NOTICES
Reporting Requirements for Nursing Homes under The Health Care-Associated Infection and Prevention Control Act
[38 Pa.B. 2542]
[Saturday, May 31, 2008]Purpose
The purpose of this announcement is to give nursing home facilities notice of their reporting requirements to the Patient Safety Authority (Authority) and the Department of Health (Department) under the Health Care-Associated Infection and Prevention Control Act (Act 52 of 2007). The reporting requirements presented in this notice were developed in consultation with the Department and the Authority's Health Care-Associated Infection (HAI) Advisory Panel.
Reporting Requirements for Nursing Homes
In addition to reporting under the Health Care Facilities Act 1979 (Pub. L. 130, No. 48), Act 52 requires that nursing homes electronically report patient-specific health care-associated infections to the Authority and the Department using nationally recognized standards based on Centers for Disease Control and Prevention (CDC) definitions.
Method of Reporting HAIs
The timelines and format for reporting HAIs is being established and will be published in a future notice. However, the Authority does not expect that Nursing Homes will begin reporting before the end of 2008. A list of reportable infections is presented at the end of this notice as Exhibit A. The criteria for determining HAIs were developed utilizing the definitions for infection surveillance in long-term care by McGeer A, Campbell B, Emori TG, and others (McGeer Criteria) together with modified CDC definitions for long-term care. The criteria are presented at the end of this notice as Exhibit B.
Serious Event Reporting
The occurrence of an HAI in nursing homes, defined as per criteria in Exhibit B is deemed to constitute a Serious Event as defined by the MCARE Act (Act 13), § 302. If an infection meets the criteria for reporting, that infection shall be reported to the Authority as a Serious Event as required by Act 13 and Act 52, subject to the additional requirements as described in this notice.
Health care-associated infections reported to the Authority are subject to the same patient notification requirements set forth by Act 13 for all Serious Events. Under Act 13, all Serious Events require that the healthcare facility notify the patient or their legal representative in writing that a Serious Event has occurred; this written notification must occur within 7 calendar days. For purposes of meeting the 24-hour reporting requirement for Serious Events set forth by Act 13, nursing homes must submit reports of HAIs to the Authority within 24 hours of their confirmation (surveillance completed and infection confirmed according to the criteria by a staff member responsible for infection control). If confirmation of an HAI occurs over a weekend or State government holiday, reports must be submitted by 5 p.m. on the next work day.
Public Comment Period
For 30 calendar days from the date of this publication, the Authority is accepting public comment about the uniform reporting requirements established jointly by the Authority and the Department of Health under Chapter 4--HAI of the MCARE (40 P. S. § 1303.401 et. seq.), (2007).
Submit comments electronically by means of e-mail to the Patient Safety Authority at patientsafetyauthority@ state.pa.us.
The Authority will review comments received and publish an additional Notice in the Pennsylvania Bulletin. This notice may include updates or changes, based on public comments, to the reporting requirements.
Persons with a disability who require an alternative format of this notice (for example large print, audio tape or Braille) should contact the PA-PSRS help desk at (866) 316-1070.
Exhibit A. List of Reportable HAIs
1. Symptomatic Urinary Tract Infection
1.1 Indwelling urinary catheter related
1.2 Nonurinary catheter related2. Respiratory Tract Infection
2.1 Pneumonia
2.2 Influenza-like illness (ILI)
2.3 Sinusitis
2.4 Bronchitis/tracheobronchitis3. Skin and Soft Tissue Infection
3.1 Cellulitis
3.2 Burns
3.3 Vascular and diabetic ulcer (chronic/non healing)
3.4 Device-associated soft tissue/wound infection for
example:* Tracheostomy site
* Peripheral/Central IV catheter site
* G-tube site
* Supra pubic catheter site
* In-dwelling drain
4. Decubitus ulcer (pressure related) Infection
5. Gastrointestinal Tract Infection
5.1 Bacterial (such as, Campylobacter, Salmonella species, Shigella)
5.2 Viral-like (such as, norovirus, rotavirus)
5.3 Clostridium difficile (C.difficile/C.diff)
5.4 Other nonviral/nonbacterial (such as, Amebiasis, Giardiasis, Cryptococcus)6. Intra-abdominal infection
6.1 Peritonitis/deep abscess7. Conjunctivitis
8. Mouth and perioral infection
9. Meningitis
10. Viral Hepatitis
11. Osteomyelitis
12. Primary Bloodstream Infection
Exhibit B. Criteria for Defining HAIs in Long-Term Care
The Centers for Disease Control and Prevention (CDC) definitions for health care-associated infections (HAIs) are generally not applicable to nursing homes.
