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Based on record review, interview and process review, the facility failed to ensure the nursing staff provided an appropriate amount of blood to give an infant would be when receiving an order to give said blood and, given that information, to evaluate what the potential for harm to the patient would be if administered (A395). This affected one of 39 sampled patients, Patient #32.

Based on medical record review, interview, and process review, the facility failed to evaluate an order for one unit packed red blood cells, about 300 cc of fluid, for the potential for harm when given to a 4.425 kg infant for one patient (Patient #32). The sample size was 39 patients.

Findings:

A review of the facility's blood transfusion process was completed on 12/11/19. The review revealed a lecture slide entitled, "critical thinking," and stated, "A general rule of thumb governing the volume to be infused is based on the patient's weight" and "10 milliliters of blood product is transfused per kg of weight but will vary with each circumstance." The slide concludes, "If an entire unit of blood ... is ordered for an infant, get clarification on the order."

The medical record review for Patient #32 revealed the less than one year old patient was admitted to the facility on 01/04/19 about one week after birth from an outside facility. The medical record contained a history and physical dated 01/04/19 at 7:25 AM that stated the patient was admitted with complaints of poor feeding, increased work of breathing, and ill appearance. The history and physical concluded with diagnoses that included a complete atrio-ventricle canal heart defect.

The medical record review revealed a physician progress note dated 05/04/19 at 8:15 AM that stated the patient required intensive care for fluid management for heart failure. The medical record review revealed the note stated the patient was being treated with two diuretics to maintain fluid balance in the presence of heart failure with "close cardiorespiratory and hemodynamic monitoring." The note stated to watch closely for signs of cardio-respiratory and hemodynamic compromise. The note also stated that packed red blood cells would be given for a low blood count "likely from blood draws."

The medical record review revealed on 05/04/19 at 9:59 AM a physician's order to transfuse one unit packed red blood cells (approximately 300 cc) for a hemoglobin of less than 15 and cyanotic congenital heart disease. The medical record review revealed on 05/04/19 at 4:12 AM the patient had a hemoglobin of 8.3 gm/dl.

A review of the computer screen seen by the ordering physician revealed "If patient weighs less than 20kg, order in milliliters. Typical volume to transfuse is 10-15ml/kg." The medical record review revealed on 05/02/19 at 8:00 AM the patient weighed 4.425 kg.

The medical record review revealed on 05/04/19 at 12:55 PM Staff A and Staff B performed a check on the unit of blood sent from the blood bank. Their co-signatures stated the tag that came with the bag matched the label on the bag of blood, the physician's order was verified, and the right patient was verified by his wristband. The whole unit was transfused on 05/04/19 at 3:55 PM.

The medical record review revealed a physician progress noted dated 05/05/19 at 6:11 AM that stated, "Received 1 unit of blood instead of the 15ml/kg that was intended" and required intravenous Lasix yesterday following transfusion.

On 12/10/19 at 8:30 AM in an interview, Staff A explained the patient was assigned to her and she administered the whole unit of blood. She stated in hindsight she should have looked closer at the amount of volume that was going to be administered.

On 12/11/19 at 8:00 AM in an interview, Staff B verified she checked the blood with Staff A. Staff B stated she denied there being any discussion of the patient's comorbidities, explaining he wasn't her patient, so she didn't ask. She also denied there being any discussion of the amount of volume to be infused as that was not policy.

The medical record review also did not reveal in the nursing notes any discussion of the patient's comorbidities and/or fluid management prior to administration of one full unit of packed red blood cells. The review did not reveal any attempt was made to clarify the order.


On 12/11/19 at 8:00 AM in an interview, Staff B explained the physician order wouldn't state how much blood volume per patient kg would be given. She said the nurse would have to do that in her head. She said 5 to 15 milliliters/kg is the typical amount transfused. She asked to see where the typical volume to transfuse is typically 10 to 15 milliliters/kg. She then stated she hadn't seen, i.e. been unable to access, the screen that the physician sees that states what the typical amount to transfuse is.

On 12/04/19 at 2:30 PM in an interview, Staff C, Staff A's manager, explained when interviewed Staff A stated she wasn't thinking of blood as a fluid, i.e. like a fluid bolus. She said she educated the staff member on that point.

On 12/04/19 at 2:30 PM in an interview, Staff D stated no hospital wide education has been provided regarding the administration of blood products in the settings of fluid management and heart failure.

