2014 Proposed HAI Reporting Requirements

Per North Carolina Administrative Code (10A NCAC 41A .0106, 10A NCAC 41), Reporting of Healthcare-Associated Infections (HAIs) in North Carolina is based on the Centers for Medicare and Medicaid Services (CMS) Inpatient Prospective Payment System (IPPS) rules (Rules on Inpatient Prospective Payment Services). Because of this, when CMS adds HAI reporting rules, North Carolina requires those same HAIs be reported to the Division of Public Health (DPH) through the National Healthcare Safety Network (NHSN).

Recently, CMS published proposed rules for 2014 for public comment (http://www.gpo.gov/fdsys/pkg/FR-2013-05-10/pdf/2013-10234.pdf). If these rules are adopted they will affect you and your reporting of HAIs to CMS and to North Carolina. Two proposed rules in particular will impact data entry, beginning on or after January 1, 2014. These include:

1. Acute Care Hospitals will be required to report Central Line Associated Blood Stream Infections (CLABSIs) and Catheter Associated Urinary Tract Infections (CAUTIs) from not only all ICUS, but all medical, surgical, and medical/surgical wards.

2. The Medicare Beneficiary Number is to be reported (when applicable) for patients for all NHSN reported events.

It is currently unknown when CMS will publish the final rules so watch for information from the DPH HAI Infection Prevention Program, APIC NC and SPICE concerning the final rules.

Of additional interest regarding CMS’ validation process for 2013 data, CMS proposes to include CLABSI, CAUTI, SSI (Colon and Hysterectomy), LabID MRSA bacteremia and CDI.

For further information, you can read comments made on the proposed rules by national APIC at: http://www.apic.org/Resource_/TinyMceFileManager/Advocacy-PDFs/Comments_on_IPPS_FY_2014_FINAL_6-24-13.pdf

Special Note: In the FY 2014 IPPS proposed rule, CMS inadvertently omitted the baseline period for the CAUTI, CLABSI, and SSI measures that were proposed to be added to the Value Based Program (VBP) for FY 2016 payment. In in their comments (see website above), APIC asked for clarification on this point, and CMS added it to the OPPS/ASC proposed rule in order to get public comments in time to finalize the measures before the start of FY 2014 (October 1, 2013).

• The performance period for these measures is January 1, 2014 – December 31, 2014. The proposed baseline period is January 1 – December 31, 2012.

Investigation of Adverse Events after Methylprednisolone Acetate Injections, 2013

On May 22, 2013, the North Carolina Division of Public Health (NCDPH) was notified by the US Food and Drug Administration (FDA) of two adverse events reported to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program. Two patients had developed soft tissue abscesses after receiving methylprednisolone acetate (MPA) injections at the same clinic. The injections contained preservative-free (PF) MPA 80mg/mL from 10mL vials compounded and distributed by Main Street Family Pharmacy (MSFP) located in Newbern, Tennessee. Five similar adverse events associated with the same MPA formulation from MSFP had been identified in April among Illinois residents. Concerns about widespread use of a potentially contaminated product led to a multi-state investigation.

As of July 25, 2013, 81 facilities in 15 states administered any MPA product from MSFP to their patients; national estimates of exposed patients were unavailable. A total of 26 cases were reported from four states: Arkansas, Florida, Illinois and North Carolina. All 26 illnesses were skin or soft-tissue abscesses at the site of injection; no life-threatening infections were reported. Four case patients had positive bacterial culture or histopathologic findings including Enterobacter cloacae, Klebsiella pneumonia, and Aspergillus species.

In North Carolina, public health and healthcare professionals partnered to mitigate further exposure and identify any additional cases. The North Carolina Board of Pharmacy (NCBOP) identified five clinics that received MPA products from MSFP and instructed clinics to discontinue use and sequester any remaining MPA products. The NCBOP also obtained the voluntary surrender of MSFP’s license in North Carolina. NCDPH and affected county health departments worked with the five clinics to notify 1,045 patients who received MPA injections of their potential exposure and to assess for any adverse events. No further cases were identified.

There was strong evidence to support that the source of the outbreak was contaminated PF MPA compounded at MSFP. FDA product testing of recalled, unopened MPA products detected bacterial and fungal pathogens from two separate lots. Pathogens included Acinetobacter ursingii, Alternaria species, Bacillus cereus/thuringiensis/mycoides, Bacillus licheniformis, Bacillus pumilus, Cladosporium species, Roseomonas gilardii and Penicillium species. Detailed information can be found on the FDA website at http://www.fda.gov/Drugs/DrugSafety/ucm355575.htm.  

