Regulatory Compliance & Quality - Section 1: Federal RHC Requirements Flashcards
The RHC and its staff are in ____ with applicable federal, state, and local laws and regulations
Compliance
The clinic is ____ pursuant to applicable state and local law
Licensed
Staff of the clinic are ____, ____, or ____ in accordance with applicable state or local laws
Licensed, certified, or registered
Examples of what the surveyor may look for under the compliance with federal, state, and local law requirement:
The clinic has a process to verify personnel are ____, ____, or ____ with applicable state laws
Licensed, certified, or registered
Examples of what the surveyor may look for under the compliance with federal, state, and local law requirement:
Personnel licenses, certifications, or registrations are ____ and ____ in an organized format
Documented and tracked
Examples of what the surveyor may look for under the compliance with federal, state, and local law requirement:
The clinic ____ all licenses, certificates, and permits to operate
Displays
Examples of what the surveyor may look for under the compliance with federal, state, and local law requirement:
All clinic documents and signage (both internal and external) are consistent with what document?
The CMS 855A enrollment application
Examples of what the surveyor may look for under the compliance with federal, state, and local law requirement:
The name must match one of the names listed on what document?
The CMS 855A enrollment application
A practice is eligible for initial RHC certification if it is located in an area that is designated as what in either population or geographic?
Medically Underserved Area (MUA) or Health Professional Shortage Area (HPSA)
____ are authorized to designate areas with a shortage of personal health services for purposes of obtaining RHC status
Governors
In order for a shortage area designation to be considered “current”, it cannot be more than ____ years old
4 years old
Only ____ can make a location decision
CMS
The clinic must be constructed, arranged, and maintained to ensure access to and safety of ____, and provides adequate space for the provision of ____ ____
Patients, direct services
The clinic has a preventive maintenance program to ensure that:
1) All essential mechanical, electrical, and patient-care equipment is maintained in ____ operating condition
2) ____ and ____ are appropriately stored
3) The premises are ____ and orderly
Safe
Drugs and biologicals
Clean
Examples of what the surveyor may look for under the physical plant and environment requirement:
The RHC is to ensure the ____ of patients, personnel, and the public
Safety
Examples of what the surveyor may look for under the physical plant and environment requirement:
The physical plan should be maintained consistent with appropriate state and local ____, ____, and ____ codes
Building, fire, and safety
Examples of what the surveyor may look for under the physical plant and environment requirement:
Fire extinguishers are checked by both staff and fire professionals ____
Annually
Examples of what the surveyor may look for under the physical plant and environment requirement:
Logs of maintenance activities are maintained for ____, ____, ____, and ____ maintenance activities
Daily, monthly, quarterly, and annual
Examples of what the surveyor may look for under the physical plant and environment requirement:
Fire and emergency drills are conducted and documented at least ____
Annually
Examples of what the surveyor may look for under the physical plant and environment requirement:
____ of ____ posted outside of clinic
Hours of operation
Examples of what the surveyor may look for under the physical plant and environment requirement:
All rooms identified by ____/____
Sign/number
Examples of what the surveyor may look for under the physical plant and environment requirement:
Bathrooms are ____, free from ____ and equipment for patient use, ____ present
Clean, storage, handrails
Examples of what the surveyor may look for under the physical plant and environment requirement:
____ lighting working, clinic well lit
Overhead
Examples of what the surveyor may look for under the physical plant and environment requirement:
____ temperature
Comfortable
Examples of what the surveyor may look for under the physical plant and environment requirement:
A ___ maintenance program should be followed by the clinic. The inspection of all clinic equipment at least ___ or as the equipment dictates
Preventive, annually
Examples of what the surveyor may look for under the physical plant and environment requirement:
The safe ___ of drugs and biologicals
Storage
Examples of what the surveyor may look for under the physical plant and environment requirement:
The clinic has a written equipment ___ policy and procedure
Management
Examples of what the surveyor may look for under the physical plant and environment requirement:
___ equipment is stored away from clean
Dirty
Examples of what the surveyor may look for under the physical plant and environment requirement:
