HospitalInspections.org

Based on review of medical records (MR), review of facility documents and interview with staff (EMP) it was determined that the facility failed to protect and promote each patient's right as evidence by: failing to ensure that the patient had a right to have their primary care physician notified of their admission to the hospital (A0133); and failing to implement and adhere to safety measures during the administration of medication to ensure a patient's safety and well being (A0144).

Cross Reference:
482.12(b)(4) Patient Rights: Admission Status Notification
482.13(c)(2) Patient Rights: Care in Safe Setting
482.23(b)(5) Patient Care Assignments
482.23(c)(1),(c)(1)(i) &(c)(2) Administration of Drugs
482.25(a)(2) Pharmacy Personnel
482.25(b) Delivery of Drugs

Based on review of medical records (MR), review of facility policies and interview with staff (EMP), it was determined that the facility failed to ensure the patient's right to have the primary care provider (PCP) notified of admission to the hospital for nine of 11 of medical records reviewed (MR1, MR4, MR5, MR6, MR7, MR8, MR9, MR10 and MR11).

Findings include:

Review on October 29, 2015, of facility policies failed to reveal a policy regarding the notification of a patient's PCP upon the patient's admission to the hospital.

Review on October 29, 2015, of MR1, MR4, MR5, MR6, MR7, MR8, MR9, MR10 and MR11 revealed no documented evidence that the patient's PCP was notified of the patient's admission to the hospital.

Interview on October 29, 2015, at 11:15 AM, with EMP6 confirmed that the facility did not have a policy to notify the patient's PCP upon admission to the hospital. Further interview with EMP6 confirmed that MR1, MR4, MR5, MR6, MR7, MR8, MR9, MR10 and MR11 did not contain any documented evidence that the patient's PCP was notified upon admission.

Based on review of medical records (MR), review of facility policy and procedures and interview with staff (EMP), it was determined that the facility failed to implement and adhere to safety measures during the administration of medications to ensure a patient's safety and well-being for one of one medical record reviewed (MR1).

Findings include:

1. Review of facility policy "Rights and Responsibilities of Patients," dated January 14, 2014, revealed "I) Policy: 1) St. Christopher's Hospital for Children is committed to providing the best possible care to children and youth in a family-centered environment. ... II) Patient Rights: Patients and/or parents or guardians acting on behalf of the patient have a right: ... 3) To provide considerate, respectful care given by competent personnel, including consideration of the psychosocial. spiritual and cultural variables that influence perception of illness. ... 18) To good quality care and high professional standards that are continually maintained and reviewed. ...25) To expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and to avoid the personal discomfort of the patient and family. The patient and the family have the right to expect reasonable safety insofar as hospital practices ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 revealed a customized "Roadmap" (a treatment protocol that contains a list of medications and dosing information to be utilized to treat a patient's specific condition) that was developed to treat the patient ' s rare form of cancer. Review of the "Roadmap" revealed " ... ICE Courses: cycles 2 ... Wt. 8.6 kg ... Ifosamide [chemotherapy medication]1800 mg m2/dose (60 mg/kg/dose if age <1 yr) days 1-5; Mesna [chemotherapy medication]360 mg/m2/dose (12 mg/kg if age <1 yr) x 5 doses: 1st dose in bag with Ifos. Dose 2 over 3 hr CI, doses 3-5 at hr 3, 6, 9. Give 100% mesna. ... Etoposide [chemotherapy medication] 100 mg/m2/day (33mg/kg if age <1 yr) days 1-5. ... " The " Roadmap " revealed the following handwritten calculation for Etoposide " ... 280 mg ... " Further review of the " Roadmap" revealed that the document was not dated, nor was it authenticated by the individual who transcribed the "Roadmap" and performed the calculations that were contained on the "Roadmap."

Review of MR1 "Physicians' Orders," dated October 1, 2015, revealed " ... Etoposide (33 mg/kg) or 280 mg IV diluted in 100 cc NS to be infused over 2 hours at 50 cc/hr. Repeat 5 days. ... "

Review of MR1 "Medication Administration," dated October 2, 2015, timed: 00:52, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP19] 10/02/2015 00:52; Verify: [EMP18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 2, 2015, performed at 06:19, by EMP18 revealed "Nursing Note: 7p-7a: Received pt. at 2030 from 5w. NGT feeds started per home regime at 2030. 55mls/hr for a total of 660mls. Retching once overnight and small emesis around 5:30. Feeds held at small intervals. UA obtained and sent, results wnl to begin chemo. 2315: Loading dose of zofran given. 2400: Carboplatin given via left chest port over one hour. 0100: VP-16 [another name for Etoposide] given over 2 hours. BP's checked Q15 min and remained stable. 0300: Ifosphamide [sic] given over one hour. + blood return pre/during/post chemo. 0400: 3 hour Mesna infusion started. 0415: Temp 38.4 MD [physician's name] informed and evaluated. Dr. [EMP15] informed. Per MD orders bld cx's x 2 obtained, tylenol given, tobra and zosyn given (abx compatible with Mesna per pharmacy). Mesna boluses to be given hrs 3, 9, 12. [patient's parent] attentive at bedside, pt. resting comfortably, will continue to monitor."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 00:53, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP20] 10/03/2015 00:53; Verify: [EMP 18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 3, 2015, performed at 06:59, by EMP18 revealed "... 01:00: Etoposide given over 2 hrs via left chest port. ... Pt. tolerate well and no adverse reactions noted. ..."

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 00:33, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:33; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 4, 2015.

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 00:47, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:21; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 5, 2015.

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 00:55, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP23] 10/04/2015 00:55; Verify: [EMP18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 6, 2015, performed at 04:55, by EMP18 revealed "...01:00: Etoposide given over 2 hours via right chest port. Towards middle to end of infusion, pump kept beeping occluded, port flushed with heparin, + blood return, but the last 5 cc of flush unable to be given as port clotted off. Port then had to be reaccessed. ... Spoke to pharmacy as chemo precipitated [deposited in solid form from a solution] in line on Sat [Saturday] morning. Per pharmacy, dose is highly concentrated because of pt. weight and this is causing the precipitate which then clotted the port. ..."

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Review of MR1 "Discharge Summary," dated October 8, 2015, authenticated by EMP14, at 10:50, revealed "... Hospital Course: ONC [Oncology]: Completed 2nd cycle of chemotherapy per protocol, including ... Etoposide ... The Etoposide precipitated on 10/1, 10/4, and 10/6 due to the highly concentrated dose of medication administered, requiring frequent line flushes per nurse. ... RESIDENT A/P Assessment: ... After discovering the incorrect Etoposide dose, [the patient] was closely monitored. ... Patient is being closely monitored for possible liver, renal, bone marrow, neurologic, and respiratory damage secondary to potential Etoposide toxicity. Plan: Oncology: Completed chemotherapy 10/6 ... patient awaiting transfer to [another health care facility] on 10/6/2015. ..."

Review of MR1 revealed no documentation pertaining to the two medication precipitating events that occurred prior to October 6, 2015. Further review of MR1 revealed no documented evidence that the physician was notified and assessed the patient during the two previous medication precipitating events that occurred prior to October 6, 2015. There was no documented evidence that pharmacy was notified of the two previous medication events that occurred prior to October 6, 2015.

Interview on January 11, 2016, at 10:00 AM, with EMP1 and EMP10 revealed that on October 6, 2015, EMP11, reviewed the dosing and concentration of Etoposide after being notified by EMP18 that the medication had precipitated during administration; EMP11 identified that the concentration/dose was too high.

Interview on January 11, 2016, at 10:20 AM, with EMP1 indicated that a root cause analysis (RCA) was performed. EMP1 revealed that they didn't know why it took the facility five days to realize that there was an error with the dosage of Etoposide that was being provided to the patient in MR1. EMP1 indicated that the event was due to a "typographical" error made by EMP13. EMP1 indicated that four oncologists, EMP13, EMP14, EMP15 and EMP16, created the custom "Roadmap" to treat the patient's illness. EMP1 indicated that "the dose was to be 3.3 [mg/kg] not 33 [mg/kg] but EMP13 wrote down '33' instead of '3.3'" and then EMP17 transcribed the order based on what was written on the "Roadmap."

