CHAPTER 151
PRIVATE HOSPITALS (REGULATION) ACT

[SUBSIDIARY LEGISLATION]

INDEX TO SUBSIDIARY LEGISLATION

   OMITTED NOTICES

   REGULATIONS

      The Private Hospitals (Standard Guidelines for Health Facilities) Regulations

OMITTED NOTICES

   The following Notices have been omitted–

G.N. No. 70 of 1980

The Private Hospitals (Regulation) Act (Application to Specified Hospitals) Notice, 1980.

G.N. No. 71 of 1980

Tangazo la Sheria ya Uongozi wa Hospitali za Watu Binafsi (Kuhusu Hospitali Teule) la mwaka [this is a Kiswahili translation of G.N. No. 70 of 1980].

G.N. No. 421 of 1986

The Private Hospitals (Approved Organisations) Notice, 1986.

REGULATIONS

THE PRIVATE HOSPITALS (STANDARD GUIDELINES FOR HEALTH FACILITIES) REGULATIONS

(Section 30)

[1st July, 1997]

G.N. No. 233 of 1997

   1. These regulations may be cited as the Private Hospitals (Standard Guidelines for Health Facilities) Regulations.

   2. In these Regulations, unless the context requires otherwise–

   "the Act" means the Private Hospitals (Regulation) Act *;

   "commencement date" means the 1st day of July, 1997;

   "dental clinic" means a clinic owned by a registered or licensed dental practitioner which offers oral health care;

   "dental laboratory" means a laboratory where the construction of dental and maxilla facial prostheses takes place;

   "dispensary" means a health facility which offers health services on outpatients basis and may include maternal, child health and laboratory services;

   "health centre" means a health unit which offers services;

   "health facility" includes a maternity or nursing home, a dental clinic or laboratory, dispensary, health centre, hospital or medical clinic, where health services are provided;

   "hospital" means a health facility which offers services to both outpatients and in patients and includes maternal and child health services;

   "maternity or nursing home" means a home established by higher level professional nurse or midwife to provide restorative, rehabilitative, curative and recuperative nursing care to individual family and community;

   "medical clinic" means a health facility which offers health services by specialists and only on outpatient basis.

   3. (1) No person shall establish, manage, operate or cause to be managed or operated a health facility unless the facility complies with the relevant standards guidelines set out in the Schedule to these Regulations.

   (2) Any person who contravenes or fails or refuses to comply with the provisions of these Regulations commits an offence against the Act.

   4. (1) Notwithstanding paragraph 4, no person shall own a health facility unless that person is authorized by a competent authority to do so.

   (2) No medical practitioner or dentist who is in the full time employment of the Government or any other employer shall own a health centre or hospital, save that such a medical practitioner or dentist may own a clinic or dispensary and may work only on part-time basis in any health facility.

SCHEDULE
STANDARD GUIDELINES FOR ALL HEALTH FACILITIES

(Paragraph 3(1))

1.   General guidelines for private health practice

   1.1   The owner has to be a Registered/Licensed Medical/Dental practitioner or an organization with a Registered/Licensed Medical/Dental practitioner approved by the Minister of Health.

   1.2   Practitioners employed full time by the Government and other organisations are not allowed to own health centres or hospitals. They may own clinics or dispensaries. They are allowed to work on all types of health facilities on a part-time basis.

   1.3   Practitioners must have a working experience, excluding internship, of Medical/Dental practice for not less than 3 years in a recognised health institution.

   1.4   A suitable facility must be available to cater for the establishment of a clinic (Medical/Dental) dispensary, health centre or hospital only. The health facility should not be in the same building with living premises, hotel, bar/restaurant, hair salon and other entertainment activities.

   1.5   The building should be easily accessible by road.

   1.6   The premises should have adequate supply of safe water, effective ventilation and adequate lighting system.

   1.7   The premises should have good and proper functioning toilets, shower or bath rooms, sluicing room or washing slab. Health Centres and Hospitals must also have an incinerator for waste management.

   1.8   There should be an effective communication and referral system including transport for emergencies and a telephone if the area is served by the telephone system.

