Conference 6 – Complaint #4237 – Case 14-0021-PHR
The following individuals were present to discuss the complaint:
1. Jacqueline Cavanagh – Pharmacist – Respondent
2. Yolanda Douthard – Chief of Pharmacy Services for Phoenix Children’s Hospital –
Respondent
3. Angela Serio-Harney – Executive Vice President of Operations for Maxor
4. Tom Kirschling – Corporate Compliance for Maxor
5. Roger Morris and Christine Cassetta – Legal Counsel for Ms. Cavanagh and
Phoenix Children’s Hospital
President Foy opened the discussion by asking Mr. Haiber to give a brief overview of the complaint.
Mr. Haiber stated that during a complaint investigation by the Compliance Officers the following allegations were investigated:
1. Compounding of hazardous products was performed without protective equipment
2. Lack of compounding training for technicians
3. Compounding preparation recipes were not provided
4. Lack of pharmacist supervision of compounding technician activities
5. Compounding room sanitation
President Foy asked the respondents to address the complaint and allegations.
Mr. Morris stated that Phoenix Children’s Hospital contracts with Maxor Pharmacy Services to
operate the outpatient pharmacy at Phoenix Children’s Hospital (PCH). Mr. Morris stated that Ms. Serio-Harney would address the issues. Ms. Serio-Harney is the Executive Vice President of Operations at Maxor.
Ms. Serio-Haney stated that she hired Lyle Brauner to be the pharmacist in charge in July of
2011. Ms. Serio-Harney stated that Mr. Brauner was given the basic Maxor policies and asked for input on changing the policies. Ms. Serio-Harney stated that Mr. Brauner was tasked with
developing the technician training program and compounding program. Ms. Serio-Harney
stated that Mr. Brauner was given carte blanche for training programs. Ms. Serio-Harney
stated that it was assumed that Mr. Brauner had attended a training program.
Ms. Serio-Harney stated that the last three years the pharmacy operated smoothly. Ms. Serio-Harney stated that the prescription volume increased, wait times were acceptable, and there were only a few medication errors. Ms. Serio-Harney stated that quality reports were sent to Ms. Douthard.
Ms. Serio-Harney stated that nothing suggested that there egregious issues within the pharmacy.
Ms. Serio-Harney stated that it was never mentioned that they were compounding hazardous
medications in the pharmacy. Ms. Serio-Harney stated that she visited the pharmacy in J
and she had no idea hazardous compounds were being made in the pharmacy.
Ms. Serio-Harney stated that while she was on maternity leave Mr. Brauner met with Ms. Douthard on May 2, 2014 concerning hazardous materials that were being compounded.
Mr. Brauner revealed on May 5, 2014 the products that were being made and that enhanced protection was needed. Mr. Brauner indicated that they needed a hood. Ms. Serio-Harney
stated that Mr. Birdsong at Maxor told Mr. Brauner to quit compounding the medications
immediately.
Ms. Serio-Harney stated that two weeks later a complaint was filed by the technician with
OSHA. Ms. Serio-Harney stated that Mr. Brauner’s employment was then terminated.
Mr. Morris asked Ms. Cavanagh to address the complaint and allegations. Mr. Morris stated that Ms. Cavanagh is now the current pharmacist in charge.
Ms. Cavanagh stated that she was hired in March of 2012. Ms. Cavanagh stated that she did have compounding experience. Ms. Cavanagh stated that she noticed deficiencies in the pharmacy and brought the issues up to Mr. Brauner and was told that they do not do that here.
Ms. Cavanagh stated that some of the issues related to good compounding guidelines. Ms.
Cavanagh stated that she backed down because she was afraid of losing her job.
Ms. Cavanagh stated that Mr. Brauner had a tendency to get angry and created an intimidating work environment. Ms. Cavanagh stated that she should have turned Mr. Brauner into the Board or reported the issues to Maxor. Ms. Cavanagh stated that she did not know what to do.
Ms. Cavanagh stated that the technicians were compounding the medications and the ingredients were not verified before they were made. Ms. Cavanagh stated that Mr. Brauner did not think it
was necessary to check the compounds. Ms. Cavanagh stated that she told the technician to come to her to check the compounds. Ms. Cavanagh stated that she could not guarantee that she
checked every compound that was made. Ms. Cavanagh stated that there were medications that she knew that they should not be making and she talked to Mr. Brauner about those medications.
Ms. Cavanagh stated that she did not know that other medications needed to made in a hood.
Ms. Cavanagh stated that it was her job to know which medications should have been made in
a hood. Ms. Cavanagh stated that she is making corrections going forward.
Ms. Cavanagh stated that she is now the pharmacist in charge and has changed functions in the pharmacy. Ms. Cavanagh stated that all compounds are checked before and after being compounded. Ms. Cavanagh stated that only a pharmacist is compounding in the pharmacy.
Ms. Cavanagh stated that she has developed new compounding sheets. Ms. Cavanagh stated that to ensure that the proper equipment is being used any products that need to compounded in a biological safety cabinet is on a bright red form indicating that it is a hazardous or chemo medication.
