In Part 1 of this series on compliance, sharpen your fluency with CMS operational requirements for your ASC

Based on my 38 years of ASC consulting experience, it appears that most RN clinical directors (myself included) came to the ASC with strong clinical skills, but without much compliance experience. Most of us learned on the job.

The more successful directors have utilized peer networking and taken advantage of meetings, articles, and online subscriptions to help them maintain compliance. These leaders know when a standard has changed, and they are constantly seeking ways to bring their centers into compliance.

This article is intended as a resource that provides all of the information that is necessary to bring your center into basic CMS compliance for operational documentation. As you understand the process better, you can build on your ASC’s methods and efficiency in fulfilling all of these requirements. CMS requires that ASCs document all of the following operations.

Quality Assurance and Performance Improvement (QAPI) Plan

Documentation is necessary to support the data collected from your QAPI plan. CMS requires you to show evidence of the actual studies as well as how you maintain compliance, train staff, and report results to your governing body (through meeting minutes). Be sure to have documented evidence of both performance improvement and quality assurance.

Performance improvement is proactive in nature. For example, if your patient satisfaction returns show a trend of patients stating, “I didn’t understand how to use my drops,” you would review and/or update your post-op instructions. Documentation of this effort shows that you fixed a problem before it had a negative effect on patient outcomes.

Conversely, quality assurance is retrospective in nature. You review specific indicators to identify problem areas. For example, document that you and your staff routinely do the following:

• Objectively and systematically monitor and evaluate the quality and appropriateness of patient care on an ongoing basis to ensure that the ASC has met quality standards.
• Systematically monitor the nursing standards of practice, standards of care, standards of performance, and consumer satisfaction
• Demonstrate effective actions that improve performance in situations where you have failed to meet standards
• Show evidence of problem resolution through tracking and follow-up
• Promote individual accountability among staff
• Identify specific needs for training
• Target problems that require action by the QAPI committee and refer them to the committee for investigation and action

Risk Management

Risk management is about protecting your center from potential legal issues. Monitor all incidents that could potentially present legal problems for your center. This starts with an incident report. Encourage staff to view incident reports as tools to protect — not judge — and be sure they initiate an incident report for any unintended outcomes (infections, transfers, and deaths, among others).

The objective is to gather the most information about each incident at the time of the incident, identify trends, and prevent the same incident from happening again. If a case goes to court months or even years later, you’ll still be able to show evidence that the ASC was policing itself and working to prevent future incidents. This goes a long way in a court of law.

Peer Review, Utilization Review, and Benchmarking

These three requirements cover documentation of your ASC’s self-evaluation. Collect and review metrics to see how your center is doing and how it can be improved — and document all of that work for CMS.

The peer review requirement says your ASC’s outcomes per provider must be measured by a peer. In this process, an ophthalmologist reviews charts from another ophthalmologist and judges that chart on outcomes, comparing the case against ophthalmic practice guidelines. Peer review occurs between providers and is considered confidential, but your center is expected to use the data collected from this process when re-credentialing providers.

Utilization review measures how well your ASC uses its resources to ensure efficient management of human and material resources. Such a review may include case volume by surgeon, specialty, or CPT code. You can evaluate staffing hours, cost per case, and equipment utilization as well.

Benchmarking is when two similar aspects of care are measured against each other. For example, you might perform an internal benchmarking study related to each provider’s cost per case, comparing the direct costs of one surgeon with other surgeons. (Confidentiality should be observed.)

For external benchmarking, you might conduct a salary survey, for example, to learn what similar ophthalmic ASCs in your region pay their scrub techs.

Infection Control

Based on your infection control plan, you’ll need to show CMS documented evidence of the following:

• Risk analysis performed on your specific patient population (by age, race, geographic location, and other demographics)
• Initial and ongoing staff/provider training on your center’s infection control plan
• CDC communicable diseases identified for your community
• Employee health, such as evidence you’ve met CDC vaccination recommendations for healthcare workers
• Environmental infection control risks, such as temperature and humidity in ORs
• Equipment infection control risks, including potential risks for each piece of equipment that touches your patient and documentation that you follow all preventive maintenance prescribed by the manufacturer
• Operating room infection control risks, such as traffic control and documentation showing you meet AORN standards
• Sterilization infection control risks
• Surgical site infection rates
• Surveillance outcome data

Clinical Charts

CMS requires that all patients admitted to the ASC for a procedure meet all aspects of CMS medical record requirements. In other words, the chart for a LASIK patient must fulfill all the same components as the chart for a cataract patient, including:

• History and physical examination within 30 days of the scheduled procedure (anything beyond 30 days has to be redone)
• History and physical examination update on the day of the procedure
• The physician’s assessment immediately prior to the procedure (which cannot be done by a CRNA)
• Documentation from the anesthetist that the patient is approved for the scheduled procedure
• Signed informed consent
• Evidence that the patient received advance notice in writing and verbally about the ASC’s disclosure of ownership, policy on advance directives, patient rights and responsibilities, and policy for patients to report grievances
• Pre-op instruction sheet
• Pre-op call record
• Surgical orders from the provider
• Pre-op record of the nursing assessment
• An anesthesia record, assessment, and recovery notes
• A comprehensive surgical checklist
• An operative record
• The surgeon’s post-op notes (made on chart before the next patient is started)
• The recovery room record
• Discharge instructions
• Post-op call record
• Medication reconciliation list/allergy list

Operational Logs

Finally, CMS requires documentation for all of the operational tasks you perform to ensure the facility meets the organization’s standards. Be sure to document compliance in these activities:

• Sterilization, including logging all biological protocols, immediate use, as well as autoclave maintenance
• HVAC filter changes and maintenance
• Pharmacy procedures, including evidence of DEA 222 management and narcotic counts
• Evidence of controls performed for all waived testing
• Cleaning logs to note that regular and terminal cleaning are completed
• Eye wash station documentation showing you ensure the proper temperature, flow, and maintenance
• Blanket warmer checks, completed on patient days to ensure blankets are not too hot
• Crash cart checks (top of cart checked every patient day, before patients arrive; defibrillator checked unplugged; a numbered lock on the cart to ensure nothing in the drawers has been compromised; drawers opened once per month and the contents updated)
• Hot water temperature tests at least weekly at different sinks to ensure the water is not too hot or cold
• Refrigerator temperatures, including both the medication refrigerator (a 24/7 monitor with a history) and the patient refreshment refrigerator (checked once per day)
• Safety inspection/walk-throughs should be documented at least quarterly to ensure safe conditions are maintained
• Flutter tests (measures air flow required for OR, sterile storage, dirty utility, and so on)
• Equipment maintenance log schedule for each piece of major equipment (based on manufacturer recommendations)
• Policy and procedure review documentation should show that every policy and plan in your ASC is reviewed every year
• Evidence of utility maintenance related to fire safety (per the NFPA 101 Life Safety Code 2012 guidelines on generators, fire doors, fire alarm systems, emergency exit lights, extinguishers, nurse call systems, and sprinkler systems)

Smooth Sailing

As a consultant, I’ve seen many ASCs that do an excellent job of meeting CMS documentation requirements — and just as many centers that do not.

As CMS strengthens its data requirements and enforcement, lax documentation is no longer an option. I hope this guide helps you understand what to document to ensure that your interaction with CMS will be smooth and organized. ■