Implementation of Quality Management System Community Health Care Clinics

Introduction
According to Crosby, “Quality is conformance with specifications and Requirements”. ISO defined the quality management system as, Coordinated activities to direct and control an organization with regard to quality”.
According to McGlynn EA, Brook RH (2001), in United States the degree to which basic health quality standards are implemented is unknown.
Need of quality management system in health care Clinics:
Brent C. James, M.D. (1989) sated that the quality management system is directly related to the health acre safety, security, attitude of staff, and role and behavior of doctors, nurses and other health care workers.
o        The quality and administration of management
o        Quality of doctors and other staff
o        Quality of hospital care
o        Laboratory managements
o        Environmental management.
o        Providing good care to the patients and clients
o        Emergency plan implementation and
o        Record keeping
Comparison of ISO and CLSI
ISO
CLSI
International Organization for Standardization
Clinical and Laboratory Standards Institute
(formerly known as NCCLS)
Guidance for quality in manufacturing and service industries
Standards, guidelines, and best practices for quality in medical laboratory testing
Broad applicability; used by many kinds of organizations
Detailed; applies specifically to medical laboratories
Uses consensus process in developing standards
Uses consensus process in developing standards
Background of quality management in clinics:
o        Laboratory Proficiency Testing Program (LPTP)
In 1974 LPTP was formed to provide Ontario laboratories with mandatory external quality assurance (EQA) testing materials.
o        Laboratory Review “Quality Improvement Model”
1992-1994 Provincial Laboratory review recommended a quality improvement model that would integrate both the EQA and an accreditation process.
o        Quality Management Program-Laboratory Services (QMP-LS)
2000 QMP-LS was formed. They would continue to provide EQA and a second arm was formed to administer an accreditation program Ontario Laboratory Accreditation (OLA).
Work flow of a health care clinic
A systematic diagram of work flow in a health care clinic shows that there are mainly 7 stages of work. All of these require Quality management system in one way and another.
Principles for Building a Quality Management plan for Health care Clinics:
Beat Widler (2012), found that the observation that quality must be understood in context. Audits, he noted, cover only about 2% of clinical-related activities, and so continuous risk evaluation should be employed by research sponsors to ensure ongoing, comprehensive quality assessment through all stages of therapeutic development. Such evaluation comprises three steps:
·                     Determine the basic risk profile
·                     Continuously evaluating key risk indicators (KRI).
·                     Defining overall entity risk
Essential elements of quality management system
ISO 9001 defines the process models to maintain a better quality of work place either it’s a business or industries (ISO, 2000). ISO 15189 defines the quality standards for medical laboratories or health care centers (ISO, 2003). The essential elements for QMS include:
o        Documents and Records
o        Organization
o        Personnel (Human resources, Job qualifications, Job descriptions, Orientation, Training, Competency assessment, Professional development, Continuing education”.
o        Equipment (acquisition, installation, validation, maintenance, calibration, troubleshooting, service and repair records)
o        Purchasing and Inventory (vendor qualifications, supplies and reagents, critical services, contract review, inventory management)
o        Process Control (quality control, sample management, method validation, method verification)
o        Information Management (confidentiality, requisition logs and records, reports, computerized laboratory,  information systems (LIS))
o        Assessment: External and Internal (audit reports, inspections, audit programs)
o        Process Improvement (opportunities for improvement (OFIs), stakeholder feedback, problem resolution, risk assessment, preventive actions, corrective actions)
o        Customer Service (customer group identification, customer needs, customer feedback)
o        Facilities and Safety (safe working environment, transport management, security, containment, waste management, laboratory safety, ergonomics).
Complexity of Laboratory System
There can be various complexities while collecting the samples from the patient or clients in the laboratories. Even a minor mistake can lead towards wrong treatment and other complications. These complexities can be divided in following three terms:
·                     Pre examination complexities
When the clients comes for diagnosis or checkup there are many space for errors and complexities to occur that can lead towards wrong detection of disease or other issues. These issues arise while:
o        Preparation of client or patient.
o        Error or complexity while collecting the samples (blood, urine or other) from patient or client.
o        There can be personnel competency in test evaluations.
o        There can be mistakes reception and handling of samples for example, wrong labeling.
o        There can be complexities in transporting the samples, for example breakage of sample storing bottles.
·                     Examination complexities
Even when the client is being examined there are chances of errors. For example:
o        There can be complexities during the examination of clients that involve the quality control sampling.  
·                     Post examination complexities
After examination when the results are prepared there can be issues like:
o        Issues of recording keeping and delivering the wrong reports to the clients.
Other Quality issues in health care clinics:
 Salewski JP. (2011) found that there are some common deficiencies in quality management systems of different clinics investigated. These include:
·                     Follow up on investigation plan and signed investigator statement, failure.
·                     Deviation from the Protocols
·                     Improper record keeping
·                     Inadequate investigational product  accountability
·                     Inadequate subject protection( it includes the  informed consent issues)
·                     Adverse Event (AE) recording and reporting
·                     Environmental and safety issues (improper storage and disposal of infectious or radioactive wastes).
     Continual quality improvement in health care clinics:
Shewart (1920) was the pioneer of continual quality improvement introduced firstly for industries in the United States.  Herman, Julie and Regner et al. (2000) stated the principles of CQI in perspectives of health care clinics are listed below:
o        The health care is not a single process it is a series of processes in a system leading towards outcomes,
o        The quality processes are affected by the defects in processes.
o        The improvement in quality can be achieved on the basis of knowledge and efforts of the individuals working on the workflow processes.
o        The main focus for improving the quality should always be the satisfaction of patients and customers.
o        The main focus of quality improvement should be the priority of problems.
Impact of the organization's culture
McInnes DK et al (2007) conducted a research in medical clinics to find out the impact of a quality improvement on systems, processes and structure. The results indicated that the survey response rate was about 85%. There was the greater availability of computers, most of them attended local and national conferences. It can be concluded from this research that a quality improved collaboration system of clinic resulted in modest organizational changes.
 Overcoming resistance to change
Robert James Campbell & EdD (2008) presented the idea for dealing with the changes in management In health care clinics and hospitals.