As a final note, this investigation raised the following important issues. PF MPA products in 10mL vials were used for multiple doses; however, as a preservative-free product it should have been treated patient as a single-dose vial and used for one patient. Healthcare professionals should be familiar with safe injection practices including appropriate use of single-dose and multi-dose vials. For more information, visit the One and Only Campaign website at http://www.oneandonlycampaign.org/.  FDA’s MedWatch was a valuable tool for identifying this multistate outbreak where few cases were dispersed throughout the country. Healthcare providers and consumers may complete a MedWatch report (http://www.fda.gov/Safety/MedWatch/default.htm) when an adverse event to a drug, product, or medical device is suspected.

SPICE Announces Gowns and Gloves Challenge Winner

Ever wonder what YOU can do help stop the spread of serious illness due to bad bugs like Antibiotic Resistant Bacteria? SPICE is creating four educational modules on infection prevention designed for all nursing home staff. The first two modules have been completed and distributed.To assist in motivating and engaging  employees to complete the modules, SPICE established the Gowns and Gloves Infection Prevention Challenge. 

Gowns and Gloves is the name of the nursing home soap opera that is embedded in the first two learning modules. The embedded video is an entertaining way to convey important information, and  the soap opera episodes with professional actors engage viewers and create some buzz about the modules.  

The objective of the Gowns and Gloves Challenge was to maximize the number of nursing home employees that complete  Modules 1 and 2 of the Enhanced Education of Infection Prevention in Nursing Homes program. Participating nursing homes had from March through July to get as many employees to view the modules as possible, with the winning nursing home to receive a party with cake and balloons!

Congratulations to our Gowns and Gloves Challenge Winner:

(drum roll, please!)

Wilkes Senior Village, North Wilkesboro, NC

121 completed modules; 90% of employees!!

Wilkes Senior Village

HONORABLE MENTIONS:

Warren Hills Nursing Center, Warrenton, NC: 90 completed modules; 69% of employees

Mountain Vista Health Park, Denton, NC: 66 completed modules; 49% of employees

Carol Woods, Chapel Hill, NC: 163 completed modules; 49% of employees

THE STATS:

Nursing Homes registered for the Gowns and Gloves Challenge: 72

Nursing Homes with 25 or more people completing a module: 13

Total modules completed to date: 985 !!

STAY TUNED FOR MODULES 3 AND 4 COMING SOON!!

For more information on Enhanced Education of Infection Prevention in Nursing Homes: www.spiceducation.unc.edu

CRE and NHSN LabID Event Webinars

There were two webinars held in mid-July by our good friends at the NC Department of Public Health.  They are currently available for viewing on the SPICE website.  

CRE Webinar

In addition to viewing the webinar, users may download the webinar slides, recommendations for CRE Infection Prevention in Acute Care and Long Term Care Facilities, templates for a transfer form, and a CRE education power point template based on the webinar.

NHSN LabID Webinar

Users can also download the webinar slides

Current Principles and Practices; New Research; and New Technologies in Disinfection, Sterilization and Antisepsis: A Special Edition of the American Journal of Infection Control, May 2013;41:S1-S114

Bill Rutala

by William A. Rutala, PhD, MPH and David J. Weber, MD, MPH

Healthcare-associated infections are an important source of morbidity and mortality with an estimated 1.7 million infections and 99,000 deaths annually in the United States.  The major source of healthcare-associated pathogens is thought to be the patient’s endogenous flora, but an estimated 20% being due to other transmission routes such as the environment and 20-40% attributed to cross-infection via the contaminated hands of healthcare personnel [1].

David Weber

A Special Editor of the American Journal of Infection Control, which was primarily developed from a symposia presented at the APIC annual meeting in 2012, provides concise reviews of the scientific literature and current guidelines in three important areas of infection control.  First, the role that the contaminated room environment plays in the transmission of several important healthcare-associated pathogens (e.g., methicillin-resistant Staphylococcus aureus [MRSA], vancomycin-resistant Enterococcus spp. [VRE], Clostridium difficile, and Acinetobacter spp.).  Second, an update of issues regarding skin antisepsis including hand hygiene.  Finally, reviews of new current issues in sterilization and disinfection of medical devices and instruments including new technologies. 

In the past decade, substantial scientific evidence has clearly demonstrated that contaminated room surfaces are an important component in the transmission of key healthcare-associated pathogens.  Evidence supporting this view includes that these pathogens persist in the environment for prolonged periods of time (hours, days, months), frequent contamination occurs of the hands/gloves of healthcare personnel, contact with the environment is equally likely to lead to hand/glove contamination, and admission to a room previously occupied by a patient colonized or infected with one of these pathogens increases the risk the subsequent patient will develop an infection with one of these pathogens.