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Guidance sheet Hospital R1

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					GUIDANCE NOTE : HEALTH CARE SERVICE SECTOR
Special Requirement


                           Moody International Certification
          Guidelines for the production of ISO 9001 Auditor Guidance Notes




                      Guidelines for the production of ISO 9001
                              Auditor Guidance Notes


                          Health Care Services Sector




                              Issued on 1 September 2003




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GUIDANCE NOTE : HEALTH CARE SERVICE SECTOR
Special Requirement


4.1      General (n/a)

4.2.1 General Documentation Requirement (n/a)

4.2.2 Quality Manual (n/a)

4.2.3 Control of Documents (n/a)

4.2.4 Control of Quality Records (n/a)

5.1      Management Commitment (n/a)

5.2      Customer Focus (n/a)

5.3      Quality Policy (n/a)

5.4.1 Quality Objectives (n/a)

5.4.2 QMS Planning (n/a)

5.5.1 Responsibility & Authority (n/a)

5.5.2 Management Representative (n/a)

5.5.3 Internal Communication (n/a)

5.6      Management Review (n/a)

6.1      Provision of Resources
The hospital shall determine and provide the resources needed to implement of strategy and the achievement to
the quality management system and continually improvement and to enhance customer satisfaction by meeting
customer requirements.
Resources need should be human resource, facility, infrastructure, information, suppliers and sub-contractors,
raw materiel, transportation, other supporting services and financial resources.

6.2 Human Resources
6.2.1 General
The competent need of performing staffs should be related with registration and health care’s requirement, also
services requirements.

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Special Requirement


Human resource is very important of hospital, especially health care’s staffs shall be competent on the basis of
education, special training, skill, experiences and be approved by authorizer’s government to be registered
health care staffs i.e. physician, nurse, medical technician, pharmaceutical. All records of education, certificate
of training, approval permit, valid license shall be maintained.
Human resource of supporting services should be qualify under education, training, skills and experiences.

6.2.2 Competence, Awareness and Training

The hospital should provide procedures to control competent need of all staffs, training plan and training
records should be maintained. The evaluation of training by supervisor or manager level should periodic
implement to ensure competent and awareness of their staffs. Training should cover to all new staffs, full-time,
part-time, sub-contractor and supplier, also manager level to improve and maintain QMS. All records should be
kept to analysis work performance and compare with competent need of staffs.
Training subject should cover;
- Skill of staffs for supporting services i.e. nutrition, maintenance, calibration and laundry.
- General hospital course i.e. sterilized technique, hospital hygiene, infectious control, risk management,
     incident control, emergency responded.
- Skill of health care’s staff i.e. special technique, high-risk unit knowledge, ICU of nurse, use of special
     medical equipment, operation technique, high sterilized technique, CPR course, transport of patient,
     emergency and critical care technique.
- Services course i.e. service mind, customer satisfaction, customer reception, customer relation
     management.
- Requirement course i.e. right of patient, law and regulation of medical and hospital.
- Development course i.e. problem solving, KPI, enterprise resource management, total quality
     management, 5s, quality management system, quality policy and objective, analysis of data.