   1.9   There should be adequate space for all the rooms offering different kinds of services.

   1.10   Each facility shall keep records on patients and other health information and produce reports on disease morbidity and mortality promptly as required by the Ministry of Health through the District Medical Officer.

   1.11   Only those drugs allowed at that level of the health facility should be available. Drugs must be stored according to the manufacturer's recommendation, should always be accompanied with records showing the source, proof of purchase, manufacturer, date of manufacture and date of expiry. Expired drugs should not be dispensed and should not be kept in the facility for more than three months after the expiry date.

   1.12   One's limitations should be clear and therefore high risk cases should be identified early and referred immediately to a facility which can handle such cases competently.

   1.13   Provide and maintain good quality care of patients. Laboratories must meet minimum standards in the national quality assurance schemes.

   1.14   Any professional malpractice, misconduct or gross negligence may result in closure of the premises or health facility plus any appropriate disciplinary action taken by the Medical Council of Tanganyika.

   1.15   Health facility will be allowed to operate after the premises have been inspected by the District Medical Officer, an application has been approved by the Private Hospitals Advisory Board and a Certificate of Registration issued by the Registrar of Private Hospitals. This registration shall be renewed annually.

   1.16.   There shall be a fee charged yearly by the Private Hospitals Advisory Board to any Medical/Dental practitioner or an approved organization owning a health facility.

   1.17   The Registered/Licensed Medical/Dental practitioner are strictly not allowed to be used as an umbrella either by a person or any organisation to establish a private health facility. Where this has occurred in the past, the practice should be sold to a competent practitioner or be closed.

   1.18   An appropriately registered/licensed practitioner or at least a clinical officer or a dental therapist should always be available at the health facility whenever it is open. The registered/licensed Medical/ Dental practitioner who owns the facility must always personally be present at the registered health facility for a minimum of 2 hours twice a week.

   1.19   The private health facility must employ the minimum number of health workers according to these guidelines.

   1.20   Those running these private health facilities will always be using guidelines issued by the Ministry of Health from time to time.

   1.21   The private health facilities must have essential equipment and supplies before offering different kinds of services.

   1.22   The costing mechanisms for various health services provided should be made available to the Ministry of Health on demand. Patients have full right to get an invoice with full details on how the total cost was reached. Each charged component must be shown separately and not only the total final cost.

   1.23   There should be no advertising either in mass media or through posters or signs. Any signs should not be more than 300 metres from the health facility itself and should only be for directional purposes.

   1.24   Facilities offering inpatient services should own an ambulance or there should be working arrangements for emergency transfer of patients.

   1.25   Independent pharmacies and laboratories are not allowed to examine and prescribe to patients.

   1.26   Operations requiring regional or general anaesthesia should only be done in a health centre or hospital and under a trained anaesthetic officer (Assistant Medical Officer or Doctor).

   1.27   Every private health facility must be insured against malpractice.

   1.28   Private health laboratories (those not part of a dispensary, health centre or hospital) will be covered under a separate Act.

   1.29   Private pharmacies (those not part of a dispensary, health centre of Hospital) are covered under the Pharmaceuticals and Poisons Act * and are managed by the Pharmacy Board.

2.   Medical Clinic

   2.1   Definition

      This is a health facility which offers health services on outpatients basis only by specialists.

   2.2   Services offered

      Depends on specialty and activities but the complete range of services within the specified specialty should be offered.

   2.3   Staffing

      The only staff will include the specialist him/herself plus any registered nurses.

   2.4   Premises

      The premise should have a minimum of three rooms:

      -   Reception

      -   One working room

      -   Toilet facilities

   2.5   Essential equipment and supplies

      These should include all those required to provide all the specialist services for which the unit is registered (see appendices).

   2.6   No drugs will be stored or dispensed in a medical clinic except for emergency or diagnostic purposes, when specialist drug administration is required, or where dispensing authority has been granted by the Ministry of Health.

3.   Dispensary

   3.1   Definition

      This is a health facility which offers health services on outpatients basis including Maternal and Child Health services and laboratory services. It may offer observation services for selected patients for less than 12 hours. The maximum number of observation beds is four.

   3.2   Services offered

      •   Treatment of common diseases on outpatient basis. A few patients are observed for not more than 12 hours.

