35
OVERVIEW OF CONTROL OF INFECTIOUS DISEASE IN PRIVATE HEALTHCARE FACILITIES
OVERVIEW OF CONTROL OF
INFECTIOUS DISEASE IN PRIVATE
HEALTHCARE FACILITIES
INTODUCTION
The regulation for private hospitals was first established in 1971 with the enactment of the Private Hospitals Act 1971 (Act 43).
The regulatory control was through licensing and inspection of the healthcare facilities: private hospitals, nursing homes and maternity homes.
An issued or renewed license was valid for a year.
Cont…
However, this Act did not provide adequate
provisions to regulate all private healthcare
facilities and services, such as medical and dental
clinics, day surgeries, haemodialysis centres and
hospice.
These limitations and omissions are addressed in
the new Act, the Private Healthcare Facilities and
Services Act 1988 (Act 586)
PRIVATE HEALTHCARE FACILITIES AND
SERVICES ACT 1998 (ACT 586)
Date of gazette: 27 August 1998.
Date of enforcement: 1 May 2006.
Replacing the Private Hospital Act 1971
PRIVATE HEALTHCARE FACILITIES AND
SERVICES ACT 1998
Act
Private Healthcare Facilities And Services Act 1998
[Act 586] – XIX Part with122 sections
It’s Regulations
1. Private Healthcare Facilities And Services (Private Medical Clinics orPrivate Dental Clinics) Regulations, 2006
- 14 Parts with 109 regulations and 7 schedules
2. Private Healthcare Facilities And Services (Private Hospital andOther Private Healthcare Facilities) Regulations, 2006
- 29 Parts with 434 regulations and 13 schedules
It’s Orders
1. Private Healthcare Facilities And Services (Official IdentificationCard) Order, 2006
Cont..
Preamble
◦ An Act to provide for the regulation and
control of private healthcare facilities
and services and other health-related
facilities and services and for matters
related hereto.
Cont.. Registration activities for private clinics
1. Act 586 2. Private Healthcare Facilities And Services (Private Medical Clinics or
Private Dental Clinics) Regulations, 2006
Licensing activities for private healthcare facilities and services other than private clinics1. Act 586 2. Private Healthcare Facilities And Services (Private Hospital and Other
Private Healthcare Facilities) Regulations, 2006
Handling Complaints & Enforcement activities & MCO1. Act 586 2. Private Healthcare Facilities And Services (Private Medical Clinics or
Private Dental Clinics) Regulations, 20063. Private Healthcare Facilities And Services (Private Hospital and Other
Private Healthcare Facilities) Regulations, 20064. Private Healthcare Facilities And Services (Official Identification Card)
