ISO 9001 and Health Care

Easier, faster and better than other accreditation programs

by James W. Kolka

While it is in an early stage of development, the ISO 9001 quality management system (QMS) is being given increasing scrutiny by various institutions for its application to the diverse U.S. health care industry. About half a dozen hospitals and clinics have registered to the standard and several other health care organizations are in the process of preparing for ISO 9001 registration.

In 1996, American Legion Hospital in Crawley, LA, became the first hospital to register to ISO, thus gaining requisite third party approval that satisfied state licensure and certification requirements and reimbursement rules of federal and state agencies.

Here is a look at ISO 9001's 20 elements and their application for health care providers wishing to gain the quality, customer service and bottom-line benefits of certification.

* 4.1--Management responsibility. This applies to both administrative and clinical operations. The purpose is to provide the leadership, structure and resources, and establish the quality policy for the entire health care quality system; for example, the hospital, clinic, nursing home or hospice.

* 4.2--Quality system. As with other ISO 9001 applications, health care providers must establish a quality manual; create a documented quality management system (QMS); and determine how the organizational structure, procedures and processes will satisfy quality objectives. Quality planning suggests continuous improvement.

The ISO 9001 quality system requirement is designed to accommodate ongoing internal and external audits of the quality system at least once a year, and more frequently when needed to maintain the integrity of the QMS.

* 4.3--Contract review. The purpose of this requirement is to ensure that all written materials creating patient expectations are accurate. This means that customer requirements are established before engaging in a contract, and some person in the organization is responsible for seeing that contract requirements are fulfilled.

ISO 9001 4.3 focuses on the fact that the patient understands and acknowledges ethical issues such as confidentiality, privacy, security, communications in regard to anesthesia plans and consents and orders (such as admission and discharge) and formally agrees with any contracts affecting his or her rights as a patient.

* 4.4--Design control. Design control has a broad application for health care providers. It defines the steps that must be taken by the hospital when new or additional services are considered for implementation. It could involve designing a plan to control patient flow or a specific service such as a new neonatal care facility, expanded oncology program or off-site human immunodeficiency virus (HIV) treatment facility.

* 4.5--Document and data control. This clause requires that the quality system provide timely access to approved instructions for the accurate and timely provision of patient care and support functions. The right documents must be available and indexed so they are readily accessible.

The clause requires that providers establish and maintain documented procedures and that pertinent documents and data are available at all locations where operations essential to the effective functioning of the quality system are performed. All charges must be approved, and all obsolete documents must be promptly removed.

Health care providers often struggle when they find as many as 30 different versions of the same form at different locations in a health care facility.

* 4.6--Purchasing. After employee health care benefits, purchasing frequently ranks number two in expenditures for health care providers. This clause covers everything from subcontractors to medical equipment to pharmaceuticals.

It is necessary that the QMS ensure the accurate and timely purchase of materials and supplies from approved vendors. It also is an area that can create runaway costs if not effectively controlled.

* 4.7--Control of customer supplied product. Any items that are used in the delivery of services, but are not the property of the health care provider must be identified and controlled. Given the mix of internal and external customers in health care settings, this area deserves serious attention.

* 4.8--Product identification and traceability. In health care settings, this clause has a special application. Patient records and patient activities are generally connected to a particular patient through the use of unique identification numbers. Yet, for some providers who interact with patients in outpatient settings, each admission is treated as unique and not effectively linked with prior admissions or tests. This can create a paper nightmare, as well as provide inefficient but expensive patient service.

* 4.9--Process control. This clause covers a broad range of services in health care settings. Pulaski Community Hospital in Pulaski, VA, describes process control as the provision of "individualized, planned patient care in the setting that most appropriately supports the patients' needs." (It could include controlled conditions concerning the use of suitable equipment and working environment or monitoring, and control of suitable process parameters and service conditions to clearly stated criteria for workmanship.

Special processes could include areas such as surgery, obstetrics, physical therapy, radiology, anesthesia, oncology and respiratory therapy.

* 4.10--Inspection and testing. This clause involves the objective monitoring of the accuracy and timeliness of patient care and all supporting functions that affect that care. It includes quality checks, assessments and inspections at all process stages, from admission through patient discharge.

Areas included would be pre-admission testing and admission, in-processing of patients and products (for example, Is this what was ordered? Has it been tested to determine if it meets purchasing requirements and final inspection?), and patient discharge and release.

