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Helpful MCN Healthcare Resources
Hospira, Inc., is informing healthcare professionals that it has initiated a voluntary recall of 10 lots of MitoXANTRONE, (both human and veterinary), due to confirmed subpotency and elevated impurity levels.
Risk factors associated with these types of out of specifications may include the potential for decreased potency which can lead to decreased effectiveness, additional dosing and the potential for cumulative impurity toxicity requiring medical intervention. To date, Hospira has not received reports of any adverse events associated with subpotency and impurities for these lots. These lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014. The lot numbers affected by the recall are provided on the recall announcement at the link below.
Hospira initiated an investigation to determine the root cause and to determine corrective and preventive actions. The root cause was subsequently found and appropriate implementations of improvements have been initiated for batches manufactured from March 2014.
Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. This recall is being carried out to the user level (both human and veterinary). Customers should notify all users in their facility. Customers who have further distributed the recalled product should notify any accounts or additional locations which may have received the recalled product and instruct them if they have redistributed the product to notify their accounts, locations or facilities to the consumer level. Hospira has notified its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.
For additional assistance in the U.S., call Stericycle at 1-844-265-7407 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday. Customers outside the United States should work with their local Hospira offices to return the product per local recall notifications.
CMS Issues Guidance Related to New State Operating Manual and Appendix N for Psychiatric Residential Treatment Facilities (PRTF)
The Centers for Medicare & Medicaid Services (CMS) has a new State Operating Manual and interpretive guidelines to reflect recent amendments to Conditions of Participation (CoPs) for Psychiatric Residential Treatment Facilities (PRTF)
In January 22, 2001, CMS published an interim final rule establishing standards for the use of restraint and seclusion in PRTFs providing inpatient psychiatric services for individuals under age 21 (the Psych Under 21 rule). This rule established a definition of a PRTF that is not a hospital and that may furnish covered inpatient psychiatric services for individuals under age 21. The rule also established a CoP for the use of restraint and seclusion that PRTFs must meet in order to provide, or to continue to provide this Medicaid inpatient benefit. The CoP specifies requirements designed to protect the residents against the improper use of restraint and seclusion. This interim rule also established validation survey, complaint survey and reporting equirements as well as annual attestation requirements.
Since December 2004, State Survey Agencies (SA) have had no direction specific to PRTFs in the State Operations Manual (SOM) and has used an interim final guidelines for PRTF survey procedures and interpretive guidelines (IG).
The new SOM and new interim procedures have been revised and are now final in the SOM at Sections 2830-2834 and Appendix N. Summary of the key changes include:
PRTF Condition of Participation, Part 483, subpart G
- State Operating Manual: A new SOM was created due to no existing PRTF program specific operating certification processes.
- Appendix N-Interpretive Guidelines: A final version of Appendix N- interpretive guidelines was created to provide guidance and protocol for surveyors.
A link to the advance copy of the new SOM and Appendices N is provided below. The new SOM and Appendix-N Interpretive Guidelines are effective immediately.
Today's notice is the last in our series reviewing the Joint Commission's (TJC) changes to their Laboratory Accreditation Manual, effective July 15, 2015. StayAlert previously reviewed the changes made to the Document and Process Control Chapter (10-7-2014), Human Resources Chapter (10-13-14) and Transplant Safety and Environment of Care Chapters (12-4-14). Today's notice reviews some of the key revisions to the Quality System Assessment for Non-waived Testing (QSA) Chapter.
Summary of Key Revisions:
- The Clinical Laboratory shall have a system in place to evaluate the accuracy and reliability of results obtained for nonregulated analytes and regulated analytes that are not included in a formal proficiently testing program and for those regulated analytes for which compatible proficiency testing samples are not available.
- The addition of a note that clarifies that a laboratory director may delegate the responsibility for handling and testing proficiency testing samples, in writing, to a technical consultant meeting the qualifications of 42 CFR 493.1409 (for moderate-complexity testing) or technical supervisor meeting the qualifications of 42 CFR 493.1447 (for high-complexity testing).
- The addition of a note that clarifies that when using automated cell counters, calibration verification requirements are met if the laboratory follows manufacturer's instructions for instrument operation and the laboratory tests two levels of quality control materials each day of patient testing provided the laboratory's quality control criteria are met.
- After calibration, in order to verify that the calibration protocol was successful., the laboratory performs quality control testing before resuming patient testing.
- When evaluating noninstrument-based testing, laboratories are required to document both external and internal quality control results.
- The addition of a note that clarifies that when the screen and transfusion history for detection of unexpected antibodies is negative, the antiglobulin phase of testing is optional. Testing to detect ABO incompatibility (serologic or computer crossmatch) is required.
- A requirement that the expiration date of blood component products is changed to reflect that of an open system if an intact seal a closed system is not maintained during aliquot preparation.
- The laboratory establishes workload limits for staff who perform primary cytology screening and workload requirements apply to all cytotechnologists, pathologists, and pathology residents in the final year of training leading to board certification.
Included with today's notice are associated policies. Please see TJC's prepublication standards link, included below, for a complete list of changes and revisions to the laboratory standards.
Featured Policy Library Manuals
MCN's NEW Ambulatory Surgical Center/Outpatient Surgery Department Policy and Procedure Manual is cross referenced to TJC standards, AAAHC standards and CMS regulations. Policies and procedures meet AORN and CDC recommendations and guidelines. This comprehensive reference guide has over 290 policies and procedures that are ready to customize to your organization. See also the Administrative Manual for Ambulatory Care Facilities and the Ambulatory Services EOC Manual.Read more »
MCN's Central Service Policy and Procedure Manual provides over 200 proven, up-to-date policies and procedures in a ready-to-customize format. This manual is cross referenced to federal regulations, as well as Joint Commission and NIAHO standards. References used include AAMI Recommended Practices, IAHCSMM Central Service Technical Manual, ASHCSP Training Manual for Health Care Central Service Technicians and AORN Recommended Practices.Read more »
MCN's Post Anesthesia Care Policy and Procedure Manual is a comprehensive resource that covers the latest "hot topic" regulatory and patient safety issues that are relevant to PACU! This manual includes administrative, operational, functional and patient-centered policies and procedures. Policies and procedures are cross-referenced to CMS regulations, Joint Commission standards and NIAHO standards.Read more »