CMS has issued S&C Memorandum 13-17-NF regarding nasogastric tubes. Additional revisions have been made to guidance on F 322 in Appendix PP of the State Operations Manual (SOM) and the associated training slides since the release of S&C 12-46 on September 27, 2012. The revisions include:
o Revision of the Regulatory Language format.
o Additional clarification regarding the Centers for Medicare and Medicaid Services (CMS) expanded definition of "Naso-Gastric tubes."
o Updating the Power Point training slides.
To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-17.pdf.
Wednesday, April 3, 2013
CMS Revises Surveyor Guidance on Advance Directives – F 155
CMS has issued S&C Memorandum 13-16-NF regarding advance directives. Revisions have been made to guidance on F 155 in Appendix PP of the State Operations Manual and the associated training slides since the release of S&C 12-47 on September 27, 2012. The revisions include:
o Removal of the term "right to accept" when referring to medical and surgical treatment.
o Addition of guidance specific to experimental research.
o Clarification that §483.10(b)(8) applies only to adult residents and not all residents regardless of age.
o Addition of definition for "Investigational or experimental drugs."
o Updating the Investigative Protocol.
o Updating the Power Point training slides/
To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-16.pdf.
o Removal of the term "right to accept" when referring to medical and surgical treatment.
o Addition of guidance specific to experimental research.
o Clarification that §483.10(b)(8) applies only to adult residents and not all residents regardless of age.
o Addition of definition for "Investigational or experimental drugs."
o Updating the Investigative Protocol.
o Updating the Power Point training slides/
To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-16.pdf.
CMS Clarifies Delegation of Physician Tasks in SNFs and NFs
S&C Memorandum 13-15-NF replaced a 2003 guidance memo concerning physician delegation of certain tasks in SNFs and NF to non-physician practitioners (NPP) such as nurse practitioners, physician assistants, or clinical nurse specialists. Due to federal regulation, there is a difference between SNFs and NFs in terms of what a physician can delegate to NPPs. The first part of the analysis is to determine (1) which setting, SNF or NF, are the physician services being provided, (2) whether the task must be personally performed by the physician, and (3) whet her the NPP is employed by the facility. Certain tasks, such as conducting physician visits, writing orders, signing certifications and re-certifications should be analyzed to ensure proper personal action by the physician or proper delegation to an NPP.
The S&C Memorandum discusses the distinctions between SNFs and NFs for physician required visits and proper delegation to NPPs and provides a helpful chart to depict the various elements at play. To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-15-.pdf.
The S&C Memorandum discusses the distinctions between SNFs and NFs for physician required visits and proper delegation to NPPs and provides a helpful chart to depict the various elements at play. To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-15-.pdf.
Tuesday, April 2, 2013
Luer Misconnections Leading to Adverse Events Identified by CMS
CMS issued Survey & Certification Memorandum, S&C: 13-14-ALL, highlighting the continuing risk of Luer misconnections in health care settings, suggesting actions providers can take to reduce the likelihood of these events; and actions surveyors should take when investigating these events. To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-14.pdf.
Summary:
• Luer Misconnections continue to result in adverse events and deaths – Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians, in any type of provider or supplier setting, can mistakenly connect the wrong devices and deliver substances through the wrong route. Despite numerous alerts and warnings, a patient’s blood pressure tubing was recently misconnected to an intravenous (IV) line in an ambulatory surgery center (ASC) resulting in a patient death.
• Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event.
• Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.
Examples of actions providers and suppliers can take to reduce the likelihood of Luer misconnections include, but are not limited to (1) changing to devices already on the market with alternative connector designs which reduce the likelihood of misconnections of incompatible lines; (2) tracing lines back to their origins when reconnecting devices; (3) positioning catheters and tubes that have different purposes on different sides of the patient’s body or in unique and standardized directions; and (4) implementing a multidisciplinary facility approach to address Luer misconnections.
Summary:
• Luer Misconnections continue to result in adverse events and deaths – Luer connectors easily link many medical components, accessories, and delivery systems. Clinicians, in any type of provider or supplier setting, can mistakenly connect the wrong devices and deliver substances through the wrong route. Despite numerous alerts and warnings, a patient’s blood pressure tubing was recently misconnected to an intravenous (IV) line in an ambulatory surgery center (ASC) resulting in a patient death.
