Short topics description about the sense of proces based QMS using ISO 9001 in health care. Doctor point of view.

1. ISO AND HEALTH CARE
M. KRUTSKÝ

2. ISO 9001:2008
- Is an internationally recognized standard (standard) of
quality that defines a framework for quality management
system. The standard length of approximately 23 pages
describing in general based on process approach all
aspects of actictivity of any organization.
- It is not an invention of genius, but smart applicable
system of feedback and logical use of information collected
QUALITY, ENVIRONMENT, SAFETY

3. The WHO definition 1966: Quality in health care
means a summary of the results achieved in the
prevention, diagnosis and treatment for the
needs of the population on the basis of medical
science and practice.
ISO 9000: Quality is the degree of meeting
customer satisfaction set of inherent
characteristics. This means the kind of care,
where you can expect the maximum benefit to
the patient's health and the expected benefits
are higher in comparison with costs at all stages
of the healing process.
QUALITY, ENVIRONMENT, SAFETY

4. LL-C (Certification) :
Quality is: Patients subjectively defined level of
health improvement or cure, in combination or
with regard to the type and stage of illness,
injury or inconvenience, the possibility of state of
the art medical sciences, the capacity of health
care facilities and/or health insurance rules.
Patient satisfaction also include attributes
associated with the satisfaction of health care as
the length of the order times, length of waiting
time before the actual care, approach of medical
stuff, accessibility and proximity to medical
equipment, environment and access to medical
personnel and costs for services rendered.
QUALITY, ENVIRONMENT, SAFETY

5. Subjective x objective
1) Quality in terms of patient (client)
2) Quality in terms of professional (doctors, EBM, nurses,
etc.)
3) Quality of governance (the management, insurance
companies, public…)
QUALITY, ENVIRONMENT, SAFETY

6. 1 CHAMBERS - sometimes addressing qualifications and
experience of the medical staff, representing doctors and
insurers to the state, there is a tendency for participation
in the certification of medical providers. (Hospital of the
21st century-stuff-based)
2 STATE- the tendency to manage health care facilities
directly (state) or by legislation (private). Sometimes
governed directly by workers' skills (for example CR). The
state generally does not support certification.
3 Certification - accredited certification company offering
certification to ISO 9001 (emphasis in management and
customer orientation - the patient, insurance, feedback
mechanisms)
4 Accreditation - an association seeking accreditation of
healthcare facilities (greater emphasis on equipment and
fixed procedures, standards) (local SAK, JCI/IHAO -
internationally)
QUALITY, ENVIRONMENT, SAFETY

7. 5 INSURANCE - evaluated only by certain indicators. So far,
only sporadic support of certified facility
6 Public Associations - Baby-Friendly Hospital, stability
ratings, patients' eyes - internet polls.
QUALITY, ENVIRONMENT, SAFETY

8. WHY ?
large vs. small health care providers
large – QMS is the part of management and monitoring
tools
small - QMS can be the systemic management tool for
operation of the whole organization
QUALITY, ENVIRONMENT, SAFETY

9. WHY ?
1. The definition of quality of the health care and policies in our
facility
2. Declaration to the public, that their needs are perceived (waiting,
ferries, information, suggestions, discontent, claims, needs ...)
3. Continual improvement of the services - provided on the basis of
facts and evidence
4. Protecting your employees and their management
5. Better control over all the documentation - to prevent later
problems
6. Increased efficiency at many levels
7. Improving safety of care – medical, patients, sides - confusions
8. Clearly defined powers, responsibilities and communication
channels to prevent confusion
9. The system is always individual, goals, policies, processes are
defined by YOU
QUALITY, ENVIRONMENT, SAFETY

10. WHY ?
PROCESS MODEL
Probably the easiest way of monitoring and
management of certain activities. Based on
the definition of inputs, outputs, metrics,
regulators, owners, responsibilities, etc..
(A system of activities that uses resources to transform inputs
into outputs that have the effect for the customer)
QUALITY, ENVIRONMENT, SAFETY

11. PROCESS MODEL II.
Defining processes in the succession and continuity
The main and the support ones:
Medical
Pharmacy
Meals
Laundry
Transport
ICT
Infrastructure
etc ... ..
QUALITY, ENVIRONMENT, SAFETY

12. QMS ICT SUPPORT
By my opinion, no one, except the staff directly involved in the
QMS, should know that doing something for an any ISO. It
should be so well established framework for its activities
(preferably ICT support, intranets, documentation in el. or
other available form) that it will not know that makes for
an ISO.
QMS must be implemented in such way to have minimal
burden and greater benefit to their creators-it takes time
In any organization the best tool for managing of quality
control processes is well-adjusted and open information
systems and good communication of personnel.
QUALITY, ENVIRONMENT, SAFETY