      •   Maternal and Child Health services including immunisations and normal deliveries.

      •   Keep records on patients, Maternal and Child Health, disease statistics and other health information and produce reports on disease morbidity and mortality promptly as required by Ministry of Health through the District Medical Officer.

      •   Health education/health promotion to people being served by a dispensary.

      •   Laboratory services. Recommended tests to be performed at this level include:

         Blood - thick or thin smear for blood parasites

         -   haemoglobin estimation

         -   white blood count total and differential

         -   blood glucose

         -   sickling test

         -   syphilis screening

         Urine - for glucose, proteins and sediment for microscopic examination.

         Stool - Direct microscopy with saline and iodine for organisms, ova and occult blood.

         Skin snips.

         Pus/exudates - Gram staining procedures and wet preparation Sputum for Acid Fast Bacillus (AFB) investigation (Z-N Stain).

         Preservation and posting of specimen to a higher laboratory (optional). Using Stewart's transport medium. The specimens include pus swabs and pap smears.

   3.3   Staffing

      Clinical Cadre

      Assistant Medical Officer 1 (Supervisor). The supervisor should spend at least two hours twice per week at the dispensary.

         Clinical Officer (MA) 1

         Clinical Assistant (RMA) 1

      Nursing Cadre

         Registered Nurse Midwife 1

         Public Health Nurse (PHNB) 1 or trained nurse at all times the clinic is open.

         MCH Aides 1

      Paramedical

         1 trained Laboratory Assistant

   3.4   Premises

      The building should have the following rooms:

         Reception and records room

         Consultation room

         Laboratory rooms -1 (Reception cum Main Working Room)

         Dressing room

         Injection room

         Dispensing room cum drug store

         Observation room(s)

         Store

         MCH room (optional)

         Toilet facilities

         Washing slab

         Incinerator

         A minimum total of 8 rooms (excluding MCH services).

   3.5   Essential equipment and supplies

      See appendices

4.   Health Centres

   4.1   Definition

      This is a health unit which offers services to both outpatients and inpatients including Maternal and Child Health services. The inpatients shall not exceed 15 beds.

   4.2   Services offered

      Services offered at health centre level are similar to those offered at dispensary level. However, health centres offer more specialized services including inpatient department with a maximum of 15 beds. The approved drug list is longer than that of a dispensary but the conditions for storage and dispensing are the same as those for a dispensary (see 3.2 above).

      Note:   The laboratory tests and essential laboratory equipment are the same as those of a dispensary.

   4.3   Staffing

      Clinical Cadre

      •   Assistant Medical Officer 1

      •   Clinical Officer 4

      Nursing Cadre

      •   Registered Nurse Midwife 2

      •   Public Health Nurse B 2

      •   MCH Aides 2

      Pharmacy

      •   Pharmaceutical Assistant 1. A trained nurse is an acceptable alternative until there are enough trained pharmaceutical personnel.

      Paramedical

      •   Trained Laboratory Assistant 1

      •   Medical Attendants 2

   4.4   Premises

      Health Centres should have the following rooms:

      •   Reception or records room

      •   Consultation room

      •   Laboratory rooms -1 (Reception cum Main Working Room)

      •   Observation room

      •   Dressing room

      •   Injection room

      •   Dispensing room cum drug store

      •   Minor theatre

      •   MCH room: antenatal & FP, under-fives

      •   Female Wards

      •   Male Wards

      •   Maternity Ward

      •   Other Sections    - Office of person in charge of Health Centre

                  - Office of person in charge of Nursing Section

      •   Store

      •   Toilet facilities

      •   Washing slab

      •   Incinerator

      A minimum total of 15 rooms (excluding Maternal and Child Health).

   4.5   Essential equipment and supplies

      See Appendices.

5.   Hospital

   5.1   Definition

      This is a health facility which offers services to both outpatients and inpatients including Maternal and Child Health services. It is a first referral centre from dispensaries and health centres. The minimum number of inpatient beds is 16 and must include major theatre, laboratory, pharmacy and blood bank with or without X-ray services.

   5.2   Services offered

      •   All Medical services including dental and any specialist care depending on type of clinical cadre present at this level.