Interview on January 11, 2016, at 10:30 AM, with EMP1 revealed that the medication precipitated on October 2, 2015, that caused the patient "temporary harm," and that the site had to be re-accessed. EMP1 revealed that a medication can precipitate if the concentration is too high or if there is not enough diluent. EMP1 confirmed that nursing is aware of what can cause a medication to precipitate. EMP1 confirmed that nursing did not document this event in the patient's medical record and revealed that nursing "documents by exception" meaning that "they document unusual occurrences." EMP1 confirmed that this event, involving the first occurrence of the Etoposide precipitating, was not reported to the Department or the Patient Safety Authority. At 10:59 AM EMP1 confirmed that there was no documented evidence that the physician and/or pharmacy was notified of this event. EMP1 indicated that "most of the medication was administered by the time it was realized." Review of MR1 revealed no documented evidence regarding the exact amount of medication that the patient received during the first precipitating event that occurred on October 2, 2015 or the second precipitating event that occurred on October 4, 2015.

2. Review of facility policy "High Risk Medications Management (High Alert)," dated March 2014, revealed "I. Policy SCHC will develop and maintain a list of High Risk Medications. Medications and medication classes on this list will be subject to greater control due to the high potential for errors or consequences of errors. II. Purpose To outline processes for defining, communicating, and enforcing medication management safety measures to promote safe use of high alert high risk medications and reduce medication errors and their consequences. III. Procedure A. Definitions 1. High risk medications: Medications that bear heightened risk of causing significant patient harm when used in error (Institute for Safe Medication Practice ISMP). ... B. Processes will be in effect at every stage of medication management that relates to high risk medication use. ... 3. Prescribing/Transcribing ... c. Dose range checking is utilized in both PowerChart CPOE and PharmNet. d. When high risk medications are ordered by the provider using an alternative to CPOE, e.g., chemotherapy protocols ... , the relevant orders will be transcribed by the pharmacist into PharmNet and thus into the eMar and PowerChart. e. Down time handling of orders will include double check by the pharmacist of all high risk medication orders and adherence to downtime policies for nursing and providers. 4. Preparation/Dispensing a. Independent double check by the person who prepares the high risk medication and a second person (one of who must be a licensed pharmacist) are mandatory. ... 5. Administration ... b. Independent confirmation of the order and visual confirmation of the medication label by two licensed personnel must occur prior to administration of the medication. ... 6. Monitoring a. Medication events are reported according to the event reporting policy. ... ."

Review of facility policy "Chemotherapy and Hazardous Medication Management," dated March 2014, revealed "I. Policy A. Special precautions will be taken whenever processing orders for cytotoxic drugs to minimize the possibility of a medication misadventure. B. All personnel will be familiar with the procedures for handling antineoplastic medications and follow them when preparing, dispensing, administering, ... these medications. ... Administration ... a. Chemotherapy is to be administered to the patient only by a chemo certified nurse in designated locations (... OTU, ...) ... ."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 00:53, revealed "Etoposide 280 mg 14 m:; ns100 100 mL IV Chemo, Infusaport ... Perform: EMP18, Witness: EMP20 10/3/2015 00:53; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 4:03, revealed "Mesna 100 mg 1 mL; d5nsh250 150 mL IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP20 10/03/2015 04:03; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 12:28, revealed "Mesna d5i25 25 mL; mesn1i 100 mg 1 mL IV Chemo, Infusaport ... Perform: EMP8; Witness: EMP24 10/4/2015 12:28; Verify: EMP8 ..."

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 12:52, revealed "Mesna mesn1i 100 mg 1 mL; d5i25 25 mL IV Chemo, Infusaport ... Perform: EMP25; Witness: EMP26 10/5/2015 12:52; Verify: EMP25 ..."

Review of MR1"Medication Administration," dated October 6, 2015, timed: 00:55, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP23 10/6/2015 00:55; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 05:12, revealed "Ifex 500 mg+ Mesnex 100 mg ... IV Chemo, Infusaport ... Perform: EMP18 10/6/2015 03:08; Witness: EMP27 10/6/2015 03:08; Modify: EMP18 10/6/2015 05:11; Witness: EMP27 10/6/2015 05:11; Verify: EMP18 ... Result comment: EMP18 Chemo started late as port clotted and had to be reaccessed. ..."

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 04:32, revealed "Mesna ... IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP23 10/6/2015 04:32; Verify: EMP18 ..."

On January 26, 2016, at 3:33 PM, a request was submitted to EMP9 for documentation of specialized training in chemotherapy medications for the nurses who administered chemotherapy medication to the patient on October 2, 3, 4, 5, and 6.

Review of documents submitted to the Department, on January 28, 2016, at 4:36 PM, by EMP9 revealed no documented evidence that EMP20 and EMP23, who participated in the administration and verification process of the administration of chemotherapy medications, were chemotherapy certified in accordance with facility policy.

Review of correspondence submitted to the Department, on February 11, 2016, at 11:39 AM, from EMP9 revealed that the facility does not "specify that the second professional must be APHON [Association of Pediatric Hematology/Oncology Nurses] Biotherapy certified."

On March 8, 2016, at 3:13 PM, another request containing a list of additional nurses who administered chemotherapy medication to the patient was submitted to EMP9.

Review of correspondence submitted to the Department, on March 9, 2016, at 12:42 PM, by EMP9, revealed that EMP24, EMP26 and EMP27, who participated in the administration and verification process of the administration of chemotherapy medications, were not chemotherapy certified in accordance with facility policy.

3. Review of facility policy "Chemotherapy and Hazardous Medication Management," dated March 2014, revealed " I. Policy A. Special precautions will be taken whenever processing orders for cytotoxic drugs to minimize the possibility of a medication misadventure. B. All personnel will be familiar with the procedures for handling antineoplastic medications and follow them when preparing, dispensing, administering, ... these medications. ... II. Purpose Certain medications carry unique hazards. This policy promotes knowledge and understanding of these effects and how to mitigate them except as applied to patient therapy. Policy will dictate the handling of these medications in a way that promotes better patient care and safety ... . IV. Procedure A. Chemotherapy ... 2. Order processing, preparation and handling a. The pharmacist receiving the order (pharmacist #1) i. Will review the order for patient appropriateness and clarify the order with the ordering heme/onc attending when necessary. ii. Will check the pertinent laboratory data iii. Will enter the order into the computer to generate a patient charge and a label for the drug which includes: ... k) Initials of preparer and the checker ... iv. Must retrieve the patient chemotherapy profile in the Oncology Clinic (if it exists) or create a new patient folder and profile. ... b. Pharmacist #1 will complete the Pharmacy Drug Profile sheets for each drug in the order; Pharmacist #2 will verify the work. ... d. Each chemotherapeutic agent must be admixed individually by a pharmacy technician and all work checked by a pharmacist. i. Chemotherapeutic agents will be prepared by personnel specially trained in chemotherapy handling. ... e. Both pharmacists will retrieve and review the label, the order, and the patient profile; then review admixing instructions with the pharmacy technician utilizing package inserts and other references needed. f. Prior to having a certified chemo technician complete the preparation of products, the pharmacist will call a second pharmacist (pharmacist #2) to check the following: i. The original orders against the printed label and all calculations ii. The original orders against the protocol and roadmap (chemotherapy profile) ... g. ... vi. The preparer will affix the prepared label and precautionary labels to the final product and indicate completeness by initialing the chemotherapy profile. h. The pharmacist witnesses the technician completing the preparation, initials the label, and initials the chemotherapy profile. ... j. The patient chemotherapy order form will be placed in the chemotherapy file for future reference. ... 4. Administration a. Chemotherapy is to be administered to the patient only by a chemo certified nurse in designated locations (... OTU, ...). If it is necessary to administer chemotherapy in non-designated areas, the administration will be done by a chemo certified nurse. ..."