Order, 2006
PRIVATE HEALTHCARE FACILITIES IN JOHOR
- UNTIL AUGUST 2015
NO PRIVATE HEALTHCARE
FACILITIES
NUMBER
1. PRIVATE HOSPITAL 16
2. PRIVATE AMBULATORY CARE CENTRE 10
3. PRIVATE NURSING HOME 7
4. PRIVATE MATERNITY HOME 15
5. PRIVATE HAEMODIALYSIS CENTRE 76
6. PRIVATE MEDICAL CLINIC 841
7. PRIVATE DENTAL CLINIC 191
TOTAL 1,156
INFECTION CONTROL
IN PRIVATE HEALTHCARE
FACILITIES AND SERVICES ACT
1998 AND IT’S REGULATIONS.
Part I –Preliminary
r.1- 2
Part II –Application
r.3-10
Part III –Organization &
Management
r.11-20
Part IV –Policy
r.21-27
Part V – Registers, Rosters
& Returns
r.28-37
Part XIV- Anesthesia
r.176-185
Part XIII –Paediatric
r.170-175Part XII –Nursery r.149-
169
Part XI – O & G
r.133-148
Part VI –Grievance
Mechanism
r.38-41
Part VII –Patient’s Medical
Record
r.42-46
Part VIII –Consent
r.47-48
Part IX –Infection Control
r.49
Part X- General Provisions
for Standards of PHFS
r.50-132
29 Parts 434
Regulations &
13 Schedule
PRIVATE HEALTHCARE FACILITIES AND
SERVICES (PRIVATE HOSPITALS AND
OTHER PRIVATE HEALTHCARE
FACILITIES) REGULATIONS 2006
Gazette date : 1 April 2006
Enforcement date: 1 May 2006
Part XXVI –Radiology or
Imaging
r.345-352
Part XXVII –PNH
r.353-387
Part XXVIII –Hospice
r.388-416Part XXIX-
Miscellaneous r.416-434
Part XVI – ICU
r.218-227
Part XV- Surgical
r.186-217
Part XXV –ACC
r.339-344
Part XXIV –Specialist
Outpt
r.333-338
Part XXIII – Rehabilitation
r.323-332
Part XXII – Hemodialisis
r.301-322
Part XXI –Blood Bank
r.277-300
Part XX–Dietary
r.263 - 276
Part XIX –CSSD
r.250-262
Part XVIII –Farmaseutikal
r.238-249
Part XVII- Emergency
r.228-237
Part IX –Infection Control r.49
R 49 (1); Holder of certificate of registration(COR) or person in charge (PIC) of private facility or services (PFS) shall establish an Infection Control Committee (ICC) which shall be responsible for development of an active premise-wide infection control programme and infection control system with measures developed to prevent, identify and control infection acquired in or brought into the PFS.
(2) ICC shall meet at least once in every 4 month and shall hold special meeting when necessary to meet their responsibilities in dealing with infection control problems.
(3)infection control programme shall include
(a) System for reporting, evaluating and maintaining data
(b) System to detect outbreak of infectious disease and inform appropriate authorities; and
(c) A system to prevent and control any outbreak of infectious disease which shall include but not limited to;
i. Ensuring that any healthcare professional who contracts any infectious or communicable disease or who is a carrier to be taken off any duty; until he permitted to do so;
ii. Ensuring any healthcare professional who attends any patient suffering from, or suspected of suffering from any infectious or CD to be withheld from attending any other pt, or from undertaking any duty; until he permitted to do so;
iii. Ensuring that any healthcare professional who attends any patient in isolated rooms, suffering from, or suspected of suffering from any infectious or CD complies with barrier nursing procedures;
Cont…R 49 (3) (c)
(iv) Ensuring that no room which has been occupied by patient suffering from, or suspected of suffering from any infectious or CD be occupied by any other patient until the room & its content has been disinfected in manner specified or approved by the ICC; and
(v) equipment, which may have become contaminated during treatment; to be withheld from use in connection with the treatment of any other patient until it has been appropriately disinfected
(4) Infection control staff shall be –
(a) appointed, trained and authorized to carry out monitoring & control activities and orientated regarding the programme and the system; and
(b) activities shall be documented, for follow- up action and use in education programme.
(5) licensee or PIC of PHFS shall institute adequate measures to safeguard all the healthcare professional staff and environment against biological hazards.
(6) licensee or PIC of PHFS shall comply with any directive or guideline issued by DG from time to time.
(7) Any person who contravenes this regulation commits an offence and shall liable on conviction to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding three months or to both.
OTHER PROVISION
PART REGULATION
X (General provision for
standard of PHFS)
51 Vector Control
58 Ceilings
68 Hand Washing Facilities
79 Clinical Examination And Examination Room
89 Ventilation
92 Hazardous Waste
94 Written Procedures (Housekeeping)
XII (Standard For Newborn
Nursery Facilities)
156 Clothing
157 Hand Washing And Gowning Area
XVI (Special Requirements
For CCU/ICU)
221 Facilities and Design Features
XXII (Special Requirements
For HD)
304 Staffing
317 Control Measures to prevent cross-infection
319 Disposal of Infectious Waste
Private Medical/ Dental Clinic
Part XIII –
Radiological
/Diagnostic r.93-99
Part XIV-
Miscellaneous r.100-
109
Private Healthcare Facilities & Services
(Private Medical Clinics or
Private Dental Clinics)
Regulations 2006
Part XII –Standards
for Outpatient r.89-92
Part XI –
Pharmaceutical r.76-88
Part X- Emergencies
r.73-75
Part IX –General
Provisions for
Standards r.34-72
Part I –Preliminary
r.1- 2
Part II –Application
r.3-6
Part III –
Organisation &
Management
r.7-13
Part IV –Policy r.14-
18
Part V – Registers,
Rosters & Returns
r.19-25
Part VII –Pts Medical
Record r.28-32
14 Parts 109
Regulations & 7
Schedules
Gazette date: 1 April 2006
Enforcement date: 1 May 2006Part VI –Patient
Grievance
Mechanism r.26-27
Part VIII –Infection
Control r.33
FIRST SCH SECOND
SCH
THIRD
SCH
FOURTH
SCH
FIFTH SCH SIXTH SCH SEVENTH
SCH
Form A-G Application
Fees
PIC Patient Medical
Record
Emergency
Services
Social
Contribution
Professional
Fees
Part VIII –Infection Control r.33
R 33 (1); Holder of certificate of registration(COR) or person in charge (PIC) of private
medical clinic (PMC) or private dental clinic (PDC) shall be responsible for development of
an active premise-wide infection control programme and infection control system with
measures developed to prevent, identify and control infection acquired in or brought into
the PMC or PDC.
