The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

MERCY REGIONAL MEDICAL CENTER 800 E MAIN VILLE PLATTE, LA 70586 Feb. 15, 2012
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on observations, staff interviews, and record reviews, the hospital failed to meet the requirements for the Conditions of Participation for Patient Rights as evidenced by:

1) A staff member failing to use the basic "5" rights to identify the correct patient, correct medication and the correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback as per the hospital's policy "Medication Management and Administration" and resulting in a hypoglycemic brain injury as documented in the Physician's Progress Notes. (See deficiency cited at A0144).

2) Failing to have a policy in place regarding how discontinued medications are removed from the Nursing units after the pharmacy closes as evidenced by nurses failing to remove IVPBs from the refrigerator after the physician discontinues the medication. This resulted in an IVPB of Regular insulin remaining in the refrigerator after the physician discontinued the medication at 1900 (7:00 p.m.). Inadequate control (storage/access) of medications was a factor which contributed to an unsafe environment and a medication error on patient #2; yet, this factor was not identified by the hospital. (See deficiency cited at A0144.)
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on observation, interview, and record review, the hospital failed to protect the patient's right to receive care in a safe setting for 1 patient (#2) out of a total sample of 13 as evidenced by:

1) A staff member failing to use the basic "5" rights to identify the correct patient, correct medication and the correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback as per the hospital's policy "Medication Management and Administration".

2) Failing to have a policy in place regarding how discontinued medications are removed from the Nursing units after the pharmacy closes as evidenced by nurses failing to remove IVPBs from the refrigerator after the physician discontinues the medication. This resulted in an IVPB of Regular insulin remaining in the refrigerator after the physician discontinued the medication at 1900 (7:00 p.m.). Inadequate control (storage/access) of medications was a factor which contributed to an unsafe environment and a medication error on patient #2; yet, this factor was not identified by the hospital.

Findings:

1) A staff member (S10) failed to use the basic "5" rights to identify the correct patient, correct medication and the correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback as per the hospital's policy "Medication Management and Administration".

Patient #2 was admitted to hospital on [DATE] at 16:42 (4:42 p.m.) per ambulance. Physician's preliminary diagnoses were Urosepsis, Hypotension, and Dehydration. Patient's past history included previous CVAs (Cerebrovascular Accidents) with a right sided deficit. Patient was placed in the Intensive Care Unit (ICU). Initial physician's orders dated at 1750 (5:50 p.m.) included Gentamycin 120 mg IV (intravenous) piggyback; 1st dose now and then place on a 5:00 a.m. and 5:00 p.m. schedule. Patient #2 had no history of diabetes.

Record review of Medication Variance Report dated 2/1/12 at 1315 (1:15 p.m.) revealed S6 Director of Medical/Surgical and ICU had been notified of an incident of patient #2 receiving the wrong medication. Patient #2 had received an unordered medication (Regular Insulin 100 units/100 Sodium Chloride) Intravenous Piggy Back (IVPB), which resulted in a Level 4 Error.

Review of the policy titled, "Medication Variances", Policy 14-03, Last revised date of 4/1/10, last reviewed date of 12/2011, with no effective date, presented as the hospital's current "Medication Administration and Medication Variance Report" policy read as follows: ''..."The medication use shall follow current standards of practice according to hospital policy...The definition of a medication variance is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer...Such events may be related to professional practice, ...procedures,...dispensing, ... distribution, ...and....administration...Following are categories of medication errors: Level 0 Error did not reach patient...Level 1 Error occurred without harm to patient...Level 2 Error occurred, increase monitoring but no change in vital signs or any patient harm...Level 3 Error resulted in need increased monitoring, there was change in vital signs but no ultimate patient harm; any error needing increased laboratory monitoring...Level 4 Error resulted in need for treatment with another drug, increased length of stay, patient transfer to higher level of care (e.g. ICU), or required intervention to prevent permanent impairment or damage...Level 5 Error resulted in permanent patient harm...Level 6 Error resulted in patient death...Types of medication errors include: Omission: Failure to administer an ordered dose or dose not given before the next scheduled dose is due. Exceptions include patient refusal or recognized contraindications or incompatibilities...Unauthorized Drug: Administration to the patient of a medication dose not authorized for the patient. This category includes a dose given to the wrong patient,...administration of an unordered drug,...Procedure: A. All medication variances are reported to the physician and nursing supervisor and facility's designated person responsible for collection and review of such reports within twenty-four hours, unless there is a change requiring medical intervention and/or added treatment, in which case immediate notification of the physician is required...B. If a medication is administered in error this must be recorded...C. A medication variance form should be completed by the person discovering the error or near miss situation as soon as possible. An occurrence report should also be completed for medication variances level 4 and above...All medication variance reports evaluated as significant (level 4 or above) will result in an occurrence report and are referred to the Pharmacy and Therapeutics Committee for review. The Director of Pharmacy will perform summary data and trend analysis. The Director of Pharmacy will make reports of actions taken and appropriate follow-up to the Pharmacy and Therapeutics Committee...".

Record review of policy titled Medication Management and Administration (pg 11 of 17) under Patient Assessments Required before the Administration of Medications reveals "The patient is identified utilizing 2 patient identifiers- Patient name and date of birth, comparing the label on the medication/MAR with the patient armband; the medication is checked for dose, route, and time of administration." Under Administering a Medication (pg 14 of 17), the steps include: Note order from the MAR and compare to physician orders for accuracy; Remove the drug from the patient's medication bin; Prepare medication as necessary; At bedside, check the ID band of the patient for the 2 patient identifiers. If no armband is present, medications are not to be administered; Administer medication according to established protocols; Record administration time on MAR sheet in space aligned with medication, initial and date."

Record review of written notes of S13 RN Risk Manager, taken during the hospital's investigation, dated 2/2/12 at 1:05 p.m. revealed S10 LPN had administered the medication without performing the 5 rights prior to administration of the IVPB.

Record review of Physician's Progress Note dated 2/4/12 at 9:20 a.m., revealed Physician's documentation indicating patient #2 experienced a hypoglycemic brain injury, which required comfort measures. The second diagnosis was Urinary Tract Infection (UTI), which required comfort measures. The physician's documentation also revealed S14 MD had spoken to the family members about using hospice services to provide the comfort measures.

On 2/15/12 at 10:00 a.m. in a face-to-face interview with S2 Assistant DON and S5 Director of Pharmacy, both confirmed S10 LPN had not followed the hospital's policy on patient identification prior to administering a medication. S2 stated this was the outcome of the hospital's investigation of the incident. S2 added S10 LPN was terminated on 2/7/12.

2) Failing to have a policy in place regarding how discontinued medications are removed from the Nursing units after the pharmacy closes as evidenced by nurses failing to remove IVPBs from the refrigerator after the physician discontinues the medication. This resulted in an IVPB of Regular insulin remaining in the refrigerator after the physician discontinued the medication at 1900 (7:00 p.m.). Inadequate control (storage/access) of medications was a factor which contributed to an unsafe environment and a medication error on patient #2; yet, this factor was not identified by the hospital.