Equipment is cleaned with appropriate ___
Disinfectant
Examples of what the surveyor may look for under the physical plant and environment requirement:
There is a list of all equipment in the clinic with a process for tracking preventive maintenance ___ ___
Due dates
Examples of what the surveyor may look for under the physical plant and environment requirement:
Manufacturer guidelines are available for key equipment either ___ or ___
Printed or online
Examples of what the surveyor may look for under the physical plant and environment requirement:
Medications/supplies ___-date with a process to check inventory
In-date
Examples of what the surveyor may look for under the physical plant and environment requirement:
Needles and syringes are ___
Secured
Examples of what the surveyor may look for under the physical plant and environment requirement:
Sample medication log meets requirements to track ___
Recalls
Examples of what the surveyor may look for under the physical plant and environment requirement:
Rx pads are ___, including electronic Rx paper
Secured
Examples of what the surveyor may look for under the physical plant and environment requirement:
___ substances are segregated, secured, and reconciled on a log
Controlled
Examples of what the surveyor may look for under the physical plant and environment requirement:
Drug __/antidote information available
Reference
Examples of what the surveyor may look for under the physical plant and environment requirement:
Medication refrigerator temperature is monitored ___ and logged
Daily
Examples of what the surveyor may look for under the physical plant and environment requirement:
Refrigerators/freezers are appropriate ___
Type
Examples of what the surveyor may look for under the physical plant and environment requirement:
No medications in the ___ of the refrigerator
Door
Examples of what the surveyor may look for under the physical plant and environment requirement:
No medications and ___ in the same refrigerator
Food
Examples of what the surveyor may look for under the physical plant and environment requirement:
Medication refrigerator in a ___/___ area
Secure/locked
Examples of what the surveyor may look for under the physical plant and environment requirement:
Medications are in a ___ cabinet or area
Locked
Examples of what the surveyor may look for under the physical plant and environment requirement:
Multi-dose vials labeled with ___ and 28- or 30-day ___ date
Date
Expiration
Examples of what the surveyor may look for under the physical plant and environment requirement:
Multi-dose vials ARE or ARE NOT permitted in treatment or procedure rooms
Are not
Examples of what the surveyor may look for under the physical plant and environment requirement:
Documentation is reviewed and staff ___ to determine what instructions for non-medical emergencies have been provided
Interviewed
Examples of what the surveyor may look for under the physical plant and environment requirement:
Staff is ___ and training is ___ for non-medical emergencies
Trained, documented
True or False:
Non-medical emergency procedures may not necessarily be the same for each clinic or area of the country (ex: earthquakes, tornados, forest fires. Floods and power outages can occur anywhere)
True
The clinic is under the medical direction of a ___ and has a health care staff that meets the requirements of 491.8.
Physician
The organization’s policies and its lines of ___ and responsibilities are clearly set forth in writing
Authority
The clinic discloses the name and addresses of:
1) Its ___, in accordance with section 1124 of the Social Security Act
2) The person principally responsible for directing the ___ of the clinic
3) The person responsible for ___ direction
Owners
Operations
Medical
Examples of what the surveyor may look for under the organizational structure requirement:
The clinic has a protocol for identifying who is in charge of ___ to ___ operations in the absence of key leadership
Day to day
Examples of what the surveyor may look for under the organizational structure requirement:
If the medical director changes, you must notify CMS via the ___
CMS29
Examples of what the surveyor may look for under the organizational structure requirement:
The clinic has a current ___ chart
Organizational
The clinic has a health care staff the includes one or more ___
Physicians
The RHC must have one or more physicians. The RHC staff must also include one or more ___ or ___
PA or NP
The physician member may be the ___ of the RHC, an ___ of the clinic or under ___ with the clinic to carry out the responsibilities required under the staffing and staff responsibilities section
Owner, employee, agreement
The PA, NP, CNM, CSW, or CP member of the staff may be the ___ or an ___ of the clinic or may furnish services under ___ to the clinic
Owner, employee, contract
At least one ___ or ___ must be an employee of the clinic
NP or PA
A PA, NP, CNM, CSW, or CP must be available to furnish patient care services at what frequency?
