Final-Chronic Dialysis Treatment Standards -Nov 2012[1]
Transcript of Final-Chronic Dialysis Treatment Standards -Nov 2012[1]
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CHRONIC DIALYSIS TREATMENT STANDARDS
The Chronic Dialysis Treatment Standards is applicable to all haemodialysis facilities and services in publicand private sectors as well as facilities and services run by not-for-profit organisations. These facilities andservices are either hospital-based or free standing and provide only chronic haemodialysis treatment.
The Chronic Dialysis Treatment Standards were developed in collaboration between the members of theMalaysian Society of Nephrology, National Kidney Foundation, Ministry of Health (MOH) and MSQH.
The purpose of these standards is to ensure safe medical practice, patient safety and quality service at thehaemodialysis facilities and services. These standards were developed in reference to the ISQuaAccreditation Federation Council principles and philosophy on standards development.
The standards cover the following areas of concerns:-
Standard 1 : GovernanceStandard 2 : Access to CareStandard 3 : Human ResourceStandard 4 : Haemodialysis TreatmentStandard 5 : Ethical Practice & Patient and Family RightsStandard 6 : Prevention and Control of InfectionStandard 7 : Facilities and EquipmentStandard 8 : Quality Improvement Activities
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
MSQH/ChronicDialysis/Stds&Tool/1/2012 Page 1 of 27Standards and Assessment Tool for Chronic Dialysis TreatmentMalaysian Society for Quality in Health (MSQH)
CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 1 GOVERNANCE
The Haemodialysis Centre shallhave a person responsible for all
aspects of the Centres operations.The Person In Charge can be theowner or appointed by the owner ofthe Haemodialysis Centre.
The Person In Charge (PIC) shalladopt a governing framework thatconstituted the internal legislationthat will fit the particular needs andcircumstances of the Centre.
1.1 Person In Charge (PIC) ofHaemodialysis Centre
The PIC of a Haemodialysis Centreshall be:
A Nephrologist or
A Paediatric Nephrologist or
An internal medicine specialistwho had completed not less than200 hours of recognized training
in haemodialysis treatment andmaintains an affiliation with anephrologist or
A registered medical practitionerother than those listed above who
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
had completed not less than 200hours of recognised training inhaemodialysis treatment before31st December 2011 and
maintains an affiliation with anephrologist.
Criteria for compliance:
i) The Person In Charge shall ensurethat the Vision and Missionstatements, Goals, Objectives andvalues of the Centre are identifiedand documented.
ii) The Person In Charge shall adopt agoverning framework in accordance
with the statutory and other legalrequirements.
iii) The Centre should have anorganisational plan which outlinesthe services provided, duties andresponsibilities of various personnelin the Centre and activities to complywith the statutory and legalrequirements.
1. Valid licence from Cawangan Kawalan AmalanPerubatan Swasta(CKAPS).
2. Vision, Mission, goals, objectives and values are welldocumented.
3. Letter of appointment of PIC if the PIC is not the owner.
4. Valid Annual Practising Certificate (APC) of the PIC.
5. Evidence of having undergone training inhaemodialysis for at least 200 hours. (If the PIC is not anephrologist).
6. Letter of affiliation with nephrologist.(If the PIC is not anephrologist)
7. Evidence of registration with National SpecialistRegister (NSR). (only physician and nephrologist)
8. List of roles and responsibilities of the PIC whichinclude but not limited to the following:
a) day-to-day medical care of haemodialysis patients;
b) ensure that each patient has a nephrologist toassume all or part of the medical care of thepatient;
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
MSQH/ChronicDialysis/Stds&Tool/1/2012 Page 3 of 27Standards and Assessment Tool for Chronic Dialysis TreatmentMalaysian Society for Quality in Health (MSQH)
CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
c) involvement in policies and proceduresdevelopment and periodic review;
d) approval of patient care policies;
e) quality assessment and improvement programme;
f) staff education and performance;
g) patient education;
h) ensure the proper functioning and maintenance ofall equipment and facilities, especially the watertreatment facility in order to ensure the safeconduct of HD treatment.
9. Evidence that PIC has complied with the statutory andother legal requirements.
10. There is an organisation chart which:
a) provides a clear representation of the structure,function and reporting relationships of the servicesand staff;
b) is accessible to all staff;
c) is revised when there is a major change in:
i) organisation;
ii) goals and objectives;
iii) staffing patterns.
d) shall be exhibited in a conspicuous part of theCentre;
e) approved and endorsed by the PIC.
