CMS Critical Access Hospital (CAH) CoPs Part 1 of 3
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CMS Critical Access Hospital (CAH) CoPs
Part 1 of 3
SpeakerSue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017 614 791-1468 (Call with
questions, No emails)
Introduction
3
You Don’t Want One of These
4
5
Mandatory Compliance Hospitals that participate in Medicare or
Medicaid must meet the Conditions of Participation (COPs) for all patients in the facilities and not just those who are Medicare or Medicaid patients,
Hospitals accredited by the Joint Commission (TJC), HFAP, CIHQ, or DNV Healthcare have what is called deemed status
Email questions to CMS at [email protected] Lisa Marunycz is in charge of CAH program
at 410 786-1638
Access to Hospital Complaint DataCMS issued Survey and Certification regarding access to hospital complaint data
Includes acute care and CAH hospitals Does not include the plan of correction but can request
Questions to [email protected]
This is the CMS 2567 deficiency data and lists the tag numbers
Updating quarterly and includes hospital’s name and address
6
Updated Deficiency Data Reports
7
www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Hospitals.html
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/LSC.html
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/LSC.html
http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/NHs.html
CAH Problematic StandardsDate and time on all orders and entries
Verbal orders, Cluttered hallways and other Life safety code issues, H&Ps, EMTALA,
Informed consent, Cleanliness of dietary
Plan of care, Privacy and whiteboard,
Handling, dispensing, storage and administration of medications
Meeting the nutritional needs of patients
Healthcare services in accordance with P&P8
CAH Problematic StandardsMedical record documentation must reflect the
nursing process, Timing of medications
Legibility of the medical record, No orders
Equipment and supplies used in life saving procedure, Hand Hygiene & Gloving
R&S for PPS hospitals but CAH still need to do something,
Failure to Monitor Patient for Safety (Suicide Precautions)
Infection control issues are big & safe injections9
AHA Critical Access Website
10
www.aha.org/aha_app/issues/CAH/index.jsp
CAH Update Issues AHA
11
Rural Health Information Hub RHIhub
12
https://www.ruralhealthinfo.org/
FAQs
13
https://www.ruralhealthinfo.org/topics
/critical-access-hospitals
CMS Updated Website www.cms.gov
14
CMS CAH WebsiteCMS has a website for resources
Includes:
State operations manuals
Program transmittals
Guidance for laws and regulations for CAH
Medicare Learning network
Other helpful information
Email questions to [email protected]
CMS CAH Website
16
www.cms.gov/Center/Provider-Type/Critical-Access-Hospitals-Center.html
17
The Conditions of Participation CoPs
First, published in the Federal RegisterFederal Register available at no charge at www.gpoaccess.gov/fr/index.html
Next, CMS publishes Interpretive Guidelines and some include survey procedures,Current CoP issued December 16, 2016CMS made many changes effective June 7, 2013 and 93 page memo January 16, 2015, effective April 7, 20151 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf
Subscribe to the Federal Register
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www.federalregister.gov/my/sign_up
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new website at www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf
Email questions to [email protected]
20
www.cms.gov/manuals/Downloads/som107ap_w_cah.pdfand is critical access hospital CoPf
Also called State Operation Manual
21
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloa
ds/som107ap_w_cah.pdf
December 16, 2016 ManualWas only a minor change and amended tag 207
Added clinical nurse specialist (CNS) to the list who has experience in emergency care who is on call or immediately available by telephone
The list is those who can show up in 30 minutes if the ED and hospital is closed when a patient comes to the ED
Adds to physicians, PA, or NP
Also discusses a RN on duty to perform a MSE if within the nurse scope of practice and the Bylaw
22
Manual Updated October 14, 2016This was a minor provision that discussed the
eligibility to be a CAH; certified as CAH and not more than 25 inpatient beds
23
Adding Section on Spouse
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www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downl
oads/som107_Appendixtoc.pdf
271 Pages
October 9, 2015 Manual If same sex partner is legally married in any state
Then each is the legal spouse of each other
This section appears at the beginning of the manual
Therefore it does not have a tag number
Important in patient rights and consent issue if one spouse is incapacitated
25
93 Page Memo January 16, 2015
26
Memo with Many Changes 93 pages long and advance copy, effective April 7,
2015, and in current manual
Changes to pharmacy, infection control, dietary, nursing, and rehab services
To reflect changes effective July 11, 2014 including responsibilities of physicians MD or DO needs to review non-physician outpatient order only
if required by state law or where a co-signature is required
Physician does not need to visit at least every two weeks the CAH
P&P committee does not need outside person27
April 7, 2015 ChangesMajor changes to pharmacy, dietary, infection control, drugs, and nursing standards and adds rehab
CMS now has an email address that questions can be addressed
[email protected] 31 tag numbers
211, 260, 261, 270-284, 286-299Changes are shown in red
28
Final Federal Register Changes
29
www.ofr.gov/(S(5jsvvwmsi4nfjrynav20ebeq))/OFRUpload/OFRData/2014-10687_PI.pdf
30
How to Find ChangesHave one person in your facility who goes out to this
website once a month and checks for updates to survey memos and if manual updated,
www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp
You can do a search for time frame and can add words to search,
Click on fiscal year to bring up most current memos
CMS issues transmittal before putting it into the CAH Manual so can check for these also
CMS Survey and Certification Website
31
www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#
TopOfPage
Click on Policy & Memo to States
CMS Survey Memos
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CMS Transmittals
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CMS Memo on Safe Injection Practices
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CMS Memo on Safe Injection PracticesCMS issues a 7 page memo on safe injection
practices
Discusses the safe use of single dose medication to prevent healthcare associated infections (HAI)
Notes new exception which is important especially in medications shortages
General rule is that single dose vial (SDV)can only be used on one patient
Will allow SDV to be used on multiple patients if prepared by pharmacist under laminar hood following USP 797 guidelines
35
Safe Injection Practices
36
http://www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/index.html?redirect=/SurveyCertificationGenInfo/PMSR/li
st.asp
CMS Memo on Safe Injection PracticesAll entries into a SDV for purposes of repackaging
must be completed with 6 hours of the initial puncture in pharmacy following USP guidelines
Only exception of when SDV can be used on multiple patients
Otherwise using a single dose vial on multiple patients is a violation of CDC standards
CMS will cite hospital under the hospital CoP infection control standards since must provide sanitary environment Also includes ASCs, hospice, LTC, home health, CAH, dialysis, etc.