      •   Conducting on job training for all health workers in the hospital.

      •   Keep records on patients, Maternal and Child Health, produce reports on disease morbidity and mortality and other health information promptly as required by the Ministry of Health through District Medical Officers.

      •   Conduct preventive/promotive and rehabilitative services.

      •   Laboratory and blood bank services.

         Recommended tests in addition to those at the dispensary/health centre level include:

         Blood      - ESR

               - Platelet count

               - Bleeding time

               - Clotting time

               - Reticulocyte count

         Blood/Serum

               - Glucose, bilirubin

               - Proteins, ALAT, ASAT

               - Creatinine/Urea

               - Cell count

         C.S.F.   - Glucose and proteins

               - White cell count, total and differential

               - Organisms

         Blood    - ABO and Rhesus grouping

               - Compatibility testing

               - HIV screening and testing

               - Syphilis and Hepatitis B screening

         Urine      - Bile pigments (Fouchet's test)

               - Urobilinogen (Ehrlich's test)

               - Pregnancy test (by agglutination)

               - Ketones (Rothera's test).

         Autopsy    - Medical - Legal autopsies.

   5.3   Staffing

      Clinical cadre

      Medical officers - 3 including medical officer in charge

      Clinic officers - 6

      Nursing cadre

      (a)   Shifts - 3 (morning, afternoon and night).

      (b)   Ratio - Registered nurses 1/3 beds/shift, (including at least one Nurse A for each morning and afternoon shift).

      Pharmacy

      Pharmacist 1

      Pharmaceutical Assistant 2

      •   For hospitals with less than 20 beds a trained nurse is an acceptable alternative to a pharmaceutical assistant for the pharmaceutical services. For hospitals with up to 50 beds, a pharmaceutical assistant is an acceptable alternative to pharmaceutical technician. Hospitals with more than 50 beds should have a registered pharmacist in charge of the pharmacy, but a pharmaceutical technician is acceptable where the beds do not exceed 100.

      Paramedical

      Laboratory Section   Laboratory Technologist - 2

                  Laboratory Assistant - 2

      Radiographer 1 where X-Ray facility services exist.

   5.4   Premises

      Vital rooms in the hospital are:

      •   Reception room

      •   Medical officers in charge of the hospital room

      •   Nursing officers in charge of the hospital

      •   Consultation room(s) at least one

      •   MCH rooms: antenatal & FP and under-fives

      •   Injection room

      •   Dressing room

      •   Dispensing room

      •   Observation room

      •   Minor theatre

      •   Medical Ward - Male and Female

      •   Surgical Ward - Male and Female

      •   Maternity Ward

      •   Major Operating Theatre

      •   2 changing rooms for doctors and nurses (Male and Female)

      •   Laboratory and blood bank

      •   Store for hospital supplies and equipment

      •   Library/teaching room, for continuing education

      •   Laundry

      •   Separate toilet facilities for staff and patients

      •   Kitchen

      •   Incinerator

      •   Mortuary

      A minimum of 20 spacious rooms is required for a hospital and a functioning incinerator for waste management.

   5.5   Essential equipment and supplies

      Surgical equipment to perform the following interventions:

      •   Traumatology including traction

      •   Hernia repair

      •   Repair of abdominal trauma

      •   Bowel resection and anastomosis

      •   Splenectomy

      •   Appendectomy

      •   Tubal ligation

      •   Ectopic Pregnancy

      •   Hysterectomy

      •   Adnexectomy

      •   Total hysterectomy

      •   Curettage and evacuation

      •   Vacuum extraction

      •   Caesarean section

      •   Craniotomy/Decapitation

      •   Vesical puncture, urethral dilation and hydrocelectomy

      •   Aspiration of pneumothorax, drainage of pyothorax

      •   Other minor surgical procedures e.g. circumcision.

   The appendices show specific items required for various surgical procedures.

6.   Dental Clinic

   6.1   Definition

      This is a clinic run by a registered/licensed dental practitioner which offers oral health care.

   6.2   Services offered

      6.2.1   Emergency oral health care:

         -   Simple and complicated extraction

         -   draining of abscesses

         -   control of acute and chronic oral infection with appropriate therapies, and

         -   first aid for maxillo-facial trauma.