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 2 ACCESS TO CARE
Patients with end-stage renaldisease shall have access to safe,
efficient and effectivehaemodialysis (HD) treatment.
2.1 Acceptance of Patient intoHaemodialysis Centre
Patients with end-stage renal diseaserequiring chronic haemodialysis (HD)treatment are accepted for treatmentbased on the Centres Mission and
resources.
Criteria for compliance:
i) The Centre has a process foraccepting patients, informing them ofthe services available and costs oftreatment. It has procedures in placeto assist them with any financialsubsidies that they are entitled to.
ii) The Centre has a system to assess
the suitability of the patients requiringhaemodialysis treatment prior to thembeing accepted by the Centre.
1. Availability of standard operating procedures (SOPs)and practice guidelines that provide for safe andefficient HD.
2. The Centre has written procedures on acceptance andassessment of patients.
3. The numbers of patients accepted do not exceed the
capabilities of the Centre both from the facilities andstaffingaspects.
4. Documented evidence of assisting relevant patients toobtain appropriate financial assistance.(This is not applicable for centre that does not providefinancial assistance.)
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
2.2 Access to Other Medical Care
The Centre has access to a hospital orother consultants services should the
patient require other medical treatment.
Criteria for compliance:
i) The Centre has arrangements withother healthcare providers, includingambulance services to provide urgentcare for patients.
ii) Arrangement for other medical careincluding but not limited to dietetic andvascular access services.
1. Letter of undertaking, agreement or Memorandum ofUnderstanding (MoU) with the nearby clinic for urgentmedical care of the patient if there is no residentmedical practitioner.
2. Evidence of access to ambulance services, e.g. atleast contact numbers of two (2) ambulance serviceproviders
3. Evidence of patient counselling on:
a) HD treatment;
b) dietetic advice,
c) access to hospital support.
(Documentation in the patient clinicalnotes/referral letter)
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
MSQH/ChronicDialysis/Stds&Tool/1/2012 Page 6 of 27Standards and Assessment Tool for Chronic Dialysis TreatmentMalaysian Society for Quality in Health (MSQH)
CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
2.3 Access to the National DeceasedDonor Kidney Transplantationwaiting list (eMOSS)
The centre under the advice ofnephrologist shall provide informationabout kidney transplantation (includingdeceased and live donor kidneytransplantation) and enrol suitablepatients into the National DeceasedDonor Kidney Transplantation waitinglist.
Criteria for compliance
i) The Centre has policy and procedureon counselling patients on kidneytransplantation.
ii) The Centre has registered witheMOSS.
1. Counselling of eligible patients on kidneytransplantation documented in patients case notes.
2. Consent by patients to be listed in the NationalDeceased Donor Kidney Transplantation waiting list(eMOSS).
3. Evidence of updating and managing patients in the e-MOSS list.
4. Evidence of any patient in the centre who is placed inthe Top 5 in the national waiting list by blood group
being evaluated if applicable.
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
3.2 Staffing
The Centre shall ensure that it hassufficient staff with formal training to
meet patient-care needs.
Criteria for compliance:
i) Nursing staff assigned to a centreshall have at least six (6) monthstraining in renal nursing and/or postbasic qualification in renal nursing.
ii) The Centre shall maintain a personalinformation file for each employeedocumenting their qualifications,training, experience and continuing
education activities.
1. Evidence of six (6) months training in renal nursingand/or post basic qualification in renal nursing.
2. Documentation of the responsibilities, duties andworking hours of staff.
3. Evidence of staff to patient ratio as per regulatoryrequirements.
4. Evidence of staff trained in cardiopulmonaryresuscitation (CPR). Roaster list for every shift withone (1) CPR trained staff.
5. Personal file of staff is kept and made available. Thefile should include qualification, training, experience,and continuing medical education (CME) activities.
6. Possession of valid Annual Practicing Certificates byStaff Nurses and Assistant Medical Officers.
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 4 HAEMODIALYSIS TREATMENT
All patients in the Centre shallreceive HD treatment according to
evidenced based guidelines.
4.1 Haemodialysis Prescription
All patients should have a prescriptionfor HD treatment which should bereviewed at least three (3) monthly.
Criteria for compliance:
i) There is a documented policy on
haemodialysis prescription.