KOTTER’S CHANGE MANAGEMENT MODEL
Kotter is one of the most widely regarded thinker and philosopher known for change model. He believed that an eight step approach can be used to manage nonlinear organizational change. These steps are:
1.                   Increase urgency
2.                  Build guiding teams
3.                  Get the vision right
4.                  Communicate for buy-in
5.                  Enable action
6.                  Create short-term wins
7.                  Don’t let up
8.                  Make it stick
According to Kotter the first three steps are categorized as “creating a climate for change”.  The steps 4-6 are categorized as phase two that means “engaging and enabling the whole organization”. And the final phase is “implementing and sustaining the change,’’ including step 7 &8.
Impact of organizational culture
·                     Client considerations
The Organizations depend on their customers and therefore for a quality management in clinics the clients are mostly the patients who may consider QM in terms of:
o        Future needs & expectations:
§  Understand current and future needs of customers in terms of treatments, laboratory instruments and other facilities.
§  meet customer requirements, and
§  Strive to exceed customer expectations.
o        Proper diagnosis
The first and foremost thing is the proper treatment of customers. It builds a good image of the clinic and attracts more customers.
o        Time
The other main issue to be considered is the time and availability of the staff. If the doctors and staff are not coming on the exact times it builds a bad impression.
o        Accuracy of results
When the patient is diagnosed or tests are conducted than the patients are looking for accurate results so that the proper treatment can be carried out but any flaws in results can lead towards wrong medications.
o        Cost:
Cost is a major constrain for most of the patients at health care clinics. Often the clinics are very high visiting fees.
o        Cleanliness and safety
Another quality management issue to the customers is regarding the cleanliness and safety of health care clinics. If the biomedical waste is improperly stored and there are chances of exposure of patients than it will have bad impact on clients. This infectious waste has potential for developing diseases to customers. Other safety issues include the safe disposal of used syringes, properly sterilized equipment in treatment and surgery.
·                     Practitioner considerations
The practitioners include the laboratory workers, lab attendants and the doctors.
Action plans and strategies:
Policy
Strategies followed
Procedures and record documents
Documents
§     Create, review and approve new documents regarding QM in Clinic.
§     Improvements in documents
§     Control of documents
§     Use of external sources of documentation
§     Record keeping

§     Heir authentic people for developing the strategies
§     Find where there is
need of improvement
§     identification, classification, and review of documents

§     Title, date of issue, number of pages, name of author, authority of issue, source identification.
§     Changing or improving document & implementation in clinic
§     Improvement in the record keeping periodically or when needed. Disposal of confidential records in proper way
Quality management in clinic in compliance with all governmental and organizational requirements
§     Define the level of authority and responsibilities
§     Internal auditing


§     Keep a record of documentation of what activities are performed along with the authority names.
Ensure methods to meet the needs of patients and needs of clinical personnel’s responsible for patient care
§     Executive management for designing, implementing, maintaining and improving the QMS
§     Perform ongoing strategic planning that centers on quality
§     Monitor the budget and rank the projects
§     Develop and maintain a quality manual.

James M. Levett (2005), a chief medical officer of Physicians at Clinic of Iowa propsed six procedures required by the standard for ISO 9001:2000 include: Control of documents, Control of records, Control of internal audits, Control on nonconformities, Control of corrective actions, Control of preventive actions.  
Some benefits to Health care clinics:
Mickey Christensen (2010) stated some benefits to health care clinics although he withheld the names of the clinics. These commonly found benefits were:
§     By adopting QM more consistent approach is provided for care.
§     It saved about $130,000 per year by better planning and management.
§     Doctors feel data from calibrated equipment more reliable and accurate.
§     Reduced number of forms and documents.
§     Improved overall efficiency.
§     Improvement in patient satisfaction
Conclusion
The quality management system is very important need for managing the processes and activities in a health care clinic. It is required along every step of the work flow process either its pre examination, during examination or post examination. The Essential elements of QM in HCC include personnel’s, documentation records, equipment, personal control, process control, and purchase and inventory. For adopting a QMS in a HCC it’s necessary to keep proper records and maintain documentation, involve internal and external QM teams, audits, and inspection and implementation programs. There are many benefits for adopting QMS which includes the improvement of efficiency, meeting universal standards, clients’ satisfaction and increase in customers.



References
Campbell,R.J. (2008). Change Management in Health Care. The Health Care Manager, Volume 27, Number 1, pp. 23–39
Christensen,M. (2010). Quality management in health care organizations. TQM Systems. Baton Rouge. LA, USA.
Herman, R.C.,Ranger,J.L., et.al. (2000). Developing a Quality Management System for Behavioral Health care. The Cambridge Health Alliance Experience, Center for Quality Assessment and Improvement in Mental Health, Cambridge, MA 02139.
 James, B. (1989). Quality Management for Health Care Delivery, the Hospital Research and Educational Trust, Chicago.

Levett,J.M. (2005). Implementing an ISO 9001 Quality Management System in a MultiSpecialty Clinic. Clinic of Iowa in Cedar Rapids. Iowa.
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