On 12/04/19 at 2:50 PM in an interview, Staff E stated because of this incident, the process of how blood is ordered and who sees what on the computer screen is being analyzed.

Based on interview, document review, and medical record review, the facility pharmacy failed to have a system in place to determine when nontherapeutic dosages of a medication is dispensed from the pharmacy how many are administered to the patients. This affected 37 of 39 sampled patients, and has a potential to affect all patients in the facility. The facility census was 490 patients.

Findings:

See A500

Based on interview, document review, and medical record review, the facility pharmacy failed to have a system in place to determine when non-therapeutic dosages of a medication is dispensed from the pharmacy how many are administered to the patients (A500). This affected 35 of 39 sampled patients, and has a potential to affect all patients in the facility. The facility census was 490 patients.

Based on interview, document review, and medical record review, the facility failed to ensure pharmacy services were able to reconcile the dosages of Clonidine (classified as a sedative and antihypertensive drug) that was ten times the labeled concentration dispensed, with those that were administered. This affected 39 of 39 patients sampled patients (Patients 1-39).

Findings include:

1. On 12/02/19 at 10:40 AM in an interview, Staff F explained a higher than therapeutic concentration of Clonidine had been prepared in the pharmacy and some had been administered to patients. Staff F then presented a spreadsheet that listed the number of patients and dosages dispensed, but not necessarily administered.

A review of the spreadsheet revealed 39 inpatients had Clonidine dispensed to them. The review revealed in all, 973 dosages were dispensed to 39 in-patients.

On 12/03/19 at 9:00 AM in an interview, Staff F explained that of the 973 dosages that were dispensed, there is no way to determine how many were actually administered.

On 12/09/19 at 5:10 PM in an interview, Staff F explained the pharmacy would draw the ordered amount of Clonidine in syringes (one dose per syringe), and send the syringe(s) to the floor for administration. Staff F said how much was dispensed and how much was administered cannot be determined; a dose could be held or the order changed. Staff F stated the pharmacy software and the clinical record software cannot be linked to determine how much of the drug that was dispensed, was administered.

2. On 12/02/19 at 11:00 AM Staff G explained how the pharmacy prepared and distributed a preparation of Clonidine that had a concentration ten times what was labeled. Staff G presented a copy of a ticker tape and the label of the prepared drug.

A review of both the ticker tape and label revealed 1440 milliliters was to be prepared at a concentration of 0.05mg/milliliters. Hence 72 milligrams of Clonidine would need to be added to 1440 milliliters of solution (.05 x 1440=72mg, therefore 0.072 g). However, a ticker tape from the scale on which the drug was weighed revealed the scale weighed .7249 g of the drug, i.e. 10 times more than the label.

On 12/02/19 at 11:00 AM Staff G explained three 480 milliliters batches were derived from the 1440 milliliters, with one sent to the outpatient pharmacy and two were sent to two different areas in the in-patient pharmacy. Staff G said the drug left the pharmacy on the morning of 10/16/19 and was pulled back on 11/11/19.

On 12/02/19 at 11:00 AM in an interview, Staff G stated the facility is still in the process of performing a failure mode and effects analysis regarding the compounding and distribution of high concentrated Clonidine.

3. On 12/03/19 at 11:10 AM in an interview, Staff H confirmed she could not sort orders of, and administration of, the Clonidine to determine whether the 10 dosages dispensed were administered.

4. On 12/03/19 at 2:45 PM in an interview, Staff I explained he/she discards any unused portions of medications. Staff I stated he/she and the nursing staff on the unit were told a high concentration of Clonidine had been dispensed to the unit. She said the patients on the unit seemed more agitated after they pulled that Clonidine from the unit.

5. On 12/04/19 at 11:23 AM in an interview, Staff J explained the Clonidine would have reached the floors on the morning of 10/23/19 and would've "rippled" out to patients during the day as the current stock was used. Staff J said there was no way to determine when that happened and/or to which patients.

6. On 12/02/19 at 2:15 PM in an interview, Staff K stated some patients who had received the high dose Clonidine had to be tapered down on the drug due to the risk of side effects.

