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Based on interview, medical record review, and policy review, the facility failed to have a a medical staff approved medication administration policy that differentiated what grace period of time would be for time critical medications and non-time critical medications having the potential to affect all patients in the hospital, failed to follow its policy on the administration of insulin, affecting six (Patients #6, #7, #8, #12, #14, and #16) of 17 sampled patients, and failed to ensure Patient #13 received the medication prescribed for him/her, resulting in Patient #13 being diagnosed with "poisoning by insulins and antidiabetic agent" and needing to be transferred to the intensive care unit as well as receiving multiple vials of 25 grams dextrose in 50 milliters of normal saline for which there isn't a physician's order recorded, and receiving hours of potassium infusions by intravenous access.

Findings include:

See A 405
This deficiency substantiated complaint number OH00065803.

Based on interview, medical record review and policy review, the facility failed to have a medical staff approved medication administration policy that differentiated what the grace period of time would be for time critical medications and non-time critical medications having the potential to affect all patients in the hospital, failed to follow its policy on the administration of insulin affecting six out of 17 sampled patients (Patient #6, #7, #8, #12, #14, and #16), and failed to ensure Patient #13 received the medication that was prescribed for her/him.

Findings include:

On the morning of 07/11/12, Nurses B, C, E, F, G, H, and U were each interviewed separately. Each of the seven stated they had a 30 minute grace period in which to give a scheduled medication.

On 07/11/12 at 2:45 P.M. during an interview, the Director of Pharmacy Services stated he/she thought clinicians had a one hour grace period in which to give scheduled medications.

On 07/12/12 a review of the facility's medication administration policy, "Number 9.1", approved on 09/12/11, was completed. The policy did not specify a time period as the grace period for scheduled medications.

On 07/11/12 at 10:30 A.M. during an interview, the Accreditation Manager stated the facility doesn't have a policy specifying what the grace period is for scheduled medications.

The clinical record review in its electronic a paper form for Patient #13 was completed on 07/12/12. The clinical record revealed the 66-year-old patient was admitted to the facility on 03/28/12. A history and physical, dictated on 03/29/12, stated the patient had a chief complaint of speech difficulty and numbness of the left hand. The history and physical indicated the patient had experienced a stroke (i.e., a cerebral vascular accident). The history and physical did not state the patient was a diabetic, had any glycemic pathology, had presented due to any glycemic-related symptoms, or was taking any kind of glycemic medications. The clinical record revealed the patient had a normal value for Hemoglobin A1C, an indicator the patient was not a diabetic.

The clinical record included a medication administration record that did not indicate the patient took any scheduled glycemic medications.

The clinical record review, in its paper form, included a rapid response team call record dated 03/30/12 at 1:45 A.M. This record revealed the patient had a blood glucose of 12 milligrams/deciliter.

The clinical record review, in its paper form, revealed a physician's progress note dated 03/30/12 at 1:50 A.M. that stated the patient was treated with 2 ampules of 25 grams of dextrose in 50 milliters of normal saline.

The clinical record, in its electronic form, revealed the patient's blood sugar at 2:52 A.M. was 96 milligrams/deciliter.

The clinical record, in its paper form, revealed a physician's progress note dated 03/30/12 at 8:00 A.M. that stated the patient's blood sugar at 3:45 A.M. was 26 milligrams/deciliter and the patient had been given one ampule of 25 grams dextrose in 50 milliters of normal saline.

The clinical record, in its electronic form, revealed a medication administration record that stated the patient was given 5% dextrose in 0.45 % normal saline solution at 50 milliliters/hour per intravenous route at 4:30 A.M.

The clinical record, in its paper form, revealed a physician progress note dated 03/30/12 at 8:00 A.M. that stated at 5:30 A.M. the patient's glucose level was 34 milligrams/deciliter and one ampule of 25 grams dextrose in 50 milliters of normal saline was given. The note stated the patient was transferred to the intensive care unit at that time. The note also confirmed the patient was hypothermic with body a temperature of 94 degrees Fahrenheit.

The clinical record, in its electronic form, revealed Patient #13 received intravenous potassium on 03/30/12 from 9:00 A.M. to 2:00 P.M.

