PD QUALITY STANDARDS - 07082019 Edit - Ong SB
PD QUALITY STANDARDS - 07082019 Edit - Ong SB
PD QUALITY STANDARDS - 07082019 Edit - Ong SB
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ISBN…………
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a database or retrieval system without prior written permission from Malaysian Society of Nephrology and the Director of
the Medical Development Division, Ministry of Health Malaysia.
CONTENTS
Page
Foreword
List of Contributors
Acknowledgements
2 Physical Facilities
2.1 Introduction
2.2 PD Exchange Area
2.3 Treatment/Consultation Area
2.4 Effluent Disposal System
3 Equipment
4 Dialysis Consumables
5 Water Quality
6 Human Resource
6.1 Introduction
6.2 Person-in-charger (PIC)
6.3 Nephrologist
6.4 Registered Nurse/Medical Assistant
11 Home Visits
12 PD Satellite Units
13 Appendices
Appendix 1: PD Standard Operating Procedures
12 References
Peritoneal Dialysis (PD) was first introduced in Malaysia in the 1960’s and PD growth has
slowly but steadily increased but steadily. Over the past 20 years, PD penetration has
contributed only 10% of the overall renal replacement therapy for end stage kidney
disease (ESKD) compared to haemodialysis in Malaysia but growth has occurred within
the public sector . This such that the penetration here is now 30% PD growth occurs
mainly in the public sector.
Currently, continuous effort has been made for passionate nephrologists to increase PD
uptake in the country not only in public sector but also in non-governmental organisation s
(NGO) and the private sectors. Health economic studies have shown that PD has more
economic value than haemodialysis in developing countries like Malaysia.
This is the first national PD quality standards document that has been prepared to provide
recommendations for a PD unit to fulfil and adhere to. This document will also serve as
guidance for enforcement units such as CKAPS/UKAPS (Cawangan/Unit Kawalan Amalan
Perubatan Swasta) to ensure acceptable treatment is provided for PD patients. It is
important that the recommendations are appropriate for the local setting from both quality
standards and economic perspective.
I hope that in years to come, peritoneal dialysis will not only become more attractive for
patients to choose as their dialysis modality but alsoalso to be taken up by NGOs and the
private sector. It is my sincere hope that this document will play an important role and
contribute better quality of care for PD patients in this country.
Peritoneal dialysis (PD) is an important modality for the treatment of end stage renal
disease. Clinical advantages of PD over haemodialysis includes better preservation of
renal function, and better anaemia management. As PD is a home-based therapy infra-
structure and staff requirements are less. It is useful for patients living in remote area and
those with difficulty in travelling to dialysis centres and it is more cost effectiveness than
building multiple small haemodialysis centres.
Since the introduction of peritoneal dialysis (PD) almost a century ago, PD technology
there have considerable improvements in the design of the PD catheter and the PD
system including the connectology and the PD solutions. Nevertheless, problems with PD
persists including peritonitis and high technique failure rate.
It is therefore important that PD units maintain a high standard to improve the performance
and outcome of patients on PD. The development of these national need for standards for
PD care is timely as Ministry of Health strives to increase the penetration of PD services
in the country.
I would like to express my gratitude to the team for their hard work in developing this
standard.
Dato Dr Ong Loke Meng
LIST OF CONTRIBUTORS
Dr Lily Mushahar
Consultant Nephrologist
Hospital Tuanku Ja’afar Seremban
Negeri Sembilan
Mahani Ahmad
Head PD Nurse
Hospital Tuanku Ja’afar Seremban
Negeri Sembilan
Noriah Othman
Head PD Nurse
Hospital Tuanku Ampuan Rahimah
Klang Selangor
Jamaiyah Supar
Senior PD Nurse
Hospital Kuala Lumpur
ACKNOWLEDGEMENTS
Acknowledgement for the contribution and participation in the preparation of this document:
Dr.Adibah Hani Haron
Senior Principal Assistant Director
Medical Development Division
Ministry of Health Malaysia
1.1. Objectives
The purpose of this standard document is to define the requirements for peritoneal
dialysis (PD) units to achieve the acceptable minimum level of quality, performance,
safety and reliability of services provided.
1.2. Scope
The standard covers essential aspects of PD treatment including physical facilities,
equipment, consumables, human resource, training & monitoring of dialysis
patients, infection control measures, quality measures, home visits and disaster
management for PD.