37
CMS Memo on Safe Injection PracticesBottom line is you can not use a single dose vial on multiple patientsCMS requires hospitals to follow nationally
recognized standards of care like the CDC guidelines which has 10 practices
SDV typically lack an antimicrobial preservative
Once the vial is entered the contents can support the growth of microorganisms
The vials must have a beyond use date (BUD) and storage conditions on the label
38
CMS Memo on Safe Injection PracticesMake sure pharmacist has a copy of this memo
If medication is repackaged under an arrangement with an off site vendor or compounding facility ask for evidence they have adhered to 797 standards
ASHP Foundation has a tool for assessing contractors who provide sterile products
Go to www.ashpfoundation.org/MainMenuCategories/PracticeTools/SterileProductsTool.aspx
Click on starting using sterile products outsourcing tool now
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CMS Memo on Safe Injection PracticesSo if make it in a single dose vial then you need to
buy it in a single dose vial If they only make it in a multi-dose vial then try and use it as a
single dose vial
If not then try and use it only on one patient
Do not take multi-dose vial into patient room or into OR Unless in OR you treat it as a single dose vial and discard
Mark multi-dose vial expires in 28 days unless sooner by manufacturer
Clean off lid even if new vial for 10-15 seconds and let dry40
Safe Injection Practices Posters
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Not All Vials Are Created Equal
42
43
Safe Injection Practices www.empsf.org
44
45
CDC One and Only Campaign
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http://oneandonlycampaign.org/
ISMP IV Push Medication Guidelines
47
ISMP IV Push Medications Guidelines ISMP has published a 26 page document called
“ISMP Safe Practice Guidelines for Adult IV Push Medications at www.ismp.org
The document is organized into factors that increase the risk of IV push medications in adults, Current practices with IV injectible medications
Developing consensus guidelines for adult IV push medication and
Safe practice guidelines
About 90% of all hospitalized patients have some form of infusion therapy
48
IV Push Medicine Guidelines
49
Remember; CMS says you have to follow standards of care and specifically mentions the
ISMP so surveyor can site you if you do not follow this.
IV Push Medications GuidelinesProvide IV push medications in a ready to
administer form
Use only commercially available or pharmacy prepared prefilled syringes of IV solutions to flush and lock vascular access devices
If available in a single dose vial then need to buy in single dose vial
Aseptic technique should be used when preparing and administering IV medication This includes hand hygiene before and after
administration50
IV Push Medications GuidelinesThe diaphragm on the vial should be disinfected
even if newly opened The top should be cleaned using friction and a sterile 70%
isopropyl alcohol, ethyl alcohol, iodophor, or other approved antiseptic swab for at least ten seconds to it dry
Medication from a glass ampule should be with a filter needle unless the specific drug precludes this
Medication should only be diluted when recommended by the manufacturer or in accordance with evidence based practice or approved hospital policies
51
IV Push Medications Guidelines If IV push medication needs to be diluted or
reconstituted these should be performed in a clean, uncluttered, and separate location
Medication should not be withdrawn from a commercially available, cartridge type syringe into another syringe for administration
It is also important that medication not be drawn up into the commercially prepared and prefilled 0.9% saline flushes This are to flush an IV line and are not approved to use to
dilute medication52
IV Push Medications Guidelines If IV push medication needs to be diluted or
reconstituted these should be performed in a clean, uncluttered, and separate location
Medication should not be withdrawn from a commercially available, cartridge type syringe into another syringe for administration
It is also important that medication not be drawn up into the commercially prepared and prefilled 0.9% saline flushes This are to flush an IV line and are not approved to use to
dilute medication53
54
IV Push Medications GuidelinesCombination of more than one medication is a
single syringe is seldom necessary and could result in unwanted changes in the medication
Never use IV solution or mini bags as a common source to flush an IV as to dilute for more than one patient
Label syringes of IVP medication unless prepared and immediately given with no break
Administer IV push medication at rate recommended by manufacturer or supported by evidenced based practices and often given too fast
55
CMS Infection Control Worksheet
Section on Safe Injection Practices
CMS Hospital Worksheets HistoryOctober 14, 2011 CMS issues a 137 page memo in
the survey and certification section and it was pilot tested three times
Memo discusses surveyor worksheets for hospitals by CMS during a hospital survey
Addresses discharge planning, infection control, and QAPI (performance improvement)
Final ones issued November 26, 2014
Infection control one is especially important to CAH to review even though not using in CAH
57
Final 3 Worksheets
58
www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage
CMS Hospital WorksheetsWill use whenever a validation survey or certification
survey is done at a hospital by CMS for PPS hospitals
Not currently being used for CAH
However, highly suggest that every CAH review and be aware of what is in these three forms
Helps to understand how the guidelines are interpreted
Especially since infection control standards are very similar
59
Infection Control Program and Resources
60
61
Injection Practices & Sharps Safety 2 B Injections prepared using aseptic technique in area
cleaned and free of blood and bodily fluids
Is rubber septum disinfected with alcohol before piercing?
Are single dose vials, IV bags, IV tubing and connectors used on only one patient?
Are multidose vials dated when opened and discarded in 28 days unless shorter time by manufacturer?
