ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 - 03/13/09) 1 The draft ASCO/ONS Standards for Safe Chemotherapy Administration were posted for public comment from January 27, 2009 to March 13, 2009. 322 public comments were received during the public comment period and are summarized in the table below. Public comment results were used to further refine the standards - standards listed below are not final. To access the final ASCO/ONS standards, go to: ASCO/ONS Chemotherapy Administration Safety Standards article. Standard Definition and Percent Number of Selected Comment(s)/Themes Action Instructions for “Yes” Comments Standards Votes 1. Practice has processes for Note: throughout the 95 45 1. Add safe handling procedures into Edit/Include oversight, verification of standards, any use of standards or reference them(5) training, and continuing the term ‘practitioner’ is 2. Standards should be written for all education for clinical staff. defined as: practice settings not just outpatient(6) A. Orders for parenteral and Licensed independent 3. Many small practices will not have an RN oral chemotherapy are written practitioner, or allow for education time and signed by licensed including physicians, 4. RN should be the minimum practitioner independent practitioners who advance practice allowed to administer chemotherapy are determined to be qualified nurses (nurse 5. Don’t understand term ...
1. Add safe handling procedures into standards or reference them(5) 2. Standards should be written for all practice settings not just outpatient(6) 3. Many small practices will not have an RN or allow for education time 4. RN should be the minimum practitioner allowed to administer chemotherapy D’ “ ” 6. B. should also include oral 7. Pharmacists should be listed in the licensed independent practitioner category
ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
chemotherapy administration assessment in that ends in competency chemotherapy assessment. administration. E. Practice site has a standard The practice site mechanism for monitoring establishes the minimum chemotherapy administration qualifications of those competency at specified who administer chemo-intervals. therapy, that includes F. All clinical staff maintain specific educational current certification in basic life preparation. support. Chemotherapy administration education must include all routes of administration used in the practice site (e,g. parenteral, oral, intrathecal, intraperitoneal, intravesicular). An example of an offsite educational program is the ONS Chemotherapy and Biotherapy Course. Annual competency ‐ ended. recomm
1. Give example of type of staff, physician, Delete RN, practice manager. Also, qualifications and whether or not they are licensed. 2. Identify who could be the back-up staff 3. A multidisciplinary approach should be used for the oversight. 4. Use the term coordination of pharmaceutical services 1 .Some drug dispensing machines (Pyxis) do Edit/Include not allow flexibility in labeling 2. Clar “ ” Give example. Small offices may not understand the need for this plus patient name. 3. Add: a. length of infusion b. rate c. expiration date and time d. hazardous label- bright color
1. ISMP,JCAHO, and WHO, all recommend Include use of mini-bags(50ml) 2. Should include a strong statement about vinca alkaloids as in WHO Statement (5 ) 3. Use a slip tip syringe instead of leur-lock 4. Boldly labeled in red or other bright color h “ Ih ” 5. JCAHO recommends double checks with
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
time-out procedure 6.Be explicit on qualifications for person administering 7. Expiration of sterility should be labeled
1. Add name of person preparing Delete 2. This is a burden to small practices. 3. Large pharmacy will have numbers on huge lots, too much burden to track. 4. How long should information be kept? (5 ) + 1. Add to text: Edit/Include a. Appropriate regimen for diagnosis b. Sequence of meds c. Route of admin d. Regimen, cycle day e. Co-signed 5. Drug volume and concentration may be done in pharmacy and nurse may not be there to verify (20+) 6. Difficult for small practices with one licensed person (20+)
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
1.Specify type of licensed personnel (10) Edit/Include 2. Add to C. – for right day in cycle 3. Co-sign (4) 4. There is only one nurse on duty (10+) 5. Substitute “ regimen ” for plan 6. Re-verification at change of shift or change of clinician
1. Does all documentation need to be Edit/Include repeated if patient changing regimen after one or two cycles? 2. Give options for outpatient infusion center not linked to specific practice. D’ h h ology each time new regimen started. This should be included on chart. 4. D’ h id tumor but might need bone biopsy for leukemia (10+) 5. Reality is patient may get care from several facilities and not all information is easily obtained especially on first visit. 6 A “ ” assessment in F.
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
1. Ch “ ” “ / ” Edit/Include 2. Specific regimens should be available to all on the multidisciplinary team
1. Where should this be documented? In the Include
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
standard regimens, include notation that practitioners provide a standard treatment is supporting reference. contraindicated due Reasons for dose modification to preexisting co-or exception orders are morbidity, organ documented. dysfunction, or prior therapy. 11. Practice site has policies Documentation of 83 that determine the ‐ appropriate time interval for laboratory tests may be ‐ part of standardized tests. regimen orders.
notes or orders? 2. Should this include off label uses?
1.Provider s should determine test intervals Edit/Include 2. Even guidelines state different intervals, currently too controversial 3. Should be site or regimen specific. Set minimum interval into policy 4. Too rigid- to much patient and physician variance “ ” 1. State that the practitioner should record Include discussion points in chart 2. Is a new consent required when the treatment plan changes? 3. This could be merged with #19. 4. How long is a signed consent valid?
1.ASHP recommends that offsite pharmacies Include be accredited 2. ASHP writing white paper about brown-bagging 3. Fifteen out of nineteen comments stated that off site preparation should not be allowed because it is not safe
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
control of that chemotherapy. 14. Practice site does not allow Verbal orders are not 90 verbal orders for chemo- permitted to start, therapy. change, stop, or hold chemotherapy.
1. Use for dose reduction only Edit/Include 2. Use only for hold or stop chemotherapy orders 3. Sites with 5 locations and 3 physicians need verbal orders. 1. Important to do but difficult for small Edit/Include practices-could ASCO help? 2. Important but not feasible even in hospitals 3. Wait until more have electronic records-this is a goal 1.Add dose calculation, state dose for 24 Edit/Include hours 2. A must! 3.BSA standard calculation 4. Give dose in mg/m2 5. Could allergies be listed in H&P particularly EM’ ? 6. Can order be written for more than on cycle. New one written for next cycle. Write order in daily dose. 8. Include order of drug administration if more than one. 9. Add frequency and types of lab tests.
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ASCO/ONS Standards for Safe Chemotherapy Administration: Public Comment Summary (Posted 01/27/09 – 03/13/09)
1.Add verbal to the standard Edit/Include 2. This is one of the most important standards 3. Goals are not often written. 4. Change “ initiation ” to “ first dose ” of chemotherapy 5. Consider the feasibility for small and private practices 6. Not all is given in writing sometimes not appropriate 7. ASCO should supply tools!