So you're responsible for preparing your surgical center for state licensure and Medicare certification and you're looking for some advice. As a registered nurse who has worked in the ambulatory surgery industry for 18 years and served as a facility administrator, a corporate director of clinical services and JCAHO coordinator, I've learned that you can boil the licensure and accreditation process down to four steps. Tackle these steps, and you'll be well on your way to getting your surgery center up and running.

Stop daydreaming
I'm sure you've already kicked back, closed your eyes and imagined what your brand-new surgery center will look like. Your vision probably includes a friendly, experienced staff and shiny, state-of-the-art equipment, satisfied patients and happy surgeons. But does it include the equally important, often-overlooked licensure and certification?

Undoubtedly you'll spend hundreds of hours pouring over architectural plans, working with contractors, grappling with finances and hiring staff. Understandably, the last thought on your mind will be licensing, Medicare certification and accreditation. But remember that without the proper center licensing and certification, your surgical center dream will never become a reality. Preparation left to the last minute will cost you dollars you didn't budget and delays you didn't plan for. So, stop daydreaming and start preparing now. Doing the licensing and accreditation piece right the first time will save you unimaginable money and a huge headache in the long run.

Do your homework
Regardless of whether you go about licensing and certifying your center alone or with a partner, do your homework. Each state's laws, rules and requirements are unique.

Because the rules and regulations for state licensing regulations and the conditions of coverage for Medicare are similar in most states, it's the differences that are typically underestimated. For example, California has no licensing criteria categorized specifically as ASC criteria. That means that, in terms of licensing, the state has to rely on acute-care hospital criteria and Medicare requirements. In comparison, New Jersey is much more prescriptive in its approach to licensing, going so far as to house the state's ambulatory surgery criteria in book format. Included in this book are specific qualifications and responsibilities for the administrator, anesthesiologists, certified registered nurse anesthetists, medical director, director of nursing services and others, as well as a requirement that there be directors of anesthesia and surgical services.

As a whole, states tend to differ in terms of their building codes/regulations and OSHA requirements. Many have unique state-level requirements such as these that must be considered above and beyond standard federal requirements.

Here's a list of the commonly held experts in the area of licensure and certification. It's never too early to start compiling a personal library of resources and information.

• Centers for Medicare and Medicaid Services (CMS). This is one of the first and most reliable sources when preparing to build a new surgery center. You can find a great deal of information at writeOutLink("www.cms.hhs.gov",1). Download all current regulations pertaining to ambulatory surgery centers and review thoroughly. The very first regulation states, "The ambulatory surgical center must comply with state licensure." If you see that your state requires licensure, you'll have to first complete that process and have evidence of a successful survey before completing a Medicare-certification survey.
• State licensing authority. Our next step takes us to the state government Web site in search of all departments that regulate health facility licensing. You may be able to find licensing rules and regulations right away, but find the contact list and start working the phones if the information isn't immediately available. You may have to call around until you reach the right person and even wait a few days for calls back, but don't give up. With a little persistence, I've always been able to find the right people to guide me to the licensing laws and regulations. Also keep in mind that oftentimes different departments are responsible for the oversight of healthcare facility construction laws and regulations. There will be different levels of review of your project for construction and licensing, as well as some co-mingling. Invest time searching for proposed legislation that has the potential to affect your project, and diligently track this legislation to its conclusion. Some state government Web sites will even give you the option to sign up for legislative tracking for your areas of interest.
• Life safety code. This book is available through the National Fire Protection Association (NFPA). Contacting this organization is a wise idea, as there are many resources available to assist you in preparing for licensing, certification and accreditation.
• Accreditation organizations. These organizations typically expand on what is mandated through CMS or the state licensing authorities by providing additional detail for meeting the required standards. You'll find them to be prescriptive in their approach. You'll also find that they have additional resources in the form of consulting services, books and educational classes. The accreditation organizations that have ambulatory surgery as a primary focus are the Accreditation Association for Ambulatory Health Care (AAAHC), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF).
• Payers. Once you determine the payer mix, start making calls to figure out what the payer's requirements are in terms of licensure, Medicare certification and accreditation. Some have no requirements, while others have any combination of the three.
• National ambulatory surgery associations. Two ambulatory surgery associations can provide you with beneficial information not only for the immediate needs of your project, but for the long run as well: the Federated Ambulatory Surgery Association (FASA) and the American Association of Ambulatory Surgery Centers (AAASC).

Learn from real-world examples
Surveyors from state licensing, Medicare and accreditation organizations will thoroughly examine your center for compliance with HIPAA regulations (as a reminder, HIPAA mandates that you secure the confidentiality of all protected health information), so don't be surprised. They'll also review your HIPAA-related policies and procedures, peruse your personnel files to see if staff have received HIPAA training and conduct interviews to test staff understanding of patient privacy standards. Although HIPAA is just one small piece of the licensure and accreditation puzzle, take every aspect of the law into consideration when designing and building your surgical center building.