6.3       Infrastructure

The hospital shall determine, provide and maintain the infrastructure needed to achieve conformity of products
and services requirement.
Lay out and building should comply with hospital hygiene requirement, medical requirement, hospital building
act and suitable for flow of patient services. Process equipment, medical equipment and machine should be
under controlled of preventive maintenance system and maintenance system of hospital, records should be kept
for analysis and preventive of un-plan brake down and for safety reason.
The special equipment and infrastructure should be considered;
1. Infrastructure and facility suitable and safety;
- Comply with medical legal (especially electric and gas equipment)
- Convenient to access, movement and transfer.
- Good house keeping, clean, enough light, suitable temperature.
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-  No noisy of working and patient.
-  Treatment room of diagnosis room should be privacy form other person and to keep secrete.
2. Infrastructure special for patient;
-  Provide special infrastructure for children, sick old and deformed person i.e. path-way, toilet, lift.
-  Comply with hospital building control act for safety equipment and emergency preparedness fill place.
-  Provide suitable waiting and rest place for customer.
-  Control of air ventilation and air-born infectious also remove gas or air pollution from risk area should be
   considered.
- Enough car’s park especially in emergency area.
- Sign and label are suitable.
3. Supporting system should be covered;
- Generator.
- Emergency light and electric.
- Alarm system.
- Medical gas system.
- Refrigerator for keeping blood, medicine, vaccine.
- Water storage.
- Chemical, medical store.
- Communication system.
- Lift and transportation.
- Computer equipment and software.
- Waste water treatment, infectious waste control.
- Waste management.

6.4      Work Environment

- Control of hospital hygiene air-born control, chemical & radiation control, temperature, lighting in special
area i.e. operation room, control of temperature for special area i.e. high risk and new born room, control of
clean room and semi clean area, isolation area.

7.       Product Realization
7.1      Planning of Product Realization
The hospital shall plan for medical service realization. Planning shall consistent with medical and customer
requirements. Planning shall determine 2 ways.
- Services and supporting plan should be base on customer’s requirements and objective of services.
- Medical care plan should comply with medical law and regulation, capacity, competency and technology
     of hospital level identified.


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7.2 Customer-Related Processes
7.2.1 Determination of Requirements Related to the Product
-     The hospital shall determine requirements of customers and medical care services, to comply with law and
      regulation.
-     Capacity, competency, specialist and technology level of hospital should be clearly defined for service
      requirements.
-     The medical service should base on moral of health care and right of patient.

7.2.2 Review of Requirements Related to the Product

-     Right of patient to know, understand and make decision for the treatment should be maintained, in case of
      refuse treatment should be agreed with by authorized person and keep records.
-     All patient information should be kept in security system and not send to other person.
-     Laboratory test or special treatment should under physician and customer agreement together.

7.2.3 Customer Communication
-     Health care information and health education to customer and relatives should be planned and clearly
      defined.
-     Customer should be communicated to services information and price, pre-caution criteria, preparedness,
      appointment system.
-     Customer feedback or complaints should be recorded and informed to responsibility person to provide
      corrective and preventive action, especially customer complaint about treatment or medical error, fast
      respond for safety reason should be provided in timely manner.

7.3       Design and Development
                    N/A

7.4 Purchasing
7.4.1 Purchasing Process
-     Control of purchased product in core material to medicine, medical equipment, chemical, sub-contractor
      should be under controlled by specialist i.e. physician, nurse team, pharmacologist or user, evaluation
      should base on quality of medical and service provided.
-     Control of supporting equipment should be under controlled by user and related person.
-     Approval person or team of purchase product should be defined.

7.4.2 Purchasing Information

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Special Requirement


Provide information should be clear.

7.4.3 Verification of Purchased Product
Verification of purchased product by user for quality control, by medicine and medical equipment committee
for checking quality of critical product.

7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision

The hospital have many sections to control and plan for product and service provision. The information provide
and plan to control critical point should follow as;
             Department                                     Plan and Control Point of Services
1. Radiation Department/Imaging             - Radiological standard method.
Service                                     - Special radiological method i.e. arteriography, arthrography,
                                                IVP, GI series.
                                            - Control quality of radiography.
                                            - Portable radiology.
                                            - Chemical allergy.
                                            - Doctor order, investigate.
2. Intensive Care Unit, Critical Care - Receiving, dispatch, refers patient.
                                            - Emergency case.
                                            - Resuscitate.
                                            - Respirator machine care, plan for off machine.
                                            - Blood circulation.
                                            - Defibrillation care.
                                            - Multi critical care.
                                            - Special equipment.
3. Blood Bank                               - Emergency request blood.
                                            - Cross-match and compatibility test prevent for incompatible
                                                transfusion 24 hours.
                                            - Cause investigate to blood reaction after transfusion.
                                            - Yellow in new-born.
                                            - Immune problem.
                                            - Method of blood collection.
                                            - Screening of donor.
                                            - Keep sample 7 days for re-checking.
                                            - Autologous, apheresis method under control of physician.