At all times the clinic operates
A PA, NP, CNM, CSW, or CP must be available to furnish patient care services at all times the clinic operates. In addition, a NP, PA, or CNM must be available to furnish patient care services at least ___% of the time the RHC operates
50%
If an established RHC does not have an NP or PA fulfilling the staffing requirements, what must the clinic do?
Submit a staffing waiver request to CMS
Whose responsibility is described below?
Provides medical orders, medical direction, medical care services, consultation, and supervision of the healthcare staff and chart review
Physician
A physician must be available through direct telecommunication for ___, assistance with medical ___, or patient ___
Consultation, emergencies, referrals
Chart review of the non-physician provider must be done by who?
An MD or DO
Chart review of the non-physician provider must be done by the MD or DO. What dictates the number of charts?
State regs or our policy
Physicians, in conjunction with the PA and/or NP members, participates in developing, executing, and periodically reviewing the clinic’s written ___ and the services provided to federal program patients
Policies
PAs and NPs participate with a physician in a periodic ___ of the patients’ health records
Review
The PA or NP performs the following functions, to the extent they are not being performed by a physician:
Provides services in accordance with the clinic’s ___
Arranges for, or ___ patients to, needed services that cannot be provided at the clinic
Assures that adequate patient health records are ___ and ___ as required when patients are referred
Policies, refers, maintained and referred
If the event of a loss of a physician, the clinic should be afforded a reasonable time to ___
Comply
In the event of a loss of a physician, the clinic must provide documentation showing good faith effort to obtain services of a physician on a ___ basis, as well as arrangements for immediate temporary coverage
Permanent
In the event of a loss of a physician, the clinic should inform the ___ of all actions taken
State
In the event of a loss of a physician, the clinic should follow closely and make ___ about approvals pending correction of deficiencies, compliance, or decertification
Recommendations
In the event of a loss of a PA, NP, or CNM, the clinic should request what?
A temporary staffing waiver
In the event of a loss of a PA, NP, or CNM, the clinic must demonstrate its ability to recruit a replacement within ___ days prior to its application for waiver
90 days
In the event of a loss of a PA, NP, or CNM, only currently ___ RHCs may request a waiver
Certified
In the event of a loss of a PA, NP, or CNM, CMS may not approve any waiver submitted less than ___ months after the expiration of a previous waiver
6 months
In the event of a loss of a PA, NP, or CNM, eligible waiver requested are deemed granted unless denied by the CMS regional office within ___ days of receipt
60 days
All services offered by the clinic are furnished in accordance with applicable ___, ___, and ___ laws
Federal, state, and local
The clinic is primarily engaged in providing ___ health services
Outpatient
The clinic must be ___% RHC services
51%
The clinic’s or center’s health care services are furnished in accordance with appropriate written policies, which are consistent with applicable ___ law
State
Provision of services policies are developed with the advice of a group of professional personnel that includes or or more ___ and one or more ___ or ___. At least one member is not a member of the clinic or center ___
Physician, NP or PA, staff
The provision of services policies include:
A description of the services the clinic or center furnishes ___ and those furnished through ___ or arrangement
Guidelines for the medical ___ of health problems, which include the conditions requiring the medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic or center
Rules for the storing, handling, and administration of ___ and ___
Directly, agreement
Management
Drugs and biologicals
How often and by whom do the provision of services policies need to be reviewed?
At least biennially by a group of professional personnel that includes one or more physicians and one or more NPs or PAs and at least one member that is not a member of the staff
The clinic or center staff furnishes those diagnostic and therapeutic services and supplies that are commonly furnished in a physician’s office or at the entry point into the health care delivery system. These include medical ___, ___ examination, assessment of health ___, and ___ for a variety of medical conditions
History, physical, status, treatment
The clinic will post a current ___ waiver license for lab services
CLIA
The clinic or center provides medical ___ procedures as a first response to common life-threatening injuries and acute illness and has the available ___ and biologicals commonly used in life-saving procedures, such as analgesics, anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids
Emergency, drugs
The clinic will have an emergency box with appropriate ___
Medication
Who should determine what drugs and biologicals will be needed to meet the needs of the clinic in the emergency box?