(2) Infection control programme shall include
(a) System for reporting, evaluating and maintaining data
(b) System to detect outbreak of infectious disease and inform appropriate
authorities; and
(c) A system to prevent and control any outbreak of infectious disease
which shall include but not limited to;
i. Ensuring that any staff who contracts any infectious or
communicable disease or who is a carrier to be taken off any duty;
until he permitted to do so; and
ii. Any equipement, which may have become contaminated during
treatment; to be withheld from use in connection with the
treatment of any other patient until it has been appropriately
disinfected.
Cont…
(3) Holder of COR or PIC shall institute adequate measures to
safeguard all personnel and the environment against biological
hazard.
(4) Holder of COR or PIC shall comply with any directive or guideline
issued by Director Genaral on managing infection control especially
during outbreak of infectious disease.
(5) Contravenes this regulation commits an offence and shall liable on
conviction to fine not exceeding 10,000 / imprisonment not
exceeding 3 months or both
OTHER PROVISION
PART REGULATION
IX (General provision for
standard of PMC/PDC)
35 Vector Control
40 Ceilings
45 Plumbing
54 Hazardous Waste
XII (Standard For
Outpatient Facilities And
Services)
91 Medical outpatient services
92 Dental Outpatient Services.
INFECTION CONTROL
ISSUES
Cases in Johor
1ST CASE; INCIDENT OF HEPATITIS C SEROCONVERSION
IN THE PRIVATE HAEMODIALYSIS CENTRE IN KLUANG
In Mac 2005, a nephrologist from the Sultanah Aminah Hospital, Johor
Bahru (HSAJB), advised a private HD centre in Kluang to screen their
patients after suspecting something is amiss following his patient who
has sero-convert to Hepatitis C after receiving haemodialysis from the
said centre.
Result showed that 30 out of 62 patients had sero-converted to
Hepatitis C.
The Johor State Health Department had instructed the centre to take
immediate control measures, that includes separation of the infected
patients from the non infected patients by using different haemodialysis
machines. However, this was found to be inadequate.
An infectious control committee comprising of the Johore
State Director of Health Services, a Consultant
Nephrologists, a Pathologist and the Director of the
Medical Practice Division, Ministry of Health met on 20
April 2005.
The committee conducted a visit to the centre and
following were the findings :
FindingPhysical Total number of HD machine, 20; 7 HD machines were used for the infected patients whereby 6
for patients with Hepatitis C and one for patients with Hepatitis B and Hepatitis C. All are located in one open area, no separation.
There were 5 reprocessing machines; 2 assigned for patients tested positive with Hepatitis C, one for patients with Hepatitis B and Hepatitis C and 2 for patients tested negative with Hepatitis C, same location, no separation.
Nephrologist
• No visiting nephrologists as the centre’s consultant
Staff The staff was cooperative and eager to help out to control the infection but do not know how as
they were nursing aides led by a retired medical assistant without much nephrology trained.
Clinical Waste Clinical waste containers have been provided but used unnecessarily reflecting their ignorance
(each container for each group of patients).