The clinical record, in its electronic form, revealed a medication administration record that stated the patient was given 10% dextrose in water at a rate of 50 milliliters/hour per intravenous route at 6:22 A.M.

The clinical record, in its electronic and paper form, lacked a physician's order for the ampules of 25 grams dextrose in 50 milliters of normal saline that were administered to the patient. The medication administration record lacked identification of the nurse who gave the ampules of 25 grams dextrose in 50 milliters of normal saline and when, exactly, the nurse had administered them.

On 07/12/12 at 12:21 P.M. in an interview, Staff R confirmed the clinical record in its electronic form lacked a physician's orders for the ampules of 25 grams dextrose in 50 milliters of normal saline. Staff R confirmed the medication administration record did not identify what nurse had given the ampules of 25 grams dextrose in 50 milliters of normal saline to the patient and when, exactly, he/she gave them.

The clinical record, in its electronic form, revealed a discharge summary, dictated on 04/02/12 at 9:04 P.M. that stated, "It was suspected that the patient may have been given the patient's roommate's insulin injection by misadministration" and "laboratory workup for the patient's severe hypoglycemia revealed levels of high insulin that were consistent with a possible exogenous administration such as a misadministration of another patient's insulin."

The clinical record, in its paper form, revealed an inpatient coding summary sheet that stated the patient's principle diagnosis was cerebral embolism with cerebral infarction. The sheet listed as secondary diagnoses, among other things, hypoglycemia, "poisoning by insulins and antidiabetic agent" and "accidental poisoning by hormone or synthetic substitute. "

The clinical record review for the Patient #14, Patient #13's roommate, was completed on 07/12/12. The clinical record, in its paper form, revealed a history and physical dated 03/26/12 that stated the patient was admitted to the hospital with a chief complaint of hyperglycemia and elevated blood sugar and was diagnosed with hyperglycemia and diabetes.

The clinical record, in its electronic form, revealed a medication administration record that identified the patient was taking an oral diabetic medication daily, and was taking a sliding scale dose of rapid acting insulin with meals and at bedtime. The medication administration record confirmed Patient #14 and Patient #13 had the same nurse, Staff Nurse S, administering their medications from at least 9:00 P.M. on 03/29/12 to 6:22 A.M. on 03/30/12.

The clinical record, in its electronic form, revealed the patient's blood sugar on 03/29/12 at 8:35 P.M. was 487 milligrams/deciliter. The review of the medication administration record revealed Staff Nurse S administered 20 units of the rapid acting insulin on 03/29/12 at 9:00 P.M. The medication administration record stated Staff Nurse T verified the amount of insulin as four units (and not 20) at 9:30 P.M.

Review of the facility's insulin administration policy, "Number 9.8", as revised on 12/11, stated in the implementation section, a second nurse is to verify the insulin order, type, and dose.

The clinical record, in its electronic form, revealed a nursing progress note dated 3/30/12 at 2:20 A.M. that stated the patient's glucose reading was 547 milligrams/deciliter. The medication administration record revealed the patient was given another 20 units of fast acting insulin. The clinical record in its electronic form revealed the patient's glucose level was 235 milligrams/deciliter at 8:27 A.M.

On 07/12/12 at 8:00 A.M. Staff Nurse T during an interview said he/she could not remember whether he/she went to the bedside of the patient with Nurse S to verify the patient's identification, or whether he/she verified the insulin dose at the bedside.

On 07/11/12 at 2:00 P.M. the Director of Nursing, the Quality Director, the Vice President of Clinical and Support Services, and Nurse Manager P (who was manager of the floor where Patient #13 and #14 resided during their respective hypo and hyperglycemic episodes) were interviewed. Nurse Manager P stated Patient #13's hypoglycemic episode was "suspicious." When presented with Patient #13's diagnoses of hypoglycemia, poisoning by insulins and antidiabetic agent, and accidental poisoning by hormone or synthetic substitute, Nurse Manager P stated it had to have come from the nurse.


