Overview

This chapter deals with the important functions of the primary care center's operation. It is important to address each element up front before opening your doors to patients. By clearly establishing policies and procedures from the onset, many problems can be avoided.

THE PATIENT RECORD SYSTEM

The patient record is the prime information source for health care practitioners. It is where the practitioner legally documents the care given to the patient. As such it requires a system that is accurate, legible, and permits the prompt retrieval of information by practitioners while at the same time maintains patient confidentiality. The system needs to provide for the timely collection, processing, maintenance, storage, retrieval and distribution of patient records.

A host of practice management publications from reputable sources are available to help you develop a patient record system. To access them, it is recommended that you go to the publication links of organizations, such as the American Medical Association ( http://www.ama-assn.org), Medical Group Management Association ( http://www.mgma.com), or the American Hospital Association ( http://www.aha.org). Oftentimes the guidance you seek regarding selection of a record jacket, determining content and forms, selecting a record identification system, choosing the best storage system, etc. will be covered in chapters of broader practice management publications rather than free-standing medical record guidance alone. In browsing what is available, you will also notice the emergence of many new publications devoted to Electronic Medical Records (EMRs). If you have a particular interest in EMRs, you may find the following Web site useful, http://www.elmrelectronic-medical-records-emr.com.

Other resources relevant to the development of clinical record systems are accreditation standards generated by the regulatory bodies. Two such organizations include the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Accreditation Association for Ambulatory Health Care (AAAHC). Their Web sites are http://www.jcaho.org and http://www.aaahc.org respectively. Both sets of standards specify the characteristics of effective clinical record systems. In addition to specifying that the records be accurate, legible, documented in a systematic and consistent manner, comprehensive, up-to-date, and readily accessible, the standards cover the following topics:

• role of patient records personnel;
• type of policies needed pertaining to patient records;
• record contents;
• information required during each patient visit; and
• transferring or acquiring patient records.

In addition to the medical record standards developed by the previous two accreditation bodies, health centers planning to participate in Medicaid managed care should also become familiar with the standards for medical records that have been developed by the National Committee for Quality Assurance (NCQA) and the Medicaid Managed Care Quality Assurance Reform Initiative (QARI). The NCQA's Web site is http://www.ncqa.org. A summary of these standards is included in Exhibit 13-1.

Exhibit 13-2 presents an example of information that may be contained in the patient's record. It should be noted that although this example is medically oriented, it can be adopted for dental, mental health and substance abuse services. Access to patient records should be restricted to only those individuals directly involved with the patient or utilizing the data. All information in the record should be considered confidential. It is important for you to develop written guidelines that clearly govern access to the records by outside parties such as lawyers, and release of the records to patients and their families. In order to ensure patient confidentiality in accordance with Federal law, all health care organizations must be familiar with the provisions of the Health Insurance Portability and Accountability Act (HIPAA) of 1996. There are numerous sources of HIPAA guidance to help you. For example, you may wish to order publications such as HIPAA Training Handbook for Physicians or Fast Lane to HIPAA Compliance from http://www.hcmarketplace.com. Additionally, there are some very helpful Web sites such as the HIPAA link maintained by the Bureau of Primary Health Care at http://bphc.hrsa.gov/hipaa. The aforementioned Web site is also linked to an excellent HIPAA checklist entitled, Example Risk Assessment Plan for Community Health Centers for HIPAA 1996. Further current information about HIPAA may be obtained by consulting the following websites: http://www.cms.hhs.gov/hipaa and http://www.hipaacomply.com.

TREATMENT PROTOCOLS

Practitioners are influenced by a wide range of factors when they make decisions about patient care. The public and professional's desire to do the "right" thing for patients is now being translated into tools that will assist practitioners with their decisions. These tools come under the domain of several labels - treatment protocols, practice parameters, and practice guidelines, to name three. The purpose of these tools is to simplify complex decisions and express the standards of practice in particular circumstances. These decision-making tools can accomplish several objectives. They can:

• address the best approach utilizing a specific piece of technology;
• specify the optimal approach to a specific patient condition;
• serve as the "gold standard" to which everyone aspires; or
• serve as the standard for the provision of care.

