Nursing Facility Survey & Regulations

Printer-friendly versionPrinter-friendly version

NEW!! CMS Releases New Interpretive Guidance for F309, F329

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 309: Quality of Care
  • 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

Topical Resources

Topical Articles

May 30, 2013
CMS Releases New Interpretive Guidance for F309, F329
The Survey and Certification group at the Centers for Medicare & Medicaid Services has published an advanced copy of interim guidance (PDF) related to surveyors’ assessment for compliance with requirements related to nursing home residents with dementia and unnecessary drug use. These updates make substantial changes to the State Operations Manual:

  • Appendix P – changes to the resident sampling process for the traditional survey
  • Appendix PP – F309 (Quality of Care) the review of care and services for residents with dementia
  • Appendix PP – F329 (Unnecessary Drugs) new severity examples
  • Appendix PP – F329 (Unnecessary Drugs) changes to Table 1 (Medication Issues of Particular Relevance/Antipsychotic Medications)

These changes are effective immediately should be implemented as soon as possible. For information about related surveyor training videos, visit ASCP's CMS Surveyor Training Videos page.

October 27, 2011
CMS Announces Survey Emphasis on Antipsychotic Drug Use in Nursing Facilities
The Centers for Medicare & Medicaid Services has announced that the Survey and Certification branch of CMS will be giving high priority to evaluating appropriate use of antipsychotic medications in nursing facility residents. CMS is concerned that atypical antipsychotic medications are being overused in nursing facilities. Check this ASCP Web page for more information about antipsychotic medication use in nursing facility residents.

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.
View 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 here. (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. (PDF)

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.
Download the report here.

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.
Download the guidelines here. (PDF)

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. The Nursing Home Compare Web site can be found at 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)
Download the list here. (PDF)

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.”
Download the document here. (PDF)

Archived CMS Survey & Certification Memos

  • CMS S&C Memo #07-39 (September 2007) (PDF) 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) (PDF) 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.

ASCP Resources

Shop the online ASCP store

Learn more about Post Acute Care Payment Reform Demonstration.

====================================
Return to the Nursing Facility Practice Resource Center homepage
====================================

User login

MEMBER LOGIN

To prevent automated spam submissions leave this field empty.
Become a Member Today ASCP