Go
HomeASCP FoundationCCGPCalendarDiscussionContactStore
Join ASCP Earn CE Credit Develop Your Practice Explore Policy Issues Read All About It
About ASCP
Education & Meetings
Practice Resources
Government Affairs & Advocacy
Publications
Members
Students
Industry
Public
spacer
ASCP 40th Anniversary
spacer
ASCP on Twitter ASCP on Facebook ASCP on LinkedIn
spacer
Monitor-Rx
Advanced SearchSite Map
Practice Resources Section
Government Affairs and Advocacy section picture
spacer
spacer
ASCP Annual Meeting and Exhibition 2010
spacer
Easy Prior Authorizations
spacer
QCCPP
spacer
Addressing Barriers to Optimal Care of Patients with MDD and GAD in the Long-Term Care Setting: The Pharmacy Perspective
spacer
Policies and Procedures: Pharmacy Services for Nursing Facilities
Nursing Facility Survey & Regulations


Quick Links

Updates

August 27, 2010
CMS Releases Memo to Surveyors Regarding Infection Control Issues when Using Point-of-Care Fingerstick Devices
In their memo, CMS states that the following practices are considered deficiencies in infection control and citable at F-Tag 441:
  • Reusing fingerstick devices (e.g., pen-like devices) for more than one resident;
  • Using a blood glucose meter (or other point-of-care device) for more than one resident without cleaning and disinfecting it after use.
View the complete memo. (PDF)

July 30, 2010
CMS Makes Interim Changes to Traditional Survey Process Due To MDS 3.0, Effective October 1, 2010
CMS has temporarily revised the Traditional Survey Process, which is outlined in Appendix P of the State Operations Manual (SOM). As a result of MDS 3.0 implementation, there will be an inability to run the Quality Measure/ Quality Indicator (QM/QI) Reports which are used offsite to assist the surveyors in selecting their Phase 1 resident sample. The survey tasks have been revised so that nursing home survey teams can select the Phase 1 survey sample without the benefit of the QM/QI Reports. This temporary revision to Traditional Survey Process Tasks 1-5C will be implemented October 1, 2010 only for those nursing home for which the traditional survey process is being used. CMS also changed the title of the Online Survey Certification and Reporting (OSCAR) reports, which are no longer being produced, to Certification and Survey Provider Enhanced Reporting (CASPER) reports.

View the CMS memo and revised survey protocols. (PDF)

August 14, 2009
CMS Releases Memo to Surveyors Regarding Surveying Facilities with Electronic Health Records (EHRs)
In the memo, CMS states that they support use of electronic health records and that providers have the right to use whatever system of medical records they choose as long as that system complies with Medicare participation requirements. During the entrance conference, surveyors will verify with the facility the process they will follow in order to have unrestricted access to the medical record. While surveyors are expected to enforce the specific health and safety regulatory requirements for providers to protect the confidentiality of medical records, they are not expected to assess EHRs to determine whether they satisfy the requirements of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules.

View the memo. (PDF)

August 7, 2009
CMS Releases Timeline for States' Implementation of QIS
CMS announced it is pushing forward with nation-wide implementation of the new Quality Indicator Survey (QIS).  The QIS replaces the current survey process.  To date, the QIS is in various stages of implementation in 11 States: Connecticut, Kansas, Ohio, Louisiana, Florida, Minnesota, North Carolina, New Mexico, West Virginia, Maryland, and Washington.  QIS training starts this summer in Delaware, Maine and Vermont, and training is scheduled to begin in Georgia and Arizona early this winter.  Training for States in band two (Colorado, Maine, Nebraska, Vermont, District of Columbia, Georgia, Indiana, Arizona, Oregon, Utah, New York) is expected to begin in late 2010 or early 2011, while the remaining states will begin implementation in 2011 and beyond.

