Randomized surveys for injection safety in ASCs

The Department of Health and Human Services (HHS) is scaling back its oversight of needle safety issues in ambulatory care and ambulatory surgery centers (ASCs), though noting that some 3,200 inspections done in fiscal years 2010 and 2011 "have found that deficient infection control practices are widespread in ASCs," according to a report by the Government Accountability Office (GAO).

The deficient practices were not specifically described in the report, and HHS referred inquiries back to its written statement included in the GAO report as an appendix. HHS stated therein that the outpatient settings have been "required to correct these deficient practices" that were detected in a survey program that began after the 2008 outbreak of hepatitis C virus in a Las Vegas endoscopy clinic. That highly publicized outbreak resulted in nine cases of confirmed HCV transmission to patients and another 100 people that were possibly infected in the now-shuttered clinic. It resulted in a partnership between two HHS agencies, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS). An infection control worksheet was developed that the CMS subsequently used to survey injection safety and other infection control measures in the ambulatory settings, many of which are not accredited by The Joint Commission and have heretofore operated well under the radar. (The link to the ASC worksheet used by Medicare accreditation surveyors can be found at http://go.cms.gov/aRcc6b.)

"CMS stopped collecting individual Worksheets from State Survey Agencies for each ASC survey conducted after FY 2011," the HHS said in the GAO report. "With over 3,000 Worksheets collected, we believe there is sufficient data to support detailed analysis of ASC infection control practices nationally. CMS was also interested in relieving the State Survey Agencies, which are operating in a resource-constrained environment, of the burden associated with preparing a consolidated Worksheet and submitting it to our contractor after each ASC survey. In its recommendation, GAO has been sensitive to CMS's concerns about the burden on State Survey Agencies, suggesting that CMS could limit this data collection to a random sample of ASCs, adjusting the sample size, and collecting the data less frequently than every year. Consistent with these GAO suggestions, CMS plans to resume collection of the Infection Control Surveyor Worksheet beginning in FY 2013 for a state-stratified, randomly selected subset of ASCs surveyed in that year, and will repeat this sampling and data collection approximately every three years thereafter." (Editor's note: To access the GAO report, go to http://www.gao.gov/assets/600/592406.pdf. For information about a meeting between the Ambulatory Surgery Center Association and the CDC about single-use vials, see story, below. For more information on the "One and Only Campaign, go to www.oneandonlycampaign.org.)

ASCA and the CDC discuss single-dose vials

Representatives of the Ambulatory Surgery Center Association (ASCA) met with Centers for Disease Control and Prevention (CDC) staff to discuss issues affecting the industry, particularly injectable drugs packaged in single-dose and multi-dose vials.1

Representatives of the CDC gave ASCA an overview of the process behind their recommendations. An outline of past and recent outbreaks of infectious diseases associated with unsafe injection practices also was discussed by the CDC.

The ASCA representatives voiced concerns from members regarding the lack of science behind these recommendations. They asked for clarity from the agency as to why a more nuanced process pertaining to single-use vials could not be developed that would protect patients while eliminating the drug waste that occurs. They also briefed the agency on the different injectable drugs that ASCA members were having difficulty obtaining or are difficult to find in appropriate doses. Finally, they responded to the CDC's notion that ASCs could use a compounding pharmacy to divide single-use vials via the US Pharmacopoeia (USP) 797. These facilities are not always located close enough to the ASC to make their use a viable option. For example, there are no compounding pharmacists in Wyoming

Members of the CDC staff stated that they would develop a clearer explanation for their position on single-use vials and pledged to work with the ASCA and others to address the drug shortage and drug packaging issues that are impacting patient care in ASCs. (For more on the drug shortage, see story, below.)

References

  1. Ambulatory Surgery Center Association. ASCA meets with the CDC to discuss single-use vials. Gov Affairs Update July 26, 2012; 2(28).

ASCA meets with FDA about drug shortages

Representations of the Ambulatory Surgery Center Association (ASCA) recently met with the Food and Drug Administration (FDA) to discuss drug shortages and the labeling of pharmaceutical vials as single-use or single-dose.1

Clinical Coordinator Cynthia Armstrong, RN, from the Surgery Center of Rockville, MD, discussed how it has become difficult to find some drugs, especially injectable anesthesia drugs. Armstrong shared that she was offered a supply of propofol for 30 times the usual price. Members of the FDA staff noted that in some cases, these situations might be localized distribution problems rather than actual shortages. They made the following suggestions:

  • ASCs that are having difficulty obtaining a drug should email the FDA at drugshortages@fda.hhs.gov, noting the drug, the dosage, the ASC's location, and the name of the distributor involved.
  • The ASC should contact the drug manufacturer directly to ascertain if this is a localized distribution problem or a shortage.
  • Any ASC that is approached by a "gray market" distributor or receives an ad from such a distributor should notify the FDA and forward the ad material to the FDA at drugshortages@fda.hhs.gov. (For additional information on drug shortages, see the April 2011 issue of Same-Day Surgery. Also visit ASCA's Drug Shortages Information Center at http://bit.ly/H3mGow.)

Senate committee releases report on shortages

A Senate hearing was held July 25 to examine why healthcare providers are struggling to obtain short-supply prescription drugs for their patients.2

During the hearing, Chairman John D. Rockefeller IV (D-WV) released a report outlining the markup of drug prices by third-party distributors within the drug supply and distribution process. In the report, the paths of 300 drugs were followed from manufacturer to final provider, and in one case a drug's cost was marked up by 8,471% by the time it reached the end user.

The hearing was held by the Senate Committee on Commerce, Science, and Transportation and was the result of a joint Congressional investigation.

President Obama recently signed into law the reauthorization of the "Prescription Drug User Fee Act," which is effective Oct. 1, 2012. The law requires manufacturers of certain drugs to report to the Department of Health and Human Services (HHS) any plan to discontinue or interrupt the manufacturing of a drug that could lead to a meaningful disruption in the supply of that drug. The law also allows hospitals owned and operated by the same entity to repackage drugs into smaller units before the FDA issues final guidance. It also directs the comptroller general to "conduct a study to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages." (We tweeted about this news on Aug. 6. Follow us on Twitter @SameDaySurgery.)

References

  1. Ambulatory Surgery Center Association. ASCA Representatives Meet with FDA Regarding Drug Shortages and Single-Dose Vials. Gov Affairs Update Aug. 16, 2012; 2(31).
  2. Ambulatory Surgery Center Association. ASCA meets with the CDC to discuss single-use vials. Gov Affairs Update July 26, 2012; 2(28).