Make sure expiration date is clear as per P&P
If multidose vial found in patient care area must be used on only one patient
62
CMS Other Survey Memos
63
Legionnaires’ Disease (LD) The bacterium Legionella can cause a serious type of pneumonia
called LD as well as Pontiac fever
Grows in parts of hospital water systems that are continuously wet such as water heaters and filters, fountains, shower heads and hoses, water storage tanks, eyewash stations, ice machines, etc.
Badly maintained water systems are linked to 286% increase in LD between 2000-2014
5,000 cases reported to the CDC in 2014
15% of outbreaks associated with hospitals
Hospitals should check their waterborne pathogen compliance as surveyors will likely pay more attention to it
Conduct a facility risk assessment to determine if it could spread in your facility water system
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65
CMS Memo on 4 IC BreachesCMS publishes 4 page memo on infection control
breaches and when they warrant referral to the public health authorities
This includes a finding by the state agency (SA), like the Department of Health, or an accreditation organization TJC, DNV Healthcare, CIHQ, or AOA HFAP
CMS has a list and any breaches should be referred
Referral is to the state authority such as the state epidemiologist or State HAI Prevention Coordinator
66
Infection Control Breaches
67
CMS Memo Infection Control BreachesUsing the same needle for more than one individual
Using the same (pre-filled/manufactured/insulin or any other) syringe, pen or injection device for more than one individual
Re-using a needle or syringe which has already been used to administer medication to an individual to subsequently enter a medication container (e.g., vial, bag), and then using contents from that medication container for another individual
Using the same lancing/fingerstick device for more than one individual, even if the lancet is changed
68
CRE and ERCP Scopes
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CMS Memo on Insulin PensCMS issues memo on insulin pens
Insulin pens are intended to be used on one patient only
CMS notes that some healthcare providers are not aware of this
Insulin pens were used on more than one patient which is like sharing needles
Every patient must have their own insulin pen
Insulin pens must be marked with the patient’s name
70
Insulin Pens
71
www.cms.gov/Medicare/Provider-Enrollment-and-
Certification/SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions.html
CMS Memo on Insulin PensRegurgitation of blood into the insulin cartridge after
injection can occur creating a risk if used on more than one patient
Hospital needs to have a policy and procedure
Staff should be educated regarding the safe use of insulin pens
More than 2,000 patients were notified in 2011 because an insulin pen was used on more than one patient
CDC issues reminder on same and has free flier72
CDC Reminder on Insulin Pens
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www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html
CDC Flier on Insulin Pens
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Insulin Pen Posters and Brochures Available
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www.oneandonlycampaign.org/content/insulin-pen-safety
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Pt Safety Briefs Free at www.empsf.org
77
CMS Issues 3rd Ebola Memo
78
CDC Vaccine Storage and Handling ToolkitCDC has 82 page document on vaccine storage
Published June 2016 to maintain the cold chain
Do not store vaccines in dorm like refrigerators
Temperature revised to range between 36 and 46 degrees (previously 35-46 degrees F) State may also have specific requirements and monitor
daily
Use a medical (biological) refrigerator that monitors temperature and set at mid range (40 degrees)
E-mail specific questions to CDC: [email protected]
80
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
Luer Misconnections MemoCMS issues memo on luer misconnections
This has been a patient safety issues for many years
Staff can connect two things together that do not belong together because the ends match
For example, a patient had the blood pressure cuff connected to the IV and died of an air embolism
Luer connections easily link many medical components, accessories and delivery devices
81
Luer Misconnections Memo
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PA Patient Safety Authority Article
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June 2010 Pa Patient Safety Authority
84
ISMP Tubing Misconnections www.ismp.org
85
TJC Sentinel Event Alert #36 www,jointcommission.org
86
http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misco
nnections—a_persistent_and_potentially_deadly_
occurrence/
http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misco
nnections—a_persistent_and_potentially_deadly_
occurrence/
http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misco
nnections—a_persistent_and_potentially_deadly_
occurrence/
http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misco
nnections—a_persistent_and_potentially_deadly_
occurrence/
http://www.jointcommission.org/sentinel_event_alert_issue_36_tubing_misco
nnections—a_persistent_and_potentially_deadly_
occurrence/
Managing Risk During the Transition
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CMS CAH Hospital CoPs
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89
CMS Hospital CoPsAppendix W, Tag C-0150 to C 0408,
See visitation memo adding tag 1000-1002 which is after tag 298
It is out of orderInterpretive guidelines updated more frequently now so check monthly for updates
Manual includes swing beds in CAHs,
CMS Hospital CoPsConsider doing a gap analysis,
Take each section and on left hand side of page document how you comply with each section,
Time consuming but will have with compliance,
Include policies and highlight section that corresponds to the required P&P in the CoP
Have one person in charge who can keep up with changes and who knows what to do if CMS shows up for validation or complaint survey
90
91
Rehab or Behavioral Health Dept CAHRemember, CAH can have up to a ten bed rehab or psych (behavioral health) unit If so it is surveyed under the regular hospital CoP program even though CAH has a separate manual It is Appendix A
Manuals changing frequently so always check the CMS website
Manual for 10 Bed Behav or Rehab
92
www.cms.hhs.gov/manuals/downloads/som107_
Appendixtoc.p
Email questions [email protected]
hs.gov
93
TJC Revised RequirementsTJC or the Joint Commission (not called JCAHO anymore) has made many changes to bring their standards into closer alignment with CMS
Having less differences is helpful to hospitals
Have some that are for hospitals that use them to get deemed status (DS) or payment for M/M patientsWill specify DS after the standard
94
IntroductionAuthority to make copies of things is at 42 CFR 489.53,Recommend you have surveyor make you a
copy also,
Please ask surveyor not to make copy of peer review material-abstract out what is needed,
Can get all CFR now electronically off Internet free at GPO access at www.gpoaccess.gov
Click on Code of Federal Regulations and can do search or click on e-CFR, or http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=%2Findex.tpl,
95
Resources to Keep HandyAppendix W Hospital CoPs (“C”) Unless CAH has a separate rehab or behavioral health unit and then you need Appendix A- Hospital CoP also for these departments
Survey protocol and module,
Q- Immediate jeopardy.