Biew CMS' latest memo, which includes background information about the QIS process. (PDF)

July 20, 2009
CMS Releases New Interpretive Guidelines for F-Tag 441 (Infection Control) 
Significant new guidance from CMS on infection control with many implications for consultant pharmacists and dispensing pharmacies servicing nursing facilities. Effective date is September 30, 2009.
June 24, 2009
CMS Releases Results of QIS Evaluation
The purpose of the Quality Indicator Survey (QIS) Study was to assess whether the QIS has beneficial effects on certain aspects of the survey process, such as improving the accuracy of citations. Interestingly, evaluation of this question found that the QIS did not improve accuracy. While being mindful of the limitations of the study, CMS has concluded that improvement of accuracy of citations must derive primarily from non-QIS factors, including (a) survey guidance clarification, (b) training of surveyors, and (c) surveyor supervision. Based on this information, CMS will continue to issue improved surveyor guidance (revised interpretive guidelines) as well as strengthen surveyor training. CMS also concluded from the evaluation that future QIS development efforts should concentrate on building upon the QIS strengths relative to consistency improvement, and giving supervisors more tools to assess performance of surveyor teams.

View the results. (PDF)

April 10, 2009
CMS Releases New Interpretive Guidelines for Environment that Mention Alternatives to Medication Carts
Revised Interpretive Guidelines were released for several Quality of Life and Environment Tags in response to public recommendations from the 2008 CMS/Pioneer Network Environment Symposium. These revisions reflect a new approach to care that focuses more on residents' social and personal needs and less on institutional processes; also known as "culture change." Of particular note, F-Tag 252 - Environment mentions medication carts. When describing practices that serve to decrease the institutional character of the environment, they mention elimination of medication carts and alternative storage of medications in locked areas within resident rooms.

Download the information at this link. (PDF)

March 31, 2009
Effective Date for new Pain Management guidance at F-Tag 309
Download ASCP's Summary (PDF) of the New Interpretive Guidelines pertaining to Pain Management.

January 23, 2009
CMS Releases New Interpretive Guidelines for F-Tag 309 (Quality of Care, Pain Management) 
Significant new guidance from CMS on pain management, including a new pain management investigative protocol to be used by surveyors.  Effective date is March 31, 2009.   Download the information at this link.

September 29, 2008
Office of Inspector General (OIG) Releases Report: "Trends in Nursing Home Deficiencies and Complaints"
This report describes the nature and extent of nursing home deficiencies and complaints in 2007 and identifies trends from 2005 to 2007.  From 2005-2007, over 91 percent of nursing homes surveyed were cited for deficiencies.  The most common deficiency categories cited were quality of care, resident assessment, and quality of life.  "Pharmacy Services" was the 7th most frequently cited category, and it was the one category that experienced the greatest increase in deficiencies from 2005-2007, largely due to the new Interpretive Guidelines that went into effect in December 2006.  In 2005, 23.8% of nursing homes were cited for deficient "Pharmacy Services," whereas in 2007, 28.8% of facilities were cited. The report also provides state-specific deficiency statistics.  Click here to download the report.

June 20, 2008
CMS Releases New Interpretive Guidelines for F-Tags 325 (Nutrition) and 371 (Sanitary Conditions)
F-Tag 325 (Nutriton) mentions pharmacists and medications frequently throughout the new Interpretive Guidelines.  Consultant pharmacists should be familiar with these new guidelines to help their facilities identify ways in which medications may impact nutrition.

June 18, 2008
CMS Announces New Ranking System for Nursing Facilities Using 5-Start System.
The ratings will be posted on the agency's Nursing Home Compare Web site by the end of 2008. A sample screen shot of the proposed star ratings is available.  The Nursing Home Compare website can be found at http://www.medicare.gov/nhcompare.

February 12, 2008
CMS Releases an Updated List of Nursing Facilities Who Performed Poorest on Surveys (also referred to as Special Focus Facilities)

January 18, 2008
CMS Issues S&C Memo (S&C-08-10) Reminding Surveyors to Cite Deficiencies Based on Regulations, not Permissive Activities Mentioned in Interpretive Guidelines
The memo reminds surveyors that all survey deficiencies cited must be based on a violation of statutory and/or regulatory requirements. The memo states: “Permissive duties (mentioned in the Interpretive Guidelines) are not requirements, and the lack of use of any particular tool does not, by itself, constitute sufficient grounds for the citation of a deficiency.”