2.1 Introduction
The PD unit should be in an enclosed and clean area. There shall be adequate
space and facilities for all PD activities to be performed in the PD units and for the
required volume of work. This includes:
i) Compulsory area for:
PD exchange
Treatment/procedure
Effluent disposal
Nurses counter
2.2.1 There shall be adequate space for PD exchange for each patient, 4.5m2 per patient
2.2.2 Each PD exchange area should have a table, chair and drip stand
2.2.4 Adequate wash basins with elbow-tap should be provided for maintenance of good
hand hygiene
2.3.1 There shall be facilities and equipment for the treatment and care of PD patients
commensurate with the clinical procedures conducted within PD facilities for
example exit site care, change of transfer set, PET and KTV testing
2.3.3 An area to accommodate a couch is required for examination and treatment, with a
minimum area of 6.0m2
The PD effluent should preferably drain into the sewerage system. If drained into a
septic tank, the tank size shall be of adequate capacity to handle the volume of
effluent
CHAPTER 3: EQUIPMENT
PD cycler
Hanging scale
Weighing Scale: Standing and Sitting
Drip stand
Oxygen supply
Dressing Trolley
Emergency Cart (Trolley) with defibrillator
Non-invasive Blood Pressure Monitoring (NIBP) set
Volumetric Infusion pump
Electrocardiograph (ECG) machine
Glucometer
Refrigerator
Thermometer
PD exchange chair* ( why asterisked? There is no footnote? )
PD exchange table*
Wheelchair
Fridge
Storage Cabinet for consumables and record keeping
Couch
Bins for clinical waste, sharp and general waste
Computer with Internet connectivity
CHAPTER 4: PD CONSUMABLES
Mask
Disposable sterile glove
Dressing set
PD catheter clamp
Transfer set
Titanium connector
Sterile gauze & cotton
On & off tray- for transfer set exchange
Hand rub
Povidone Iodine
Copper sulphate
Alcohol 70% solution
Alcohol Swab
Water for injection
Heparin
Gentamicin and/or Mupirocin cream
Syringes (1, 3, 5,10 and 20cc)
Needle (19, 21 and 23G size)
Venofix (21 and 23G size)
Plaster (1cm & 5cm width size)
IV Drip Tubing
Surgical blade size 11
Specimen bottle for blood
Specimen bottle for PD fluid
Culture bottles
Spillage kit
CHAPTER 5: PD TRAINING
• Patients can be trained in the PD centre, PD satellite unit or in their own homes
• The PD trainer must be a qualified PD nurse (see Human resources section)
6.1 Introduction
This section defines the pre-requisite qualifications and responsibilities of the key
personnel of a PD unit
6.2.1 Definition
6.2.2 Qualification
6.2.3 Responsibilities
6.3 Nephrologist
6.3.1 Definition
6.3.2 Qualifications
A nephrologist shall be registered and comply with the conditions stipulated in the
National Specialist Register
6.3.3 Responsibilities
6.4.1 Qualifications
• Shall be credentialed by the National Credentialing Committee i.e:
i) Have a recognised post basic renal certificate/ advanced
diploma/equivalent and
ii) Have at least six (6) weeks training and six (6) months working
experience in an accredited PD unit under the supervision of a
registered nephrologists prior to performing PD treatment
• Those without post-basic certificate have to be privileged and work
under the supervision of an accredited PD nurse.
i) Requirement for privileging is minimum of six (6) weeks training
and six (6) months working experience with a completed log
book in an accredited PD unit under the supervision of a
registered nephrologist prior to performing PD treatment. The
validity of the credentialing is for 3 -years after certification and
credentialing needs to be renewed.
6.4.2 Responsibilities
6.4.3 PD Manager
2. Accredited college
a. College with Malaysian Qualification Agency (MQA) Certification
• Dialysis adequacy shall be monitored at least every six (6) monthly. This can be
calculated using Kt/V or Urea Reduction Ratio (URR)
• The target delivered Kt/V shall be more or equal than 1.7
8.1 Introduction
8.1.1 All PD units shall have stringent measures to minimise the risk of cross-infection
amongst PD patients
8.3.4 Seroconversion
The licensee/person-in-charge shall notify Ministry of Health of any Hepatitis B
seroconversion
8.4.4 Seroconversion
The licensee/ person-in charge shall notify the Ministry of Health of any Hepatitis C
seroconversion
8.5.1 Patients shall be tested for anti-HIV antibody and/or NAT before initiating PD
treatment
8.5.3 In HIV negative patients, serologic test shall be performed at least every 6 months
8.5.4 The licensee/person-in charge shall notify the Ministry of Health of any cases of HIV
seroconversion
8.6.1 PD staff should be screened for blood- borne viruses before working in the PD unit
10.3 Response
11.3 During the home visit, the PD nurse need to be observe and monitor:
home environment
PD exchanges
PD record book
PD solution and medication storage
In addition, the PD nurse should pProvides health education
A PD satellite unit shall provide holistic care and management of PD patients including
administrative duties, day-to-day troubleshooting for problems (e.g. constipation, leaking,
poor outflow etc), uncomplicated peritonitis, and non-infectious complications of PD. IfThe
unable to provide this service, the unit shall refer patients to the accredited PD centre.
Appendix 1
Appendix 2
Appendix 3
HbA1C 6 monthly
(diabetics)
Appendix 4
PD fluid sampling refer appendix 1 (PD Standard Operating Procedure 2015, Ministry of Health
Malaysia) – if this is already in appendix 1 , not necessary to rpt?
Appendix 5
Appendix 6
Staff Training
Training and education for all employees at risk for occupational exposure to blood shall
be provided at least annually, given to new employees before they begin working in the
unit, and documented. At a minimum, they shall include information on the following topics:
Proper hand hygiene technique
Proper use of protective equipment
Modes of transmission for blood borne viruses, pathogenic bacteria, and other
microorganisms as appropriate
Infection control practices recommended for PD unit and how they differ from
Standard Precautions recommended for other health-care settings
Proper handling and delivery of patient medication
Centralised record keeping to monitor and prevent complications, including routine
serologic testing results for HBV and HCV, Hepatitis B vaccination status, episodes
of bacteraemia and loss of access caused by infection and other adverse events
Training and education of patients (or family members care-givers for patients unable to
be responsible for their own care) regarding infection control practices shall be given on
initiation of peritoneal admission to dialysis and at least annually thereafter.T and shall
address the following topics shall be addressed:
• Personal hygiene and hand hygiene technique
• Patient responsibility for proper care of the PD access and recognition of signs of
infection, which shall be reviewed each time the patient has a ?? PD-related
infection rather than change in PD access ( does change refer to removal and
reinsertion of cath / means change in condition of PD access i.e. ESI or peritonitis )
• Recommended vaccinations
References