V-EMTALA,
W-Hospital swing beds-if you have these,
B- Home health
I-Life safety code
96
Survey ProcedureThe interpretive guidelines provide instructions to
the surveyors on how to survey the CoPs-like questions to the test,
They have survey procedure instructions to determine the hospital policy for notifying patients of their rights,
Ask patients to tell you if the hospital told them about their rights,
Deficiency citation show how the entity failed to comply with regulatory requirements and not the guidelines!
97
Survey ProtocolFirst 26 pages list the survey protocol,
Includes a section on:Off-survey preparation,Entrance activities,Information gathering/investigation,Preliminary decision making and analysis of finding,Exit conference,Post survey activities,
98
Swing Bed ModuleWhen patients need brief transitional care at
the hospital at the end of their acute care stay,
If swing beds then do survey under CAH swing-bed requirements found at 42 CFR Part 485.645,
Reimbursement is for Skilled Nursing care as opposed to Acute Care,
Term is for reimbursement and has no relationship to geographic location in the hospital,
99
Swing Bed ModuleMay be in acute care status one day and then in swing bed status the next day,
3-day qualifying stay for the same spell of illness in any hospital or CAH is required as an inpatient (not observation) prior to admission to swing-bed status for Medicare patients,
– Give Notice letter to outpatient observation patients (MOON Form)
Actual swing-bed survey requirements are referenced in the Medicare Nursing Homes requirements at 42 CFR Pt 483
100
Swing Bed CountsSurveyor will verify 25 bed rule,Will count inpatient beds but not observation beds, Does not count OR, PACU, L&D, newborn nursery (unless
medical treatment) or ED stretchers, sleep lab beds, exam tables, or observation beds (210), Do count birthing beds where patients remain after giving
birth, Do not count beds in Medicare certified rehab or
psychiatric distinct part units,Will conduct open record review on all swing bed patients, Swing bed deficiencies are documented on a separate
form even though survey done simultaneously,
101
Regulation/Interpretive GuidelinesStarts with a tag number, example C-0150,
C refers to the CAH CoPs,
Recall first is the section from federal register (CFR)
Then the section called the “interpretive guidelines”,
Some have a section called “Survey Procedure” and will explain how it is surveyed or what policies will be reviewed, what questions to ask or documents to look at,
102
Compliance with Laws C-150Standard: The CAH must be in
compliance with all federal, state, and local laws, Surveyor may interview CEO or other designated
by hospital to determine this,
May refer non-compliance to proper agency with jurisdiction such as OSHA
TB, blood borne pathogen, universal precautions, or EPA (haz mat or waste issues),
Advance Directives 151Standard: CAH must be in compliance with federal laws and regulations related to the health and safety of patients Inpatients and outpatients have the right to make
advance directives
Staff must comply with their advance directives
Patients have the right to refuse treatment
May have a DPOA or another person such as a support person/patient advocate
103
Advance Directives 151May use advance directives to designate a
support person for a person for exercising the visitation rights
If patient incapacitated and DPOA then must give this information to make informed decisions and consent for the patientCAH must also seek the consent of the patient’s
representative when informed consent is required for a care decision
Surrogate decision makers step into the shoes of patient when incompetent
104
Advance Directives 151Must provide advance directive information to
the competent patient when admitted
Must also give to the outpatient if in the ED, observation, or same day surgery patient
Must document you gave it in the medical record
If incapacitated then to the family or surrogate
Has conscience objector clause but must still allow DPOA or support person to make decision if incapacitated
105
Advance Directives 151Can not require one
Document in the medical record
Must make sure staff is educated on the P&PThis includes the right to make a psychiatric
advance directive or mental health declaration
Should still give consideration even if not a state specific law
Must provide community education106
Physician Ownership Disclosures 151Must disclose if physician owned hospital This includes ownership by immediate family member and
must be in writing
If none of physician owner refer then the hospital must sign attestation to this effect
Physicians must also disclose to patients who they refer This must be as a condition for getting MS privileges
Disclose in writing if physician not on premise 24 hours a day for emergencies Sign acknowledgement if patient admitted
107
Compliance with Laws/Licensure Standard: Patient care services must be provided
with in accordance with laws (152),
Ensure delegation as allowed by law, Ensure practicing according to scope of practice,
such as NP, CNS, PA, Standard: Hospital must be licensed (153) Personnel must be licensed or certified if required
by state (Tag 154: doctors, nurses, PT, PA, OT, x-ray tech. et. al.), Review sample of personnel files and make sure
credentials and licensure is up to date,108
109
Status/Location 160 7-3-2015 If CAH moves then status and location
must be reassessed Harder to relocate now, See tag 166 on relocation
Many changes to relocation and allows for grandfathering (see SOM Manual 2) Criteria for determining mountainous terrain,
revised definitions of primary and secondary roads, documentation needed to relocate CAH and 75% rule,
110
Status and Location 160-162 2015
CAH must meet the location requirements at the time of the initial survey (160)
Compliance is reconfirmed at the time of every subsequent full surveyTag 162 discusses information regarding if the
CAH has been classified as an urban hospitalDiscusses CAH located outside any area that is a
metropolitan statistical area
CAH must be in a rural area111
112
113
114
Agreement with Network Hospitals 191
Standard: CAH that is a member of a rural network must have agreement with at least one hospital that is a member of the networkA CAH must develop agreements with an acute care hospital related to patient referral and transfer, communication, emergency and non-emergency patient transportationWill ask how CAH communicates with other
hospitals?
115
Working with the Other HospitalWhat P&P related to communication system?