Ms. Cavanagh stated that everyone must sign a sheet indicating they understand that when certain medications are handled they must wear masks and gloves. Ms. Cavanagh stated that they have a chemo spill kit in the lab and every other Friday the hospital cleans the lab. anuary
Ms. Cavanagh indicated that she would attend an off-site compounding course when she finds the right course.
Mr. Morris asked Tom Kirschling from Maxor to address the audits he conducted at the site.
Mr. Kirschling stated that he was contacted on June 3, 2014 to conduct an inspection at the site.
Mr. Kirschling stated that he has pediatric and compounding experience. Mr. Kirschling stated
that he is familiar with USP 797 and compounding regulations.
Mr. Kirschling stated that he investigated the situation and for employee safety and the patient’s
safety immediate steps were taken to move the compounding to the inpatient system.
Mr. Kirschling stated that he recommended training, documentation, and facilities be updated to be 795 compliant. Mr. Kirschling stated that Ms. Cavanagh has made some changes and he is
assisting in the compliance.
Dr. Foy asked Mr. Kirschling if he conducted any prior audits of the facility. Mr. Kirschling stated that he did not conduct any previous audits. Mr. Kirschling stated that this was the first audit he conducted at the site.
Ms. Serio-Harney stated that visual inspections were conducted at the site. Ms. Serio-Harney stated that she reviewed dispensing records, purchase records, and medication errors.
Ms. Serio-Harney stated that no red flags were raised and there were no employee complaints.
Ms. Serio-Harney stated that she was not aware that they were compounding chemo drugs in January and had not been aware that they had been compounding the medications since 2011.
Dr. Foy asked Ms. Serio-Harney if she reviewed the purchase records. Ms. Serio-Harney
replied that she did review the purchase records but did not realize they were compounding
chemo medicatins.
Mr. Morris asked Ms. Douthard , Chief of Pharmacy Services at PCH, to address the issues in the complaint.
Ms. Douthard stated that she joined the staff at PHC on April 1, 2013. Ms. Douthard stated that she is in charge of all the Phoenix Children Hospital sites. Ms. Douthard stated that she was aware that there was a contracted pharmacy in the building.
stated that she met with Mr. Brauner and walked the space with him. Ms. Douthard stated that they were outgrowing their current space.
Ms. Douthard stated that she asked Mr. Brauner if he had SOPs and he replied that he did.
Ms. Douthard stated that she did not look at his SOPs.
Ms. Douthard stated that she met Ms. Serio-Harney via telephone.
Ms. Douthard stated that there was no evidence of hazardous compounding. Ms. Douthard stated that Mr. Brauner told her that less than 20% of their business is compounding. Ms. Douthard stated that Mr. Brauner did have prn help as his volume had increased.
Mr. Wright, Pharmacy Operations Manager at PCH, met with Mr. Brauner and indicated the business metrics were good.
Ms. Douthard stated that they had looked at the Board inspections and the inspections looked
good.
Ms. Douthard stated that Mr. Wright contacted her and stated that they needed to meet with Mr. Brauner concerning the compounding of hazardous compounds.
Ms. Douthard stated that they asked Mr. Brauner and Ms. Schweitzer to bring a list of the
compounds that they are currently compounding and the products they anticipate compounding.
Ms. Douthard stated that when she reviewed the list she also saw three products that were teratogenic. Ms. Douthard stated that she told them to stop compounding the medications at this point.
Ms. Douthard stated that she asked Mr. Wright to contact Ms. Frush at the Board of Pharmacy to see if the Board would allow the outpatient pharmacy to prepare the products in the
inpatient pharmacy. Ms. Frush told Mr. Wright that she would talk with Mr. Wand because she had some concerns and would call him back. Ms. Frush told Mr. Wright that she discussed the issues with Mr. Wand and they stated that the outpatient pharmacy could use the inpatient pharmacy but there were several issues that needed to be addressed. Ms. Frush told Mr. Wright that the individuals (pharmacists or technicians) need to be properly trained on the compounding of the products. Also, if a technician compounds the medications they must be properly supervised. Ms. Frush told Mr. Wright that the inpatient pharmacy could compound the medications for the outpatient pharmacy. Ms. Douthard stated that the issues raised by the Board were the same concerns that she had concerning the compounding of the medications.
Ms. Douthard stated that they decided that the outpatient pharmacy would schedule a time to use the hood in the inpatient pharmacy and the employees needed to be trained.
Ms. Douthard stated that their current options are to redesign the space for the outpatient pharmacy, continue to use the inpatient pharmacy hood, or outsource the preparation of the
hazardous compounds.
Dr. Musil asked Ms. Serio-Harney how many outpatient childrens hospital pharmacies they manage. Ms. Serio-Harney stated just this one. Ms. Serio-Harney stated that they manage a
specialty infusion pharmacy for children.
Dr. Musil asked Ms. Serio-Harney if they conducted any audits and reviewed compounding policies. Ms. Serio-Harney stated that they had not conducted any audits prior to this complaint.