22432

Patient #6 was admitted to the hospital on 07/09/12 with diagnoses which included diabetes mellitus. Review of the clinical record was completed on 07/11/12. The clinical record revealed the patient had physician's orders for 2 different types of insulin to be injected. The patient had received mixed insulin (combination of rapid and intermediate acting insulin) injections on 07/10/12 at 9:00 A.M. and again at 5:00 P.M. The Medication Administration Record (MAR) indicated the nurse had electronically initialed the medications as administered at these times but the MAR lacked the required electronic initialing by a second nurse verifying the correct dose of medication was prepared and administered to the right patient for both of these administered insulin doses. In addition to the mixed insulin the patient also had a physician's orders for a rapid acting insulin to be administered per sliding scale dosing before meals and at bedtime. The MAR revealed nurses had administered this rapid acting insulin at lunch time on 07/10/12 but the administration of this insulin, according to the electronic MAR, was not verified for accuracy by the second nurse as required.


Patient #7 was admitted to the hospital with diagnoses which included severe chronic obstructive pulmonary disease, pneumonia and hypertension. The clinical record review was completed on 07/11/12. The patient had a physician's order, secondary to steriod use, for sliding scale rapid acting insulin to be administered at each meal and at bedtime. The Medication Administration Record indicated insulin was administered to the patient on the following dates and times but was not witnessed and verified by the second nurse to ensure accuracy of the right medication to the right patient as required. The administration times that lacked the second nurse's verification were 07/08/12 at bedtime, 07/09/12 at bedtime, and at breakfast on 07/10/12.

Patient #8 was admitted to the hospital on 03/25/12 with diagnoses which included diabetes mellitus. Clinical record review was completed on 07/12/12. The patient's Medication Administration Record (MAR) revealed the patient had a physician's order for rapid acting insulin to be administered per sliding scale dosing before meals and at bedtime for the management of diabetes. The MAR indicated the patient had received insulin injections that lacked the accuracy verification by a second nurse as required. The dates and time of administration of those injections were as follows; 03/26/12 at breakfast and dinner, 03/27/12 at dinner, 03/28/12 at bedtime, 03/29/12 at dinner time.

Patient #12 was admitted to the hospital on 03/27/12 with diagnoses which included diabetes mellitus. Clinical record review was completed on 07/12/12. The Medication Administration Record (MAR) indicated the patient had a physician's order for rapid acting insulin per sliding scale dosing to be administered before meals and at bedtime. The MAR indicated the patient had received insulin injections that lacked the accuracy verification by a second nurse as required. The dates and time of administration of those insulin injections were as follows; 03/28/12 at lunch and dinner, 03/31/12 at lunch, 04/01/12 at all 3 meals, 04/02/12 at breakfast and dinner, 04/04/12 at lunch, dinner and bedtime, and again on 04/05/12 at dinner and bedtime.

Patient #16 was admitted to the hospital on 03/25/12 with diagnoses which included diabetes. Clinical record review was completed on 07/12/12. The Medication Administration Record (MAR) indicated the patient had a physician's order for a long acting insulin to be administered every morning. The MAR indicated this medication was administered daily from 04/10 through 04/15/12 but lacked the accuracy verification by the electronic initialing by a second nurse on all days except 04/12/12. Additionally, the patient had a physician's order for the administration of a rapid acting insulin before meals and at bedtime per sliding scale dosing. The MAR indicated the patient had received insulin injections that lacked the required the accuracy verification by a second nurse. The dates and times of those administrations were as follows; 04/10/12 breakfast, lunch and bedtime, 04/11/12 all meals and at bedtime, 04/12/12 lunch and bedtime, 04/13/12 at breakfast, lunch and bedtime, 04/14/12 the dinner time dose, 04/15/12 the dinner dose and 04/16/12 the breakfast dose.

Review of the hospital's December 2011 "Insulin Administration Policy and Procedure" documented that insulin was considered a high alert medication and that extra precaution will be taken when prescribing, dispensing, administering and monitoring. The policy and procedure directed that the five rights of medication (the right patient, medication, dose, route, and time) will be verified by two nurses before insulin was injected and that the insulin would be checked against the eMAR (electronic MAR), the vial from which it is to be drawn, and the syringe that is drawn for the patient.

Interview with Staff #R during the morning of 07/12/12 verified the floor nursing staff were not verifying insulin accuracy with the required second nurse before administration of the insulin.