1. The Centre has a set of practice guidelines that
covers all aspects of HD treatment.
2. Clinical charts of patients documenting eachtreatment shall be made available.
3. Dialysis prescription for each patient shall be madeavailable. This prescription shall include dialysistreatment parameters such as:
a) dry weight;
b) blood flow;
c) dialysate flow;
d) type and amount of anticoagulation;
e) type of dialysers;
f) medications to be given on during dialysis (e.g.Erythropoietin, Intravenous Iron);
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
g) medications to be taken by patient;
h) any other appropriate treatment based on thepatients general health.
4.
The prescription shall be renewed after the three (3)monthly reviews by the nephrologist or morefrequently as appropriate.
4.2 Haemodialysis Outcome
All patients shall have HD outcomeindices monitored at least three (3)monthly.
Criteria for compliance:
i) There is a documented policy onmonitoring of haemodialysis outcome.
1. Investigations done at least every three (3) monthsshall include but not limited to the following:
a) studies on anaemia;
b) nutritional status;
c) adequacy of dialysis;
d) mineral metabolism;
e) Virology studies. Virology studies shall be done at
least six (6) monthly. The results of theinvestigations shall be documented and monitored.(Refer Appendix 1)
2. There is documented evidence on action taken basedon the indices monitored.
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MSQH Standards and Assessment Tool for Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
4.3 Nephrologist Review
All patients shall be regularly reviewedby a nephrologist at least three (3)
monthly.
Criteria for compliance:
i) The nephrologist review shall becomprehensive and includesassessment of dialysis related as wellas other medical problems of thepatient.
ii) Following the review, a care plan for
the patient is developed
1. Evidence of nephrologist review in the patientsmedical notes. This review shall include:
a) history and physical examination of anycomplaints relating to the general health of thepatient;
b) any intradialytic complications;
c) dialysis clinical charts;
d) results of the recent investigations done;
e) status of vascular access;
f) complications of long term HD treatment includingnutritional status;
g) review of current kidney transplant status.
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MSQH Standards and Assessment Tool for Haemodialysis Centre - Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
5.2 Confidentiality of Patients Personaland Medical History.
Information on the patients personal
and medical history shall be keptconfidential at all times.
The Centre shall abide by theMalaysian Medical Councils guidelineon confidentiality of patients record.
Criteria for Compliance:
i) There are written procedures toprotect the confidentiality of thepatients personal and medical
information.
1. Evidence of patients personal and medicalinformation is kept in a secure manner and accessibleonly to designated staff.
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MSQH Standards and Assessment Tool for Haemodialysis Centre - Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
5.3 Patient Rights and Responsibilities
The Centre shall ensure that at alltimes the best interests of patients
shall prevail when there is a conflictbetween the business interests of theCentre and the patients welfare.
The Centre shall have a guide on theresponsibilities of the patientundergoing dialysis to ensure his well-being and a best possible outcome.
This shall be communicated to thepatient when he/she starts treatment
at the Centre.
Criteria for compliance:
i) The Person In Charge (PIC) of aCentre shall ensure adequatemonitoring of patients during dialysisand subsequent patient care.
ii) In the case of closure of the Centre,the PIC shall ensure there is acontinuation of care of all patientsincluding transfer of patients to
another Haemodialysis Centre.
iii) Charter of patients rights is madeavailable to all patients.
1. The Centre shall provide services six (6) days a weekincluding on public holidays.
2. Patients rights and responsibilities are displayedprominently in the Haemodialysis Centre:
a) There shall be adequate written information to thepatient on the nature of treatment, level of care
expected and the fees charged.
b) Patients have a right to change HD centres andPIC must facilitate the transfer to the best interestof the patients.
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
iv) Responsibilities of patients are clearlycommunicated to them.
c) There shall be established a grievancemechanism and such mechanism be prominentlydisplayed in the Centre.
d) Evidence that patients have been informed andagreed to their responsibilities as a patient in theCentre. This can be in the form of a patientinformation sheet which is formally acknowledgedby the patient.
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 6 PREVENTION AND CONTROL OFINFECTION
The Centre shall have a policy aswell as guidelines on prevention,
monitoring and management ofdialysis-related infection.
Dialysis-related infection shallinclude but not limited to BloodBorne Viral Infections, CatheterRelated Blood Stream Infections(CRBSI) and other healthcarerelated infections.
6.1 Infection Control System andProcesses
There is a designed coordinationmechanism for all prevention andcontrol of infection activities thatinvolve staff, patients and others asappropriate.