Ms. Serio-Harney stated that they sent out three compounds for testing and two of the products were fine.
Dr. Musil asked Ms. Serio-Harney if they conducted any compounding audits in their contracted pharmacies. Ms. Serio-Harney replied no.
Mr. Van Hassel asked Ms. Cavanagh when she started at PCH and what position she held.
Ms. Cavanagh stated that she started as a staff pharmacist in March of 2012.
Mr. Van Hassel asked if there was any additional staffing. Ms. Cavanagh stated that Mr. Brauner was the only other full-time pharmacist. Ms. Cavanagh stated that there was additional prn help.
Mr. Van Hassel asked about the cleaning of the compounding room. Ms. Cavanagh stated that the room was cleaned daily.
Mr. Van Hassel asked Ms. Cavanagh what was used to clean the room. Ms. Cavanagh stated that the room was never cleaned that they used Lysol wipes to clean the counters.
Mr. Van Hassel asked Ms. Cavanagh about the supervision of the technicians. Ms. Cavanagh stated that she expressed her concerns to Mr. Brauner but she was afraid of going around him to check the compounds. Ms. Cavanagh stated that it was not an excuse but she was placed in a hard position. Ms. Cavanagh stated that she could not guarantee the workflow issues.
Mr. Van Hassel asked Ms. Cavanagh if she believed that the technician was adequately trained.
Ms. Cavanagh stated that there were some deficiencies that she noted. Ms. Cavanagh stated that she believes that there was not enough supervision of the technicians. Ms. Cavanagh stated that one of the technicians indicated that the training course was a joke.
Mr. Van Hassel asked Ms. Serio-Harney about the training course Mr. Brauner attended.
Ms. Serio-Harney stated that she signed the expense sheet authorizing Mr. Brauner to attend a
training class and assumed he attended a class.
Dr. Musil asked about the compounding sheets that were used in the past. Ms. Cavanagh stated that the compounding sheets used in the past indicated the drug and concentration and the number of tablets to be made. Ms. Cavanagh stated that there were no specific instructions.
Ms. Cavanagh stated that they listed the lot number and expiration date of the items used.
Ms. Cavanagh stated that there were no step by step procedures.
Dr. Musil asked if there was a master formula record. Ms. Cavanagh stated that no formulation sheet was used.
Dr. Musil asked what corrections Ms. Cavanagh has made. Ms. Cavanagh stated that the new sheet identifies the individual that prepared the compound and the verifying pharmacist. Ms. Cavanagh stated that the lot number, expiration date, and NDC number of the product used is
recorded. Ms. Cavanagh indicated that if it is a hazardous product it is made in a biological safety cabinet.
Mr. Minkus asked Ms. Serio-Harney if there is any follow up with the forms to see if people are doing what they are supposed to be doing. Ms. Serio-Harney stated that the processes were
driven by barcode technology and no red flags were raised.
Mr. Minkus asked Ms. Cavanagh why she did not come forth when these issues occurred.
Ms. Cavanagh stated that she could not change her actions that occurred in the past.
Mr. Van Hassel asked Mr. Kirschling about changes at the site. Mr. Kirschling stated that there
are still some issues that need to be addressed. Mr. Kirschling stated that they use USP 797 as
best practices for employee and patient safety. Mr. Kirschling stated that they would have an independent expert inspect the site when the remodel is finished.
Dr. Foy asked Ms. Serio-Harney what plans they have going forth to monitor the site. Ms.
Serio-Harney stated that they plan to use an outside consultant. Ms. Serio-Harney stated that
have plans to audit the compounding records.
Dr. Foy asked Ms. Douthard if there are internal departments providing audits. Ms. Douthard
stated that risk management and the legal department would be providing audits.
Mr. Francis asked Ms. Serio-Harney how they manage other compounding sites. Ms. Serio-Harney stated that she is not aware of any other sites doing this type of compounding.
Ms. Rosas asked who the pharmacist in charge was when this incident took place. Ms. Cavanagh replied that Mr. Brauner was the pharmacist in charge.
Ms. Rosas asked Ms. Cavanagh who was responsible for checking the technicians work.
Ms. Cavanagh stated that she and Mr. Brauner were responsible for checking the technician’s
work. Ms. Cavanagh stated that prn pharmacists were also responsible for checking the
technician’s work.
Dr. Foy asked Ms. Serio-Harney if Maxor has an ethics line that is confidential. Ms. Serio-Harney stated that they have a 1-800 compliance line. Ms. Serio-Harney stated that the employee should report the incident to the first line supervisor and move up the chain to the next position. Ms. Serio-Harney stated that the number is posted in the pharmacy and on the
ADP site (payroll site).
Dr. Foy asked Ms. Cavanagh if she was aware that she could report issues. Ms. Cavanagh stated that she was not aware that she could report issues in this manner.
Ms. Serio-Harney stated that each employee receives a handbook and the information is in the handbook.
Mr. Kirschling stated that the number is listed on the front page of the ADP site.