Review of the medical records and
1. The medical record review for Patient #25 revealed a discharge summary dated 11/08/19 that stated the seven-year-old female was admitted for intractable chorea-a neurological disorder characterized by involuntary movements. The discharge summary included in the list of discharge diagnoses "medication complications due to compounding error." The note stated: "Of note, there was a complication during her admission with a compounding error of Clonidine in the pharmacy that resulted in (the patient's) episodes of increased sleepiness and bradycardia causing excess sedation."

A review of medical records and a spreadsheet presented on 12/02/19 at 10:40 AM by Staff F that listed the patients and dosages dispensed to the patients (but not necessarily administered) with and without documented adverse outcomes, as follows:

1. A review of the spreadsheet revealed Patient #25 had 10 dosages of the high concentration dispensed to him/her. On 12/03/19 a review of Patient #25's clinical record could not determine whether all 10 dosages dispensed had been administered.

2. A review of the spreadsheet revealed Patient #31 had one dosage dispensed, but the medical record review for Patient #31 revealed it had not been administered.

3. A review of the spreadsheet revealed Patient #14 had one dosage dispensed, but the medical record review revealed it had not been administered.

4. The medical record review for Patient #20 was completed on 12/11/19. The review revealed a history and physical dated 11/09/19 that stated the three-year-old patient was admitted on 11/09/19 with a chief complaint of lethargy, bradycardia, and delayed capillary refill at the extremities. The note stated the patient began taking liquid Clonidine on 11/06/19 from a bottle dispensed from the facility's pharmacy. The review of the spreadsheet revealed the pharmacy dispensed to Patient #20 two doses of the incorrect Clonidine concentration.

The medical record review revealed a physician progress note dated 11/09/19 at 7:06 PM that stated the bradycardia seems most likely due to adverse effect of Clonidine "especially because HR increased toward normal while holding Clonidine ...".

A physician progress note dated 11/10/19 at 9:57 PM that stated the patient would be treated for optimization of Clonidine dosing and "will discuss investigating current bottle of Clonidine with pharmacy."

A physician progress note dated 11/12/19 at 6:47 AM that stated "bradycardia and lethargy thought to be related to adverse effect of Clonidine secondary two compounding issue" and "bradycardia likely related to the dosing error and not a response to the ordered Clonidine dose" and "initial dose of Clonidine give in the PICU was 10x the ordered dose due to a compounding error."

5. The medical record review for Patient #27 was completed on 12/11/19. The review revealed the eight-month-old patient was admitted to the facility on 03/18/19 for management of single heart ventricle physiology.

The review of the spreadsheet revealed the pharmacy dispensed to Patient #27 46 doses of the incorrect Clonidine concentration.

A physician progress note dated 11/14/19 at 6:00 AM stated according to pharmacy, a variable number of doses of Clonidine between 10/23/19 and 11/10/19 that were 10 times the ordered dose was given. The note stated, "No interventions were required."

6. The medical record review for Patient #28 revealed the three-month-old patient was admitted to the facility on 08/07/19 with diagnoses of hydrops fetalis and respiratory failure. The medical record review revealed a physician progress note dated 11/12/19 at 3:24 PM that stated, "Notified by pharmacy that infant received inappropriate dose of Clonidine for multiple doses due to compounding error" and a recent escalation in medical care and vital sign instability "might have been related to the incorrect Clonidine dosing." The review of the spreadsheet revealed the pharmacy dispensed to Patient #28 60 doses of the incorrect Clonidine concentration.

7. The medical record review for Patient #30 was completed on 12/11/19. The review revealed the three-year-old patient was admitted to the facility on 10/25/19 with diagnoses of increased work of breathing with vomiting and gagging. The medical record review revealed a situation awareness concern note dated 10/27/19 at 9:08 AM that stated the patient was difficult to arouse and bradycardic to the 40s overnight and this morning. The note stated it was unclear if the change was secondary to Clonidine administration/overdose. The review of the spreadsheet revealed the pharmacy dispensed to Patient #30 19 doses of the incorrect Clonidine concentration.

The medical record review revealed a discharge summary dated 10/27/19 at 10:16 AM that stated, "The clinical picture appears consistent with Clonidine overdose despite the documented dosing."

