CMS ASC Guidelines

From CrnaBIZ-Wiki

Interpreting the CMS Conditions for Coverage for ASCs This outline was created for the Spokane Eye Surgery Center and may not be applicable to your facility. 1. Basic Requirements a. Copy of our Medicare Agreement b. Paperwork demonstrating physical separation (floorplan) c. Log listing any patients staying longer than 24 hours d. Policy regarding LASIK patients e. Policy regarding entries into medical record regarding admission and discharge time 2. Condition for Coverage (CfC): Compliance with State Licensure Law a. Copy of state license b. Policy listing all licensed personnel 3. CfC: Governing Body and Management a. Listing of Owners

i. Listing of dates and minutes of medical staff meetings regarding Surgery Center

b. Org Chart c. Minutes of Policy and Procedure meetings

i. Copies of staff sign-off sheets

d. Policy identifying data submitted

i. Refer to QI meeting minutes where data is submitted

e. Refer to QAPI committee meetings and minutes f. Contract Services

i. Policy delineating all contract services

1. Janitorial 2. Engineering 3. Laundry 4. Controls/HVAC/Maintenance 5. Landscaping/Snow removal 6. IRB g. Standard: Hospitalization

i. Policy for emergency transfer

1. How is it communicated to staff a. Staff must understand policies for emergencies and transport b. Denote where transport

ii. Copies of hospital transfer agreements
iii. Log of emergency transfers

1. Include in log comments on how we could have anticipated the problem for future use in evaluating patients

iv. Policy on non-emergent transfer

h. Standard: Disaster Preparedness Plan

i. Policy outlining Disaster Preparedness plan

1. Protecting staff and patients 2. Give roles and responsibilities of staff 3. Make physicians aware of plan and contents 4. Copy of correspondence with state/local disaster preparedness planners 5. Policy and documentation of annual drill a. How to conduct b. How to test c. Written evaluation 4. CfC: Surgical Services a. Policies on surgical privileges and credentialing are under medical staff b. Policy on time-outs

i. Include checking of documentation, including consent

c. Policy on marking surgical site d. Policy on reducing risk of surgical fires

i. Policy on enriched Oxygen and notification of surgeon
ii. Policy on use of alcohol preps

e. Standard: Anesthetic Risk and Evaluation

i. Policy on physician assessment of risk for planned surgery and anesthesia

1. Include reference to ASA Physical Status 2. Include reference to type of anesthetic, making distinction between conscious sedation and general anesthesia a. Cardiac stents b. General anesthesia cancellations vs conscious sedation 3. Log of cases cancelled due to medical condition prior to surgery 4. Also, refer to log of hospital transfers a. See 3.g.iii above for log

ii. Postanesthesia recovery

1. Make distinction between general anesthesia and conscious sedation 2. Have CRNA sign off on the general anesthesia discharge f. Standard: administration of anesthesia

i. Refer to medical staff policies for anesthesia personnel

5. CfC: Quality Assessment and Performance Improvement a. Standard: Program Scope

i. QAPI Policies

1. Outline of program a. Indicators measured

i. Rationale for choice of indicators
ii. Refer to hospital transfers
iii. Refer to infection control logs
iv. Refer to adverse event log
v. Incident reports and tracking

b. Data collection methods and frequency c. Staff responsibilities

i. Data collection and analysis
ii. Credentials
iii. Ongoing training

d. Policies on Root cause analysis e. Program evaluation

i. Use of findings to improve care

b. Standard: Performance Improvement Projects

i. Policy describing QAPI projects

1. Project log a. Description b. Timeline c. Outcomes d. Evaluation e. Follow up and changes

ii. Governing body responsibilities

1. Show minutes where Board approved the QAPI program 2. Demonstrate staff knowledge of program (sign off sheet, orientation checklist) 3. Put QAPI program on staff meeting agenda 4. Refer to 5.a.i.1.a above 5. Preamble to QAPI policies describing the role and expectations of the Governing body a. Patient safety is a priority

i. Tracking adverse events
ii. Analyzing and making changes in operation based on Quality input

b. Identify sufficient resources dedicated

i. Training
ii. Consultants
iii. Education
iv. Certification
v. Log of all of these types of activities
vi. Include annual review of QAPI program in the minutes of the Governing Body