RecommendationAn infectious control committee ordered further control
measures;
◦ To confirm the patients current status of Hepatitis B, C and HIV. Blood samples from all 62 patients and eight staff will be taken for
the investigation of Hepatitis B, Hepatitis C and HIV.
The blood samples will be sent to HSAJB immediately in batches
◦ To have formal communication with the Management of the Haemodialysis Centre to inform – Immediate actions
Short term
Long term
Cont..
The immediate actions need to be taken by the Management;
Not to take in any new patient until otherwise informed
To assign each haemodialysis machine for specific patients e.g. machine A only for patients 1, 2, 3 and 4
To report any relevant news or any abnormal incident in the haemodialysis centre to the Kluang District Health Office
To practice the infection control measures as directed by the Medical Officer of Health, Kluang district
To provide a report for the Ministry of Health regarding actions taken.
To implement the Infection Control Measures
◦ To practice proper cleaning and disinfection of the haemodialysis machine with disinfectant for about 30 minutes after each session, assist by the nephro-trained staffs.
◦ To use of disposable dialyser until the patients status are confirmed
◦ To practice proper aseptic techniques usage of disposable glove for each patient and proper hand washing techniques
◦ To request the Management to provide dedicated staff to cater for the infectious cases
To segregate the patients according to the blood Investigations results
To segregate the infected cases to different rooms or partitions accordingly based on the four groups of patients; Hepatitis C, Hepatitis B, Hepatitis B and C and non-infected group
(2)The Short Term Plan
• To train and educate the staff regarding the infection control measures including proper handling of blood contaminated facilities and equipments such as syringes, needles, dialyser etc, hand washing technique, using proper barrier in carrying out the nursing care such as wearing disposable gloves etc
• To supervise and ensure the implementation of infection control measures and aseptic techniques in the haemodialysis centre by –
• scheduled visits by two staff nurses (everyday) from the Kluang District Hospital for a reasonable period
The long term actions to be taken by the Management;
to provide and assigned different hand washing facilities with elbow tap for different groups of patients and the staff
to employ a private nephrologists as the centre’s consultant
to provide a proper isolation bay for infected patients
to provide continuous renal nursing care and infection control training for the staff
to have three - monthly blood investigation for all patients and to pay for the cost of investigation to ensure no new or recurrent infection
to educate and counselling the patients and their family members under the supervision of Public Health team
to do the contact tracing and pay for the cost of blood screening for the infected patients’ family
Since the directive, the above infection control measures
have been fully complied.
Infectious control committee is satisfied that the above is
the best that could be done to control such state of
infection so far.
However, the committee does not preclude the possibility
to recommend for an order of closure of the haemodialysis
centre as provided under section 18(1)(a) of the Prevention
and Control of Infectious Disease Act 1988 if the problems
continues.
2ND CASE; SUDDEN DROP OF Hb COUNT IN LARGE
GROUP OF PATIENT
Basis for Investigation
• On 28 Feb 2006 - received a complaint from Nephrologist (HSAJB) –
• 19 patients develop heart failure – needed hospitalization & blood
transfusion.
• 1 patient have bacterial endocarditis with vegetative growth on
Tricuspid valve.
• Initial visit to the centre was done by UKAPS on 1st March 2006
• RO Water – small leak detected on 12/2 2006
• 16/2/2006 – technician attended and replaced coupling
• Routine maintenance including disinfection of loop – rinsing took 4 hour
• 27/2/2006 – routine maintenance of reprocessor – found to be in good working
order.
Investigation
1. FBPs & bilirubin level.
2. Full analysis for chemical in ROW
3. EPO exchanged for fresh stock – while the batch that was being used was sent for test to exclude break in the cold chain.
4. Total bacteria count & Endotoxin levels checked in the ROW, HD machine & reprocessor.
5. pre & post HD haematocrit levels.
