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Based upon observations made on 09/09/10 (11AM through 12:10PM, 1:50PM-2:25PM, and 4:45PM-5:20PM), reviews of 2 of 10 medical records (patient #1,3), hospital policies/procedures, administrative and staff interviews, the hospital failed to ensure the nursing care of each patient was evaluated and documented as evidenced by failing to ensure the Registered Nurse (RN): 1) evaluated and documented patient #1's feet/skin every 8 hours per physician's order (08/06/10-08/12/10) and turned every 2 hours per order (07/22/10-09/10/10); and 2) evaluated/re-assessed and documented patient #3's mental status changes on 09/09/10. Findings:

Review of patient #1's medical record revealed he was admitted 07/21/2010 with diagnoses of Sacral Decubitus, Kidney Failure, Septic Knee, and Protein Malnutrition. Patient #1 also had a history of diabetes and was on dialysis treatments. Review of physician's order revealed physician S15 documented: "08/6/10 ...booty on B (bilateral) feet remove Q (every) 8 (hrs) and inspect feet/skin".

Review of Nursing Notes/Shift Assessment, dated 08/06/10 through 08/12/10, revealed there lacked documented evidence the RN assigned to care for patient #1 followed physician S15's order to inspect feet/skin every 8 hours.

Continued review of Nursing Notes/Shift Assessment forms revealed there lacked documented evidence patient #1 had been turned every 2 hours per order. Review of the Nursing Notes/Shift Assessment revealed nurses assigned to provide care to patient #1 failed to document his turning (ordered every 2 hours) on the following dates and shifts: 07/22/10 RN S17 7AM-6PM; 07/27/10 Licensed Practical Nurse (LPN) S19 7PM-7AM; 07/31/10 LPN S19 7PM-7AM; 08/05/10 RN S22 7AM-7PM; 08/06/10 RN S21 7AM-7PM; 08/09/10 RN S22 7AM-7PM; 08/15/10 RN S18 7AM-7PM; 08/19/10 RN S18 7AM-7PM; 08/20/10 RN S24 7PM-7AM; 08/24/10 LPN S23 7AM-7PM; 08/24/10 LPN S19 7PM-7AM; 08/27/10 LPN S20 7AM-7PM; 08/27/10 LPN S19 7PM-7AM; 08/29/10 RN S25 7PM-7AM; 09/01/10 LPN S20 7AM-7PM; and 09/02/10 LPN S20 7AM-7PM.

Observations, 09/09/10, 11:40AM, revealed patient #3 was in bed with her eyes closed. Patient #3's husband approached the surveyor and requested assistance because "you see my wife, she has been like this since she had her dialysis treatment yesterday, I can't seem to get her to wake up to eat." The surveyor questioned patient #3's husband relative to her other medical problems and he replied patient #3 also had diabetes and was on dialysis for her kidney disease. He further stated she had been admitted for treatment of a "bed sore". (Review of patient #3's medical record revealed she had been admitted from a local nursing home for treatment of the bed sore which was located on her buttocks.) RN S4 entered the room and was questioned by the surveyor relative to patient #3's mental status changes.

RN S4 stated she had provided nursing care to patient #3 and according to RN S4 the "patient seemed confused". The surveyor questioned RN S4 if that had been a change for patient #3. The surveyor asked RN S4 if patient #3's presentation today (09/09/10) was changed as compared with that of yesterday (09/08/10), RN S4 did not reply.

In the presence of the surveyor, patient #3's husband stated to RN S4 that yesterday his "wife had been awake, talking, and had gone to the gym for physical therapy and was not sleeping yesterday and this morning when I got here, I found her like this" (husband made reference to patient #3 sleeping and difficult to arouse).

Review of patient #3's medical record revealed 09/09/10, 6AM, her blood sugar was documented as 49 (normal blood sugar range 90-130); she received one ampule of Dextrose 50% (D-50) via intravenous (IV) push (per physician's order) at 6AM. Patient #3's blood sugar was re-evaluated, at 6:30AM, and documented as 126; patient #3 was re-assessed and nursing documentation revealed "awake and alert".

Continued review of patient #3's medical record revealed RN S4 documented 09/09/10, 11:00AM blood sugar 80. Further review of the patient's medical record revealed there failed to be documented evidence RN S4 re-assessed the patient after the husband informed her that he could not get patient #3 awake to eat her lunch.

Director of Nursing (DON) S2 was informed, 09/09/10, 11:45AM, of the occurrences between patient #3, her husband, the surveyor and RN S4. DON S2 and the surveyor reviewed patient #3's documented blood sugar tests (as indicated above) and RN S4's documented nursing assessment dated 09/09/10. RN S4 had documented "seems confused,...refused 9AM Senokot (medication used to stimulate bowel movement) because of diarrhea".

