Subject: Request for Calendar Year 2007 Flu & Pneumonia Immunization Information

Act 95 of the 2001 Legislative session, the Long Term Care Resident and Employee Immunization Act, requires that the Department of Health provide the legislature with a report regarding influenza and pneumococcal immunizations each three year period. In March 2005, we reported the information for years 2002, 2003, and 2004. In March 2008, we must report information for the years 2005, 2006, and 2007. Since 2007 has just concluded, we must collect information for that calendar year from each nursing care facility. Attached are the Influenza and Pneumonia Immunization Information questionnaire and instructions for completing it. Please complete this form for calendar year 2007 for your facility, and send it to the Division of Nursing Care Facilities in Harrisburg. You may fax the completed form to (717) 772-2163, you may email it to bshowalter@state.pa.us or you may mail it to the following address: Pennsylvania Department of Health Division of Nursing Care Facilities Room 526, Health & Welfare Building 7th & Forster Streets Harrisburg, PA 17120   It is essential that we receive the completed questionnaires no later than February 15, 2008 in order to provide time to validate and enter the data into the historical database and to correct any disparities. We appreciate your cooperation in this matter.

Attachments: questionnaire.pdf instructions.pdf Act 95.pdf 

From CMS:  

 January 24, 2008   Special Open Door Forum on Minimum Data Set, Version 3.0    

 Special Open Door Forum: Minimum Data Set, Version 3.0 (MDS 3.0)

Thursday, January 24, 2008 1:00 pm to 3:00 pm EST CMS Auditorium

This Minimum Data Set, Version 3.0 (MDS 3.0) Special Open Door Forum (ODF) is scheduled to report on the findings of a 5-year CMS Nursing Home MDS 3.0 Validation Study.  CMS will post the MDS 3.0 timeline for implementation on the “MDS 3.0 for Nursing Homes” page of its Nursing Home Quality Initiative website on December 31, 2007 at:   http://www.cms.hhs.gov/NursingHomeQualityInits/25_NHQIMDS30.asp#  

The updated Draft version of the MDS 3.0 form and written introduction is delayed and will be posted before the ODF.  The MDS has not had extensive clinical updating since 1995. The changes in MDS 3.0 have been designed to improve data assessment, care planning, and quality measurement. Changes were based on extensive written and oral provider feedback, a Town Hall meeting, CMS/Veterans Administration Research Collaborative, technical expert review and data collection in 8-States. CMS now plans to evaluate the impact of the MDS 3.0 changes on the resident classification system, Resource Utilization Group (RUG-III), used in the Medicare payment structure. This analysis will be conducted as part of the Staff Time and Resource Intensity Verification (STRIVE) study and the results will be available in late 2008/early 2009. Then, the MDS 3.0 changes can be finalized and implemented nationally on October 1, 2009.    

We look forward to your participation.   T

o participate (onsite or by telephone) in this Special ODF, please register on the CMS website at   http://registration.intercall.com/go/cms2  

Upon registering, you will receive a confirmation email containing further participation information. The deadline for registration is 2:00 PM EST, January 22, 2008. Capacity is limited so register early.  

An audio recording of this special forum will be posted to the Special ODF website at   http://www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp   and will be accessible for downloading beginning January 30, 2007 and available for 30 days.  

Thank you for your interest in CMS Open Door Forums.

From the PA Department of Health Message Board, December 6, 2007

Carbon Monoxide (CO) is an odorless, colorless and toxic gas. Because it is impossible to see, taste or smell the toxic fumes, it is often referred to as the "silent killer." At lower levels of exposure, CO causes mild effects that are often mistaken for the flu. These symptoms include headaches, dizziness, disorientation, nausea, fatigue and shortness of breath. Because CO replaces oxygen in the blood, it can make people sleepy, or if they are already asleep, it can prevent people from waking up. The effects of CO exposure can vary greatly from person to person, depending on age, overall health and the concentration and length of exposure. The elderly, children, and people with heart or respiratory conditions may be particularly sensitive to CO. In severe cases, CO poisoning can cause brain damage and death.

The most common sources of CO exposure in facilities are: leaking chimneys and furnaces, back-drafting from furnaces, gas water heaters, fireplaces, gas stoves, generators and other gasoline powered equipment.

Incomplete oxidation during combustion in gas ranges and unvented gas or kerosene heaters may cause high concentrations of CO in indoor air. Worn or poorly adjusted and maintained combustion devices (e.g., boilers, furnaces) can be significant sources, or if the flue is improperly sized, blocked, disconnected, or is leaking.