1. Motion: That the Board acknowledge review and acceptance of QAPI program. a. Document this motion in the minutes b. Keep copy of motion and dates of acceptance in log 6. CfC: Environment a. Copies of materials supporting our having met design standards

i. Correspondence with state inspectors
ii. Floor plans
iii. Certification documents

1. Manufacturer certifications 2. Logs of equipment testing and maintenance b. Standard: Physical Environment

i. Refer infection control questions to Infection Control Condition policies
ii. List of reportable diseases will be put under Infection Control as well

c. Standard: Safety from Fire

i. Policy on emergency lighting

1. Address NFPA 21.2.9.1

ii. Policy on alcohol-based handrubs and skin preparations
iii. Policy on emergency power

1. Generator log d. Standard: Emergency Equipment

i. Policy on Emergency equipment

1. Identify quantity required and location 2. Readily available 3. Inspection log on equipment 4. Log of emergency drugs and outdates e. Standard: Emergency Personnel

i. Policy documenting ACLS and BLS training for all staff

7. CfC: Medical Staff a. Policy detailing how Governing Body holds medical staff accountable

i. Credentialing
ii. Peer review
iii. Quality Incident reporting
iv. Adverse event reporting

b. Standard: membership and clinical privileges

i. Policy documenting process for granting clinical privileges

1. State licensure 2. Certification by specialty organization 3. Other training or pertinent experience 4. Recommendations from other medical practitioners regarding competence 5. Scope of privileges a. Don’t get into specifics c. Standard: Re-appraisals

i. Policy regarding frequency of reappraisals (at least every 2 years)

1. Review credentials 2. ASC case records a. Cases and types b. Complications

i. Infection
ii. Transfer to hospital

d. Standard: Other practitioners

i. Policy documenting the same as above for CRNAs

8. CfC: Nursing Service a. Policy regarding role and job description of DON. b. Skills checklist for each RN and tech c. Standard: Organization and Staffing

i. Job Descriptions that include patient care responsibilities
ii. Have all RNs ACLS trained

9. CfC: Medical Records a. Standard: Organization

i. Policy on what goes into the medical record and how they are stored, etc.

1. When do records go off-site 2. Maintenance of records b. Standard: Form and Content of Record

i. Patient Id
ii. Significant Hx and results of medical exam
iii. Pre-op dx studies if performed
iv. Findings and techniques of operation, including pathology reports
v. Allergies and drug reactions
vi. Anesthesia record
vii. Informed consent
viii. Discharge diagnosis
ix. Policy to create chart audit that includes all of this
x. Policy on handling of tissue to exempt categories of tissue from exam, along with rationale

1. Any exemptions a. Pterygium b. Blepharoplasty 10. CfC: Pharmaceutical Services a. Policy designating consulting pharmacist and outlining their responsibilities

i. Designate frequency of visits
ii. Document visits and correspondence

b. Standard: Administration of Drugs

i. Policy stating that we must have an order signed by a physician/CRNA for every drug or biological administered to patients
ii. Policy stating administration of drugs are only by registered nurses or under the supervision of registered nurses
iii. Policy regarding storage, labeling, and expiration of drugs 
iv. Policy regarding safe injection practices (see infection control survey tool)
v. Scheduled Drugs