Interview on January 11, 2016, at 10:13 AM, with EMP10 revealed that the " ' normal chemo' pharmacist [EMP4]" was not working during the time Etoposide was prepared and dispensed to the patient in MR1. EMP10 revealed that the pharmacists who prepared and dispensed the Etoposide don't frequently prepare chemotherapy medications. EMP1 indicated that the pharmacists are not certified in chemotherapy medication preparation and that there is no facility policy that requires it. EMP1 revealed that these pharmacists "have been here for years but that they received training during orientation on pediatric dosing and mixing chemotherapy medications." EMP10 revealed that as a result of the medication error, involving Etoposide, the pharmacist working in oncology will rotate as to who prepares chemotherapy medications in order to maintain competency.

On January 26, 2016, at 9:03 AM, a request was submitted to EMP9 for a list of the actual pharmacists who prepared and dispensed Etoposide on October 2, 3, 4, 5, and October 6, 2015. EMP9 was also asked for a copy of their last training/education that each pharmacist received regarding chemotherapy pharmacy.

Review of correspondence submitted to the Department, on January 28, 2016, at 4:22 PM, from EMP9 revealed that the facility did not have record as to which pharmacists actually prepared and dispensed Etoposide on October 2, 3, 4, 5 and October 6, 2015. EMP9 indicated that the pharmacist signs the label after it is printed, but then the label is discarded once the medication is finished. EMP9 revealed that there are no specialized educational requirements or oncology specific requirements that are required of the pharmacists in order to work in oncology. EMP9 indicated that " ... pharmacists orient with [EMP4] in the oncology clinic checking and verifying orders and learning the processes involved until they feel that they can handle clinic and chemotherapy admissions. This is usually a 3 to 6 month period depending on it they have any prior experience.

There was no documented evidence that pharmacy double-checked the physician's order for Etoposide to ensure accuracy and patient appropriateness in accordance with facility policy.

4. Interview on February 4, 2016, at 9:00AM, with EMP9 revealed that EMP13 typed the " Roadmap. "

Interview on February 4, 2016, at 9:09 AM, with EMP10 revealed that literature was used to develop the patient's treatment protocol, the customized "Roadmap." EMP10 revealed that the literature was not included in the patient's chart nor was it sent to pharmacy to allow for pharmacy to review with the "Roadmap" prior to filling the orders. EMP10 revealed that the literature used to develop customized "Roadmaps" would "sometimes" be sent to pharmacy, "but not always." EMP10 revealed that the facility did not have an established policy for this process.

Interview on February 4, 2016, at 9:17 AM, with EMP1 revealed that standardized " Roadmaps " are " vetted and go through an IRB process " prior to implementation. EMP1 indicated that custom " Roadmaps " do not go through the same " vetting " process like the standardized " Roadmaps."

Interview on February 4, 2016, at 9:24 AM, with EMP9 confirmed that the "Roadmap" document, contained in MR1, was not dated nor was it authenticated. EMP9 indicated that the document should have been authenticated and dated.

On February 4, 2016, the facility was asked for a policy related to oncologists reviewing and signing custom " Roadmaps " to ensure accuracy prior to sending to pharmacy, since custom " Roadmaps " are not " vetted " in the same manner. At 9:24 AM, EMP9 revealed that the facility did not have a policy.

There was no evidence that the facility had a mechanism in place to ensure the accuracy of customized "Roadmaps" that were being used to treat rare medical conditions.

5. Review of facility policy "Charting Guidelines, Medical Records," dated October 25, 2012, revealed "I) POLICY: To ensure that St. Christopher's Hospital for Children has medical records that are clear and legible; the following charting guidelines shall be forwarded by all staff that has responsibility for documenting patient care and/or status. II) PROCEDURE: ... d) Each entry shall be signed by the individual making the entry. ... f) Documentation shall record precisely what was stated, observed, or reported and what professional services were rendered to the patient. ... h) All entries in a patient's medical record shall be consistent and noncontradictory; information recorded in one section of the record must be consistent with information recorded in other locations. i) All entries shall be read before countersigning. Countersignature attests to the authenticity of what has been written. ..."

Review of MR1 "Oncology Daily Progress Note," dated October 2, 2015, timed 14:01, authenticated by EMP14 on October 3, 2015 at 21:00, revealed "... Plan: Oncology: ... - etoposide 280 mg x 5 days ...".

Review of MR1 "Physician Progress Notes," dated October 3, 2015, timed 01:11, authenticated by EMP14 at 20:59, revealed ""... Plan: Oncology: ... - etoposide 280 mg x 5 days ...".

Review of MR1 "Physician Progress Notes," dated October 4, 2015, timed 04:03, authenticated by EMP14, revealed " ... Plan: Oncology: ... - etoposide 280 mg x 5 days ...".

Review of MR1 "Physician Progress Notes," dated October 5, 2015, timed 19:56, authenticated by EMP14, revealed "... Plan: Oncology: ... - etoposide 280 mg x 5 days ...".

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Interview on January 11, 2016, at 10:20 AM, with EMP1 indicated that a root cause analysis (RCA) was performed. EMP1 revealed that they didn't know why it took the facility five days to realize that there was an error with the dosage of Etoposide that was being provided to the patient in MR1. EMP1 indicated that the event was due to a "typographical" error made by EMP13. EMP1 indicated that four oncologists, EMP13, EMP14, EMP15 and EMP16, created the custom "Roadmap" to treat the patient's illness. EMP1 indicated that "the dose was to be 3.3 [mg/kg] not 33 [mg/kg] but EMP13 wrote down '33' instead of '3.3', omitting the decimal point. EMP17 then transcribed the order based on what was written on the "Roadmap."

Review of MR1 "Physician Progress Notes" revealed that EMP14, who was involved in creating the customized "Roadmap" to treat the patient's condition, repeadly authenticated the incorrect dose: "etoposide 280 mg x 5 days."
The facility failed to implement and adhere to safety measures during the administration of medication to ensure a patient's safety and well-being.

Based on review of medical records (MR), review of facility policy and procedures and interview with staff (EMP) it was determined that the facility failed to ensure that nursing staff participating in the administration of chemotherapy medications were chemotherapy certified in accordance with facility policy for one of one medical record reviewed (MR1).


Findings include:

Review of facility policy "Infusion Medication Administration (IMAR), Last Rev [review] Date: 10/12 [2012] Next Rev Date: 12/13 [2013]," revealed " I. POLICY: An infusion medication administration record will be maintained for every high-risk medication administration as an infusion. Every infusion will require an individual record. Two RNs will participate in the verification and documentation of these infusions. ... II. PERFORMED BY: 2 Registered Nurses III. DESIRED OUTCOME: In order to ensure accurate verification and documentation of all high-risk infusions, two RNs will participate in the verification and documentation of all high-risk infusions. ... ".

Review of facility policy "Chemotherapy and Hazardous Medication Management," dated March 2014, revealed "I. Policy A. Special precautions will be taken whenever processing orders for cytotoxic drugs to minimize the possibility of a medication misadventure. B. All personnel will be familiar with the procedures for handling antineoplastic medications and follow them when preparing, dispensing, administering, ... these medications. ... Administration ... a. Chemotherapy is to be administered to the patient only by a chemo certified nurse in designated locations (... OTU, ...) ... ."