This deficiency substantiated complaint number OH00065803.

Based on interview, observation, clinical record review, review of medication errors in the facility, and in the emergency department in particular, review of the meeting minutes from the Pharmacy and Therapeutics Committee, and policy review, the facility failed to ensure adverse drug reactions and drug administration errors are being fully investigated, affecting two (Patients #13 and #17) of 17 sampled patients, failed to address and implement a plan to reverse an identified increase in medication errors in the emergency department that was first noticed in August, 2011, affecting all patients who will come to the emergency department, failed to address why medications meant to be stored in a automated medication dispensing system were found in medication bins on individual units, and failed to ensure within the automated medication dispensing system itself dangerous medications were stored in labeled bins and separated from other medications, having the potential to affect all patients in the hospital.

Findings:

See A500 and A508

This substantiated complaint number OH00065803.

Based on observation and interview, the facility failed to ensure medications dispensed from automated medication dispensing system machines were not stored and dispensed through other means, and failed to ensure dangerous medications were kept in labeled bins, separate and distinct from other medications in the automated medication dispensing system. This has the potential to affect all patients in the facility.

Findings include:
In the afternoon of 07/10/12 from 1:45 P.M. to 2:25 P.M., a tour of the unit called Four West was conducted with the Director of Pharmacy. The surveyor observed a box secured to the wall that contained patient medications. In an interview during the tour, the Director of Pharmacy explained if medications are not stocked in the automated medication dispensing system, then pharmacy delivers them to the box.
Observation of the Four West medication storage wall bin on 07/10/12 between 1:45 P.M. and 2:25 P.M. revealed the presence of the patient's home medications which included Cymbalta (an antidepressant medication) along with a bag of other home medications. Interview, during the tour, with the Director of Pharmacy revealed when patients brought their home medications with them to the hospital the hospital policy and procedure, was to attempt to send them home with family. If this is not possible to send them to the main pharmacy to be held until the time the patient was discharged or the medications could be released to family to take home. This was to avoid the dual administration of medications. The Director of Pharmacy verified these medications should not be in the wall bin but should have been sent to pharmacy.

During the tour, a container in the box labeled for patient room 432, bed 2, was observed to contain four medications. The Director of Pharmacy, during the tour, confirmed those medications were stocked in the automated medication dispensing system, and couldn't explain why they were being kept in the box.

Inspection of the facility's fourth floor medication room on 07/10/12 at 2:18 P.M. revealed an automated medication dispensing machine contained a previously opened box of one milligram per milliliter box which contained a prefilled syringe of injectable Atropine one milligram per milliliter (used to rapidly raise blood pressure and heart rate). Interview with the Director of Pharmacy, at the time of this observation, verified the presence of this emergency medication in an altered form and verbalized "that shouldn't be there, pharmacy will replace that."

On 07/10/12 at 2:40 P.M. a tour of the intensive care unit was conducted with the Assistant Director of Pharmacy and the Accreditation Manager. The surveyor observed in a medication cart, in a patient container, a previously accessed vial of heparin-a type of blood thinner-without any patient identifier information. In an interview the Accreditation Manager stated it may have been used in a procedure and should have been discarded immediately afterward.
During the tour of the intensive care unit, the unit's automated medication dispensing system was observed to have in its refrigeration section vials of pneumonia vaccines lying next to three vials of succinylcholine-a paralyzing agent that when administered inappropriately can result in death. Neither medication was in any type of labeled container.

This observation was confirmed by the Assistant Director of Pharmacy at 2:45 P.M.

Continued tour of the medication storage units revealed the third floor wall storage bin which serviced the 300 hall was found to contain a 25 milligram tablet of Metoprolol (anti hypertension medication) as well as a two ten milliEquivalent tabs of potassium chloride (mineral supplement). Both of these medications were available through the automated medication dispensing system and should not be stored in the wall bin medication storage areas according to the Director of Pharmacy. The Director of Pharmacy further verbalized the antihypertensive medication was stopped by the physician on 07/07/12. The Director of Pharmacy verbalized the automated medication dispensing system was reported as malfunctioning over the weekend but the concerns were resolved on 07/09/12. The pharmacy and nursing staff should have returned to using the automated medication dispensing system effective 07/09/12 and medications available by the automated medication dispensing system should be retrieved through that method. The medications in this wall bin should have been removed.