Ms. Douthard stated that she told Ms. Cavanagh that she can take issues to the hospital staff because the hospital is the permit holder.
replied no. Ms. Cavanagh stated that when she started she did not know anyone and all communication was with Mr. Brauner and no one else within the hospital.
Ms. Douthard stated that Mr. Brauner did not always have direct access to someone within the
hospital because there was a lot of transition occurring in the staffing. Ms. Douthard stated that her position was vacant for a long period of time.
Mr. Francis asked about the training programs that Maxor offers online. Ms. Serio-Harney stated that they offer abuse training, HIPAA training, harassment training, and prescription filling. Ms. Serio-Harney stated that the completion of these programs are tracked at the
corporate level.
Mr. Minkus asked Ms. Serio-Harney how often the complaint process has been used. Ms. Serio-Harney stated that she is not sure and would have to ask for the statistics.
Mr. Kennedy asked Ms. Cavanagh if they were preparing hazardous products when she started in 2012. Ms. Cavanagh replied that they were preparing hazardous products before she started and in the past year the business doubled.
Mr. Kennedy asked Ms. Cavanagh if she talked to Mr. Brauner about preparing hazardous
products without a hood. Ms. Cavanagh stated that she did not know that the products were
to be made in a hood. Ms. Cavanagh stated that she does not recall when she brought up other compounding issues with Mr. Brauner.
Mr. Kennedy asked Ms. Cavanagh when she became aware of the issues. Ms. Cavanagh stated
that the complaint became evident at the end of April
Mr. Kennedy asked what happened to the concerns that she and the technicians expressed to Mr. Brauner. Ms. Cavanagh stated that that as far as she knew the complaints stopped at Lyle.
Ms. Rosas asked if there were any complaints that involved these compounded medications.
Ms. Serio-Harney stated that there were no issues related to the compounds.
Mr. Wand asked if there were any mistakes found when they checked the technicians work.
Ms. Cavanagh stated that no wrong medications were used but she did have an issue with the way the technician qs’ed a medication.
Ms. Locnikar asked if Maxor provides CE education for the pharmacists and technicians.
Ms. Serio-Harney stated that they completed the employee training provided.
Ms. Locnikar asked if the training was internally through the hospital. Ms. Serio-Harney stated that Maxor has their own internal training program.
Dr. Foy stated that the hazardous drug policies were last updated in August of 2012.
Mr. Kirsching stated that they have updated those policies to include USP 800.
Dr. Foy asked if there were hazardous compounding policies in effect in 2012. Ms. Cassetta stated that they only had policies for oral medications that were not compounded.
Dr. Foy asked if these policies were provided to Mr. Brauner. Ms. Serio-Harney stated that
the new policies developed in 2014 were not provided to Mr. Brauner.
Dr. Musil asked about the compounding assessment. Mr. Kirschling stated that the employee reviews the ASHP online program on sterile products and must have a passing assessment score.
Dr. Musil asked what happens if the employee fails the quiz. Mr. Kirschling stated that the pharmacist in charge would not certify the individual to compound if they do not pass the test.
Mr. Kirschling stated that it would be up to the pharmacist to determine how many times the
employee can take the test.
Dr. Musil asked who supervises the technicians in the lab. Ms. Serio-Harney stated that no technicians are compounding at this time.
Dr. Foy asked Ms. Serio-Harney did she communicate to Mr. Brauner that this was a compounding pharmacy when his background was in retail pharmacy. Ms. Serio-Harney
stated that she told Mr. Brauner that there would be a fair amount of compounding.
Dr. Foy asked Ms. Serio-Harney why Mr. Brauner was hired if he had no compounding training.
Ms. Serio-Harney stated that Mr. Brauner was working fulltime prior to the pharmacy opening.
Ms. Serio-Harney stated that Mr. Brauner could have made up the gap by taking an outside compounding course prior to the opening of the pharmacy.
Dr. Foy noted that Mr. Brauner would not have had any experience in pediatric compounding.
Ms. Serio-Harney stated that they purchased a recipe book and paid for training. Ms. Serio-Harney stated that she had assumed Mr. Brauner attended a training course.
On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to
offer a consent agreement to Ms. Cavanagh with the following terms:
1. A fine of $3,000
2. Attend a compounding training course
3. Probation for one year. May appear in front of the Board in 6 months from the
effective date of the Consent to ask for the probation to be removed if the fine
and training have been completed.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
On motion by Dr. Musil and seconded by Mr. Kennedy, the Board unanimously agreed to
offer a consent agreement to Phoenix Childrens Hospital Outpatient Pharmacy with the following terms:
1. The permit be placed on suspension for two years with the suspension stayed 2. A fine of $5,000
3. Two inspections within 12 months at the cost of the permit holder. After the second inspection, the pharmacy shall appear before the Board. If the pharmacy fails either inspection, the pharmacy shall appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
quoted from
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The following individuals were present to discuss the complaint:
1. Jacqueline Cavanagh – Pharmacist – Respondent
2. Yolanda Douthard – Chief of Pharmacy Services for Phoenix Children’s Hospital –
Respondent
3. Angela Serio-Harney – Executive Vice President of Operations for Maxor
4. Tom Kirschling – Corporate Compliance for Maxor
5. Roger Morris and Christine Cassetta – Legal Counsel for Ms. Cavanagh and
Phoenix Children’s Hospital
President Foy opened the discussion by asking Mr. Haiber to give a brief overview of the complaint.