6. Weekly Hb.
7. Patient, especially those who had transfusion were interviewed in detail.
8. Premise to prepare water piping layout and to check piping system.
Finding & Analysis
Result came back
1. Significant drop in Hb from Jan – Feb; 2-6gms
2. No correlation drop of Hb between single-user & re-use dialyser.
3. No correlation between drop of Hb & ESR
4. No correlation drops of Hb & Aluminium levels
5. EPO supplier reported no evidence of break in cold chain protocol
6. Total bacterial count post disinfection came back on 27/2/2006; 202 (100)
7. The only possibility was the presence of biofilm in the piping.
Recommendation
Re-piping
piping redone and complete on 28/3/2006
During re-piping - discover blind loop in first floor
while dismantling
Educate staff; ROW to be run daily
Monthly endotoxin
Akta Kemudahan dan Perkhidmatan Jagaan Kesihatan Swasta 1998 [Akta 586]
v Perundangan Subsidiari
Kemudahan & Peralatan Profesional/Para Profesional Perkhidmatan/Amalan
Radioactive material, nuclear
material/ prescribed substance
The Atomic Energy Licensing
Act 1984 [Akta 304]Pegawai Perubatan
Akta Perubatan 1971
[Akta 50]Psychiatric services
Mental Health Act 2001
[Act 615]
Land, Certificate of Completion and
Compliance of buildings or
equivalent & signboard approval
Uniform Building By-Laws 1984
By Local Authorities Pegawai Pergigian
Akta Pergigian 1971
[Akta 51]
Consent and Causing
miscarriagePenal Code [Act 574]
Steam Boiler, Unfired Pressure
Vessel + machinery equipments
Factories and Machinery Act,
1967 [64/1967] By Department
of Occupational Safety and
Health
Ahli Farmasi
Registration of
Pharmacists Act 1951,
(Revised 1989) [Akta 371]
Drugs & MedicinesPoisons Act 1952 (Revised
1989) [Act 366]
Safety for fire exitFire Services Act 1988 [Act
341] By Fire DepartmentOptician & Optometrist
Optical Act 1991
[Akta 469]
Hydrogen Cyanide
(Fumigation) Act 1953
(Revised 1981) [Act 260]
Keselamatan persekitaran
Environmental Quality Act
1974 [Act 127] By Department
of Environment
Jururawat Nurses Act 1950 [Akta 14] Dangerous Drugs Act 1952
(Revised 1980) [Act 234]
Untuk pekerja estet
Workers’ Minimum Standards of
Housing and Amenities Act
1990 [Act 446]
BidanMidwives Act 1966
(Revised 1990) [Akta 436]
Sale of Drugs Act 1952
(Revised 1989) [Act 368]
Penolong Pegawai
Perubatan
Medical Assistants
(Registration) Act 1977
[Akta 180]
Advertisements
Medicines (Advertisements
and Sale) Act 1956
(Revised 1983) [Act 290]
Pembantu Hospital
Estet
Estate Hospital
Assistants (Registration)
Act 1965 (Revised 1990)
[Akta435]
Therapeutic, medical
education and research
Human Tissues Act 1974
[Act 130]
Staf TeknikalInfectious Diseases
Control
Destruction of Disease-
Bearing Insects Act 1975
[Act 154]
Pembantu Jagaan
Peribadi dll
Prevention and Control of
Infectious Diseases Act
1988 [Act 342]
Food safety Food Act 1983 [Act 281]
Health Promotion
Programmes and
Activities
Malaysian Health
Promotion Board Act 2006
[Act 651]
YET TO BE ENFORCED
Pathology LaboratoryPathology Laboratory Act 2007
[Act 674]
Allied Health
professionals
Allied Health
Professional Bill Practise telemedicine
Telemedicine Act 1997
[Act 564]
Medical devicesMedical Device Act 2012 [Act
737]TCM practitioners
Traditional and
Complementary Medicine
Act 2013
1 Hospital swasta
2 Hospital psikiatri swasta*
3 Pusat jagaan ambulatori swasta
4 Rumah jagaan kejururawatan swasta5 Rumah jagaan kejururawatan psikiatri swasta*
6 Rumah bersalin swasta
7 Bank darah swasta
8 Pusat hemodialisis swasta
9 Hospis swasta
10 Pusat kesihatan mental masyarakat swasta*
11 Klinik perubatan swasta
12 Klinik pergigian swasta13 Kemudahan gabungan (dari No.1-10)
* + Akta 615
THANKS YOU