Review of facility policy "Chemotherapy Administration (Antineoplastic and Cytotoxic Drugs), dated February 2015, revealed "I. Policy During preparation for chemotherapy administration, health care personnel, the patient and the environment will be protected from unnecessary exposure to potentially hazardous substances. ... II. General Information A. Physician Orders: 1. ...Physician orders are required and must include the following information: protocol number, day, week, pre and post hydration orders, anti-emetics, drug, height, weight, Body Surface Area (BSA), dosage, route, diluent, administration frequency, and special precautions. ...C. Intravenous Infusion Chemotherapy: The following guidelines shall govern the administration of IV chemotherapeutic agents: ... 8. ... When using a Buretrol to administer medications, flush with appropriate agent between chemotherapy drug and medication. ... 13. Hourly assessment of peripheral and/or central venous access site is required during infusion of IV chemotherapeutic agents. During central line infusions, check dressing and chest wall every hour during chemotherapy administrations for signs of infiltration. ... 14. Hourly checks of infusion container, buretrol and pump settings should be completed and documented in the electronic record. 15. Special nursing consideration: Etoposide (VP-16) and Teniposide (VM-26) require the RN to be present and monitor the administration of either of these drugs throughout the infusion ... III. PERFORMED BY: Registered Nurses: RN ' s in the Oncology Unit, Oncology Clinic, and 5 West (Oncology Unit overflow) are required to be APHON Biotherapy Certified. ... VI. PROCEDURE: A. Preparatory Phase 1. Check physician ' s order, review BSA, check the label of all chemotherapy containers for patient ' s name, date, correct medication, dosage and diluent, expiration date and bottle number prior to infusion. This step needs to be independently double checked by another licensed practioner and documented on the MAR. ... C. Follow-Up Phase ... 3. Document chemotherapy administration in the electronic record and EMR including the following information: location and type of line, chemotherapy dose, amount infused, sequence of drugs, type of flush solution and amount, description of infusion site, pre-medications, any reactions and/or interventions, responses, and indication that orders were double-checked. a. I/O Inet: Location and type of line, amount infused (chemotherapy), flush amount, description of infusion site, reactions and/or interventions, and responses. b. EMR: Pre-medications, chemotherapy dose, sequence of drugs, and type of flush, indication that orders were double-checked. ... "

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 00:53, revealed "Etoposide 280 mg 14 m:; ns100 100 mL IV Chemo, Infusaport ... Perform: EMP18, Witness: EMP20 10/3/2015 00:53; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 4:03, revealed "Mesna 100 mg 1 mL; d5nsh250 150 mL IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP20 10/03/2015 04:03; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 12:28, revealed "Mesna d5i25 25 mL; mesn1i 100 mg 1 mL IV Chemo, Infusaport ... Perform: EMP8; Witness: EMP24 10/4/2015 12:28; Verify: EMP8 ..."

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 12:52, revealed "Mesna mesn1i 100 mg 1 mL; d5i25 25 mL IV Chemo, Infusaport ... Perform: EMP25; Witness: EMP26 10/5/2015 12:52; Verify: EMP25 ..."

Review of MR1"Medication Administration," dated October 6, 2015, timed: 00:55, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP23 10/6/2015 00:55; Verify: EMP18 ..."

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 05:12, revealed "Ifex 500 mg+ Mesnex 100 mg ... IV Chemo, Infusaport ... Perform: EMP18 10/6/2015 03:08; Witness: EMP27 10/6/2015 03:08; Modify: EMP18 10/6/2015 05:11; Witness: EMP27 10/6/2015 05:11; Verify: EMP18 ... Result comment: EMP18 Chemo started late as port clotted and had to be reaccessed. ..."

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 04:32, revealed "Mesna ... IV Chemo, Infusaport ... Perform: EMP18; Witness: EMP23 10/6/2015 04:32; Verify: EMP18 ..."

On January 26, 2016, at 3:33 PM, a request was submitted to EMP9 for documentation of specialized training in chemotherapy medications for the nurses who administered chemotherapy medication to the patient on October 2, 3, 4, 5, and 6.

Review of documents submitted to the Department, on January 28, 2016, at 4:36 PM, by EMP9 revealed no documented evidence that EMP20 and EMP23, who participated in the administration and verification process of the administration of chemotherapy medications, were chemotherapy certified in accordance with facility policy.

Review of correspondence submitted to the Department, on February 11, 2016, at 11:39 AM, from EMP9 revealed that the facility does not "specify that the second professional must be APHON [Association of Pediatric Hematology/Oncology Nurses] Biotherapy certified."

On March 8, 2016, at 3:13 PM, another request containing a list of additional nurses who administered chemotherapy medication to the patient was submitted to EMP9.

Review of correspondence submitted to the Department, on March 9, 2016, at 12:42 PM, by EMP9, revealed that EMP24, EMP26 and EMP27, who participated in the administration and verification process of the administration of chemotherapy medications, were not chemotherapy certified in accordance with facility policy.

Based on review of medical records (MR), review of facility documents and policies, and interview with staff (EMP), it was determined that the facility failed to prepare and administer medications in accordance with acceptable standards of practice for one of one medical records reviewed (MR1).

Findings include:

Review of facility policy "Rights and Responsibilities of Patients," dated January 14, 2014, revealed "I) Policy: 1) St. Christopher's Hospital for Children is committed to providing the best possible care to children and youth in a family-centered environment. ... II) Patient Rights: Patients and/or parents or guardians acting on behalf of the patient have a right: ... 3) To provide considerate, respectful care given by competent personnel, including consideration of the psychosocial. spiritual and cultural variables that influence perception of illness. ... 18) To good quality care and high professional standards that are continually maintained and reviewed. ...25) To expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and to avoid the personal discomfort of the patient and family. The patient and the family have the right to expect reasonable safety insofar as hospital practices ... ."

Review of facility policy "High Risk Medications Management (High Alert)," dated March 2014, revealed "I. Policy SCHC will develop and maintain a list of High Risk Medications. Medications and medication classes on this list will be subject to greater control due to the high potential for errors or consequences of errors. II. Purpose To outline processes for defining, communicating, and enforcing medication management safety measures to promote safe use of high alert high risk medications and reduce medication errors and their consequences. III. Procedure A. Definitions 1. High risk medications: Medications that bear heightened risk of causing significant patient harm when used in error (Institute for Safe Medication Practice ISMP). ... B. Processes will be in effect at every stage of medication management that relates to high risk medication use. ... 3. Prescribing/Transcribing ... c. Dose range checking is utilized in both PowerChart CPOE and PharmNet. d. When high risk medications are ordered by the provider using an alternative to CPOE, e.g., chemotherapy protocols ... , the relevant orders will be transcribed by the pharmacist into PharmNet and thus into the eMar and PowerChart. e. Down time handling of orders will include double check by the pharmacist of all high risk medication orders and adherence to downtime policies for nursing and providers. 4. Preparation/Dispensing a. Independent double check by the person who prepares the high risk medication and a second person (one of who must be a licensed pharmacist) are mandatory. ... 5. Administration ... b. Independent confirmation of the order and visual confirmation of the medication label by two licensed personnel must occur prior to administration of the medication. ... 6. Monitoring a. Medication events are reported according to the event reporting policy. ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplatin x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 "Physicians' Orders," dated October 1, 2015, timed 1030, revealed "... Etoposide (33mg/kg) or 280 mg IV diluted in 100 cc NS to be infused over 2 hour at 50 cc/hr. Repeat for 5 days. ... Ifosfamide (60 mg/kg) or 500 mg with MESNA (12mg/kg) 100 mg IV combined & diluted in D5 1/2 NS(200ml/m2) or 80 cc to run over 1 hour at 80 cc/hour. Repeat for 5 days." The physicians' order, written by EMP17 and countersigned by EMP13, did not clarify the location and type of intravenous access device that was to be utilized for administration of chemotherapy medications to the patient.

Review of MR1 "Nursing/Clinical Info," dated October 3, 2015, performed at 06:59, by EMP18 revealed "... 01:00: Etoposide given over 2 hrs via left chest port. ... Pt. tolerate well and no adverse reactions noted. ..."

