Ambulatory Surgery Centers

Ambulatory Surgery Centers Patrick Waldron, M.Ed., LMSW-November 2013

A little explanation:Medicare Certified • 1864 agreement • Agreement between CMS and the State • DADS is the primary State agency • DSHS draws moneys from DADS

By the 1864 agreement • The federal government (HCFA/CMS) was told that they would HAVE to work with the States.

Of the total Medicare budget • Survey and Certification gets • 1/100th of one cent of every dollar!

Federal mandates • NURSING HOMES!!!! • Why DADS gets the money first • Validation surveys • When an ambulatory surgery center has “deemed” status, the State Agency, at the request of CMS, goes behind the accrediting body to make sure that they found everything they were supposed to.

All other activity • Spelled out in the annual Mission and Priority Document

Mission and Priority • Every year about this time, we (the State) receive a draft of the M & P Document- about 75 pages long. In the M & P, we get our “marching orders” for the coming year.

We also get our instructions: • State Operations Manual- Chapter two (for certification) • RS&C Letters • S&C Letters • Admin Info • E-mails • Verbal CMS region 6 • Etc….

The M & P established the Tier System

All based on funding • CMS tells us how much money we’re going to get; we tell them how much work we’re going to do. • CMS tells us there’s work we HAVE to do (the upper tiers), what they would like us to do (Tier III), and what we can put off (Tier IV).

Changes in survey process • In 2008, there were some infection control issues identified in one of the Western States, that put patients’ lives at risk. This prompted CMS to re-examine their policies towards the inspections of ASCs as well as other facility types.

Plus the growth of the industry • 2002- 3478 Certified ASCs in the nation • 2012- 5359 Certified ASCs in the nation • a 54.1 % increase • This doesn’t include those ASCs that are not certified or are licensed only • Accreditation- giving deemed status, has also grown dramatically • 2008- 893 accredited ASCs having deemed status • 2012- 1368 accredited ASCs having deemed status- that’s a 53.2 % increase

In Texas • On October 1, 2012, there were 352 certified ASCs, by September 30, 2013 there were 357. • Texas has 7% of all ASCs in the nation and 63% of all ASCs in CMS Region 6!

Ambulatory Surgical Center is: A Distinct entity Operates EXCLUSIVELY to provide surgical services -to patients not requiring hospitalization - expected stay not more than 24 hours If receiving Medicare reimbursement: Has an ASC provider agreement Complies with the CMS ASC Conditions for Coverage (CfCs)

Distinct Entity • Must be physically separate OR • Must be temporally separate • Same physical space but not opened at the same time. • Two (or more) ASCs may share the same physical space as long as they are not open at the same time.

If two or more share the same space… • No overlapping hours • Records kept separate • Different governing bodies • Different CCN (if they all participate in Medicare) • If one of these has a condition out-like environment- they may all have that condition out

An ASC may NOT share space with: • A Hospital • A Critical Access Hospital • An Independent Diagnostic and Testing Facility

What is Surgery • An invasive procedure performed to structurally alter the body by incision or destruction of tissues OR • Diagnostic or therapeutic treatment by any instruments causing localized alteration/transposition of live tissue

Tissue • Can be~ • Burned, vaporized, frozen, sutured, probed, manipulated by closed reductions for major dislocations or fractures, or otherwise altered by mechanical, thermal, light-based, electromagnetic, or chemical means and

includes • The injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs, and the central nervous system. • Doesn’t include nurses administering IVs, IMs, or Sub-q injections.

not more than 24 hours • A patient stay in the ASC should not usually be more than 23 hours, 59 minutes. Clock starts when the patient moves from the waiting room into a clinical part of the ASC (pre-op) and stops at discharge, leaving the ASC about 15-30 minutes after discharge from the recovery room.

If more than 24 hours • Then it may have been an inappropriate patient for an ASC (more on that under assessment). If just one patient or occasional, may not be an issue. However, if frequent or shows a trend- may be a citation waiting to be written.

So, beginning in 2008, ASCs became a “Special focus” on CMS. • In Federal fiscal year 2010, the States were told to survey 33% of all ASCs. • In Federal fiscal year 2011, it became standard policy that the States would survey 25% of all ASCs. • For those ASCs with “deemed status”, the States would conduct “validation” surveys at the direction of CMS- 5 to 10%

There were also other CMS mandated changes • Hightened awareness of infection control processes. • Use of the Infection Control Surveyor Worksheet • Tracer patient • One surveyor MUST BE an RN

The top 10 deficiencies • Sanitary Environment • Administration of Drugs • Infection Control Program • Form and Content of Record • Infection Control Program- Direction • Physical Environment • Disaster Preparedness Plan • Organization and Staffing • Infection Control • Notice- Posting (ownership)

Infection Control Includes completing the required worksheet

Infection Control and ASCs (416.51) • The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases • Presents remarkable challenges: • Patients are in common areas • Rapid turnarounds in ORs, PACUs • Patients bringing in communicable diseases that may or may not have been identified (especially if the H & P is nearing 30 days) • Patients go home quickly- uncertainty of appropriate post-surgical care • Surgical site infections common

416.51 (a) • The ASC must provide a functional and sanitary environment for the provision of surgical services by adhering to professionally acceptable standards of practice.

