February 2008

QIO Scope of Work to Focus on Pressure Ulcers, Restraints
As part of the Ninth Scope of Work for Quality Improvement Organizations (QIOs), the Centers for Medicare and Medicaid Services (CMS) released a list of 4,000 nursing homes which it says need to "improve their performance" on one or both of these two indicators. The list will be published on Nursing Home Compare, and all facilities on the list received direct notification from CMS last week. CMS charged QIOs to work with the listed nursing homes in their areas to reduce their rate of restraint use and/or pressure ulcers. AAHSA is providing counsel to homes that feel they are on the list in error and those who have had media inquiries about the list. Contact: Evvie Munley, (202) 508-9478. Please read the CMS announcement.

CMS Publishes Expanded List of Special Focus Facilities
CMS has published the complete list of the 131 nursing homes currently designated as Special Focus Facilities (SFFs). The SFF list is divided into five tables, including "New Additions"; "Not Improved", which are those facilities that have failed to demonstrate significant improvement after a standard survey; and "Improving" which lists facilities that have demonstrated improvement and are being monitored as part of the SFF program to see if the improvement is sustained. The last two tables identify those facilities that are no longer active SFFs, and include homes that have "Recently Graduated" from the program and those that are "No longer in the Medicare and/or Medicaid Program" because they have been terminated or are otherwise no longer certified for Medicare and/or Medicaid. CMS plans to update the list quarterly. Contact: Evvie Munley, (202) 508-9478. Read the CMS Press Statement and view the current SFF list.

New Quality First Guidelines Available
New Guidelines are available to help you on your journey to put quality first. These seven Guidelines enhance the quality characteristics in the Aging-Services Providers' Checklist for AAHSA Quality First. Each one focuses on different aspects of the 10 Elements of Quality. View all of the available Guidelines. More Guidelines will be coming throughout the year.

New Survey and Cert Letter on Use of Interpretive Guidance
CMS issued its January 18 survey and certification letter, Use of Interpretive Guidance by Surveyors for Long Term Care Facilities, in response to requests for clarification on the use of the State Operations Manual (SOM) Guidance to Surveyors to determine compliance with the Long Term Care Requirements of Participation (42 CFR Part 483]. According to the letter:
  • Surveyors must cite all deficiencies based on violations of statutory and/or regulatory requirements, not on the interpretive guidelines.
  • CMS notes its ongoing efforts to improve quality of care via the survey system and cites updating interpretive guidance as "...one method used to improve the survey process…," stating that the guidelines facilitate consistency in interpretation and approach to the assessment of compliance and the "...regulatory determination of the gravity and pervasiveness of identified deficiencies…"
  • The memo clarifies the distinction in the guidelines between "permissive duties and requirements", with one indication being the use of "should" or "may" vs. "shall" or "must." The reference at 483.25(c)-Pressure Sores, to repositioning as an intervention for residents with or at risk for pressure ulcers is provided as an example: "The care plan for a resident at risk for friction or shearing during repositioning may require the use of lifting devices…" "May" indicates a permissive action "vs. a requirement, i.e., not using lifting devices would not, in-and-of-itself, constitute a deficient practice.
  • The memo refers surveyors to SOM Section 2712, "Use of Survey Protocols in the Survey Process" and Principle #5 in the Principles of Documentation [footnoted and included in the memo] for clarification in use of information contained in the Interpretive Guidance: "Both sources make it clear that surveyors must base all cited deficiencies on a violation of statutory and/or regulatory requirements, rather than sections of the interpretive guidelines. The deficiency citation must be written to explain how the entity fails to comply with the regulatory requirements, not how the facility fails to comply with the guidelines for the interpretation of those requirements."
Read the new survey and certification letter.

Survey and Certification Task Force Discusses Enforcement Proposals
At its most recent meeting, AAHSA's member task force discussed proposals for reforming the enforcement process under the federal survey and certification system. The task force has begun to finalize its work and is drafting a report to the AAHSA board outlining all of its recommendations for changes in the system. Contact: Evvie Munley, (202) 508-9478.

