Determining it Serious Injury, Serious Harm, Serious Impairment, or Death has Occurred or is Likely to Occur as a Result of Noncompliance:
The team must differentiate between noncompliance which RISES to the Level of I J (because it is serious I, H, I, or D and that which does not (i.e; lower level of noncompliance).
~>WHAT IS outcome/impact had or is likely to have on the recipient(s) ??
What is an F-tag?
“F” federal
tag number corresponds to a specific regulation within the CFR (Code of Federal Regulations)
What is a K-tag?
(Requirements pertaining to the adopted codes & related standards ensuring compliance w Life Safety and Health Care Facilities codes
What are Mandatory Task Assignments
-Dining (observations for 1st full meal)
-Infection Control
-Beneficiary Protection Notification Review
-Kitchen
-MEDication Admin /Storage & Labeling
-Resident Council Pres (day 2)
-Sufficient & Competent RN Staffing
What are Triggered Task Assignments
- Personal Funds
- Environment
- RESident Assessment
When is QAA/QAPI done & by whom?
complete of end of the survey by TC only
Offsite PREP Steps for TC to complete
- Create Survey Shell (ACO to ASEQ)
- Select Team Roster
- Link Complaints & FRIs
- Review CASPER 3 Report (for Patterned Repeat DPs)
- Document Results of Last Standard Survey
- Note any variances/waivers
- Contact Ombudsman (ANY concerns? can give proposed entrance)
- Team reviews offsite info independently only
- MDS Indicator Facility Report
- QIS reporting process
Sample Selection
• Share Completed I P data (TC confirms completion)
• Finalize selection of residents:
•(1) resident (×1) each: hospice, dialysis, ventilator, & smoker
(2) residents (×2) for Transmission Based Precautions (include 1-COVID)
(3) Closed RRs (x3)
Entrance Conference Worksheet
Info Needed:
* Immediately @EC
* within 1 hrs
* within 4 hrs
* by End of 1st day
* within 24 hrs
INFOrmation needed immediately
1 Census Number
2 Complete Matrix (new admissions last 30 days)
3 Alphabetical list all residents (note any out of facility)
4 List resident smokers & designated smoking times & areas
5 List residents with confirmed/suspected COVID
6 Staff responsible: Infection Prevention Control
7 Staff responsible: COVID vaccines
Entrance Conference Needed/Discussed
1 brief Entrance Conference with DOA
2 Info regarding FT DON coverage (verbal acceptable)
3 Into re:emergency water source (verbal is acceptable)
4 Signs announcing survey (posted in high visibility areas)
5 Copy of facility floor plan/changes with COVID (Observation & COVID units noted)
6 Name of RES Council President
: 7 Provide facility w/copy of CASPER 3
Info Needed within 1 HR of EC
1. a. Schedule of MEAL times
b. locations of dining rooms
c. location al dining rooms (inc therapeutic menus) to be served for duration of survey
d. policy for outside food
2. Schedule of MEDication ADMINistration times
3. Number/location of MED storage Room & MED Carts
4. Actual working schedules (for all staff, separated by departments, for the survey time period)
5. CONTACT LIST (*name, location & phone #)
(* key staff personnel
* contract staff (i.e. rehab services)
* staff responsible for notifying all residents & families of COVID cases (confirmed or suspected)
6. Paid Feeding Assistants:
a. approved training program (min 8 hrs)
b. Names of staff (including agency staff) who have successfully
completed training for paid FA & currently assisting selected residents with meals/snacks
C. List of residents eligible for assistance and currently receiving assistance from paid FA
7. Mechanism(s) used to inform residents, their reps & families of COVID
INFO needed by end of first day
1. Each surveyor access to all Resident electronic health records (EHR)
2. Complete Medicare/Medicaid Application (CMS-671)
3. Complete Census & Condition Information (CMS-672)
4. Complete Beneficiary Notice form of Residents Discharged within last 6 months
INFO Needed within 4 Hours of EC
1. Matrix for all Residents
2. Admission Packet
3. Dialysis Contract, Agreement/Arrangements P&P
4. List qualified staff providing hemodialysis or assistance for peritoneal dialysis treatment
5. Agreements or P&P for transport to/from dialysis treatments
6. Does the facility have an onsite separately certified ESRD unit?
7. Hospice agreement, P&P for each hospice used (name facility designee who coordinates services with hospice providers)
8. Infection Prevention & Control Program Standards P&P, Surveillance Plan, Antibiotic Stewardship
9. Influenza, Pneumococcal, COVID Immunization P&P
10. List of residents & COVID vaccination status
11. COVID Staff Vaccination Matrix
12. COVID Healthcare Staff Vaccination P&P
13. QAA committee info
14. QAPI Plan
15. Facility assessment
16. Abuse Prohibition P&P
Noncompliance
Failure to meet one or more federal health, safety, and/or quality : regulations.