May review any written agreements with local EMS
Need to provide for transport between the two facilities
Do the two hospitals have electronic sharing of patient data, telemetry and medical records? (193)
116
Credentialing and QA Agreement 195
Standard: The CAH has to have an agreement with a hospital that is a member of the network or QIO for quality improvement and credentialing
State networking requirements varyAgreement for QA need to include a medical record
review as part of quality and to establish medical necessity of care at CAH,
Surveyor will review P&P to determine how information is obtained, used and how confidentiality is maintained,
Telemedicine Agreements C&P 196Standard: Agreements for C&P Telemedicine
Physicians
Board must make sure agreement with distant-site hospital (DSH) or distant-site telemedicine entity (DSTE)
Decide what category of practitioners are eligible for appointment to the MS
Board appoints with recommendation of the MS
Board approves the MS bylaws and other MS rules and regulations
117
Agreements for C&P 196Make sure MS is accountable to the board for
quality of care provided to the patients
Must have and follow criteria for selection of MS that is based on individual character, competence, training, experience, and judgment
Make sure under no circumstance is privileges based solely on certification, fellowship, or membership in a special body or society
118
119
Emergency Services 200 Standard: Must provide emergency care
necessary to meet the needs of its inpatients and outpatients,
The ED cannot be a provider-based off-site location,
Must comply with acceptable standards of practice, Including those established by national professional
organizations such as ACEP, ENA, ACS, ANA, AMA, American Association for Respiratory Care,
120
Emergency Services Need qualified medical director,
MS must have P&P regarding the care provided in the ED,
Policies current and revised based on QA activities,
MS must establish qualifications to get privileges to provide ED care,
ED must be adequately staffed,
Must have adequate equipment,
121
Emergency Services 200Must determine the categories and numbers of staff needed in the ED MD/DO, RN, ward clerks, PA, NP, EMTs,
The scope of diagnostic and/or therapeutic respiratory services offered by the CAH should be defined in writing, and approved by the medical staff CT scans, venous Doppler's, ultrasound et. al.,
122
14 ED Written PoliciesP&P must be developed approved by MS,
And mid-level practitioners who work in the ED,
Need triage procedures,
Each type of service provided,
Qualifications, education, training, of personnel authorized to perform respiratory care services and if supervision is needed,
123
ED Written Policies• Equipment assembly and operation;
• Safety practices, including infection control measures;
• Handling, storage, and dispensing of therapeutic gases;
• Cardiopulmonary resuscitation;
• Procedures to follow in the advent of adverse reactions to treatments or interventions;
• Pulmonary function testing;
124
ED Written Policies• Therapeutic percussion and vibration;
• Bronchopulmonary drainage;
• Mechanical ventilator and oxygenation support;
• Aerosol, humidification, and therapeutic gas administration;
• Administration of medications; and
• Procedures for obtaining and analyzing ABGs.
125
ED Staff TrainingSurveyor will interview ED staff to make sure knowledgeable including (so include in education of ED staff):
1. Parenteral administration of electrolytes, fluids, blood and blood components;
2. Care and management of injuries to extremities and central nervous system;
3. Prevention of contamination and cross infection; and
4. Provision of emergency respiratory services.
126
EMTALA and ED 24 hours Must still meet EMTALA (anti-dumping)
requirements,
Revised July 16, 2010 into 68 pages,
Must have 24 hour ED services available,
A CAH without inpatients is not required to have emergency staff on site 24 hours a day (If no patients, CAH may close),
Can have NP, PA, CNS, or MD on site within 30 minutes,
EMTALA, CAH & Telemedicine MemoCMS welcomes the use of telemedicine by
CAH
CAH not required to have a doctor to appear when patient comes to the ED
PA, NP, CNS, or physician with emergency care experience must show up within 30 minutes
If MD/DO does not show up must be immediately available by phone or radio contact 24 hours a day
127
CMS S&C Memo EMTALA & CAH
128
129
Availability of Drugs 201 CAH must maintain the types, quality and
numbers of supplies, drugs and biologicals, blood and blood products, and equipment,
Required by state and local law and in accordance with accepted standards of practice,
Surveyor will ask how you make sure equipment, supplies, and medications are always available,
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Emergency Drugs 203Drugs used in life-saving procedures, includes;Analgesics, local anesthetics, antibiotics, anticonvulsants, antidotes and emetics, serums and toxoids, antiarrythmics, cardiac glycosides, antihypertensive, diuretics, and electrolytes and replacement solutions.
Know how you maintain your inventory and how drugs are replaced,
131
Emergency Equipment 204Equipment and supplies commonly used in life-saving procedures, includes; Airways, Endotracheal tubes, ambu bag/valve/mask, oxygen, tourniquets, immobilization devices, nasogastric tubes, splints, IV therapy supplies, suction machine, defibrillator, cardiac monitor, chest tubes, and indwelling urinary catheters.
