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Based on record review and interview, the hospital failed to provide a safe environment for 1 (P #1) of 20 (P #1 through #20) patients sampled by failing to 1) ensure that the dose of medication administered was appropriate and correct for a 20-day old infant and 2) double check infant dose of antibiotic prior to administration per facility pediatric medication administration policies and procedures. This deficient practice resulted in P #1 recieving an overdose of antibiotic which has the potential to cause kidney problems and irreversible hearing problems, and could result in significant injury and/or death to all patients (Refer to A0144).

Based on record review and interview, the hospital failed to provide a safe environment for 1 (P #1) of 20 (P #1 through #20) patients sampled by failing to ensure that the dose of medication administered was appropriate and correct for a 20-day old infant and failed to double check infant dose of antibiotic prior to administration per facility pediatric medication administration policies and procedures. This deficient practice resulted in P #1 receiving an overdose of antibiotic which has the potential to cause kidney problems and irreversible hearing problems, and has the likelihood to result in significant injury and/or death to all patients.


Findings:

Record review of P #1's medical chart revealed the following:

1) P #1's Medication Administration Record revealed on 10/01/18 at 6:06 am, S #13 administered 80 mg Gentamicin to P #1 at the rate of 80 mL/hr (milliliters per hour) over 1 hour, dispensed: 80 mL bag.


2) P #1's History and Physical dated 10/01/18 revealed "Impression: Pyelonephritis (a sudden and severe kidney infection), neonatal fever and Gentamicin overdose."


On 10/04/18 at 2:40 pm during an interview, S #9 stated, "The baby got too much medication. It was a calculation error. It was my fault. I think S #13 gave the medication. S #9 further stated, "I don't remember any one questioning the dose. Double checks are helpful for pediatrics medications, there should be 2 nurses checking."


On 10/04/18 at 2:55 pm during an interview, S #7 stated the facility pharmacy is open Monday through Friday from 7:30 am to 7:00 pm, and confirmed, "The House Supervisors are to check new orders and if there are problems, they can call pharmacy on-call which is available from 7:00 pm to 7:30 am the next day and on weekend". S #7 also stated, "This would be a med error" and "The nurses should of questioned this".


On 10/04/18 at 3:20 pm during an interview, S #15 stated, "I was called in to see a baby (on 08/16/18) in the morning (time unknown). I was going over lab reports and saw the 80 mg (milligram) dose, when I calculated, it was supposed to be 16 (mg). I told the nurse 'it was too high'. S #15 stated, the consequences (of a high dose of Gentamicin, an antibiotic) are hearing and kidney problems, "Kidney problems are reversible, the ears are not." S #15 revealed that two RNs were mixing and administering the medication and "at some point someone should double checked the medication."


On 10/09/18 at 3:05 pm during an interview, S #14 stated, "For Pediatric patients, 2 nurses have to sign off on the dose and route (of the medication)." When asked if that happened, S #14 stated, "No."


On 10/10/18 at 7:15 am during an interview, S #12 confirmed knowledge of the medication overdose of P #1. S #12 stated, "[Name of S #9] wrote the order for 80 mg of Gentamicin. It sounded high to me. There is a protocol in place for two nurses to double check meds."


Review of facility's Policies and Procedure revealed the following:

1) Medication Management-Medication Orders, dated 10/2002, last revised and approved on 09/2017, revealed the following, "Policy: the ordering, prescribing, and administration of medication will be accomplished according to the following guidelines under Pediatric Medications: Intravenous (IV) or intramuscular medication which needs to be calculated prior to administration to pediatric patients in the ED are to be verified by two (2) licensed RN's. Medication dosages for neonatal patients are to be verified by two licensed RN's.

2) Pediatric Medication Administration Guidelines, dated 07/2011, last revised and approved on 12/2017 reveals the following: "Policy - Nurses should follow guidelines to safely and effectively provide medications to patients. Purpose: to provide guidelines for the administration of prescribed medications to pediatric patients. General instructions: The nurse administering the dose shall verify dose with medication reference, in addition to verifying medication dose with another registered nurse. Intramuscular Injections: Maximum of amounts of solutions to be administered intramuscularly in one site: new born and infants 1/2 milliliter (ML).

3) Medication Management - After Hours Acquisition, Retrospective Review, dated 05/2014, last revised 08/2016. "Pharmacy Policy. The House Supervisor shall review the order for appropriateness of the medication, dose, frequency, and route of administration. The services of a licensed pharmacist will be provided 24 hours a day (onsite or on-call).