Substantial Compliance
One or more standard-level deficiencies with an acceptable Plan of Correction (PoC)
A deficiency cited at severity Level One for SN/NFs (i.e. Scope & Severity A, B, or C) with an acceptable PoC for B & C level deficiencies
Serious injury, Serious harm, Serious impairment or death are adverse outcomes which result in, or are likely to result in
* death
* a significant decline infunctioning (physical, mental, or psychosocial) not solely due to normal progression of disease or aging)
* loss of limb/disfigurement;
* avoidable pain that is excruciating & more than transient
bsongeebiWI
* other serious harm that creates life-threatening complications/conditions
Removal Plan/Immediate Action
All actions the entity has taken or will take to immediately address the noncompliance that resulted in or made serious injury, serious harm, serious impairment, or death likely.
Recipient at Risk
Recipient who, as a result of noncompliance, & in consideration of recipient's physical, mental, psychosocial or health needs, and/or vulnerabilities, is likely to experience a serious adverse outcome.
Recipient
person (patient, resident, or client) receiving care/services from a Medicare/Medicaid participating provider/supplier
or a patient/individual served by a lab subject to CLIA.
Psychosocial
refers to combined influence of psychological factors + surrounding social environment on physical, emotional, and/or mental wellness
Laboratory Requirements (CLIA) - §493.2
Congressional Act established quality standards for all lab testing (to ensure accuracy, reliability, & timeliness of test results, regardless of where test performed)
CLIA laboratories are in compliance when
a credible Allegation of Compliance (AoC) is received & verified
Determining if Noncompliance Exists
- to establish NONcompliance with one or more of the federal health, safety, and/or quality regulations - gather sufficient evidence through OILRR to support citation - to understand extent, nature/scope, impact (likely) of noncom pliance use SOM Appendix Q
Surveyors do not have to prove when the serious harm will occur, or that it will occur within a specific timeframe.
It is sufficient to show that serious harm either has occurred or is likely to occur.
Determining Need for Immediate Action
When entity’s noncompliance causes a serious adverse outcome
THIS IS Done
to remove systemic problem which contributed to, caused, or IS a factor in causing the serious adverse outcome (i.e., serious injury, harm, impairment, or death to a recipient) creates the likelihood such an outcome likely
& to prevent from occurring / recurrence.
(Even when recipient has been removed from situation, immediate action still necessary)
CITATIONS
A facility would actually be cited for F 371 J
The first "F" means a federal violation
The "J" at the end corresponds to a level 4 citation Immediate
jeopardy with a scope of isolated.
The first "F" means a federal violation.
The "J" at the end corresponds to a level 4 citation Immediate jeopardy with a scope isolated.
Level 1
No harm, no potential for harm
A Isolated
B Patterned
C Widespread
Level 2
No Harm, but potential for harm
D Isolated
E Patterned
F Widespread
Level 3
Actual Harm - COMPROMISED
G Isolated
H Patterned
I Widespread
Level 4
Harm - Immediate Jeopardy
J Isolated
K Patterned
L Widespread
OMBUDSMAN
- a legal advocate for residents in LTC facilities
- MUST be notified of Findings of noncompliance or any adverse action taken against SNF
For NURSING HOMES, the State Agency provides the State LTC
Ombudsman with the following information:
- Statement of deficiencies
- List of isolated deficiencies that cause no harm with the potential
for minimal harm
- Report on adverse actions imposed
- Provider's written response
- Provider's request for appeal and the results of that appeal
CMS Reports & FORMS
1. CMS 2657 report of DP requiring POC
2. If no POC required then Notice of Isolated Deficiencies issued
3. CMS 671 - Application/Renewal (Medicare & Medicaid Certification
4. CMS 672 - Resident Census/Condition
5. CMS 801 - Offsite Worksheet
6. 6. CMS 802 - Roster/Sample Matrix
7. CMS 803 - Observation of Facility
8. CMS 805 - Resident Review Worksheet
"IF" No POC Required
then Notice of Isolated Deficiencies would be issued
CMS 671
Application for Medicare & Medicaid certification (renewal)
CMS 672
Resident Census & Condition
CMS 801
Offsite Surveyor Worksheet
CMS 802
Roster/Sample Matrix
CMS 803
Observation of Facility
CMS 805
Resident Review Worksheet
conflict of laws
When between state & federal laws, use the most stringent higher standard
ALL facilities
must be licensed by the state
A "Licensed" facility is:
- NOT Medicare/Medicaid certified.