Mr. Haiber stated that during a complaint investigation by the Compliance Officers the following allegations were investigated:
1. Compounding of hazardous products was performed without protective equipment
2. Lack of compounding training for technicians
3. Compounding preparation recipes were not provided
4. Lack of pharmacist supervision of compounding technician activities
5. Compounding room sanitation
President Foy asked the respondents to address the complaint and allegations.
Mr. Morris stated that Phoenix Children’s Hospital contracts with Maxor Pharmacy Services to
operate the outpatient pharmacy at Phoenix Children’s Hospital (PCH). Mr. Morris stated that Ms. Serio-Harney would address the issues. Ms. Serio-Harney is the Executive Vice President of Operations at Maxor.
Ms. Serio-Haney stated that she hired Lyle Brauner to be the pharmacist in charge in July of
2011. Ms. Serio-Harney stated that Mr. Brauner was given the basic Maxor policies and asked for input on changing the policies. Ms. Serio-Harney stated that Mr. Brauner was tasked with
developing the technician training program and compounding program. Ms. Serio-Harney
stated that Mr. Brauner was given carte blanche for training programs. Ms. Serio-Harney
stated that it was assumed that Mr. Brauner had attended a training program.
Ms. Serio-Harney stated that the last three years the pharmacy operated smoothly. Ms. Serio-Harney stated that the prescription volume increased, wait times were acceptable, and there were only a few medication errors. Ms. Serio-Harney stated that quality reports were sent to Ms. Douthard.
Ms. Serio-Harney stated that nothing suggested that there egregious issues within the pharmacy.
Ms. Serio-Harney stated that it was never mentioned that they were compounding hazardous
medications in the pharmacy. Ms. Serio-Harney stated that she visited the pharmacy in J
and she had no idea hazardous compounds were being made in the pharmacy.
Ms. Serio-Harney stated that while she was on maternity leave Mr. Brauner met with Ms. Douthard on May 2, 2014 concerning hazardous materials that were being compounded.
Mr. Brauner revealed on May 5, 2014 the products that were being made and that enhanced protection was needed. Mr. Brauner indicated that they needed a hood. Ms. Serio-Harney
stated that Mr. Birdsong at Maxor told Mr. Brauner to quit compounding the medications
immediately.
Ms. Serio-Harney stated that two weeks later a complaint was filed by the technician with
OSHA. Ms. Serio-Harney stated that Mr. Brauner’s employment was then terminated.
Mr. Morris asked Ms. Cavanagh to address the complaint and allegations. Mr. Morris stated that Ms. Cavanagh is now the current pharmacist in charge.
Ms. Cavanagh stated that she was hired in March of 2012. Ms. Cavanagh stated that she did have compounding experience. Ms. Cavanagh stated that she noticed deficiencies in the pharmacy and brought the issues up to Mr. Brauner and was told that they do not do that here.
Ms. Cavanagh stated that some of the issues related to good compounding guidelines. Ms.
Cavanagh stated that she backed down because she was afraid of losing her job.
Ms. Cavanagh stated that Mr. Brauner had a tendency to get angry and created an intimidating work environment. Ms. Cavanagh stated that she should have turned Mr. Brauner into the Board or reported the issues to Maxor. Ms. Cavanagh stated that she did not know what to do.
Ms. Cavanagh stated that the technicians were compounding the medications and the ingredients were not verified before they were made. Ms. Cavanagh stated that Mr. Brauner did not think it
was necessary to check the compounds. Ms. Cavanagh stated that she told the technician to come to her to check the compounds. Ms. Cavanagh stated that she could not guarantee that she
checked every compound that was made. Ms. Cavanagh stated that there were medications that she knew that they should not be making and she talked to Mr. Brauner about those medications.
Ms. Cavanagh stated that she did not know that other medications needed to made in a hood.
Ms. Cavanagh stated that it was her job to know which medications should have been made in
a hood. Ms. Cavanagh stated that she is making corrections going forward.
Ms. Cavanagh stated that she is now the pharmacist in charge and has changed functions in the pharmacy. Ms. Cavanagh stated that all compounds are checked before and after being compounded. Ms. Cavanagh stated that only a pharmacist is compounding in the pharmacy.
Ms. Cavanagh stated that she has developed new compounding sheets. Ms. Cavanagh stated that to ensure that the proper equipment is being used any products that need to compounded in a biological safety cabinet is on a bright red form indicating that it is a hazardous or chemo medication.
