http://www.medscape.com/viewarticle/549259_4

Developing Pharmacy-Based POCT Services
The process involved in developing a POCT service in the ambulatory or community setting is similar to many of the basic steps involved in the creation of any pharmaceutical care, disease management, or medication therapy management program. We will focus upon the aspects of this process that are specific to POCT. Multiple resources are available for pharmacists that provide detailed descriptions on the nuts and bolts of implementing expanded patient care services in community and ambulatory pharmacy settings (Table 1).

The steps involved in developing a POCT service include conducting a needs assessment for the pharmacy site, researching and organizing information pertaining to the service being developed, developing the program materials, implementing the service, and evaluating the service. Each of these steps will be expanded upon individually.

Conduct Needs Assessment
The first step is to assess your pharmacy environment. Before you decide what type of POCT service to institute, you need to be sure the service fits the needs of your current environment. This involves a SWOT analysis, which helps you to identify the strengths, weaknesses, opportunities, and threats surrounding your current practice. Strengths and weaknesses are those factors that are internal to your practice, whereas opportunities and threats are external factors. An example of a completed SWOT analysis can be found in Figure 1. This process may seem overwhelming at first. The key is to take the analysis step by step. Begin with your patient population; ask the question, "Who are the patients that currently visit my pharmacy?" This task can be accomplished through prescription record reports and experience in the environment. Most current dispensing systems have the capability of producing ad hoc reports, from which you should be able to determine characteristics of your patient population, such as age, gender, residence, and the most common chronic diseases in your patients. A general estimation of the incidence of chronic diseases in your patients can be determined through an assessment of the frequency of certain indicative medications dispensed. Ask yourself, "How many prescriptions for diabetes medications do we dispense per month?" Compare this number with the number of blood pressure or lipid medications dispensed. Also, realize that pharmacists, technicians, and other staff practicing at the pharmacy site may have a good perspective on the types of patients visiting the pharmacy and can help provide insight on the types of POCT services that are most likely to be successful.


SWOT Analysis—Oasis Pharmacy

Another aspect of the SWOT analysis involves gathering the perspective of multiple stakeholders who may influence the success of the POCT service. To identify potential internal and external barriers and successes, assess the interest and potential for involvement in the service by patients, health care providers in the community, and pharmacy staff. This can be done using surveys, physician office visits, or focus groups; focus groups are especially effective for internal staff assessments. While determining the physicians' perspectives on your upcoming service, investigate collaborative opportunities with these local physician offices. From your initial prescription records report, you may also be able to determine which physicians prescribe most of the prescriptions filled by the pharmacy. You may already have existing relationships with one or more physicians. Be sure to let them know what you are planning to do, and invite them to be involved.

Local health departments and/or community groups should also be consulted. Some local resources may already provide some POCT services, such as blood glucose screening, with whom you could partner. These organizations may be able to identify larger scale community health needs. The local health department is an excellent place to start; beyond their own programs, they often can share information on most of the local community groups that offer health services. Through this thorough investigation of community resources, you will feel confident in choosing a POCT service that fills a need within your community.

Practice Site Restructuring
Along with the evaluation of the perspectives of your pharmacy staff, you want to evaluate other aspects of your pharmacy site. These include staffing, time, workflow, and space. Ask yourself, "How will this POCT service fit into my current environment?" Assess your current workflow. Consider pharmacist overlap, the hours the pharmacy is open relative to prescription volume, and technician responsibilities. When evaluating the time required for POCT services, include not just the time for laboratory testing and patient care activities but also the time for documentation and follow- up. Determine whether you will provide POCT services by appointment, on a walk-in basis, or both. You may need to schedule appointments before and after business hours if you have limited staffing, or you may be able to conduct screenings during times of pharmacist overlap. Be sure to choose times when you are not rushed. This ensures that both you and the patient have an effective interaction and reduces the risk of laboratory error. Involve your entire staff in the evaluation of the current workflow and job responsibilities of each individual; this will provide you with the most accurate picture of your current work environment.

An integral part of the implementation of a POCT patient care service is securing a designated area to provide the service. POCT must follow the state and federal regulations for privacy and safe laboratory practices; thus, you will need to have either a private patient-counseling area or a procedure for ensuring privacy in a semiprivate area to conduct POCT and adequately counsel patients on their results. Be creative; if you have a small store with no office, you may be able to create a small counseling area in your storeroom with a desk and dividers. Take a detailed look at your pharmacy site and determine what may need to be changed to create an environment conducive to dedicated POCT and patient care.

Research and Organize
This second step of the process of developing POCT patient care services involves information gathering, interpretation, and decision making. While the needs assessment plays a major role in deciding what type of service to develop, this step helps you make logistic decisions. These include determining what changes need to be made in the pharmacy to meet federal and state regulations, what training your staff needs, and what monitor to use. For help in this step, consider employing student pharmacists and pharmacy residents. Research is a great way to involve them in the process of implementing a service. Involving student pharmacists and pharmacy residents may also reduce your workload, while providing excellent hands-on experience for these trainees. Think about collaborating with a local university or college of pharmacy. Collaboration with these groups may provide exposure to innovative program development ideas and access to additional resources such as libraries or grant opportunities.

Federal and State Regulations
The federal and state regulations that must be followed to legally conduct POCT are a major consideration, especially since these differ from those governing other typical pharmacy activities. The first consideration is state law. You must be sure that pharmacists are permitted to perform POCT according to your state's scope of practice for pharmacists. Your state board of pharmacy can provide you with this information.