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4. Anesthetic                      - Discharge from recovery room.
                                   - How to do when fail on respiratory tube?
            Department                            Plan and Control Point of Services
                                   - Resuscitate.
                                   - Emergency case.
                                   - Treatment of patient in recovery room.
                                   - Confirmation to right person with operation schedule.
                                   - Dead in operation room.
                                   - Fast respond.
                                   - Maintain function of organ and safe life.
                                   - Prevent infectious.
5. Health Education                - Implement follows health education plan, behavior plan.
                                   - Special health education plan, information control.
                                   - Evaluate of content.
                                   - Planning, implementation and evaluation of results.
                                   - Public available.
                                   - Control epidemic.
6. In-Patient Department (IPD)     - Standard of medical care, nursing care practices.
                                   - Criteria of patient investigate symptom.
                                   - Plan of treatment, discharge, refer.
                                   - Respirator equipment.
                                   - HIV control and all pre-caution of infectious.
                                   - Nursing care for each status of patient i.e. infectious, low
                                     resistant, mental disorder, crisis.
                                   - Plan to go home and follow up.
                                   - Plan to treat complicated symptom patient, post operation, clinic,
                                     end stage, mental disorder before discharge.
                                   - Visit by physician daily and nurse visit as plan.
7. Laboratory / Pathology & Post   - Standard of collect specimen, methods, time, date and price.
Room                               - Collection method.
                                   - Writing of label.
                                   - Method of laboratory analysis agency.
                                   - Test of agency, mixing method.
                                   - Control by code of practice.
                                   - Comply with international standard method.
8. New Born Department             - First AIDS, resuscitate.
                                   - Feedings schedule and nutrition control.


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               Department                     Plan and Control Point of Services
                             -   Observe abnormal condition.
                             -   Treat of new born hygiene
                             -   Cord hygiene, bath method.
                             -   Vaccination and laboratory.
9. Nutrition                 -   Produce of food.
                             -   Receiving order process.
                             -   Safety condition control.
                             -   Food Service.
                             -   Nutrient therapy control.
                             -   Consoling of nutrition method.
                             -   Nutrition clinic control.
                             -   Control of food contaminated from infectious patient or
                                 disposable control.
                             -   Reagent control.
                             -   Pest control.
10. Obstetric                -   Resuscitate of mother and newborn.
                             -   Other treatments more than labor.
                             -   Control of infectious patent.
                             -   Treat of newborn.
                             -   High-risk pregnancy or transfer.
                             -   Complication pregnancy.
                             -   Evaluate of symptom before labor.
                             -   Abnormal situation.
                             -   Evaluate after labor.
                             -   Gyenetic and disease of mother.
                             -   Vaccination.
                             -   Fetal care.
                             -   Observe of latent phase, active phase.
                             -   Pregnancy in teenage
                             -   Mental disorder.
                             -   Health behavior.
                             -   Drug usage.
                             -   Mother younger than 15 or older than 35 year.
11. Out-Patient Department   -   Screening, priority of patient.
                             -   Investigate process.
                             -   Support treatment.