Whatever their objective, they are a useful tool for imparting knowledge derived from the scientific analysis of information in a format that is useful to practitioners. Such knowledge is often referred to as Evidence-based Medicine (EBM).

Treatment protocols are generally developed by organizations that have the requisite expertise and skill necessary to synthesize a broad array of information - studies, clinical experience, and expert opinion. Quite frequently, these organizations are professional associations that then make the protocols readily accessible to the population interested in using them. Other organizations that have developed treatment protocols include the Harvard Community Health Plan in Boston and the Geiger Institute in Philadelphia. Resources appropriate to nursing include "Patient Care Guidelines for Nurse Practitioners" by Hoole, Greenberg, and Pickard, and "Clinical Guidelines in Family Practice" by Uphold and Graham. In addition, the American Medical Association (AMA) has worked with 65 organizations to compile over 1,300 practice parameters to date. A directory is available from the AMA Office of Quality Assurance and Healthcare Organizations ( http://www.ama-assn.org).

Health centers that wish to learn more about evidence-based, "best practice" treatment protocols and guidelines are encouraged to contact their particular state's Primary Care Organization (PCA) clinical network. Additionally, those who may wish to conduct their own research into this subject may find the following Web sites helpful.

Institute for Clinical Systems Improvement - http://www.icsi.org
Primary Care Practice Guidelines - http://www.ncsf.edu/resources/guidelines
National Heart, Lung, and Blood Institute - http://www.nhlbi.nih.gov/guidelines
National Guideline Clearinghouse: http://www.guideline.gov
Agency for Healthcare Research and Quality - http://www.ahcpr.gov/clinic
Evidence-based Research Center - http://www.ebmny.org
BPHC Evidence-Based Health Care Project - http://bphc.hrsa.gov/quality/BestPractices.htm

Treatment protocols, once developed, need to be reviewed regularly and updated to ensure that they provide the appropriate guidance to practitioners and do not hinder health care delivery. When used appropriately, they can serve as a valuable means of assessing practitioner performance.

CASE MANAGEMENT

Case management is defined as a system of coordinating and monitoring patient care and available resources. Case management systems and services have different levels of sophistication and they can be used for specific patient populations as well as the general patient population. In some organizations, there is an individual hired to assume the responsibilities of a case manager. In other organizations, the task of case management is assigned to one or more staff. The essential components include:

• identification of patient/outreach;
• patient assessment;
• case planning and design;
• treatment plan development;
• service delivery and referral management and coordination;
• financial review and assistance;
• patient assistance throughout the process;
• follow-up and monitoring;
• education and counseling;
• case record maintenance; and
• service termination

These components work together to ensure and document the provision of services through coordinated and continuous care for patients.

A general case management system should allow for recall for routine preventive services and chronic disease care. Also, the system should allow for tracking patients who are referred to specialists and other off-site services, require x-ray or lab, or are hospitalized. The system should also allow for the assessment of the user population - its age, gender, race/ethnicity, diagnoses, care providers and services rendered. Be sure to check with your site's Patient Management System (PMS) vendor to see if a compatible case management/patient tracking system module is available before purchasing or developing any alternative stand-alone systems to help you manage patient care. If a suitable module is available, it will surely preclude duplication of data already in your PMS.

For specific patient populations, check with your state health department to determine if any case management services are funded. For example, many states will reimburse for maternity case management services that include intake, assessment, patient tracking, service coordination, patient education and outreach, and follow-up. It may require a caseload of 50 to 60 patients to justify the case management function. However, when the volume is sufficient and the funding available, case management services can help to ensure appropriate and effective care. Exhibit 13-3 is a sample of a perinatal tracking pathway process used by one organization to manage its perinatal cases. Case management services are often reimbursed by Medicaid under an option called Primary Care Case Management (PCCM). Physicians who participate in the Medicaid PCCM program receive a set fee per enrollee per month (e.g., $5.00) to serve as a "gate-keeper" for ancillary and specialty service referrals in addition to regular fee-for-service reimbursement for all primary care services rendered by the gate-keeper.