Review of MR1 "Nursing/Clinical Info," dated October 6, 2015, performed at 04:55, by EMP18 revealed "...01:00: Etoposide given over 2 hours via right chest port. Towards middle to end of infusion, pump kept beeping occluded, port flushed with heparin, + blood return, but the last 5 cc of flush unable to be given as port clotted off. Port then had to be reaccessed. ... Spoke to pharmacy as chemo precipitated [deposited in solid form from a solution] in line on Sat [Saturday] morning. Per pharmacy, dose is highly concentrated because of pt. weight and this is causing the precipitate which then clotted the port. ..."

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 13:44, revealed "Mesna 100 mg 1 mL; d5i25 25 mL IV Chemo, Saphenous [vein in the leg] Left ... Perform: EMP28; Witness: EMP29 10/6/2015 13:44; Verify EMP28 ... ."
Review of MR1 revealed no documented evidence that a physician's order was obtained to administer Mesna through a vein in the patient's leg. Further review of MR1 revealed a discrepency as to the location of the actual port that was being utilized to administer chemotherapy medication.

Review of M1 "Physician Progress Notes," dated October 6, 2015, timed: 19:14, revealed " ... This morning I [EMP14] was notified of a severe medication error involving the VP-16 (Etoposide) that [patient] had received for the past 5 days. It was found to be a typographical error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... This is 10x the daily dose we intended for [patient]. ... "

Review of MR1 "Discharge Summary," dated October 8, 2015, revealed "... Hospital Course: Onc [oncology]: Completed 2nd cycle of chemotherapy per protocol, including ... Etoposide ... . The Etoposide precipitated on 10/1, 10/4, and 10/6 due to highly concentrated dose of medication administered, requiring frequent line flushes per nurse. ... On 10/5/15, the last day of [patient's] chemotherapy treatment, the patient was to be discharged but it was discovered that [patient] received an incorrect dose of Etoposide due to an error for the 5 days of chemotherapy. ..."

Review of MR1 revealed no documentation pertaining to the two medication precipitating events that occurred prior to October 6, 2015. Further review of MR1 revealed no documented evidence that the physician was notified and assessed the patient during the two previous medication precipitating events that occurred prior to October 6, 2015. There was no documented evidence that pharmacy was notified.

Interview on January 11, 2016, at 10:00 AM, with EMP1 and EMP10 revealed that on October 6, 2015, EMP11, reviewed the dosing and concentration of Etoposide after being notified by EMP18 that the medication had precipitated (medication separated from the diluent causing it to be deposited in a solid from a solution) during administration; EMP11 identified that the concentration/dose was too high.

Interview on January 11, 2016, at 10:20 AM, with EMP1 indicated that a root cause analysis (RCA) was performed. EMP1 revealed that they didn't know why it took the facility five days to realize that there was an error with the dosage of Etoposide that was being provided to the patient in MR1. EMP1 indicated that the event was due to a "typographical" error made by EMP13. EMP1 indicated that four oncologists, EMP13, EMP14, EMP15 and EMP16, created the custom "Roadmap" to treat the patient's illness. EMP1 indicated that "the dose was to be 3.3 [mg/kg] not 33 [mg/kg] but EMP13 wrote down '33' instead of '3.3'" and then EMP17 transcribed the order based on what was written on the "Roadmap."

Interview on January 11, 2016, at 10:59 AM, with EMP1 confirmed that there was no documented evidence that nursing notified the physician and/or pharmacy of the medication precipitating event on October 2, 2015. EMP1 indicated that "'most' of the medication was administered by the time it was realized." EMP1 revealed that EMP18 completed an internal report regarding the event and that, according to EMP1, under "what actions were taken" EMP18 documented "no treatment necessary." At 11:09 AM EMP1 revealed that nursing is aware of the causes related to a medication precipitating and indicated that if the patient received "most" of the medication then pharmacy would not be contacted. EMP1 revealed that that facility does not have a policy related to this process.

Review of MR1 revealed no documented evidence regarding the exact amount of medication that the patient received during the first precipitating event that occurred on October 2, 2015 or the second precipitating event that occurred on October 4, 2015. Furthermore, there was no documented evidence that the physician and/or pharmacy was notified of the medication precipitating event that occurred on October 4, 2015, prior to October 6, 2015.

The facility failed to prepare and administer medications in accordance with acceptable standards of practice.

Based on review of medical records (MR), review of facility policy and procedures and interview with staff (EMP) it was determined that the facility failed to maintain a complete medical record for one of one medical records reviewed (MR1).

Findings include:

Review of facility policy "Charting Guidelines, Medical Records," dated October 25, 2012, revealed "I) POLICY: To ensure that St. Christopher's Hospital for Children has medical records that are clear and legible; the following charting guidelines shall be forwarded by all staff that has responsibility for documenting patient care and/or status. II) PROCEDURE: ... d) Each entry shall be signed by the individual making the entry. ... f) Documentation shall record precisely what was stated, observed, or reported and what professional services were rendered to the patient. ... h) All entries in a patient's medical record shall be consistent and noncontradictory; information recorded in one section of the record must be consistent with information recorded in other locations. i) All entries shall be read before countersigning. Countersignature attests to the authenticity of what has been written. ... 3) All atypical treatments shall be recorded with explanation as to why the treatments were rendered. a) All usual occurrences/incidents such as falls, medication errors, equipment malfunctions, and emergency situations shall be documented in the record. b) In all incidents, the recorder should objectively document only what was actually witnessed or observed. ... 5) The record must reflect ... physical condition, ... time physicians were notified, and the details of treatment ordered or rendered. ... 8) Physician, specialist, and consultant vitals to the patient and the professional services rendered shall be charted in the progress notes and on a consult form. 9) Documentation shall include: (i) Patient's ... responses to treatment ... . 14) Charting must be objective and leave no room for conjecture, doubt, or misunderstanding of what is being recorded. ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 revealed a customized "Roadmap" (a treatment protocol that contains a list of medications and dosing information to be utilized to treat a patient's specific condition) that was developed to treat the patient ' s rare form of cancer. Review of the "Roadmap" revealed " ... ICE Courses: cycles 2 ... Wt. 8.6 kg ... Ifosamide [chemotherapy medication]1800 mg m2/dose (60 mg/kg/dose if age <1 yr) days 1-5; Mesna [chemotherapy medication]360 mg/m2/dose (12 mg/kg if age <1 yr) x 5 doses: 1st dose in bag with Ifos. Dose 2 over 3 hr CI, doses 3-5 at hr 3, 6, 9. Give 100% mesna. ... Etoposide [chemotherapy medication] 100 mg/m2/day (33mg/kg if age <1 yr) days 1-5. ... " The " Roadmap " revealed the following handwritten calculation for Etoposide " ... 280 mg ... " Further review of the "Roadmap" revealed that the document was not dated, nor was it authenticated by the individual who transcribed the "Roadmap" and performed the calculations contained on the "Roadmap."

Review of MR1 "Physicians' Orders," dated October 1, 2015, revealed " ... Etoposide (33 mg/kg) or 280 mg IV diluted in 100 cc NS to be infused over 2 hours at 50 cc/hr. Repeat 5 days. ... "

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 00:33, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:33; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 4, 2015.

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 00:47, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:21; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 5, 2015.

Interview on January 11, 2016, at 10:30 AM, with EMP1 revealed that nursing "documents by exception" meaning that "they document unusual occurrences."

Interview on February 4, 2016, at 9:09 AM, with EMP10 revealed that literature was used to develop the patient's treatment protocol, a customized "Roadmap." EMP10 revealed that the literature was not include in the patient's medical record nor was it sent to pharmacy, with the "Roadmap" and physician orders.

Based on review of medical records (MR), review of facility policies and procedures and interview with staff (EMP), it was determined that the facility failed to adequately document complications for one of one medical record reviewed (MR1).