CMS Updates MDS Resident Assessment Instrument User's Manual
CMS has made minor updates to the nursing home Minimum Data Set Resident Assessment Instrument User's Manual for sections I (Disease Diagnoses), K (Oral/Nutritional Status), L (Oral/Dental Status), M (Skin Condition), and contact information in Appendix B. Changes are effective January 1, 2008. Contact Karyn Downie (202) 508-9410. Review the MDS RAI Manual Updates.

MDS 3.0 Special Open Door Forum Recording Available
A recording of the January 24 MDS 3.0 Special Open Door Forum is still available on the CMS website. More information on materials are also posted on our website. Contact Karyn Downie (202) 508-9410.

Information on the latest MDS 3.0 Draft
Please review the MDS 3.0 Introduction
View details on the MDS 3.0 Implementation Timeline

Therapy Caps Extension Process Continued Through June 30
Medicare beneficiaries with a documented medical need for outpatient physical, speech, or occupational therapy exceeding the annual caps on coverage may continue to qualify for exceptions through the end of June. This year's caps are $1,810 for combined physical therapy and speech-language pathology services and another $1,810 for occupational therapy services. We are advocating for repeal of the caps or at least a longer extension of the exceptions process. Contact: Iara Woody, (202) 508-9429. See more details on how the automatic exemption process works.

FDA MedWatch Safety Information and Adverse Event Reporting Notices

Heparin and Normal Saline Pre-Filled Flushes- Nationwide Recall for Bacterial Contamination. AM2 PAT, Inc. has recalled all lots of both Heparin and Saline pre-filled flushes, which are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor. See the complete safety summary on the nationwide recall of both Heparin and Saline pre-filled flushes.

Leukine (sargramostim): liquid formulation withdrawn from the market due to increased reports of adverse reactions. Leukine is a growth factor that helps fight infection and disease by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). No increase in adverse reaction reporting rates has been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer. More details on the complete safety summary for the Leukine recall.

Medtronic Inc. SnychroMed EL Implantable Infusion Pump: Class I Recall of Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue, which could stop drug delivery suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer. See the complete safety summary regarding the Medtronic Inc. SnychroMed EL Implantable Infusion Pump.

Fentanyl transdermal patches: nationwide recall by Actavis Inc. of certain lots of Fentanyl transdermal system CII Patches with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr. See the complete safety summary, including a link to the firm's press release listing the specific lots to which the recall applies.

Duragesic 25 mcg/hr (fentanyl transdermal system) Pain Patches: Nationwide recall by PriCara and Sandoz Inc. because some patches may have a cut along one side of the drug reservoir within the patch. A possible result could be the release of fentanyl gel that may expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose, that may be fatal. Patches with a cut edge should not be used. These recalled patches have expiration dates on or before December 2009 and are all manufactured by ALZA Corporation. See the complete safety summary regarding Pain Patches.

Heparin Sodium Injection use: FDA informed healthcare professionals of reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.

The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency. View the complete safety summary including recommendations to healthcare professionals on the use of heparin sodium for injection.

Icy Hot Heat Therapy products: voluntary nationwide recall by Chattem, Inc. because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:

Icy Hot Heat Therapy Air Activated Heat - Back
Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal - Arm, Neck, and Leg
single consumer use "samples" contained on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream

Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer. See the complete safety summary on Icy Hot Heat Therapy products.

Intravenous Colchicine: FDA will take enforcement action against companies marketing unapproved, injectable colchicine, a drug used to treat gout. Colchicine is a highly toxic drug that can easily be administered in excessive doses, especially when given intravenously. There is a narrow margin between an effective dose of the drug and a toxic dose that can result in serious health risks, including death. The FDA is aware of 50 reports of adverse events associated with the use of intravenous colchicine, including 23 deaths. Potentially fatal effects include low blood cell counts, cardiac events, and organ failure. This action does not affect colchicine products that are dispensed in tablet form.

Individuals and companies must stop making these products within 30 days and stop shipping the product within 180 days or face regulatory action. After these dates, all injectable colchicine drug products must have FDA approval to be manufactured or shipped interstate. For more information about Intravenous Colchicine see the complete safety summary.

FDA Patient Safety News: The February issue includes significant safety alerts, recalls, new product approvals, and articles related to patient protection. Please view the February issue of the FDA Patient Safety News.

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