In early August, a story was published stating the Illinois Department of Public Health had issued citations for infection control problems to two-thirds of same-day surgery centers in Illinois inspected during the past year. The story documented many of the infection control problems with resulted in the citations. While these problems had all been corrected, according to the report, they provide insight into aspects of infection control where surgery centers could use improvement.
Phenelle Segal, RN CIC, president of Infection Control Consulting Services, based in Blue Bell, Pa., addresses 14 of the problems identified in the report and offers practical guidance and best practices to help your ASC ensure it does not experience the same problems.
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1. Failure to label disinfectant with expiration date. "Liquid products must be labeled with date of opening and expiration date," Ms. Segal says. "If the manufacturer does not have an imprinted expiration date on the bottle, the facility must find out the shelf life of the product and hand write an expiration date on the bottle based on the information obtained from the company."
2. Failure to ensure doctors were regularly trained in infection control. The Conditions for Coverage from CMS requires that "training must be provided to appropriate staff upon hire/granting of privileges with some refresher training thereafter." Facilities must provide educational programs for all staff members, including medical staff, she says. "Educational programs provided should be documented by the facility to ensure that credit is obtained," Ms. Segal says. "It is also suggested that some type of education be provided for contractual services such as environmental cleaning services, pharmacy, etc., as they are often overlooked and CMS surveyors have been known to review these records."
3. Sink used to clean eye instruments had no hot water. "Cleaning, disinfecting and sterilizing all instruments must be conducted in compliance with manufacturer's instructions as well as evidence-based guidelines and nationally recognized standards," she says. If hot water is required to clean instruments, the facility has a responsibility to ensure that it is available at all times.
4. Confusion over who headed infection control program. The Conditions for Coverage requires that an ASC "has a licensed healthcare professional qualified through training in infection control and designated to direct the ASC's infection control program." It further states the qualified professional does not have to necessarily be certified (i.e., certified in infection control (CIC).
"It is up to the discretion of the facility as to who will head the program," Ms. Segal says. "Many facilities hire an external consultant who oversees the program — preferably a CIC even though a certified person is not required by CMS — while, at the same time, designating a facility staff member as the on-site 'go-to' person. Hiring a qualified and certified consultant to assist the on-site staff member provides the facility with the expertise and experience of a professional who can provide guidance and education to the facility."
5. Unqualified person coordinating infection control program. "It's difficult to determine the definition of 'qualified person' and it varies from surveyor to surveyor," she says. "I strongly suggest that facilities employ or contract a person who is experienced in the field to oversee the program. Although it is not required by CMS, a certified infection preventionist eliminates the risk of being cited for 'retaining an unqualified person.
6. Torn edges and exposed mattress foam on stretchers in use for patients. "Mattresses should be intact and disposed of if worn and torn to mitigate the potential risk of contamination of inanimate objects," Ms. Segal says.
7. Infection control committee failed to investigate why one surgeon had an unusually high post-operative infection rate. CMS requires that ASCs "have a system to actively identify infections that may have been related to procedures performed at the ASC." It is suggested that the surveillance system includes methods of collecting of data as well as documentation that tracking of infections is occurring, she says.
"Surveillance for post-operative wound infections goes beyond tracking and extends to documenting findings and, most importantly, sharing the outcomes with pertinent staff members including specific surgeons whose patients have developed infections," Ms. Segal says. "One of the roles of an infection control committee is to share and disseminate pertinent information amongst members and to take action if needed."
8. Staff member placed contaminated instruments on table with clean instruments. "Ongoing monitoring of processes as well as educational programs should be in place to orient new employees and update current employees as to the procedures within the operating room suite regarding to sterility and the potential for cross contamination," Ms. Segal says. "The key to a successful program is ongoing education and monitoring of processes and outcomes."
9. Failure to ensure surgical instruments were sterilized for required length of time. The report indicated state regulators shut down the ASC with this problem for 45 minutes until the unsafe instruments were pulled from use. "Strict adherence to guidelines and standards for cleaning, decontamination and sterilization is imperative, and ongoing monitoring by facility staff as well as ongoing education is paramount," she says. "It is unacceptable and risky for any facility to fall short on procedures relating to cleaning/disinfecting and sterilizing of instruments." This is an area CMS focuses on very heavily and any breaches in processes, including minor ones, will result in some type of citation or deficiency, Ms. Segal says.
10. Anesthesiologist left operating room with mask dangling around his neck and used same mask when he returned. Medical staff members are often overlooked when the facility provides infection control education, Ms. Segal says. "It is a CMS requirement that all staff members — including medical staff — are educated, and the two most common areas that are often left out are related to hand hygiene and the correct use of personal protective equipment (PPE)," she says. "It is unacceptable for any staff member to reuse PPE, including face masks." Ms. Segal says in her experience when conducting on-site visits, it is not uncommon to find anesthesiologists in violation of PPE and hand hygiene practices. This indicates a need for improved efforts to involve anesthesiologists in training and education.
11. Surgical staff with exposed hair in operating room. Standards of practice must be adhered to at all times, and that includes use of PPE — including hair coverings — to avoid the risk of contamination of the sterile area, she says.
12. Failed to ensure proper testing of sterilizers. CMS requires that sterilizers are properly tested and precise and strict documentation is necessary. Specific standards for sterilization —including the appropriate use of chemical and biological indicators — must be adhered to at all times to avoid the possibility of placing the patient at risk of infection from improperly sterilized instruments, Ms. Segal says.
13. Multi-dose vial of medication unlabeled. When an ASC in Illinois failed to label a multi-dose vial of medication, it placed 19 patients at risk for cross-contamination, according to the Illinois Department of Public Health records. "It is well known that CMS developed the infection control Conditions for Coverage as a result of unsafe injection practices that were taking place in Nevada," she says. "One of the conditions is that 'multi-dose medications used for more than one patient are dated when they're first opened and discarded within 28 days of opening or according to manufacturer's recommendations, whichever comes first. It is absolutely unacceptable for any facility to use unlabeled multi-dose vials. If a multi-dose vial has been opened and is unlabeled, it should be discarded immediately. It is preferable to use one vial for one patient, but not mandated."
14. Staff left sterile area with cover gowns open, exposing scrubs to contamination. The purpose of cover gowns is to completely cover the scrubs that are worn in sterile areas, Ms. Segal says. "It is best to keep the cover gown closed at all times if the scrubs will be worn for future procedures to avoid the risk of contamination," she says.
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