Annex 1: Provisional law #31 for year 2003 Food and Drug Administration FDA Article (1): This law will be called the Food and Drug Administration law # 31 for year 2003 and it will be in force from date of its publication in the Gazette. Article (2): a) Minister: Minister of Health. Ministry: Ministry of Health. Administration: Food and Drug Administration. Council: Board of Directors. Chairman: Chairman of the Board. Director General: Director General of the FDA. b) For The aims and purposes of this law and as necessitated from the Food law # 79 for year 2001 and the Drug and Pharmacy law # 80 for the year 2001. The Establishment of FDA and its goals: Article (3): a) FDA will be established here in Jordan enjoys judicial person financial and administrative independence and by this capacity, it is entitled to exercise all legal actions that are deemed necessary to achieve its goals or purposes, including the possession of transferable and non transferable properties and enter into contracts and accept donations. It is also entitled to assign an attorney general to act on its behalf. b) The Establishment (The head office of the FDA) will be based in Amman. Article (4): The Establishment aims to guarantee: a) The safety of food stuffs, their quality and their suitability for human consumption through out their use. b) The safety of Drug (medications) and their quality control. c) The safety of other stuffs specified in the Drug and Pharmacy law which is in effect. Article (5): To achieve the goals specified in Article 4.The Establishment will acquire all the responsibilities and jobs entitled to them as established in the law of supervision and inspection of food stuffs and the Drug and Pharmacy law in effect. a) Supervision and inspection of the quality and suitability of food stuffs in accordance with technical rules, specifications and standards stipulated in the legislations in force. b) To achieve the requirements and take measures in connection with drug and pharmacy law, also to guarantee and supervise the safety and quality of medication in accordance with the rules and standards specified in the legislations in effect. c) To exercise any other supervision and inspection in connection with food stuffs and drug specified in the inspection in Food Law and Drug and Pharmacy Law in effect in food. The Establishment Administration Article (6): The Administration will have a Board of Directors headed by the Minister of Health and the following as members of the Board: a) The Director General as Vise Chairman b) The Undersecretary of the MOH acting for Administrative and Financial Affairs. c) The Undersecretary of the MOH acting for Technical Affairs. d) The Director of Food Directorate at the FDA Establishment. e) The Director of Drug Directorate at the FDA Establishment. f) Four members with experience and specialization in the fields of Food stuffs and Drug to be appointed by a decision from the Council of Ministers according to Minister's nomination. Their membership will be for two years renewable for one term only by the same procedure any one of these four members may be replaced by another member for the remaining period of term. Article (7): The Board of Directors will be entitled of implementing the tasks and goals that the FDA will seek for: a) Implementing the general policy that relate to Food and Drug and the supervision on them and set plans and tasks required for good implementations. b) The agreement of enter into contracts with local and national and international organizations in parallel with the FDA goals and achievements. And authorize the vice chairman or the chairman to sign and approve these contracts. c) The accreditation of technical basis or documentation or evidence from other countries and national and international organizations. d) The approval of structuring and restructuring the FDA Establishment. e) The approval of future plans for FDA improvement in relation to staff and proceeding the studies and research to achieve organization goals. f) The approval of annual budget of the FDA and send it to the Council of Ministers for approval. g) The approval of annual report upon the general councils work and general budget and final accounts about and regarding previous year for the Establishment and submit it for council of Ministers for approval. h) Appointment of legal auditor and set his fees. i) Periodical revision for the Establishment achievement. j) Form any specialized committees that Establishment may need according to nomination from Director General and prescribe duties for each of them. k) Seeking for national and international support for the establishment. l) The approval for specified directions for Food and Drug inspection and quality control submitted by higher committee. m) Prepare the legislative draft that is related to the Establishment work. Article (8): a) The Council should convene at an invitation from the chairman or the vice chairman upon his absence once every three months at least with not less than seven of its member conditioned by presence of chairman or vice chairman. b) The chairman in entitled to invite an expert to seek his opinion about issues in question for discussion with no right to vote. c) The Director General can appoint any of the FDA staff to be secretary for the Council to call for meeting and to follow up the decision made by its members. Article (9): The Director General is appointed by a decision made by the Council of Ministers upon Minister's nomination. The decision also specified his salary and allowances and all his financial rights are determined by the same decision. His service is terminated in the same procedure. The Council of Minister decision to appoint the Director General is subjected to Royal Decree to that effect. Article (10): The Director General has the responsibilities and duties followed: a) Following up the general policy related to Food and Drug inspection that Council lay down and exercise the plans and programs related to it. b) Execution the decisions made by the Council. c) The Supervision on the executive body of the establishment for good cooperation at work to achieve the goals required. d) Decision making of what committees has recommended. e) Preparation of annual budget and submit it for the Council for approval. f) Preparation of annual report regarding the Establishment achievement and general annual budget regarding pervious year and submit it to the Council for approval. g) Any other responsibilities related to the Establishment work that the Council might authorize him by The FDA Budget and Financial Resources Article (11): The FDA shall have an independent budget beginning on the first of January till the thirty first of December of the same year. Article (12): a) The Financial Resources for the FDA consists of: 1- The appropriations allocated by the general budget. 