In a second (face-to-face) interview with S7 RN, on 2/14/12 at 8:30 a.m., she confirmed IVPB medications are already refrigerated and on the unit. She stated the pharmacy places the IVPBs in the refrigerator without any special order (i.e. high risk medications on first shelf; non-high risk medications on the second shelf). S7 added if patient #2 did not receive the 0500 dose of Gentamycin, the bag should still be in the refrigerator. S7 RN confirmed she was not aware that the 0500 dose of Gentamycin had not been given (S10 LPN had not reported the Gentamycin was still in the refrigerator). S7 RN added she does not check the refrigerator to ensure all medications have been given, especially if she has assigned the patients to the LPN.

On 2/13/12 at 3:05 p.m. in a face-to-face interview with S5 Director of Pharmacy, explained that patient #13 was admitted to the hospital at 1354 (1:54 p.m.) on 1/31/12. He was admitted with a diagnosis of diabetic ketoacidosis. S5 stated on the physician's admit orders, patient #13 was to receive an IVPB of Regular insulin 100 units/100 ml (milliliters) of Normal Saline upon admit. Physician's orders indicated patient #13 was to receive 0.1 units of Regular insulin/ kg (kilogram)/ hr. S5 stated the pharmacy department closes at 7:00 p.m. and all IVPBs are brought to the units prior to pharmacy technicians leave the hospital. S5 confirmed patient #13 received the first dose of Regular insulin at 1520 (3:20 p.m.). Pharmacy mixed another IVPB and brought it to the ICU at 1825 (6:25 a.m.) in case the patient needed another infusion of Regular insulin after the pharmacy closes at 7:00 p.m.

S5 stated the physician had ordered the IVPB of Regular insulin to be discontinued on 1/31/12 at 1900 (7:00 p.m.). The nurse scanned the order to pharmacy at 1915 (7:15 p.m.), which indicated the Regular insulin IVPB was to be discontinued. S5 stated the nurses on the units are responsible for removing discontinued medication from the refrigerator and place the medications in the bin located in the medicine room. Pharmacy arrives at the hospital 7:00 a.m. and picks up all of the discontinued medications throughout the hospital.

On 2/13/12 at 4:00 p.m. in a telephone interview with S7 RN ICU, she stated discontinued IVPB medications would stay in the refrigerator until the pharmacy picks up the medication.

On 2/13/12 at 4:30 p.m. in a face-to-face interview with S8 LPN, she stated if IVPB medication is discontinued, then the medication is left in the refrigerator until pharmacy picks it up the next day.

On 2/14/12 at 8:30 a.m. in a face-to-face interview with S9 LPN, she stated only pharmacist and/or pharmacy tech's handle discontinued IVPBs in the refrigerator.

Record review of policy titled "Medication Management and Administration" (pg 15 of 17) Discharge or Death of Patient" revealed the following procedure: " -Remove patient's medication bin from medication cart and place in Pharmacy basket. Also, place all IV's, enteral feeding solutions, bulk liquids, Mdin's in Pharmacy basket for pick up and crediting."

On 2/13/12 at 3:05 p.m. S5 Director of Pharmacy and S2 Assistant DON confirmed the hospital's policy did not address the steps the nurses are to take if the medication is discontinued and still in the hospital, which could contribute to medication errors. S2 added the nurses on 7 PM- 7 AM shift on 1/31/12 are expected to pull the IVPB of Insulin out of the refrigerator once the physician discontinued the medication at 1900 (7:00 p.m.).

On 2/13/12 at 3:30 p.m. in a face-to-face interview with S6 RN, she stated she would expect her licensed staff to remove discontinued medications and place in the bin for the pharmacy to pick up, mark through the medication on the MAR (Medication Administration Record), and write d/C (discontinued) on the MAR.

Record review of policy titled "High-Risk Medications" pg 1 of 3 under Procedure revealed "High risk medications are eliminated from floor stock whenever possible and after-hours access is limited to nursing supervisor or other authorized personnel."

On 02/14/12 from 9:50 a.m. through 10:00 a.m., a tour of the ICU with S3RN, ICU and S12RN, Quality Director was conducted. Further observation of the ICU revealed there was a locked medication refrigerator noted on the unit. Further observation revealed there was a drawer noted in the bottom of the refrigerator that had a red label, "High Risk Medication" on it. At this time, S3RN, ICU indicated all high risk medications such as insulin, gentamycin, and heparin are stored in the drawer labeled, "High Risk Medication". At 10:00 a.m., S12RN, Quality Director indicated the bottom drawer in the refrigerator labeled, "High Risk Medication" was implemented last Thursday, 02/9/12 by pharmacy after an unordered IVPB of insulin medication was administered to a patient (#2). S12RN further indicated there was no separation between the high risk medications and/or other medications in the refrigerator in ICU prior to last Thursday, 02/09/12.
VIOLATION: PATIENT SAFETY Tag No: A0286
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and staff interviews, the hospital failed to (1) track medication errors for one (1) missed medication administration of Gentamycin for Patient #2 on 02/01/12 at 5:00 a.m. (0500) and for four (4) missed medication administrations of Zipsor for Patient #3 on 02/12/11 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700) and at 9:00 p.m. (2100) as evidenced by failing to have completed Medication Variance Reports for the missed medication administrations/medication errors for Patient #2 and #3 as per the "Medication Variances" policy for 2 out of 10 focused sampled records reviewed for medication administration out of a total of 13 sampled records reviewed.
(2) Failing to have a policy in place regarding how discontinued medications are removed from the units after the pharmacy closes as evidenced by nurses failing to remove high risk medication IVPBs from the refrigerator after the physician discontinued the medication. This resulted in an IVPB of Regular insulin remaining in the refrigerator after the physician discontinued the medication at 1900 (7:00 p.m.), which was a factor contributing to the medication error on patient #2.

Findings:
(1) Patient #2
Review of the medical record for Patient #2 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of urosepsis and dehydration. Review of the "Physician's Orders" dated/timed 01/31/12 at 5:50 p.m. (1750) for Patient #2 revealed an order for Gentamycin 120 mg IVPB (intravenous piggy back) first dose now and put on schedule at 5:00 a.m. (0500) and 5:00 p.m. (1700).
Review of the "Medication Administration Record" dated 01/31/12 through 02/01/12 revealed Gentamycin 120 mg IVPB now and put on 5:00 a.m. (0500) and 5:00 p.m. (1700) schedule. Further review of the "Medication Administration Record" for Patient #2 revealed the administration time of 05:00 a.m. (0500), on 02/01/12 was left blank on the form. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#2).
Patient #3
Review of the medical record for Patient #3 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of abdominal pain, constipation, and blood in stool. Review of the "Physician's Orders" dated/timed 02/11/12 at 3:10 p.m. (1510) for Patient #3 read in part, "ID (identify) & (and) cont (continue) home meds (medications)...". Further review of the "Physician's Orders" for Identification of Home Medications/Reconciliation form verbal order dated/timed 02/12/11 at 6:00 a.m. (0600) for Patient #3 read in part, "...Zipsor 25 mg (milligrams) take 1 (one) by mouth 4 X (four times) daily...". Further review of the medical record revealed there was no documentation the physician was notified of the four (4) missed medication administrations of Zipsor to Patient #3 on 02/12/11 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100).
Review of the "Medication Administration Record" dated 02/12/12 to 02/13/12 revealed Zipsor 25 mg i (one) po (oral) 4 X daily at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100). Further review of the "Medication Administration Record" for Patient #3 revealed the administration time of 9:00 a.m. (0900), of 1:00 p.m. (1300), of 5:00 p.m. (1700), and of 9:00 p.m. (2100) were left blank on the form and "med unavailable" was hand written next to the times that the medication was to be administered to the patient. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#3).
Review of the "Medication Variance Report" dated 01/31/12 through 02/13/12 revealed no documentation of missed medication administration of Gentamycin for Patient #2 on 02/01/12 at 5:00 a.m. (0500) and/or for the four (4) missed medication administrations of Zipsor for Patient #3 on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100).
During an interview on 02/15/12 at 9:10 a.m., S11Registered Nurse (RN) verified she provided nursing care to the patient (#3) during the night shift on 02/12/12. S11RN indicated it is policy for the nurse to mark a line through the time that the medication was administered to the patient on the "Medication Administration Record" and initial the administration time indicating the patient was administered the medication as ordered by the physician. S11RN verified there was no documentation Patient #3 was administered the Zipsor medication on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100) on the "Medication Administration Record" and/or in the medical record as per policy. S11RN indicated Patient #3's Zipsor medication was unavailable. Pharmacy did not have the medication (Zipsor) available for administration to Patient #3 on 02/12/12. S11RN verified there was no documented evidence in the medical record the physician was notified that the patient (#3) was not administered the Zipsor medication as ordered on [DATE] as per policy. The RN (S11) indicated she did not complete a "Medication Variance Report" for the four (4) missed medication administrations of Zipsor on 02/12/12 as per policy.

