Healthcare Accreditation Certification Program Newsletter
May 2020

ARS Regulatory Alerts

CIHQ-ARS notifies member organizations of any new or modified accreditation standard, or CMS COP for acute care hospitals. Each alert summarizes the standard / regulation, likely impact to members, and recommends compliance strategies. Whenever possible, alerts are limited to one-page in length so that they can be quickly read and disseminated.

New Regulatory Alert

Alert Date
April 30, 2020
Alert Subject
CMS Issues Guidance on COVID-19 Testing & CLIA Requirements
Alert Applicability
Acute Care Ambulatory Care Behavioral Health
Critical Access Home Health / Hospice Laboratory
Long Term Care Other: __________  
Alert Background
In a letter to State enforcement agencies dated 4/30/20, CMS issued guidance on CLIA requirements and COVID-19 laboratory testing. In the guidance, CMS reaffirmed the requirement that “laboratories need a CLIA certificate to perform SARS-CoV-2 testing. Under CLIA, laboratories are prohibited from testing human specimens for the purpose of diagnosis, prevention, treatment, or health assessment without a valid CLIA certificate. Clinical laboratories and facilities such as academic laboratories, research laboratories, pharmacies, physician offices, urgent care clinics, and veterinary laboratories need CLIA certification to perform SARS-CoV-2 testing on human specimens”.
Discussion & Recommendations
To view the discussion & recommendations ARS Organization Members can download this alert in its entirety when logged-in/connected to the ARS Members section. All alerts are archived in the member’s only section of our web site for future access and reference.
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New Regulatory Alert

Alert Date
April 22, 2020
Alert Subject
CMS Issues Guidance on Medicare Participation by Freestanding ED’ during COVID-19 Public Health Emergency
Alert Applicability
Acute Care Ambulatory Care Behavioral Health
Critical Access Home Health / Hospice Laboratory
Long Term Care Other: __________  
Alert Background
In a letter to State enforcement agencies dated 4/21/20, CMS announced that it will temporarily allow licensed independent freestanding emergency departments (FSED’) to participate in Medicare and Medicaid to help address the urgent need to increase hospital capacity to provide care to patients. Under this allowance, an FSED could provide – and bill – for hospital level care in one of three ways:
  • Become affiliated with a Medicare/Medicaid-certified hospital under the temporary expansion 1135 emergency waiver.
  • Participate in Medicaid under the clinic benefit if permitted by the State, or
  • Enroll temporarily as a Medicare/Medicaid-certified hospital to provide hospital services.
The first option (affiliation with a hospital) is the subject of this alert. Under this option, an FSED may become an outpatient department of a Medicare/Medicaid certified hospital. To do this, the hospital and the FSED would work with the State to obtain approval for the FSED to operate as the hospital’s outpatient department (i.e., become hospital-affiliated), if appropriate.
In this option, there is no requirement for the FSED to submit a separate enrollment application to CMS. The FSED would bill under the hospital’s Medicare number (CCN) just like any other outpatient department.
Discussion & Recommendations
To view the discussion & recommendations ARS Organization Members can download this alert in its entirety when logged-in/connected to the ARS Members section. All alerts are archived in the member’s only section of our web site for future access and reference.
Not an ARS Member Organization?
» Find out how to Enroll and enjoy these as well as other benefits from ARS!