The surveyor questioned RN S4, in the presence of DON S2, if patient #3 had diarrhea; she replied, "no, her stools were just soft". RN S4 was questioned as to why she documented the refusal of the medication because of diarrhea; however, there was no response from RN S4.

DON S2 agreed patient #3 was very difficult to arouse, and agreed perhaps her blood sugar had decreased again. RN S4 did not re-evaluate patient #3's blood sugar as a possible cause of her lethargy.

On 09/09/10, 2PM, Charge Nurse S26, was asked by DON S2 to re-evaluate patient #3's blood sugar; the results were documented as 49. Charge Nurse S26 telephoned patient #3's physician to obtain an order for a different route of administration of the D-50, as the IV access had come out of patient's vein.

Review of physician's order, 09/09/10, 2:15PM, revealed "one amp (ampule) Glucagon, Subcutaneously (SQ) now, recheck BS (blood sugar) in 2 hours, if < (less than) 120 call physician". Continued review of patient #3's medical record revealed a re-evaluation of the BS at 4:30PM revealed RN S4 documented 120.

Interview, 09/09/10, 5:45PM, with DON S2 and RN S4 revealed RN S4 was questioned if patient #3's change in mental status could be the result of her low blood sugar, she did not respond.

Review of a nursing policy titled "Patient Assessment", revealed if a nurse who provided care to a patient assessed the patient and discovered a negative change in the patient's status, they were supposed to have notified the charge nurse and patient's physician. There lacked documented evidence RN S4 notified the charge nurse or patient's physician of the changes in patient #3's mental status.

DON S2 confirmed RN S4 failed to document patient #3's mental status changes. DON S2 agreed RN S4 failed to re-assess patient #3's blood sugar after documented results indicated patient #3's blood sugars had trended down and could be the cause of patient #3's decreased mental status (as evidenced by the patient would awaken and talk after she received medication, Glucagon, to increase her blood sugar level).

DON S2 confirmed RN S4 failed to notify Charge Nurse RN S26 of patient #3's change, nor did she contact patient #3's physician.

Based upon reviews of 1of 10 medical records (#3), hospital policy/procedures, administrative and staff interviews the hospital failed to ensure nursing staff developed, implemented and kept current a nursing care plan as evidenced by Registered Nurse (RN) S4 failed to document the nursing care plan on a patient (#3) who was a diagnosed diabetic and had experienced a changed mental status as a result of low blood sugar. Findings:

Review of patient #3's medical record revealed she had diabetes and was on dialysis for kidney disease.
In the presence of the surveyor, patient #3's husband stated to RN S4 that yesterday (09/08/10), his "wife was awake, talking and had gone to the gym for physical therapy, was not sleeping yesterday and this morning when I got here, I found her like this", (husband made reference to patient #3's sleeping and difficulty to arouse).

Review of patient #3's medical record revealed 09/09/10, 6AM, her blood sugar was documented as 49 (normal blood sugar range 90-130). Continued review revealed after the administration of Dextrose 50% her blood sugar increased to 120.

Review of patient #3's medical record revealed there failed to be a nursing care plan developed and implemented for diabetes. Further review of the medical record revealed RN S4 failed to develope and implement a nursing care plan relative to patient #3's mental status changes and the documented low blood sugar results.

Review of a hospital policy titled "Transdisciplinary Plan of Care" revealed: "...the admitting RN is responsible for initiating the care plan upon admission...You should write an evaluation note at these times at a minimum: Upon initiation of an intervention; ...When the patient's condition changes...when an intervention or problem has to be re-initiated..."

Interview, on 09/10/10, with DON (Director of Nursing) S2 confirmed there failed to be a nursing care plan developed relative to patient #3's changes in mental status and low blood sugar results.

Based on observations made of the medication room refrigerator (09/08/10, 10:30AM) and medication preparation (09/09/10, 3:00PM), 1 of 10 medical record reviews (#10), reviews of pharmacy and nursing policies procedures, administrative and staff interviews the hospital failed to ensure Registered Nurse (RN) S5 followed pharmacy policies/procedures and accepted standards of practice relative to the preparation and administration of intravenously (IV) administered medications (#10). Findings:


Observations, 09/08/10, 10:30AM, made of the medication room refrigerator revealed a 4 milliliter (mL) vial of Norepinephrine 4 milligrams (mg)/4mL and a 250 ml bag of Dextrose 5% to use as the diluent; and a 25 ml vial of Diltiazem 125mg/25mL with a 100 ml bag of Normal Saline to be used as the diluent. Continued observation revealed both medications were for PRN (as needed) use for patient #10 in case he experienced a low blood pressure and/or heart problems.