2- The income fees and service allowances stipulated in the Food and Drug in force. 3- Any other resources accepted and approved by the Council of Ministers. b) Any excess sum of money is considered to the treasury and should be translated to it at the end of the year. Article (13): The Establishment enjoys facilities and exemptions that other Ministers and Governmental Directories enjoys. Article (14): The Establishment money is considered general money and collected according to the state money law in effect. Article (15): The Establishment account should be organized according to proper accounting and submitted to Audition Department for revision. Article (16): a) All the employees at the Drug Directorate and the Food Directorate and Food and Drug quality control Labs at the Ministry as well as some of the employees that work at the inspection domain at the Ministry of Health Shall be translated to the FDA Establishment with all their rights. b) Upon the Director General nomination, the Minister can delegate any of the Directors at Directorates at Governorates or any of the employees there to carry the inspection responsibilities upon the provision of this law. Article (17): The Establishment is entitled to issue incentives for its employees according to certain criteria implemented by the council for this purpose conditioned by Council of ministers approval. Article (18): None of the provisions included in any contradicting law or articles will be put in force or in effect. Article (19): The Council of Ministers shall issue the required regulations according to the provision of this law. Annex 2: Drugs Testing Regime issued by virtue of Article (104 b) of the Provisional Drug and Pharmacy Act No. 80 of 2001 Article 1: This Regime is called (The Drug Testing Regime No…..of ……) and becomes in force from the date of publishing it in the Official Gazette. Article 2: The following words and phrases, wherever they appear in the Regime shall have the designated meaning thereto, unless the context indicates otherwise. Director General: The Director General of the Food and Drug Administration The Administration: The Food and Drug Administration. The Directorate: The Drug Directorate. The Director: The Director of the Drug Directorate. The Laboratory: The Pharmaceutical Control Laboratory Directorate. The Drug: As mentioned in the Drug and Pharmacology Act No. 80 of 2001 and for the purposes of implementing this Regime, wherever the word product appears it shall mean drug and vice versa. The Sample: The number of drug units withdrawn from the batch whereby it is a representation thereof. The Batch: A specific number of production units of a single drug that has been manufactured from the same materials and under the same conditions all at once, or a series of integrated manufacturing processes whereby the product is uniform. Each batch shall carry a number and/or a code. The Test: The Descriptive and Laboratory Analysis of the Sample. The Pharmaceutical Corporation: The public or private pharmacy or the factory or the drug store by virtue of the legislation in force. The Quality Control Committee: The Committee formed by virtue of this Regime. The Responsible Pharmacist: The Responsible Pharmacist in the drug store or the Technical Manger of the factory. ARTICLE 3: The foregoing should be followed regarding the sample submitted for registration: a) The Directorate delivers to the laboratory a copy of the Technical File in accordance with Appendix 1/ Third of the Criteria of Registration. b) The responsible pharmacist provides the laboratory with the Reference Standard, Degradation Products and Related Substances mentioned in the technical file. c) The instructions issued by the Administration regarding receipt and delivery of the sample, its size and the test result, must be followed. d) The laboratory conducts the tests and analyses to the Sample of registration in accordance with the methods of analysis and specifications submitted in the Technical File of the product and/or in accordance with the drugs codes of the pharmacopoeia products. Article 4: The foregoing should be followed regarding the registered Sample: a) The drug batches that are registered after the issuance of this Regime shall be subject to laboratory analysis for a period of at least two consecutive years from the date of registration whereby the number of analyzed batches is at least seven for each drug. b) In the event that the batches mentioned in (a) pass the test, the Directorate issues a decision permitting the marketing of the batches that follow by applying the random principle in accordance with the instructions that shall be issued in that respect. c) A random choice of a drug is done for the purposes of laboratory analysis for a maximum of three batches annually. d) With due observance of the text of clauses (a, b and c) of this Article, it is forbidden to market any drug batch except after: 1. Its successful passing of all laboratory tests in accordance with the approved specifications in the drug’s Technical File and/or in accordance with the drug codes of the pharmacopoeia. 