The Medical Director and non-physician provider
The clinic ___ staff on emergency care and the training is documented
Trains
The clinic or center has agreements or arrangements with one or more providers or suppliers participating under Medicare or Medicaid to furnish other services to its patients, including:
1) ___ hospital care
2) ___ services, whether furnished in the hospital, office, patient’s home, SNF, or elsewhere
3) Additional and specialist ___ and ___ services that are not available in the clinic
Inpatient
Physician
Diagnostic and lab
If the agreements are not in writing, there is evidence that patients referred by the clinic are being ___ and ___
Accepted and treated
The clinic maintains a ___ record system in accordance with written policies and procedures
Clinical
A designated member of the professional staff is responsible for ___ the patient health records an for ensuring they are completely and accurately ____, readily ___, and systematically ___
Maintaining
Documented
Accessible
Organized
The clinic maintains the ___of record information and provides safeguards against loss, destruction, or unauthorized use
Confidentiality
Written policies and procedures governs the use and ___ of patient health records from the clinic and the conditions for release of information
Removal
The patient’s ___ ___ is required for release of information in the patient’s health record not authorized to be released without such consent
Written consent
Patient health records are retained for at least ___ years from the date of last entry, and longer if required by state statute
6 years
The clinic completes a ___ evaluation of a clinic’s total operation including the overall organization, administration, policies and procedures, fiscal, quality improvement, and patient safety
Biennial
The biennial evaluation of a clinic’s total operation should also include a review of:
1) The ___ of clinic services, including at least the number of patients served and the volume of services (Medicare, Medicaid, commercial, and self-pay)
2) A representative ___ of both open and closed charts
3) The clinic’s health care ___
Utilization
Sampling
Policies
What is the purpose of a biennial program evaluation?
To determine if the services were appropriate and policies were followed
The purpose of a program evaluation is to determine if the services were appropriate and policies were followed. What must the clinic staff do with the findings?
Consider the findings and take corrective action, if necessary
True or False:
The biennial program evaluation must be done all at once and by the same individuals
False; does not have to be done all at once or by the same individuals
If the biennial program evaluation is not done all at once, no more than ___ years should elapse between evaluating the same parts
2 years
A facility operating less than 1 year may not have done a biennial program evaluation, but they must have what in place?
A policy in place that specifies who is to do the eval, when and how it is to be done, and what will be covered
The RHC must comply with all applicable federal, state, and local emergency ___ requirements
Prepardeness
The RHC must have an emergency preparedness plan that does all of the following:
1) Be based on and include a documented, ___-based and ___-based risk assessment, utilizing an all-hazards approach
2) Include strategies for addressing ___ events identified by the risk assessment
3) Address patient ___, including, but not limited to, the type of services the RHC has the ability to provide in an emergency, and continuity of operation, including delegations of authority and succession plans
4) Include a process for cooperation and collaboration with local, tribal, regional, state and federal emergency preparedness
Facility-based, community-based
Emergency
Population
The RHC must develop and implement emergency preparedness policies and procedures based on its emergency preparedness plan, risk assessment, and the communication plan. The policies must be updated at least every ___ years
2 years
The emergency preparedness policies and procedures should include safe ___ from the RHC, which includes appropriate placement of exit signs, staff responsibilities, and needs of the patients
Evacuation
The emergency preparedness policies and procedures should include a means to ___ in ___ for patients, staff, and volunteers who remain in the facility
Shelter in place
The emergency preparedness policies and procedures should include a system of medical documentation that ___ patient information, protects ___ of patient information, and secures and maintains the ___ of records
Preserves
Confidentiality
Availability
The emergency preparedness policies and procedures should include the use of ___ in an emergency or other emergency staffing strategies, include the process and role for integration of state and federally designated health care professionals to address surge needs during an emergency
Volunteers
The emergency preparedness policies and procedures should include how refrigerators/frozen medications, such as vaccines, are handled in a power ___
Outage
In the event of a power outage, the clinic should have a back up generator for what purpose?