Changes to SOM Survey Guidance Within Past 5 Years
  • F-Tag 441 - Infection Control, EFFECTIVE September 30, 2009 (SEE ABOVE)
  • F-Tag 309 - Quality of Care/Pain Management, EFFECTIVE March 31, 2009 (SEE ABOVE)
  • F-Tag 325 – Nutrition, FINAL in June 2008 (SEE ABOVE)
  • F-Tag 371 – Sanitary Conditions, FINAL in June 2008 (SEE ABOVE)
  • F-Tag 373 – Feeding Assistants, FINAL in August 2007
  • F-Tags 425, 428, 431, and 329 – Pharmacy Services and Unnecessary Drugs, FINAL in December 2006 (SEE BELOW)
  • F-Tag 334 – Influenza and Pneumococcal Immunizations, FINAL in October 2006
  • F-Tags 248-249 – Activities, FINAL in June 2006
  • F-Tags 520-521 – Quality Assurance and Assessment, FINAL in June 2006
  • Psychosocial Outcomes Severity Guidance in Appendix P, FINAL in June 2006
  • F-Tag 501 – Medical Director, FINAL in November 2005
  • F-Tag 315 – Urinary Incontinence, FINAL in June 2005
  • F-Tag 314 – Pressure Ulcers, FINAL in November 2004
Archived CMS Survey & Certification Memos
  • CMS S&C Memo #07-39 (September 2007) regarding nutritional and dietary supplements and the medication pass observation, F-Tags 332-333
    • Medication administration errors associated with vitamins and minerals should be COUNTED
    • However, administration errors associated with nutritional and dietary supplements should NOT be counted
    • Interactions between meds and nutritional/dietary supplements must still be monitored
  • CMS S&C Memo #06-30 (September 2006) clarifying that it is acceptable for nursing home surveyors to cite a significant medication error at F333 based upon either resident review, and/or observation of medication preparation or administration.  Previously, interpretive guidance in the State Operations Manual at F333 directed surveyors to observe a medication preparation or administration before citing significant medication errors.

Background

All nursing facilities are subject to inspection or survey by virtue of their:
  • certification to participate in Medicare and Medicaid, and/or
  • licensure by the state in which they operate.
State licensure standards, generally, have followed Federal certification standards, and state personnel perform the vast majority of surveys - simultaneously assessing compliance with both licensure and certification requirements. The Federal government also provides training for state surveyors and periodically conducts inspections with federal surveyors as a check on the performance of state surveyors. These are called FOSS surveys (Federal Oversight and Support Surveys).  Compliance with the survey process and requirements established by the Centers for Medicare and Medicaid Services (CMS) and published in the State Operations Manual (SOM) is the primary regulatory focus for nursing facilities and consultant pharmacists.

The information contained in this section applies to both the skilled nursing facility (SNF) and the nursing facility (NF) categories of facilities. (See Glossary located in Appendix A of SOM for definitions of these categories.) Not only will these standards be reviewed during the facility’s annual survey, but they may also be reviewed during any inspection resulting from a complaint against the facility. Furthermore, any deficiency cited against the facility will result in regulatory and/or monetary penalties to the facility, will become a part of the public record about the facility, and may reflect poorly on the providers and facility.

The SOM has multiple components and sections.  Appendices P, PP, and R of the SOM are the three appendices related to the nursing home setting.
Each Appendix includes the:
  • Regulations, including the regulatory citation from the Codified Federal Regulations (CFR),
  • Tag numbers (the alpha-numeric indexing system used to denote specific sections in each SOM Appendix), and
  • Interpretive Guidelines, also known as “Guidance to Surveyors.”
For some of the recently revised Tags, CMS includes additional guidance to surveyors related to deficiencies for that particular Tag, namely deficiency categorization and severity guidance.

For example, SOM Appendix PP contains CFR Section 483.60 dealing with the standards for providing pharmacy services to a long-term care nursing facility.  This section of the regulations is divided into three F-Tags: F-425, F-428, and F-431. The “F” preceding the term “Tag” indicates that the section pertains to long-term care facilities and can be found in Appendix PP.  Each SOM Appendix has its own Tag designation (e.g., W-Tags for ICFs, G-Tags for Home Health Agencies, etc.).  When a survey identifies a deficient practice and non-compliance with the regulations and guidelines, the surveyor must name the specific Tag under which the deficient practice falls.  This is how the citation is officially classified and documented.

