NOTICES

PATIENT SAFETY AUTHORITY

Change of Reporting Criteria for Nursing Homes under the Health Care-Associated Infection and Prevention Control Act

[43 Pa.B. 2793]
[Saturday, May 18, 2013]

 The purpose of this announcement is to notify nursing homes of changes to the surveillance criteria for health care-associated infections that affect the reporting requirements to the Patient Safety Authority (Authority) and the Department of Health (Department) under Chapter 4 of the Medical Care Availability and Reduction of Error (MCARE) Act (MCARE Act) (40 P. S §§ 1303.401—1303.411), added by the act of July 20, 2007 (P. L. 331, No. 52) (Act 52), known as the Health Care-Associated Infection and Prevention Control Act. The reporting requirements presented in this notice were developed in consultation with the Department, Authority's Board of Directors and the Authority's Healthcare-Associated Infection (HAI) Advisory Panel.

Reporting Requirements for Nursing Homes

 Under the Health Care Facilities Act (35 P. S. §§ 448.101—448.904b), Act 52 requires nursing homes to electronically report patient-specific HAIs to the Authority and the Department using Nationally recognized standards (McGeer, Centers for Disease Control and Prevention).

 For those infections determined to be Serious Events, the original McGeer criteria was modified to remove requirements that relied on laboratory tests and radiology for confirmation, as many nursing homes would not have ready access to these services. At the time, it was believed that creating criteria to which all nursing homes would be able to adhere to was more important than strict adherence to the McGeer criteria.

 In October 2012, the revised McGeer criteria were published by Stone et al. The argument that facilities not using labs or radiology would have systematically lower infection rates and could unfairly receive bonus payments as a result no longer appears valid, as the bonus payments contemplated in Act 52 have not materialized. In addition, access to laboratory and radiology services for nursing homes has increased since the reporting requirements were originally established.

Method of Reporting HAIs

 A list of reportable HAIs is provided in Exhibit A. The criteria for determining HAIs were developed using the definitions for infection surveillance in long-term care by Stone et al. (McGeer criteria) together with modified Centers for Disease Control and Prevention definitions. The criteria are presented in Exhibit B. Definitions for constitutional criteria will follow specifics set forth by Stone et al.¹

Serious Event Reporting

 The occurrence of an HAI in a nursing home, defined as per criteria in Exhibit B, is deemed to constitute a Serious Event as defined in section 302 of the MCARE Act (40 P. S. § 1303.302). If an infection meets the criteria for reporting, that infection shall be reported to the Authority as a Serious Event, as required by the MCARE Act and Act 52, and subject to the additional requirements as described in this notice.

 HAIs reported to the Authority are subject to the same patient notification requirements under the MCARE Act for all Serious Events. Under the MCARE Act, all Serious Events require that the health care facility notify the patient or his 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 the MCARE Act, 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 workday.

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 under Act 52.

 Submit comments electronically to the 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.

 Individuals with disabilities who require an alternative format of this notice (for example, large print, audio tape or Braille) should contact the Authority help desk at (866) 316-1070.

Exhibit A. List of Reportable HAIs

A. Urinary tract infection

 1. Asymptomatic bacteremic urinary tract infection

 2. Catheter-associated urinary tract infection

 3. Symptomatic urinary tract infection

B. Respiratory tract infection

 1. Lower respiratory tract infection

 2. Influenza like illness

 3. Pneumonia

C. Gastrointestinal infection

 1. Clostridium difficile

 2. Norovirus

 3. Bacterial gastroenteritis

D. Skin and soft-tissue infection

 1. Cellulitis, soft-tissue or wound infection

 2. Conjunctivitis

 3. Scabies

E. Device-related bloodstream infection

 1. Central-line-associated bloodstream infection—di-alysis

 2. Central-line-associated bloodstream infection—tem-porary

 3. Central-line-associated bloodstream infection—per-manent

Exhibit B. Criteria for Defining HAIs in
Long-Term Care

A. Urinary tract infection

 1. Asymptomatic bacteremic urinary tract infection
Both criteria 1 and 2 must be present.

 Criteria 1. Any of the following:

  • A voided urine with >=10⁵ CFU/mL of no more than two species of microorganisms

  • Positive culture with >=10² CFU/mL of any microorganisms from straight in/out catheter specimen

  • Positive culture with >=10⁵ CFU/mL of any microorganisms from indwelling catheter specimen

 Criteria 2.

