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PMDA Public Policy Committee Report 2007-2008 Thomas Lawrence, MD David A. Nace, MD, MPH Co-Chairs, PMDA Public Policy Committee

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Presentation on theme: "PMDA Public Policy Committee Report 2007-2008 Thomas Lawrence, MD David A. Nace, MD, MPH Co-Chairs, PMDA Public Policy Committee"— Presentation transcript:

1 PMDA Public Policy Committee Report 2007-2008 Thomas Lawrence, MD David A. Nace, MD, MPH Co-Chairs, PMDA Public Policy Committee


3 “I’m David Nace and I approved this message”

4 Objectives Review Act 52 key points – “Healthcare Facilities Act” Discuss new developments on Act 52 Discuss F 441-444 – “Infection Control and Hand Hygiene Regulations” Discuss HHS HCW influenza Initiative (Priority) & late season immunization push Discuss HB 2098 “Preventable Serious Adverse Events Act”

5 Healthcare Associated Infections Act (Act 52) Health Care Facilities Act Signed into law July 2007 Intent to reduce healthcare associated infections in PA healthcare facilities –Includes nursing facilities Key agencies –Patient Safety Authority –Health Care Cost Containment Council –DOH

6 Act 52 - 6 Key Components 1.Comprehensive Infection Control Plan 2.Active Surveillance System 3.Electronic Reporting of HCAI 4.Incentive Payments 5.Surcharge 6.Penalties

7 Comprehensive Infection Control Plan Multi-disciplinary Committee (if applicable) –Medical staff –Administration –Lab personnel –Nursing staff –Pharmacy staff –Physical plant –Patient Safety Officer –Infection Control team –Community member

8 Comprehensive Infection Control Plan Effective measures for the –Detection –Prevention –Control of HCAI

9 Comprehensive Infection Control Plan Culture surveillance processes & policies –Surveillance for the HCAI’s defined in the PA Bulletin –Active case finding –Role of the Infection Preventionist critical

10 Comprehensive Infection Control Plan System to ID and designate patients known to be colonized or infected with MRSA/MDRO –Must culture all nursing home residents admitted to the hospital –Procedures for identifying other high risk residents admitted to hospital

11 Comprehensive Infection Control Plan Procedures & protocols for staff with potential exposure to resident known to be colonized or infected –When to culture or screen TB MRSA outbreaks –Prophylaxis Flu –Follow-up care Needlestick injuries

12 Comprehensive Infection Control Plan Outreach process for notifying receiving health care facility or ASF of any patient known to be colonized or infected prior to transfer –Hospital transfers –Ambulance transport –Surgical centers –Other NFs

13 Comprehensive Infection Control Plan Infection Control Protocol –IC Precautions CDC Guidelines –Intervention Protocols Evidence based standards –Physical Plant Operations –Appropriate Use of Antimicrobials –Mandatory Education Programs for Staff –Fiscal / Human Resource Requirements

14 Comprehensive Infection Control Plan Process for Patient Safety Advisories –Healthcare workers –Medical staff –Physical plant personnel Patient Safety Authority

15 Electronic Reporting All NF must electronically report HCAI to DOH and PSA –Definitions – Finalized and published PA Bulletin 9/20/08 –Effective Date TBD April 1, 2009

16 Electronic Reporting –Mechanism PA Patient Safety Reporting System (PA-PSRS) Single web-based interface –Format TBD –Training In-person –Across state Jan – Mar 2009 On-line



19 Quality Incentive Payment Jan 1, 2009 - Payments for 10% reduction in total HCAI in facility 2010 – benchmarks for reduction Must be compliant for payment Funds as available

20 Nursing Home Assessment July 1, 2008 – surcharge on license fee –Maximum aggregate $ 1 million –Penalty for failure to pay $1000 / day –Reimbursable cost DPW to make a pass through payment to the facility

21 Penalties Failure to report HCAI Failure to develop, implement, or comply with a plan $1000 / day

22 Healthcare Associated Infection (HCAI) A localized or systemic condition that results from an adverse reaction to the presence of an infectious agent or its toxins that: 1.Occurs in a patient in a health care setting 2.Was not present or incubating at the time of admission, unless the infection was related to a previous admission to the same setting. 3.If occurring in a hospital setting, meets the criteria for a specific infection site as defined by the CDC and its National Health Care Safety network (NHSN)

23 HAI Caveats HAI not present or incubating upon admission All signs and symptoms must be acute, new, or rapidly worsening Non-infectious causes should always be considered first before defining an infection Physician diagnosis plays a significant role, especially where lab and Xray resources are limited

24 HAI Caveats Use of abx alone is not indicative of infection Fever in the elderly –Oral or equivalent temp of 100.4 F (38C) or an increase of 2 F (1.1 C) over baseline.