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Emergency Equipment 204Make sure staff know where the equipment is located,
Know how supplies are replaced and who is responsible for doing this,
Will examine sterilized equipment for expiration dates,
Will check for equipment maintenance schedule (defibrillator),
133
Blood and Blood Products 205Need services for the procurement,
safekeeping, and transfusion of blood, including the availability of blood products needed for emergencies on a 24-hours a day basis , No requirement to store blood on site,
Can provide in emergency directly or through arrangement,
Some cases more practical to transport patient to where the blood is,
134
Blood and Blood Products If CAH does tests on blood will be surveyed
under CLIA if tests are done,
If collecting blood you must register with the FDA,
If only storing blood for transfusion and refers all tests to outside lab then not performing test as defined by CLIA,
Need agreement in writing regarding the provision of blood between CAH and testing lab,
135
Blood and Blood Products Blood must be appropriately stored to
prevent deterioration,
If type and cross match blood must have necessary equipment
Or can keep 4 units O Negative on hand at all times,
Release to give, signed by doctor, is needed if not cross matched when indicated in an emergency
136
Blood Storage 206Blood storage must be under the control and supervision of a pathologist or other qualified doctor,If blood banking done under arrangement, the arrangement has to be approved by MS and administration,Will look for an agreement,
137
Staffing Personnel 207 Must have practitioner (physician, PA, CNS,
NP) with training in emergency care on call and immediately available within 30 minutes, 60 minutes if CAH in frontier area (with less than 6
residents per sq. mile and area meets criteria for remote by the state and CMS) and state determines longer time than 30 minutes needed is only way to provide care,
Will review call schedules,
Will ask staff if they know who is on call,
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Staffing Personnel 207Will review documentation that PA, NP, CNS, or
MD was on site within this time frame,
RN will satisfy this if for temporary period and CAH has less than 10 beds and is in frontier area (state governor has to sent letter to CMS as part of rural health plan),
CAH must submit this letter to surveyor and demonstrate shortage and unable to provide,
Also if state law has more stringent staffing requirements, like MD on duty 24 hours, must follow, See CMS Memo
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RN Tag 207CMS also added December 16, 2016 that RN with
training and experience in emergency care can be used to conduct specific medical screening exam
Must be on site and immediately available when a patient requests care and
The nature of the request must be within the scope of practice for a RN and consistent with state law, medical staff bylaws and R/R Note most state boards of nursing do not allow a RN who
is not an advance practice nurse to do ordering and interpretation of things like x-rays, lab, and EKGs
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Coordination with EMS 209 Must coordinate with EMS,
Have a procedure where available by phone or radio on 24 hour basis to receive calls,
Should have policies and procedure in place to ensure MD/DO is available by phone or radio contact,
And when emergency instructions are needed,
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25 Available Beds 211 2015CAH maintains no more than 25 acute care
inpatient beds at any one time
Doesn’t include observation beds, sleep studies or ED
Any of the inpatient 25 beds can be used to provide acute or long term care (swing beds) dependent on patient need
Does not count if CAH has up to 10 bed rehab unit or behavioral health unit
Average basis of 96 hours per patient,
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Observations/LOS 211 2015 Previously, could not operate distinct units, Observations stay is usually not more than 48 hours,
unless more strict state limit of 24 hours, Rewrite your policy on observation beds to meet this
section and the 2 midnight rule, They do not count observation beds in 25 bed count
now or in calculating average LOS, Make sure you are using appropriately,
See the CMS memo on the two midnight rule and 2015 changes Place in an outpatient observation bed Admit as an inpatient to telemetry
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Observations 211Have specific criteria for placing patient in and
discharging from observation Inappropriate use of observation beds could subject
Medicare beneficiary to increased coinsurance liability 20% of CAH customary charges then if properly admitted
as inpatient,
Observation is not appropriate for : Substitute for inpatient admission For continuous monitoring Medically stable patients who need diagnostic testing or
outpatient procedure (blood chemo, dialysis)
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Observation Not Appropriate Patients awaiting nursing home placement
For convenience to the patient or family
For routine prep or recovery prior to or after diagnostic or surgical services
As a routine stop between the ED and inpatient admission
No prescheduled observations services
Observation services begin and end with the order of the physician
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Observation 211Must provide documentation to show that observation bed is not an inpatient bed
Need specific criteria for observation services
Must be different than inpatient criteria
10 bed observation unit might be disproportionately large
Surveyor might determine observation is actually inpatient overflow unit
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Don’t Count in 25 Bed Count 211Exam or procedure tables
Stretchers
OR tables and PACU bed
Newborn bassinets and isolettes for well baby boarders unless baby held for treatment
OB beds if active labor but do count birthing rooms where patient stays after giving birthED carts
10 bed distinct unit rehab or behavioral health
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Beds/ LOS Hospice 211 Observation starts and ends with order
No standing orders for observation
Hospice beds can be dedicated are also counted as part of the 25 beds,
Except 96 hour average LOS rule does not apply,
Medicare does not reimburse the CAH for hospice patients only the Hospice,
So the CAH has to negotiate payment from the hospice through an agreement,
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Length of Stay 212 That does not exceed, on an annual
average basis, 96 hours per patient, State Fiscal Intermediary (FI) will determine
compliance with this CoP, Calculate the CAH’S length of stay based
on patient census data, If CAH exceeds the length of stay limit, the FI will
send a report to the CMS-RO as well as a copy of the report to the SA,
CAH will have to do plan of correction,
ConstructionStandard: CAH is constructed, arranged, and maintained to ensure access to and safety of patients Additionally, it must provide adequate space to provide
care to patients
Must be constructed in accordance with state and federal law
Will look to see if maintained in a manner to ensure safety of patients Conditions of ceilings, walls, and floors
See Facility Guideline Institute (FGI)150
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Physical Environment 222 2014Must have housekeeping and preventative
maintenance (PM) programs,
All essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition
These means facilities, supplies and equipmentmust be maintained,
How do you ensure your equipment is maintained properly Boilers, elevators, air compressors, ventilators, X-ray
equipment, IV pumps, stretchers, IV equipment, air compressors, elevators, maintenance log,
CMS Hospital Equipment Maintenance
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Equipment Memo August 2014
153
Equipment Memo Discusses preventive maintenance and inspection of equipment As recommended by the manufacturer or based
on a risk-based assessment unless federal or state law of CoP specifies otherwise
Discusses alternative equipment maintenance (AEM) program
Must demonstrate that qualified personnel are performing risk based assessments, PM, or establishing the AEM program
154
Equipment Memo PMTo comply consider the following:
Maintain a written inventory of all medical equipment or written inventory of selected equipment categorized by risk assessment Such as life support equipment
Identify high risk medical equipment on the inventory for which there is a risk of serious injury or death should it fail such as life support equipment
Staff must be qualified to perform
Identify in writing how to maintain, inspect, and test the medical equipment on the inventory
155
Equipment MemoMake sure the frequency is in accordance with
manufacturers recommendation or with strategies of an alternate equipment maintenance (AEM) program An example for medical equipment is the American
National Standards Institute for the Advancement of Medical Equipment Handbook
The frequency in testing, inspecting, and maintaining must be in accordance with manufacturers recommendation for the following: medical device lasers, new medical equipment with insufficient maintenance history to support use of AEM, imaging and diagnostic equipment, etc.