1. Policy document flow of scheduled drugs through the ASC a. Ordering b. Receiving c. Administration to patient d. Disposal of waste e. Documentation (chart and narcotic record) f. Return to manufacturer (if necessary, for example if narcotics outdate) 2. Policy regarding reconciliation of scheduled drugs a. Narcotic record b. Incident report on incorrect counts c. Identify loss and diversion and steps to take when diversion is identified or suspected d. Policy should show how we minimize diversion

vi. Policy regarding what to do in the case of adverse drug reaction

1. Report to responsible physician 2. Document on chart 3. Adverse drug reactions are noted as incident reports a. QAPI has agenda item identifying adverse drug reactions 4. Report to govt. agency if appropriate

vii. Blood or blood products:  We don’t use any
viii. Policy on verbal orders

1. Must be followed by a written order and signed by physician a. Date and time as soon as possible b. Readback and verify process 11. CfC: Laboratory and Radiologic Services a. Standard: Laboratory Services

i. Policy describing arrangement with outside lab, does not need to be contractual
ii. Policy regarding disposition of lab reports

b. Standard: Radiological Services: We don’t have any 12. CfC: Patient Rights a. Policy on notification of rights in advance of date of Surgery

i. Patient Rights
ii. Physician Ownership
iii. Advance directives
iv. Special communication needs

1. Have consents in several languages 2. In cases where no consent is available, have script to use to convey essential rights.

v. Include what to do with exceptions
vi. Log exceptions

1. Document same day notice 2. Physician indicates medical necessity for same day surgery

vii. Notice of patients’ rights should be conspicuously posted
viii. Advance Directives

1. Policy addressing handling of patients with advanced directives a. Notice in chart of advance directive form b. How to supply form to patients who request it c. We suspend advanced directives while they are in our care d. We will forward their advance directive if they require hospitalization. 2. Policy regarding training of staff in this regard b. Standard: Submission and investigation of grievances

i. Policy addressing grievance process

1. Documentation – log of grievances 2. Submission 3. Investigation 4. How findings are used to dispose of grievance 5. Address regulatory requirements for reporting, time frame, and notice of disposition 6. Education – difference between complaint handled on the spot and a grievance 7. Notice to patients on whom to contact

ii. Policy addressing regulatory requirements for special types of grievances

1. Mistreatment, abuse, neglect, or other serious harm 2. What to do 3. Reporting 4. Identify person who handles grievances, and what they should know. c. Standard: Exercise of Rights and Respect for Property and Person

i. Policy how to treat patients who have filed grievance

1. How to respond to grievances

ii. Informed Consent

1. Policy a. Who may obtain it (surgeon, nurse, etc.) b. Circumstances under which someone other than the patient can give informed consent. c. Content of form and instructions for completion d. Process used to obtain it, and how it should be documented in the medical record e. Mechanisms making sure the document is in the record prior to surgery. f. Exercise of rights on a patient judged to be legally incompetent g. Address delegation of the exercise of rights to a representative d. Standard: Privacy and Safety

i. Policy on providing privacy to patients 
ii. Curtailing Unwanted visitors or contaminated materials 
iii. Policy on staff and patient safety
iv. Abuse and harassment

1. Instruction to staff on what to do if they witness it e. Confidentiality of Clinical Records

i. Policy on preventing release or disclosure of patient information
ii. Policy on location of PHI where visible to others
iii. Security measures in place

13. CfC: Infection Control (note: many of these items are taken from Attachment 2, “Infection Control Surveyor Worksheet”) a. Policy outlining an explicit infection control program

i. Policy outlining infection control training for staff and documenting such training

1. At orientation 2. Periodically afterward 3. Include janitorial personnel b. Policy identifying nationally-recognized infection control guidelines we use- can choose from:

i. CDC/HICPAC
ii. Perioperative Standards and Recommended Practices (AORN)
iii. Any others

c. Policy identifying infection control RN position

i. List qualifications and training required to fill the position
ii. List qualifications, training, and certification of individual who is filling the position (either in the policy or by reference to their personnel file)
iii. Track continuing education received by the individual in their personnel file

d. Policies on prevention, control, and investigation of infections and communicable diseases among patients and ASC personnel, including contract workers and volunteers.

i. We will rely on the physician performing the procedure to let us know about patient post-surgical infections

