Food and Drug Administration (FDA): This agency oversees the manufac- turing and distribution of pharma- ceuticals, medical devices and other consumer products. ASCs use medi- cal devices and administer prescrip- tion medicines that are regulated and approved by the FDA. Additionally, ASCs interact


with compounding


pharmacies and reprocess single-use medical equipment that is subject to FDA oversight.


and no federal requirement that com- pels ASCs to implement an EHR, cer- tified or otherwise.


ASCs, however, still need to be


aware of ONC’s activities as the recent expansion of health IT and electroni- cally stored health information will undoubtedly continue. In 2020, ONC issued a final rule implementing provi- sions stemming from the 21st Century Cures Act of 2016. Among the new regulations in the final rule are possi- ble penalties for providers found to be engaging in “information blocking,” or practices that are “likely to interfere with, prevent, or materially discour- age access, exchange, or use of elec- tronic health information.” ASCs are subject to this rule and must comply or risk monetary penalties, although the process for adjudicating and assess- ing the penalties is still uncertain. The rule was scheduled to go into effect on November 2, 2020, but the compliance date was pushed back to April 5, 2021, to give providers additional flexibil- ity in the midst of the COVID-19 pan- demic. More information on this rule


24 ASC FOCUS APRIL 2021 | ascfocus.org


can be found under the Federal Regu- lations tab on ASCA’s website.


Office for Civil Rights (OCR): OCR enforces the Health Insurance Porta- bility and Accountability Act (HIPAA) Privacy Rule. The rule covers four key provisions related to health data: privacy, security, breach notification and enforcement. Healthcare provid- ers, such as ASCs, that are subject to HIPAA must protect the privacy and security of patient health information or risk being liable for enforcement actions such as monetary penalties and correction plans. ASCA facility and corporate members have free access to ASCA’s HIPAA Workbook for ASCs, a comprehensive resource for design- ing, updating and evaluating a HIPAA compliance program. ASCA also pub- lishes a bi-annual update of enforce- ment actions undertaken by OCR that incorporates


“lessons learned” that


ASCs can reference to avoid sim- ilar


Debut section of ASC Focus online at ascfocus.org/news/digital-debut).


penalties (found in the Digital


Agency for Healthcare Research & Quality (AHRQ): The federal agency tasked with improving the safety and quality of America’s health- care system, AHRQ conducts research to improve care quality and safety, curbs wasteful spending, generates meaningful data measures and teaches and trains professionals. AHRQ has released a toolkit to help ASCs deliver safer care to patients, including apply- ing the Comprehensive Unit-based Safety Program (CUSP) to prevent sur- gical infections and improve overall safety culture. AHRQ also has devel- oped a survey designed to help ASC staff gauge the culture of patient safety in their facilities.


Centers for Disease Control and Prevention (CDC): The nation’s pri- mary health protection agency, CDC is tasked with saving lives and protect- ing citizens from public health threats. To accomplish this, CDC conducts research,


aggregates data, provides


information on various health topics that includes occupational safety and health, infectious diseases, science and advanced technology, and injury and death prevention. ASCs participate in CDC’s National


Healthcare Safety Network (NHSN), which is a national healthcare-associ- ated infection (HAI) tracking system. ASC enrollment in NHSN is mandatory to fulfill CMS’ Ambulatory Surgical Center Quality Reporting (ASCQR) Program requirements, a prerequisite


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