Minnesota ASC AssociationMinnesota ASC Association 2012 2012

Dawn Q. McLane RN, MSA, CASC, CNOR VP Consulting, Development and Integration

Health Inventures

Complying with Medicare’s Complying with Medicare’s Conditions for Coverage: Conditions for Coverage:

Preparing for a SurveyPreparing for a Survey

2DQMK

Are You Becoming Are You Becoming a Boiled Frog?a Boiled Frog?

Overview Medicare CfCOverview Medicare CfC Conditions for Coverage (CfC) = the requirements that

ASCs have to meet to participate in Medicare (CFR sec. 416)

Must meet requirements for all patients not just Medicare patients

Effective date final rule: May 18, 2009, December 23, 2011 There are 13 Conditions with 35 Standards Interpretive guidelineshttp://ww.cms.gov/site-search/search-results.html?

q=ASC%20interpretive%20guidelines- CfC interpretive guidelines – December 2011

Infection Control - http://www.cms.gov/site-search/search-results.html?

q=infection%20control%20worksheet%20for%20asc– Infection Control Surveyor Worksheet Exhibit 351 revises 11.24.10

Summary of ChangesSummary of ChangesConditions Standard

Change?

State Law No Change

Governing Body and Management Contract Services Hospitalization Disaster Preparedness Plan

Revised

Surgical Services Anesthetic Risk and Evaluation Administration of Anesthetic State Exemption

Revised

Quality Assessment and Improvement Program Scope Program Data Program Activities Performance Improvement Projects Governing Body Requirements

Revised

Summary of Changes Summary of Changes Continued…Continued…

Environment Physical Environment Safety from Fire Emergency Equipment Emergency Personnel

No Change

Medical Staff Membership and Clinical Reappraisals Other practitioners

No Change

Nursing Services Organization and Staff

No Change

Medical Records Organization Form and Content

No Change

Pharmaceutical Services Administration of Drugs

No Change

Summary of Changes Summary of Changes Continued…Continued…

Laboratory and Radiologic Services Laboratory Services Radiologic Services

Revised

Patient Rights Notice of Rights Advance Directives Submission and Investigation of Grievances Exercise of Rights and Respect for Property and Person Privacy and Safety Confidentially of Clinical Records

Change

Infection Control Sanitary Environment Infection Control Program

Change

Patient Admission, Assessment and Discharge Admission and Pre-Surgical Assessment Post- Surgical Discharge Discharge

Change

Change in Definition of an Change in Definition of an ASCASC

a distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization

the expected duration of services would not exceed 24 hours following admission

must have agreement with CMS and meet the CfC

Governing Body and Governing Body and ManagementManagement

responsible for policies governing operations

Oversight and accountability for QAPI program

Develops and maintains disaster preparedness plan

ASC has transfer agreement with CMS hospital or physicians performing surgery have admitting privileges at hospital (that meets CMS requirements)

Governing Body and Governing Body and ManagementManagement

Disaster preparedness plan written plan provides for emergency care of patients,

staff and others in the facility in the event of fire, natural disaster, functional failure of equipment or other unexpected events that would threaten the health and safety of those in the ASC

coordinates the plan with state and local authorities, as appropriate

conducts drills at least annually & completes written evaluation of drill, promptly implementing corrections

Quality ImprovementQuality Improvement Develop, implement, and maintain an ongoing, data-driven QAPI program Standard - Scope:

demonstrates measurable improvement in patient outcomes

improves patient safety – use of quality indicators, performance measures or reduced medical errors

measure, analyze and track quality indicators, adverse patient events, infection control and other aspects of care

Standard - Data: must incorporate data to:

monitor the effectiveness of services and quality of care

identify areas for improvement and changes in patient care

Quality ImprovementQuality ImprovementStandard - Program Activities: Set

priorities for PI activities focus on high risk, high volume, and problem-

prone areas consider incidence, prevalence and severity of

problems affect health outcomes, patient safety and quality

of care track adverse patient events, examine cause,

implement improvement and ensure improvement is sustained implement preventative strategies targeting

adverse patient events and assure staff is familiar

Quality ImprovementQuality Improvement Standard – PI projects

number and scope of projects reflects scope and complexity of the organization document projects being conducted – including