In 1991, McGeer et al developed a set of definitions for determining HAIs in long-term care. The criteria were developed by modifying the CDC definitions and taking into consideration the difference in population, services and resources.
The criteria set forth below have been developed in accordance with the requirements of Act 52, using McGeer criteria and further modification of the CDC--based criteria.
Key Points in Defining Infections in the Elderly
* The CDC defines an HAI as a localized or systemic condition that was not present or incubating upon admission to a facility.
* All signs and symptoms of an infection must be acute, new or rapidly worsening.
* Noninfectious causes should always be considered before defining an infection.
* A change in mental or functional status is often indicative of a developing infection.
* Physician diagnosis plays a significant role in defining certain infections particularly where laboratory and radiology resources would be preferable but are limited.
* Antimicrobial treatment alone is not indicative of an HAI.
* In the elderly population, a fever is defined as: an oral or equivalent temperature* of 100.4° F (38° C) or an increase of 2° F (1.1° C) over baseline.
*Note: Discussion concerning the definition of temperature readings by means of alternative monitoring routes (such as, tympanic and axillary) has ensued. As there is lack of standardization of readings for these alternative routes, we invite comments addressing this issue.
Symptomatic urinary tract infection
Resident with Urinary Catheter
Two or more of the following with no other recognized cause:
* Fever and/or chills with no other source.
* Flank or suprapubic pain or tenderness (self- described or identified upon examination).
* Gross hematuria or change in character of urine.
* Change in mental and/or functional status from daily baseline.
Resident without Urinary Catheter
Three or more of the following:
* Fever and/or chills.
* New burning pain on urinating (dysuria), frequency or urgency.
* Flank or suprapubic pain or tenderness (self described or identified upon examination).
* Gross hematuria or change in character of urine.
* Change in mental and/or functional (including incontinence) status from daily baseline.
Note: If an appropriately collected and processed urine culture was taken and the resident was not receiving antibiotics at the time, then the culture must be positive IN the presence of defined signs and symptoms.
Respiratory Tract Infection
Pneumonia
Interpretation by a physician of a chest x-ray as demonstrating pneumonia, or probable pneumonia in the presence of an infiltrate and/or consolidation.
and
Three or more of the following:
* Fever with no other cause.
* New or increased cough.
* New or increased sputum production.
* Pleuritic chest pain.
* Rhonchi, rales, wheezes and/or bronchial breathing.
* New and/or increased shortness of breath and/or tachypnea (normal respiratory rate = 16--25 breaths/min).
* Change in mental and/or functional status from baseline in the presence of symptoms.
Note: Congestive heart failure and other noninfectious causes of similar signs and symptoms should be ruled out.
Influenza-Like Illness (ILI)
Fever
and
Three or more of the following during Influenza season (October 1 to April 30):
* Chills.
* Headache or eye pain.
* Malaise or loss of appetite.
* Sore throat.
* Dry cough.
* Myalgias.
Sinusitis
Physician diagnosis of sinusitis
and
Two or more of the following:
* Fever with no other recognized cause.
* Pain or tenderness over the sinuses.
* Headache.
* Purulent exudate or nasal obstruction.
Bonchitis/Tracheobronchitis
Symptoms must be acute and either NO chest X-ray or X-ray does NOT meet the criteria for Pneumonia
Three or more of the following:
* Fever.
* New or increased cough.
* New or increased sputum production.
* Pleuritic chest pain.
* Rhonchi, rales, wheezes and/or bronchial breathing.
* New and/or increased shortness of breath.
* Tachypnea (> breaths/min--normal respiratory rate = 16--25 breaths/min).
* Change in mental and functional status from baseline in the presence of symptoms.