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            Department                                     Plan and Control Point of Services
                                         -    Interview, sign.
                                         -    Follow up and appointment.
                                         -    Receive, admit and transfer.
                                         -    Emergency situation.
                                         -    Mental care.
                                         -    Drug addicted, right of patient, rape case.
                                         -    Counseling service.
                                         -    Appointment system.
12. Operation Room                       -    Drug allergic.
                                         -    Resuscitate.
                                         -    Sterilized technique.
                                         -    Spare of blood.
                                         -    Preparation of operation set.
                                         -    Preparation of patient to operation.
                                         -    Operation standard practice of each case investigate.
                                         -    Crisis management i.e. DIC, coagulopathy, major trauma,
                                              multiple system involvement.
13. Pharmacy Department                  -    Drug counseling usage.
                                         -    Control of drug incompatibility.
                                         -    Control of drug expired and nearly expired.
                                         -    Drug preparation control.
                                         -    Criteria of select medication.
                                         -    Control of medical list.
                                         -    Medical order.
                                         -    Emergency drug.
                                         -    Control own drug of patient.
                                         -    Return of medication.
                                         -    Drug usage without doctor order.
                                         -    Drug error, drug reaction and side effect control.
                                         -    Patient medication dose system.
                                         -    Drug management and drug education.

7.5.2 Validation of Processes for Production and Service Provision
Validation of medical treatment will be responded by physician and health care team for validate results of care
plan.


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7.5.3 Identification and Tractability
Identify system should be appropriate;
- Identify patient.
- Identify medicine, medication system and machine.
- Identify food, beverage.
- Identify documentation.
- Identify all specimen, blood, urine and laboratory agent.
- Identify sterilized status on equipment, also all expired date.

7.5.4 Customer Property
-   Customer property should be kept by financial department, in case of document or specimen should be
    clearly recorded and kept by responsibility persons.


7.5.5 Preservation of Product

             Department                                   Plan and Control Point of Services
1. Radiation Department/Imaging          -    Film quality preservation.
Service
2. Intensive Care Unit, Critical Care    -   Preserve of medical, specimen, reagent in suitable temperature
                                             and area.
3. Blood Bank                            - Preservation of blood and serum.
                                         - Control of specimen.
                                         - Reserve blood.
                                         - Monitoring of temperature of refrigerator.
                                         - Check blood expired.
4. Anesthetic                            - Preservation of medication, electrolyte, specimen.
5. Health Education                      - N/A
6. In-Patient Department (IPD)           - Preserve of medical, specimen, reagent in suitable temperature
                                             and area.
7. Laboratory / Pathology & Post         - Preservation technique of specimen and reagent i.e. dead body,
Room                                         gross specimen, organ of dead body, slide of cell, slide of
                                             Surgeology.
                                         - Destroy of specimen process.
                                         Note: Paraffin block should keep in cold area, prevent from sunshine.
8. New Born Department                   - Keep warm temperature.
                                         - Preservation of nutrition and milk.

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             Department                                    Plan and Control Point of Services
9. Nutrition                              -    Preservation of fresh food and food.
10. Obstetric                             -    Preserve of medicine, vaccine.
11. Out-Patient Department                -    Medicine, specimen.
12. Operation Room                        -    Medicine, specimen.
13. Pharmacy Department                   -    Preservation of medication and medication supply.
                                          -    Special preservation.
                                          -    Expired control.

7.6      Control of Monitoring & Measuring Devices

Calibration of thermometer, blood pressure, pressure gauge, all medical device that have monitoring and
measurement system i.e. respirator machine, infusion pump, blood circulation, defibrillator, incubator, external
calibrator should be qualify, identify calibration status should be legible.

8.       Measurement, Analysis and Improvement
8.1      General

The hospital should analysis and improvement process needed to continual improvement.

8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Customer satisfaction should be monitored and recorded.

8.2.2 Internal Audit (n/a)

8.2.3 Monitoring & Measurement of Processes
Process control should be determined. The monitoring and measurement points should follow medical care
plan, services plan and be checked by authorized person.

8.2.4 Monitoring & Measurement of Product

             Department                               Monitoring and measurement control points
1. Radiation Department/Imaging           -    Investigation of film.
Service                                   -    Analysis film.
2. Intensive Care Unit, Critical Care     -    Monitoring to progress of treatment comply with medication
                                               plan.
3. Blood Bank                             -    Monitoring of blood transfusion, reagent and equipment.