Ms. Cavanagh stated that everyone must sign a sheet indicating they understand that when certain medications are handled they must wear masks and gloves. Ms. Cavanagh stated that they have a chemo spill kit in the lab and every other Friday the hospital cleans the lab. anuary
Ms. Cavanagh indicated that she would attend an off-site compounding course when she finds the right course.
Mr. Morris asked Tom Kirschling from Maxor to address the audits he conducted at the site.
Mr. Kirschling stated that he was contacted on June 3, 2014 to conduct an inspection at the site.
Mr. Kirschling stated that he has pediatric and compounding experience. Mr. Kirschling stated
that he is familiar with USP 797 and compounding regulations.
Mr. Kirschling stated that he investigated the situation and for employee safety and the patient’s
safety immediate steps were taken to move the compounding to the inpatient system.
Mr. Kirschling stated that he recommended training, documentation, and facilities be updated to be 795 compliant. Mr. Kirschling stated that Ms. Cavanagh has made some changes and he is
assisting in the compliance.
Dr. Foy asked Mr. Kirschling if he conducted any prior audits of the facility. Mr. Kirschling stated that he did not conduct any previous audits. Mr. Kirschling stated that this was the first audit he conducted at the site.
Ms. Serio-Harney stated that visual inspections were conducted at the site. Ms. Serio-Harney stated that she reviewed dispensing records, purchase records, and medication errors.
Ms. Serio-Harney stated that no red flags were raised and there were no employee complaints.
Ms. Serio-Harney stated that she was not aware that they were compounding chemo drugs in January and had not been aware that they had been compounding the medications since 2011.
Dr. Foy asked Ms. Serio-Harney if she reviewed the purchase records. Ms. Serio-Harney
replied that she did review the purchase records but did not realize they were compounding
chemo medicatins.
Mr. Morris asked Ms. Douthard , Chief of Pharmacy Services at PCH, to address the issues in the complaint.
Ms. Douthard stated that she joined the staff at PHC on April 1, 2013. Ms. Douthard stated that she is in charge of all the Phoenix Children Hospital sites. Ms. Douthard stated that she was aware that there was a contracted pharmacy in the building.
stated that she met with Mr. Brauner and walked the space with him. Ms. Douthard stated that they were outgrowing their current space.
Ms. Douthard stated that she asked Mr. Brauner if he had SOPs and he replied that he did.
Ms. Douthard stated that she did not look at his SOPs.
Ms. Douthard stated that she met Ms. Serio-Harney via telephone.
Ms. Douthard stated that there was no evidence of hazardous compounding. Ms. Douthard stated that Mr. Brauner told her that less than 20% of their business is compounding. Ms. Douthard stated that Mr. Brauner did have prn help as his volume had increased.
Mr. Wright, Pharmacy Operations Manager at PCH, met with Mr. Brauner and indicated the business metrics were good.
Ms. Douthard stated that they had looked at the Board inspections and the inspections looked
good.
Ms. Douthard stated that Mr. Wright contacted her and stated that they needed to meet with Mr. Brauner concerning the compounding of hazardous compounds.
Ms. Douthard stated that they asked Mr. Brauner and Ms. Schweitzer to bring a list of the
compounds that they are currently compounding and the products they anticipate compounding.
Ms. Douthard stated that when she reviewed the list she also saw three products that were teratogenic. Ms. Douthard stated that she told them to stop compounding the medications at this point.
Ms. Douthard stated that she asked Mr. Wright to contact Ms. Frush at the Board of Pharmacy to see if the Board would allow the outpatient pharmacy to prepare the products in the
inpatient pharmacy. Ms. Frush told Mr. Wright that she would talk with Mr. Wand because she had some concerns and would call him back. Ms. Frush told Mr. Wright that she discussed the issues with Mr. Wand and they stated that the outpatient pharmacy could use the inpatient pharmacy but there were several issues that needed to be addressed. Ms. Frush told Mr. Wright that the individuals (pharmacists or technicians) need to be properly trained on the compounding of the products. Also, if a technician compounds the medications they must be properly supervised. Ms. Frush told Mr. Wright that the inpatient pharmacy could compound the medications for the outpatient pharmacy. Ms. Douthard stated that the issues raised by the Board were the same concerns that she had concerning the compounding of the medications.
Ms. Douthard stated that they decided that the outpatient pharmacy would schedule a time to use the hood in the inpatient pharmacy and the employees needed to be trained.
Ms. Douthard stated that their current options are to redesign the space for the outpatient pharmacy, continue to use the inpatient pharmacy hood, or outsource the preparation of the
hazardous compounds.
Dr. Musil asked Ms. Serio-Harney how many outpatient childrens hospital pharmacies they manage. Ms. Serio-Harney stated just this one. Ms. Serio-Harney stated that they manage a
specialty infusion pharmacy for children.
Dr. Musil asked Ms. Serio-Harney if they conducted any audits and reviewed compounding policies. Ms. Serio-Harney stated that they had not conducted any audits prior to this complaint.
Ms. Serio-Harney stated that they sent out three compounds for testing and two of the products were fine.
