When Ambulatory Surgery Center of Niagara had to overhaul how it treats the water used to clean surgical instruments, it learned firsthand how much compliance costs a small, privately owned center.
The Niagara Falls, N.Y.-based ASC had long rinsed instruments with distilled water. To meet a national water-quality standard for medical device processing, it installed a reverse osmosis system with ultraviolet treatment and endotoxin filtration. The new system also requires ongoing testing.
“There’s all these rules in place which help keep patient care really great, but it comes with a high price tag to keep up with all of these new requirements,” Kimberly Fullone, administrator of the center, told Becker’s.
The standard is ANSI/AAMI ST108, which the Association for the Advancement of Medical Instrumentation published in 2023. It sets quality levels for the water used at each stage of instrument processing, including the final rinse before sterilization, and calls for validation testing and routine monitoring.
ST108 is a voluntary consensus standard, not a federal or state rule. But CMS requires ASCs to select and follow nationally recognized infection control guidelines. Ms. Fullone said ST108 is the major guideline in this area, which is why the center had to invest.
The Joint Commission, in alignment with CMS, uses ST108 as a benchmark during accreditation surveys. That makes it “a de facto enforceable standard even though it is not explicitly mandated,” Ray Schwalbe, a mechanical engineer at HGA, wrote in a Jan. 5 article for PHCPPros.
Hospitals have an edge on costs like these, Ms. Fullone said. Health systems buy in larger quantities and negotiate better pricing on equipment and supplies.
“The hospitals get better pricing than we get, just because they buy so much more of whatever they’re buying,” she said.
Infection control is already the area where ASCs are cited most. Of 3,023 ASC surveys in 2023, the most frequently cited CMS health survey deficiency was sanitary environment, with 507 citations. Infection control program requirements ranked second, with 372, according to CMS data reported by the Ambulatory Surgery Center Association. The Joint Commission’s most challenging ambulatory care requirement in 2023 covered high-level disinfection and sterilization of equipment and devices.
Ms. Fullone’s advice for other small centers starts with the budget. She said leaders should assume new requirements will keep coming and plan for them.
“Plan on it,” she said. “Know that there’s going to be things that are going to come up.”
She also recommended shopping hard on price. For any major purchase, the center gets multiple quotes from different vendors. Ms. Fullone also asks peers through the Ambulatory Surgery Center Association which companies they used and what they paid.
She said industry conferences serve the same purpose. “There is always somebody that knows more than you, and you can definitely learn from each other,” she said.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