(minimum) reason for implementing the project and a description of

the project’s results Standard – GB responsibilities – ensure that the QAPI program:

defined, implemented, and maintained addresses the ASC’s priorities and all improvements are

evaluated for effectiveness clearly establishes expectations for safety adequately allocated sufficient staff time, information

systems and training to implement the program

Patient RightsPatient Rights October 24. 2011 CMS published a final rule

on Patient Rights Effective December 23, 2011 Memo to surveyors to clarify March 30, 2012 Revised regulation:

No longer required to provide notification in advance of the date of the procedure. Now prior to the procedure is acceptable

Notice may now be made to the patient, patient’s representative or surrogate.

Disclose and provide list of physicians with ASC financial interest / ownership in writing.

Patient RightsPatient RightsASC must inform the patient of

patient’s rights and must protect and promote the exercise of such rights Notice of rights

provide patient verbal and written notice of patient’s rights

in advance of the procedure in a language and manner that the

patient understands

Patient RightsPatient Rights

Post the written notice of rights in place(s) where it will be noticed by patients waiting for treatment, including: name, address, phone of State agency where

patient can report complaint website for Office of the Medicare Beneficiary

Ombudsman

Disclose physician financial interests or ownership in the ASC in writingIn advance of the procedure

Patient RightsPatient Rights Advanced Directives

Provided the patient in advance of the procedure:information concerning policies on advanced

directivesdescription of applicable state health and safety

laws if requested, official state advanced directives

form Inform patient of right to make informed

decisions regarding their care Document in MR whether or not the patient

has executed an advanced directive

Patient RightsPatient Rights Submission and investigation of

grievances grievance policy documenting existence,

submission, investigation and disposition of a patient’s written or verbal grievance to ASC

related to mistreatment, neglect, verbal, mental sexual or physical abuse document grievance reported immediately to person in authority if substantiated, reported to state and/or local

authority specify timeframe for review and response

Patient RightsPatient Rightsinvestigate all grievances about care provided document how grievance was addressed and

written notice of decision to patient including o name of contact person at ASC o steps taken to investigateo results of grievance processo date grievance process completed

Respect for property and person no discrimination or reprisal voice grievances regarding treatment be fully informed about treatment / procedure

and expected outcomes prior to procedure if incompetent, rights of patient exercised by

person appointed to act on behalf of patient

Patient RightsPatient Rights

Privacy and safety receive care in a safe setting free from all forms of abuse or harassment

Confidentiality of clinical records comply with HIPAA related to privacy and

security of PHI and ePHI

Infection ControlInfection Control ASC maintains ongoing program to

prevent, control, and investigate infections and communicable diseases: include documentation that ASC is

following nationally recognized infection control guidelines

Program is: under direction of designated and qualified

professional with specialized training in infection control

integral part of QAPI program responsible for providing plan of action for

preventing, identifying and managing infections and communicable diseases and immediately implementing corrective and preventative measures resulting in improvement

Pt admission, assessment and Pt admission, assessment and dischargedischarge

ASC ensures patient has appropriate pre-surgical and post-surgical assessments

all elements of discharge requirements are met

Pre-surgical H&P not more than 30 days before date of

surgery (may be performed same day) comprehensive medical H&P completed

by a physician or other qualified practitioner (state defined)

Pt admission, assessment and Pt admission, assessment and dischargedischarge

Upon admission pre-surgical assessment completed by a physician

or other qualified practitioner includes:

updated medical record entry documenting an exam for any changes in the patient’s condition since the H&P

patient allergies to drugs and biologicals placed in MR prior to surgical procedure

Post surgical assessment condition must be assessed and documented in

the MR by a physician or other qualified practitioner or RN with post –op experience

post surgical needs must be assessed and included in the discharge notes

Pt admission, assessment and Pt admission, assessment and dischargedischarge Discharge – ASC must:

provide patient with written discharge instructions and overnight supplies

make FY appointment with physician when appropriate

either prior to procedure or before discharge, provide

prescriptions post-op instructions Physician contact information for follow-up care

ensure patient has discharge order signed by the physician who performed the procedure

ensure patients are discharged in the company of a responsible adult, except patients exempted by the attending physician