Review of patient #10's medical record revealed a physician's order for : 1) Diltiazem was to be administered PRN at 5mg/hr (hour) titrate to 10mg/hr to keep heart rate < (less than) 100 and/or systolic blood pressure > (greater than) 90; 2) administer PRN Norepinephrine 2 mcg (micrograms)/min. (minute) titrate to keep systolic blood pressure > 90.

Observations made, 09/09/10, 3:30pm, during a mock medication administration performed by RN S5, revealed RN S5 prepared to mix the 4 mL vial of Norepinephrine with a 250 mL bag of Dextrose 5%. (The mock medication administration was performed as RN S5 did not have medications that were due to be administered at that time; the surveyor instructed RN S5 to select an IV medication and she was to proceed as if it was an actual administration.)

RN S5 selected a PRN dose of Norepinephrine to be administered via IV route to patient #10. The surveyor observed RN S5 obtain a Sani-wipe and disinfected an area on the countertop (the designated IV prep area--located in the medication room), that had been outlined in red tape. She donned a pair of non-sterile examination gloves; obtained a syringe and needle to withdraw 4mL Norepinephrine from the vial. At this point, (prior to the removal of the top of the vial of Norepinephrine) the surveyor had the RN to stop and asked her to simulate the removal of the top from the vial. RN S5 stated she would have inserted the needle into the vial and would have withdrawn all 4mLs and injected it into the injection port on the 250mL bag of Dextrose 5%; 2) would have written patient #10's name, her initials, the date and time, the name of the medication, and amount of medication added to the diluent, and 3) then administered via the IV route as ordered. (It should be noted, there was not a pharmacological hood for use in the nurses designated IV prep area.)

The surveyor questioned RN S5 why she would mix the medication instead of the pharmacy, especially since the pharmacy was open; she replied, "I'm used to doing it this way, guess it was quicker."

Review of a posting above the designated IV mixing area (red tape outlined area on countertop in the medication room) revealed:

"IMMEDIATE USE IV THERAPY PREPARATION Intravenous medication therapy for immediate use on nursing units will be prepared only by nurses who have certification. Preparation of IV therapy outside the pharmacy is discouraged and should only be done if pharmacist is not immediately available and therapy is emergent or if stability of the admixture is a problem.
Steps in preparation: All intravenous medications should be prepared in an area away from heavy traffic, preferably the med room.
1. Gather all ingredients necessary for the preparation of the medication; this includes active ingredient, diluent, syringes, and appropriate label for patient. Information on the medication label should contain the patient's name, the name and amount of the medication, type of diluent, preparation date and time, and initials of the person preparing the medication.
2. Clean an appropriate surface with 70% isopropyl alcohol.
3. Using aseptic technique, clean the injection port of the drug diluent and the medication to be mixed.
4. Add the medication to the diluent fluid
5. Invert bag several times to ensure proper mixing.
6. Hold bag upright and check for particulate matter.
7. Affix label to finished bag."

Interview, 09/09/10, with the hospital Administrator, S1 and Director of Nursing (DON) S2, confirmed the nurses had mixed IV medications for administration.

Interview, 09/10/10, 9:45AM, with Director of Pharmacy, Registered Pharmacist (RPh) S8 revealed she stated she was not aware nurses had mixed these medications (norepinephrine and diltiazem) in the medication room. RPh S8 further commented the pharmacy policy/procedure stated IV medications were to be prepared by pharmacists and she was unaware the nursing personnel had mixed IV medications.

Review of pharmacy policy/procedures confirmed IV medications were to be prepared by pharmacists to ensure sterility and compliance with regulations (pharmacy and regulatory).

RPh S8 was further questioned as to what was meant by the statement found on the displayed information in the medication room that stated: "..Intravenous medication therapy for immediate use on nursing units will be prepared only by nurses who have certification." RPh S8 stated she did not know what that meant unless it was in reference to Licensed Practical Nurses (LPN) and the fact "they must have IV certification unless they were in school when LPN schools began including IV therapy as part of the curriculum."

Interview, 09/10/10, with RPh S8 and DON S2 revealed when both were questioned if the pharmacy responded to emergencies in the hospital, they both replied when there was a code/emergency situation the pharmacy had a designated pharmacist, during normal pharmacy hours (8AM-5PM), who was responsible for the emergency medications that may be needed.

The Director of Pharmacy, S8, hospital Administrator, S1, and DON S2 confirmed RNs on the nursing units had prepared IV medications for administration and agreed the RNs had performed pharmacy duties, which were not within the RNs scope of practice.