALTH

5.6.1. The health center shall institute systems and processes that minimize employees’ risks, protect employees and provide access to care when needed.

5.6.2. A comprehensive Occupational Health and Safety (OHS) program shall have the following components:

(a) Staff assigned to coordinate OHS activities,

(b) Policies and Procedures that define components of the program,

(c) Training for staff on program components.

5.6.3. The health center shall have a full-time designated qualified individual (occupational health and safety officer) to coordinate and develop the health center’s occupational health and safety activities.

5.6.4. The standards outlined below define the core elements of an OHS program and specify minimum requirements needed to address OHS issues.

(a) The health center shall have an occupational health and safety policy and procedures in place to identify, assess and address identified health and safety risks to staff and prevent those risks that will potentially compromise their health and safety.

The health center assesses and documents safety risks through formalized, structured assessments that are done at regular intervals.

The assessments shall be logged in some format—for example a register or report.

The information gathered from the assessment shall be documented and reported to the management (management committee and boards).

Interventions shall be designed and implemented to address the risks that are identified.

(b) The health center shall establish a means of communicating to staff their risks and prevention measures or interventions.

(c) The health center shall regularly monitor its occupational health and safety activities to assess how effective it has been in reducing risk.

(d) The health center shall have written policies and procedures to manage manual handling risks.

(e) The health center shall have written policies and procedures which define how harassment, physical violence and/or aggression against staff (from patients, caregivers, other staff etc) are addressed.

(f) The health center shall provide services to staff to minimize work-related stress.

(g) The health center shall ensure all employees have access to full pre-employment health screening, and are declared fit for their respective roles prior to employment. This shall include having:

Written instructions for health care workers to follow in notifying the health center’s administration of infectious status.

Documentary evidence of vaccination records for all health care workers employed, including Hepatitis B status for all health care workers who perform exposure-prone procedures. All staff shall be tested for and vaccinated against Hepatitis B, if there is no evidence of previous vaccination produced.

(h) The health center ensures that all employees are provided with immunization services to protect against infectious/communicable diseases.

(i) The health center shall have a program in place to address injuries that could lead to the transmission of blood-borne viruses (needle stick and other injuries). The program shall include:

Measures to prevent needle stick and other injuries, Training on infection prevention techniques, Sharps risk reduction, Provision of post-exposure prophylaxis, Working hours and duty hours.

5.6.5. The health center shall provide personal protective equipment (please refer to standards for Infection Prevention and Control and Sanitation).

5.6.6. The health center shall provide the following facilities to employees

a) Cafeteria and/or Break room (equipped with a television and other recreational equipment),

b) Green area,

c) Library, and

d) Adequate toilet and shower facilities.

5.7. DRESS CODE AND EMPLOYEE IDENTIFICATION BADGE

For areas involving direct patient contact:

5.7.1. Footwear shall be safe, supportive, clean, and non-noise producing.

5.7.2. No open toe shoes shall be worn.

5.7.3. Artificial nails are prohibited. Natural nails must be kept short and jewelry must be kept to a minimum.

5.7.4. Hair must be worn in a way that prevents contamination and does not present a safety hazard.

5.7.5. The dressing shall not interfere in any way the service provision.

5.7.6. The health center shall specify a particular style and/or color of uniform with different style/color code; separate for each human resource category.

5.7.7. The employee shall keep the uniform neat, wrinkle free and in good repair.

5.7.8. The health center shall be responsible for providing employee identification badges.

5.7.9. The identification badge shall be worn at all times while at work and be easily visible, with name, profession and department facing outward.

SECTION 6: SERVICE STANDARDS

6.1. GENERAL MEDICAL SERVICES

6.1.1 Practices:

6.1.1.1 The health center general medical service shall provide the following core functions as per the outpatient service standard:

a) Care of ambulatory patients and Follow up of ambulatory patients for common chronic conditions including TB/Leprosy, HIV and other acute and chronic diseases management;

b) MCH services with new born corner;

c) Basic ENT, Dental, Eye, and Mental health services which will be provide in an integrated manner (by general practitioner, health officer or trained nurse);

d) Basic rehabilitative service;

e) Preventive and health promotive services;

6.1.1.2 The service shall be directed by a licensed medical practitioner or health officer or professional nurse.

6.1.1.3 The general medical service shall be available in working days for at least eight hours a day.

6.1.1.4 The medical assessment at OPD level shall include;

a) Comprehensive medical and social history;

b) Physical examination including at least:

Vital sign (BP, PR, RR, To) and weight, Clinical examination pertinent to the illness.

c) Diagnostics impression;

d) Laboratory and other medical workups when indicated.

6.1.1.5 The range of relevant treatment options and the clinical impression shall be fully described to client and/or their families and documented accordingly.

6.1.1.6 The general medical service shall have clinical protocols for management of at least common disease entities like malaria, hypertension and locally significant diseases and management of common dental, eye, ENT and mental health problems in line with the national and or international guidelines.

6.1.1.7 The service shall avail national guidelines for malaria (where prevalent), TB/Leprosy, HIV/ART, VCT/PMTCT, pain management, STD and others.

6.1.1.8 The outpatient service shall have functional referral system which include at least:

SOP for selection of cases for referral

Procedure for referring patients directly to respective services

List of potential referral sites with contact address (referral directory)

Referral forms

Referral tracing mechanism (linkage)

Feedback providing mechanism

Documentation of referred clients

6.1.1.9 The health center shall have a system to report ‘diseases under national surveillance’ to nearest respective health office.

6.1.1.10 The health center shall provide basic rehabilitative service as part of integrated general medical service including contracture and foot ulcer prevention activity.

6.1.1.11 There shall be training service for patients on copping disability. It includes utilization of prostheses, orthoses, wheelchairs, walking aids.

6.1.1.12 There shall be patient education on prevention of:

(a) pressure sores in clients with sensory loss,

(b) contractures in clients with limb and/or trunk paralysis,

(c) phantom limb pain for amputees,

6.1.2…