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Based on observation, record review and interview, the Hospital failed to administer medications to 1 of 10 sampled patients (Patient #1), in accordance with physician orders and approved medical staff policies.

Findings include:

Surveyor #1 interviewed Registered Nurse (RN) #1 at 7 A.M. on 8/12/13. RN #1 said he took a telephone order from the Attending Physician for Patient #1, to administer 40 milliequivalents (mEq) of Potassium, per feeding tube, every four hours to begin at 1:00 P.M on 7/28/13 and end after three doses (1:00 P.M., 5:00 P.M. and 9:00 P.M. on 7/28/13).

The Pyxis (automated medication dispensing system) Report for Potassium removed from the system for Patient #1 indicated Potassium 40 mEq was removed on 7/28/13 at 12:20 P.M., 3:55 P.M. and 6:40 P.M.

Patient #1's 7/28/13 Pro-Touch (Electronic Medical Record) indicated that 40 mEq of Potassium was administered at 12:13 P.M. and 6:42 P.M. RN #1 said he did not remember if he gave the dose of Potassium that was was removed from Pyxis at 3:55 P.M. to Patient #1.

Based on medical record and policy review, the Hospital failed to adhere to its Informed Consent policy for 1 of 10 sampled patients (Patient #4).

Findings include:

The Hospital policies titled Transfusion Therapy and Informed Consent indicated that informed consent must be obtained prior to initial blood or blood product transfusion. The Informed Consent policy indicated a physician or a physician designee (e.g. Licensed Independent Practitioner or Allied Health Practitioner) must obtain the consent.

The Blood Transfusion Order Form for Patient #4, dated 8/11/13, indicated a telephone order was obtained to administer 2 units of red blood cells. The Physician/Nurse Practitioner/Physician Assistant signature was taken by the nurse as a telephone order and no Practitioner signature indicating informed consent was obtained.

Based on interview, record review and inspection of the electronic medical record system (Pro-Touch), the Hospital failed to provide pharmaceutical services to ensure safe medication processes that substantially reduce or eliminate adverse drug events and duplication of treatment.

Findings include:
As a result of user error and systems limitations, Patient #1 suffered a cardiac arrest and died due to an overdose of Potassium Chloride administered via his/her gastrostomy tube.

Please see tag A-500

Based on interview, record review and inspection of the electronic medical record system
(Pro-Touch), the Hospital failed to develop and implement guidelines, protocols, policies and procedures for the provision of pharmaceutical services that ensure patient safety through the appropriate control and distribution of medications resulting in a fatal medication (Potassium chloride) error.

Findings include:

Surveyor #1 interviewed the Pharmacy Director at 3:05 P.M. on 8/8/13 and Surveyor #1 and the Pharmacy Consultant Surveyor interviewed the Pharmacy Director at 5:45 P.M., on 8/8/13. The Pharmacy Director said Pro-Touch is an Electronic Medical Record system used nationally in approximately 120 corporate hospitals. The system was introduced into this hospital, approximately 5 years ago. The Pharmacy Director said Pro-Touch also served as the computerized physician order entry (CPOE) system and there is no other mechanism for a physician to enter orders. The Pharmacy Director said the Hospital had a policy on High Alert medications and oral Potassium was not considered a High Alert medication . The Pharmacy Director said Patient #1's original Potassium order was verified by the Pharmacist prior to Patient #1 receiving the medication. The Pharmacy Director said Pro-Touch does not communicate renewal orders to the pharmacy system (RxConnect) for review and verification and therefore, Patient #1's Potassium renewed orders were not reviewed/verified by a pharmacist.

The Pharmacy Director said she was not certain what the end users were taught about renewable versus non-renewable medications, but said some medications were automatically non-renewable. Review of the Pro-Touch users manual defines the renewable/non-renewable feature as "Adds or removes the ability to renew the order". Specific recommendations on how to use this feature could not be located. The Pharmacy Director said the Pro-Touch program choices were corporate decisions and not a hospital specific feature.

Surveyor #1 interviewed Patient #1's Attending Physician at 9:22 A.M. on 8/12/13. The Attending Physician said she was called by RN #1 to report a low potassium level of 3.2 (normal serum potassium 3.6-5.2). The Attending Physician said she gave a telephone order to replace the potassium.