Records need to be kept, and nonconforming product must be appropriately quarantined. Clause 4.10 can make a powerful and effective impact in a health care setting.

* 4.11--Control of inspection, measuring and test equipment. The objective here is to develop a comprehensive system and training process to assure that all instruments and devices affecting quality health care have been properly calibrated.

* 4.12--Inspection and test status. This clause requires verification that assessments, inspections and tests have been performed, and a patient's medical record shows what procedures, lab tests, results and assessments have been made. The information should be readily accessible (a problem for some multisite health care providers) and retrievable (a problem for some providers who archive recent information). In short, this information should be an elemental part of a QMS.

* 4.13--Control of nonconforming product. In health care settings, nonconforming product also includes nonconforming service.

Nonconforming products could be an improperly functioning magnetic resonance imaging (MRI) machine, an in-vitro diagnostic computer that is out of calibration, in-vitro reagents that do not meet purchasing requirements, or sterile drapes in packaging that was punctured in transit.

Nonconforming services could be electrical outages that shut down a surgical room, untrained personnel conducting a patient testing procedure, or a loss of critical patient records.

ISO 9001 requires that health care providers follow established procedures to prevent unintended use or installation. Nonconforming product or service must be evaluated and its root cause determined to prevent a reccurrence of the nonconformity.

* 4.14--Corrective and preventive action. This requires special attention in health care settings. As noted, nonconformities can appear in both products and services. Fortunately, corrective and preventive action in ISO 9001 systems is also driven by the internal audit process, which identifies nonconformities, drives corrective and preventive action and reports corrective actions, processes and any quality trends to management review on a periodic basis. It is one of the strengths of an ISO 9001 QMS.

* 4.15--Handling, storage, packaging, preservation and delivery. This covers issues such as handling of patients and medical supplies, storing medical supplies, packaging and sterilizing medical devices for use in the operating room, postoperative instructions, preserving and disposing of medical supplies, andmi delivering supplies to hospital personnel and patients.

* 4.16--Control of quality records. This differs from 4.5--Document and data control because it concerns quality records. Which records must be kept and how they are stored are at issue. For liability purposes, management should consider regulatory requirements and what is stored for liability purposes.

The absence of key records can be extremely damaging to liability exposure.

* 4.17--Internal quality audits. An ISO 9001 QMS is audited regularly. Audits can be internal (first party), insurance underwriters (second party) or qualified health care registrars (third party). They could also be state licensure audits.

It is not possible to have an ISO 9001 registered QMS without a third party audit. The existence of the three-tiered audit system driven by internal audits on a frequent basis is one of the strengths of ISO 9001.

* 4.18--Training. The focus of training relates to quality. It means that health care providers must ensure that employees have the requisite skills to do their jobs.

Further, internal auditors must have quality training certificates on record. Training must be documented, and a central training records database must be preserved.

With the increased hiring of temporary employees, auditors evaluate to see if people have been trained to do their jobs.

* 4.19--Servicing. This can cover servicing equipment or providing services to customers. It also can include internal suppliers.

* 4.20--Statistical techniques. While at first blush, statistical techniques might seem remote, statistical process control has been used with great effect in health care management. It can provide significant insight to the efficacy of the system and areas that should be addressed.

ISO 9001 registration is relatively new to health care providers. The first hospital to register to an ISO 9001 QMS did so in January 1996. Registration to ISO 9001 by a qualified health care registrar provided the requisite third party approval that satisfied state licensing and certification requirements and reimbursement by state and federal agencies.

Clearly, ISO 9001 registration offers some powerful improvements to other accreditation programs. Although others are better known and recognized among health care providers, it should be noted that ISO 9001 registration offers a disciplined and systematic approach to health care as it has to other manufacturing and service industries.

While it might seem daunting at first, a documented, internally managed ISO 9001 quality management system subject to frequent external review (once established) is easier to maintain, financially less demanding and capable of offering better service to its customers.

JAMES W. KOLKA is a senior consultant with EXCEL Partnership, Inc. and author of ISO 9000: A Legal Perspective, produced by INFORM and co-published by INFORM and ASQ Press. He earned a law degree from the University of Wisconsin-Madison and a doctorate in political science and international affairs from the University of Kansas.

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