7.6.1 Patients shall be tested for HIV at 6-monthly intervals.
7.6.2 Patient with HIV/AIDS can be dialysed in any hospital-based or free standing dialysing unit that uses standard infection control precautions. Isolation is not required unless the patient has concomitant illnesses that require isolation e.g. pulmonary tuberculosis, or resistant bacteria as recommended by hospital infection control committees.
7.6.3 The routine infection control precautions used in dialysis centres when dialysing all patients are considered adequate to prevent HIV transmission i.e. blood precautions, routine cleaning and disinfection of dialysis equipment and surfaces that are frequently touched and restriction of non-disposable supplies to individual patients unless they have been sterilised between uses.
7.6.4 Dialysers and AV blood lines of HIV positive patients must not be reused and shall be disposed of in biohazard bags.
7.6.5 Strict adherence to standard infection control practices shall be enforce for all patients regardless of their HIV status since patients can be in the "window" period of seroconversion.
8. Dialysis Centre's Responsibility to Patients
8.1 The dialysis centre is responsible for the medical care of the patients including the management of complications arising from dialysis and end stage renal failure.
8.2 The physician in charge must ensure adequate monitoring of patients during dialysis, and subsequent outpatient aftercare.
8.3 The dialysis centre is responsible for registering all suitable patients for cadaberic renal transplantation with:
The Transplat Coordinator
c/o The Department of Renal Medicine Singapore General Hospital
Outram Road Singapore 169608
9. Safety
9.1 There must be provision for emergency electric power supply for life-saving equipment in case of power failure.
9.2 Fire precautions must be taken and fire escapes shall be clearly visible.
10. Death of Patient
10.1 All deaths occurring whilst on dialysis or as a consequence of dialysis or any procedure related to dialysis must be reported immediately to the Coroner and MOH.
11. Periodic Review of Dialysis Centres
11.1 All dialysis centres will be subject to a regular review by a team appointed by the Ministry of Health, at least one of whom will be a renal physician.
부록 7. 해외 인공신장실 자료: 홍콩
Hong Kong College of Physicians & Central Renal Committee (Hospital Authority) Accreditation of Renal Dialysis Unit
Prepared by the Working Group on Quality Assurance in Renal Services
Membership of the Working Group on Quality Assurance of Renal Services Representing
Specialty Board in Nephrology, Hong Kong College of Physicians Dr. Li, Chun Sang (Chairman), Queen Elizabeth Hospital
Dr. Lui, Siu Fai, Prince of Wales Hospital Representing
Hong Kong Society of Nephrology
Dr. Cheng, Kum Po Ignatius, private practice Dr. Li, Kam Tao Philip, Prince of Wales Hospital Representing
Central Renal Committee, Hospital Authority Dr. Tong, Kwok Lung, Princess Margaret Hospital Dr. Wong, Kui Man Andrew, Kwong Wah Hospital Representing
Renal Nursing
Ms. Kong, Lim Lim Irene, Princess Margaret Hospital
Ms. Man, Bo Lin Manbo, Hong Kong Sanatorium and Hospital
Membership of the QA (Renal) Nursing Subcommittee Working Group on Quality Assurance in Renal Services Kong, Lim Lim Irene Princess Margaret Hospital Chairperson Man, Bo Lin Manbo Hong Kong Sanatorium & Hospital Deputy Chairperson
Au, Yim Fong Integrated Dialysis Facilities (HK) Ltd.