To keep refrigerated/frozen medications, such as vaccines, patient ready
The RHC must develop and maintain an emergency preparedness communication plan that complies with federal, state, and local laws and must be reviewed and updated at least every ___ years
2 years
The emergency preparedness communication plan must include the ___ and ___ information for staff, entities providing services under arrangement, patients’ physicians, other RHCs, and volunteers
Names and contact information
The emergency preparedness communication plan must include ___ and ___ means for communicating with RHC staff and federal, state, tribal, regional, and local emergency management agencies
Primary and alternate
The emergency preparedness communication plan must include a means of providing information about the general ___ and ___ of patients under the facility’s care
Condition and location
The emergency preparedness communication plan must include a means of providing information about the RHC/FQHC’s needs, and its ability to provide ___, to the authority having jurisdiction or the incident command center, or designee
Assistance
The clinic’s emergency preparedness plan must have an organized process for handling an on-site emergency (e.g., fire) which addresses the following:
1) How ___ will be notified of an emergency
2) Staff responsible for calling the ___ department
3) Location of where employees should meet ___ of the building
4) Staff person responsible for doing a head ___ upon evacuation of the building
Employees
Fire
Outside
Count
The clinic’s emergency preparedness communication plan must have an organized process for handling an off-site emergency (e.g., snowstorm, flood, hurricane, etc.) which addressed the following:
1) How ___ will be notified of an emergency
2) Staff responsible for notification and ___ of patient services
3) Contingency plan that includes ___ provider in the event the clinic cannot service its own customers
Employees
Triaging
Alternate
The RHC must develop and maintain an emergency preparedness training and testing program that is based on the emergency preparedness plan, risk assessment, policies and procedures, and the communication plan. It must be reviewed an updated at least every ___ years
2 years
The emergency preparedness training plan must provide initial training in emergency preparedness policies and procedure to all ___ and ___ staff, individuals providing services under ___, and ___, consistent with their expected roles
New and existing
Agreement
Volunteers
The emergency preparedness training plan must provide emergency preparedness training at least every ___ years
2 years
The emergency preparedness training plan must maintain ___ of the training
Documentation
The emergency preparedness training plan must demonstrate staff ___ of emergency procedures
Knowledge
The emergency preparedness testing program must have the RHC conduct exercises to test the emergency plan at least every ___ years
2 years (1 per year)
The emergency preparedness testing program must have the RHC participate in a full-scale exercise that is ___-based
Community-based
The emergency preparedness testing program must have the RHC participate in what type of full-scale exercise if a community-based exercise is not available?
An individual, facility-based exercise
If the RHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC is exempt from engaging in a community-based or individual, facility-based full-scale exercise for ___ year following the onset of the actual event
1 year
The RHC must conduct an additional exercise to test the emergency plan that may include, but is not limited to the following:
1) A second ___-___ exercise that is community-based or individual, facility-based
2) A ___ exercise that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan
Full-scale
Tabletop
If the emergency preparedness policies and procedures are significantly updated, what must the RHC do?
Conduct training on the updated policies and procedures
True or False:
If a clinic that is part of a healthcare system consisting of multiple separately certified healthcare facilities elects to have a unified and integrated emergency preparedness program, the clinic may choose to participate in the health care system’s coordinated emergency preparedness program
True
If the clinic elects to participate in the healthcare system’s emergency preparedness plan, the unified and integrated emergency preparedness program must demonstrate that each separately certified facility within the system ___ participated in the development of the unified and integrated emergency preparedness program
Actively
If the clinic elects to participate in the healthcare system’s emergency preparedness plan, the unified and integrated emergency preparedness program must be developed and maintained in what manner?
A manner that takes into account each separately certified facility’s unique circumstances, patient populations, and services offered
If the clinic elects to participate in the healthcare system’s emergency preparedness plan, the unified and integrated emergency preparedness program must demonstrate that each separately certified program is capable of actively ___ the unified and integrated emergency preparedness program and is in ___ with the program
Using
Compliance
If the clinic elects to participate in the healthcare system’s emergency preparedness plan, the unified and integrated emergency preparedness program must be based on and include all of the following:
1) A documented community-based risk assessment, utilizing an all-___ approach
2) A documented individual ___-based risk assessment for each separately certified facility within the health system, utilizing an all-hazards approach
Hazards
Facility-based