Dr. Musil asked Ms. Serio-Harney if they conducted any compounding audits in their contracted pharmacies. Ms. Serio-Harney replied no.
Mr. Van Hassel asked Ms. Cavanagh when she started at PCH and what position she held.
Ms. Cavanagh stated that she started as a staff pharmacist in March of 2012.
Mr. Van Hassel asked if there was any additional staffing. Ms. Cavanagh stated that Mr. Brauner was the only other full-time pharmacist. Ms. Cavanagh stated that there was additional prn help.
Mr. Van Hassel asked about the cleaning of the compounding room. Ms. Cavanagh stated that the room was cleaned daily.
Mr. Van Hassel asked Ms. Cavanagh what was used to clean the room. Ms. Cavanagh stated that the room was never cleaned that they used Lysol wipes to clean the counters.
Mr. Van Hassel asked Ms. Cavanagh about the supervision of the technicians. Ms. Cavanagh stated that she expressed her concerns to Mr. Brauner but she was afraid of going around him to check the compounds. Ms. Cavanagh stated that it was not an excuse but she was placed in a hard position. Ms. Cavanagh stated that she could not guarantee the workflow issues.
Mr. Van Hassel asked Ms. Cavanagh if she believed that the technician was adequately trained.
Ms. Cavanagh stated that there were some deficiencies that she noted. Ms. Cavanagh stated that she believes that there was not enough supervision of the technicians. Ms. Cavanagh stated that one of the technicians indicated that the training course was a joke.
Mr. Van Hassel asked Ms. Serio-Harney about the training course Mr. Brauner attended.
Ms. Serio-Harney stated that she signed the expense sheet authorizing Mr. Brauner to attend a
training class and assumed he attended a class.
Dr. Musil asked about the compounding sheets that were used in the past. Ms. Cavanagh stated that the compounding sheets used in the past indicated the drug and concentration and the number of tablets to be made. Ms. Cavanagh stated that there were no specific instructions.
Ms. Cavanagh stated that they listed the lot number and expiration date of the items used.
Ms. Cavanagh stated that there were no step by step procedures.
Dr. Musil asked if there was a master formula record. Ms. Cavanagh stated that no formulation sheet was used.
Dr. Musil asked what corrections Ms. Cavanagh has made. Ms. Cavanagh stated that the new sheet identifies the individual that prepared the compound and the verifying pharmacist. Ms. Cavanagh stated that the lot number, expiration date, and NDC number of the product used is
recorded. Ms. Cavanagh indicated that if it is a hazardous product it is made in a biological safety cabinet.
Mr. Minkus asked Ms. Serio-Harney if there is any follow up with the forms to see if people are doing what they are supposed to be doing. Ms. Serio-Harney stated that the processes were
driven by barcode technology and no red flags were raised.
Mr. Minkus asked Ms. Cavanagh why she did not come forth when these issues occurred.
Ms. Cavanagh stated that she could not change her actions that occurred in the past.
Mr. Van Hassel asked Mr. Kirschling about changes at the site. Mr. Kirschling stated that there
are still some issues that need to be addressed. Mr. Kirschling stated that they use USP 797 as
best practices for employee and patient safety. Mr. Kirschling stated that they would have an independent expert inspect the site when the remodel is finished.
Dr. Foy asked Ms. Serio-Harney what plans they have going forth to monitor the site. Ms.
Serio-Harney stated that they plan to use an outside consultant. Ms. Serio-Harney stated that
have plans to audit the compounding records.
Dr. Foy asked Ms. Douthard if there are internal departments providing audits. Ms. Douthard
stated that risk management and the legal department would be providing audits.
Mr. Francis asked Ms. Serio-Harney how they manage other compounding sites. Ms. Serio-Harney stated that she is not aware of any other sites doing this type of compounding.
Ms. Rosas asked who the pharmacist in charge was when this incident took place. Ms. Cavanagh replied that Mr. Brauner was the pharmacist in charge.
Ms. Rosas asked Ms. Cavanagh who was responsible for checking the technicians work.
Ms. Cavanagh stated that she and Mr. Brauner were responsible for checking the technician’s
work. Ms. Cavanagh stated that prn pharmacists were also responsible for checking the
technician’s work.
Dr. Foy asked Ms. Serio-Harney if Maxor has an ethics line that is confidential. Ms. Serio-Harney stated that they have a 1-800 compliance line. Ms. Serio-Harney stated that the employee should report the incident to the first line supervisor and move up the chain to the next position. Ms. Serio-Harney stated that the number is posted in the pharmacy and on the
ADP site (payroll site).
Dr. Foy asked Ms. Cavanagh if she was aware that she could report issues. Ms. Cavanagh stated that she was not aware that she could report issues in this manner.
Ms. Serio-Harney stated that each employee receives a handbook and the information is in the handbook.
Mr. Kirschling stated that the number is listed on the front page of the ADP site.
Ms. Douthard stated that she told Ms. Cavanagh that she can take issues to the hospital staff because the hospital is the permit holder.
replied no. Ms. Cavanagh stated that when she started she did not know anyone and all communication was with Mr. Brauner and no one else within the hospital.