In an interview on 02/15/12 at 9:50 a.m. and at 11:35 a.m., S5Pharmacy Director and S2 ADON (Assistant Director of Nursing) both verified there was no documented evidence Patient #2 was administered the Gentamycin antibiotic medication on 02/01/12 at 5:00 a.m. (0500) and/or Patient #3 was administered the Zipsor medication on 02/12/12 at 9:00 a.m., at 1:00 p.m., at 5:00 p.m. and/or at 9:00 p.m. as ordered by the physicians. Both the Pharmacy Director (S5) and ADON (S2) indicated the missed medication administration of Gentamycin on 02/01/12 at 5:00 a.m. for Patient #2 is a medication error requiring a "Medication Variance Report" to be completed by nursing staff as per policy. S5 and S2 both stated the four (4) missed medication administrations of Zipsor on 02/12/12 are a medication error requiring a "Medication Variance Report" to be completed by nusing staff as per policy. S5Pharmacy Director indicated there was no "Medication Variance Report" submitted to pharmacy for the missed medication administration/medication error of Gentamycin for Patient #2 on 02/01/12 and/or Zipsor for Patient #3 on 02/12/12 as ordered by the physician as per policy. S5Pharmacy Director further indicated there was no tracking/trending for the five (5) missed medication administrations/medication errors of Gentamycin on 02/01/12 for Patient #2 and/or of Zipsor on 02/12/12 for Patient #3.
The policy titled, "Medication Management and Administration", with no policy number, revised/reviewed dates of 12/2011, with no effective date, page 10 of 17, presented as the hospital's current "Medication Administration" policy, under the heading titled, "Medications Are Administered by the Following Individuals", indicated medications will be given as ordered by the physicians unless within the professional judgement of the RN (registered nurse) that it should be withheld. In this case, the RN will notify the physician of this decision.
Review of the policy titled, "Medication Variances", Policy 14-03, Last revised date of 4/1/10, last reviewed date of 12/2011, with no effective date, presented as the hospital's current "Medication Administration and Medication Variance Report" policy read as follows: ''..."The medication use shall follow current standards of practice according to hospital policy...The definition of a medication variance is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer...Such events may be related to professional practice, ...procedures,...dispensing, ... distribution, ...and....administration...Following are categories of medication errors: Level 0 Error did not reach patient...Level 1 Error occurred without harm to patient...Level 2 Error occurred, increase monitoring but no change in vital signs or any patient harm...Level 3 Error resulted in need increased monitoring, there was change in vital signs but no ultimate patient harm; any error needing increased laboratory monitoring...Level 4 Error resulted in need for treatment with another drug, increased length of stay, patient transfer to higher level of care (e.g. ICU), or required intervention to prevent permanent impairment or damage...Level 5 Error resulted in permanent patient harm...Level 6 Error resulted in patient death...Types of medication errors include: Omission: Failure to administer an ordered dose or dose not given before the next scheduled dose is due. Exceptions include patient refusal or recognized contraindications or incompatibilities...Unauthorized Drug: Administration to the patient of a medication dose not authorized for the patient. This category includes a dose given to the wrong patient,...administration of an unordered drug,...Procedure: A. All medication variances are reported to the physician and nursing supervisor and facility's designated person responsible for collection and review of such reports within twenty-four hours, unless there is a change requiring medical intervention and/or added treatment, in which case immediate notification of the physician is required...B. If a medication is administered in error this must be recorded...C. A medication variance form should be completed by the person discovering the error or near miss situation as soon as possible. An occurrence report should also be completed for medication variances level 4 and above...All medication variance reports evaluated as significant (level 4 or above) will result in an occurrence report and are referred to the Pharmacy and Therapeutics Committee for review. The Director of Pharmacy will perform summary data and trend analysis. The Director of Pharmacy will make reports of actions taken and appropriate follow-up to the Pharmacy and Therapeutics Committee...".

2) In a second (face-to-face) interview with S7 RN, on 2/14/12 at 8:30 a.m., she confirmed IVPB medications are already refrigerated and on the unit.She stated pharmacy places the IVPBs in the refrigerator without any special order (i.e. high risk medications on first shelf; non-high risk medications on the second shelf). S7 added if patient #2 did not receive the 0500 dose of Gentamycin, the bag should still be in the refrigerator. S7 RN confirmed she was not aware that the 0500 dose of Gentamycin was not given (S10 LPN had not reported the Gentamycin was still in the refrigerator). S7 RN added she does not check the refrigerator to ensure all medications have been given, especially if she has assigned the patients to the LPN.

On 2/13/12 at 3:05 p.m. in a face-to-face interview with S5 Director of Pharmacy, explained that patient #13 was admitted to the hospital at 1354 (1:54 p.m.) on 1/31/12. He was admitted with a diagnosis of diabetic ketoacidosis. S5 stated on the physician's admit orders, patient #13 was to receive an IVPB of Regular insulin 100 units/100 ml (milliliters) of Normal Saline upon admit. Physician's orders indicated patient #13 was to receive 0.1 units of Regular insulin/ kg (kilogram)/ hr. S5 stated the pharmacy department closes at 7:00 p.m. and all IVPBs are brought to the units prior to pharmacy technicians leave the hospital. S5 confirmed patient #13 received the first dose of Regular insulin at 1520 (3:20 p.m.). Pharmacy mixed another IVPB and brought it to the ICU at 1825 (6:25 a.m.) in case the patient needed another infusion of Regular insulin after the pharmacy closes at 7:00 p.m.

S5 stated the physician had ordered the IVPB of Regular insulin to be discontinued on 1/31/12 at 1900 (7:00 p.m.). The nurse scanned the order to pharmacy at 1915 (7:15 p.m.), which indicated the Regular insulin IVPB was to be discontinued. S5 stated the nurses on the units are responsible for removing discontinued medication from the refrigerator and place the medications in the bin located in the medicine room. Pharmacy arrives at the hospital 7:00 a.m. and picks up all of the discontinued medications throughout the hospital.