PATIENT FLOW SYSTEM

Patient flow and appointment systems need to foster continuity of care and minimize appointment and office waiting time, as well as "no-shows." Patient flow and appointment systems should include triage for emergencies and walk-in patients, as well as for the provision of other special health services such as immunizations, pregnancy tests and so forth. Key tasks you will need to undertake include the following:

• selecting a receptionist/bookkeeper;
• setting up an appointment system;*
• establishing a good relationship with patients;
• maintaining efficient patient flow;
• handling referrals;
• obtaining information on new patients; and
• building front desk efficiency.

*Note: Most PMSs have an appointment scheduling module.

HOSPITAL LINKAGES

Ideally, physicians, dentists and nurse-midwives should have admitting privileges and staff membership in one or more hospitals where they are able to follow their patients and provide the necessary continuity of care. When direct coverage is not possible, the organization should ensure that referral arrangements are in place for hospitalization and discharge planning. It should be noted that state laws and local hospitals vary in their allowing admitting/staff privileges for various professions.

ADJUNCT SERVICES

It is expected that your primary care center will ensure the availability of needed services for its clientele either through direct provision or through contractual arrangements with providers in the community, e.g. call coverage, after-hours coverage, etc. If you elect to provide these specific services directly, it must be done in a manner that ensures patient safety. Some of these services are highlighted below along with a brief description of service expectations. If patients are to be referred outside the center for specialty services, these referrals should be tracked through the established case management system.

• Anesthesia and Surgical Services. These services must be provided in a safe environment by qualified practitioners taking into account the physical, material and human resources available within the organization. It is expected that policies and procedures address at least the types of procedures that can be safely carried out, where the procedures may be performed, the number and type of staff to be present and their responsibilities, staff qualifications, the frequency of safety checks for machinery and physical space, patient rights and consent, infection control practices, monitoring and recording of patient status, patient discharge, and emergency back-up plans.
• Emergency Services. These services, if advertised, must be available 24 hours per day with a qualified practitioner present to render the care. It is expected that the organization establish the necessary linkages with other emergency care organizations (fire, ambulance, police, hospital, etc.) and be able to immediately provide for laboratory and radiology needs of the patient. Policies and procedures should cover the range of services offered, hours of service, triage system to be used, and the number, type and qualifications of staff to render the care.
• Pharmacy Services. When pharmacy services are provided, it is expected that policies and procedures cover the appropriate, safe and effective storage, preparation, dispensing, and administration of drugs. It is also expected that pharmacy services meet the needs of the patients and that they are delivered in accordance with professional practice and legal requirements. If your practice site is also a Federally Qualified Health Center (FQHC) or approved as an FQHC Look-Alike, be sure to participate in the PHS 340B Drug Pricing Program in order to derive the benefits of significant cost savings. For additional information about this program, please visit the following Web site: http://bphc.hrsa.gov/opa.
• Pathology and Clinical Laboratory Services. The amount and type of clinical laboratory services to be provided should meet the needs of the individuals served by the organization as determined by the clinical staff. It is expected that the service provided meets applicable federal and state standards for clinical laboratories and that staff are qualified and competent to perform the tests. Even when only limited testing is performed, there is a need for policies and procedures that address specimen collection and preservation, equipment performance and testing.
• Radiology Services. These services will be dictated by the needs of the patient population but it is expected that the center will assure their availability. At a minimum, diagnostic and treatment services should be available to your patients. Provision for interpretation of x-rays and timely report/record keeping by qualified personnel is an important component of this service. If you elect to provide radiology services at your center, policies and procedures are needed to cover the safety and quality aspects of radiology, e.g., adequate space, equipment, supplies and staffing and the identification of persons authorized to order radiology services. If you decide to contract for radiology services, procedures for appropriate referral must be clearly outlined.

