Minnesota ASC Association 2011

1. Complying with Medicare’s Conditions for Coverage: Preparing for a Survey Minnesota ASC Association 2011 Dawn Q. McLane RN, MSA, CASC, CNOR RVP, Health Inventures

2. 2DQMK Are You Becoming a Boiled Frog?

3. Overview of Changes • 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: May 18, 2009 • Currently 10 Conditions with 16 Standards • New: 13 Conditions with 35 Standards • Interpretive guidelines • http://ascassociation.org/guidelines.pdf - CfC interpretive guidelines – December 2009

4. Summary of Changes

5. Summary of Changes Continued…

6. Summary of Changes Continued…

7. Change in Definition of an ASC • 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

8. Governing Body and Management • 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)

9. Governing Body and Management • 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, promptlyimplementing corrections

10. Quality 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

11. Quality Improvement • Standard - 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

12. Quality 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

13. Patient Rights • ASC 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 date of the procedure • in a language and manner that the patient understands

14. Patient 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 writing • In advance of the date of the procedure

15. Patient Rights • Advanced Directives • Provided the patient in advance of the date of the procedure: • information concerning policies on advanced directives • description 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

16. Patient 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

17. Patient Rights • investigate all grievances about care provided • document how grievance was addressed and written notice of decision to patient including • name of contact person at ASC • steps taken to investigate • results of grievance process • 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

18. Patient 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

19. Patient Rights Notification Urgent Cases • May notify the patient on the day of surgery only if the case is considered urgent – must be documented by the physician • the patient would be harmed (reduced likelihood of good outcome if the procedure is not performed same day or the patient would suffer increased pain) • the ASC is an appropriate site of service for this procedure • rights notification is performed prior to consenting the patient

20. Infection 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

21. Pt admission, assessment and discharge • 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)

22. Pt admission, assessment and discharge • 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

23. Pt admission, assessment and discharge • 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

24. Hot Topics - Session Objectives • Review & Discuss Specific CMS Regulations for the ASC - Identify “Hot Buttons” YTD - Assess Compliance Approach w/Attendees - Implementation Strategies

25. CMS “Hot Buttons” for 2011 ASC - 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”.

26. Implementation 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.

27. 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.

28. 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

29. CMS “Hot Buttons” for 2011 ASC - 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).

30. CMS “Hot Buttons” for 2011 Same Day Procedures: • Patients may be admitted for procedures the same day as the procedure if: • the procedure is urgent and peforming the procedure same day will • Result in an improved outcome • Waiting will cause the patient increased pain and suffering

31. CMS “Hot Buttons” for 2011 • The surgeon must document the following: • reason for performing the procedure the same day as notification of patient rights (see previous slide) • the ASC is the appropriate site of service • the patient received Patient Rights Notification prior to consent for the procedure

32. 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.

33. CMS “Hot Buttons” for 2011 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)

34. 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)

35. Implementation Strategies: (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)

36. CMS “Hot Buttons” for 2011 ASC - 416.42(b) Administration of Anesthesia • Anesthetics 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.

37. 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.

38. CMS “Hot Buttons” for 2011 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).

39. 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.

40. CMS “Hot Buttons” for 2011 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).

41. Implementation Strategies: • Any drawn syringes must be labeled with: • Time of draw, initials of person drawing, medication name, strength, expiration date or time. • Drawn syringes must be used on 1 patient and discarded after the initial use. • 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) • This should only be administered by the person who drew it up.

42. CMS “Hot Buttons” for 2011 ASC – 416.48(a) Administration of Drugs • Orders given orally for drugs and biologicals must be followed by a written order & signed by the prescribing physician.

43. Implementation Strategies: • Must have P&P’s pertaining to a verification process for verbal orders rec’d by a licensed professional (ie, VORB). • 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).

44. Take Aways…. • Ongoing, periodic re-assessment of educational needs for employees and medical staff regarding “CMS Hot Buttons”. • 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).

45. Thank You ! Questions?