On 2/13/12 at 4:00 p.m. in a telephone interview with S7 RN ICU, she stated discontinued IVPB medications would stay in the refrigerator until the pharmacy picks up the medication.

On 2/13/12 at 4:30 p.m. in a face-to-face interview with S8 LPN, she stated if IVPB medication is discontinued, then the medication is left in the refrigerator until pharmacy picks it up the next day.

On 2/14/12 at 8:30 a.m. in a face-to-face interview with S9 LPN, she stated only pharmacist and/or pharmacy tech's handle discontinued IVPBs in the refrigerator.

Record review of policy titled "Medication Management and Administration" (pg 15 of 17) Discharge or Death of Patient" revealed the following procedure: " -Remove patient's medication bin from medication cart and place in Pharmacy basket. Also, place all IV's, enteral feeding solutions, bulk liquids, Mdin's in Pharmacy basket for pick up and crediting."

On 2/13/12 at 3:05 p.m. S5 Director of Pharmacy and S2 Assistant DON confirmed the hospital's policy did not address the steps the nurses are to take if the medication is discontinued and still in the hospital, which could contribute to medication errors. S2 added the nurses on 7 PM- 7 AM shift on 1/31/12 are expected to pull the IVPB of Insulin out of the refrigerator once the physician discontinued the medication at 1900 (7:00 p.m.).

On 2/13/12 at 3:30 p.m. in a face-to-face interview with S6 RN, she stated she would expect her licensed staff to remove discontinued medications and place in the bin for the pharmacy to pick up, mark through the medication on the MAR (Medication Administration Record), and write d/C (discontinued) on the MAR.

Record review of policy titled "High-Risk Medications" pg 1 of 3 under Procedure revealed "High risk medications are eliminated from floor stock whenever possible and after-hours access is limited to nursing supervisor or other authorized personnel."

On 02/14/12 from 9:50 a.m. through 10:00 a.m., a tour of the ICU with S3RN, ICU and S12RN, Quality Director was conducted. Further observation of the ICU revealed there was a locked medication refrigerator noted on the unit. Further observation revealed there was a drawer noted in the bottom of the refrigerator that had a red label, "High Risk Medication" on it. At this time, S3RN, ICU indicated all high risk medications such as insulin, gentamycin, and heparin are stored in the drawer labeled, "High Risk Medication". At 10:00 a.m., S12RN, Quality Director indicated the bottom drawer in the refrigerator labeled, "High Risk Medication" was implemented last Thursday, 02/9/12 by pharmacy after an unordered IVPB of insulin medication was administered to a patient (#2). S12RN further indicated there was no separation between the high risk medications and/or other medications in the refrigerator in ICU prior to last Thursday, 02/09/12.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on interview and record review, the hospital failed to meet the requirements for the Conditions of Participation as evidenced by:

1) A staff member failing to use the basic "5" rights to identify the correct patient, correct medication and correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback and resulted in a hypoglycemic brain injury according to Physician's Progress Notes dated 2/4/12 (See deficiency cited at A404).

2) Failing to identify adverse reaction of the effects of insulin on patient #2 who is a nondiabetic, as evidenced by two staff nurses (S4 RN and S9 LPN) failing to assess that insulin had been administered to the patient even though patient was exhibiting signs of an insulin reaction (tachycardia, tremors, pallor, motor dysfunction, speech disturbances, and coma). (See deficiency cited A0395.)
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on observation, interview, and record review, the hospital staff failed to demonstrate professional standards of practice for 1 of 13 patients as evidenced by:

1) A staff member failed to use the basic "5" rights to identify the correct patient, correct medication and correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback and resulted in a hypoglycemic brain injury according to Physician's Progress Notes dated 2/4/12.

2) Two staff nurses (S4 RN and S9 LPN) failing to assess that insulin had been administered to patient #2 even though patient #2 was exhibiting signs of an insulin reaction (tachycardia, tremors, pallor, motor dysfunction, speech disturbances, and coma).

Findings:

1) A staff member failed to use the basic "5" rights to identify the correct patient, correct medication and correct dose to be administered to 1 of 13 patients, which resulted in the administration of an insulin IV piggyback to a nondiabetic patient instead of following the doctor's orders of administering Gentamycin IV piggyback and resulted in a hypoglycemic brain injury according to Physician's Progress Notes dated 2/4/12.

Record review of the policy titled "Medication Management and Administration" reviewed on 12/2011 and revised 12/2011 (pg 10 of 17) revealed a section delineating who can administer medications. Under "Medications are Administered by the Following Individuals" the policy states "Licensed Registered Nurses may administer medication by the following routes: Oral, Intramuscular, Intravenous, Subcutaneous, Rectally, Vaginally, Nasogastric, Gastrostomy Tube, Intradermal, Transdermal, Inhalation, and Endotracheal. Licensed Practical Nurses (LPNs) may administer medications in the routes listed above with the exception of: Intravenous and Endotracheal". The hospital failed to follow their Medication Management and Administration policy by allowing LPNs to administer Intravenous medications.

According to the Nurse Practice Act 3703. Managing and Supervising the Practice of Nursing of "directing the nursing care and evaluating the outcomes of that care" , S7 RN ICU failed to evaluate the nursing care after S10 LPN administered an unordered insulin IVPB to Patient #2 during her night shift on 02/01/12.

On 2/13/12 at 4:00 p.m. in a telephone interview with S7 RN ICU, she stated she makes assignments to LPNs based on patients' acuity levels. S7 confirmed she (S 7 RN) would administer high-risk IVPBs such as an insulin IVPB. She also stated she assesses the amount of fluid in all lines infusing. She stated if the IVPB is empty, then she does not assess what is hanging. S7 stated it was her responsibility to ask the LPNs if there are any changes to patients' conditions.

In a second (face-to-face) interview with S7 RN, on 2/14/12 at 8:30 a.m., she confirmed IVPB medications are already refrigerated and on the unit. She stated pharmacy places the IVPBs in the refrigerator without any special order (i.e. high risk medications on first shelf; non-high risk medications on the second shelf). S7 added if patient #2 did not receive the 0500 dose of Gentamycin, the bag should still be in the refrigerator. S7 RN confirmed she was not aware that the 0500 dose of Gentamycin was not given (S10 LPN had not reported the Gentamycin was still in the refrigerator). S7 RN added she does not check the refrigerator to ensure all medications have been given, especially if she has assigned the patients to the LPN.

Record review of the hospital's "Criteria-Based Performance Evaluation/Job Description System" for the title of RN revealed under Position Summary: Major Tasks, Duties, and Responsibilities: "Assumes full nursing responsibility for the delivery of care to all patients on designated units." Under Standard II-Nursing Process, the RN supervises all assessments and nursing care of assigned co-workers. Under Standard V- Clinical Skills, the RN prepares IV solutions, performs veni-punctures and administeres IV/IM medications. Under Standard VI- Safety, the RN appraises situation and condition of all patients on the unit."