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               Department                      Monitoring and measurement control points
                                   - Monitoring reagent before use.
                                   - Monitoring quality of blood and component follow by QC.
                                   - Monitoring right before issued and before transfuses to patient.
                                   - Serology results.
                                   - ABO cell grouping, serum grouping.
                                   - Infectious disease makers =negative.
4. Anesthetic                      To save life and organism during operate and transfer to other unit i.e.
                                   - Monitoring require.
                                   - Blood pressure.
                                   - Pulse Oximeter.
                                   - EKG Monitor.
                                   - Capnograph.
                                   - Nerve stimulator.
                                   - Evaluate of medical care for respond with plan.
5. Health Education                - Monitoring behavior of patient and relative in scope of response.
6. In-Patient Department (IPD)     - Monitor of medical care plan to comply with doctor order and
                                       nursing plan.
                                   - Monitor of progress report and nursing report.
7. Laboratory / Pathology & Post   - Monitoring to accuracy of laboratory result.
Room                               - Check against standard.
8. New Born Department             - Monitoring of size, weight, temperature, length, symptom, urine,
                                       stool and feeding.
                                   - Monitoring Abnormal.
                                   - Apgar score.
9. Nutrition                       - Condition of cooking, keeping.
                                   - Symptom condition of patient.
                                   - Measurement of food weight, calorie, safety condition.
                                   - Toxicology monitoring, contamination monitoring.
10. Obstetric                      - Evaluate and monitor of progress labor, vital sign.
                                   - Monitor of anesthesic process.
                                   - Fetal heart sound monitoring.
                                   - Laboratory monitor.
                                   - Apgar score.
                                   - Blood lost, balance of fluid.
11. Out-Patient Department         - Screening monitor.
                                   - Vital sign, physical sign.

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             Department                                Monitoring and measurement control points
                                           -    Laboratory results.
12. Operation Room                         -    Monitoring of trend and progress of operation.
                                           -    Lost of blood.
                                           -    Electrolyte and fluid balance.
                                           -    All sign, symptom sign, neuro-sign and vital sign.
                                           -    All laboratory and x-ray.
                                           -    Checking of operation equipment record.
                                           -    Spore test, cleaning test.
13. Pharmacy Department                    -    Read doctor order by pharmacologist.
                                           -    Last verify of corrective by pharmacologist.
                                           -    Calculate of medication for extra case i.e. children.
                                           -    ADR monitoring. (adverse drug reaction)
                                           -    Follow up drug reaction result.
                                           -    Drug use evaluation.

8.3       Control of Nonconforming Product

Control of incident and non-conformity should be closely controlled and recorded in incident report, especially
medical care error report.

8.4       Analysis of Data

Consider objectives results, process control results, internal audit results, supplier and sub-contractor evaluation
results, customer satisfaction and feedback results.

8.5 Improvement
8.5.1 Continual Improvement
The continual improvement points should consider:

             Department                                       Continual Improvement Points
1. Radiation Department/Imaging            -    Quality of film and correct of investigate result.
Service
2. Intensive Care Unit, Critical Care      -    Mortality rate by disease and severity.
                                           -    Infectious control.
                                           -    Incident. (see IPD)
3. Blood Bank                              -    Infectious disease marker rate.
                                           -    Usage blood rate, blood component.