Findings include:

Review of facility policy "Charting Guidelines, Medical Records," dated October 25, 2012, revealed "I) POLICY: To ensure that St. Christopher's Hospital for Children has medical records that are clear and legible; the following charting guidelines shall be forwarded by all staff that has responsibility for documenting patient care and/or status. II) PROCEDURE: ... d) Each entry shall be signed by the individual making the entry. ... f) Documentation shall record precisely what was stated, observed, or reported and what professional services were rendered to the patient. ... h) All entries in a patient's medical record shall be consistent and noncontradictory; information recorded in one section of the record must be consistent with information recorded in other locations. i) All entries shall be read before countersigning. Countersignature attests to the authenticity of what has been written. ... 3) All atypical treatments shall be recorded with explanation as to why the treatments were rendered. a) All usual occurrences/incidents such as falls, medication errors, equipment malfunctions, and emergency situations shall be documented in the record. b) In all incidents, the recorder should objectively document only what was actually witnessed or observed. ... 5) The record must reflect ... physical condition, ... time physicians were notified, and the details of treatment ordered or rendered. ... 8) Physician, specialist, and consultant vitals to the patient and the professional services rendered shall be charted in the progress notes and on a consult form. 9) Documentation shall include: (i) Patient's ... responses to treatment ... . 14) Charting must be objective and leave no room for conjecture, doubt, or misunderstanding of what is being recorded. ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 "Medication Administration," dated October 2, 2015, timed: 00:52, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP19] 10/02/2015 00:52; Verify: [EMP18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 2, 2015, performed at 06:19, by EMP18 revealed "Nursing Note: 7p-7a: Received pt. at 2030 from 5w. NGT feeds started per home regime at 2030. 55mls/hr for a total of 660mls. Retching once overnight and small emesis around 5:30. Feeds held at small intervals. UA obtained and sent, results wnl to begin chemo. 2315: Loading dose of zofran given. 2400: Carboplatin given via left chest port over one hour. 0100: VP-16 [another name for Etoposide] given over 2 hours. BP's checked Q15 min and remained stable. 0300: Ifosphamide [sic] given over one hour. + blood return pre/during/post chemo. 0400: 3 hour Mesna infusion started. 0415: Temp 38.4 MD [physician's name] informed and evaluated. Dr. [EMP15] informed. Per MD orders bld cx's x 2 obtained, tylenol given, tobra and zosyn given (abx compatible with Mesna per pharmacy). Mesna boluses to be given hrs 3, 9, 12. [Patient's parent] attentive at bedside, pt. resting comfortably, will continue to monitor."

Review of MR1 "Medication Administration," dated October 3, 2015, timed: 00:53, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP20] 10/03/2015 00:53; Verify: [EMP 18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 3, 2015, performed at 06:59, by EMP18 revealed "... 01:00: Etoposide given over 2 hrs via left chest port. ... Pt. tolerate well and no adverse reactions noted. ..."

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 00:33, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:33; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 4, 2015.

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 00:47, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:21; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 5, 2015.

Review of MR1 "Medication Administration," dated October 6, 2015, timed: 00:55, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP18] ; Witness: [EMP23] 10/04/2015 00:55; Verify: [EMP18] ... ."

Review of MR1 "Nursing/Clinical Info," dated October 6, 2015, performed at 04:55, by EMP18 revealed "...01:00: Etoposide given over 2 hours via right chest port. Towards middle to end of infusion, pump kept beeping occluded, port flushed with heparin, + blood return, but the last 5 cc of flush unable to be given as port clotted off. Port then had to be reaccessed. ... Spoke to pharmacy as chemo precipitated [deposited in solid form from a solution] in line on Sat [Saturday] morning. Per pharmacy, dose is highly concentrated because of pt. weight and this is causing the precipitate which then clotted the port. ..."

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Review of MR1 "Discharge Summary," dated October 8, 2015, authenticated by EMP14, at 10:50, revealed " ... Hospital Course: ONC [Oncology]: Completed 2nd cycle of chemotherapy per protocol, including ... Etoposide ... The Etoposide precipitated on 10/1, 10/4, and 10/6 due to the highly concentrated dose of medication administered, requiring frequent line flushes per nurse. ..."

Review of MR1 revealed a discrepancy in between the date when the patient's medication first precipitated. Review of MR1 revealed that the administration of chemotherapy was started on the patient on October 2, 2015.

Further review of MR1 revealed no documentation pertaining to the two medication precipitating events that occurred prior to October 6, 2015.

Interview on January 11, 2016, at 10:30 AM, with EMP1 revealed that the medication precipitated on October 2, 2015, that caused the patient "temporary harm," and that the site had to be re-accessed. EMP1 revealed that a medication can precipitate if the concentration is too high or if there is not enough diluent. EMP1 confirmed that nursing is aware of what can cause a medication to precipitate. EMP1 confirmed that nursing did not document this event in the patient's medical record and revealed that nursing "documents by exception" meaning that "they document unusual occurrences." EMP1 confirmed that nursing should have documented this event in the patient's medical record. At 10:59 AM EMP1 indicated that "'most' of the medication was administered by the time it was realized."

Review of MR1 revealed no documented evidence regarding the exact amount of medication that the patient received during the first precipitating event on October 2, 2015 and during the second precipitating event that occurred on October 4, 2015.

Based on review of medical records (MR), review of facility policy and procedures and interview with staff (EMP), it was determined that the facility failed to ensure that necessary information was included in a patient's medical record in order to adequately monitor a patient's condition and provide appropriate care for one of one medical record reviewed (MR1).

Findings include:

Review of facility policy "Charting Guidelines, Medical Records," dated October 25, 2012, revealed "I) POLICY: To ensure that St. Christopher's Hospital for Children has medical records that are clear and legible; the following charting guidelines shall be forwarded by all staff that has responsibility for documenting patient care and/or status. II) PROCEDURE: ... d) Each entry shall be signed by the individual making the entry. ... f) Documentation shall record precisely what was stated, observed, or reported and what professional services were rendered to the patient. ... h) All entries in a patient's medical record shall be consistent and noncontradictory; information recorded in one section of the record must be consistent with information recorded in other locations. i) All entries shall be read before countersigning. Countersignature attests to the authenticity of what has been written. ... 3) All atypical treatments shall be recorded with explanation as to why the treatments were rendered. a) All unusual occurrences/incidents such as falls, medication errors, equipment malfunctions, and emergency situations shall be documented in the record. b) In all incidents, the recorder should objectively document only what was actually witnessed or observed. ... 5) The record must reflect ... physical condition, ... time physicians were notified, and the details of treatment ordered or rendered. ... 8) Physician, specialist, and consultant vitals to the patient and the professional services rendered shall be charted in the progress notes and on a consult form. 9) Documentation shall include: (i) Patient's ... responses to treatment ... . 14) Charting must be objective and leave no room for conjecture, doubt, or misunderstanding of what is being recorded. ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 revealed a customized "Roadmap" (a treatment protocol that contains a list of medications and dosing information to be utilized to treat a patient's specific condition) that was developed to treat the patient ' s rare form of cancer. Review of the "Roadmap" revealed " ... ICE Courses: cycles 2 ... Wt. 8.6 kg ... Ifosamide [chemotherapy medication]1800 mg m2/dose (60 mg/kg/dose if age <1 yr) days 1-5; Mesna [chemotherapy medication]360 mg/m2/dose (12 mg/kg if age <1 yr) x 5 doses: 1st dose in bag with Ifos. Dose 2 over 3 hr CI, doses 3-5 at hr 3, 6, 9. Give 100% mesna. ... Etoposide [chemotherapy medication] 100 mg/m2/day (33mg/kg if age <1 yr) days 1-5. ... " The " Roadmap " revealed the following handwritten calculation for Etoposide " ... 280 mg ... "

Review of MR1 "Nursing/Clinical Info," dated October 2, 2015, performed at 06:19, by EMP18 revealed "Nursing Note: 7p-7a: Received pt. at 2030 from 5w. NGT feeds started per home regime at 2030. 55mls/hr for a total of 660mls. Retching once overnight and small emesis around 5:30. Feeds held at small intervals. UA obtained and sent, results wnl to begin chemo. 2315: Loading dose of zofran given. 2400: Carboplatin given via left chest port over one hour. 0100: VP-16 [another name for Etoposide] given over 2 hours. BP's checked Q15 min and remained stable. 0300: Ifosphamide [sic] given over one hour. + blood return pre/during/post chemo. 0400: 3 hour Mesna infusion started. 0415: Temp 38.4 MD [physician's name] informed and evaluated. Dr. [EMP15] informed. Per MD orders bld cx's x 2 obtained, tylenol given, tobra and zosyn given (abx compatible with Mesna per pharmacy). Mesna boluses to be given hrs 3, 9, 12. [Patient's parent] attentive at bedside, pt. resting comfortably, will continue to monitor."