QUALITY MANAGEMENT

The issue of quality - its definition, measurement, and assurance - has taken on increased importance in recent years. Quality management is a shared responsibility among the entire interdisciplinary team and encompasses several important concepts:

• quality of care which can be defined as the "degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with professional knowledge;"
• quality assessment where the quality of care for individuals, groups or populations is measured and evaluated;
• quality assurance where activities are undertaken to safeguard the quality of care by assessing the quality of care or service and taking action to correct deficiencies. Quality Assurance activities have been largely driven by regulators and third-party payors; and
• quality improvement where there are efforts to improve the level of performance of key processes or systems within an organization in order to meet or exceed customer needs and expectations.

Exhibit 13-4 presents sample methodologies for Quality of Care Assessment and Assurance. At the heart of continuous quality management are several basic principles. These principles, when taken together, encourage managers and practitioners to provide the best possible care and service and to heighten the satisfaction of their clients. These principles include a focus on:

• identifying "customer groups" and determining their needs and expectations. It is generally recommended that customer groups be identified by stages in the life cycle, such as pediatric, adolescent, adult, geriatric, perinatal, etc.
• preventing rather than reacting to problems;
• streamlining, designing and standardizing cost effective work processes and systems;
• addressing indicators of quality care;
• leading and empowering staff to make decisions within the scope of their responsibility that will result in increased customer satisfaction; and
• using data rather than perception to drive decision making.

See the reference list at the end of this Chapter for resources that can aid the transition from traditional quality assurance to continuous quality improvement. While these references differ somewhat on the specifics to be included in a quality management system, there are some common elements in an effective system, which include the following:

• written description of the quality management program which notes components, responsibilities, and activities and is evaluated and updated at least annually;
• governing body accountability for the program and annual activities plan;
• substantial involvement of practitioners and management in quality management activities;
• adequate resources to carry out the program and planned activities;
• identification of important aspects of care and services that include high volume and high risk services;
• methods to measure, monitor and analyze quality of care including quality indicators that are specific, measurable, achievable, and relevant; and
• methods to improve quality of care based on an effectiveness evaluation of the follow-up system and activities.

In addition to the references noted at the end of this chapter, a particularly good description of CQI, authored by Dr. Marc Babitz, is included as Exhibit 13-5.

In addition to the foregoing general principles common to all Quality Management (QM) systems, readers should also become familiar with other potential components of QM such as the following:

Peer Review - Peer review is the process by which the performance of professionals is assessed. Using professionals with similar types of degrees of expertise, the care provided by one practitioner is evaluated by another (e.g., the evaluation of one dentist's practice by another dentist).

Utilization Management - Utilization management is a term used to cover the evaluation of patient use of health care resources. It is expected that each organization will develop policies and procedures that will evaluate the necessity of care, the criteria used to determine appropriate use of services, information sources to be utilized and a process for reviewing and reporting on instances where inappropriate or excessive utilization of services occurs.

Patient Satisfaction - Patients expect that they will be treated in a manner consistent with their basic rights as a human being. Consequently, it is important that the organization develop policies and procedures that protect and enforce these rights. Additionally, your center needs to ensure that patients are satisfied with the quality of care provided. Some of the topic areas to be covered by the policy and procedures include:

• patient rights - considerate and respectful care, confidential treatment of personal information, information about his/her diagnosis, participation in decisions that affect his/her care, adherence to advance directives, acceptance and refusal of care, information about research projects involving him/her;
• patient complaints - methods to identify, resolve and report action;
• patient education/information - about service availability, fee and fee payment system, rights and responsibilities, methods of communication; and
• patient information materials - accessible, easy to understand, readable, in language(s) of major population served.

It is recommended that your center develop a system for assessing patient satisfaction with services. This system can include the periodic sampling of patient complaints and requests to change practitioners and/or organizations. Plan to conduct a periodic survey of patients to identify sources of satisfaction and dissatisfaction. It is anticipated that this information will be reported to the practitioners and other personnel and that it will be a part of the quality management system where improvement is desired. Additionally, it is recommended that your practice site develop its own customized Patient Bill of Rights and Responsibilities statement to be prominently displayed at your facility and in your patient literature. A sample statement of Patient Rights can be found at http://www.consumer.gov/qualityhealth/rights.htm; and sample statements of Patient Responsibilities can be found at http://www.cc.nih.gov/participate/legal/responsibilities.shtml.