Criteria for compliance:
i) There is designated mechanism for
the coordination of the prevention andcontrol of infection programme.
ii) Coordination of prevention andcontrol of infection involve all staff,patients and others as appropriate.
1. The Centre has a written guideline on infection control
programme that includes but not limited to thefollowing :
a) Infection control policies and procedures.
b) Infection control systems.
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
6.3 Monitoring of Infections
All patients in Haemodialysis Centreshall undergo regular scheduled
monitoring for Blood Borne ViralInfections.
Criteria for compliance:
i) There shall be a policy on monitoringfor Blood Borne Viral Infections for allpatients in a Haemodialysis Centre.
ii) There shall be procedures for handlingpatients with such positive infections.
1. Evidence of a plan of schedule monitoring.(Refer Appendix 1)
2. Where applicable, evidence of designated treatmentareas or procedures for those who are positive forHBV, HCV and HIV with corresponding segregationof reprocessing facilities and storage of reprocesseddialysers.
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
6.4 Screening for Visiting Patients andCentres patients who havetemporary dialysis elsewhere
Patients from other centres whorequest to dialyse at the Centre shallundergo screening for Blood BorneViral Infections. The Centres ownpatients who return from dialysistreatment at other centres shallundergo similar screening.
Criteria for compliance:
i) Policies and procedures are in placeto ensure screening of patients who
dialyse temporarily in the Centre.
ii) Policies and procedures forscreening of the Centres patientswho temporary dialyse outside theCentre.
(Reference: Haemodialysis Quality &Standards Ministry of Health, April2012)
1. Evidence of result on screening tests of visitingpatients.
2. Evidence of tests being performed for the Centrespatients who have returned to dialyse in the Centreafter treatment elsewhere.
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
6.5 Training of Staff in Infection Control
A designated staff who has training inprevention and control of infection
shall oversee all prevention andcontrol of infection measures in theCentre.
Criteria for compliance:
i) The Centre has a training programmefor the staff responsible for infectioncontrol.
1. The PIC has standard operating procedures (SOP)on infection control and training of staff on suchmeasures.
6.6 Documentation of Infections
There shall be completedocumentation of infectiouscomplications within the Centre, whichinclude Catheter Related BloodStream Infections (CRBSI) and BloodBorne Viral infections.
Criteria for compliance:
i) The Centre shall have
documentation and reportingmechanism when above infectionshas occurred.
1. Clinical and laboratory evidence of such infections.
2. Evidence of actions being taken following suchinfection.
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MSQH St d d d A t T l f H di l i C t Ch i Di l i T t t
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 7 FACILITIES AND EQUIPMENT
The Centre complies with therequirements of the local authority,
Private Healthcare Facility andServices (PHFS) Act, MedicalDevices Act and any other relevantregulatory requirements.
7.1 Physical Structure of HaemodialysisCentre
The Centre shall have adequatespacefor the different functions of HD
treatment as provided for under theRegulations for HD treatment of thePHFS Act and its regulations.
Criteria for compliance:
i) There is adequate space and storageareas to allow staff to carry out theirduties safely and efficiently accordingto standards set by the relevantauthorities and regulatoryrequirements.
1. The floor plan of the Centre approved by theregulatory body (CKAPS) should be available anddisplayed in the Centre.
MSQH St d d d A t T l f H di l i C t Ch i Di l i T t t
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
7.2 Equipment Standard
Major equipment use in HD treatmentshall have certification from relevantregulatory authorities.
1. There is documented evidence that equipmentcomplies with relevant standards, e.g. those set bySIRIM Berhad (Standards and Industrial Research
Institute of Malaysia) and current statutoryrequirements.
7.3 Maintenance of Equipment
The facilities and equipment in theCentre are maintained in good workingorder and subject to ongoing plannedpreventive maintenance (PPM) andcalibration.
Criteria for compliance:
i) List of inventory is available.
ii) Contract for equipmentmaintenance.
1. There should be a log book on the maintenance andrepairs of all major equipment.
MSQH St d d d A t T l f H di l i C t Ch i Di l i T t t
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
Std 8 QUALITY IMPROVEMENTACTIVITIES
The Centre has a framework ofquality objectives and the
processes to achieve theseobjectives.
8.1 Plan for Quality ImprovementActivities
The PIC and staff have clear plansincluding budgetary allocations toimprove quality of care in the Centre.