Review of MR1 "Medication Administration," dated October 4, 2015, timed: 00:33, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:33; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 4, 2015.

Review of MR1 "Medication Administration," dated October 5, 2015, timed: 00:47, revealed "Etoposide 280 mg 14 mL; ns100 100 mL IV Chemo, Infusaport ... Perform: [EMP21] ; Witness: [EMP22] 10/04/2015 00:21; Verify: [EMP21] ... ."

Review of MR1 revealed no "Nursing/Clinical Info" documentation during the infusion of Etoposide on October 5, 2015.

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Review of MR1 "Discharge Summary," dated October 8, 2015, authenticated by EMP14, at 10:50, revealed " ... Hospital Course: ONC [Oncology]: Completed 2nd cycle of chemotherapy per protocol, including ... Etoposide ... The Etoposide precipitated on 10/1, 10/4, and 10/6 due to the highly concentrated dose of medication administered, requiring frequent line flushes per nurse. ..."

Interview on January 11, 2016, at 10:30 AM, with EMP1 revealed that the medication precipitated on October 2, 2015, that caused the patient "temporary harm," and that the site had to be re-accessed. EMP1 confirmed that nursing did not document this event in the patient's medical record.

Interview on February 4, 2016, at 9:00AM, with EMP9 revealed that EMP13 typed the customized "Roadmap."

Interview on February 4, 2016, at 9:09 AM, with EMP10 revealed that literature was used to develop the patient's treatment protocol, the customized "Roadmap." EMP10 revealed that the literature was not included in the patient's chart nor was it sent to pharmacy to allow for pharmacy to review with the "Roadmap" prior to filling the orders. EMP10 revealed that the literature used to develop customized "Roadmaps" would "sometimes" be sent to pharmacy, "but not always." EMP10 revealed that the facility did not have an established policy for this process.

The facility failed to ensure that necessary information was included in a patient's medical record in order to adequately monitor a patient's condition and provide appropriate care.

Based on review of medical records (MR), review of facility policies and procedures and interview with staff (EMP), it was determined that the facility failed to provide pharmaceutical services that met the needs of a patient by promoting a safe medication use process as evidence by: failing to ensure that all pharmacists engaging in the preparation and dispensing of chemotherapy medications received specialized training in order to provide quality services, maintain competency and meet the needs of the patient population being served (A0493); and failing to ensure that medication orders were adequately reviewed for appropriateness and prepared, in accordance with facility policy, prior to dispensing (A500).

Cross Reference:
482.13 Patient Rights
482.13(c)(2) Patient Rights: Care in Safe Setting
482.25(a)(2) Pharmacy Personnel
482.25(b) Delivery of Drugs

Based on review of medical records (MR), review of facility policy and procedures and interview with staff (EMP), it was determined that the facility failed to ensure that all pharmacists engaging in the preparation and dispensing of chemotherapy medications received specific training in order to provide quality services, maintain competency and meet the needs of the patient population being served for one of one medical record reviewed (MR1).

Findings include:

Review of facility policy "Rights and Responsibilities of Patients," dated January 14, 2014, revealed "I) Policy: 1) St. Christopher's Hospital for Children is committed to providing the best possible care to children and youth in a family-centered environment. ... II) Patient Rights: Patients and/or parents or guardians acting on behalf of the patient have a right: ... 3) To provide considerate, respectful care given by competent personnel, including consideration of the psychosocial. spiritual and cultural variables that influence perception of illness. ... 18) To good quality care and high professional standards that are continually maintained and reviewed. ...25) To expect good management techniques to be implemented within the hospital considering effective use of the time of the patient and to avoid the personal discomfort of the patient and family. The patient and the family have the right to expect reasonable safety insofar as hospital practices ... ."

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplatin x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 revealed a customized "Roadmap" (a treatment protocol that contains a list of medications and dosing information to be utilized to treat a patient's specific condition) that was developed to treat the patient ' s rare form of cancer. Review of the "Roadmap" revealed " ... ICE Courses: cycles 2 ... Wt. 8.6 kg ... Ifosfamide [chemotherapy medication]1800 mg m2/dose (60 mg/kg/dose if age <1 yr) days 1-5; Mesna [chemotherapy medication]360 mg/m2/dose (12 mg/kg if age <1 yr) x 5 doses: 1st dose in bag with Ifos. Dose 2 over 3 hr CI, doses 3-5 at hr 3, 6, 9. Give 100% mesna. ... Etoposide [chemotherapy medication] 100 mg/m2/day (33mg/kg if age <1 yr) days 1-5. ... " The " Roadmap " revealed the following handwritten calculation for Etoposide " ... 280 mg ... "

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Interview on January 11, 2016, at 10:13 AM, with EMP10 revealed that the " 'normal chemo' pharmacist, [EMP4]," was not working during the time Etoposide was prepared and dispensed to the patient in MR1. EMP10 revealed that the pharmacists who prepared and dispensed the Etoposide don't frequently prepare chemotherapy medications. EMP1 indicated that the pharmacists are not certified in chemotherapy medication preparation and that there is no facility policy that requires it. EMP1 revealed that these pharmacists "have been here for years but that they received training during orientation on pediatric dosing and mixing chemotherapy medications." EMP10 revealed that as a result of the medication error, involving Etoposide, the pharmacists working in oncology will rotate as to who prepares chemotherapy medications in order to maintain competency.

On January 26, 2016, at 9:03 AM, a request was submitted to EMP9 for a list of the actual pharmacists who prepared and dispensed Etoposide on October 2, 3, 4, 5, and October 6, 2015. EMP 9 was also asked for a copy of their last training/education that each pharmacist received regarding chemotherapy pharmacy.

Review of correspondence submitted to the Department, on January 28, 2016, at 4:22 PM, from EMP9 revealed that the facility did not have record as to which pharmacists actually prepared and dispensed Etoposide each day. EMP9 indicated that the pharmacist signs the label after it is printed, but then the label is discarded once the medication is finished. EMP9 revealed that there are no specialized educational requirements or oncology specific requirements that are required of the pharmacists in order to work in oncology. EMP9 indicated that " ... pharmacists orient with [EMP4] in the oncology clinic checking and verifying orders and learning the processess involved until they feel that they can handle clinic and chemotherapy admissions. This is usually a 3 to 6 month period depending on it they have any prior experience. "

The facility failed to ensure that all pharmacists engaging in the preparation and dispensing of chemotherapy medications received specific training in order to provide quality services, maintain competency, and meet the needs of the patient population being served.

Based on review of medical records (MR), review of facility policies and procedures and interview with staff (EMP), it was determined that the facility failed to ensure that medication orders were adequately reviewed for appropriateness and prepared, in accordance with facility policy, prior to dispensing for one of one medical record reviewed (MR1).

