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Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Risk

By | May 27th, 2020|Uncategorized|0 Comments

Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Healthcare Providers

The U.S. Food and Drug Administration (FDA) recommends that healthcare providers continue to use serological tests intended to detect antibodies to SARS-CoV-2 to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. Healthcare providers should also be aware of the limitations of these tests and

By | April 27th, 2020|alerts|0 Comments

Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat Coronavirus Disease 2019 (COVID-19)

Summary Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death. Clinicians and public health officials should discourage the public from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums). Clinicians should advise patients and the public that chloroquine, and the related compound hydroxychloroquine,

By | April 2nd, 2020|alerts|0 Comments

BodyGuard Infusion Pump System by CME America – Class I Recall

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product BodyGuard Infusion Pump Systems All Serial Numbers of Affected Model Numbers Model Numbers: BG 323 Pump* BodyGuard 121 Twins Pump* BodyGuard 545 ColorVision Pump * BodyGuard 575

By | April 2nd, 2020|alerts|0 Comments

Class II Recall of Ten Lots of the Revaclear Capillary Dialyzer 300, Product Code 114745L

The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions.  Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401. Learn More

By | March 16th, 2020|alerts|0 Comments

ESRD QIP Updates & Reminders

QIP Reminders On Oct. 31, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that updates payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2020. This rule also updates the acute kidney injury (AKI)

By | November 27th, 2019|Uncategorized|0 Comments

Cybersecurity Updates Affecting Medtronic Implantable Cardiac Device Programmers: FDA Safety Communication

The U.S. Food and Drug Administration (FDA) is informing patients, health care providers and facility staff, and manufacturers about cybersecurity vulnerabilities that may introduce risks for certain medical devices and hospital networks. The FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities is already publicly

By | October 9th, 2019|alerts|0 Comments

Promising Practice Alert! – My Questions

Continue your focus on Shared Decision Making by encouraging your patients to be a part of their healthcare team.  Patient engagement in the Plan of Care is one way to encourage patients to take part in Shared Decision Making. The Network has developed the “Do You Have Questions About Your Dialysis?” flyer to help patients

By | September 17th, 2019|Uncategorized|0 Comments

Public Comment Period for CY 2020 ESRD PPS Proposed Rule Closing Soon

On July 29, 2019 the Centers for Medicare & Medicaid Services (CMS) announced the public display of the proposed rule for the CY 2020 ESRD Prospective Payment System (PPS), available online at the Federal Register. The CY 2020 ESRD PPS proposed rule includes proposed requirements for the ESRD Quality Incentive Program (ESRD QIP) beginning with Payment

By | September 17th, 2019|Uncategorized|Comments Off on Public Comment Period for CY 2020 ESRD PPS Proposed Rule Closing Soon

NHSN Data – Due Sept. 30

To meet the CMS ESRD QIP NHSN reporting requirements for Payment Year 2021, outpatient hemodialysis clinics must submit their second quarter 2019 Dialysis Event data collected from April 1st, 2019 through June 30th, 2019, by Monday, September 30, 2019. New or revised second quarter data entered into NHSN after September 30th will not be sent to

By | September 17th, 2019|Uncategorized|Comments Off on NHSN Data – Due Sept. 30