156
157
Disposal of Trash 223Standard: There is proper routine storage and prompt disposal of trash, Includes biohazardous waste,
Must be disposed of in accordance with standards (EPA, OSHA, CDC, environmental and safety),
Includes radioactive materials,
Will look for policies for proper storage and disposal,
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Storage of Drugs 224Standard: Drugs and biologicals must
be appropriately stored, Must be properly locked in the storage area, Make sure medication carts in C-section rooms are
locked
Make sure drugs are not left out in open in tube system or on dumb waiter ledge
Surveyor will ask what standards, guidelines, or law you using to make sure they are stored,
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Physical Environment 225 Standard: Premises clean and orderly Means uncluttered with equipment not
stored in corridors,
Area is neat and well kept
Spills not left unattended,
No peeling paint or floor obstructions,
No visible water leaks or plumbing problems
Proper Ventilation 226 Standard; There must be proper
ventilation, lighting, and temperature controls,
In pharmaceutical, patient care and food preparations
Proper ventilation in areas with nitrous oxide, glutaraldehyde, xylene, pentamidine, or other potentially hazardous substances,
Isolation rooms comply with laws such CDC 2007 Isolation Guidelines, OSHA, NIH, et al,
160
161
Physical Environment 226 Temperature, humidity and airflow in the operating rooms
must be maintained within acceptable standards to inhibit bacterial growth and prevent infection, Including anesthetizing locations where inhalation
anesthesia agents are used Excessive humidity in the operating room is conducive to
bacterial growth and compromises the integrity of wrapped sterile instruments and supplies, RH at 35% or greater unless waiver is used of 20% or
greater
Acceptable standards such as from AORN or the Facilities Guideline Institute or FGI) should be incorporated into CAH policy.
CMS Memo April 19, 2013CMS issues memo related to the relative
humidity (RH)
AORN use to say temperature maintained between 68-73 degrees and humidity between 30-60% in OR, PACU, cath lab, endoscopy rooms and instrument processing areasCMS says if no state law can write policy or
procedure or process to implement the waiver
Waiver allows RH between 20-60% In anesthetizing locations- see definition in memo
162
Humidity in Anesthetizing Areas
163
Impact of Lowering the Humidity Lowering humidity can impact some equipment and
supplies
Can affect shelf life and product integrity of some sterile supplies including EKG electrodes
Some electro-medical equipment may be affected by electrostatic discharge especially older equipment Can cause erratic behavior of software and premature failure
of the equipment
It can affect calibration of the equipment
Follow the manufacturers instructions for use that explains any RH requirements
164
CMS Memo on Low Relative Humidity
165
Impact of Lowering the Humidity
166
Lowering Humidity Can Have Other Effects
167
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Physical Environment 226Must have adequate number of refrigerators to make sure foods and meds are stored,Surveyor will verify these areas are well lit,Surveyor will verify compliance with ventilation in patients with TB or other airborne diseases,Surveyor will verify food products are stored under appropriate conditions (time, temperature, packaging) based on national sources like USDA and FDA,
Emergency Preparedness Appendix ZCMS has moved the emergency preparedness final rules to Appendix ZSeptember 16, 2016 the final rules were published
The rule’s effective date is November 15, 2016 but implemented November 15, 2017
An advanced copy of the emergency preparedness final rule and survey process was published on June 2, 2017
These are located at the end for reference
Questions: [email protected]
Emergency Preparedness Appendix Z
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www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertEmergPrep/Emergency-Prep-Rule.html
FIRE Inspections 231-233Must meet LSC of National Fire Protection Association such as NFPA-99 (231)
CMS can allow state surveyor to apply state’s fire and safety code if CMS finds that it adequately protects patients
CMS can waive specific provisions of the LSC if it would result in unreasonable hardshipBut only if the waiver does not put patients at risk
172
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FIRE Inspections 234Maintains written evidence of regular inspection and approval by State or local fire control agencies,
Surveyor will examine copies of inspection and approval reports from State and local fire control agencies,
174
Governing Body 241 Standard; CAH has a governing body or individual
that assumes legal responsibility for implementing and monitoring P&Ps Board must approve all policies
Must have 1 governing body or responsible person, Board must determine what categories of
practitioners are eligible for appointment and reappoint to MS (NP, PA, dentist, CRNA) and there is written criteria for staff appointments
Done with advice of MS,
Board Must Approve All Policies
175
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Governing Body 241Must be consistent with state and federal law requirements,
Board approves MS bylaws and any revisions
Surveyor will look for this,
Board responsible for conduct of CAH and for quality of care to patients,
All patients must be under the care of a member of the MS Or under care of member of MS under their supervision
177
Governing Body Criteria for MS is based on individual
character, competence, training, experience and judgment,
Surveyor will look to see Board or written documentation of person responsible for CAH,
Will look to verify that Board has categories of practitioners for appointment to MS,
Confirm that Board appoints all members to the MS,
178
Disclosure 242CAH discloses the names and addresses of its
owners or those with controlling interest,
Either directly or indirectly has 5% or more ownership,
Surveyor will look for policy on reporting changes of ownership,
Need policy on how to reporting changes for person responsible for operation of hospital (CEO) to state agency and also for reporting changes in medical director (243,244),
179
Staffing 250Standard: CAH has professional staff
that includes one or more physicians, and may include PA, NP, or CNS,
Need to have organizational chart which shows names of all MD/DO and mid-level providers PA, NP, or CNS
Surveyor will review work schedules,
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Staffing 252Standard: All ancillary staff must be supervised by professional staff,Have sufficient staff to take care of patients Emergency services, nursing services, Tag 253,
Will review staffing schedules and daily census records,Make sure answer call lights promptly
Make sure address monitor that alarms timely
181
Staffing 254MD, DO, NP, PA, or CNS must be available at all times to furnish care,