- can only take ins & private pay.
- will only have a state survey.
Medicare & Medicaid FAs
- must be certified by the CMS
- will have both a state & federal survey per OBRA 1987
Inspection process focuses on
OUTCOMES
QoL - Quality oF RESident life
(Based on QI report: #number of pressure sores, dehydration, residents on anti-psychotics; *before OBRA 1987, focus on "process")
Preparation of acceptable POC must state:
1. How corrective action will be achieved
2. How facility will identify other residents having potential to be affected
3. What measures will be put in place (or systemic changes - to ensure that deficient practice does not recur)
4. How facility plans to monitor performance (to ensure solutions
are sustained by integrating into facility QA program)
Deficiencies
Issued for standards of care NOT MET.
Divided into:
Resident-centered & Facility-centered
Level A Deficiency
Might involve one resident who did not receive proper access to nutritious snacks as required
Level C Deficiency
Might be issued for the HOT Water for the entire facility being 2 degrees warmer than permitted.
This would be Level C because the Scope was widespread but no actual harm occurred and there was potential for only minimal harm
Higher Level Deficiencies
of scope and severity) risk facility being placed on FAST TRACK or decertification of the facility for (Medicare / Medicaid funding within 60 days if satisfactory corrections are NOT corrected
Deficiency vs Scope & Severity
Deficiency is a regulatory requirement that a survey finds unmet vs
Scope & Severity is a national system used by all state survey agencies and the Health Care Financing Administration when conducting nursing home Medicare and Medicaid certification surveys
Severity Matrix
determine reimbursement for services rendered to the resident
(processes integral part of how nursing homes scores calculated in system)
Social Security Act of 1965
signed into law (Pres Johnson) on July 30, 1965
Established both Medicare (the health insurance program for Americans over 65) & Medicaid (the health insurance for low-in-come)
Medicare
Signed into law in 1965, Medicare is a Health Insurance Program for:
- People age 65 or older
- People under age 65 with certain disabilities
- People of all ages with ESRD
Medicaid
Medical assistance program (jointly financed by State & Federal) for eligible low-income individuals.
Program covers the needy, elderly, blind, & disabled, receiving cash assistance (under the Supplemental SS Program)
STATE program provides medical services to clients of the state public assistance program and, @State’s option, other needy individuals with medical bills that qualify them as categorically or medically needy.
Medicaid also augments the hospitals and Nursing Facility (NF) services (mandated under Medicaid.)
(States may decide on the amount, duration, and scope of additional services, except that care in institutions primarily for the care and treatment of mental health issues, may not be included for persons over age 21 and under age 65.)
Title XVI (SSA of65)
Title (18) established regulations for Medicare program.
Provides insurance coverage (for hospital, post-hospital, home health services, and hospice) for the aged / disabled regardless of income or health status.
Title XIX (SSA of 65)
Title (19) established regulations for Medicaid program
Appropriates money to families with dependent children, the aged, blind, or disabled, whose income and resources are insufficient to meet the costs of necessary medical services.
Title XVIII (18) + Title XIX (19)
Both mandate establishment of minimum health & safety standards (that must be met by providers and suppliers participating in the Medicare and Medicaid programs)
42 CFR Part 431.51
Provides Medicaid recipients with free choice of providers.
(On a statutory basis, 42CFR Part431.51 provides beneficiaries may obtain services from any qualified Medicaid provider that undertakes to provide the services to them)
PROVIDERS
resident care institutions such as hospitals, hospices, nursing homes, and home health agencies.