26 Reportable Conditions

27 UTI Residents w / Urinary Catheter (Must have 2 or more) –Fever +/- chills –Flank or suprapubic pain –Gross hematuria or change in character of urine –Change in MS or functional status from daily baseline Residents w / o Urinary Cather (Must have 3 or more) –Fever +/- chills –New burning pain on urination, frequency, urgency –Flank or suprapubic pain –Gross hematuria or change in character of urine –Change in MS or functional status from daily baseline

28 UTI If urinalysis obtained, 1 or more must be positive IN the presence of signs and symptoms –Positive leukocyte esterase –Positive nitrite –Pyuria (10 or more WBC) If urine culture obtained, must have signs and symptoms –> 100,000 colonies, AND –No more than 2 organisms present

29 Lower Respiratory Tract Infection Must have 3 or more –Fever –New or increased cough –New or increased sputum –Pleuritic chest pain (gets worse with breathing) –Rhonchi, rales, wheezes or bronchial breathing –New or increased SOB –Tachypnea (> 25 breaths/min) –Change in MS or functional status from baseline –No other conditions that could account for symptoms –If CXR, physician confirmation of infiltrate with symptoms/signs

30 Influenza-Like Illness Fever, AND 3 or more of the following –Chills –Headache or eye pain –Malaise or loss of appetite –Sore throat –Dry cough –Myalgias

31 Skin & Soft Tissue Infection (Cellulitus, IV site, Burns, Vascular / diabetic ulcer, device associated, decubitus ulcer) Purulent drainage, pustules or vesicles at wound, skin or soft tissue site, AND 4 or more of the following –Fever –Heat –Redness –Swelling –Pain –Serous drainage

32 GI Tract 1 or more of the following –2 or more loose / watery stools above normal for the resident in 24 hour period –2 or more episodes of vomiting with 24 hour period –Laboratory confirmed enteric pathogen from stool w/ compatible clinical syndrome –Stool toxin assay for C difficile –Single IgM or fourfold increase in IgG for pathogen in paired sera No evidence of non-infectious cause (meds, tube feeds, laxatives, PUD) C difficile is HAI if it presents after day 3 of admission

33 Intra-abdominal Infection (peritonitis / abscess) 2 or more of the following –Fever –Nausea –Vomiting –Abdominal pain –Jaundice AND one of the following –Physician diagnosis of intra-abdominal process –Xray evidence –Organism cultured from drainage from surgically placed drain or tube

34 Meningitis Physician diagnosis, AND 3 or more of the following –Fever –Headache –Stiff neck –Meningeal signs as per physician –Cranial nerve signs as per physician –Irritability

35 Viral Hepatitis Positive antigen or antibody test for Hepatitis A, B, C, delta, AND 2 or more of the following –Fever –Nausea –Anorexia –Vomiting –Abdominal pain –Jaundice –History of transfusion within previous 3 months

36 Osteomyelitis Physician diagnosis AND 2 or more of the following –Fever –Localized swelling –Tenderness at suspected site of bone infection –Heat at suspected site of bone infection –Drainage at suspected site of bone infection

37 Primary Bloodstream Infection 2 or more blood cultures drawn on separate occasions documented with a common skin contaminant –Diphtheroids, Bacillus, Proprionibacterium, coag neg staph, micrococci OR single blood culture documented with pathogenic organism (not a typical contaminant AND –Fever –Drop in systolic BP > 30 mm Hg over baseline –Change in MS Not related to infection at another site.

38 Training DOH Training Grants LTCF –$1000 per facility –Identification –Reporting –Prevention November 26, 2008 wse.asp?a=188&bc=0&c=38963

39 Written Notification All Serious Events (SE) require that the healthcare facility notify the patient or their legal representative in writing that a SE has occurred. This written notification must occur within seven (7) calendar days.

40 Written Notification 24 comments submitted regarding applicability of written notification requirements –Act 13 did not include NF –Act 52 did not specifically require this PMDA working with other organizations to remove this requirement –NF setting is different than acute care –High percentage of care maintenance and palliative / end of life care –Most such patients will ultimately have an infection at time of death which is neither avoidable or unexpected.