      6.2.2   Restorative care:

         -   Class I, II, III, IV and fillings

         -   scaling and polishing of teeth and dentures

         -   oral Health Education for individuals or groups

         -   prosthodontics (partial dentures, full dentures, crown & bridge)

   6.3   Staffing

      Dental surgeon 1 or Assistant Dental officer 1

      A Dental Surgery Assistant 1

      A Dental Therapist may assist the Dental Surgeon or Assistant Dental officer

   6.4   Working Space (minimum of 2 rooms)

      a.   A room of area 5m x 3m with at least one large window which is dust proof.

      b.   Wash-hand basin

      c.   Fluorescent light in the middle of the room

      d.   Walls with oil paint from floor to height of at least 1½m

      e.   Easily cleaned floor

      f.   Waiting room.

   6.5   Equipment/Instruments (see Appendix A)

7.   Dental Laboratory

   7.1   Definition

      This is a laboratory where the construction of dental maxillo and facial prostheses takes place.

   7.2   Services offered

      •   Construction of dental and maxillo-facial prosthesis

      •   Repair of dental and maxillo-facial prosthesis.

   7.3   Staffing

      Dental Laboratory Technologist

      At present there is no dental laboratory assistant and no training is envisaged.

   7.4   Working Space (minimum of 2 rooms)

      Same as dental clinic.

   7.5   Equipment/Instrument (see Appendix A)

8.   Nursing/Maternity Homes

   8.1   Definition

      Homes established by higher level professional Nurse/Midwife to provide restorative, rehabilitative, curative and recuperative nursing care to individual family and community.

   8.2   Proprietor has to be a registered nurse/midwife "A" level and above.

   8.3   Must have a working experience of nursing/midwifery practice for not less than 5 years in a recognized health institution.

   8.4   Must have a suitable facility to cater for the establishment of nursing/maternity services safely.

   8.5   The building should be easily accessible.

   8.6   The premises should have good supply of water, effective ventilation and natural lightning system. The premises should have toilets, shower, bath rooms, sluicing room, or washing slab and an incinerator.

   8.7   There should be established effective communication and referral system for the premises.

   8.8   There should be adequate space for rooming, recuperation, delivery room, sterilization, injections and minor treatments.

   8.9   There shall be a register book maintained to record attendance and re-attendance, inpatients, deliveries and also vital signs charts.

   8.10   Only drugs allowed for midwives should be stocked and any prescriptions should be limited to those specific drugs.

   8.11   Homes' limitations should be clear, and high risks cases identified early and referred immediately.

   8.12   Provide and maintain quality care within limits of Nursing/Midwifery profession and adhere to nursing ethics.

   8.13   Any professional malpractice, misconduct or gross negligence may result in closure of the premises and any other disciplinary action may be taken by the council with a possibility of being removed from Nurses/Midwives register.

   8.14   The registered nurses/midwives will be allowed to practise after the premises have been inspected by the District Medical Officer, approval from the Tanganyika Nurses and Midwives Council and a certificate issued by the Register of Tanganyika Nurses and Midwives Council.

   8.15   There shall be a fee charged by the Tanganyika Nurses and Midwives Council to any nurse/midwife engaged in private practice as specified by the Tanganyika Nurses and Midwives Council from time to time.

   8.16   Services offered

      •   Provided comprehensive professional nursing care (including rehabilitation and recuperation therapy) to patients in a homely atmosphere.

      •   Provide Maternal and Child Health care services.

   8.17   Staffing

      •   Registered Nurse A 1

      •   Registered Nurse B 1

      •   PHNB 1

      •   MCH Aide 1 for MCH Services.

         Where the facility offers inpatient care, there should be at least one registered/licensed nurse for each 8 hours.

   8.18   Premises (to be used solely for this purpose)

      Floor Plan or layout of physical structure.