• Adverse Event Complaint Investigation: During a complaint investigation for an adverse event involving delivery of an incorrect substance or utilization of an incorrect delivery route, surveyors must be alert to whether the event involved misconnection of a Luer device. If so, surveyors must determine whether the facility has taken actions to ensure systems are in place to prevent recurrence of this type of adverse event.
• Facility Reporting to Food & Drug Administration (FDA): Surveyors should encourage health care facilities to report problems with Luer misconnections to the FDA, even if no adverse event occurred.
Examples of actions providers and suppliers can take to reduce the likelihood of Luer misconnections include, but are not limited to (1) changing to devices already on the market with alternative connector designs which reduce the likelihood of misconnections of incompatible lines; (2) tracing lines back to their origins when reconnecting devices; (3) positioning catheters and tubes that have different purposes on different sides of the patient’s body or in unique and standardized directions; and (4) implementing a multidisciplinary facility approach to address Luer misconnections.
Expanded Time Period for Postings of 2576s on Nursing Home Compare
On March 22, CMS issued S&C Memo 13-21-ALL that highlighting changes to public reporting of survey findings/statements of deficiencies on the web. CMS has been posting 2567s to Nursing Home Compare since July of 2012, and starting this month CMS will expand 2567 postings from a single survey cycle to a 3 year period of standard and complaint surveys. CMS will also be adding indicators for the scope and severity of each deficiency cited on the forms. To read the memo, see https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-13-21.pdf.
CMS Releases New Civil Money Penalty Analytic Tool
AHCA recently obtained an CMS Administrative Information Memo concerning a new process for calculating CMPs when it is determined they should be imposed. The memo and accompanying instructions direct CMS Regional Offices to apply a new methodology and process for determining CMPs when such an enforcement remedy is appropriate. The new policy guidance has been issued to promote more consistent application of enforcement remedies, and all CMS Regional Offices will use the guidance to choose, impose, and calculate CMPs. CMS also included guidance for the Regional Office to consider when determining whether to impose a CMP or an alternate remedy regardless of whether or not the State Survey Agency recommended a CMP.
The memo states that failure of a State to recommend a CMP or other remedy, or a State policy of not recommending CMPs, are not acceptable reasons for not imposing such remedies. In such a case, the RO must on its own review the survey findings and impose the appropriate remedy.
CMS describes this effort as a six-month pilot, to be evaluated for the usefulness and overall effectiveness of the Analytic Tool and guidance. At the end of six months, they will assess whether or not the tool and guidance have provided greater consistency in the use and application of CMPs and assess whether or not the imposition of CMPs had an effect on a facility’s ability to achieve and sustain compliance with Federal requirements. At that point, CMS will make any needed revisions to the tool and guidance as applicable.
The CMS Administrative Memo and Instructions are accessible in the Members Only section of the IHCA website. IHCA also has a copy of an Excel spreadsheet that Regional Offices will use to calculate the dollar amount of CMPs and if you would like a copy, please contact Zach Cattell at zcattell@ihca.org.
The memo states that failure of a State to recommend a CMP or other remedy, or a State policy of not recommending CMPs, are not acceptable reasons for not imposing such remedies. In such a case, the RO must on its own review the survey findings and impose the appropriate remedy.
CMS describes this effort as a six-month pilot, to be evaluated for the usefulness and overall effectiveness of the Analytic Tool and guidance. At the end of six months, they will assess whether or not the tool and guidance have provided greater consistency in the use and application of CMPs and assess whether or not the imposition of CMPs had an effect on a facility’s ability to achieve and sustain compliance with Federal requirements. At that point, CMS will make any needed revisions to the tool and guidance as applicable.
The CMS Administrative Memo and Instructions are accessible in the Members Only section of the IHCA website. IHCA also has a copy of an Excel spreadsheet that Regional Offices will use to calculate the dollar amount of CMPs and if you would like a copy, please contact Zach Cattell at zcattell@ihca.org.
Notice of Involuntary Transfer and Discharge – Change of Procedure
The ISDH announced on Monday, April 1 that it is requesting facilities to send completed involuntary transfer and discharge notices to the ISDH in order to speed up the transfer/discharge hearing process. Completed forms can be faxed to either 317-233-7143 or 317-234-6278, and can also be emailed to incidents@isdh.in.gov.
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