41 PMDA Position Written Notification While PMDA strongly supports disclosure of medical errors, PMDA specifically opposes a mandatory requirement for written notification of healthcare associated infections in LTC facilities as defined by the PSA –A majority of such infections as defined by the PSA will not be preventable (and hence not represent system failures) –Infection is a common and expected mode of death for those whose care wishes are for either care maintenance or palliative care (as opposed to life sustaining care wishes)

42 F 441-445 Federal Nursing Facility Licensure Regulations: Infection Control

43 F 441-445 January 2007 began revision of F 441-445 –F 441 - Infection Control & Infection Control Program (483.65 & 483.65a) –F 442 – Preventing Spread of Infection (483.65b) –F 443 – Staff with Communicable Diseases (483.65(b)(2)) –F 444 – “Hand Washing” (483.52 (b)(3)) –F 445 – Linen Handling (483.65(c))

44 F 441-445 September 2008 final revised guidelines back to CMS –Collapsed all tags into two F 441 “Infection Control” F 444 “Hand Washing” Release for Stakeholder comment September 17, 2008 –Due back October 31, 2008

45 F 441-445 Expert panel will meet to review comments first week of November


47 Health workers administer flu and pneumonia inoculations at Embarkation Camp in Genicart, France, during the 1918 flu pandemic.

48 Health & Human Services Healthcare Worker (HCW) Influenza Immunization Initiative

49 Healthcare Workers HCW are at risk for Getting the flu Personal Safety HCW are at risk for Giving the flu Patient Safety

50 HHS – HCW Influenza Immunizations Overall mortality reduced in LTC facilities when staff immunized against influenza. –40% reduction in several studies Healthy People 2010 goal is a 60% HCW influenza immunization rate –National average is 37-40% –National average unchanged in past decade

51 Study of Influenza Prevalence in HCW BMJ 1996;313:1241-2. Percent Staff w / Flu Percent Flu + Staff w / No Recollection of Infection 1993-1994 Glasgow 518 subjects, influenza A/B antibodies w/paired serum samples Survey questionnaire

52 HHS – HCW Influenza Immunizations HHS is requesting all healthcare workers be immunized against influenza HHS is requesting all healthcare provider organizations work with their membership to improve HCW influenza immunization rates.

53 PMDA Position Healthcare Worker Influenza Immunization PMDA recommends all healthcare workers be immunized against influenza PMDA recommends that facilities include the use of a declination form in the HCW immunization programs


55 Health & Human Services Late Season Influenza Immunizations


57 Late Season Immunizations National Influenza Vaccination Week DECEMBER 8-14, 2008 –Provider immunization efforts typically end November –Flu doesn’t end in November or December

58 PMDA Position Late Season Influenza Immunizations Healthcare providers should continue to immunize all LTC residents through the end of flu season APRIL or MAY depending on the season Healthcare providers consider observing National Influenza Vaccination Week

59 PA House Bill 2098 Preventable Serious Adverse Events Act

60 PA House Bill 2098 Session of 2007 Objective –Reduction in payment for preventable serious adverse events within the Commonwealth Health care providers may not knowingly seek payment from health payors or patients for a preventable serious adverse event or services required to correct or treat the problem created by such an event when such an event occurred under their control.

61 PA House Bill 2098 Session of 2007 Health care providers –A healthcare facility or a person, including a corporation, University, or other educational institution, licensed or approved by the Commonwealth to provide health care or professional medical services. Physicians, nurse midwifes, podiatrists, CRNP, PA, chiropractor, hospitals, ASC, nursing homes, or birth centers.

62 PA House Bill 2098 Session of 2007 Preventable Serious Adverse Event –An event that occurs in a healthcare facility that is within the healthcare provider’s control to avoid, but that occurs because of an error or other system failure and results in a patient’s death, loss of body part, disfigurement, disability or loss of bodily function lasting more than 7 days or still present at the time of discharge from a healthcare facility. –Such events shall be within the list of reportable serious events adopted by the National Quality Forum

63 PA House Bill 2098 Session of 2007 Passed by House Referred to Senate Senate session ended before passage PMS –Key is in the wording of “preventable serious adverse events” –Will pass

64 PMDA Position House Bill 2098 No position at this time –Under review –Engage in discussion definitions


66 Leadership Leadership is communicating to a person, their worth & potential so clearly that they come to see it in themselves – Stephen Covey, 8 th Habit

67 Contact Information

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