  • Positive blood culture with one matching organism in urine culture

 2. Catheter-associated urinary tract infection
Both criteria 1 and 2 must be present.

 Criteria 1. At least one of the following:

  • Rigors, new onset hypotension or fever, with no alternate site of infection

  • New onset confusion or functional decline, with no alternate site of infection and leukocytosis (>14,000cells/mm³) or left shift (>6% or 1,500 bands/mm³)

  • Purulent drainage at the catheter site or acute pain, swelling or tenderness of the testes, epididymis or prostate

 Criteria 2.

  • Urinary catheter specimen with at least 10⁵ CFU/mL of any organisms

 3. Symptomatic urinary tract infection
Both criteria 1 and 2 must be present.

 Criteria 1. At least one of the following signs or symptoms:

  • Acute dysuria, acute pain or swelling or tenderness of the testes, epididymis or prostate

  • Fever or leukocytosis and at least one of the following:
o Acute costovertebral angle pain or tenderness
o Gross hematuria
o Suprapubic pain
o New or marked increase in incontinence
o New or marked increase in urgency
o New or marked increase in frequency

 Criteria 1a. In the absence of criteria 1 infection signs or symptoms, then two or more of the following localizing urinary tract signs or symptoms:

  • Gross hematuria

  • New or marked increase in incontinence

  • New or marked increase in urgency

  • New or marked increase in frequency

 Criteria 2. One of the following:

  • A voided urine with at least 10⁵ CFU/mL of no more than two species of microorganisms

  • Positive culture with at least 10² CFU/mL of any microorganisms from straight in/out catheter specimen

B. Respiratory tract infection

 1. Lower respiratory tract infection

 Criteria 1—3 must be present.

 Criteria 1.

  • Chest radiograph not performed or negative results for pneumonia or new infiltrate

 Criteria 2. At least two of the following:

  • Respiratory rate of equal to or greater than 25 breaths per minute taken manually for a full minute

  • Pleuritic chest pain

  • New or changed lung examination abnormalities

  • New or increased sputum production

  • New or increased wet cough

  • Oxygen saturation <94% on room air or a reduction in oxygen saturation of >3% from baseline

 Criteria 3. At least one of the following:

  • Leukocytosis or left shift

  • Fever

  • Acute change in mental status from baseline

  • Acute functional decline

 2. Influenza like illness

 The patient is tested for influenza and is either positive or negative for influenza. If positive, system will flag as influenza. If negative and criteria is met system, will flag as influenza like illness.

 Criteria 1 and 2 must be present.

 Criteria 1.

  • Fever

 Criteria 2. At least three of the following:

  • Chills

  • New headache or eye pain

  • Myalgias or body aches

  • Malaise or loss of appetite

  • Sore throat

  • New or increased dry cough

 3. Pneumonia

 Criteria 1—3 must be present.

 Criteria 1.

  • Interpretation of a chest radiograph positive for pneumonia or a new infiltrate

 Criteria 2. At least one of the following:

  • Respiratory rate of equal to or greater than 25 breaths per minute taken manually for a full minute.

  • Pleuritic chest pain

  • New or changed lung examination abnormalities

  • New or increased sputum production

  • New or increased wet cough

  • Oxygen saturation <94% on room air or a reduction in oxygen saturation of >3% from baseline

 Criteria 3. At least one of the following:

  • Fever

  • Leukocytosis or left shift

  • Acute change in mental status from baseline

  • Acute functional decline

C. Gastrointestinal infection

 1. Clostridium difficile (C. difficile)

 Criteria 1 and 2 must be present.