2. The issuance of the permission for the marketing, by the Directorate. ARTICLE 5: The submitted Sample for the purpose of marketing the registered drug, before the implementation of this Regime: a) The results of the last seven consecutive batches of drugs that were permitted to be marketed in the Kingdom prior to this Regime becoming into force, shall be relied upon for the purposes of implementing clause (b) of Article (4) of this Regime. b) In the event that the results of seven consecutive batches of the drug are not at hand, the completion of analysis is made until the number of which reaches seven consecutive batches and then it shall be subject to the stipulations of clause (b) of Article (4) of this Regime. ARTICLE 6: a) If any of the seven consecutive batches fails as mentioned in Article (4-a), testing of the seven consecutive batches that follow is carried out. b) If any of the yearly random batches fails as mentioned in article (4-c), testing of the seven consecutive batches that follows is carried out. c) In the event of the failure of any of the batches mentioned in Article (5), test of the seven consecutive batches that follow is carried out. d) If any sample does not satisfy the special conditions of packing materials or secondary packing (information, stickers, carton containers) of any of the specifications mentioned in the Technical File, but it passes the laboratory, physical, microbial and biological tests, then the issue of this batch is referred to the Quality Control Committee to make the appropriate decision and it shall not be subject to clauses (a) and (b) of this Article. ARTICLE 7: The foregoing should be followed in respect of the non-conforming products: a) The non-conforming products shall be retained in accordance with the approved mechanism for recalling the violating drugs. b) The responsible Pharmacist is entitled to object to the Directorate about the test result within fifteen days from the date of retaining the batch provided the objection is supported by the necessary documents and justifications. c) The objection is reviewed by the Quality Control Committee formed by virtue of this Regime within special instructions, provided it makes a decision within a maximum period of fifteen days from the date of objection. 1. In case the objection and justification of the responsible pharmacist is acceptable, a decision to permit the marketing shall be issued by the Director General. 2. In case the objection and justification of the responsible pharmacist is not acceptable, a rejection for marketing shall be issued by the Director General provided the responsible Pharmacist is given a notice of one month from the date of the Director General’s letter to determine the fate of the retained drug. ARTICLE 8: The marketing of any batch of any drug of the foregoing is forbidden except after passing the approved tests in the Technical File of the drug, as for the pharmacopoeia products, the approved specifications mentioned in the codes of drugs shall be followed and the permission decision for marketing shall be issued by the Directorate after the result of the test is issued: a) Donation Drugs b) The drugs of biological origin or where a substance of biological original enters in its composition. c) Medical Gases Drugs ARTICLE 9: a) The marketed drugs existing in the public and private pharmacies are subject to testing and re-testing without a consideration, in accordance with instructions issued by the Director General. b) In case a decision is issued to discontinue the marketing, the batch or batches are recalled in accordance with the approved mechanism of drug recall. ARTICLE 10: The Director General forms a Committee called (Drug Quality Control Committee) on the following basis: a) 1) The director of the Directorate – President. 2) Director of the Laboratory – Vice President. 3) (A pharmacist specializing in pharmaceutical control) named by the Jordanian Union of Drug Producers. 4) a faculty member specialized in pharmaceutical analysis from any official school of pharmacology at any official university. 5) A pharmacist representing the Royal Medical Services 6) A pharmacist representing the Supply Directorate/Ministry of Health. 7) A representative of drug importers. 8) The division Head of the Pharmaceutical Control Division at the Directorate. 9) A delegate from the registration division. The secretariat shall be from the Pharmaceutical Control Division. a) The Committee undertakes the following tasks and powers: 1) Recommendation to the Director General to approve the laboratories of reference. 2) to exclude the un-registered drugs imported with non-commercial quantities to specifically named patients, from the laboratory test as mentioned in the Pharmacology Act Article (5-a) Item (13). 3) Acknowledge lists of drugs or batches excluded from tests or some of them. 4) Look into submitted objections about results of drug tests and issue the appropriate decision within a maximum period of 15 days from the date of the objection submission. 5) Make the appropriate decision regarding the marketing of batches mentioned in Article (6-d) 6) Lay the ground work to be relied upon by the Committee to revise the situation of the drugs and the companies manufacturing it where failure of passing tests is recurring and to recommend to the Director General to make the appropriate decision. Article 11: The laboratory shall charge a fee of JD. 25 for each batch against issuing a marketing license for it. Article 12: The Director General is entitled to issue the necessary instructions to implement the stipulations of this Regime. ARTICLE 13: Anyone breaching the stipulations of this Regime shall be penalized by the penalties stated in the Drugs and Pharmacology Act No. 80 of 2001. ARTICLE 14: This Regime replaces and cancels the Drugs Testing Regime No. (7) of 1994. Annex 3: Provisional Law No. (67) For the Year 2001, and the amendment No. (44) For the year 2003 Law of Clinical Trials Article (1): This law shall be named the (law of clinical trials 2001). It shall come into force 30 days after its publication in the official Gazette. Article (2): The following words and expressions wherever mentioned in this law, shall have the meanings specified hereunder for it unless the context indicates otherwise: • The Ministry: Ministry of Health • The Minister: Minister of Health • Administration: Food & Drug Administration • Director General: Director General of Food & Drug Administration • Institutional Review Board Committee: The committee for review of clinical researches and studies formed in pursuance of the provisions of this law. • Clinical Studies Committee: The committee formed at the Administration in compliance with the provisions of this law. • Clinical Studies: Therapeutic and Non-Therapeutic studies conducted on human beings according to the provisions of this law. • Bioavailability: Rate of absorption and availability of the drug on its receptors and blood or its sites of action in the body reflect the availability of it in the mentioned site. Or the extent (if or %) and rate of drug absorption into the blood circulation at the site of administration in reference to IV Dose. • Bioequivalence: There is no