According to the Nurse Practice Act 3915. Standard Number 7: Professional Performance A.3 reads "The registered nurse demonstrates the following professional nursing practice behaviors: Considers factors related to safety, effectiveness, and cost in planning and delivering nursing care", S4 RN failed to assess the empty insulin IVPB bag left hanging on patient #2's IV pole on 4 separate occasions. A family member and a friend of patient #2 found the empty bag still hanging on the IV pole 7.5 hours after the unordered Insulin had been administered by S10 LPN.

On 2/13/12 at 2:14 p.m. in a face-to-face interview with S4 RN ICU, she stated she was the nurse in charge when S9 LPN ICU was told about the empty IV bag by a family member, which contained Insulin, hanging on patient #2's IV pole. S4 stated she made rounds on all 4 of the ICU patients 2/1/12 and then assigned two patients (#2 and #13) to S9 LPN. S4 stated she normally checks all infusion bags (both empty and those infusing), but on the morning of 2/1/12, she failed to check the empty IVPB bag hanging on patient #2's IV pole. She stated the bag was facing the wall and the label wasn't showing. She also stated if the bag had been facing the front of the IV pole, she would have recognized the bag contained a high-risk medication because it would have had a red sticker on the bag. S4 also confirmed she did not check the IVPB bags remaining in the refrigerator when she came on duty.

Record review of the hospital's "Criteria-Based Performance Evaluation/Job Description System" for the title of RN revealed under Position Summary: Major Tasks, Duties, and Responsibilities: "Assumes full nursing responsibility for the delivery of care to all patients on designated units." Under Standard II-Nursing Process, the RN supervises all assessments and nursing care of assigned co-workers. Under Standard V- Clinical Skills, the RN prepares IV solutions, performs veni-punctures and administeres IV/IM medications. Under Standard VI- Safety, the RN appraises situation and condition of all patients on the unit."

On 2/13/12 at 2:14 p.m. in a face-to-face interview with S4 RN ICU, she confirmed she had assessed patient #2 at 0700 (7:00 a.m.) and did not assess the empty IVPB. She confirmed she assessed the change in patient #2's condition at 0830 (8:30 a.m.), but had not checked the empty insulin IVPB. She confirmed she had to change the IV due to an infiltration at 1045 (10:45 a.m.) and moved the IV to patient #2's right foot. She did not assess the empty insulin IVPB still hanging on the IV pole.

Record review of Interdisciplinary Patient Notes dated 2/1/2 and written by S9 LPN, ICU revealed she interacted with patient #2 at 0815 (when she brought the breakfast tray to patient who was awake and alert); at 0830-0845 when she provided hygiene care to patient #2 with S4 RN. (It was at this time she noticed a change in patient's level of consciousness.); at 0930 when she accompanied patient #2 to have a CT scan; at 1045 when she assisted S4 RN in reinitiating the IV in patient #2's right foot.

On 2/14/12 at 9:00 a.m. in a face-to-face interview with S9 LPN, she confirmed she did not check the empty insulin IVPB during the encounters with patient #2. She also confirmed it was the hospital's policy to assess only the running infusions, not the empty ones.

Record review of policy titled "Assessment, Screening & Reassessment" pg 1 of 16 under Policy reveals "The goal of the assessment/reassessment process is to determine care needs and subsequently to provide the patient the best intervention possible. The patient assessment will include content regarding: Past medical history; Allergies; Pain rating per appropriate scale; Biophysical (major body systems, physiologic parameters); Psychosocial; Environment (special equipment used by the patient); Self-care; Education; Discharge Planning; Age Specific assessment parameters."

2) Two staff nurses (S4 RN and S9 LPN) failing to assess that insulin had been administered to patient #2 even though patient #2 was exhibiting signs of an insulin reaction (tachycardia, tremors, pallor, motor dysfunction, speech disturbances, and coma).

According to Nurse Practice Act 3903. Standard Number 1: Collection and Recording of Individual's Health Status A.1." The priority of data collection is determined by the individual's immediate condition and needs"as evidenced by S4 RN failing to recognize signs and symptoms of "insulin shock" or hypoglycemic signs and symptoms (rapid bounding pulse, pale moist skin, weakness, coma).

In a face-to-face interview with S9 LPN ICU, she confirmed patient #2 was awake and alert the morning of 2/1/12 at 0730 (7:30 a.m.). When she brought the breakfast tray to patient #2's room at 0750 (7:50 a.m.) and asked patient #2 if she was hungry, patient #2 stated she was. S9 stated she asked S4 RN for assistance at 0835 (8:35 a.m.) to provide hygiene care after patient #2 had a bowel movement. She stated patient #2 had become unresponsive by this time. S9 stated she placed oxygen on patient #2 by nasal cannula and notified S4 RN.

On 2/13/12 at 2:14 p.m. in a face-to-face interview with S4 RN ICU, she stated she had performed a head-to-toe assessment on patient #2 earlier the morning of 2/1/12. When she was asked to help clean patient #2, S4 RN stated she noticed a change in patient #2's condition. She assessed patient #2's head was turned to the left side, she was drooling, and had facial flushing. S4 also assessed patient's facial muscles were flaccid and would not respond to painful stimuli. She immediately called the physician who ordered a CT scan of the head to determine if patient #2 had a stroke.

Record review of Interdisciplinary Patient Notes dated 2/1/12 and timed at 0950 (9:50 a.m.) revealed S4 documented after patient returned from the CT scan, there was still no changes in patient's condition. At 1045 (10:45 a.m.), S4 documented patient #2's 20 gauge IV on the right antecubital area had infiltrated and needed to be restarted. IV was restarted in patient #2's right foot. (Insulin IVPB was still hanging empty on the IV pole at this time)

Record review of ICU Flow Sheet (Nurse's notes), patient #2's vital signs at 0600 (6:00 a.m.) on 2/1/12 were recorded by S10 LPN as Temperature (T) 96 Axillary; Pulse (P) 70; Respirations (R) 16; Blood pressure (B/P) 90/40. 0700 vital signs were documented by S9 LPN as T 98; P 100; R 14; B/P 98/40; 0800 vital signs documented by S9 LPN as P >100; R 26; B/P 115/50; 0900 vital signs P 110, R 26; B/P 110/45; Vital signs documented at 1000 P >90; R 21, B/P 110/50; Vital signs documented at 1300 (1:00 p.m.) P 90, R 20, B/P 90/50.

Record review of policy titled "Assessment, Screening, & Reassessment" pg 4 of 6 under Inpatient Unit revealed "Aspects of data collection is delegated to qualified patient care unit personnel with the RN retaining responsibility for interpreting the data and identifying patient care needs."

Record review of the Criteria-Based Performance Evaluation/Job Description System for the title of LPN, under Standard II- Clinical Skills, the LPN "demonstrates knowledge and understanding of normal limits of vital signs.."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and staff interviews, the hospital failed to ensure the drugs and biologicals were administered in accordance with the orders of the practitioners responsible for the patient's care as evidenced by failure to administer Gentamycin antibiotic medication on 02/01/12 for patient #2 and failure to administer Zipsor (NSAID) medication on 02/12/12 for patient #3 as per the "Medication Management and Administration" policy for 2 of 10 focused sampled records reviewed for medication administration out of a sample of 13 sampled records reviewed. Findings:

Patient #2
Review of the medical record for Patient #2 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of urosepsis and dehydration. Review of the "Physician's Orders" dated/timed 01/31/12 at 5:50 p.m. (1750) for Patient #2 revealed an order for Gentamycin 120 mg IVPB (intravenous piggy back) first dose now and put on schedule at 5:00 a.m. (0500) and 5:00 p.m. (1700).