Chan, Ro Ro Ann Tsuen Wan Adventist Hospital Cheuk, Wai Han Hong Kong Baptist Hospital Chiu, Hing Frances Queen Mary Hospital Lai, Lai-fun St. Teresa's Hospital Lee, Wai Mui Justine St. Paul's Hospital
Leung, Mei Tong Rachel Hong Kong Adventist Hospital LI, Ngan Ping Anne Canossa Hospital
Mok, Lai Chun Anna Precious Blood Hospital Ng, Gar Shun Hong Kong Sanatorium & Hospital Tam, Mee Ling Bonnie Queen Elizabeth Hospital
Wan, Lai Hing Hong Kong Renal Centre Yuen, Hing Wah Hong Kong Kidney Foundation
Contributing Authors Dr. Chan, Tak Mao Daniel
Professor of Medicine, Department of Medicine, University of Hong Kong, Queen Mary Hospital
MD(HK), FRCP(Edin,Lond,Glas), FHKCP, FHKAM(Med) Dr. Cheng, Kum Po Ignatius
Private Consultant Nephrologist
MBBS(HK), PhD(Syd), FRACP, FRCP(Edin,Lond), FHKCP, FHKAM(Med) Ms. Kong, Lim Lim Irene
Nursing Specialist (Renal Care), Princess Margaret Hospital RN, RM, B App Sc (Nsg), MN, Cert Renal Nsg (UK) Dr. Li, Chun Sang
Consultant Physician and Nephrologist
Department of Medicine, Queen Elizabeth Hospital
MBBS(HK), FRCP(Edin,Glas,Lond,), FACP, FHKCP, FHKAM(Med) Dr. Li, Kam Tao Philip
Consultant Physician and Nephrologist
Department of Medicine and Therapeutics, Prince of Wales Hospital MBBS(HK), FRCP(Edin,Lond), FACP, FHKCP, FHKAM(Med) Dr. Lui, Siu Fai
Consultant Physician and Nephrologist
Department of Medicine and Therapeutics, Prince of Wales Hospital MBChB(Manch), FRCP(Edin,Lond,Glas), FHKCP, FHKAM(Med) Ms. Man, Bo Lin Manbo
Matron, Hong Kong Sanatorium and Hospital Dr. Szeto, Cheuk-Chun
Associate Professor,
Department of Medicine and Therapeutics, Prince of Wales Hospital Chinese University of Hong Kong
MD (CUHK), MRCP, FHKCP, FHKAM(Med) Dr. Tong, Kwok Lung
Consultant Physician and Nephrologist
Department of Medicine and Geriatrics, Princess Margaret Hospital MBBS(HK), FRCP(Edin,Glas,Lond), FHKCP, FHKAM(Med)
Dr. Wong, Kui Man Andrew
Consultant Physician and Nephrologist
Department of Medicine and Geriatrics, Kwong Wah Hospital MBBS(Birm), FRCP(Edin,Lond), FHKCP, FHKAM(Med)
Dr. Yu, Wai Yin Alex
Consultant Physician and Nephrologist,
Department of Medicine, Alice Ho Miu Ling Nethersole Hospital MBBS(HK), FACP, FRCP(Edin), FHKCP, FHKAM(Med)
All Copyrights reserved by the Hong Kong College of Physicians and the Central Renal Committee and no part of this document can be reproduced without the prior approval from the Hong Kong College of Physicians and the Central Renal Committee
Supported by a donation from the Li Shu Fan Education Foundation
ACKNOWLEDGEMENT
On behalf of the Working Group on Quality Assurance in Renal Services, I would like to acknowledge the support of the following parties in the production of this report.
We are grateful to the Li Shu Fan Education Foundation for financially
supporting this project. We would like to thank the Hong Kong College of Nursing (Specialty Standard Subcommittee . Renal Nursing) for permitting us to reprint the “17 statements of the Standards for Renal Nursing Practice”. We would express our gratitude to the Coordinating Committee in Nursing (Hospital Authority) and the Working Group on Guidelines for Specialty Nursing Services for permitting us to reprint the 10 Nursing Standards from the “Guidelines for Specialty Nursing Services (Renal Care)”.
During the preparation of this report, the Working Group has organized two forums to solicit feedback from medical and nursing professionals on the report. Their enthusiastic and constructive response contributed towards its refinement and finalization.
The Working Group takes this opportunity to thank Dr. CH Leong, President of the Academy of Medicine, for his encouragement and writing a foreword for this report and Dr Richard Yu, President of the College of Physicians, for his advice.
Accreditation of Renal Dialysis Unit
(I) Introduction
1. This section contains guidelines leading to accreditation of a renal dialysis unit.
2. A sample of application form for accreditation of renal dialysis unit is attached at the back for reference.
(Standards are categorized as “Recommended” and denoted (R) or as “Desirable” and denoted (D) based on the strength of evidence that such practices will affect the patients’ outcome.)
