Critical Access Hospitals (CAH)

1. Critical Access Hospitals (CAH) What every CAH needs to know about the Conditions of Participation (CoPs)

2. Speaker Sue Dill Calloway RN, Esq. CPHRM, CCMSCP AD, BA, BSN, MSN, JD President Board Member Emergency Medicine Patient Safety Foundation www.empsf.org 614 791-1468 sdill1@columbus.rr.com 2 2

3. You Don’t Want One of These

4. 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), AOA, CIHQ, or DNV Healthcare have what is called deemed status,

5. CAH Problematic Standards • Date and time on all orders and entries • Verbal orders, Cluttered hallways • H&Ps, Life safety code issues, 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&P

6. CAH Problematic Standards • Medical 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 • What else should we add???

7. Access to Hospital Complaint Data • CMS issued Survey and Certification memo on March 22, 2013 regarding access to hospital complaint data • Includes acute care and CAH hospitals • Does not include the plan of correction but can request • Questions to bettercare@cms.hhs.com • This is the CMS 2567 deficiency data and lists the tag numbers • Updating quarterly • Available under downloads on the hospital website at www.cms.gov

8. Access to Hospital Complaint Data • There is a list that includes the hospital’s name and the different tag numbers that were found to be out of compliance • Many on restraints and seclusion, EMTALA, infection control, patient rights including consent, advance directives and grievances • Two websites by private entities also publish the CMS nursing home survey data • The ProPublica website for LTC • The Association for Health Care Journalist (AHCJ) websites for hospitals

9. Access to Hospital Complaint Data

10. Updated Deficiency Data Reports www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Hospitals.html

11. Small or Rural Hospitals • American Hospital Association has Web site with good information for CAH • Has recent issues of interest to CAH • Excellent resources including current list of all CAHs in the US • Has CAH newsletters • go to http://www.aha.org/aha/issues/Rural-Health-Care/update-newsletters.html

12. AHA CAH Resources www.aha.org/aha/issues/Rural-Health-Care/update-newsletters.html

13. AHA CAH Resources www.aha.org/advocacy-issues/rural/update-newsletters.shtml

14. AHA Critical Access Website www.aha.org/aha_app/issues/CAH/index.jsp

15. Rural Assistance Center www.raconline.org

16. Rural Assistance Center www.raconline.org

17. CMS Updated Website www.cms.gov

18. CMS CAH Website • CMS 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 CAHscg@cms.hhs.gov

19. CMS CAH Website ww.cms.gov/center/cah.asp http://www.cms.gov/Center/Provider-Type/Critical-Access-Hospitals-Center.html?redirect=/center/cah.asp

20. The Conditions of Participation CoPs • First, published in the Federal Register • Federal 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 Nov 10, 2014 • Changes to tag 162 and 226 on January 31, 2014 and April change from MR/DD to intellectual disability and November 10, 2014 to Tag 222 regarding maintenance and equipment • CMS made many changes effective June 7, 2013 and 93 page memo January 16, 2015 • 1 www.cms.hhs.gov/manuals/downloads/som107_Appendicestoc.pdf

21. Subscribe to the Federal Register Free http://listserv.access.gpo.gov/cgi-bin/wa.exe?SUBED1=FEDREGTOC-L&A=1

22. new website at www.cms.hhs.gov/manuals/downloads/som107_Appendixtoc.pdf

23. www.cms.gov/manuals/Downloads/som107ap_w_cah.pdf and is critical access hospital CoPf

24. CAH Manual 236 Pages

25. 93 Page Memo January 16, 2015

26. January 16, 2015 Memo • 93 pages long and advance copy • 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 person

27. January 16, 2015 Memo • Major changes to pharmacy and nursing standards and add rehab • CMS now has an email address that questions can be addressed • CAHSCG@cms.hhs.gov • Amends 31 tag numbers • 211, 260, 261, 270-284, 286-299 • Changes are shown in red • Advance copy and may see some minor tweaking with final copy

28. CAH Services Direct Services or Contracts • CMS published more than 2 dozens changes to the hospital CoP in FR on May 16, 2012 and went into effect June 7, 2013 • Several that impact CAHs • Currently. The CAH CoP requires that certain types of services be provided directly rather than through contracts or under arrangements • This included diagnostic and therapeutic services, lab and radiology services, and emergency procedures • CMS eliminated this requirement

29. Final Federal Register Changes www.ofr.gov/(S(5jsvvwmsi4nfjrynav20ebeq))/OFRUpload/OFRData/2014-10687_PI.pdf

30. How to Find Changes • Have one person in your facility who goes out to this website once a month and checks for updates, • 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 • Person in charge of CAH at CMS is Kianna Banks, kianna.banks@cms.hhs.gov, 419 786-3498

31. CMS Survey and Certification Website www.cms.gov/SurveyCertificationGenInfo/PMSR/list.asp#TopOfPage Click on Policy & Memo to States

33. CMS Transmittals www.cms.gov/Transmittals/01_overview.asp http

34. CMS Memo on Safe Injection Practices • CMS issues a 7 page memo on safe injection practices • Discusses the safe use of single dose medication to prevent healthcare associated infections (HAI) • Notes 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 http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/index.html?redirect=/SurveyCertificationGenInfo/PMSR/list.asp

36. CMS Memo on Safe Injection Practices • All 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 Practices • Bottom line is you can not use a single dose vial on multiple patients • CMS has section in IC worksheet on this • CMS requires hospitals to follow nationally recognized standards of care like the CDC guidelines • 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 Practices • Make 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

39. Not All Vials Are Created Equal

40. CMS Memo on Insulin Pens • CMS 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

41. CMS Memo on Insulin Pens • Regurgitation 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 flier

42. CDC Reminder on Insulin Pens www.cdc.gov/injectionsafety/clinical-reminders/insulin-pens.html

43. CDC Has Flier for Hospitals on Insulin Pens

44. VA Alert on Insulin Pens • Pharmacist found several insulin pens not labeled for individual use • Found used multi-dose pen injectors used on multiple patients instead of one patient use • New requirement that can only be stored in pharmacy and never ward stocked • Instituted new education for staff on use • Part of annual competency of staff • Instituted new policy of safe use of pen injectors

45. VA Issues Alert

46. VA Alert on Insulin Pens • Decided to prohibit multi-dose insulin pen injectors on all patient units except the following: • Patients being educated prior to discharge to use a insulin pen injector • Eligible patient is self medication program • Patient needing treatment and no alternative formulation is available • Patients participating in a research protocol requiring an insulin pen • Pen injectors dispensed directly to patients as an outpatient prescription

47. FDA Issues An Alert in 2009

48. Insulin Pen Posters and Brochures Available www.oneandonlycampaign.org/content/insulin-pen-safety

50. Pt Safety Briefs Free at www.empsf.org