statistical difference related in this drug when compared with other drugs of same pharmacological item resembling it. • Reference Drug: Any preparation licensed for the first time for usage worldwide. Article (3): Clinical Trials are divided into: a) Therapeutic clinical trials: Any clinical study performed on sick or healthy volunteers. b) Non-Therapeutic clinical trials: Any study performed on healthy volunteers in terms of effectiveness, kinetics, bioavailability and bioequivalence. Article (4): a) (a)- Clinical trials shall not be conducted unless the conducting authority has obtained an authorization from the Minister upon a recommendation from the Clinical Studies Committee pursuance of the provisions of this law. b) (b)- Clinical trials shall be conducted by any authority licensed in accordance with the provision of paragraph (a) of this article: 0) Public and Private Hospitals , which possess technical potential to provide the required emergency and intensive care in addition to diagnostic laboratory that caries out clinical tests . 0) University, Academic institutions specialized scientific Research Institutions and Pharmaceutical Manufacturing Companies, which have the required technical potential in compliance with clause (1) of this paragraph. In case these entities do not have such potential, any of these entities may perform the clinical part of this study at any authorized Hospital. e) (c)- Analyses of biological samples dedicated for clinical trials shall be made by Accredited Laboratories which have the requirements necessary for conducting such analysis and assure they are accurate and precise. Article (5): a) Clinical trials shall not be performed on human beings unless by his written approval (signed consent form) and after undergoing the medical tests necessary for his/her safety. b) Any authority requesting permission to conduct a clinical trials shall comply with the following : 0) Prepare a protocol for the study to be conducted, provided that such protocol must include the scientific justifications for conducting the study in addition to any other details specified in this law. 0) Sign insurance contract with an insurance company having business within the Kingdom of Jordan to cover any damage sustained by this study specially those related to the human beings undergoing such study , provided that cases where such contract can be concluded shall be defined with its terms and requirements under instructions to be issued by the Minister upon the recommendation of the Clinical trials committee . Article (6): a) Requirements for licensing Research Centers and accrediting the Laboratories specified in article (4) of this law shall be defined by virtue of instructions to be issued by the Minister and upon the recommendations of the Clinical trials committee. b) The Minister, upon recommendation from the Clinical Trial committee, may temporarily suspend any license issued by him, or revoke the same in case of any violation to the provision of this law without prejudice to any other penalty specified in such license. Article (7): a) A committee shall be formed within any of the entities stated in article (4) of this law to be called. (The Institutional Review Board Committee) consisting of at least five members from both sexes with enough experience and quite competent provided that one of them should be legal advisor in addition to a representative from local community. b) 0) Membership of the Institutional Review Board Committee shall be valid for two renewable years. 0) The Committee shall in its first meeting elect from among its members the chairman and his deputy. Article (8): a) The Institutional Review Board Committee shall assume the following responsibilities and powers: 0) Assure the authenticity of scientific justifications for conducting the clinical study. 0) Approve the study protocol and authorize its conduction and follow up. 0) Assure that the research team is competent and capable of performing such study, and that they comply with the good clinical practice. 0) Assure that volunteers willing to accept, to undergo such study. 0) Coordinate with the Clinical trials Committee and inform the same if any relative or unknown side effects related to the drug , which would appear during or after this study . g) The Institutional Review Board Committee shall meet upon a call from its chairman or his deputy upon his absence whenever necessary. Such meeting shall be deemed legal with the presence of at least two thirds of its members, conditioned, that the chairman or his deputy should be among them, and shall take its decisions with majority of its members. Article (9): a) The Entity conducting the clinical study shall observe the following: 0- Form a Research Team from scientifically competent members with enough practical experience to perform the same in accordance with the requirements of the study. The head of this team shall be responsible for executing this study in the most proper manner. 0- Provide a physician to supervise the conduction of such study to be responsible for medical care while this study being conducted. b) The Entity conducting this study shall be legally responsible for any damages sustained by the volunteer. Article (10): a) (a)- Conducting clinical trials on medicines that have a registered reference drug in Jordan for such usage, shall obtain prior approval of the Institutional Review Board, and inform the Administration of this approval. b) (b)- As for conducting clinical trials on medicines that the reference drug is not registered in Jordan, a prior approval of the Minister shall be obtained upon a recommendation from the Clinical trials Committee. Article (11): Any Entity conducting clinical trials shall observe the study protocol approved by Clinical trials Committee, provided that “The Declaration of Helsinki” relevant to conducting clinical trials on human beings is observed. Article (12): A committee shall be formed at the administration to be called (Clinical trials Committee) and chaired by the Director General and the membership of the following: a) Drug Directorate Director (Deputy Chairman). b) Director Assistant of drug control laboratory. c) Pharmacy Director of at the Royal Medical Services. d) Five persons representing universities and private sector who are specialized in the field of Kinetic, Analytical pharmacy, Biostatistics, Clinical