It is important for the consultant pharmacist to understand all regulations and interpretive guidelines applied to these facilities, especially those that relate specifically to pharmacy.  The major pharmacy-related F-Tags include:
  • F-Tag 329:  Unnecessary Drugs
  • F-Tag 332-333:  Medication Errors
  • F-Tag 425:  Pharmacy Services
  • F-Tag 428:  Medication Regimen Review
  • F-Tag 431:  Storage, Labeling, and Controlled Medications      
Chapter 7 and Appendix P of the CMS State Operations Manual contains information about the step-by-step process used by surveyors when conducting a survey of a nursing facility.  ASCP has put together a brief summary of the survey process, which answers questions such as: How surveys nursing facilities?  How are surveyors trained?  How often do surveys occur?  What is this new “QIS” survey?  How do I find information about my facilities’ survey performance/record?  What are the components of a “plan of correction” in response to a deficiency?


December 2006 Changes to Pharmacy Sections of SOM

On December 18, 2006, CMS implemented revised versions of the pharmacy-related sections of SOM Appendices P and PP.  The changes affected the:
  • “Medication Pass” observation and “Adverse Drug Reaction” protocol in Appendix P, and
  • “Pharmacy Services” (F-Tags 425, 428, and 431) and “Unnecessary Drugs” (F-Tag 329) sections in Appendix PP.
These revisions constitute the first substantial change in the pharmacy sections since 1999 and reflect much work over many years by CMS and appointed Expert Panels, of which ASCP was a participant.
ASCP developed a number of resources to educate pharmacists and other long-term care professionals about the pharmacy-related changes to the SOM, as seen below:

Archived Webcast:  “Gradual Dose Reduction/Tapering Myths Versus Reality – A Clinical Perspective
Even though the Centers for Medicare and Medicaid Services (CMS) regulations and guidelines require or suggest tapering of medications, the clinical implementation of such a tapering attempt can be complicated in the long-term care population. This session will attempt to address the practical application of the tapering guidelines for each of the medication classes mentioned in the CMS document (i.e., psychopharmacological, antipsychotic, sedative/hypnotic) while focusing on relevant current standards of practice and recent clinical trials that inform such practice.

Archived Webcast:  “Gradual Dose Reduction/Tapering Myths Versus Reality – A Regulatory Perspective
The Centers for Medicare & Medicaid Services (CMS) made significant changes to the survey guidelines of the State Operations Manual (SOM) related to gradual dose reductions and tapering.  In addition, the final version of the guidelines released in December 2006 contained several notable alterations from the Advance Copy released in September.  This program will outline these specific changes and clarify the correct final guidelines; define psychopharmacological medications and the rationale for tapering; describe criteria and necessary documentation for clinical contraindications; and discuss the impact of the new guidelines. 

Summary of Changes and Answers to Frequently Asked Questions

The Consultant Pharmacist journal article: “Changes in the State Operations Manual: Implications for Consultant Pharmacy Practice – December 2006

The Consultant Pharmacist journal article: “Implementing Changes to the State Operations Manual - February 2007

The Consultant Pharmacist journal article: “Gradual Dose Reduction and Medication Tapering: A Clinical Perspective – August 2007


Products/Resources

Policies and Procedures: Pharmacy Services for Nursing Facilities
Extensively updated in 2006 to address the changes to the pharmacy sections of the CMS State Operations Manual

SOM Quick Reference Cards
The Consultant Pharmacist’s Guide to Nursing Facility Regulations and the Survey Process
Contains Appendix P and Appendix PP from the CMS State Operations Manual along with forms used by surveyors during their survey of nursing facilities

Unnecessary Medications in the Elderly: A Guide to Improving Therapeutic Outcomes
Focuses on effective care delivery processes for the management of medications

The Consultant Pharmacist Handbook: A Guide for Consulting to Nursing Facilities
Includes sections on:
  • Background on regulatory issues affecting consultant pharmacist
  • Stepwise approach to performing a thorough medication regimen review
  • Patient assessment principles and links to geriatric screening tests
  • Quality improvement techniques through use of the Minimum Data Set (MDS), quality indicators, and quality measures
  • Effective strategies for inter-professional communication and serving a culturally diverse population
  • Role of technology in the nursing home
  • Infection control guidelines
  • Clinical information resources
Print PagePrint Page  Email PageEmail Page 
Copyright & DisclaimerPrivacy StatementGuidelines
#Email Address