(II) Design and Space
1. The design of the facility meets the building and fire safety regulations of the government.
(R)
2. The treatment area provides safe and comfortable environment for patients receiving haemodialysis. (D)
3. If the renal dialysis unit also provides Continuous Ambulatory Peritoneal Dialysis (CAPD) service, separate rooms are recommended for peritoneal dialysis training and care for complications related to CAPD. (D)
(III) Staffing:
1. Haemodialysis and peritoneal dialysis services are provided in centres with qualified nephrologist(s) and renal nurse(s). (R)
2. Training of CAPD or Automated Peritoneal Dialysis (APD) is done by qualified renal nurses.
(R)
3. Hemodialysis procedures are ordered by nephrologists and monitored closely by qualified renal nurses. (R)
4. Medical doctor is available for consultation when needed. (R)
5. Resuscitation guidelines are in place and all medical and nursing staff of the dialysis centres are trained to perform CPR. (R)
(IV) Equipment:
1. All equipment used by a facility, including backup equipment, are operated within manufacturer’s specifications, and maintained free of defects. Maintenance is performed by qualified staff or contract personnel. (R)
2. Preventive maintenance program to equipment related to patient care is developed and enforced. (R)
3. Staff is trained to identify malfunctioning of equipment and to report to appropriate staff for immediate repair. (R)
4. All maintenance and repair record is kept on file for future reference and inspection. (R) 5. Emergency equipment and supplies include the following: (R)
Oxygen
Ambu bag and oxygen mask Oximeter
Suction equipment
Electrocardiograph and ECG monitor.
Defibrillator
(V) Water Treatment System:
1. Dual water treatment system is preferred. (D)
2. Each water treatment system includes reverse osmosis membranes or deionization tanks. (R) 3. The water treatment system components are arranged and maintained so that bacterial and chemical contaminant level in the product water do not exceed the standards for hemodialysis water quality. (Please refer to the “Haemodialysis” section for standards) (R)
4. Proper function of water treatment system is continuously monitored during patient treatment and be guarded by audible or visual alarm that can be heard or seen in the dialysis treatment area in case performance of the water treatment system drops below specific parameters. (D) 5. Written logs of the operation of the water treatment system for each treatment day are in place. (R)
6. Procedure guidelines for Disinfection of Reverse Osmosis Machine and Loop as recommended by the manufacturer are in place. (R)
7. No hemodialysis procedure is performed during disinfection of the water treatment system and the loop. (R)
8. Microbiological testing of the treated water from the water treatment system and the loop is done regularly and preferably monthly. (R)
9. For dialysis unit performing HDF, testing of treated water for endotoxin at regular interval is needed. (R)
10. Written record and results of microbiological and chemical testing of water are in place and reviewed. Corrective action is recorded if indicated. (R)
(VI) Reuse of haemodialyzers and related devices
1. Procedure guidelines for dialyzer reprocessing are in place. (R)
2. Testing for presence of disinfectant in the reprocessed dialyzer before rinsing and absence of disinfectant after rinsing are performed and documented. (R)
3. Each dialyzer is clearly labeled and identified to be re-used by the same patient. (R)
(VII) Haemodialysis machines
1. At least one unoccupied haemodialysis machine is available on-site as backup for every ten haemodialysis machines. (R)
2. Procedure guidelines on preparation of haemodialysis machine for haemodialysis are in place.
(R)
3. Routine disinfection of active and backup dialysis machines are performed according to defined protocol. Documentation of absence of residual disinfectants is required for machines using chemical disinfectant. (R)
4. Samples of dialysate from machines chosen at random are cultured monthly. Microbial count shall not exceed 200 colony forming units per millilitre (cfu/ml) for HD and shall not exceed 10 .1 cfu/ml for online HDF before IV infusion into the patient’s circulation. (R)
5. Testing of dialysate for endotoxin using Limulus amoebocyte lysate (LAL) before IV infusion into patient is performed for dialysis unit performing HDF and documented. Endotoxin level should not exceed 0.03 EU/ml. (R)
6. Testing of inorganic contaminant is desirable. (D)
7. Regular testing of dialysate for electrolytes is suggested to ensure proper function of haemodialysis machines. (D)
8. Repair, maintenance and microbiological testing results of the haemodialysis machine are recorded with corrective actions where indicated. (D)
(VIII) Standards of Equipment, Solutions and Training for Peritoneal Dialysis
1. All automated peritoneal dialysis (APD) machines complies with international standards for electromechanical safety. (R)
2. Fluids for peritoneal dialysis satisfy the current international quality standards. (R) 3. Procedure and guidelines for the use of APD machines are in place. (R)