CMS Hot TopicsCMS Hot Topics

Hot Topics - Session ObjectivesHot Topics - Session Objectives

Review & Discuss Specific CMS Regulations for the ASC

- Identify “Hot Buttons” - Assess Compliance Approach w/Attendees- Implementation Strategies

CMS “Hot Buttons” for CMS “Hot Buttons” for 20122012ASC - 416.41(a) Contract Services: “When services are provided through a contract with an outside resource, the ASC must assure that these services are provided in a safe and effective manner”. Contracts spreadsheet with contract information, dates and QI quarter assignment

Implementation Implementation Strategies:Strategies:

Housekeeping:- Review proposed cleaning schedule, products,

supplies & compare w/facility P&P; do OIG query.- Contract should contain HIPAA language and/or

have on-site staff sign confidentiality/security statements.

- Request immunization status for TB (suggest Hep.B)

- Evaluation process w/their supervisor should be established.

- Direct observation, provide feedback.- This service must be reviewed by GB on annual

basis.

Implementation Strategies:Implementation Strategies:

Lab/Pathology:Obtain copy of license from physician lab Director, perform verification; perform OIG query.Obtain copy of malpractice insurance.Obtain copy of the lab’s CLIA & CAP certification.Ensure HIPAA language is included in contract. Assess services performed (ie, timing of PAT results, critical lab values, path reports).This service must be reviewed by GB on annual basis.

Implementation Strategies:Implementation Strategies:Radiology: (also 482.26c)Radiologist (MD/DO) must be credentialed effective 12/30/09 for at least consulting privileges.Radiology techs must be credentialed as AHP (AAAHC only), otherwise obtain copy of license, do verification; OIG query; obtain malpractice insurance.Assess timeliness of follow-up radiology reports when applicable.Obtain input from Radiology Director for educational purposes (ie., Radiation Safety, QC checks, etc.).This service must be reviewed by GB on annual basis

CMS “Hot Buttons” for 2012CMS “Hot Buttons” for 2012ASC - 416.52(a) Admission and Pre-surgical Assessment:Each patient must be examined by a physician (or other qualified practitioner in accordance w/state law) on the DOS, prior to the start of the surgery/procedure in order to assess changes in their medical condition since the most recent H&P was done. The physician may decide the extent of the update assessment needed.

(This regulation should not be confused w/416.42(a) which states that a physician must examine the patient immediately before surgery to evaluate the risk of anesthesia & of the procedure to be performed).

Implementation Strategies:Implementation Strategies:

• If the physician finds no changes in the patient’s condition since the most recent H&P was performed, the following documentation in the medical record is suggested per CMS IG:

• H&P reviewed, patient examined, no changes noted in patient’s condition since H&P performed. (check-box?)

• Likewise, any changes in patient condition must be documented by the physician in the update note prior to start of surgery/procedure.

• The H&P and this pre-surgical assessment (DOS) must be placed in the medical record before the surgery/procedure is performed.

CMS “Hot Buttons” for 2012 CMS “Hot Buttons” for 2012

ASC - 416.42(a) Anesthetic Risk and Evaluation:Before discharge from the ASC, each patient must be evaluated by a physician (or by an anesthetist in accordance with applicable State health and safety laws*, standards of practice, ASC policy) for proper anesthesia recovery.*(ie, Opt-out states such as IA, KS, MN, NE)

Implementation Strategies:Implementation Strategies: Although the regulations do not specify the criteria that

must be used for this post-op evaluation, the IG suggest that “recognized guidelines” be followed (ie, ASA as in the article below).

Based on Practice Guidelines for Post-anesthetic Care, Anesthesiology, Vol 96, No 3, March ‘02, the assessment should include: Respiratory function (RR, airway patency, O2 sat) CV function (BP, P) Temp Pain Nausea/Vomiting Post-op Hydration Mental Status Other (depending on type of surgery/procedure)

Implementation Strategies: Implementation Strategies: (continued)(continued)

Example Discharge Assessment (a check box could be used for applicable items or Y, N, NA):