 Criteria 1. One of the following:

  • A stool sample positive for C. difficile toxin A or B

  • A toxin-producing C. difficile organism identified from stool culture or by molecular testing

  • Pseudomembranous colitis identified through endoscopic examination, surgery or biopsy

 Criteria 2. One of the following:

  • Diarrhea in the absence of vomiting

  • A positive radiologic test for toxic megacolon

 2. Norovirus

 Criteria 1 and 2 must be present.

 Criteria 1.

  • Diarrhea and/or vomiting and negative C. difficile results

 Criteria 2.

  • A stool sample positive for norovirus

 3. Bacterial gastroenteritis

 Criteria 1 and 2 must be present.

 Criteria 1.

  • Diarrhea and/or vomiting and negative C. difficile results

 Criteria 2.

  • Stool sample positive for a bacteriologic pathogen

 And at least one of the following:

  • Nausea

  • Vomiting

  • Abdominal pain or tenderness

  • Diarrhea

D. Skin and soft-tissue infection

 1. Cellulitis, soft-tissue or wound infection

 The following must be present:

  • Pus present at a wound, skin or soft-tissue site

 or

 New or increasing presence of at least four of the following:

  • Heat at the affected site

  • Redness at the affected site

  • Swelling at the affected site

  • Tenderness or pain at the affected site

  • Serious drainage at the affected site

  • One of the following: Fever, leukocytosis, left shift, acute change in mental status or acute functional decline

 2. Conjunctivitis

 At least one of the following must be present:

  • Pus appearing from one or both eyes, present for at least 24 hours

  • New or increased conjunctival erythema, with or without itching

  • New or increased conjunctival pain, persistent for at least 24 hours

 3. Scabies

  Both criteria 1 and 2 must be present.

 Criteria 1.

  • A maculopapular and/or itching rash

 Criteria 2. At least one of the following:

  • Physician diagnosis

  • Laboratory confirmation by means of scraping or biopsy

  • Epidemiologic linkage to a case of scabies with laboratory confirmation

E. Device-related bloodstream infection (BSI)

 1. Dialysis-catheter-related BSI (any tunneled, nontunneled, implanted or nonimplanted centrally placed catheter used for dialysis)

 One of the following criteria must be met:

 Criteria 1.

  • Patient has a recognized pathogen cultured from one or more blood cultures.

 and

  •  Organism cultured from blood is not related to an infection at another site.

 Criteria 2. Patient has at least one of the following:

  • Fever

  • Chills

  • Hypotension

 and

  • Organism cultured from blood is not related to an infection at another site.

 and

  • A common commensal is cultured from two or more blood cultures drawn on separate occasions.

 2. Central-line-associated BSI—temporary (a centrally placed nontunneled or implanted catheter)

 One of the following criteria must be met:

 Criteria 1.

  • Patient has a recognized pathogen cultured from one or more blood cultures.

 and

  • Organism cultured from blood is not related to an infection at another site.

 Criteria 2. Patient has at least one of the following:

  • Fever

  • Chills

  • Hypotension

 and

  • Organism cultured from blood is not related to an infection at another site.

 and

  • A common commensal is cultured from two or more blood cultures drawn on separate occasions.

 3. Central-line-associated BSI—permanent (a centrally placed tunneled catheter or implanted catheter, including accessed ports)

 One of the following criteria must be met:

 Criteria 1.

  • Patient has a recognized pathogen cultured from one or more blood cultures.

 and

  • Organism cultured from blood is not related to an infection at another site.

 Criteria 2. Patient has at least one of the following:

  • Fever

  • Chills

  • Hypotension

 and

  • Organism cultured from blood is not related to an infection at another site.

 and

  • A common commensal is cultured from two or more blood cultures drawn on separate occasions.

MICHAEL C. DOERING, 
Executive Director

[Pa.B. Doc. No. 13-938. Filed for public inspection May 17, 2013, 9:00 a.m.]

_______

¹  Stone N. D., MD, Ashraf M. S., MD, Calder J., PhD, et al. (2012). ''Surveillance definitions of infections in long-term care facilities: revisiting the McGeer Criteria.'' Infection Control Hospital Epidemiology, 33(10), 965-977.

---

No part of the information on this site may be reproduced for profit or sold for profit.

This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.

---