Criteria for compliance:
i) There is written policy on qualityimprovement activities.
ii) There is a budget allocation for qualityimprovement activities.
1. Documentation of activities to improve quality of theCentre.
2. Documentation of outcome of quality improvementactivities.
MSQH Standards and Assessment Tool for Haemodialysis Centre Chronic Dialysis Treatment
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CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
8.2 Training in Quality ImprovementActivities
Staff are trained in qualityimprovement activities and undergocontinuing education in theseactivities.
Criteria for compliance:
i) The PIC or the designated staff isassigned responsibilities for qualityimprovement activities.
1. Records of staff attending continuing educationactivities.
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MSQH Standards and Assessment Tool for Haemodialysis Centre - Chronic Dialysis Treatment(Rating: SC-substantial compliance, PC-partial compliance, NC-non-compliance, NA-not applicable)
MSQH/ChronicDialysis/Stds&Tool/1/2012 Page 27 of 27Standards and Assessment Tool for Chronic Dialysis TreatmentMalaysian Society for Quality in Health (MSQH)
CriterionNo.
Survey ItemEvidence of Compliance
(Completed by the Haemodialysis Centre)Self
RatingSurveyor's Comments
SurveyorRating
8.3 Documentation of QualityImprovement Activities
There are planned and systematicsafety and quality improvement
activities that monitor and evaluate theperformance of the Centre including aplan for action and follow up to ensurethat the action taken is effective incontinually improving the quality ofcare. Innovation is advocated.
Criteria for compliance:
i) There are data collection formats tomonitor quality improvementactivities.
1. Documentation of quality parameters to include:
a) Clinical outcome measures(Refer Appendix 3)
b) Water quality (Refer Appendix 4 & 5 )
2. Records of any incident reporting and mandatoryincident reporting to Ministry of Health (MOH):
a) All Hepatitis and HIV seroconversion
b) Intradialytic death in chronic stable dialysispatient.
3. Records of submission of data to the National RenalRegistry (NRR) and action taken on feedback from theregistry.
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Appendix 1
Minimum scheduled laboratory investigations for chronic haemodialysis patients:
Tests Frequency
Full blood count Every 3 monthly
Iron Study:
Serum Iron
Serum ferritin
Total Iron Binding Capacity (TIBC)
Iron saturation (Tsats)
Every 3 monthly
Blood Urea (pre & post dialysis) Every 3 monthly
Renal Function Test Every 3 monthly
Liver Function Test
Alanine TransaminasesAlkaline phosphatase
Serum albumin
Every 3 monthly
Consider monthly transaminases for 3 months inpatients who has been dialyzing elsewhere or
patients who received blood transfusion.
Calcium & phosphate Every 3 monthly
Fasting iPTH Every 3-6 monthly
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Appendix 2
Infection Control Precautions for A ll Patients
(Adapted from CDC guidelines)
Proper hand washing technique.
Wear disposable gloves when caring for the patient or touching the patient's equipment atthe dialysis station. Ensure a supply of clean non-sterile gloves and a glove discardcontainer near each dialysis station.
Wash hands after gloves are removed and between patient contacts, as well as aftertouching blood, body fluids, secretions, excretions, and contaminated items.
A sufficient number of sinks with warm water and soap shall be available to facilitate handwashing.
If hands are not visibly soiled, use of a waterless antiseptic hand rub can be substituted forhand washing.
Items taken to a patient's dialysis station, including those placed on top of dialysis
machines, shall be disposed of, dedicated for use only on a single patient, or cleaned anddisinfected before being returned to a common clean area or used for other patients.
Unused medications or supplies (e.g., syringes, alcohol swabs) taken to the patient'sstation shall not be returned to a common clean area or used on other patients.
Prepare medications in a room or area separated from the patient treatment area anddesignated only for medications.
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Appendix 2
Staff members shall wear gowns, face shields, eye wear, or masks to protect themselves
and prevent soiling of clothing when performing procedures during which spurting orspattering of blood might occur (e.g., during initiation and termination of dialysis, cleaningof dialyzers, and centrifugation of blood).
Such protective clothing or gear shall be changed if it becomes soiled with blood, bodyfluids, secretions, or excretions.
Staff members shall not eat, drink, or smoke in the dialysis treatment area or in thelaboratory.