Tour of the five south floor medication storage areas revealed the medication wall bin to contain a 25 milligram tablet of hydralazine (used to treat hypertension) and a 100 milligram capsule of a commonly used stool softener. The wall bin also contained an unlabeled paper medication administration cup for an unspecified patient which contained a half tablet of hydrochlorothiazide (used to treat hypertension). Interview with the Director of Pharmacy on 07/10/12, at the time of this discovery revealed the hydralazine and stool softener were available in the automated medication dispensing system and should not have been in the wall bin.

Based on interview, clinical record review, review of the facility's documentation of medication errors in the facility as a whole, and in the emergency department in particular, review of the meeting minutes from the Pharmacy and Therapeutics Committee, and policy review, the facility failed to ensure adverse drug reactions and drug administration errors were immediately reported to the Pharmacy and Therapeutics Committee and fully investigated, affecting two (Patients #13 and #17) of 17 sampled patients, and failed to address an increase in medication errors in the emergency department, affecting all patients who come to the emergency department.
Findings include:
The clinical record review, in its electronic a paper form, for Patient #13 was completed on 07/12/12. The clinical record revealed the 66-year-old patient was admitted to the facility on 03/28/12. A history and physical, dictated on 03/29/12, stated the patient had a chief complaint of speech difficulty and numbness of the left hand. The history and physical indicated the patient had experienced a stroke (i.e., a cerebral vascular accident). The history and physical did not identify the patient was a diabetic, had any glycemic pathology, presented for any glycemic-related symptoms, or was taking any kind of glycemic medications. The patient had a normal value for Hemoglobin A1C, an indicator the patient was not a diabetic. The medication administration record lacked documentation the patient took any scheduled glycemic medications.
A rapid response team call record, dated 03/30/12 at 1:45 A.M., stated the patient had a blood glucose level of 12 milligrams/deciliter.
A discharge summary, dictated on 04/02/12 at 9:04 P.M., stated, "It was suspected that the patient may have been given the patient's roommate's insulin injection by misadministration" and "laboratory workups for the patient's severe hypoglycemia revealed levels of high insulin that were consistent with a possible exogenous administration, such as a misadministration of another patient's insulin."
The clinical record revealed an inpatient coding summary sheet that stated the patient's principle diagnosis was cerebral embolism with cerebral infarction. The sheet listed as secondary diagnoses, among other things, hypoglycemia, "poisoning by insulins and antidiabetic agent" and "accidental poisoning by hormone or synthetic substitute."
The clinical record review for the Patient #14, Patient #13's roommate, was completed on 07/12/12. The clinical record revealed a history and physical dated 03/26/12 that stated the patient was admitted to the hospital with a chief complaint of hyperglycemia and elevated blood sugar and was diagnosed with hyperglycemia and diabetes.
The clinical record revealed a medication administration record that stated the patient was taking an oral diabetic medication daily, and was taking a sliding scale dosing of rapid acting insulin with meals and at bedtime. The medication administration record confirmed Patient #14 and Patient #13 had the same nurse, Staff Nurse S, administering their medications from at least 9:00 P.M. on 03/29/12 to 6:22 A.M. on 03/30/12.
The clinical record revealed the patient's blood sugar on 03/29/12 at 8:35 P.M. was 487 milligrams/deciliter. The medication administration record revealed Staff Nurse S administered 20 units of the rapid acting insulin on 03/29/12 at 9:00 P.M. The medication administration record stated Staff Nurse T verified the amount of insulin as four units at 9:30 P.M.

On 07/11/12 at 2:00 P.M. the Director of Nursing, the Quality Director, the Vice President of Clinical and Support Services, and Nurse Manager P (who was manager of the floor where Patient #13 and #14 resided during their respective hypo and hyperglycemic episodes) were interviewed. Nurse Manager P stated Patient #13's hypoglycemic episode was "suspicious." He/she confirmed Nurse T electronically co-signed the insulin given to Patient #14. He/she said he/she never interviewed Nurse T as to why he/she cosigned the insulin on 03/29/12 at 9:30 P.M. (30 minutes after administration) and why Nurse T verified the insulin dose as four units, but 20 units was documented as being administered.