Clinical Outcome Measures - It is expected that the services provided by a primary care site will positively impact the health status of the community. The extent to which impact is possible is determined by the number, amount and type of services provided and the population being served. Nevertheless, it is important that the organization take the time to establish outcome measures as part of the overall clinical strategy. These measures should tie into the national Healthy People 2010 initiative noted in chapter 2 which focus on health promotion and disease prevention. Your site will also need to establish baseline measures for specific outcomes and develop a three to five year plan for realizing its goals. In order to help you get a "head start" toward developing a Clinical Outcome Measures program for your site you may wish to review the Clinical Outcome Measures Instruction Manual included as Exhibit 13-6. This excellent reference was produced by the Connecticut Primary Care Association and includes an overview of lifecycle specific indicators, audit forms, performance standards and management plans. As previously noted your site's progress toward improving its clinical performance relative to an existing baseline for each clinical outcome measure should be tracked over time and for that reason a copy of a Sample Clinical Outcome Measures Progress Chart is included as Exhibit 13-7. Should you wish to have further dialog regarding interpretation and/or use of the Clinical Outcome Measures Instruction Manual you are welcome to contact the Connecticut Primary Care Association via their website: http://www.ctpca.org or by phone by calling 1-888-294-2722.

ENVIRONMENTAL QUALITY

A system is needed to ensure that the environment for your staff and patients is safe and free from hazards. The system needs to include infection control, safety management and plant and technology management components. The reader is referred to the JCAHO standards manual for what is expected by way of a minimal standard to address environmental quality. Below, we highlight some of the key points.

Infection Control - Whatever the program, it must be all inclusive including both patient care and support care services. It needs to specify what activities will be undertaken to prevent infection, both in patients and staff. This is particularly true regarding such things as needle disposal and dressings in an outpatient setting. Specific activities can include: isolation precautions and procedures, infectious waste containers for hazardous materials, and cleaning supplies in patient care areas. It also needs to specify the procedures in relation to sterilization, stored sterile materials, and laundry services.

Safety Management - A safety management system is needed to ensure that the physical environment reduces the risk of human injury. Activities to be included in the safety management program include:

Physical Plant:

• evaluation of safety of the building, the grounds, and the fixed power equipment used by personnel. The evaluation should occur at least semiannually with a report that identifies issues and their resolution;
• system for identifying, reporting and resolving safety issues. (The system should have a mechanism for reporting all incidents involving property damage, occupational illness, or patient, visitor or personnel injury.);
• evaluation of the clientele and the specific safety needs of the groups served (e.g. physically disabled, elderly, children);
• communication with management and board of directors at least annually on issues pertaining to plant safety;
• training and education for all staff on plant safety policies and procedures; and
• emergency procedures to deal with unplanned disasters that disrupt patient care. The procedures need to be tested at least twice per year to ensure that staff understand their roles and that safety provisions are adequate and effective.

Fire:

• ensure compliance with the National Fire Protection Association provisions;
• a smoking policy which is posted and followed;
• a fire safety program that covers inspection and testing of all fire related equipment - alarms, detection systems, extinguishers, smoke management systems;
• training and education for all staff on fire drills including specific duties and evacuation procedures; and
• process for ensuring that new products - furnishings, draperies, etc.-meet fire safety requirements.

Equipment:

• assess and control clinical and physical risks of fixed and portable equipment used in patient care; and
• develop a policy for testing all new and existing equipment regularly.

To obtain the most recent environmental quality standards for your facility, you may wish to order a copy of A Guide to Environment of Care Management Plans from the publications link of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Web site at http://www.jcaho.org.

ACCREDITATION

Accreditation is a voluntary process by which a primary care center is willing to be evaluated against a set of standards designed to measure the quality of care provided by an organization. Surveyors who are practicing professionals take time from their schedule to visit other organizations and undertake a peer review process using established accreditation standards. The standards are generally developed over many years by experts in the field and they are often modified over time by the very organizations whose performance is being measured. The standards relate to characteristics of an effective quality oriented organization, and include almost every area of an organization from administration and management to clinical care and records. Organizations seek accreditation to:

• find new ways to improve care and. services;
• increase efficiency and reduce costs;
• motivate staff and instill pride and loyalty;
• strengthen public relations and marketing efforts;
• demonstrate public accountability; and
• deliver high quality patient care.