416.51(b) • The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines. The program is…..

416.51 (b) continued • (1) Under the direction of a designated and qualified professional who has training in infection control; • (2) An integral part of the ASC’s QAPI program, and • (3) Responsible for providing a plan of action for preventing, identifying and managing infections and communicable diseases and for immediately implementing measures that result in improvement.

The ASC must have • One staff member has to be designated as the infection control person with responsibility for the program. Can have other duties, even be a contract employee. Certification is desirable, but not required. Ongoing training in infection control is required. • If the ASC is part of a national chain, the corporate infection control officer is OK but not sufficient; have to have somebody on-site- but no designation as to how long or how often they have to be on site.

416.44(a)(3) • The ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to the appropriate authorities.

Some components of an infection control program • All staff must be trained (includes MDs) • Based on a recognized program • Establish policies and procedures regarding infection control • Hand hygiene • Safe practices for injecting meds, saline, and other infusions

Hand hygiene • Extremely important • Healthcare provides should wear gloves for procedures that might involve contact with blood or body fluids • When handling potentially contaminated patient equipment • After doing a gloved task, remove gloves, wash hands, glove and go to next task.

Injection safety • Needles are used for only ONE patient • Syringes are used for only ONE patient • Medication vials are always entered with a new needle and a new syringe (multidose for more than one patient)

Pre-drawing medications • Labeled with • Date and time the meds were drawn • Initials of the person drawing the meds • Name of the medication • Strength • If the above items aren’t present, don’t use.

Multidose vials • Ideally, used for only one patient; however, if used for more than one patient… • Rubber septum disinfected with alcohol PRIOR to each entry • Vials dated when opened- discarded by day 28 (unless manufacturer says earlier) • Not stored where direct patient contact can occur (like the bedside)

Sharps disposal • Disposed in a puncture resistant “sharps container” • Container discarded when the line is reached. • No matter what you drop in there, its just not worth trying to fish it out. Your husband can always buy you another diamond; but he can’t get another you.

Sterilization/equipment reprocessing • “Spaulding Classification” • Critical devices-items that enter normally sterile tissue or the vascular system (surgical instruments) • Semicritical devices: items that come in contact with non-intact skin or mucous membranes (endoscopes, laryngoscope blades) • Noncritical devices: items that come in contact with intact skin but not mucous membranes (blood pressure cuffs, pulse oximeters)

Critical devices • Need to be cleaned prior to sterilization • As soon as possible after use • With detergent and water or enzyme cleaner and water • (get the chunks off first), then • Sterilize: • Steam autoclave • Peracetic acid • Ethylene oxide • Hydrogen peroxide gas plasma • Flash sterilization- should be the exception rather than the rule

Semi-critical devices • High-level disinfected (at a minimum) • Manual • Automated (stericycle) • Following manufacturer’s instructions • Disinfected for the appropriate length of time • Disinfected at the appropriate temperature • Allowed to dry before use • Stored in a clean place

Noncritical devices • Cleaned as needed

Environmental cleaning • Operating rooms- cleaned and disinfected after each surgical or invasive procedure • “terminal clean” at end of day after last procedure. • Cleaning of all surfaces, including floors • High touch surfaces in rest of facility cleaned and disinfected as needed • Facility has a procedure for cleaning up gross blood spills

Point of Care testing • Glucose testing • A new single-use auto-disabling lancet is used for each patient • If allowed by manufacturer to be used on numerous patients, blood glucose monitor is cleaned and disinfected after every use

Infection Control Worksheet • All 16 pages must be completed- facility can assist with some, if not most, of the completion of the forms. • If more than one surveyor, each completes one of the forms and team lead collates the info. • Faxed to CMS data people at end of survey

Patient Assessment and Discharge Tracer Patient

Before Surgery History and Physical Pre-surgical assessment Anesthesia/procedure risk H & P no more than 30 days old Presurgical done at the time of admit Anesthesia risk assessment done immediately before surgery After Surgery Anesthesia recovery Performed by MD, other qualified practitioner Availability of a responsible adult to whom the patient can be discharged Two types of assessments:

History and Physical • Comprehensive, performed by a MD, DO, DDS, podiatrist (within the scope of their practice), required prior to surgery. • No more than 30 days before-can be immediately prior to admit to ASC in the case of a same day surgery • Can be used for more than one surgery if multiple surgeries are done within 30 days; but not more than 30 days.

Presurgical assessment • Done at the time of admission of the patient to the ASC- ascertains any changes since H & P done-update must be in medical record prior to surgery. May be combined with anesthesia/procedure assessment, done by physician immediately before surgery to evaluate risks

Post-op assessments (416.52(b) and 416.42(a)(2)) • Performed by MD/other qualified practitioner • Assess patient’s overall condition after anesthesia: • Respiratory function/airway patency • O2 Saturation • Cardiovascular functioning (pulse/ blood pressure) • Mental status • Pain • Nausea/vomiting

Ambulatory Surgery Centers