Based on record review and interview, the facility failed to ensure that medications were prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient's care as specified under §482.12(c), and accepted standards of practice for 1 patient (P #1) of 10 (P #1 through P #10) sampled patients. This deficient practice resulted in P #1 receiving an overdose of antibiotic which has the likelihood to cause kidney problems and irreversible hearing problems, and has the likelihood to result in significant injury and/or death to all patients.


Fndings:

Record review of P #1's medical chart revealed the following:

1) P #1's Medication Administration Record revealed on 10/01/18 at 6:06 am S #13 administered 80 mg Gentamicin to P #1 at the rate of 80ml/hr over 1 hour, dispensed: 80 mL bag.

2) Page 11 of P #1's "Labs" ED notes revealed, "Gentamicin dose was 80 mg. Mother was informed of the overdosing of the Gentamicin. Poison Control has monitored the case and repeat Gentamicin levels have shown to be decreasing. The highest level obtained was 13.4 with peak levels range should be 5-10".

3) P #1's History and Physical dated 10/01/18 revealed "Impression: Pyelonephritis (a sudden and severe kidney infection), neonatal fever, and Gentamicin overdose."



On 10/04/18 at 2:30 pm during an interview, S #8, stated, "There was a complaint about 2 days ago when a patient (P #1), an infant, was brought into the Emergency Department (ED) with a fever. There was an order for 80 mg (milligrams) of Gentamicin (Antibiotic). S #8 stated, "[P #1] weighed around 4 kilos (8.1 pounds) in weight. [Staff S #14], the charge nurse at the time, got the Gentamicin and a bag of fluid and asked S #9 if it was the correct amount to put the antibiotic in the 100 milliliters (ml) bag and was told 'yes'. [Staff S#13] came in, looked over the meds and said it was too much". S #8 further stated, "One side effect of the antibiotic is ear/hearing loss."


On 10/04/18 at 2:40 pm during an interview, S #9 stated, "The baby got too much medication. It was a calculation error. It was my fault. I think S #13 gave the medication. S #14 asked about the volume (it was being mixed with)." S #9 further stated, "I don't remember anyone questioning the dose. Double checks are helpful for pediatrics medications, there should be 2 nurses checking."


On 10/04/18 at 2:55 pm during an interview, S #7 revealed the facility pharmacy is open Monday through Friday from 7:30 am to 7:00 pm, and stated, "The House Supervisors are to check new orders and if there are problems, they can call pharmacy on-call which is available from 7:00 pm to 7:30 am, the next day and on weekends". S #7 confirmed acknowledgment of an incident with P #1 and stated, "[P #1] got 5 times as much as he should of." S #7 confirmed, "This would be a med error" and stated, "The nurses should have questioned this. [P #1] should have gotten 22 mg in 24 hour time frame. The thing that worries me is kidney damage and hearing loss, this is still a possibility of damage."


On 10/04/18 at 3:20 pm during an interview, S #15 stated, "I was called in to see a baby (on 08/16/18) in the morning. I was going over lab reports and saw the 80 mg dose, when I calculated, it was supposed to be 16 mg. I told the nurse 'it was too high'". S #15 revealed, the House Supervisor was told of the issue and stated, "I knew this was a big dose." S #15 stated, "I called Poison Control and ordered a 'Peak and Trough' (blood serum levels of the antibiotic) and then I went and told mom." S #15 stated the consequences (of a high dose of Gentamicin) are hearing and kidney problems, "Kidney problems are reversible, the ears are not." S#15 revealed that two RNs were mixing and administering the medication and "at some point someone should double check the medication."


On 10/04/18 at 3:32 pm during an interview, S#17 stated, "The baby got an extremely high dose of medication. The baby had enough to last almost 48 hours. It was a med error."


On 10/09/18 at 3:05 pm during an interview, S #14 revealed being the Acting Charge Nurse the day P #1 came to the ED and recalled P #1 had a fever, there was suspicion of meningitis (an inflammation of the membranes surrounding your brain and spinal cord), and the antibiotic Gentamicin was given. S #14 stated, "At the time, I didn't realize it was an issue. I didn't notice it was too high (of a dose)." S #14 stated, "For pediatric patients, 2 nurses have to sign off in the dose and route (of the medication)." When asked if that happened, S #14 stated, "No." S #14 further stated, "We talked about it but didn't do the process the way it is suppose to be done. This was a med error."