SUPPLIERS
Agencies for diagnosis & therapy rather than sustained resident care, such as laboratories, clinics, & physical therapist (PT) offices.
Provide sufficient staffing (nursing)
-meet adequate resident needs
-reasonable work loads
-no reports of insufficient staff from residents, families, or ombudsman
-staff should be responsive to residents needs
Nursing Staffing Info
FA must post in clear, readable format, in a prominent place accessible to residents & visitors the daily nurse staffing info
Include: name/date/census total # and actual hours worked by licensed & unlicensed staff directly responsible for resident care per shift (RN / LPN / CNA)
Paid Feeding Assistants
- work under supervision of licensed RN
- may only feed residents with no complicated feeding problems
(ex: difficulty swallowing, recurrent lung aspirations)
Screening & Training Employees
- criminal background checks for all employees
- OIG checks
- Annual training
- 6hrs initially Alzheimers/Dementia training then 3hrs annually thereafter
- infection control
- disaster
- needs of specialized population
- resident's rights
- abuse
Consultant Pharmacist
-a facility must employ or obtain services of licensed pharmacist
-consults all aspects of pharm services
review med regimens monthly of all residents
-establish system of records of receipt & disposition of all controlled meds
-determine drug records are in order & periodically check reconciliation of all controlled meds
Pharmacy Services
-labeling prescriptions
-over the counter medications identifying
-must store all drugs and biological in locked compartments
-must provide separately locked affixed compartments for storage
of controlled drugs
Labeling prescription drugs includes.
-residents full name
-physicians name
-prescription number
-name and strength of drug
-directions for use
-date of issue
-expiration date
-name of pharmacy that filled the prescription
OTC meds identified with following:
-resident name
-physician name
-expiration date
-name of drug
-strength
Infection Control
- program designed to provide a safe/sanitary comfortable environment & to help prevent develop/transmission of diseases/infection
-must obtain a chest x-ray completed no more than 6 months prior to admission & complete a two step tuberculin skin test
Environment & Physical standards
FA must provide a safe, functional, sanitary, and comfortable environment (for residents, staff, & the public)
Facility must do the following:
-establish procedures to ensure that water is available to essential areas when there is a loss of normal water supply
-adequate outside verification of window or mechanical ventilation
-secured handrails
-effective pest control program
-home-like environment for residents
linens
- handle, store, process, transport in a manner that prevents spread of infection
- if soiled, shall be securely contained at source & handled in manner that protects workers & prevents contamination
- maintained in good repair
bathroom
each resident must have or be near toilet or bathing facilities
nurses station
must be equipped to receive resident calls through communication system from resident rooms, bathrooms, activity, dining, and therapy areas
Pet Policies
pets may be permitted at facility but cannot create nuisance/safety hazard
must have periodic vet exams & required immunizations (state/local health regulations)
Dietary Services
-must provide each resident w/nourishing, palatable, well balanced diet that meets nutritional & special needs
- employ qualified dietician (FT, PT or consultant)
-if not employed FT, must designate qualified person to serve as director of food service who will provide consultation as qualified dietician
- # of consultant dietician hrs based on # of residents, complexity of resident services & qualification of food service director
Food
prepared by methods that conserve nutrient value, flavor, and
appearance
-food is palatable, attractive, and at proper temp.
prepared in a form designed to meet individual needs
-substitutes offered of similar nutritive value to residents who refuse to be served
Therapeutic Diets
must be prescribed by attending
Assistive Devices
-must provide special eating equipment and utensils for residents who need them
Federal, state, local regulation of Food
-must procure food from sources approved and are satisfactory
-store, prepare, distribute in sanitary conditions
-provide storage space in room near kitchen that can hold at least a 3 day supply of staple food for normal and emergency needs
-dispose of garbage properly
Sanitary Conditions
-must procure food from sources approved by federal, state, and local authorities
-must store, prepare, and distribute, and serve food under sanitary conditions
Physician Services
-must personally approve in writing that a person be admitted to a facility
-each resident must remain under care of a physician
-physician must review resident's total plan of care at each visit
-required at each visit to write, sign, and date progress notes, sign and date all orders
-available 24/7