Generators are useful when temporary or remote electric power is needed, but they also can be hazardous. The primary hazards to avoid when using a generator are CO poisoning from the toxic engine exhaust and fire.

• It is important that all appliances and heating equipment, including all generators, be cleaned, professionally maintained, and monitored.

• Carbon Monoxide Detectors are widely available and you may want to consider utilizing one as a back-up—BUT NOT AS A REPLACEMENT—for proper use and maintenance of your fuel-burning appliances.

• If you suspect symptoms that could be from CO poisoning, open doors and windows immediately and activate your emergency procedure.

• Provide staff education regarding signs and symptoms of CO poisoning and their immediate response if CO poisoning is suspected.

• Update your emergency plan, if indicated, to include CO poisoning.

From the PA Department of Health Message Board 11/2/07:

DATE: November 19, 2007

SUBJECT: INFECTION CONTROL PLAN SUBMISSION

TO: AMBULATORY SURGICAL FACILITY ADMINISTRATORS

HOSPITAL ADMINISTRATORS/CEO

NURSING HOME ADMINISTRATORS

FROM: William Cramer, Director

Healthcare Associated Infection Prevention Section Quality Assurance Act 52, signed into law by Governor Edward G. Rendell July 20, 2007, requires that hospitals, ambulatory surgical facilities and nursing homes develop and implement Infection Control Plans that contain the following elements:

1. A multidisciplinary committee including representatives from each of the following, if applicable

to the specific Health Care Facility:

I. Medical staff that could include the Chief Medical Officer or the Nursing Home Medical

Director.

II. Administration representatives that could include the Chief Executive Officer, the Chief

Financial Officer or the Nursing Home Administrator.

III. Laboratory personnel.

IV. Nursing staff that could include a Director of Nursing or a Nursing Supervisor.

V. Pharmacy staff that could include the Chief of Pharmacy.

VI. Physical plant personnel.

VII. A Patient Safety Officer.

VIII. Members from the Infection Control Team, which could include an epidemiologist.

IX. The community, except that these representatives may not be an agent, employee or

contractor of the health care facility or ambulatory surgical facility.

2. Effective measures for the detection, control and prevention of health care-associated infections.

3. Culture surveillance processes and policies.

4. A system to identify and designate patients known to be colonized or infected with MRSA or

other MDRO that includes:

I. The procedures necessary for requiring cultures and screenings for nursing home residents

admitted to a hospital.

II. The procedures for identifying other high-risk patients admitted to the hospital who

necessitate routine cultures and screening.

5. The procedures and protocols for staff who may have had potential exposure to a patient or

resident known to be colonized or infected with MRSA or MDRO, including cultures and

screenings, prophylaxis and follow-up care.

6. An outreach process for notifying a receiving health care facility or an ambulatory surgical

facility of any patient known to be colonized prior to transfer within or between facilities.

7. A required infection-control intervention protocol which includes:

I. Infection control precautions based on nationally recognized standards, for general

surveillance of infected or colonized patients.

II. Intervention protocols based on evidence-based standards.

III. Isolation procedures.

IV. Physical plant operations related to infection control.

V. Appropriate use of antimicrobial agents.

VI. Mandatory educational programs for personnel.

VII. Fiscal and human resource requirements.

8. The procedure for distribution of advisories issued under Section 405(B)(4) so as to ensure easy

access in each health care facility for all administrative staff, medical personnel and health care

workers.

Infection control plans must be received by the Department not later than December 31, 2007.

Two hard copies of the document and all attachments should be submitted to the following address with a

cover letter identifying the submitting facility, responsible CEO/Administrator, and facility Infection

Control contact person name and e-mail address:

PA Department of Health

c/o BFLC, Attn: William Cramer

Room #912, Health & Welfare Building

7th & Forster Streets

Harrisburg, PA 17120

Please contact me at (717) 787-5193 or wcramer@state.pa.us with any questions or concerns that

arise. Thank you for your on-going support and cooperation in the state-wide effort to improve patient

and resident safety through effective infection control practice.

Criminal Background Check Backlogs

We have been informed that the Pennsylvania State Police have a backlog relating to

criminal background checks. We understand that this backlog has affected the providers’

ability to receive criminal background checks for newly hired employees within the

required 30 days of employment for in state residents and 90 days for out of state

residents.