1. Either create a document specific to the task, or show that surgeons have been requested to email us in the event of possible infection

ii. Create a document that confirms this tracking activity

1. Actions taken and results after infection identified 2. Any changes to practice after infection identified 3. Note that QAPI program was notified

iii. Policy describing notification of State authorities in compliance with disease reporting requirements (what are these for Washington?)

e. List Janitorial responsibilities f. Policy on cleaning of patient care areas

i. Policy on cleaning of Operating rooms

1. Operating rooms are terminally cleaned daily 2. High-touch surfaces in patient care areas are cleaned and disinfected with an EPA-registered disinfectant g. Policy on what to do with gross spills of blood or body fluids h. Policy on Sharps i. Policy on hand hygiene and use of gloves j. Policy on re-use of single-use devices k. Policy on Sterilization

i. Precleaning
ii. Chemical indicator in each load
iii. Biologic indicator at lease weekly and with all implantables
iv. Mechanical indicators (time, temp, pressure)
v. Documentation of maintenance of sterilizers 
vi. Documentation for each load
vii. Proper handling of sterilized items
viii. Proper storage of sterilized items
ix. Inspection of items prior to use

l. Policy on high-level disinfection or sterilization (use of cold sterilants)

i. Precleaning and inspection
ii. Chemicals for high-level disinfection are

1. Used according to manufacturer’s recommendations 2. Tested according to manufacturer’s recommendations 3. Replaced according to manufacturer’s recommendations 4. Documented to have been prepared and replaced according to manufacturer’s recommendations

iii. Instruments requiring high-level disinfection are:

1. Disinfected for the appropriate length of time as specified by manufacturer’s instructions or evidence-based guidelines 2. Disinfected at the appropriate temperature as specified by manufacturer’s instructions or evidence-based guidelines

iv. Items are allowed to dry before use
v. Proper storage in a designated clean area in a manner to prevent contamination

m. Policy on pest control

i. Log of pest control visits and who does them

n. List of reportable diseases and log of any reported o. Policy on Point of Care Devices (e.g. blood glucose meter)

i. A new single-use, auto-disabling lancing device is used for each patient
ii. The glucose meter is not used on more than one patient unless the manufacturer’s instructions indicate this is permissible.
iii. The glucose meter is cleaned and disinfected after every use.

14. CfC: Patient Admission, Assessment and Discharge a. Standard: Admission and Pre-surgical assessment

i. Policy on H&Ps

1. No more than 30 days prior 2. Who may perform: Physician and/or ARNP a. State you will accept an H&P from physicians and ARNPs not on the medical staff 3. Be able to show that CRNAs can perform H&Ps

ii. Policy on Pre-surgical assessment and update of H&P

1. includes, at a minimum, an updated medical record entry documenting an examination for any changes in the patient’s condition since completion of the most recently documented medical history and physical assessment, including documentation of any allergies to drugs and biologicals.

iii. Document evaluation of Pre-anesthetic risk by physician
iv. Identify allergies

b. Standard: Post-surgical Assessment

i. Policy identifying training and qualifications necessary for an RN to be allowed to perform post-surgical assessments.  
ii. Policy creating document to be in RNs personnel file showing they have met the training and qualification requirements.
iii. Make sure the discharge record shows

1. Evaluation for recovery from anesthesia signed off by surgeon or CRNA (conscious and moderate sedation are not considered anesthesia and thus are exempt from this requirement- see page 56 of the Guidelines). Include: a. Respiratory function, including respiratory rate, airway patency, and oxygen saturation; b. Cardiovascular function, including pulse rate and blood pressure; c. Mental status; d. Temperature; e. Pain; f. Nausea and vomiting; and g. Postoperative hydration. 2. Performance of post-surgical assessment 3. Needs identified 4. Actions taken to address needs c. Standard: Discharge

i. Documentation should show:

1. Discharge instructions provided in writing a. Postoperative care instructions 2. Copies of prescriptions given 3. Physician contact information 4. Follow up appointments 5. Supplies for overnight needs were given 6. Discharge order, signed by surgeon 7. Responsible adult who accompanied the patient a. Exemption provided should be specific