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PA - PSRS © 2008 Pennsylvania Patient Safety Authority PA - PSRS Healthcare-Associated Infections: Reporting Requirements for Nursing Homes Healthcare-Associated Infections: Reporting Requirements for Nursing Homes
PA - PSRS © 2008 Pennsylvania Patient Safety Authority 2 Agenda Act 52 of 2007: Reporting Requirements Statewide training on the mandatory reporting system List of Reportable Infections Criteria for determining the infections Questions and Answers 1
PA - PSRS © 2008 Pennsylvania Patient Safety Authority 3 Act 52 of 2007 Added a chapter to Act 13: Healthcare- Associated Infections (HAIs) Required the Authority and DOH to develop a list of reportable HAIs in nursing homes. Required nursing homes to report specific HAIs to the Authority and DOH Requires electronic patient/resident-specific reports of HAIs to the Authority and DOH 2
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reporting Requirements Criteria based on nationally recognized standards in consultation with the HAI panel Developed using McGeer Criteria together with CDC definitions, adapted to the long-term care setting Does not replace mandatory notification to DOH of reportable diseases – Chapter 211.1 Stated that reportable HAIs are “Serious Events” and requires written notice to residents or their representative 3
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Act 52 Legal Requirements for Nursing Homes Serious Event: HAIs 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. Written Notification to take place within seven days of the confirmation of a Serious Event. 4
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Act 52 Legal Requirements for Nursing Homes Written notice to resident or representative Adds element that notification must be in writing Related to move towards more transparency in healthcare towards disclosure of adverse events Related to duty to notify of change in condition – CMS F-Tag 157 The letter is then a formality, documenting that disclosure took place 5
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reporting Requirements Nursing homes begin mandatory reporting on April 1, 2009 Report to Authority and DOH through a single interface: PA Patient Safety Reporting System (PA-PSRS) Eliminates need for duplicate reporting Detailed requirements published in PA Bulletin September 20, 2008 6
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reporting Requirements The format for electronic reporting is being established by the Patient Safety Authority in consultation with the Department of Health and the HAI Advisory Panel and will be addressed during training programs for nursing homes. A series of in-person and electronic sessions will be held throughout the State in February and March 2009. Nursing homes will be notified of available training opportunities through direct mailings, outreach to industry associations and future public notices. 7
PA - PSRS © 2008 Pennsylvania Patient Safety Authority 9 HAI Infection Training 30 training sessions throughout PA 8
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reportable Infections List of Reportable Infections 1. Symptomatic Urinary Tract Infection 1.1 Indwelling urinary catheter related 1.2 Non-urinary catheter related 2. Respiratory Tract Infection 2.1 Lower Respiratory Tract Infection (Pneumonia/Bronchitis/tracheobronchitis) 2.2 Influenza-like illness 9
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reportable Infections 3. 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 > Tracheostomy site > Peripheral/ Central IV catheter site > G-tube site > Supra pubic catheter site > In-dwelling drain > In-dwelling vascular catheters (dialysis) 3.5 Decubitus Ulcer (pressure related) 10
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Reportable Infections 4. Gastrointestinal Tract Infection 5. Other infections 5.1 Intra-abdominal infection (peritonitis/deep abscess) 5.2. Meningitis 5.3. Viral Hepatitis 5.4. Osteomyelitis 5.5. Primary Bloodstream Infection 11
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Definition of Healthcare-associated Infection (HAI) An HAI is a localized or systemic condition that was not present or incubating upon admission to a facility. Each infection should be considered individually when assessing the incubation period. If an infection resulting from an invasive device (such as a central or peripheral line or indwelling urinary catheter) occurs within 48 hours of transfer from a hospital to the nursing home, the HAI should be reported to the hospital and NOT reported as a nursing home related HAI. 12
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Definition of Healthcare-associated Infection (HAI) In the event that a resident is transferred from a hospital and an in-dwelling device is inserted in the nursing home upon admission (such as a peripheral IV or indwelling urinary catheter) and an infection occurs within 48 hours after insertion, in the absence of signs and symptoms and/or documentation of an infection upon transfer from the hospital, the infection should be reported as a nursing home HAI. 13
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Surveillance Methods Prospective/Concurrent Surveillance Prospective or concurrent surveillance is defined as the monitoring of residents while in the facility for evidence and confirmation/rule-out of a healthcare-associated infection (HAI). Prospective or concurrent surveillance in a timely fashion (at least weekly) is suggested in order to simplify the process of the confirmation of an infection. 14
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Surveillance Methods “Walking rounds” and chart reviews are commonly used methods for collecting concurrent and prospective infection data. “Walking rounds” if done daily are helpful in the event that initiation of infection control measures are needed. Post-discharge chart reviews may be necessary in the event that a resident is transferred out of the nursing home facility at the time of or shortly after development of signs and symptoms. 15
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Confirmation of Infection Confirmation of infection is defined as: Surveillance completed and HAI confirmed according to the standardized criteria utilized by a staff member responsible for infection control. Confirmation is NOT defined as the onset of signs and symptoms or suspicion of an infection. 16