Per the 6 Pennsylvania Code, Chapter 15 Protective Services for Older Adults; 15.147

Provisional hiring section 7(e) which states “If the criminal history record report, the

letter of determination issued by the Department, or both, has not been provided due to

the inability of the State Police or the Federal Bureau of Investigation to provide them

timely, the period of provisional employment shall be extended until the facility receives

the required reports. During the extended provisional employment period, the

supervision and documentation requirements of this section shall be continued.”

The Department of Health expects facilities that have been affected by this backlog and

have submitted requests to the State Police or the FBI will abide by the requirements as

indicated above, as well as, have proof of the request containing the date of the original

request.

Upon reviewing and confirming proof of the above, the DOH will not cite facilities in

this situation.

                                                                                               

By
Paula G. Sanders, Esquire
On July 20, 2007, Governor Ed Rendell signed Senate Bill 968, the Health Care-Associated Infection Prevention and Control Act ("HAI Act") into law. The HAI Act was drafted to address the reduction of health care-associated infections in hospitals, nursing homes and ambulatory surgical facilities. Not surprisingly, the new law requires health care facilities to implement a number of new and potentially costly policies, procedures and practices, some of which must occur before the end of this calendar year.

• Implementation of mandatory Internal Infection Control Plans which must be submitted to the Department of Health ("DOH") no later than December 31, 2007.

• Mandatory reporting of health care-associated infections. Hospitals will be subject to mandatory reporting of health care-associated infections to the Centers for Disease Control’s ("CDC") National Health Safety Network ("NHSN") and the reporting of health care-associated infections as serious events to the Patient Safety Authority.
  
• Culturing and screening of all nursing home residents upon admission to hospitals to determine if they are colonized or infected with methicillin resistant staphylococcus aureus ("MRSA") or other multi-drug resistant organisms ("MDRO").
  
• Implementation of electronic surveillance systems pursuant to strategic assessment in hospitals.
  
• Starting July 1, 2008, assessment of a surcharge on each nursing home license not to exceed statewide $1,000,000 in the aggregate in fiscal year 2008-2009, increasing by the consumer price index annually thereafter to fund activities of the Patient Safety Authority.
  
• Potential eligibility for incentive payments for reducing health care-associated infections.
  
• Administrative "penalties" of $1,000 per day.

      Related Links:

      Provider Bulletin 54

      Provider Bulletin 16

      Act 52

      The full text article will appear in future PADONA Journal.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard,

Mail Stop S2-12-25

Baltimore, Maryland 21244-1850

Center for Medicaid and State Operations/Survey and Certification Group

TO: State Survey Agency Directors

FROM: Director Survey and Certification Group

SUBJECT: Clarification of Terms Used in the Definition of Physical Restraints as Applied to

the Requirements for Long Term Care Facilities

The Centers for Medicare & Medicaid Services (CMS) is committed to reducing unnecessary

physical restraint use in nursing homes and ensuring residents are free of physical restraints

unless permitted by regulation. Proper interpretation of the physical restraint definition is

necessary in order to understand whether or not nursing homes are accurately assessing devices

as physical restraints and meeting the federal requirement for restraint use.

42 C.F.R. 483.13(a) provides that “the resident has the right to be free from any physical or

chemical restraints imposed for discipline or convenience, and not required to treat the resident’s

medical symptom.” CMS defines “physical restraints” in the State Operations Manual (SOM),

Appendix PP as, “any manual method or physical or mechanical device, material, or equipment

attached or adjacent to the resident’s body that the individual cannot remove easily which

restricts freedom of movement or normal access to one’s body.” Albeit for different functions,

this same definition is used in the SOM, the Resident Assessment Instrument User’s Manual and

subsequently the Minimum Data Set (MDS), and in the Quality Measure (QM). Despite using

the same definition, the MDS and QM do not capture all physical restraints used because of the

MDS’s limited categories and the QM’s calculation methods. Ultimately, surveyors should

focus on the appropriate use of all physical restraints, whether or not those restraints are captured

on the MDS or in the QM.

The following clarifications are meant to be used in conjunction with the definition of physical

restraints.

• Clarifies the phrases “remove easily” and “freedom of movement” as related to the

physical restraints definition.

• Further clarifies the meaning of “medical symptom.”

“Freedom of Movement” means any change in place or position for the body or any part of

the body that the person is physically able to control.

“Remove Easily” means that the manual method, device, material, or equipment can be

removed intentionally by the resident in the same manner as it was applied by the staff (e.g.,

siderails are put down, not climbed over; buckles are intentionally unbuckled; ties or knots

are intentionally untied; etc.) considering the resident’s physical condition and ability to

accomplish objective (e.g., transfer to a chair, get to the bathroom in time).