Alert / Oriented Ambulating Voided Tolerated PO nourishment Op site satisfactory Peripheral circ. satisfactory Reviewed instructions Written instructions Prescriptions Pain Minimal <5 on Pain Scale (0-10) Pt. assessed; medical condition and all vital signs (BP/P/R/O2sat/temperature)

are stable, may discharge per routine.  MD Signature: Time: In the above example, nursing staff could complete the 1st section, a physician

must complete the bottom section after reviewing the information in section 1. Ultimately, the time documented above for the physician evaluation must

reflect a time prior to the patient’s actual discharge from the facility (HI Recommends eval done within 45-1 hr prior to pt. D/C)

 

CMS “Hot Buttons” for CMS “Hot Buttons” for 2012 2012

ASC - 416.42(b) Administration of AnesthesiaAnesthetics must be administered only by:

- A qualified anesthesiologist.- A physician qualified to administer

anesthesia, a CRNA or an AA. - Unless state exempted for non-physicians, the CRNA must be under the supervision of the operating physician; AA’s must be under the supervision of an anesthesiologist.

Implementation Strategies:Implementation Strategies:

Local, topical anesthesia, IV moderate sedation must be included on DOP form for applicable physician in credentialing file.

CRNA’s should have a sponsoring/supervising physician listed on DOP.

CRNA supervision must be listed on DOP of corresponding physician or have a separate DOP for this purpose.

Anesthesia contract/agreement and facility P&P’s should address supervision of CRNA’s.

CMS “Hot Buttons” for CMS “Hot Buttons” for 2012 2012

ASC - 416.52(c)(2) Discharge:The ASC must ensure that each patient has a discharge order, signed by the physician who performed the surgery or procedure.

ASC - 416.52(c)(3) Discharge:The ASC must ensure all pts are D/C’d in the company of a responsible adult, except those pts exempted by the attending physician (exemptions must be specific to individual pts).

Implementation Strategies:Implementation Strategies: IG states, “no patient may be discharged

from the ASC unless the physician who performed the surgery or procedure signs a discharge order”.

IG also says, “it is expected that a patient will actually leave the facility within 15-30 minutes after the discharge order is signed. (???)

Verify on pre-op phone call if pt will have a responsible adult accompany them (get name and number); provide rationale, facility policy. If no-show upon D/C, decisions will have to be made for signing out AMA vs. calling cab, etc.

CMS “Hot Buttons” for CMS “Hot Buttons” for 20122012

ASC - 416.48(a) Administration of Drugs Drugs must be prepared and administered according to established policies and acceptable standards of practice*.*(In accordance w/state, federal laws and nationally recognized expertise).

Infection Control and Medication Administration“One and Only Campaign” http://oneandonlycampaign.org/

Implementation Strategies:Implementation Strategies: Any drawn syringes must be labeled with:Time of draw, initials of person drawing, medication

name, strength, expiration date or time. 5 Rights of Medication Administration!! All items labeled for single patient use must

be used on only 1 patient Medications should not be prepared too far

in advance of their use (ie, do not draw up day before or early morning for use throughout the day) – USP 797 and APIC: IVs within 1 hour of being spiked

Meds should only be administered by the person who drew it up.

CMS “Hot Buttons” for CMS “Hot Buttons” for 20122012

ASC – 416.48(a) Administration of DrugsOrders given orally for drugs and biologicals must be followed by a written order & signed by the prescribing physician.

Implementation Implementation Strategies:Strategies: Must have P&P’s pertaining to a verification

process for verbal orders rec’d by a licensed professional

ASC - The prescribing physician must sign, date and time the written order in the patient’s medical record as soon as possible after the verbal order is issued (and in accordance w/state law).

Take Aways….Take Aways….• Ongoing, periodic re-assessment of

educational needs for employees and medical staff regarding CMS requirements

• Each CMS CfC is “pass or fail” from a regulatory compliance perspective.

• Review your facility P&P Manuals; ensure that corresponding documentation has been updated to reflect CMS/AAAHC/TJC/state-specific regs as applicable.

• All policies/procedures must be reflective of active practice; assess if new process needed in a certain area(s).