RN #1 said he entered the telephone order for Patient #1's Potassium as a renewable which enabled the ordering physician to renew an order instead of re-entering the order as a new order. RN #1 said he usually took telephone orders as renewable. RN #1 said he did not recall exactly what he had been taught about when to take renew versus non-renew orders.

Surveyor #1 interviewed the Educator at 4:30 P.M. on 8/8/13. The Educator said she was responsible for training new Pro-Touch users and was aware that certain medications defaulted to non-renewable status while others did not. She was not certain which medications defaulted to non-renewable status.

Patient #1's electronic medical record indicated a telephone order for 40 mEq of liquid Potassium chloride, via feeding tube every four hours, stop after 3 doses. Patient #1's electronic medical record indicated this order was verified by a pharmacist on 7/28/13 at 12:03 P.M.

The Attending Physician said she visited the Hospital in the evening of 7/28/13. The Attending Physician said she opened Patient #1's electronic medical record to find a pharmacy screen message that she mistakenly believed was an acknowledgment of the telephone order she gave for Patient #1's Potassium earlier that day.

Pro-Touch automatically displays a screen that reads Renewable active physician orders expiring within 72 hours. The physician can choose to renew, discontinue, or allow order to expire.

The Attending Physician said she inadvertently clicked on the word renew three times without realizing that this action re-ordered the three dose Potassium order three times.

The Attending Physician said Patient #1 was to begin on a maintenance dose of Potassium (40 mEq. every 12 hours) after the completion of the three dose Potassium order.

The Attending Physician said she had worked with the electronic medical record system since it was introduced at the Hospital, approximately 5 years ago. The Attending Physician said she was oriented to the system by the system representatives and now often teaches new practitioners about the electronic medical record system. The Attending Physician said she believed all timed medication doses, like Patient #1's Potassium order for three doses, were always non-renewable.

Surveyor #1 interviewed RN #1 at 7 A.M. on 8/12/13. RN #1 said he took the telephone order from the Attending Physician. RN #1 said he considered this a common order to replenish a low Potassium. RN #1 said he saw that the Potassium order in Patient #1's electronic medical record, originally due for three doses, had increased to 10 doses. RN #1 said he saw the increase in Patient #1's Potassium doses after he gave report to RN #2, and he assumed the renew orders were for the next three days rather than consecutively administered.

During the interview with RN #1 at 7 A.M. on 8/12/13, RN #1 used the Pro-Touch system to demonstrate what the medication nurse views during medication administration. RN #1, demonstrated the Pro-Touch system which allows the nurse to view medications that are scheduled during the nurse's shift. RN #1 said that additional information on individual medication was available in other Pro-Touch screens, but these screens were not routinely used during medication administration. RN #1 demonstrated the additional steps a medication nurse used to view individual medication information or the complete medication record. RN #1 said the medication nurse does not routinely see prior doses or times of a regularly scheduled medication, but does see that information for "PRN" (medications that are administered as needed) medications. RN #1 said that to electronically sign for medications that were administered, the nurse must press the "process" button three times.

Surveyor #1 observed two medication passes at 8:55 A.M. and 9:10 A.M. on 8/8/13. Both of the nurses observed worked from a printout from the electronic medication system. The printout enabled the nurses to see what medications were due for a patient during their shift but not what medications were administered during a previous shift.

Surveyor #1 and the Pharmacy Consultant Surveyor interviewed RN #2 at 7:45 A.M. on 8/12/13. RN #2 said that she saw the Potassium order after 7 P.M. nursing report on 7/28/13 and asked RN #1 what Patient #1's serum potassium level was. RN #2 said she was told 3.2.

Review of the Code Blue (cardiac arrest) record, dated 7/29/13, indicated Patient #1 suffered a cardiac arrest at 8:15 A.M.

Review of the laboratory report indicated Patient #1's serum potassium collected on 7/29/13 at 8:05 A.M. was 8.9. The Laboratory Report indicated Patient #1's blood specimen was slightly hemolyzed (can cause a falsely elevated Potassium reading). The Laboratory Report indicated the results were checked and called to personal on Patient #1's unit at 8:53 A.M. on 7/29/13.