In ambulatory care, there are two recognized accrediting organizations-the JCAHO and the Accreditation Association for Ambulatory Health Care (AAAHC). Both organizations publish their standards and survey process. Even without undertaking a survey, the standards enable an organization to understand and learn about those attributes that are deemed necessary to operate a "quality" organization. For further information regarding accreditation standards and protocols, visit the JCAHO Web site at http://www.jcaho.org and/or the AAAHC Web site at http://www.aaahc.org.

CREDENTIALING OF CLINICAL STAFF

A process is needed to ensure that all practitioners are appropriately credentialed to practice in the state. The process needs to cover the original credentials as well as recredentialing, recertification and/or reappointment of licensed practitioners. The process will include:

• initial verification activities and a statement from the practitioner;
• periodic review and verification of credentials similar in nature to the initial review (at least every two years);
• review of quality management data when recredentialing occurs;
• method for reporting to appropriate authorities serious quality deficiencies resulting in termination or suspension; and
• appeal mechanism for suspension or termination.

In the initial credentialing process, information to be verified from primary sources include:

• current license to practice (from state licensing body);
• clinical privileges in good standing at any hospitals where admission privileges have been granted;
• graduation from an appropriate school and completion of a residency program and/or certification program, as appropriate;
• work history;
• current, adequate malpractice insurance; and
• professional liability claims history.

Credentialing and privileging inquiries may be undertaken in a number of ways: some practice sites conduct the entire investigation themselves; others choose to partner with their local hospital which must also maintain its own credentialing and privileging system; and still others may delegate some or all of the work to a commercial source such as the Credentialing Resource Center ( http://www.onlinecrc.com). Whatever path you choose, you should be sure that your inquiry has included the National Practitioner Data Bank (NPDB), which may be referenced from http://bhpr.hrsa.gov/dqa, 301-443-2300, and the Healthcare Integrity and Protection Data Bank (HIPDB) which can be referenced at http://www.npdb-hipdb.com, 800-767-6732. With regard to the data bank query process, please note that in lieu of registering with the NPDB/HIPDB themselves, some Centers require physician candidates to perform their own self-query through NPDB/HIPDB and provide a copy of the results in a sealed envelope.

When collecting information from the practitioner, it is helpful to develop an application form that is completed by the person who attests to the correctness and completeness of the information. The application needs to include information about the practitioner's:

• physical and mental health status;
• lack of impairment due to chemical dependency/substance abuse;
• history of loss of license and/or felony convictions; and
• history of loss or limitation of privileges or disciplinary activity.

CONTINUING EDUCATION

Each center needs to improve the skills, competence and performance of its health care practitioners, employed personnel and others who contract with the facility for services. An effective educational program starts with a comprehensive orientation on the mission, goals, and objectives of the organization, and training pertaining to the specific role and function of the position.

After orientation, it is important that practitioners have access to health information pertinent to the services offered by the facility. This access can be accomplished through a variety of means, including:

• Attendance at local, regional, national seminars, workshops, conferences. Contact professional and health associations to get on the mailing lists for educational program information. Remember to set aside funds to cover the cost of attending educational sessions outside of the area.
• Subscription to relevant clinical and administrative publications. Determine those books, journals and periodicals that are currently readily accessible in the community/neighborhood, e.g. hospital, university, public health agency libraries. Select a few that will keep the practitioner current in his/her field and budget for their cost.
• Linkage with local teaching facilities. Many colleges and universities offer continuing education opportunities either directly or through correspondence courses.
• Telecommunication linkages.
• Educational program teleconferencing.

Keep in mind that many states have specific continuing education requirements that must be met to keep a current license. Call your state licensing body and find out what the continuing education requirements are and ensure that your continuing education program will enable the practitioners to remain current.