Skin and Soft Tissue Infection
Cellulitis, IV Site, Burns, Vascular/diabetic Ulcer, device associated
Purulent drainage, pustules or vesicles at wound, skin, or soft tissue site
or
Four or more of the following signs and symptoms:
* Fever with no other recognized cause.
* Heat.
* Redness.
* Swelling.
* Pain or tenderness.
* Serous drainage.
Decubitus Ulcer (pressure related) Infection
Resident has at least two of the following signs and symptoms with no other recognized cause:
* Redness.
* Tenderness.
* Swelling of decubitus wound edges.
and
At least one of the following:
* Organisms cultured from properly collected fluid or tissue (see note to follow).
* Organisms cultured from blood (no other recognized cause).
Note: Purulent drainage alone is not sufficient evidence of an infection. Surface organisms cultured from the decubitus ulcer are not sufficient evidence of an infection. Needle aspiration of fluid or a biopsy of the tissue from the ulcer margin is required.
Gastrointestinal Tract Infection
Symptoms for Viral and Bacterial Infections to include:
One or more of the following signs and symptoms
* Two or more loose or watery stools above what is normal for the resident in a 24 hour period
* Two or more episodes of vomiting within a 24 hour period
* Laboratory confirmed enteric pathogen from stool WITH a compatible clinical syndrome.
* Stool toxin assay (C.difficile).
* Single IgM or fourfold increase in IgG for pathogen in paired sera.
Note: These criteria must include NO evidence of a noninfectious cause: such as, DIARRHEA: laxatives, change in tube feeding or medication; VOMITING: change in medication, other G.I. diseases such as peptic ulcer disease.
CDC defines a C.difficile laboratory confirmed infection as health-care acquired if it presents > 3 days after admission (that is, on or after day 4).
Intra-abdominal Infection
Peritonitis/Deep Abscess
Two or more of the following with no other recognized cause:
* Fever
* Nausea
* Vomiting
* Abdominal pain
* Jaundice
and
One of the following:
* Organism(s) cultured from drainage from surgically placed drain or tube.
* Radiographic evidence of infection.
* Physician diagnosis of an intra-abdominal infection.
Conjunctivitis
New pain, itching or redness of conjunctiva
and
Purulent exudate from one or both eyes for >= 24 hours
Note: Allergies and foreign body trauma should be ruled out.
Mouth and Perioral Infection
Physician or Dentist diagnosis and treatment of infection
and
One or more of the following with no other recognized cause:
* Abscess
* Ulceration
* Raised white patches on inflamed mucosa
* Plaque on oral mucosa
Meningitis
Physician diagnosis of Meningitis
and
Three or more of the following with no other recognized cause:
* Fever
* Headache
* Stiff neck
* Meningeal signs as determined by a physician
* Cranial nerve signs as determined by a physician
* Irritability
Viral Hepatitis
Positive antigen or antibody test for Hepatitis A, B, C or delta antigen
and
Two or more of the following with no other recognized cause:
* Fever
* Anorexia
* Nausea
* Vomiting
* Abdominal pain
* Jaundice
* History of transfusion within the previous 3 months
Osteomyelitis
Two or more of the following with no other recognized cause:
* Fever
* Localized swelling
* Tenderness at suspected site of bone infection
* Heat at suspected site of bone infection
* Drainage at suspected site of bone infection
and
Either
* Organism cultured from blood with no other recognized cause
or
* Physician diagnosis of Osteomyelitis
Primary Bloodstream Infection
Two or more blood cultures drawn on separate occasions documented with a common skin contaminant (such as, diphtheroids, Bacillus sp., Propionibacterium sp., coagulase-negative staphylococci, or micrococci).
or
A single blood culture documented with a pathogenic organism (noncontaminant)
and
One of the following:
* Fever or new hypothermia
* Drop in systolic blood pressure of > 30 mm Hg over baseline
* Change in mental or functional status
Note: Organism in blood culture is not related to infection at another site (secondary bacteremia).
MICHAEL C. DOERING,
Executive Director
[Pa.B. Doc. No. 08-1036. Filed for public inspection May 30, 2008, 9:00 a.m.]
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