4. Procedure and guidelines for the training of CAPD and management of its complications are in place. (R)
(IX) Sanitary Conditions, Hygienic Practices and Infection Control
1. All medical and nursing staff are trained to practice universal precautions in the dialysis unit.
(R)
2. Universal precautions are followed in the facility for all patient care activities. (R)
3. Hand washing sinks are readily accessible in each patient care area to allow hand washing before and after each patient contact. (R)
4. Gloves, aprons, face-masks, goggles and sharps containers are readily available. (R)
5. All staff including janitorial staff is educated with clear instruction on handling blood spillage on equipment and the floor. (R)
6. All blood stained surface shall be soaked and cleaned with 1:100 sodium hypochlorite if the surface is compatible with this type of chemical treatment. (R)
7. All new dialysis patients or patients who return to the dialysis unit after treatment from high- or unknown-risk areas are tested for HbsAg and Anti-HCV. (R)
8. HBsAg-positive patient is treated in a segregated area with designated haemodialysis machines. (R)
9. Carrier of HCV receives haemodialysis using designated machines. (D)
10. Patient with unknown viral status is dialyzed using designated hemodialysis machines until the status is known. (D)
(X) Other Quality Assurance Activities for patient care
1. Blood chemistry and haematocrit (or haemoglobin) of each dialysis patients are checked at regular interval (preferably every two to three months) to ensure patient’s well being. (R) 2. Contingency plan or procedures are available in case of equipment failure, power outages, or fire so that the patient healthy or safety can be ensured. (R)
3. Drill for CPR and emergency conditions outlined as mentioned in item 2 above are performed regularly. (D)
The Hong Kong College of Physicians Application for Accreditation of Dialysis Unit
Hospital:
Address:
Nephrologist in-charge:
Tel: Fax:
No. of haemodialysis beds:
No. of haemodialysis patients:
No. of peritoneal dialysis patients:
Staffing:
No. of qualified nephrologists:
No. of qualified renal nurses:
No. of R.N.:
Availability of doctor during emergency. (R) yes / no
Formal training of all nursing & medical staff to perform CPR. (R) yes / no Formal training of all staff to practice universal precautions. (R) yes / no
Formal training of all nursing staff to operate water treatment system. (R) yes / no
Formal training of all nursing staff to operate haemodialysis machine. (R) yes / no
Space and equipment:
Cleanliness of the patient treatment area, water treatment plant and haemodialysis machines. (R)
yes / no
Separate area for haemodialysis and peritoneal dialysis. (D) yes / no Enough hand washing sinks readily accessible to staff. (R) yes / no Central water treatment system. (Reverse Osmosis membranes or Deionization tanks) (R)
yes / no
Portable water treatment system. (Reverse Osmosis membranes or Deionization tanks) (R)
yes /
no
Backup water treatment system. (D) yes /
no
No. of HD machines:
No. of backup HD machines:
Designated area and haemodialysis machines for HBsAg positive patient. (R) yes / no
Designated haemodialysis machines for HCV positive patient. (D) yes /
no
Resuscitation equipment (R): Ambu bag & oxygen mask yes / no
Oxygen yes / no
Oximeter yes / no
Suction equipment yes / no
Electrocadiograph yes / no
ECG monitor yes / no
Defibrillator yes / no
Quality Assurance Activities:
Audible or visual alarms in patient treatment area for water treatment system monitoring. (D)
yes / no Preventive maintenance and repair record of hemodialysis machine and water treatment system.
(R) yes / no
Written logs of the operation of the water treatment system for each treatment day. (R) yes / no
Procedure guidelines for disinfection of water treatment system, product water delivery system
and haemodialysis machines. (R) yes /
no
Written record on results of microbiological and chemical testing of water. (R) yes / no Written record on results of dialysate microbiological culture of the haemodialysis machines. (R)
yes / no
Written record on results of dialysate microbiological culture and endotoxin level of the HD machines performing HDF. (R)
yes/no/NA
Procedure guidelines on preparation of haemodialysis machine for haemodialysis. (R) yes / no
Procedure guidelines for dialyzer re-use. (R) yes/no/NA
Protocols for CAPD, APD training, IPD and management of complications are available. (R)
yes/no/NA Contingency plan to handle fire, power outages, or equipment that may threaten the health of
safety of patients and staff. (R) yes /
no
Regular drill for CPR and to handle emergency situations. (D) yes / no Accumulative record of blood tests results of each patient taken at regular interval. (R)
yes / no Presence of clinical audit to monitor quality of patient care. (R) yes / no
Remarks:
(Accreditation Team) (Chief, Dialysis Unit)
Date:
부록 8. 해외 인공신장실 자료: 대만
혈액 투석 감사 업무 평가표(기관 자체평가 부분 포함) 자체 평가 기관:
자체 평가 작성자 서명: 감사위원 서명:
주: 1. 세부항목의 평가 등급이 [E]일 경우 학회의 이해를 돕기 위해 설명란에 원인을 기재하시오.