New Regulatory Alert

Alert Date
April 21, 2020
Alert Subject
CMS Issues Recommendations to Re-Open Health Care Systems in Areas with Low Incidence of COVID-19
Alert Applicability
Acute Care Ambulatory Care Behavioral Health
Critical Access Home Health / Hospice Laboratory
Long Term Care Other: __________  
Alert Background
In a notification dated 4/19/20, CMS issued recommendations for reopening healthcare facilities to provide non-emergent / non-COVID-19 healthcare. The recommendations align with President Trump’s Phase I Gating Criteria under the recently published “Guidelines for Opening up America Again” – which can be found at the following link: https://www.whitehouse.gov/openingamerica/#criteria.
The recommendations are as follows:
General Considerations
  • In coordination with State and local public health officials, evaluate the incidence and trends for COVID-19 in the area where re-starting in-person care is being considered.
  • Evaluate the necessity of the care based on clinical needs. Providers should prioritize surgical/procedural care and high-complexity chronic disease management; however, select preventive services may also be highly necessary.
  • Consider establishing Non-COVID Care (NCC) zones that would screen all patients for symptoms of COVID-19, including temperature checks. Staff would be routinely screened as would others who will work in the facility (physicians, nurses, housekeeping, delivery and all people who would enter the area).
  • Sufficient resources should be available to the facility across phases of care, including PPE, healthy workforce, facilities, supplies, testing capacity, and post-acute care, without jeopardizing surge capacity.
Personal Protective Equipment
  • Consistent with CDC’s recommendations for universal source control, CMS recommends that healthcare providers and staff wear surgical facemasks at all times. Procedures on the mucous membranes including the respiratory tract, with a higher risk of aerosol transmission, should be done with great caution, and staff should utilize appropriate respiratory protection such as N95 masks and face shields.
  • Patients should wear a cloth face covering that can be bought or made at home if they do not already possess surgical masks.
  • Every effort should be made to conserve personal protective equipment. See https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppestrategy/index.html.
Workforce Availability
  • Staff should be routinely screened for symptoms of COVID -19 and if symptomatic, they should be tested and quarantined. Staff who will be working in these NCC zones should be limited to working in these areas and not rotate into “COVID-19 Care zones” (e.g., they should not have rounds in the hospital and then come to an NCC facility).
  • Staffing levels in the community must remain adequate to cover a potential surge in COVID-19 cases.
Facility Considerations
  • In a region with a current low incidence rate, when a facility makes the determination to provide in person, non-emergent care, the facility should create areas of NCC which have in place steps to reduce risk of COVID-19 exposure and transmission; these areas should be separate from other facilities to the degrees possible (i.e., separate building, or designated rooms or floor with a separate entrance and minimal crossover with COVID-19 areas).
  • Within the facility, administrative and engineering controls should be established to facilitate social distancing, such as minimizing time in waiting areas, spacing chairs at least 6 feet apart, and maintaining low patient volumes.
  • Visitors should be prohibited but if they are necessary for an aspect of patient care, they should be pre-screened in the same way as patients.
Sanitation Protocols
  • Ensure that there is an established plan for thorough cleaning and disinfection prior to using spaces or facilities for patients with nonCOVID-19 care needs.
  • Ensure that equipment such as anesthesia machines used for COVID-19 (+) patients are thoroughly decontaminated, following CDC guidelines. 2 4/19/2020
Supplies
  • Adequate supplies of equipment, medication and supplies must be ensured, and not detract for the community ability to respond to a potential surge.
Testing Capacity
  • All patients must be screened for potential symptoms of COVID-19 prior to entering the NCC facility, and staff must be routinely screened for potential symptoms as noted above.
  • When adequate testing capability is established, patients should be screened by laboratory testing before care, and staff working in these facilities should be regularly screened by laboratory test as well.
All facilities should continually evaluate whether their region remains a low risk of incidence and should be prepared to cease non-essential procedures if there is a surge. By following the above recommendations, flexibility can allow for safely extending in-person non-emergent care in select communities and facilities.
Discussion & Recommendations
To view the discussion & recommendations ARS Organization Members can download this alert in its entirety when logged-in/connected to the ARS Members section. All alerts are archived in the member’s only section of our web site for future access and reference.
Not an ARS Member Organization?
» Find out how to Enroll and enjoy these as well as other benefits from ARS!

New Regulatory Alert

Alert Date
April 1, 2020
Alert Subject
Joint Commission Issues Statement to Support Use of Personal Face Masks Provided from Home Amid COVID-19 Pandemic
Alert Applicability
Acute Care Ambulatory Care Behavioral Health
Critical Access Home Health / Hospice Laboratory
Long Term Care Office-Based Surgery  
Alert Background
In an online posting published March 31 2020, The Joint Commission issued a statement supporting the use of standard face masks and/or respirators provided from home when health care organizations cannot provide access to protective equipment that is commensurate with the risk health care workers are exposed to amid the COVID-19 pandemic.
Discussion & Recommendations
To view the discussion & recommendations ARS Organization Members can download this alert in its entirety when logged-in/connected to the ARS Members section. All alerts are archived in the member’s only section of our web site for future access and reference.
Not an ARS Member Organization?
» Find out how to Enroll and enjoy these as well as other benefits from ARS!