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Confirmation of Infection 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. 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. 17
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Key Criteria for ALL Infections All signs and symptoms of an infection must be acute, new or rapidly worsening. Non-infectious causes should always be considered before defining an infection. A change in mental or functional status is often indicative of a developing infection. Antimicrobial treatment alone is not indicative of an HAI. 18
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Key Criteria for ALL Infections Physician Diagnosis Physician diagnosis plays a significant role in defining certain infections particularly where laboratory and radiology resources would be preferable but are limited (see criteria for individual infections). Physician diagnosis for infections that rely on clinical signs and symptoms only, should NOT be considered for defining the infection (see criteria for individual infections). 19
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Key Criteria for ALL Infections Fever 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: Tympanic thermometers are widely used in long-term care and manufacturer’s recommendations together with baseline temperatures are utilized to determine a fever. If baseline temperatures are not obtained or available, refer to manufacturer’s recommendations. 20
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Symptomatic UTIs Symptomatic Urinary Tract Infection Resident with Urinary Catheter* TWO or more of the following (one from each category/line) 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 * defined as an indwelling device inserted into the bladder through the urethra, left in place and connected to a closed collection system. Indwelling catheters do NOT include straight in and out catheters or other catheters that are not placed in the urethra (such as suprapubic catheters). 21
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Symptomatic UTIs Resident without Urinary Catheter THREE or more of the following (one from each category/line) : 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 22
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Symptomatic UTIs Note: Asymptomatic Bacteriuria (ASB) is NOT reportable to PA-PSRS If a URINALYSIS is obtained, one or more of the following must be positive IN the presence of defined signs and symptoms. > Positive for leukocyte esterase and/or nitrate > Pyuria (greater or equal to10 white blood cells- wbcs) If a urine CULTURE is obtained, greater or equal to 100,000 microorganisms per cc of urine with no more than 2 species of microorganisms must be present together WITH defined signs and symptoms. 23
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Respiratory Tract Infections Lower Respiratory Tract Infection THREE or more of the following (one from each category/line) 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 Tachypnea (normal respiratory rate = 16 - 25 breaths/min) Change in mental and/or functional status from baseline in the presence of symptoms 24
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Respiratory Tract Infections Note: Congestive heart failure and other non-infectious causes of similar signs and symptoms should be ruled out. A chest x-ray is NOT required for diagnosis but in the event that it is obtained, the presence of a pneumonia must be confirmed by a physician/radiologist IN the presence of defined signs and symptoms. 25
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Respiratory Tract Infections Influenza-Like Ilness (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 26
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Skin & Soft Tissue Infections Skin and Soft Tissue Infection Cellulitis, IV site, Burns, Vascular/diabetic ulcer, device associated, decubitus ulcer* 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 *Presence of an ulcer in the absence of criteria is not indicative of an infection. 27
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Gastrointestinal Infections 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 28
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Gastrointestinal Infections Note: These criteria must include NO evidence of a non-infectious cause: e.g. 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 (i.e. on or after day 4)*. * The National Healthcare Safety Network (NHSN) Manual -Patient Safety Component Protocol. Multidrug-resistant Organism (MDRO) and Clostridium difficile-Associated Disease (CDAD) Module Page 21 – April 2008 29
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Intra-abdominal Infections 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: Physician diagnosis of an intra-abdominal infection Radiographic evidence of infection Organism(s) cultured from drainage from surgically placed drain or tube 30
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Meningitis 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 31
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Viral Hepatitis 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 * In addition, Viral Hepatitis to be reported to DOH –under Chapter 211.1 of the Program Standards published in the PA Bulletin, July 24, 1999 32
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Osteomyelitis Osteomyelitis Physician diagnosis of Osteomyelitis and 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 33
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Primary Bloodstream Infection Primary Bloodstream Infection TWO or more blood cultures drawn on separate occasions from separate sites documented with a common skin contaminant or A SINGLE blood culture documented with a pathogenic organism (non- contaminant) and ONE of the following: Fever or new hypothermia (core body temperature of <35˚C) Drop in systolic blood pressure of > 30 mm Hg over baseline Change in mental or functional status 34
PA - PSRS © 2008 Pennsylvania Patient Safety Authority Criteria: Primary Bloodstream Infection Note: Organism in blood culture is not related to infection at another site (secondary bacteremia) e.g. positive blood culture secondary to a urinary tract or lower respiratory tract infection 35
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