Findings include:

Review of facility policy "Chemotherapy and Hazardous Medication Management," dated March 2014, revealed " I. Policy A. Special precautions will be taken whenever processing orders for cytotoxic drugs to minimize the possibility of a medication misadventure. B. All personnel will be familiar with the procedures for handling antineoplastic medications and follow them when preparing, dispensing, administering, ... these medications. ... II. Purpose Certain medications carry unique hazards. This policy promotes knowledge and understanding of these effects and how to mitigate them except as applied to patient therapy. Policy will dictate the handling of these medications in a way that promotes better patient care and safety ... . IV. Procedure A. Chemotherapy ... 2. Order processing, preparation and handling a. The pharmacist receiving the order (pharmacist #1) i. Will review the order for patient appropriateness and clarify the order with the ordering heme/onc attending when necessary. ii. Will check the pertinent laboratory data iii. Will enter the order into the computer to generate a patient charge and a label for the drug which includes: ... k) Initials of preparer and the checker ... iv. Must retrieve the patient chemotherapy profile in the Oncology Clinic (if it exists) or create a new patient folder and profile. ... b. Pharmacist #1 will complete the Pharmacy Drug Profile sheets for each drug in the order; Pharmacist #2 will verify the work. ... d. Each chemotherapeutic agent must be admixed individually by a pharmacy technician and all work checked by a pharmacist. i. Chemotherapeutic agents will be prepared by personnel specially trained in chemotherapy handling. ... e. Both pharmacists will retrieve and review the label, the order, and the patient profile; then review admixing instructions with the pharmacy technician utilizing package inserts and other references needed. f. Prior to having a certified chemo technician complete the preparation of products, the pharmacist will call a second pharmacist (pharmacist #2) to check the following: i. The original orders against the printed label and all calculations ii. The original orders against the protocol and roadmap (chemotherapy profile) ... g. ... vi. The preparer will affix the prepared label and precautionary labels to the final product and indicate completeness by initialing the chemotherapy profile. h. The pharmacist witnesses the technician completing the preparation, initials the label, and initials the chemotherapy profile. ... j. The patient chemotherapy order form will be placed in the chemotherapy file for future reference. ... "

Review of facility policy "High Risk Medications Management (High Alert)," dated March 2014, revealed "I. Policy SCHC will develop and maintain a list of High Risk Medications. Medications and medication classes on this list will be subject to greater control due to the high potential for errors or consequences of errors. II. Purpose To outline processes for defining, communicating, and enforcing medication management safety measures to promote safe use of high alert high risk medications and reduce medication errors and their consequences. III. Procedure A. Definitions 1. High risk medications: Medications that bear heightened risk of causing significant patient harm when used in error (Institute for Safe Medication Practice ISMP). ... B. Processes will be in effect at every stage of medication management that relates to high risk medication use. ... 3. Prescribing/Transcribing ... c. Dose range checking is utilized in both PowerChart CPOE and PharmNet. d. When high risk medications are ordered by the provider using an alternative to CPOE, e.g., chemotherapy protocols ... , the relevant orders will be transcribed by the pharmacist into PharmNet and thus into the eMar and PowerChart. e. Down time handling of orders will include double check by the pharmacist of all high risk medication orders and adherence to downtime policies for nursing and providers. 4. Preparation/Dispensing a. Independent double check by the person who prepares the high risk medication and a second person (one of who must be a licensed pharmacist) are mandatory. ...".

Review of MR1 "History and Physical," dated October 1, 2015, revealed that the patient was admitted to the hospital's OTU for inpatient chemotherapy treatment. Further review of MR1 "History and Physical" revealed " ... 1. Oncology: Admit for ICE chemotherapy: carboplain x 1 day, ifosamide/etoposide x 5 days with mg/kg dosing as [patient] is < [less than] 1 year old. ..."

Review of MR1 revealed a customized "Roadmap" (a treatment protocol that contains a list of medications and dosing information to be utilized to treat a patient's specific condition) that was developed to treat the patient ' s rare form of cancer. Review of the "Roadmap" revealed " ... ICE Courses: cycles 2 ... Wt. 8.6 kg ... Ifosamide [chemotherapy medication]1800 mg m2/dose (60 mg/kg/dose if age <1 yr) days 1-5; Mesna [chemotherapy medication]360 mg/m2/dose (12 mg/kg if age <1 yr) x 5 doses: 1st dose in bag with Ifos. Dose 2 over 3 hr CI, doses 3-5 at hr 3, 6, 9. Give 100% mesna. ... Etoposide [chemotherapy medication] 100 mg/m2/day (33mg/kg if age <1 yr) days 1-5. ... " The " Roadmap " revealed the following handwritten calculation for Etoposide " ... 280 mg ... "

Review of MR1 "Physicians' Orders," dated October 1, 2015, revealed " ... Etoposide (33 mg/kg) or 280 mg IV diluted in 100 cc NS to be infused over 2 hours at 50 cc/hr. Repeat 5 days. ... "

Review of MR1 "Orders," dated October 1, 2015, revealed " ... Etoposide ... Order Details: 280 mg= 14 mL, Injection, IV Chemo, ... Pharmacist Verify: Electronically Signed, EMP12 on 10/1/2015 16:10 ...".

Review of MR1 "Nursing/Clinical Info," dated October 6, 2015, performed at 04:55, by EMP18 revealed "...01:00: Etoposide given over 2 hours via right chest port. Towards middle to end of infusion, pump kept beeping occluded, port flushed with heparin, + blood return, but the last 5 cc of flush unable to be given as port clotted off. Port then had to be reaccessed. ... Spoke to pharmacy as chemo precipitated [deposited in solid form from a solution] in line on Sat [Saturday] morning. Per pharmacy, dose is highly concentrated because of pt. weight and this is causing the precipitate which then clotted the port. ..."

Review of MR1 "Physician Progress Notes," dated October 6, 2015, authenticated by EMP14, at 20:49, revealed "This morning I was notified of a severe medication error involving the VP-16 (Etoposide) that [Patient] had received for the past 5 days. It was found to be a typographic error on the custom roadmap lead to a dose of 33 mg/kg/day per dose instead of the 3.3 mg/kg/day per dose based on the typical dosing of 100mg/M2 per day. The VP-16 was already finished when the error was discovered. ... due to the error [patient] received the above noted dose of Etoposide (VP-16). This is 10x the daily dose we intended for [patient]. ... I was very concerned that this error could have severe, life threatening and used the word lethal consequences. ... I explained that this was due to a decimal error on the custom roadmap. ... I told [patient's parent] that it was my responsibility as the Section Chief. ... They assured [patient's parent] that an exhaustive review of this would occur. ..."

Review of MR1 "Discharge Summary," dated October 8, 2015, authenticated by EMP14, at 10:50, revealed " ... Hospital Course: ONC [Oncology]: Completed 2nd cycle of chemotherapy per protocol, including ... Etoposide ... The Etoposide precipitated on 10/1, 10/4, and 10/6 due to the highly concentrated dose of medication administered, requiring frequent line flushes per nurse. ... RESIDENT A/P Assessment: ... After discovering the incorrect Etoposide dose, [the patient] was closely monitored. ... Patient is being closely monitored for possible liver, renal, bone marrow, neurologic, and respiratory damage secondary to potential Etoposide toxicity. Plan: Oncology: Completed chemotherapy 10/6 ... patient awaiting transfer to [another health care facility] on 10/6/2015. ..."

Interview on January 11, 2016, at 10:00 AM, with EMP1 and EMP10 revealed that EMP12 and EMP31 prepared and dispensed the Etoposide on on October 2, 2015 but they were unsure as to who prepared and dispensed the Etoposide on October 3, 4, 5, and October 6, 2015. EMP1 indicated that pharmacy only verifies the order once for a "multiple fill order," they do not complete the full verification process on each day the medication is being prepared and dispensed. EMP1 indicated that the pharmacists receive the order and check it with the "Roadmap" and then verify the dose.

Review of correspondence submitted to the Department, on January 28, 2016, at 4:22 PM, from EMP9 revealed that the facility did not have record as to which pharmacists actually prepared and dispensed Etoposide each day. EMP9 indicated that the pharmacist signs the label after it is printed, but then the label is discarded once the medication is finished.

There was no documented evidence that pharmacy reviewed the physician's order for accuracy and appropriateness, nor completed the verification and check proces, in accordance with facility policy.