Ms. Douthard stated that Mr. Brauner did not always have direct access to someone within the
hospital because there was a lot of transition occurring in the staffing. Ms. Douthard stated that her position was vacant for a long period of time.
Mr. Francis asked about the training programs that Maxor offers online. Ms. Serio-Harney stated that they offer abuse training, HIPAA training, harassment training, and prescription filling. Ms. Serio-Harney stated that the completion of these programs are tracked at the
corporate level.
Mr. Minkus asked Ms. Serio-Harney how often the complaint process has been used. Ms. Serio-Harney stated that she is not sure and would have to ask for the statistics.
Mr. Kennedy asked Ms. Cavanagh if they were preparing hazardous products when she started in 2012. Ms. Cavanagh replied that they were preparing hazardous products before she started and in the past year the business doubled.
Mr. Kennedy asked Ms. Cavanagh if she talked to Mr. Brauner about preparing hazardous
products without a hood. Ms. Cavanagh stated that she did not know that the products were
to be made in a hood. Ms. Cavanagh stated that she does not recall when she brought up other compounding issues with Mr. Brauner.
Mr. Kennedy asked Ms. Cavanagh when she became aware of the issues. Ms. Cavanagh stated
that the complaint became evident at the end of April
Mr. Kennedy asked what happened to the concerns that she and the technicians expressed to Mr. Brauner. Ms. Cavanagh stated that that as far as she knew the complaints stopped at Lyle.
Ms. Rosas asked if there were any complaints that involved these compounded medications.
Ms. Serio-Harney stated that there were no issues related to the compounds.
Mr. Wand asked if there were any mistakes found when they checked the technicians work.
Ms. Cavanagh stated that no wrong medications were used but she did have an issue with the way the technician qs’ed a medication.
Ms. Locnikar asked if Maxor provides CE education for the pharmacists and technicians.
Ms. Serio-Harney stated that they completed the employee training provided.
Ms. Locnikar asked if the training was internally through the hospital. Ms. Serio-Harney stated that Maxor has their own internal training program.
Dr. Foy stated that the hazardous drug policies were last updated in August of 2012.
Mr. Kirsching stated that they have updated those policies to include USP 800.
Dr. Foy asked if there were hazardous compounding policies in effect in 2012. Ms. Cassetta stated that they only had policies for oral medications that were not compounded.
Dr. Foy asked if these policies were provided to Mr. Brauner. Ms. Serio-Harney stated that
the new policies developed in 2014 were not provided to Mr. Brauner.
Dr. Musil asked about the compounding assessment. Mr. Kirschling stated that the employee reviews the ASHP online program on sterile products and must have a passing assessment score.
Dr. Musil asked what happens if the employee fails the quiz. Mr. Kirschling stated that the pharmacist in charge would not certify the individual to compound if they do not pass the test.
Mr. Kirschling stated that it would be up to the pharmacist to determine how many times the
employee can take the test.
Dr. Musil asked who supervises the technicians in the lab. Ms. Serio-Harney stated that no technicians are compounding at this time.
Dr. Foy asked Ms. Serio-Harney did she communicate to Mr. Brauner that this was a compounding pharmacy when his background was in retail pharmacy. Ms. Serio-Harney
stated that she told Mr. Brauner that there would be a fair amount of compounding.
Dr. Foy asked Ms. Serio-Harney why Mr. Brauner was hired if he had no compounding training.
Ms. Serio-Harney stated that Mr. Brauner was working fulltime prior to the pharmacy opening.
Ms. Serio-Harney stated that Mr. Brauner could have made up the gap by taking an outside compounding course prior to the opening of the pharmacy.
Dr. Foy noted that Mr. Brauner would not have had any experience in pediatric compounding.
Ms. Serio-Harney stated that they purchased a recipe book and paid for training. Ms. Serio-Harney stated that she had assumed Mr. Brauner attended a training course.
On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to
offer a consent agreement to Ms. Cavanagh with the following terms:
1. A fine of $3,000
2. Attend a compounding training course
3. Probation for one year. May appear in front of the Board in 6 months from the
effective date of the Consent to ask for the probation to be removed if the fine
and training have been completed.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
On motion by Dr. Musil and seconded by Mr. Kennedy, the Board unanimously agreed to
offer a consent agreement to Phoenix Childrens Hospital Outpatient Pharmacy with the following terms:
1. The permit be placed on suspension for two years with the suspension stayed 2. A fine of $5,000
3. Two inspections within 12 months at the cost of the permit holder. After the second inspection, the pharmacy shall appear before the Board. If the pharmacy fails either inspection, the pharmacy shall appear before the Board.
A roll call vote was taken. ( Ms. Locnikar – aye, Dr. Musil – aye, Mr. Francis – aye, Mr. Minkus-aye, Ms. Rosas – aye, Mr. Kennedy – aye, Mr. Van Hassel – aye, and Dr. Foy – aye)
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