pharmacy, Pharmacology. To be elected by a decision from the Minister upon recommendation from Director General for two renewable years. Article (13): The Clinical Study Committee shall assume the following responsibilities and power: a) Approve the formation of the Institutional Review Board Committee and control their work. b) Evaluate the reports on studies presented to them for their approval. c) Conduct studies to verify the authenticity of information presented to them and take any procedures for this purpose. d) Assure that the Entities licensed to conduct clinical studies in pursuance of the provisions of this law are complying with the principles of Good Clinical Practice and Good Laboratory Practice conformant to the directions issued by the Minister for this purpose. Article (14): a) The Clinical trial Committee shall meet whenever necessary, upon a call from the chairman or his Deputy, in case of his absence. And such meeting is legal document with the presence of the majority of its members, provided that the chairman or his Deputy be among, and shall pass its decisions either by plenary voting or by majority of at least five of its members.. b) The Clinical trial Committee may form technical sub-committees to help in carrying out its responsibilities and in presenting the recommendation necessary to this respect. c) The Director General shall appoint a secretary for the Clinical trials Committee from among the staff of the Drug Directorate in the Administration to be assisted by a number of its personnel. d) The secretary shall assume the following responsibilities; preparing the agenda, call for meetings, follow up the decisions and archiving the files. Article (15): The Director General may delegate the responsibility of performing inspection visits to, the Director of Drug Directorate or any of the Administration staff, in any Entity licensed for carrying out clinical studies, at anytime to assure that they are observing the requirements in terms of their license. Article (16): a) Fees for licensing any Entities or for accreditation any Laboratories provided for in article (4) of this law shall be defined under a bylaw to be issued for this purpose on condition that such bylaw should be provided for cases of exemption from those fees. b) Charges collected by the Administration against the services provided by the Clinical trials Committee under the Minister's directions shall be defined, and any returns from those charges shall be used to cover any bonuses payable to members of the committee and any required expenses. Article (17): a) Any person who accepts the conduction of clinical trials, supervise or perform the same without observing the terms and requirements specified by the law shall be punished either by one to three years of imprisonment or by payment of a fine not less than five thousand Jordanian Dinars not more that twenty thousand Dinars or by both penalties. b) Any of the following persons shall be punished either six months up to one year of imprisonment or by payment of a fine not less than two thousand Jordanian Dinars and not exceeding five thousand Dinars, or by both penalties: 0) 1-Any physician appointed to supervise conducting a study in case of his absence during this process, or in case of his non-compliance with medical care responsibility required for the volunteers. 0) 2-Any person who tries to conceal any previously unknown side effects of the drug or does not inform the Clinical trials Committee ) Any person non-complying with the protocol of this study without any scientific Justification approved by the Clinical trials Committee will be subjected to a penalty in the form of payment of a fine not less than two thousand Jordanian Dinars and not exceeding five thousand Jordanian Dinars. ) Any Hospital, Scientific Research Institution, Academic Institution University of Medicine, Pharmaceuticals Manufacturing Company, carrying out a clinical trials on human beings without being licensed, or any Laboratory performing any analysis on the biological samples without being licensed under this law or without observing its provisions shall be subjected to a penalty in the form of payment of a fine not less than twenty thousand Jordanian Dinars, and not exceeding fifty thousand Jordanian Dinars . ) The perpetration of any other breach to any of the provision of this law related to the conduction of clinical trials and no such penalty is being provided for to this respect in this law, will be subjected to a penalty in the form of payment not more than three thousand Dinars. Annex 4 Organizational structure of Ministry of Health Consultants Minister Office Minister of Health Minister of Health Planing & Coordination Committee International Relations Non Jordanian Patients Service Office Dir. Gen. Development Legal Medicine Center Dir. Internal Auditing Dir. Gen. Civil & planning Health Insurance Information Center Financial Affairs Secretariat Chief of Specialists Committee Education & Secretary Secretary Technical Affairs Training Correspondence General General Attorney Office Auditing Planing & Project Office Management Studies & Research Studies & Research Insured & dependants Administrative Dev. Unit Public Relation Computer Dir. General Primary Dir. General Health Dir. Gen. Financial Dir. Gen. Administrative Dir. General Bashir Dir. General Curative Health Care Governorate Economical Affairs Affairs Hosp. Services Auditing Purchasing Environmental Nursing Drugs Health Health Safety Expenses Supply School Health Disease Control Budgeting Personnel Dental Specialized Centers Health Economics Land & Building Drugs Control Laboratories Nutrition & food Occupational safety Health Finance & Accounting Transportation MCH Med. Professions & Medical equipment Institutions Annex 5: Hospital Accreditation (Work Plan) in Jordan (August 2004-September 2006) (Revised June 2005) Goal #1: 2004 2005 2006 To Establish a Hospital Accreditation Organization, Which Manages the C = Completed Accreditation System in Jordan and Fosters a Culture of Quality Improvement Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N De Jan F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o c e ar p a u u u e g p v c n b r r y n y g pt v b r y n l g p i e y t l 1.1 Conduct a two day national workshop for X C all key stakeholders to present hospital accreditation concepts, principles, issues, and a time frame for