Must show practitioner is available and shows up when patient presents to the hospital,
Doesn’t mean they have to be there 24 hours a day,
182
Nurse on Duty 255
Standard: Must have a RN, CNS, or LPN on duty whenever there is one or more inpatients,
Surveyor will review staff schedules to make sure,
183
Physician Responsibilities 257 Standard: MD/DO must provide medical
directions and supervision of staff,
Surveyor will make sure is available for consultation and supervision of staff,
PA or NP participate in developing and reviewing written P&P (258)
Physicians must periodically review charts of PA and NP and surveyor will look for documentation of same (259),
184
Physician Supervision 260 2015
Must have a doctor on staff and must perform medical oversight,
Must be present for sufficient period
No longer says must be present at least once every two week to provide direction
Will want evidence that the Dr. provides oversight and is available for consultation or patient referral,
Want evidence that there is periodic review of patient records by the doctor
Physician Supervision 2015Periodically reviews and signs records of all
inpatients cared by PA, NP, or CNS
MD/DO signs records after review completed
If case is managed by doctor and care given by non-physician review is not required
Periodically reviews and signs sample of outpatient records
Of NP, CNS, PA, or CNM
ONLY if state law requires review or co-signature or state requires collaborating physician to sign
185
Physician Supervision 2015There is no time frame in the rule for the periodic
review of PA or NP for inpatient
CAH must specify a time frame in P&P for the maximum interval between inpatient reviews
Must take into account the volume and types of services provided in developing the P&P
4 bed CAH would have different time frame than 25 bed CAH
Also does CAH have EHR that can be reviewed and signed off remotely?
186
Physician Present in the CAH 261 2015
MD or DO must be present in the CAH for sufficient periods of time No longer says every two weeks
To provide medical direction, consultation and supervision
And is available through radio or telephone or electronic communication (telemedicine)
Develop P&P on this and document compliance
CAH with busy ED and large outpatient unit would expect more frequent visits
187
Physician Present in the CAH 261
Biweekly visit might be burdensome for small CAH in a remote area with low patient volume
Remember the federal EMTALA law
MD, DO, PA, CNS, or NP must be on call and available to provide emergency care
Must have list of on-call physicians
Must make sure MD or DO is available via phone, radio, video conferencing etc to handle patient emergencies and refer patients to other facilities
188
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PA, NP, CNS 263 Must be members of CAH staff,
Must participate in development and review of P&P,
Interview them to determine their participation and knowledge of policies,
Will interview to determine their level of involvement in development of P&Ps and make updated,
Policies also need to be consistent with state standards of practice,
190
Transfer of Patients 267Standard: Arrange for transfer of patients who need services that can not be furnished,Must send a copy of the patient’s
medical records,Remember EMTALA is a separate CoP
that every CAH must follow,
Make sure you have a transfer policy and it should be consistent with EMTALA,
191
Patient Admission 268 Standard: Whenever a patient is admitted by
NP, PA, or CNS, a physician on the staff must be notified,CMS requires that Medicare and Medicaid patients be
under the care of a MD/DO if patient has medical or psych problems that are outside of the scope of their practice,
Admitting privileges must be consistent with what state law allows,
Surveyor will look to make sure MD/DO monitor care for any medical problem outside their scope of practice,
192
Patient Care Policies 2015 Standard: Services are provided in accordance with
appropriate P&P (271) Provision of Services :Related to P&P and services
and services provided including through contract (270)
Need P&P governing the healthcare services that are available
Must follow them in delivering care
Will review policies on healthcare services that are provided in the CAH
Observe staff delivering care to the patient
Patient Care Policies 272 2015 P&P need to be developed by group of professional
staff and include: 1 MD/DO
1 or more PA, NP, CNS if on staff (if CAH has these individuals on their staff)
Removed requirement for one member is who not a member of the staff
Removed section that said will interview CNO to determine role in policy development but in nursing section
Review annually by above and as needed such as when change in a law
193
Patient Care Policies 272Must maintain documentation of the P&P
committee’s activityMust show evidence that group reviewed all the
P&P at least yearly Must reflect any changes made
To review existing and new P&P
Final decision on P&P is made by the board
If the P&P recommendations by the advisory group are rejected, then board must include in the record the rational for the change
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Policies (Scope of Services) 273 2015
Standard: Need P&P on description of services provided by CAH directly or through contract Often called scope of services or provision of care
Should include statements like “taking complete medical histories, providing complete physical examinations, laboratory tests including” (with a list of tests provided) would satisfy this requirement,
Should include arrangements made with Hospital X for providing the following services with list of specialized diagnostic and lab testing,
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Emergency Medical Services 274 2015
Need P&P for providing emergency medical servicesPolicies should show how the CAH would meet
all of its emergency services requirements
Will look at what equipment, supplies, medications, and blood is available on siteHow does CAH coordinate with local EMS?
What type of staff are available to provide care in the ED?
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Guideline for Medical Management 275 2015
Need guidelines on managing health problems that include when medical consultation or referral is needed
Need written guidelines on maintaining medical records and procedure for periodic review and evaluation of the services provided at the CAH Such as general instructions or protocols on how
to medically manage the patient’s health problems commonly seen in the CAH
198
Medical Management 275
Needs to include P&P on the scope of medical acts which may be done by PA, CNS, or NP
When should physician be consulted or referred outside the CAH?
What medical procedures can PA or NP do?
Guidelines need to describe the medical conditions, signs or development that require consultation,
The End! Questions??Sue Dill Calloway RN, Esq.
CPHRM, CCMSCP
AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017 614 791-1468
[email protected] Call with questions. No emails
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