2. 평가표 내 자체평가 항목은 [※]으로 표시하시오.
3. 감사위원이 현지 감사에 사용할 수 있도록 기관에서는 자체평가한 항목에 점수를 매겨 2014년 3월 14일 전에 이메일로 학회에 송부바랍니다. (학회 홈페이지에서 '투석기관 품질/투석평가' 다운로드)
4. 대만신장학회 주소: 타이페이시 100칭다오 서로 11-4 전화: (02) 2331-0878, 팩스: (02) 2383-2171, 이메일: [email protected]
평가 기준 평점 설명 평점 등급 1.1 투석 질병 안전 의료 환경 구축
1.1.1 응급 설비
필 1.1.1.1 전기충격기,기관삽관, 산소공급장치, 석션장치, 응급(카트)상자
A: 응급 설비가 투석실 내에 구비되어 있고 수량이 충분하며 정상적으로 작동됨
C: 응급 설비를 언제든 손쉽게 찾을 수 있고 수량이 충분하며 정상적으로 작동됨
E: 응급 설비 부족 혹은 작동 이상 평점 E
설명란:
필 1.1.1.2 필수 구비 약품 (항목 수량, 유효기간, 정기 점검 기록)
A: 응급 약품이 투석실 내에 구비되어 있고 수량이 충분하며 유효기간이 지나지 않음
C: 응급 약품을 언제든 손쉽게 찾을 수 있고 수량이 충분하며 유효기간이 지나지 않음
E: 응급 약품이 부족하거나 유효기간이 지남 평점 E
설명란:
※ 1.1.1.3 (기관 자체 평가 항목)
설비가 정상적으로 작동하는지 정기적으로 점검한다(정기 점검 기록 有).
A: 응급 설비를 매주 점검하고 조회할 수 있는 기록을 남겼으며 설비에서 발견된 문제에 대해 즉각 수리 및 교체함
C: 응급 설비를 매월 점검하고 조회할 수 있는 기록을 남겼으며 설비에서 발견된 문제에 대해 즉각 수리 및 교체함
E: 응급 설비를 정기적으로 점검하지 않거나 노후 설비를 즉시 수리 혹은 교체 하지 않음
평점 E 설명란:
※ 1.1.2 (기관 자체 평가 항목)
투석실 주변 설비 1.비상전기공급설비 2.소방안전설비
C: 의료기관 설비 기준에 부합하고 검사 합격증이 있음 E: 의료기관 설비 기준에 부합하지 않거나 검사 합격증이
없음
평점 E 설명란:
1.2 감염 관리 업무 1.2.1 감염 관리 조치-인원
필 1.2.1.1 투석실 직원들은 B,C형 간염 혈청 검사를 받아야 한다.
A: 직원 100%가 B,C형 간염 검사 기록이 있고 B형 간염에 음성 반응을 보인 직원들은 정기(1년)적으로 추적 검사함
C: 직원 75% 이상이 B,C형 간염 검사 기록이 있음 E: 직원 30% 이하가 B, C형 간염 검사 기록이 있음 평점 E
설명란:
※ 1.2.1.2 (기관 자체 평가 항목)
손을 씻을 수 있는 설비가 갖춰져 있고 의료진들은 손을 씻는 습관과 올바른 손 씻는 방법을 숙지하고 있어야 한다.
A: 투석실에 페달형 혹은 센서식 손 씻는 설비(혹은 기존 손 씻는 설비에 건식 손 씻는 설비가 추가된)가 침대 15개 당 하나씩 설치되어 있음. 투석실 혹은 모든 층에 비상 손 헹굼 설비가 갖춰져 있음.
C: 투석실에 페달형 혹은 센서식 손 씻는 설비(혹은 기존 손 씻는 설비에 건식 손 씻는 설비가 추가된)가 침대 30개 당 하나씩 설치되어 있음. 투석실 혹은 모든 층에 비상 손 헹굼 설비가 갖춰져 있음.
1장 질병 안전