implementation 1.2 Recruit a PHRplus Resident Advisor to x x x x x x x C assist with the development and implementation of hospital accreditation 1.3 Resident Advisor to evaluate and update X C X C x x Work Plan 1.4 Assist the Hospital Accreditation X X X x x Committee (HAC) to finalize Terms of Reference (TOR) for itself for approval by Sept 2005 1.5 Appoint a Task Force made up of X X X X representatives from all hospital sectors, primary healthcare facilities, and specialty programs; professional associations; and Goal #1: 2004 2005 2006 To Establish a Hospital Accreditation Organization, Which Manages the C = Completed Accreditation System in Jordan and Fosters a Culture of Quality Improvement Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N De Jan F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o c e ar p a u u u e g p v c n b r r y n y g pt v b r y n l g p i e y t l legal, legislative, & financial experts to develop the legislation, by-laws, organizational structure, role and responsibilities, and financial sustainability of the Jordanian Healthcare Accreditation Agency. 1.6 The NAC to approve recommendations of x the Task Force that developed the JHAA 1.7 Help implement the JHAA with board X X X X membership represented by medical, dentistry, nursing, pharmacy, consumers, primary health care, MOH, RMS, private hospitals, and others to insure broad healthcare representation. 1.8 Establish a JHAA office with appropriate X X X X equipment and other resources, appoint Chief Executive, and hire staff. Goal #1: 2004 2005 2006 To Establish a Hospital Accreditation Organization, Which Manages the C = Completed Accreditation System in Jordan and Fosters a Culture of Quality Improvement Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N De Jan F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o c e ar p a u u u e g p v c n b r r y n y g pt v b r y n l g p i e y t l 1.9 JHAA develops a national strategy for X X X accrediting healthcare facilities and a five year work plan highlighting is accreditation, education, and publishing goals including activities, staffing needs, and budget 1.10 Establish membership of JHAA with X X X X X X International Accreditation Agency (ISQua) and follow ALPHA guidelines for Healthcare Accreditation 1.11 JHAA develops policies and procedures X X X X X X X X X X on accreditation model, fees, methods, standards, measurement instruments, hiring and training of surveyors, self-survey instruments evaluation process, and database (These are separate , activities and will take 2-3 years to develop and implement as outlined below:) 1.11.1 Determine steps, application form, and X X X timing that hospitals must take to be surveyed for accreditation. Goal #1: 2004 2005 2006 To Establish a Hospital Accreditation Organization, Which Manages the C = Completed Accreditation System in Jordan and Fosters a Culture of Quality Improvement Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N De Jan F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o c e ar p a u u u e g p v c n b r r y n y g pt v b r y n l g p i e y t l 1.11.2 Determine fees paid by hospitals for X X X surveys (annual subscription, per survey, other) and what hospitals will receive for payment. 1.11.3 Develop a Manual for Surveyors and X X X X X X test out the manual 1.11.4 Prepare job descriptions for X X X X X surveyors, determine number needed, recruit, interview, hire, and train 1.11.5 Continue to develop and upgrade X X X X X X standards and self-evaluation process with feedback and refinement until satisfactory 1.11.6 Develop performance indicators, X X X scoring, weighting, and compliance process 1.11.7 Develop the type and levels of X X X Accreditation, Awards, and Incentives Goal #1: 2004 2005 2006 To Establish a Hospital Accreditation Organization, Which Manages the C = Completed Accreditation System in Jordan and Fosters a Culture of Quality Improvement Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N De Jan F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o c e ar p a u u u e g p v c n b r r y n y g pt v b r y n l g p i e y t l X X X 1.11.8 Develop computer program to generate Accreditation Report and database Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l X X 2.1 Develop criteria for selecting public, private, RMS and university C hospitals to be pilot hospitals 2.2 Select pilot hospitals X X C Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l 2.3 Select internationally accepted X X C standards clusters to be used for the first standards (Patient/Family Rights, Clinical Safety, Medical Records, etc.) 2.4 Develop system for self- X X C assessment, feedback, and work plans for pilot hospitals 2.5 Prepare role and X C responsibilities for pilot hospitals 2.6 Conduct an orientation X C workshop for all pilot hospitals on their role and responsibilities as pilot hospitals in the Jordan hospital accreditation project. 2.7 Conduct first standards setting X C workshop in April 2005 (Clinical & Environmental Safety) Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l 2.8 Conduct 3 regional orientation X X C workshops for those 75 hospitals who are not pilot hospitals in May 2005 2.9 Send Draft 1 standards to all X C 92 hospitals for review and comment 2.10 Obtain feedback from all 92 X X X X X X hospitals on standards and use feedback to develop Draft 2 of standards 2.11 Assist pilot hospitals with X X X X X X X X X X X their self assessments (beginning with Clinical and Environmental Safety standards) to determine their present standards compliance and the development of their work plans to meet the standards Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l 2.12 After standards have been X C X X X X distributed, hold meetings with the pilot hospitals to determine their progress, problems with self- assessment and Work Plans and how the project can assist them 2.13 Based on the pilot hospitals X X X X X X X X work plans, develop a strategy on how best to assist them in preparing to meet the standards within the limits of the project resources 2.14 Continue standard setting X X X workshops from June to August 2005 to complete the development of all standards clusters by September 2005 2.14.1 Conduct a 2 day standard X setting workshop on the Human Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l Resources standards cluster in June 2005 2.14.2 Conduct 2 day standards X setting workshop on Medical