AMBULATORY

SURGERY

CENTERS

P A T R I CK W

A L D R O N , M. E

D . , L M S W - N O V E M B E R

2 0 1 3

A LITTLE EXPLANATION:MEDICARE CERTIFIED

1864 agreementAgreement between CMS and the State

DADS is the primary State agencyDSHS 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 gets1/100th of one cent of every

dollar!

FEDERAL MANDATESNURSING HOMES!!!! Why DADS gets the money first

Validation surveysWhen an ambulatory surgery centerhas “deemed” status, the State Agency, at the request of CMS, goes behind the accrediting body to make surethat they found everything they were supposed to.

ALL OTHER ACTIVITYSpelled out in the annual

Mission and Priority

Document

MISSION AND PRIORITYEvery 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 LettersS&C LettersAdmin Info E-mailsVerbal CMS region 6Etc….

THE M & P ESTABLISHED THE TIER SYSTEM

ALL BASED ON FUNDINGCMS 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 PROCESSIn 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

• 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!

In Texas

Ambulatory Surgical Center is:A Distinct entityOperates 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 agreementComplies 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 ControlIncludes 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

Two types of assessments: 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

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

Discharge (416.52(c)) Discharge order-signed by the physician

who did the surgery Discharge instructions Any necessary supplies to last through

the night Follow-up appointments Adult accompaniment, unless the MD

expressly in writing exempts the patient

Discharge- continued 416.52(c)(1): Discharge instructions include any

prescriptions to be filled, how to contact the MD or the ASC staff in case of an emergency

Order reading “discharge when stable” is okay.

Discharge-the final word Patient should be ready to leave the

facility within 15 to 30 minutes after the discharge order is written, therefore, very important that the physician dates and TIMES his order.

HB 15– the SONOGRAM bill

• Enacted by the 82nd legislature• Applies to:

• General Hospitals• Ambulatory Surgical Centers• Abortion facilities

HB 15- Mandates

• A woman seeking an abortion • Will have a sonogram performed at least 24 hours before

the scheduled procedure• Fetal development and gestational age will be described to

the woman• Heart sounds will be made available for the woman to hear• Woman’s Right to Know booklet made available

HB 15

• Document• Document• Document

• Did I say Document?

HB 2- THE ABORTION BILL Enacted by the second Special called

Session of the 83rd Legislature Applies to:

Abortion FacilitiesAmbulatory Surgery CentersGeneral HospitalsPhysicians’ offices (to a limited extent)

Parts of the law took effect 10/29/2013, the remainder will take effect September of 2014.

EFFECTIVE 10/29/2013 Physicians who perform abortions must

have admitting privileges at a hospital within 30 miles of the facility in which the abortion is performed

The medical abortion “pill” must be administered by a physician and there must be two follow-up visits by the patient following the appointment in which the “pill” is administered

ABORTIONS Are outlawed post 20 week gestation

Determined by established medical practice and guidelines

IN 2014 Any facility that offers abortion services

must meet the physical plant guidelines of an Ambulatory Surgical Center at a minimum.

As you are aware, federal judge in Austin “enjoined” (stopped) the Department from enforcing the rules that took effect 10/29/13, Federal 5th Circuit overruled him.

On its way to the Supreme Court

Planned Parenthood has petitioned the U.S. Supreme Court to reverse the 5th Circuit and reinstate the injunction.  Justice Scalia has given the state until Nov. 12 to respond to the request.  He will likely forward to the full court for decision.  (11/4/13)

The END!