8. The medical record review for Patient #8 was completed on 12/11/19. The medical record review revealed the patient was admitted to the facility on 08/02/19 with a diagnosis of chronic respiratory failure, and discharged on 11/23/19. The medical record review revealed a physician progress note dated 11/12/19 that stated:
"Per Pharmacy, increased Clonidine concentration (10X dose) on majority of doses 10/23-11/10 without obvious side-effect. Possibly increased sedation the preceding weekend but was in the context of febrile illness requiring increased respiratory support. No interventions were required."

9. The review of the spreadsheet revealed the pharmacy dispensed to Patient #1 18 doses of the incorrect Clonidine concentration.

10. The review of the spreadsheet revealed the pharmacy dispensed to Patient #2 42 doses of the incorrect Clonidine concentration.

11. The review of the spreadsheet revealed the pharmacy dispensed to Patient #3 13 doses of the incorrect Clonidine concentration.

12. The review of the spreadsheet revealed the pharmacy dispensed to Patient #4 24 doses of the incorrect Clonidine concentration.

13. The review of the spreadsheet revealed the pharmacy dispensed to Patient #5 one dose of the incorrect Clonidine concentration.

14. The review of the spreadsheet revealed the pharmacy dispensed to Patient #6 31 doses of the incorrect Clonidine concentration.

15. The review of the spreadsheet revealed the pharmacy dispensed to Patient #7 three doses of the incorrect Clonidine concentration.

16. The review of the spreadsheet revealed the pharmacy dispensed to Patient #9 47 doses of the incorrect Clonidine concentration.

17. The review of the spreadsheet revealed the pharmacy dispensed to Patient #10 34 doses of the incorrect Clonidine concentration.

18. The review of the spreadsheet revealed the pharmacy dispensed to Patient #11 six doses of the incorrect Clonidine concentration.

19. The review of the spreadsheet revealed the pharmacy dispensed to Patient #12 28 doses of the incorrect Clonidine concentration.

20. The review of the spreadsheet revealed the pharmacy dispensed to Patient #13 four doses of the incorrect Clonidine concentration.

21. The review of the spreadsheet revealed the pharmacy dispensed to Patient #15 13 doses of the incorrect Clonidine concentration.

22. The review of the spreadsheet revealed the pharmacy dispensed to Patient #16 59 doses of the incorrect Clonidine concentration.

23. The review of the spreadsheet revealed the pharmacy dispensed to Patient #17 21 doses of the incorrect Clonidine concentration.

24. The review of the spreadsheet revealed the pharmacy dispensed to Patient #18 42 doses of the incorrect Clonidine concentration.

25. The review of the spreadsheet revealed the pharmacy dispensed to Patient #19 45 doses of the incorrect Clonidine concentration.

26. The review of the spreadsheet revealed the pharmacy dispensed to Patient #21 eight doses of the incorrect Clonidine concentration.

27. The review of the spreadsheet revealed the pharmacy dispensed to Patient #22 60 doses of the incorrect Clonidine concentration.

28. The review of the spreadsheet revealed the pharmacy dispensed to Patient #23 40 doses of the incorrect Clonidine concentration.

29. The review of the spreadsheet revealed the pharmacy dispensed to Patient #24 35 doses of the incorrect Clonidine concentration.

30. The review of the spreadsheet revealed the pharmacy dispensed to Patient #26 13 doses of the incorrect Clonidine concentration.

31. The review of the spreadsheet revealed the pharmacy dispensed to Patient #29 46 doses of the incorrect Clonidine concentration.

32. The review of the spreadsheet revealed the pharmacy dispensed to Patient #32 58 doses of the incorrect Clonidine concentration.

33. The review of the spreadsheet revealed the pharmacy dispensed to Patient #33 one dose of the incorrect Clonidine concentration.

34. The review of the spreadsheet revealed the pharmacy dispensed to Patient #34 three doses of the incorrect Clonidine concentration.

35. The review of the spreadsheet revealed the pharmacy dispensed to Patient #35 48 doses of the incorrect Clonidine concentration.

36. The review of the spreadsheet revealed the pharmacy dispensed to Patient #36 64 doses of the incorrect Clonidine concentration.

37. The review of the spreadsheet revealed the pharmacy dispensed to Patient #37 two doses of the incorrect Clonidine concentration.

38. The review of the spreadsheet revealed the pharmacy dispensed to Patient #38 six doses of the incorrect Clonidine concentration.

39. The review of the spreadsheet revealed the pharmacy dispensed to Patient #39 two doses of the incorrect Clonidine concentration.