Records, Management of Information, & Management and Leadership clusters in July 2.14.3 Conduct 3 days of X workshops to write standards for the Pt. & Family Rights, Access and Continuity of Care, Pt. Assessment, Patient Care, Quality Improvement and Pt. Safety, Support Services, Medical Staff, & Nursing services clusters in August 2.15 After standards have been X X X X X X developed (draft 1), distribute them to all 93 hospitals in Jordan for feedback. Goal #2: 2004 2005 2006 To Develop Hospital C = Completed Accreditation Standards and Test Them Using Pilot Hospitals Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M Jun J A S O N D J F M A m J J A S Oct Activities / Tasks u e ct o e a e a p a ul u e ct o e a e ar p a u u u e g p v c n b r r y y g pt v c n b r y n l g p i e y t l 2.16 After pilot hospitals conduct X X X X X X X X self assessment and determine if standards need to be eliminated, changed, or reclassified, Draft 2 will be written 2.17 Draft 2 standards will go to X X X X X X X X X X X X the NAC for approval until the JHAA board is appointed who will then take over the function of approving standards 2.18 Prepare the final draft of all X X hospital standards and distribute copies to all 92 hospitals Goal #3: (revised March 1, 2005) 2004 2005 2006 To Prepare Pilot Hospitals for Accreditation C = Completed Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N D J F M A M J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o e a e ar p a u u u e g p v c n b r r y n y g pt v c n b r y n l g p i e y t l 3.1 Pilot hospitals will appoint a X X X C Quality Improvement Coordinator, a Quality Improvement Committee/Counsels and a Safety Committee to help with standards assessment and Work Plan development. 3.2 Conduct a workshop for the x pilot hospitals QIC to clarify their role and responsibilities in relationship to the hospital accreditation project 3.3 Develop a manual entitled, X X X Guidelines for Implementing Hospitals Standards to assist pilot hospitals in preparing for accreditation 3.4 Based on the pilot hospitals X X X X X X X X self assessment and work plans develop a strategy with each hospital on how best to assist them in meeting the standards Goal #3: (revised March 1, 2005) 2004 2005 2006 To Prepare Pilot Hospitals for Accreditation C = Completed Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N D J F M A M J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o e a e ar p a u u u e g p v c n b r r y n y g pt v c n b r y n l g p i e y t l 3.5 Assist pilot hospitals by doing an in-depth assessment of their self assessments and Work Plans and evaluate their commitment to the hospital accreditation process 3.6 Prepare technical assistance X X X X X X X X X X (TA) required to develop a series of workshops for all hospitals in selected clusters as preparation for accreditation survey by JHAA 3.6.1 Conduct workshop on how to X meet nursing services standards 3.6.2 Conduct workshop on how to X meet Quality Improvement and Patient Safety, and Clinical, and Environmental Safety standards 3.6.3 Conduct workshop on how to X meet Management and Leadership, Support Services, and Human Resources standards Goal #3: (revised March 1, 2005) 2004 2005 2006 To Prepare Pilot Hospitals for Accreditation C = Completed Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8 Q9 A S O N D J F M A M J J A S O N D J F M A M J J A S Oct Activities / Tasks u e ct o e a e a p a u ul u e ct o e a e ar p a u u u e g p v c n b r r y n y g pt v c n b r y n l g p i e y t l 3.6.4 Conduct workshop on how to X meet Patient & Family Rights, Medical Records, and Management of Information standards 3.6.5 Conduct workshop on how to X meet Access and Continuity of Care, Patient Assessment, and Patient Care standards 3.6.6 Conduct workshop on how to X meet Medical Staff standards 3.7 Do “mock surveys” on pilot X X X hospitals to determine the readiness of surveyors and hospitals for an actual accreditation survey 3.8 Begin surveying those X X X hospitals which feel they can achieve accreditation based on Jordan hospital standards Source: PHRplus, Jordan, 2005. Summary Five Year Plan for Hospital Accreditation in Jordan (2005-2009)* Major Activity Year: 2005 2006 2007 2008 2009 Revised April 2005 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1. Develop and Implement a X X X Jordanian Healthcare Accreditation Agency (JHAA) 2. Develop and Pilot X X X X X X X X International Standards in Jordan Hospitals 3. Implement International X X X X X X X X X X X X X X X X X X Standards in Jordan Hospitals 4. Prepare hospitals for X X X X X X X X X X X X X X X survey by JCAA 5. Select and train surveyors X X X X X X 6. Begin mock surveys X X 7. JCAA to begin to X X X X X X X X X X X “Accredit” Hospitals to International Standards Total = 93 Hospitals; Private=56 MOH=28, RMS=7, University=2 * PHRplus commitments shown only through funding period, October 2006 Table 5.8: Profile of Contractual Arrangements between MOH and other Health Care Providers. Source: The Role of Contractual Arrangements in Improving Health Sector Performance in Jordan, WHO, 2004. Manag. Annual Length Geographical Type of Date of Services Payment Co- Performance & cost/ Provider of scope of provider contract covered mechanism payment measures financial JD contract contract effort Million Tertiary/ Fee-for-service RMS Public/ Military 1982 Open secondary All regions ------- ------ High 4.5 (30% discount) levels Tertiary/ Public/ Fee-for-service If self- JUH 1973 Open secondary All regions ------ High 11 University (25% discount) referred levels Al- Hussein Hematology Fee-for-service Cancer Philanthropy/ 2001 Annual and cancer All regions ----- ------ High 1.7 (25% discount) Center not-for-profit cases Mainly Fee-for-service If self KAH Public/ university 2002 Annual North regions High 6 tertiary level (25% discount) referred ------ Bed leasing (all Mainly Direct services Al- secondary supervision included/MOH Mowasah & July (General and Private/for profit Annual East Amman specialist ------ Low 1.5 Al-Hayah /2003 medicine+ monitoring of physicians Hospitals General MOH provide care for Surgery physicians referred patients) Lozmila Secondary Fee-for-service If self Private/for profit 2001 Annual Amman Area ------ High 0.5 Hospital care level (25% discount) referred Fee-for-service Red Philanthropy/not- Secondary (30% discount) + If self Crescent 1999 Annual Amman Area ------ High 0.4 for-profit care level prospective (per referred Hospital case) Other Emergency Very Private Private/for profit ------ ------ All regions Fee-for-service ------ ------ 6 cases High Hospitals Table 3.2: Population by Directorate for 2004 and Projected for 2014 Estimated Population 2004 Projected Population 2014 Region Directorate Estimated Estimated Estimate Estimated Pop. > 1 Females Total Pop. d Pop. > Females Total Pop. year 15-44 1 year 15-44 Capital 40,466 371,093 1,618,635 48,427 444,098 1,937,066 East Amman 10,131 92,911 405,259 12,125 111,189 484,985 Madaba 3386 31,053 135,446 4,052 37,162 162,092 Central Zarqa 20,208 185,316 808,312 24,183 221,773 967,331 Balqa 6,826 62,597 273,036 8,169 74,912 326,750 Dair Alla 1,210 11,100 48,415 1,449 13,284 57,940 South Shuneh 964 8,841 38,563 1,154 10,580 46,149 Irbid 14,870 136,369 594,813 17,796 163,196 711,829 North Agwar 2,231 20,456 89,227 2,670 24,481 106,780 Ramtha 2,699 24,755 107,975 3,230 29,625 129,217 Al-Kura 2,361 21,649 94,428 2,825 25,908 113,005 North Bani Kenanah 1,991 18,254 79,622 2,382 21,846 95,286 Ajlun 3,091 28,350 123,658 3,700 33,927 147,985 Jarash 4,009 36,761 160,344 4,797 43,993 191,888 Mafraq 2,627 24,088 105,066 3,143 28,827 125,736 North Badiah 3,648 33,456 145,927 4,366 40,037 174,635 Karak /1 5,326 48,839 213,028 6,373 58,448 254,937 Tafieleh 1,964 18,013 78,570 2,351 21,557 94,027 South Ma’an 2,418 22,172 96,709 2,893 26,534 115,735 Aqaba 2,654 24,340 106,168 3,176 29,129 127,054 NATIONAL TOTAL 133,080 1,220,413 5,323,200 159,261 1,460,504 6,370,426 Sources: Preliminary results of the 2004 Population census, with age group proportions and annual population growth provided by the Department of Statistics in February 2005. Table 3.1: Profiles of Health Sub-Systems in Jordan Benefits by Health Coverage/ Special Principal Financing Provider-Payer % of Population Size of Subsystems Categories Source Relationship Covered or Eligible Operation Describes coverage Describes Number of people As indicated by and eligibility relationship Describes types of services Describes main sources covered or eligible by staff, beds, or criteria, special between financing and benefits available. of financing health system number of programs for specific and service nationwide. facilities. population groups. delivery functions. Government Services/ MOH a) Provides comprehensive Civil servants and Ministry of Ministry of Health 20 percent (persons Operates public health services; dependents; and Finance (general integrated delivery enrolled in CHIP). 53 primary, preventive, and individuals tax revenues). system-services comprehensive curative care through its certified as poor, Ministry of Social provided by Under public law, MOH health centers. facilities. the disabled, Affairs. government facilities is required to provide 340 primary b) Performs the following children under Services fees financed through subsidized care to all health centers. financing functions: age of six, and collected at budget and salaried civil Jordanian citizens. 260 village Administers Civil Health blood donors. health facilities. services staff. health centers. Insurance Program (CHIP). Highly subsidized Co-payment for 353 maternity Insurer of last resort for the primary and services and and child poor. curative care for pharmaceuticals. health care the entire Payroll centers. population. deductions. 251 dental Donor clinics. assistance. 11 chest World Bank loan diseases centers. 29 hospitals. 3,456 hospital beds (37%) Cont… Table (1) Benefits by Health Coverage/ Special Principal Provider-Payer % of Population Size of Operation Subsystems Categories Financing Source Relationship Covered or Eligible Royal Medical Services Primary and curative care Military personnel Government budget. Integrated delivery 27 percent Operates: services. and their User fees. system comprising RMS 5 health center. dependents. Premiums outpatient clinics and 10 hospitals Other referrals (based on army rank hospitals. 1801 hospital From MOH and and status). Referrals to MOH beds (19%) contractual Minor cost sharing facilities. agreements with for pharmaceuticals. public firms. Jordan University Hospital Serves as a fee-for-service Covers its Ministry of Serves as fee-for- 1.33 percent. Operates referral center for other public employees and Finance service referral center 1 hospital. programs and private payers. dependents. Ministry of for other public Health. programs and private 540 beds Owns and operates outpatient User fees payers. (5.8%). clinics and inpatient facilities for primary and curative care. King Abdullah Hospital Serves as a fee-for-service Covers its employees Ministry of Serves as fee-for-service 1.0 percent Operates: referral center for other and dependents. Finance referral center for other 1 hospital. public programs and private Ministry of public programs and 650 hospital beds payers. Health. private payers. (the hospital Owns and operates outpatient User fees. operates now 200 clinics and inpatient facilities RMS. beds only). for primary and curative care. Benefits by Health Coverage/ Special Principal Provider-Payer % of Population Size of Operation Subsystems Categories Financing Relationship Covered or Eligible Source United Nations Relief Work Agency Owns and runs primary Provides primary Financed through Operates and owns 11 percent Operates health care centers. health care to 0.6 outside donor primary health care 23 Health Centers. million Palestinian contributions. clinics managed by its 30 clinics. Refers hospital care to MOH refugees. staff. 23 family Health or private facilities. Clinics. 21 Dental Clinics. Private Health Owns and operates Beneficiaries of Direct out-of- Private hospitals and All citizens with Operates: private clinics and any private health pocket clinics, by contract. willingness to pay are Number of clinics hospitals for primary and plan self-insured. payment. eligible. not available. curative care. Company Payments Fee-for-service, or 56 hospitals employees and from through a third-party 3,275 hospital Own and operates their dependents. insurance payer (insurance beds (35%). pharmacies. All citizens with plans. company or employer) 1,564 pharmacies. willingness to Payments pay. from employees and employers. Source: Jordan’s National Health Accounts, Draft Report, 2004. MOH Annual Report, 2003.
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