The definition of “medical symptom” has not changed. The information below is a combination

of current SOM guidance and some additional clarifications.

“Medical Symptom” is defined as an indication or characteristic of a physical or

psychological condition.

Objective findings derived from clinical evaluation and the resident’s subjective symptoms

should be considered to determine the presence of a medical symptom. The resident’s

subjective symptoms may not be used as the sole basis for using a restraint. In addition, the

resident’s medical symptoms should not be viewed in isolation; rather, the symptoms should

be viewed in the context of the resident’s condition, circumstances, and environment. Before

a resident is restrained, the facility must determine that the resident has a specific medical

symptom that cannot be addressed by another, less restrictive intervention and a restraint is

required to treat the medical symptom, protect the resident’s safety, and help the resident

attain or maintain his or her highest level of physical or psychological well-being.

There must be a link between the restraint use and how it benefits the resident by addressing

the medical symptom. Medical symptoms that warrant the use of restraints must be

documented in the resident’s medical record, ongoing assessments, and care plans. While

there must be a physician’s order reflecting the presence of a medical symptom, CMS will

hold the facility ultimately accountable for the appropriateness of that determination. The

physician’s order alone is not sufficient to justify restraint use. It is further expected, for

residents whose care plans indicate the need for restraints that the facility engages in a

systematic and gradual process towards reducing restraints (e.g., gradually increasing the

time for ambulation and strengthening activities). This systematic process also applies to

recently admitted residents for whom restraints were used in the previous setting.

Physical restraints as an intervention do not treat the underlying causes of medical symptoms.

Therefore, as with other interventions, physical restraints should not be used without also

seeking to identify and address the physical or psychological condition causing the medical

symptom. Restraints may be used, if warranted, as a temporary symptomatic intervention

while the actual cause of the medical symptom is being evaluated and managed.

Additionally, physical restraints may be used as a symptomatic intervention when they are

immediately necessary to prevent a resident from injuring himself/herself or others and/or to

prevent the resident from interfering with life-sustaining treatment, and no other less

restrictive or less risky interventions exist.

Note: Falls do not constitute self-injurious behavior or a medical symptom that warrants

the use of a physical restraint. Although restraints have been traditionally used as a falls

prevention approach, they have major, serious drawbacks and can contribute to serious

injuries. There is no evidence that the use of physical restraints, including but not limited

to side rails, will prevent or reduce falls. Additionally, falls that occur while a person is

physically restrained often result in more severe injuries.1

If the resident needs emergency care, restraints may be used for brief periods to permit

medical treatment to proceed, unless the resident or legal representative has previously made

a valid refusal of the treatment in question. The resident's right to participate in care planning

and the right to refuse treatment are addressed at 42 C.F.R. §§483.10(b)(4) and

483.20(k)(2)(ii) respectively. The use of physical restraints should be limited to preventing

the resident from interfering with life-sustaining procedures only and not for routine care.

A resident who is injuring himself/herself or is threatening physical harm to others may be

restrained in an emergency to safeguard the resident and others. A resident whose

unanticipated violent or aggressive behavior places him/her or others in imminent danger

does not have the right to refuse the use of restraints, as long as those restraints are used as a

last resort to protect the safety of the resident or others and use is limited to the immediate

episode.

Although the requirements describe the narrow instances when physical restraints may be used,

growing evidence supports that physical restraints have a limited role in medical care. Restraints

limit mobility and increase the risk for a number of adverse outcomes. Physical restraints

certainly do not eliminate falls. In fact in some instances reducing the use of physical restraints

may actually decrease the risk of falling.2

1 American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel

on Falls Prevention. Guideline for the prevention of falls in older persons. Journal of the American Geriatrics

Society. 49(5):664-72, 2001 May.

Neufeld RR, Libow LS, Foley WJ, Dunbar JM, Cohen C, Breuer B. Restraint reduction reduces serious injuries

among nursing home residents. J Am Geriatr Soc 1999;47:1202-1207.

Si M, Neufeld RR, Dunbar J. Removal of bedrails on a short-term nursing home rehabilitation unit. Gerontologist

1999;39:611-614.

Hanger HC, Ball MC, Wood LA. An analysis of falls in the hospital: can we do without bedrails? J Am Geriatr

Soc 1999;47:529-531.

Tinetti ME, Liu YB, Ginter S. Mechanical restraint use and fall related injuries among residents of skilled nursing

facilities. Ann Intern Med 1992;116:369-374.