Patients can be served meals or eat food brought from home at their dialysis station. Theglasses, dishes, and other utensils shall be cleaned in the usual manner; no special care ofthese items is needed.
Establish written protocols for cleaning and disinfecting surfaces and equipment in thedialysis unit, including careful mechanical cleaning before any disinfection process. If themanufacturer has provided instructions on sterilization or disinfection of the item, theseinstructions shall be followed. For each chemical sterilant and disinfectant, follow themanufacturer's instructions regarding use, including appropriate dilution and contact time.
After each patient treatment, clean environmental surfaces at the dialysis station, includingthe dialysis bed or chair, countertops, and external surfaces of the dialysis machine,including containers associated with the prime waste. Use any soap, detergent, ordetergent germicide.
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Appendix 2
Routine bacteriologic assays of water and dialysis fluids shall be performed according to
the recommendations. (Refer page 13-14)
Venous pressure transducer protectors shall be used to cover pressure monitors and shallbe changed between patients, not reused. If the external transducer protector becomes wet,replace immediately and inspect the protector. If fluid is visible on the side of the transducerprotector that faces the machine, have qualified personnel open the machine after thetreatment is completed and check for contamination. This includes inspection for possibleblood contamination of the internal pressure tubing set and pressure sensing port. Ifcontamination has occurred, the machine must be taken out of service and disinfectedusing either 1:100 dilution of bleach (300--600 mg/L free chlorine) or a commerciallyavailable, EPA-registered tuberculocidal germicide before reuse.
Housekeeping staff members in the dialysis facility shall promptly remove soil andpotentially infectious waste and maintain an environment that enhances patient care.
All disposable items shall be placed in bags thick enough to prevent leakage. Wastesgenerated by the haemodialysis facility might be contaminated with blood and shall be
considered infectious and handled accordingly.
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Appendix 3
Clinical Outcome Measures and Quality Initiatives in Dialysis
1. Dialysis Adequacy (Kt/V)
95% of patients have prescribed Kt/V more than 1.3
85% of patients have delivered Kt/V more than 1.2
2. Urea Reduction Ratio (URR)
85% have URR more than 65%
3. Haemoglobin (Hb)
For those patients in erythropoietin (EPO), 70% of patients should achievedHb level 10- 12 g/dl.
4. Transferrin Saturation (Tsats)
80% achieved tsat20%
5. Annual mortali ty rate
Annual mortality rate for dialysis patient taking of all factors should not be
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Appendix 4
Water Quality
1. Dialysis water shall be produced by the process of Reverse Osmosis.
2. The minimum standards indicated below is based on the ISO 23500:2011.
3. Chemical Contaminants
3.1 Permissible levels of chemical contaminants shall be observed and adhered to.
(See Appendix 5)
3.2 Method of Testing
Chlorine and Chloramines and water hardness testing shall be performed on
site using commercially available test kits.
Full analysis for chemical contaminants shall be performed by an accredited
laboratory.
3.3 Minimum Frequency of Testing
Daily using commercially available test kits for chlorine and chloramines.
Six (6) monthly testing in an accredited laboratory for chemical analysis.
3.4 Site of Testing
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Calibrated loop technique shall not be used.
The presence of pyrogen/endotoxin shall be determined using Limulus
Amoebocyte Lysate (LAL) method.
4.2 Frequency of Testing
Monthly for bacterial count and endotoxin test.
4.3 Sites of Sampling
Minimum sites of sampling for testingi. Post RO membrane
ii. First point of the distribution loop
iii. End point of distribution loop (Last machine port)
iv. Reprocessing bay (for indirect feed)
4.4 Handling of water sample
Assay within 30 minutes of collection
If immediate assay is not possible, refrigerate immediately at 5C and assay
within24 hours of collection
4.5 Limits and Action Level
MaximumAllowed
CFU level
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Appendix 5
Maximum allowable levels of toxic chemicals and dialysis fluid electrolytes in
dialysis water
Contaminants with documented toxicity in haemodialysis
Contaminant Maximum Concentration (mg/l)
Alumin ium 0.01
Total Chlorine 0.1
Copper 0.1
Fluoride 0.2
Lead 0.005Nitrate (as N) 2
Sulfate 100
Zinc 0.1
Electrolytes normally included in dialysis fluid
Electrolytes Maximum Concentration(mg/dl) (mmol/l)
Calcium 2 0.05
Magnesium 4 0.15
Potassium 8 0.2
Sodium 70 3.0
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