Review of the "Medication Administration Record" dated 01/31/12 through 02/01/12 revealed Gentamycin 120 mg IVPB now and put on 5:00 a.m. (0500) and 5:00 p.m. (1700) schedule. Further review of the "Medication Administration Record" for Patient #2 revealed the administration time of 05:00 a.m. (0500), on 02/01/12 was left blank on the form. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#2).

Patient #3
Review of the medical record for Patient #3 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of abdominal pain, constipation, and blood in stool. Review of the "Physician's Orders" dated/timed 02/11/12 at 3:10 p.m. (1510) for Patient #3 read in part, "ID (identify) & (and) cont (continue) home meds (medications)...". Further review of the "Physician's Orders" for Identification of Home Medications/Reconciliation form verbal order dated/timed 02/12/11 at 6:00 a.m. (0600) for Patient #3 read in part, "...Zipsor 25 mg (milligrams) take 1 (one) by mouth 4 X (four times) daily...". Further review of the medical record revealed there was no documentation the physician was notified of the four (4) missed medication administrations of Zipsor to Patient #3 on 02/12/11 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100).

Review of the "Medication Administration Record" dated 02/12/12 to 02/13/12 revealed Zipsor 25 mg i (one) po (oral) 4 X daily at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100). Further review of the "Medication Administration Record" for Patient #3 revealed the administration time of 9:00 a.m. (0900), of 1:00 p.m. (1300), of 5:00 p.m. (1700), and of 9:00 p.m. (2100) were left blank on the form and "med unavailable" was hand written next to the times that the medication was to be administered to the patient. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#3).

Review of the "Medication Variance Report" dated 01/31/12 through 02/13/12 revealed no documentation of missed medication administration of Gentamycin for Patient #2 on 02/01/12 at 5:00 a.m. (0500) and/or for the four (4) missed medication administrations of Zipsor for Patient #3 on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100).

During an interview on 02/15/12 at 9:10 a.m., S11Registered Nurse (RN) verified she provided nursing care to the patient (#3) during the night shift on 02/12/12. S11RN indicated it is policy for the nurse to mark a line through the time that the medication was administered to the patient on the "Medication Administration Record" and initial the administration time indicating the patient was administered the medication as ordered by the physician. S11RN verified there was no documentation Patient #3 was administered the Zipsor medication on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100) on the "Medication Administration Record" and/or in the medical record as per policy. S11RN indicated Patient #3's Zipsor medication was unavailable. Pharmacy did not have the medication (Zipsor) available for administration to Patient #3 on 02/12/12. S11RN verified there was no documented evidence in the medical record the physician was notified that the patient (#3) was not administered the Zipsor medication as ordered on [DATE] as per policy.

In an interview on 02/15/12 at 9:50 a.m. and at 11:35 a.m., S5Pharmacy Director and S2 ADON (Assistant Director of Nursing) both verified there was no documented evidence Patient #2 was administered the Gentamycin antibiotic medication on 02/01/12 at 5:00 a.m. (0500) as ordered by the physician. Both the Pharmacy Director (S5) and ADON (S2) indicated the missed medication administration of Gentamycin on 02/01/12 is a medication error requiring a "Medication Variance Report" to be completed by nursing staff as per policy. S5Pharmacy Director and S2ADON reported the physician should be notified of the missed medication administration/medication error for Patient #2's Gentamycin medication on 02/01/12 as per policy. The Pharmacy Director (S5) and ADON (S2) confirmed there was no documented evidence in the medical record the physician was notified that Patient #2 was not administered the Gentamycin medication as ordered by the physician on 02/01/12 as per policy. S5Pharmacy Director indicated there was no "Medication Variance Report" submitted to pharmacy for the missed medication administration/medication error of Gentamycin for Patient #2 on 02/01/12 as ordered by the physician as per policy. Both S5Pharmacy Director and S2ADON both verified there was no documented evidence Patient #3 was administered the Zipsor on 02/12/12 four times a day at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100) as ordered by the physician. The Pharmacy Director (S5) and ADON (S2) both indicated the four (4) missed medication administrations of Zipsor on 02/12/12 is a medication error requiring a "Medication Variance Report" to be completed by nursing staff as per policy. S5Pharmacy Director and S2ADON reported the physician should be notified of the four (4) missed medication administrations/medication errors for Patient #3's Zipsor on 02/12/12 as per policy. The Pharmacy Director (S5) and ADON (S2) both confirmed there was no documented evidence in the medical record the physician was notified that Patient #3 was not administered the Zipsor medication on 02/12/12 as per policy. S5Pharmacy Director indicated there was no "Medication Variance Report" submitted to pharmacy for the four (4) missed medication administrations/medication errors of Zipsor for Patient #3 on 02/12/12 as ordered by the physician as per policy.

The policy titled, "Medication Management and Administration", with no policy number, revised/reviewed dates of 12/2011, with no effective date, page 10 of 17, presented as the hospital's current "Medication Administration" policy, under the heading titled, "Medications Are Administered by the Following Individuals", indicated medications will be given as ordered by the physicians unless within the professional judgement of the RN (registered nurse) that it should be withheld. In this case, the RN will notify the physician of this decision.

Review of the policy titled, "Medication Variances", Policy 14-03, Last revised date of 4/1/10, last reviewed date of 12/2011, with no effective date, presented as the hospital's current "Medication Administration and Medication Variance Report" policy read as follows: ''..."The medication use shall follow current standards of practice according to hospital policy...The definition of a medication variance is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer...Such events may be related to professional practice, ...procedures,...dispensing, ... distribution, ...and....administration...Following are categories of medication errors: Level 0 Error did not reach patient...Level 1 Error occurred without harm to patient...Level 2 Error occurred, increase monitoring but no change in vital signs or any patient harm...Level 3 Error resulted in need increased monitoring, there was change in vital signs but no ultimate patient harm; any error needing increased laboratory monitoring...Level 4 Error resulted in need for treatment with another drug, increased length of stay, patient transfer to higher level of care (e.g. ICU), or required intervention to prevent permanent impairment or damage...Level 5 Error resulted in permanent patient harm...Level 6 Error resulted in patient death...Types of medication errors include: Omission: Failure to administer an ordered dose or dose not given before the next scheduled dose is due. Exceptions include patient refusal or recognized contraindications or incompatibilities...Unauthorized Drug: Administration to the patient of a medication dose not authorized for the patient. This category includes a dose given to the wrong patient,...administration of an unordered drug,...Procedure: A. All medication variances are reported to the physician and nursing supervisor and facility's designated person responsible for collection and review of such reports within twenty-four hours, unless there is a change requiring medical intervention and/or added treatment, in which case immediate notification of the physician is required...B. If a medication is administered in error this must be recorded...C. A medication variance form should be completed by the person discovering the error or near miss situation as soon as possible. An occurrence report should also be completed for medication variances level 4 and above...All medication variance reports evaluated as significant (level 4 or above) will result in an occurrence report and are referred to the Pharmacy and Therapeutics Committee for review. The Director of Pharmacy will perform summary data and trend analysis. The Director of Pharmacy will make reports of actions taken and appropriate follow-up to the Pharmacy and Therapeutics Committee...".
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on interview and policy review, the hospital failed to follow their policy of administering intravenous medication for 1 of 13 sampled patients (#2) as evidenced by a allowing an LPN to administer an unordered IVPB of Regular insulin and not following the patient identification process resulting in a hypoglycemic brain injury. Findings:

Record review of notes written by S13 RN Risk Manager during the investigation of the medication error on patient #2, revealed S10 LPN denying she had administered the Regular insulin IVPB. S10 LPN had admitted she thought the Gentamycin trough level was due on 2/1/12, so she had the lab draw the trough level. S10 stated this was the reason why she had not hung the Gentamycin IVPB. S10 LPN admitted to S13 RN Risk Manager, according to the written notes, that S10 did not do 5 rights during administration of the IVPB. S10 stated she administered the 0600 IVPB dose of Zosyn, which she removed from the refrigerator.