13. ELEMENTS EXPALNATION EXAMPLES
Some elements are already fulfilled, only to recognize them in
the form of general standard
Use or modification of existing documents, procedures and
standards
(There is No point in doing something completely different
just for the "iso", when it works well)
In medicine, nothing can be 100%. It is non-exact science
till today but if something is beyond the standard practice
there is need to know why?
QUALITY, ENVIRONMENT, SAFETY

14. 7. Product /service realization
7. 1. Planning of product realization
Identify and decide the need to provide emergency
treatment including urgent care
Ensure appropriate diagnosis for the decision (testing,
equipment, samples, laboratory availability)
Decision to specialized care
Procedures for the acute surgery
Adaptation to the specifics of the population
Determine deadlines for the provision of treatment
QUALITY, ENVIRONMENT, SAFETY

15. 7. Product /service realization
7. 1. Planning of product realization II.
Ensure maximum coordination of treatment
Provide relevant records to the patient's medical records
Minimize the "differences" in treatment between patients
Defined responsibility for patient
Non Stop - to ensure the availability of information 24/7
(medical records, patient, PACS, X-ray) to all physicians
providing care especially emergency
Ensure the protection of personal data
QUALITY, ENVIRONMENT, SAFETY

16. 7. Product /service realization
7. 2. 1 Determination of requirements related to the product
Define the conditions of access to care (ordering system,
channels, pipeline of care)
Ensure the principle of priority in case of the provision of acute
care
Provide options for changing the terms of the patient's care under
changing condition
Reduce the language, cultural and other barriers for patients
Provide appropriate information to the patient (family) the
waiting period, duration and method of treatment
Ensure that a patient know about alternative therapies - if they
are available.
QUALITY, ENVIRONMENT, SAFETY

17. 7. Product /service realization
7. 2. 1 Determination of requirements related to the product
Ensure coordination of treatment by a qualified person
Ensure proper records for further treatment
Contract to ensure cooperation with specialist
Deliver properly the information between the various units in
providing care facility
Ensure the availability of medical records of patients in all units
Provide qualified supervision of the tranfers
QUALITY, ENVIRONMENT, SAFETY

18. 7. Product /service realization
7. 2. 2 Review of requirements related to the product
Ensure diagnosis based on careful examination of symptoms and
anamnesis data reported by the patient.
Discussion of appropriate diagnosis and treatment with the
patient if possible.
Review of legislation requirements (infectious diseases , STD,
detention, coma patients, transplantation programmes)
Review the need for acute emergency care
Examining options for providing care facilities (equipment, skills,
capacity) and the subsequent mediation services
Review of patient medical records when available
QUALITY, ENVIRONMENT, SAFETY

19. 7. Product /service realization
7. 2. 3 Customer communication
Patient (family) must be informed about offered therapies,
duration, risks, constraints in the future
Patient must be able to choose treatment (where the nature of
the disease and the patient's condition and treatment options
allows this option)
Patient must be able to choose alternative treatment (if the
nature of the disease and the patient's condition and treatment
options allow this option)
The patient must be able to refuse risky treatment, (consents
system)
The patient and family must be aware of the possibilities of organ
donation
Patients must be familiar with using the results of treatment
research and procedures for complaints
QUALITY, ENVIRONMENT, SAFETY

20. 7.4 Purchasing
Equipment, tools and materials for use in medical
processes must be approved in specific country for medical
use.
Equipment, tools and materials for use in the treatment
process must have instructions for use, including
maintenance, cleaning and methods of sterilization,
disinfection, higher degree of disinfection, etc. - see the
legislation.
Suppliers of services must have an approved medical
procedures (special cleaning, laundry, disposal of biological
waste)
Laboratory – separate chapter
QUALITY, ENVIRONMENT, SAFETY

21. 7.5.1. Control of Production and service provision
- All patients with similar problems have to receive care
without discrimination.
- Care should be provided as a complete process in possible
- Diagnosis and the treatment must be recorded in writing,
and treatment must take place under these procedures
- Changing medical practice must be made in writing and on
the basis of the objective and subjective assessment)
- Treatment must comply with "good clinical practice",
„Guidelines of scientific/clinical communities‚“
- Patient or family, if they take a decision, must be informed
of the procedures, risks and prospects of therapy
QUALITY, ENVIRONMENT, SAFETY