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            Department                              Continual Improvement Points
                                 -   Ratio of cross-match and blood usage.
                                 -   Incident.
                                 -   Suitable of blood result with plan.
                                 -   Comply with code of practice.
                                 -   Quality assurance from committee.
                                 -   External quality assurance every quarter.
                                 -   Internal quality assurance, results will be improved.
4. Anesthetic                    -   Number of patient with method of anesthetic.
                                 -   Number of visit patient after, before operate.
                                 -   Wrong place of endotrachea tube.
                                 -   Resuscitate in OR
                                 -   Drug side effect.
                                 -   Refer to ICU without plan.
                                 -   Dead in or after 48 hours.
                                 -   Longer than 20 minute awake.
                                 -   Rest in recovery room longer than 2.5 hours.
                                 -   Complication from anesthetic.
                                 -   Pneumonia or atelectasis in 72 hours after operation.
                                 -   Liver or kidney failure after operation.
                                 -   Systolic during or after Transfer from OR lower than 80 mmhg.
                                 -   Postpone or incident happening.
                                 -   Problem of equipment or warning.
5. Health Education              -   Action research.
                                 -   Quasi-evaluative research.
                                 -   Explanatory research.
                                 -   Improve health care service in long term.
6. In-Patient Department (IPD)   -   Fast responds for emergency, success rate of resuscitation.
                                 -   Laboratory test investigates against treatment care plan.
                                 -   Incident of drug, treatment.
                                 -   Re-treatment or re-admit in same diagnosis without plan.
                                 -   Re-operation without plan.
                                 -   Nosocomial infection.
                                 -   % of infectious rate.
                                 -   Mortality rate.
                                 -   Complication that prevent available.
                                 -   Sudden dead.


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               Department                            Continual Improvement Points
                                   - Complaints.
                                   - Day of stay in IPD.
7. Laboratory / Pathology & Post   1. Quantity of each laboratory from each department.
Room                               2. Correction of specimen, request, label.
                                   3. Turn around time, waiting time.
                                   4. Non-correspond report.
                                   5. Re-checking.
                                   6. Internal and external QC.
                                   7. Cost of reagent, expired control.
                                   8. Incident control.
                                   9. Cost of each laboratory.
                                   10. Frequency of each laboratory.
                                   11. Critical lab for making decision.
                                   12. Frequency of re-occurrence problem.
                                   13. Accuracy of analysis and verify result of:
                                   - Cell result not relevant with histology.
                                   - Clinical results.
                                   - Pathological results.
                                   - Conference results.
                                   - Result of re-screen in female is false negative.
                                   - Review all problem case.
                                   - Record of collect more than 1 time.
                                   - Frozen section non-correspond with final diagnosis
                                   - Cell result is malignant or high grade pre-malignant but can not
                                   find out history.
8. New Born Department             - Complication analysis.
                                   - Morbidity and mortality.
                                   - Hygiene of cord and physical problem during hospital and after
                                        discharge.
                                   - Instruction of mother and relative success rate.
9. Nutrition                       - Improvement rate of patient in nutrient therapy plan.
                                   - Promotion of nutrition control after discharge.
                                   - Customer satisfaction.
10. Obstetric                      - Mortality rate.
                                   - Mobility rate.
                                   - Complication of mother and newborn.


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            Department                                       Continual Improvement Points
                                         -    Operation rate.
11. Out-Patient Department               -    Investigate effectiveness.
                                         -    On-timer treatment.
                                         -    Self care education.
                                         -    Self group conference.
                                         -    Waiting time, time checking point.
                                         -    Refer rate.
                                         -    Follow up rate.
                                         -    Customer satisfaction.
                                         -    Customer complaint.
12. Operation Room                       -    Infectious rate.
                                         -    Complication rate.
                                         -    Mortality rate.
                                         -    Dead in 48 hours after operation.
                                         -    Re-operation in 24 hours without plan.
                                         -    Errors investigate from last plan.
13. Pharmacy Department                  -    Improve of drug use evaluation.
                                         -    ADR monitoring analysis. (adverse drug reaction)
                                         -    Medication error.
                                         -    Patient complaint.
                                         -    Waiting time.
                                         -    Minimum stock control and expired analysis.
                                         -    Critical drug control and spare system.


8.5.2& 8.5.3 Corrective & Preventive Action (n/a)

Reference
-   Hospital accreditation standard and criteria of consideration : The institute of hospital quality improvement
    and accreditation, 1999.




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