Review of the facility's policy on adverse drug reactions, "Number 9.3", last revised on 12/11, was completed on 07/12/12. The policy stated adverse drug reactions are reported at least quarterly to the Pharmacy and Therapeutics Committee.

Review of the facility's Pharmacy and Therapeutics Committee meeting minutes from 01/01/12 to present was completed on 07/12/12. The review lacked documentation of any discussion of Patient #13's "poisoning by insulins and antidiabetic agent" and "accidental poisoning by hormone or synthetic substitute."

Review of the facility's policy on adverse drug reactions, Number 9.3, last revised on 12/11, was completed on 07/12/12. The policy stated severe adverse drug reactions are "immediately" reported to the Director of Pharmacy.

On 7/11/12 at 2:45 P.M. in an interview, the Director of Pharmacy said he/she didn't recall the incident involving Patient #13. Had there been a formal report he/she would have investigated and reported what role, if any, the pharmacy played in the incident involving Patient #13. He/she said the pharmacy had not been involved because the incident had not been assessed as being severe enough.

On 07/11/12 at 4:30 P.M. in an interview, the Director of Quality explained the incident involving Patient #13 was brought to Administration's attention because of the diagnosis coding. He/she explained each reported incident is given a letter of severity, and, the extent and type of investigation that follows is dependent upon the assessed severity of the event. He/she said the incident involving Patient #13 was never assessed a level of severity and he/she didn't know why.

Review of a facility report for medication errors in the emergency department from January to June 2012 was completed on 07/12/12. The review revealed an event involving Patient #17 that stated the patient was given an intravenous antibiotic, but that the peripheral intravenous access site had failed. A central line was asked for and given to the patient, the antibiotic was restarted-and found later to have been ordered orally, and not intravenously.

Review of Patient #17's clinical record was completed on 07/12/12. The patient presented to the emergency department on 05/05/12 at 1:35 P.M. with a chief complaint of weakness and not being able to eat. The review confirmed that at 9:46 P.M. the patient's peripheral intravenous was removed because the site had failed. The review confirmed the patient was given a central line 10:04 P.M.

On 07/12/12 at 10:25 A.M. the Emergency Room Nurse Manager was interviewed. He/she confirmed the patient was given a central line for venous access for an antibiotic that, although reported verbally as ordered to be given intravenously, was in fact ordered to be given orally. The Emergency Room Nurse Manager said he/she counseled the nurse. The Emergency Room Nurse Manager said he/she conducted no further interviews, did not interview the physician to determine whether he/she in fact gave a verbal order, nor the physician who placed the central line as to why he/she did so when the antibiotic was ordered orally, had talked informally with the Director of Pharmacy about the issue, but did not conduct a formal interview.

On 07/12/12 at 10:35 A.M. in an interview, the Director of Pharmacy confirmed no formal dialog had occurred between the nursing department and the pharmacy department. The issue has not been discussed in the Pharmacy and Therapeutics Committee. He/she said this was because the incident was assessed as not being serious enough.

Review of the facility's policy on adverse drug reactions, "Number 9.3", last revised on 12/11, was completed on 07/12/12. The review revealed adverse events are reported at least quarterly (and not immediately) to the Pharmacy and Therapeutics Committee.

On 07/12/12 at 10:25 A.M. the Emergency Room Nurse Manager in an interview stated he/she had noticed an increase in medication errors in her/his department since the change to electronic medical records in August, 2011.

A review of the facility's report of medication errors from January 2012 to April 2012 was completed on 07/12/12, and revealed the emergency department had sustained more medication errors than any other unit in February, March, and April of 2012.

Review of the minutes of the Pharmacy and Therapeutics Committee meetings since January 2012, revealed the minutes lacked documentation of discussion of the increase of medication errors in the emergency department, of the Emergency Room Nurse Manager's assessment of an increase in medication errors in August, 2011, or how the facility was going to address the issue.

On 07/12/12 at 10:35 A.M. in an interview, the Director of Pharmacy confirmed no such discussions has taken place.

This deficiency substantiated complaint OH00065803.