22. 7.5.2. Validation of processes for production and service
provision
- automated processes such as analysis of blood or
sterilization must be validated by
7.5.3. Identification and traceability
- identification of the patient's medical records
identification of the samples (blood, tissue, vials, etc.)
identification of drugs in preparation for the application
(infusion, p.o. medication)
identification of patients themselves
QUALITY, ENVIRONMENT, SAFETY

23. 7.5.4. Customer Property
Clothing and personal items the patient
Medical equipment (crutches, wheel chairs, prosthetics,
hearing aids ...)
Fetched medication
Blood-autotransfusion ?, Authorities ?
Personal Data
7.5.5. Product Protection
Drugs expiration, environment control
Medical equipment and appliances - packages?
Blood and organs
Personal Data
Unauthorized entry to the facility – workplace prevention
QUALITY, ENVIRONMENT, SAFETY

24. 6 Resource management
6.2.2 Competence , training and awareness
Qualification "must" comply with legislative requirements
and regulations of the chambers and professional
organizations
(It's not always easy)
- Continue the evaluation of personality traits (empathy,
manners, tact, communication skills, dress code, etc.) - the
same importance
QUALITY, ENVIRONMENT, SAFETY

25. 6 Resource management
6.3 Infrastructure
Internal Information System
Diagnostic equipment and laboratories
Biochemistry, microbiology, haematology
Pathology
X-rays
Sterilization and special cleaning
Emergency service equipment maintenance
The backup source of energy, water
IT Emergency Service
Transport
Medical gas, pharmaceuticals, materials
Biological Waste Disposal
IN HOSPITAL ENSURE 24/7 AVAILABILITY
QUALITY, ENVIRONMENT, SAFETY

26. 8 Measurement, analysis and improvement
8.2.2. Internal audit (examples)
special internal audit in disinfection and sterilization area
(sanitary procedures, Authority approvals, fulfilling)
Special internal audit of the medical procedures,
documentation
Special internal audit of the conduct of research
(legislation, ethics, privacy, new emerging technologies)
System Audit of functionality and applications of feedback
(P-D-C-A).
QUALITY, ENVIRONMENT, SAFETY

27. 8 Measurement, analysis and improvement
8.2.3. Monitoring and measurement of product
Quality and safety of laboratory and radiological services
Surgery analysis (number, complication, mortality, cost-benefit…)
Use of drugs and their costs
Dealing with cases of misconduct
Use and efficacy of utility equipment
Ventilation, water supply, energy, waste collection
Mortality comparison
8.3 Control of nonconforming product
Clear and documented procedures
Identifying, assessing and recording risks – feedback
Recording and resolving complaints of patients
Report "unfortunate" cases – teaching from mistakes
QUALITY, ENVIRONMENT, SAFETY

28. 4.2 Documentation requirements
4.2.4. Control of records
- The medical records of patients has to have:
accessibility, transparency, restricted to approved personel, actual,
updatable, protected
legislation given framework in most countries - system of periodic
applications and check
Patient docs. identification ,ALL PAGES, legibility
medical procedures description in clear form
working. and final diagnosis
Treatment
use of drugs
laboratory and imaging tests
positive and negative consents
side effects of drugs
action after treatment, recommendations for further treatment
and monitoring
the final expected state after treatment
QUALITY, ENVIRONMENT, SAFETY

29. 5. Management responsibility
5.2. Customer focus
- Patient rights initiation
- Respect for the patient and his family
- The patient is regularly informed about the treatment
- Comments from the patient and his family are percieved
and settled
- To distinguish between public and personal data
QUALITY, ENVIRONMENT, SAFETY

30. 5.3 QUALITY POLICY
- Identification and analysis of risks in relation to the patient's health
- Medical Research
- Unification of care (standards)
- Caring for patients at risk (children, elderly, psychiatric...)
- Dealing with blood
- Caring for people in a coma, etc.
- Storage of medicines and other materials in chain
- Use of radioactive substances
- Ensuring disinfection management, management of hospital
aquired infection
- Ethics Management
- Waiting schedules
- Education….
QUALITY, ENVIRONMENT, SAFETY

31. PROBLEMS IN HEALTH CARE CERTIFICATION
1) high involvement of the state, certification is not supported
in general
2) lack of funds
3) there is not much pressure from customers like in other
sectors, at private facilities is beginning to emerge
4) there is not much pressure of insurance companies
5) low knowledge's about standards, myths, demotivation of
personel
QUALITY, ENVIRONMENT, SAFETY

32. QUALITY, ENVIRONMENT, SAFETY
LL-C
(Certification)
THANK YOU
And what else - dear auditor ?
Michal Krutský, M.D.