      •   Building should be durable, safe and of permanent materials

         i.e. concrete blocks or bricks

      •   Well-ventilated rooms

      •   Admission cum reception room

      •   A sterilization room for injection

      •   Room for dressing and minor treatments

      •   Ante-natal room

      •   Delivery room

      •   Post-natal room

      •   Room for general observations

      •   Adequate sluice room and for laundry or concrete slab

      •   Small pantry

      •   Store for linen, equipment and appliances

      •   Store for drugs, dressings and cupboard

      •   One changing room and utility room for staff

      •   Two toilets with two bathrooms

      •   Incinerator

   8.19   Essential equipment/supplies (see Appendices)

APPENDIX A
ESSENTIAL REQUIREMENTS FOR ASSORTED PLACES

1.   Records and Reception Room

   •   1 Office table and 2 chairs

   •   Large notice board 1

   •   Large benches 2

   •   Small bench 1

   •   Bucket, foot-operated 1, or any provided it has a lid or cover

   •   Shelves for patient's cards

   •   Clock - Wall (Optional)

2.   Consultation Room

   General and Medical Furniture

   •   1 Office table with drawer and 3 chairs

   •   Small bench 1

   •   Small wooden step 1

   •   Medicine cupboard 1

   •   Screen four folds 1

   •   Examination couch 1

   Equipment and Instruments

   •   Sphygmomanometer, aneroid 1

   •   Stethoscope 1

   •   Clinic thermometer 2

   •   Small jar with tongue depressor 1

   •   Diagnostic set "Min" 1

   •   Vaginal examination tray 1

   •   Hand torch 1

   •   Hurricane or pressure lamp

   •   Sink with running water or hand wash basin with soap dish

   •   Dust bin or bucket, foot-operated 1

3.   Dressing Room

   General and Medical Furniture

   •   1 Office table with 2 chairs

   •   Small medicine cupboard 1

   •   Small instrument cupboard 1

   •   Dressing stool 1

   •   Small notice board 1

   •   Small bench 1

   •   Wooden step - four folds 1

   •   Dressing trolley 1

   •   Screen - four folds 1

   •   Bowl stand 1

   •   Examination couch 1 for patients with perineal/genital wounds

   Equipment and Instruments

   •   Sterilizer electric or stove 1

   •   Instrument tray ss large 1

   •   Instrument tray ss medium 1

   •   Instrument tray with lid ss large 1

   •   Instrument tray with lid ss medium 1

   •   Instrument tray with lid ss small 1

   •   Kidney dish ss large 1

   •   Kidney dish ss medium 1

   •   Kidney dish ss small 1

   •   Gallipot 3

   •   Bowl lotion large 1

   •   Bowl lotion medium 1

   •   Bowl lotion small 1

   •   Jar forceps with Cheadle forceps 1

   •   Dressing drum deep large 1

   •   Dressing drum deep small 1

   •   Dressing drum shallow large 1

   •   Dressing drum shallow small 1

   •   Forceps bowl 1

   •   Dressing tray 2

   •   Buckets, foot-operated or dustbin 1

   •   Sink with running water or hand washbasin with soapdish 1

   •   Necessary disinfectants/antiseptics

4.   Injection Room

   General and Medical Furniture

   •   1 Office table with 2 chairs

   •   Small bench 1

   •   Small medicine cupboard 1

   •   Small instrument cupboard 1

   •   Dressing trolley 1

   •   Medicine trolley 1

   •   Bowl stand 1

   •   Examination couch 1

   •   Register books

   Equipment and instruments

   •   Sterilizer electric or stove 1

   •   Instrument tray ss large 1

   •   Instrument tray ss medium 1

   •   Instrument tray with lid ss large 1

   •   Instrument tray with lid ss medium 1

   •   Instrument tray with lid ss small 1

   •   Kidney dish ss large 2

   •   Kidney dish ss medium 2

   •   Kidney dish ss small 2

   •   Gallipot 3

   •   Bowl lotion small with 2 bowl forceps 1

   •   Jar forceps ss with 2 Cheadle forceps 1 (each in its own jar)

   •   Dressing drum ss deep small 1

   •   Dressing drum ss shallow small 1

   •   Forceps or needle/Syringe holder 2 dissecting

   •   Rubber tourniquet 1

   •   Sink with running water or hand wash basin with soap dish 1

   •   Bucket foot operated or a bucket with a lid

5.   Dispensing Room

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