I always review HIPAA-related state laws first to help me determine which laws and regulations (federal or state) prevail. From a construction perspective, it's important to consider the secure storage of medical records, the positioning of work stations and computer screens away from patients and visitors, and the type of patient cubicles necessary to assure privacy between medical staff and patients.

Now let's take a look at Medicare requirements and how they can impact your infrastructure (note that these topics often overlap with state licensing requirements). Remember that if you've already gone through your state's licensing survey, it's possible you'll have the same surveyors for the Medicare survey. If this is the case, the surveyor will be looking primarily to see how well you've cared for your initial patients since he already has background information on your center from his first survey. If you're not required to have the state licensing survey, then you must prepare for an exhaustive Medicare survey. The Medicare regulation contains 32 categories of conditions, standards and elements. Each has an interpretative guideline to assist you in preparing.

On the topic of governance, Medicare requires that your surgery center have a governing body with ultimate authority and full legal responsibility over all aspects of the center's operational management. The surveyors will want to see the bylaws established to outline the duties and responsibilities of this governing body. They'll also want to review meeting minutes to ensure you acted on those duties and responsibilities. Examples of this include

• the review and approval of all center policies and procedures;
• the review and approval of all human resources materials, including the employee handbook and HR policies and procedures;
• the final review and approval of the medical staff bylaws;
• the final approval or denial of all credentialing applications; and
• the final approval of the filling of leadership positions and delegation of authority to individuals like the medical director, administrator and director of nursing.

Lastly, the surveyors will make sure that the governing body has approved the facility budget along with all service contracts and agreements.

On the topic of surgical services, Medicare requires that surgical procedures be performed in a safe manner by qualified physicians granted clinical privileges by the governing body and in accordance with approved policies and procedures. Interpretation of this requirement implies that physicians are doing only those procedures for which they've been credentialed. The surveyors will do a thorough review of the procedure list as approved by the governing body and the physician-credentialing files. State licensing surveyors will do the same.

Physician credentialing is a complex process; the individuals responsible need to either have appropriate training or outsource the process to a credible credentialing service. The surgical services interpretative guideline requires that you restrict access to the operative and recovery areas. The surveyors will be looking to make sure that there are individual clean and dirty areas distinctly separate from the operating rooms, and that the recovery room is distinctly separate from the patient and visitor waiting areas and business office. The interpretative guidelines for this condition consist of other additional elements, including

• a transfer agreement or evidence of medical staff admitting privileges;
• ambulance service, equipment and supplies capable of conducting surgery in a manner that does not endanger patient health and safety;
• that all individuals in the surgical area conform to aseptic techniques;
• the cleaning of rooms between cases; and
• equipment available for sterilization, and policies and procedures in place that address, among other things, resuscitative techniques, aseptic techniques and scrub procedures, care of surgical specimens, and cleaning and care of anesthesia equipment.

Be aware that these interpretative guidelines aren't all-inclusive and that you'll need to expand on them as dictated by the services you'll be providing.

When preparing for your survey, you'll need to be ready to address each and every category. Not only will every square inch of your facility be surveyed, but your surveyor will expect evidence that you've addressed these categories in your written policies and procedures and that your actual practices align with these policies and procedures.

As a brand-new center, the surveyors will rely heavily on these documents, so make sure you know them inside and out.

Surround yourself with experts
Choose an architect and contractor who have experience working in ambulatory surgery construction ' and I'm not talking physician offices here.

Involve the architect in the licensing process since most states and Medicare have guidelines for both structure and process. Not doing so can have devastating consequences if you don't realize you have a problem until the surveyor has already arrived. Unfortunately, this happens more often than it should despite qualified architects.

When it comes to architectural review, some states have authority over plan approval, others have limited authority and still others have no review criteria at all. State architectural review will always be longer than you anticipate; in some states, it might even involve multiple departments. This becomes a moving target in your overall timeline projection and can cause substantial delays.

A co-worker experienced firsthand the importance of careful licensure and certification planning when it comes to developing a new ASC. Her story goes something like this: She went with a colleague of hers to visit an ASC that was under development in a beautiful historic building. While touring the building, she innocently asked how the group was planning to go about licensing the center. Confused, they asked what she meant. She replied that the state they were in required licensure and that she was concerned the building would not meet federal life safety codes. Without meeting those codes, the center wouldn't be able to get state-licensed or Medicare-certified. Unfortunately, her suspicion was correct, and the group was forced to abandon the project at considerable cost to everyone involved.

A final word
Start early, plan ahead and be thorough. Be ready on survey day. Most surveyors are reasonable and want you to be successful. Don't disappoint them - be prepared.

Realize that states are highly individualized on licensing application fees, survey processes, pre-review of policies and procedures, pre-survey conferences, staffing and employee credentials, patient rights, safety programs and pharmacy requirements. Additionally, some states require that accreditation be completed within a certain timeframe (usually 12 months) and will only issue a temporary license initially. It's a good idea to make direct contact with your state to verify that you are on the right track. Clarify any issues you might have up front, but don't expect them to educate you on the process.