On 10/10/18 at 7:15 am during an interview, S #12 confirmed knowledge of the medication overdose with P #1. S #12 stated, "[Staff S #9] wrote the order for 80 mg of Gentamicin. It sounded high to me." S #12 stated, "There is a protocol in place for two nurses to double checking meds."


Record review of P #1's "Order Detail" (physician orders/notes throughout P #1's stay at the facility) log, revealed, S #9 ordered a one-time injectable antibiotic, 80 mg of Gentamicin on 10/01/18 at 5:46 am.


Review of facility's Policies and Procedure revealed the following:

1) Medication Management-Medication Orders, dated 10/2002, last revised and approved on 09/2017, reveals the following, "Pediatric Medications: Intravenous (IV) or intramuscular medication which needs to be calculated prior to administration to pediatric patients in the ED are to be verified by two (2) licensed RN's. Medication dosages for neonatal patients are to be verified by two licensed RN's.

2) Pediatric Medication Administration Guidelines, dated 07/2011, last revised and approved on 12/2017, reveals the following: Policy - "Nurses should follow guidelines to safely and effectively provide medications to patients. Purpose: to provide guidelines for the administration of prescribed medications to pediatric patients. General instructions: The nurse administering the dose shall verify dose with medication reference, in addition to verifying medication dose with another registered nurse. Intramuscular Injections: Maximum of amounts of solutions to be administered intramuscularly in one site: new born and infants 1/2 milliliter (ML).

3) Medication Management - After Hours Acquisition, Retrospective Review: dated 05/2014, last revised on 08/2016 reveals, Pharmacy Policy: " The House Supervisor shall review the order for appropriateness of the medication, dose, frequency, and route of administration. The services of a licensed pharmacist will be provided 24 hours a day (onsite or on-call).


Record review of a statement written by S #9 revealed, "I made a tenfold med error on the dose of Gentamicin and did not catch the fact that was obviously too high a dose."


Immediate Jeopordy Findings:

1) On 10/01/18, a 3 week old patient was brought to the facility's Emergency Department (ED) by a parent after the parent struggled to keep the child's temperature down. The patient was given 80 milligrams (mg) of Gentamicin (an antibiotic used to prevent or treat a wide variety of bacterial infections) which was deemed too high for a patient of that age.

2) Staff interviews revealed a medication error occurred and the patient was overdosed which has the likelihood to result in kidney damage and/or irreversible ear and hearing problems.


This resulted in Immediate Jeopardy (IJ) being called due to the severity of the outcome from overdose on 10/04/18 at 3:50 pm. The facility's Chief Execute Officer (CEO) was notified of the IJ and that an immediate plan was required to remove the IJ.


A Plan of Removal was received on 10/05/18 at 7:15 am and was approved at 8:05 am. It is as follows:

Plan of Removal/Corrective Action Plan dated 10/05/18: The facility discovered and addressed 5 issues: 1) Provider dosing calculation error, 2) Independent RN dosing verification did not occur, 3) RN was uncertain ordered dose was correct, verified order with physician, but proceeded to administer incorrect dose despite uncertainty, 4) Parent expressed discomfort with medicating dosing. Nurse proceeded to administer incorrectly ordered dose without independently verifying the medicating dosing and 5) Provider/staff fatigue.

Each issue listed the following sections: Action Plan, a Monitoring and Evaluation, and a Cause. Each also listed a responsible party for overseeing the plan.

Effective immediately: Corrective Action Plans for staff involved in incident, a pediatric's weight based dosages order will be listed in the Emergency Room (ER), two-RN verification will be documented in all three facility electronic records and a high risk medications requiring two-nurse verification, including all pediatric medication will be clearly posted. Policy Pediatric Medication Administration Guidelines will be applied system wide, including ER; the policy will also be combined with Policy Pediatric IV Therapy and revised to include instruction on weight-based dosing and metric weight measurement.

Action Plan items listed for each section also included provider education, peer audits, system review of all Medication Administration Policies, review by Quality Assurance and Performance Improvement (QAPI) and on-going and annual training. The Action Plan will be evaluated weekly by the Chief Quality Officer (CQO) and reported at Administrative Council to ensure all components are progressing as described.

















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