Record review of the policy titled "Medication Management and Administration" reviewed on 12/2011 and revised 12/2011 (pg 10 of 17) revealed a section delineating who can administer medications. Under "Medications are Administered by the Following Individuals" the policy states "Licensed Registered Nurses may administer medication by the following routes: Oral, Intramuscular, Intravenous, Subcutaneous, Rectally, Vaginally, Nasogastric, Gastrostomy Tube, Intradermal, Transdermal, Inhalation, and Endotracheal. Licensed Practical Nurses (LPNs) may administer medications in the routes listed above with the exception of: Intravenous and Endotracheal". The hospital failed to follow their Medication Management and Administration policy by allowing LPNs to administer Intravenous medications.

Record review of policy titled Medication Management and Administration (pg 6 of 17) under Ordering and Administering Medications, reveals "Objectives are to observe the five rights of proper medication administration: the right drug, the right dose, the right route, the right time, and the right patient." On pg 11 of 17 under Patient Assessments Required before the Administration of Medications reveals "The patient is identified utilizing 2 patient identifiers- Patient name and date of birth, comparing the label on the medication/MAR with the patient armband; the medication is checked for dose, route, and time of administration." Under Administering a Medication (pg 14 of 17), the steps include: Note order from the MAR and compare to physician orders for accuracy; Remove the drug from the patient's medication bin; Prepare medication as necessary; At bedside, check the ID band of the patient for the 2 patient identifiers. If no armband is present, medications are not to be administered; Administer medication according to established protocols; Record administration time on MAR sheet in space aligned with medication, initial and date."

Record review of Physician's Progress Notes dated 2/4/12 and timed at 9:20 a.m. revealed S14 MD documented patient #2 experienced a hypoglycemic brain injury and would require comfort measures.

On 2/15/12 at 9:30 a.m. in a face-to-face interview with S1 DON and S2 ADON, they both confirmed S10 LPN had admitted she had not performed the 5 rights of proper medication administration as outlined in the Medication Management and Administration policy.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on record reviews and staff interviews, the Pharmacy failed to ensure all drugs and biologicals were distributed/administered as ordered by the practitioners as evidenced by:
1) failed to administer Gentamycin medication on 02/01/12 at 5:00 a.m. (0500) to Patient #2 and Zipsor medication on 02/12/11 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100) to Patient #3 as per the physician's orders and/or as per the "Medication Management and Administration" policy for 2 of 10 focused records reviewed for medication administration out of a total of 13 sampled records reviewed; and
2) failed to complete a "Medication Variance Report" for the missed medication administration/medication error for the Gentamycin medication on 02/01/12 to Patient #2 and for the four (4) missed medication administrations/medication errors for the Zipsor medications on 02/12/12 to Patient #3 as per the "Medication Variances" policy for 2 of 10 focused records reviewed for medication administration out of a total of 13 sampled records reviewed. Findings:

Patient #2
Review of the medical record for Patient #2 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of urosepsis and dehydration. Review of the "Physician's Orders" dated/timed 01/31/12 at 5:50 p.m. (1750) for Patient #2 revealed an order for Gentamycin 120 mg IVPB (intravenous piggy back) first dose now and put on schedule at 5:00 a.m. (0500) and 5:00 p.m. (1700).
Review of the "Medication Administration Record" dated 01/31/12 through 02/01/12 revealed Gentamycin 120 mg IVPB now and put on 5:00 a.m. (0500) and 5:00 p.m. (1700) schedule. Further review of the "Medication Administration Record" for Patient #2 revealed the administration time of 05:00 a.m. (0500), on 02/01/12 was left blank on the form. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#2).
Patient #3
Review of the medical record for Patient #3 revealed the patient was admitted into the hospital on [DATE] with the diagnosis of abdominal pain, constipation, and blood in stool. Review of the "Physician's Orders" dated/timed 02/11/12 at 3:10 p.m. (1510) for Patient #3 read in part, "ID (identify) & (and) cont (continue) home meds (medications)...". Further review of the "Physician's Orders" for Identification of Home Medications/Reconciliation form verbal order dated/timed 02/12/11 at 6:00 a.m. (0600) for Patient #3 read in part, "...Zipsor 25 mg (milligrams) take 1 (one) by mouth 4 X (four times) daily...". Further review of the medical record revealed there was no documentation the physician was notified of the four (4) missed medication administrations of Zipsor to Patient #3 on 02/12/11 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100).
Review of the "Medication Administration Record" dated 02/12/12 to 02/13/12 revealed Zipsor 25 mg i (one) po (oral) 4 X daily at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and at 9:00 p.m. (2100). Further review of the "Medication Administration Record" for Patient #3 revealed the administration time of 9:00 a.m. (0900), of 1:00 p.m. (1300), of 5:00 p.m. (1700), and of 9:00 p.m. (2100) were left blank on the form and "med unavailable" was hand written next to the times that the medication was to be administered to the patient. There was no documentation of a line drawn through the time of medication administration and/or an initial of the nursing staff that administered the medication to the patient (#3).
Review of the "Medication Variance Report" dated 01/31/12 through 02/13/12 revealed no documentation of missed medication administration of Gentamycin for Patient #2 on 02/01/12 at 5:00 a.m. (0500) and/or for the four (4) missed medication administrations of Zipsor for Patient #3 on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100).
During an interview on 02/15/12 at 9:10 a.m., S11Registered Nurse (RN) verified she provided nursing care to the patient (#3) during the night shift on 02/12/12. S11RN indicated it is policy for the nurse to mark a line through the time that the medication was administered to the patient on the "Medication Administration Record" and initial the administration time indicating the patient was administered the medication as ordered by the physician. S11RN verified there was no documentation Patient #3 was administered the Zipsor medication on 02/12/12 at 9:00 a.m. (0900), at 1:00 p.m. (1300), at 5:00 p.m. (1700), and/or at 9:00 p.m. (2100) on the "Medication Administration Record" and/or in the medical record as per policy. S11RN indicated Patient #3's Zipsor medication was unavailable. Pharmacy did not have the medication (Zipsor) available for administration to Patient #3 on 02/12/12. S11RN verified there was no documented evidence in the medical record the physician was notified that the patient (#3) was not administered the Zipsor medication as ordered on [DATE] as per policy. The RN (S11) indicated she did not complete a "Medication Variance Report" for the four (4) missed medication administrations of Zipsor on 02/12/12 as per policy.