Regulatory Update 2012Regulatory Update 2012

ASC ConversionsASC Conversions 13 US Senators sent a letter to CMS

ASC Quality and Access Act of 2011 sponsors

requesting data on the trend to convert ASCs to HOPDs

costs to Medicare specifically regarding the 65 conversions since Jan 1, 2009

pointed out the inappropriate use of the CPI (CPU) to update ASC payments disparity between ASC and HOPD reimbursement rates

Participation in CDC Annual ASC Participation in CDC Annual ASC SurveySurvey

ASCA requesting that ASCs who are invited - participate in the CDC Annual Hospital Care Survey

surgeries performed in ASCs and HOPDs - an important of information for researchers and policy makers

information submitted is confidential and de-identified

House Letter – Single Use Vial House Letter – Single Use Vial PolicyPolicy

STAY TUNED!!STAY TUNED!! 16 Republican House members Seeks to modify CMS guideline

prohibiting use of vials labeled “single use”

Argue that the policy is misguided and increases costs; “there is no data available to support that implementation of one vial per patient will improve quality or reduce patient harm.”

2013 ASC Payment Increase2013 ASC Payment Increase

MedPac recommended in March of 2012: ASC rates increase by 0.5% in 2013 HOPD recommendation for 1% increase

ASC Association – ASC Quality & Access Act with goal to draft VBP Bill that would tie ASC annual inflation update to the Hospital Market Basket instead of the CPI

CMS CMS Affordable Care Act requires CMS to

develop a true PfP system for ASCs which resulted in VBP (value bases purchasing) program sent in April 2011 CMS does not have authority to

implement VBP for ASC payments CMS published 1525-p (800 pg proposal)

on 7/18/11 updating the OPPS (hospital Outpatient Prospective Payment System) and the ASC system for 2012 and provides information related to quality measures

CMS Quality ReportingCMS Quality ReportingMandatory reporting begins 10.1.12 Failure to report results in a 2%

reduction in future year reimbursement rates beginning with 2014

5 Quality Measures patient fall * patient burn * patient transfer / hospital admission * wrong site, side, patient, procedure,

implant * prophylactic IV antibiotic timing ** Developed by ASC QC; endorsed by NQF

CMS Quality ReportingCMS Quality Reporting CY 2013

surgical site infection rate CY 2014

use of safe surgery checklist ASC volume data on selected

procedures CY 2015

influenza vaccination coverage among healthcare workers

Safe Surgery ChecklistSafe Surgery Checklist

ASC may use any checklist as long as it addresses effective communication and safe surgery practices in 3 areas: prior to administering anesthesia prior to start of procedure prior to the patient leaving the OR

Safe Surgery ChecklistSafe Surgery Checklist

Examples: WHO Surgical Checklist

http://www.who.int/patientsafety/safesurgery/ss_checklist/en/index.html

JC’s Universal Protocolhttp://www.jointcommission.org/standards_information/up.aspx

AORN’s Comprehensive Checklist http://www.fiercehealthcare.com/press-

releases/aorn-supports-patient-safety-and-accreditation-release-

comprehensive- surgical-checkli

Safe Surgery ChecklistSafe Surgery Checklist

ASCs go to www.qualitynet.org between July 1, 2013 and August 15, 2013 and answer “yes” or “no” to the question of whether a surgery checklist was used at the ASC between January 1, 2012 and December 31, 2012

Results of the survey will be made public by CMS – no financial penalties at this time for answering “no”

CMS Quality ReportingCMS Quality ReportingASC G-codes announcedASC G-codes announced

ASC Transmittal #2425 effective April 1, 2012 – may begin

reporting G-codes on Medicare claims

mandatory reporting of G-codes on Medicare claims by October 1, 2012

Codes are posted ASC Association website www.ascassociation.org federal registration quality reporting G codes

Top 10 Patient Safety IssuesTop 10 Patient Safety IssuesBecker’s ASC Review – Clinical Quality & Infection Control

February 2012

1) Hand hygiene

2) Safe surgery checklist3) Patient selection criteria4) Surface disinfection5) Wrong site procedures 6) Dependence on safety tool (thinking!)7) Burns8) Distractions in the OR9) Houskeeping10) Properly trained staff / contract services

Compliance & Safety is Compliance & Safety is EVERYONE’S Responsibility!EVERYONE’S Responsibility!

Monument Valley, Utah 2012

Thank You !Thank You !

QuestionsQuestions??