The next step toward compliance with governmental regulations is to apply for a CLIA waiver. The final CLIA regulations, approved in 1992, establish quality standards for all laboratory testing; ensure accuracy, reliability, and timeliness, regardless of where testing is performed; and base laboratory requirements on complexity of the test being performed. In accordance with these regulations, the Centers for Medicare and Medicaid Services (CMS) issues three levels of certificates based upon complexity of the laboratory tests being performed, and these must be applied for and granted by CMS to all laboratories. A CLIA Certificate of Waiver is the type of certificate that is required to conduct the most basic types of laboratory testing, including POCT. CLIA requirements may differ from state to state, so it is important to consult your state CMS office to determine the specifics for obtaining and maintaining a CLIA Certificate of Waiver. The basic process for applying for and keeping a "CLIA Waiver" involves filling out a CMS-116 form, sending the application to the State Survey Agency, paying the biennial certificate fee, and following manufacturer guidelines, both for procedure and quality control. The entire process, starting with the completed application being sent, takes generally 2–3 months. To maintain your CLIA license, you must also agree to permit announced inspections by CMS. The purpose of these inspections is to ensure the quality of the POCT being conducted in each laboratory with a Certificate of Waiver.

OSHA is the third major regulatory body with which it is important to become familiar as you develop your pharmacy's POCT service. OSHA is housed within the U.S. Department of Labor; it develops and enforces workplace safety and health regulations in an effort to save lives, prevent injuries, and protect the health of America's workers. Nearly every working person in the United States is covered under OSHA. Some common exceptions include miners, public employees, and self-employed individuals. OSHA regulations cover every aspect of workplace hazard avoidance; however, when considering POCT, focus your research on OSHA regulations for health care workers and needlestick precautions. As was mentioned with CLIA, consult your regional or state office since OSHA requirements also vary accordingly. General regulations put forth by OSHA related to POCT include the consistent use of personal protective equipment, such as gloves and laboratory coats, and work practice and engineering controls to prevent needlesticks through consistent and safe procedures when performing laboratory tests. Other important requirements relate to employee training, recordkeeping, and the creation and updating of an easily accessible exposure control plan to be used in the event of a needlestick. All needlestick precautions must be provided at no cost to the employee. OSHA provides numerous publications and tools to help practitioners maintain compliance with OSHA regulations, including resources in multiple languages. Table 2 provides various Web sites that can assist practitioners in navigating the regulatory requirements for POCT.

Provider Training
While you are working through the governmental regulations surrounding POCT, or once you have this research completed, you should investigate resources to support the clinical content of your patient care service and to ensure adequate and appropriate provider training. Consult national clinical therapeutic guidelines to learn about recommendations for screening and laboratory monitoring (Table 1); these will assist with the organization of your service and serve as excellent resources for clinical recommendations. After determining the need for further pharmacist development from your initial needs assessment, you may want to look into continuing education and certificate programs dedicated to training practitioners on the detailed process of caring for patients with specific chronic diseases. Ask yourself, "What are the basic qualifications each pharmacist should have to be a provider within this new POCT patient care service?"

To assist you with the answer to this question, network with other providers. Visit another pharmacy that is providing POCT patient care services to learn about its program structure, the qualifications of its pharmacy providers, and the barriers overcome and successes enjoyed through the process of development and implementation. This networking is an important part of the research and organize step. Networking can also be a valuable means of evaluating which POCT device you will use in your pharmacy.

Selecting a POCT Device
Four general areas should be considered when choosing a POCT testing device: device specifications, portability, testing procedure, and cost. Choose a device that meets your identified population's needs as well as the needs of the pharmacy. The device should be accurate and reliable, and have good manufacturer support. Since literature reviews on POCT devices are sparse,[22–29] manufacturer representatives are often your best sources for information on device specifics. Important questions to ask as you select a device include "What type of warranty does the device have?" and "Will the manufacturer provide a replacement device if this one malfunctions and needs repair?" Feel free to ask the manufacturer to provide you with references in the form of people who are currently using the device. Ask about practitioners using the device in settings similar to yours. Talk with these practitioners about what they like and dislike about using the machine. Also, ask the manufacturer for a demonstration of the device. Some companies will lend you a device for a period of time for you to evaluate it. With manufacturers, "it doesn't hurt to ask" is especially applicable.

Portability is another issue to consider. If you would like to conduct off-site health fairs, the machine must be small enough to transport easily as well as easy to assemble and disassemble. Consider also storage of the device in your pharmacy. You will need room for both the machine and testing supplies.

The device should also have a simple testing procedure. The more steps involved in a testing procedure, the greater the opportunities for error. Evaluate the time it takes for the test. Ideally, you would like a device with a very simple testing procedure that provides fast, accurate results. This increases its usability, especially if you would like to participate in screenings involving larger populations. Ask the manufacturer about correlation studies; the manufacturer should be able to demonstrate the device's accuracy in comparison to standard testing measures. You can also conduct a correlation study with the device at your site; if this is feasible, the manufacturer may be able to provide the funding for the study. There should be a quality assurance procedure for the device, often in the form of control solutions or cassettes. Consider how often this should be performed as well as the associated costs.

Finally, the overall cost of the device and testing procedure should be examined. Determine how much the testing supplies cost and how they can be purchased. Many devices have only a single source for supplies, creating problems with cost increases and supply shortages. Overhead costs should be included in your calculations. Determine the overhead needed to keep the machine running. Overhead includes utilities, occupancy, inventory costs, and liability insurance.

Many options are available for gaining access to a POCT device. While a machine may be purchased outright, you may also decide to lease it or buy a pre-owned machine to decrease your initial costs of starting a program. Be aware that manufacturers often offer promotions and rebates on monitors. Some pharmacies even partner with another pharmacy or health care provider to purchase a machine and then set up an agreement for sharing the equipment. Purchasing a POCT monitor is a significant financial endeavor. Through adequate research and preparation, your financial investment will pay off with the successful use of an accurate, reliable, and easy-to-use device.