In an interview on 02/15/12 at 9:50 a.m. and at 11:35 a.m., S5Pharmacy Director and S2 ADON (Assistant Director of Nursing) both verified there was no documented evidence Patient #2 was administered the Gentamycin antibiotic medication on 02/01/12 at 5:00 a.m. (0500) and/or Patient #3 was administered the Zipsor medication on 02/12/12 at 9:00 a.m., at 1:00 p.m., at 5:00 p.m. and/or at 9:00 p.m. as ordered by the physicians. Both the Pharmacy Director (S5) and ADON (S2) indicated the missed medication administration of Gentamycin on 02/01/12 at 5:00 a.m. for Patient #2 is a medication error requiring a "Medication Variance Report" to be completed by nursing staff as per policy. S5 and S2 both stated the four (4) missed medication administrations of Zipsor on 02/12/12 are a medication error requiring a "Medication Variance Report" to be completed by nursing staff as per policy. S5Pharmacy Director and S2ADON reported the physician should be notified of the missed medication administration/medication error for Patient #2's Gentamycin medication on 02/01/12 and Patient #3's Zipsor on 02/12/12 as per policy. The Pharmacy Director (S5) and ADON (S2) both confirmed there was no documented evidence in the medical record the physician was notified that Patient #2 was not administered the Gentamycin medication as ordered by the physician on 02/01/12 as per policy. S5 and S2 both verified there was no documentation in the medical record the physician was notified that Patient #3 was not administered the Zipsor medication on 02/12/12 as per policy. S5Pharmacy Director indicated there was no "Medication Variance Report" submitted to pharmacy for the missed medication administration/medication error of Gentamycin for Patient #2 on 02/01/12 and/or Zipsor for Patient #3 on 02/12/12 as ordered by the physician as per policy.
The policy titled, "Medication Management and Administration", with no policy number, revised/reviewed dates of 12/2011, with no effective date, page 10 of 17, presented as the hospital's current "Medication Administration" policy, under the heading titled, "Medications Are Administered by the Following Individuals", indicated medications will be given as ordered by the physicians unless within the professional judgement of the RN (registered nurse) that it should be withheld. In this case, the RN will notify the physician of this decision.
Review of the policy titled, "Medication Variances", Policy 14-03, Last revised date of 4/1/10, last reviewed date of 12/2011, with no effective date, presented as the hospital's current "Medication Administration and Medication Variance Report" policy read as follows: ''..."The medication use shall follow current standards of practice according to hospital policy...The definition of a medication variance is any preventable event that may cause or lead to inappropriate medication use... Such events may be related to professional practice, ...procedures,...dispensing, ... distribution, ...and....administration...Following are categories of medication errors: Level 0 Error did not reach patient...Procedure: A. All medication variances are reported to the physician and nursing supervisor and facility's designated person responsible for collection and review of such reports within twenty-four hours, unless there is a change requiring medical intervention and/or added treatment, in which case immediate notification of the physician is required...C. A medication variance form should be completed by the person discovering the error or near miss situation as soon as possible...".
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on interview and policy review, the hospital failed to have a policy to ensure discontinued medications are not available for patient use as evidenced by an LPN administering an IVPB of Regular Insulin to patient #2 which was a discontinued medication for patient #13. Findings:

On 2/13/12 at 3:05 p.m. in a face-to-face interview with S5 Director of Pharmacy, explained that patient #13 was admitted to the hospital at 1354 (1:54 p.m.) on 1/31/12. He was admitted with a diagnosis of diabetic ketoacidosis. S5 stated on the physician's admit orders, patient #13 was to receive an IVPB of Regular insulin 100 units/100 ml (milliliters) of Normal Saline upon admit. Physician's orders indicated patient #13 was to receive 0.1 units of Regular insulin/ kg (kilogram)/ hr. S5 stated the pharmacy department closes at 7:00 p.m. and all IVPBs are brought to the units prior to pharmacy technicians leave the hospital. S5 confirmed patient #13 received the first dose of Regular insulin at 1520 (3:20 p.m.). Pharmacy mixed another IVPB and brought it to the ICU at 1825 (6:25 a.m.) in case the patient needed another infusion of Regular insulin after the pharmacy closes at 7:00 p.m.

S5 stated the physician had ordered the IVPB of Regular insulin to be discontinued on 1/31/12 at 1900 (7:00 p.m.). The nurse scanned the order to pharmacy at 1915 (7:15 p.m.), which indicated the Regular insulin IVPB was to be discontinued. S5 stated the nurses on the units are responsible for removing discontinued medication from the refrigerator and place the medications in the bin located in the medicine room. Pharmacy arrives at the hospital 7:00 a.m. and picks up all of the discontinued medications throughout the hospital.

In a second (face-to-face) interview with S7 RN, on 2/14/12 at 8:30 a.m., she confirmed IVPB medications are already refrigerated and on the unit.She stated pharmacy places the IVPBs in the refrigerator without any special order (i.e. high risk medications on first shelf; non-high risk medications on the second shelf). S7 added if patient #2 did not receive the 0500 dose of Gentamycin, the bag should still be in the refrigerator. S7 RN confirmed she was not aware that the 0500 dose of Gentamycin was not given (S10 LPN had not reported the Gentamycin was still in the refrigerator). S7 RN added she does not check the refrigerator to ensure all medications have been given, especially if she has assigned the patients to the LPN.

On 2/13/12 at 4:00 p.m. in a telephone interview with S7 RN ICU, she stated discontinued IVPB medications would stay in the refrigerator until the pharmacy picks up the medication.

On 2/13/12 at 4:30 p.m. in a face-to-face interview with S8 LPN, she stated if IVPB medication is discontinued, then the medication is left in the refrigerator until pharmacy picks it up the next day.

On 2/14/12 at 8:30 a.m. in a face-to-face interview with S9 LPN, she stated only pharmacist and/or pharmacy tech's handle discontinued IVPBs in the refrigerator.

Record review of policy titled "Medication Management and Administration" (pg 15 of 17) Discharge or Death of Patient" revealed the following procedure: " -Remove patient's medication bin from medication cart and place in Pharmacy basket. Also, place all IV's, enteral feeding solutions, bulk liquids, MDI's in Pharmacy basket for pick up and crediting."

On 2/13/12 at 3:05 p.m. S5 Director of Pharmacy and S2 Assistant DON confirmed the hospital's policy did not address the steps the nurses are to take if the medication is discontinued and the patient is still in the hospital. S2 added the nurses on 7 PM- 7 AM shift on 1/31/12 would be responsible for pulling the IVPB of Insulin out of the refrigerator once the physician discontinued the medication at 1900 (7:00 p.m.).

On 2/13/12 at 3:30 p.m. in a face-to-face interview with S6 RN, she stated she would expect her licensed staff to remove discontinued medications and place in the bin for the pharmacy to pick up, mark through the medication on the MAR (Medication Administration Record), and write d/C (discontinued) on the MAR.

Record review of policy titled "High-Risk Medications" pg 1 of 3 under Procedure revealed "High risk medications are eliminated from floor stock whenever possible and after-hours access is limited to nursing supervisor or other authorized personnel."