Capezuti E, Evans L, Strumpf N, Maislin G. Physical restraint use and falls in nursing home residents. J Am

Geriatr Soc 1996;44:627-633.

Capezuti E, Strumpf NE, Evans LK, Grisso JA, Maislin G. The relationship between physical restraint removal

and falls and injuries among nursing home residents. J Gerontol A Biol Sci Med Sci 1998;53:M47-M52.

2 University of California at San Francisco (UCSF)-Stanford University Evidence-based Practice Center

Subchapter 26.2. Interventions that Decrease the Use of Physical Restraints” of the Evidence

Report/Technology Assessment, No. 43 entitled, “Making Health Care Safer: A Critical Analysis of Patient Safety

Practices.” The full report can be accessed at: http://www.ahrq.gov/qual/errorsix.htm

Effective Date: The information contained in this memorandum clarifies current policy and

must be implemented no later than 30 days after issuance of this memorandum. The information

will be incorporated into the State Operations Manual, Appendix PP.

Training: This clarification should be shared with all survey and certification staff, surveyors,

their managers, and the state/RO training coordinator. Please direct any question or comments to

Jeane Nitsch at  Jeane.Nitsch@cms.hhs.gov.

Thomas E. Hamilton

cc: Survey and Certification Regional Office Management

Quality Improvement Organizations

PROPOSED RULEMAKING STATE BOARD OF NURSING [49 PA. CODE CH. 21] Continuing Education for Professional Nurses
 

http://www.pabulletin.com/secure/data/vol37/37-17/743.html

FOR IMMEDIATE RELEASE P07-98 June 4, 2007

Media Inquiries: Karen Riley, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration today approved a device that measures glucose levels continuously for up to seven days in people with diabetes.

While a standard fingerstick test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.

“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics ages 18 and older with a way to see trends and track patterns,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals and suggest how exercise and diet might affect glucose levels.”

The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.

Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them.

An estimated 20.8 million people in the United States—7 percent of the population—have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5 percent to 10 percent of people with this chronic disease have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day.

Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.

While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease.

FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults.

A three-day version of the device, the STS Continuous Glucose Monitoring System, was approved in March 2006.

Need information about nursing research? Want to find out how nursing research is working to improve the health of the nation? Access to information about this vital area of science and the programs of the National Institute of Nursing Research (NINR), one of 27 Institutes and Centers at the National Institutes of Health, just got easier with the recent launch of the Institute�s improved website: http://www.ninr.nih.gov/.

Per the PA Department of Health Website on January 9, 2007, the Department of Health has a limited supply of influenza vaccine (for administration to persons 18 years of age or older) available upon request. Any facility that wants to order this vaccine and administer for no cost to residents, staff or their families should call: 717-787-5681 and ask to speak to Elaine Rubb or Alex McFall.

________________________________________________________________________________

As an interim step toward today's announcement, in March 2005, CMS began requiring all nursing homes that did not have sprinklers to install battery-operated smoke alarms in all patient rooms and public areas.  Lack of smoke alarms in the facilities in Hartford and Nashville that had fatal nursing home fires in 2003 may have contributed to a delayed response time to the fires, according to a report by the Government Accountability Office issued in July 2004.

CMS has already taken many actions to increase resident safety over the past several years, such as a 17-fold increase in the number of life safety code (LSC) inspections performed between 2004 and 2005.  The agency will also publish the number of LSC violations, as well as information on smoke alarms and sprinkler systems for every nursing home in the country on its Nursing Home Compare Web site by the end of this year.

Under existing CMS regulations, newly constructed nursing homes and nursing homes undergoing major renovations, alterations or modernizations must be equipped with sprinkler systems.  Currently, older homes are not required to have such systems.  "While new facilities must already meet sprinkler requirements, this proposed rule would require all nursing homes to do so."  Norwalk added.  "We appreciate the collaboration of the National Fire Protection Association and stakeholders throughout the industry in making these safety improvements as soon as possible."

CMS follows the fire safety guidelines developed by the National Fire Protection Association (NFPA) and all new sprinkler systems installed as a result of this proposed rule will have to meet NFPA technical specifications.

The proposed rule asks for public and industry input on an appropriate phase-in time to allow older homes to retrofit their facilities.  The comment period will remain open until December 26, 2006.

For more information on the proposed rule, visit: http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/pdf/E6-17911.pdf

____________________________________________________________________________________________________
Per the PA Dpartment of Health Message  Board  on  12/12/06: