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I. Based on medical record reviews, staff interviews, and review of the contractual agreement for pharmacy services, the Critical Access Hospital (CAH) failed to ensure the policies and procedures were followed pertaining to a suspected adverse drug reaction for 1 of 12 (Patient 11) patient records reviewed. The CAH is licensed for 25 beds and had a census of 7 acute inpatients and 1 hospice patient upon entrance for investigation. Findings include:

A. Review of the written agreement the CAH has for telepharmacy services dated 4/28/09 showed the contractor supplies one or more pharmacists to provide remote pharmaceutical care services for pharmacist review of medication orders, including medication therapy management and order entry into CAH's pharmacy. The written agreement specifies the contracted pharmacist:
1. Prospective review includes verification that the order is safe and appropriate for the patient in accordance with the CAH's policies and professional pharmacy practice standards.
2. Provides and documents medication profile review and medication therapy management services at least once per 24-hour period.
3. Provides drug information as necessary for patient care to health care professionals 24 hours/day, 7 days per week.

B. Interview with CAH Registered Pharmacist (RP), Director of Nursing (DON), Chief Nursing Officer (CNO), and Corporate Compliance Officer (CCO) on 7/20 at 1:30PM revealed the following:
- CAH utilizes the contracted pharmacy services 24 hours a day, 7 days a week, 365 days per year.
- CAH also employs 2 Registered Pharmacists, one pharmacist was recently hired and is currently in orientation.
- CAH has a Pyxis medication system that is stocked and checked daily by a CAH pharmacist.
- Pyxis system identifies an override allowing qualified staff immediate access to approved medications for standard use or in an emergency situation.
- Electronic pharmacy system with the contracted pharmacist group allows for qualified personnel to acknowledge and enter all physician medication orders and allergies.
- After the information is entered into the system, it is sent electronically or faxed to the contracted pharmacist group for review and approval.
- The contracted pharmacist group then compares the physician orders, the patient allergies identified, and any other information concerning the patient.
- After the contracted pharmacist approves the medication, the assigned nurse can gain access to medication through the Pyxis medication system and the medication is administered to the patient.

C. Record review for Patient 11 on 7/19/10 at 2:00 PM reveals patient presented to the emergency room (ER) on 5/15/10 at 5:15 PM with complaints of chest pain, shortness of breath and noted had been seen previously with chest pain and has orders for nitroglycerin. Patient 11 was idenitified as stable in the ER with administration of oxygen and nitroglycerin and then admitted as an inpatient to the intensive care unit (ICU). ER record identified Patient 11 as being allergic to steriods, aspirin and morphine. The admission History & Physical does not document allergies to steriods or morphine. The Medication Reconciliation Report reviewed by the contracted pharamcist idenitified allergies as aspirin and morphine. Notes show that on 5/16/10 at 1930 Patient 11 complained of a headache, rated at 3 out of 10 on pain scale (with 10 being highest rating) and refused Tylenol. At 2125 patient rated headache at 8 out of 10. Dr-A was called and ordered Phenergan 25 mg intravenously one time and Stadol 2 mg intravenously one time. Phenergan was administered first at 2140 (it was accessbile from the Pyxis system). Stadol order was forwarded to the contracted pharmacist for review prior to administration per facility policy. Documentation shows that Stadol was administered at 2154. At 2210 Patient 11 complained of arm spasm and was yelling for help. Dr-A was notified and ordered Benadryl 50 mg intramuscularly which was administered. Blood pressure readings noted to be down in the 60s/40s range. At 2230 a bolus of normal saline was given and blood pressure was noted at 142/68. Patient complaining of severe spasms in arm. Fentanyl 75 mcg administered intravenously. At 2245 patient continued to have pain/spasms in right arm, burning and numbness to face. Dr-A notified and orders received for Ativan 1 mg intravenously one time and if continues then Fentanyl. At 2250 Ativan 1 mg was administered. At 2310 nurses notes state Ativan given with no relief. Second dose of Fentanyl given with some relief. Patient resting at this time.

D. Review on 7/21/10 of ADR report form completed by RN-A for Patient 11 on 5/16/10 documented suspected drug reaction to Phenergan or Stadol with reaction documented as "spasms-right arm, burning all over, numbness to lips and nose". Allergies listed were aspirin and morphine. There was no mention of allergy to steroids as documented on the ER record. Provider is listed as being notified on 5/16/10 at 2210. The section for "Provider Designation of Reaction" on the ADR report form is not completed or signed by the provider/physician. Section "Reporting of Allergy by Pharmacy" on the ADR report form is checked for patient profile and physician group and signed by the CAH pharmcist; however, there is no date of completion. As of 7/21/10 review of ADR report form showed it was not completed as per CAH policy. Patient 11 was discharged from the CAH on 5/17/10.

E. Review of the CAH pharmacy policies and procedures on 7/20/10, page 2, 3.11 reads: "The ordering provider shall be contacted immediately in the event of a potential adverse drug reaction (ADR). All concurrently reported potential ADR reports shall be reviewed by a provider and a pharmacist. Reports of potential ADRs shall be submitted in writing to the Pharmacy Department on a variance form by the care giver who idenitified the adverse reaction. The provider reviewing the potential ADR will make the determination regarding whether or not the reaction was a true adverse drug reaction. True ADRs shall be discussed with the patient or patient's family."

F. Website at http://www.clinicalpharmacology-ip.com indicates that the use of Stadol in a morphine sensitive or allergic patient should be avoided and that Stadol is chemically similar to morphine.

G. Interview with CAH pharmacist and review of override medications in Pyxis system lists Benadryl, Fentanyl, and Phenergan as immediate accessible medications. Stadol requires a pharmacist review prior to staff being able to access from the Pyxis system. Neither review of CAH records or staff interviews indicated that an issue had been identified for this patient with the compatibiliby of administering Stadol when a patient reports an allergy to morphine. The contracted pharmacist group was aware of Patient 11's allergy to morphine and aspirin during their review and Stadol was authorized for administration to Patient 11.

H. Interview with CCO revealed on 7/22/10 she had contacted the contracted pharmacist group and found that they had not been notified that Patient 11 may have had an allergic reaction to Stadol on 5/16/10.

II. Based on review of medical records and staff interviews, the CAH failed to ensure medications were administered according to the physician orders. Findings include:

A. Interview with the DON and CCO revealed that medication errors have been closely tracked since 1/1/10 and identified the CAH has the following medication errors per hospital area since 1/1/10:
- Medical-surgical area=32
- Emergency Room=3
- Contracted Pharmacist group=6

Medication errors ranged from the wrong medication, wrong dose, wrong time, wrong patient, and medication transcription errors. Examples include:
1. Patient 6 presented to the ER on 1/23/10 with acute abdominal pain. Patient was to be given initially 25 mcg of Fentanyl and the nurse administered 25 mg of Phenergan. Variance report was completed.
2. Patient 7 presented to the ER on 3/14/10 with neck and head pain from a fall several days prior and was complaining of muscular strain to the cervical region. Medication order was for Fentanyl 50 mg intramuscularly (IM) and Vistaril 25 mg IM. Patient 7 was given Vistaril 25 mg IM and Demerol 50 mg IM. Variance report was completed.
3. Patient 8 was admitted to an acute inpatient status on 6/10/10 with pertinent diagnoses of SIADH and biliary tract obsturction. Order for Amoxicillin 500 mg PO BID ( by mouth, twice a day) through 6/13/10. The contracted pharmacist failed to enter a stop date for the medication. Patient 8 had an extra 2 doses administered than were ordered. Variance report completed.

B. Interview on 7/21/10 with the CNO and CCO revealed concern about the medication errors. The CAH has an electronic work station on wheels that is used to scan a patient's arm band as part of the medication administration system. The work station on wheels is approximately 7 years old and over the past 6 months it has not been working properly by dropping signals. CAH is in the process of ordering new scanners and work station on wheels.

Interview also revealed that when a medication error is noted a Variance report is filled out by the nurse and submitted to the CAH RP and the contracted pharmacist group is notified. The severity level of the medication error or ADR is documented by the physician as:
1. Non-adverse drug reaction: an event unrelated to drug therapy;
2. Minor: an adverse drug reaction which requires no medical treatment or has no effect on continuation of therapy;
3. Significant: an adverse drug reaction which results in hospital admission, increases length of hospital stay, requires medical treatment or requires discontinuation of therapy;
4. Severe: an adverse drug reaction which is life-threatening or causes permanent injury or death.

C. Review of the Pharmacy Quality Improvement plan does not list medication errors as an active issue other than the monitoring of medication errors that occur and the significance of the errors.

Based on record reviews, staff interviews, and review of the Bylaws/Medical Staff Rules and Regulations, the Critical Access Hospital (CAH) failed to ensure 2 of 12 clinical records reviewed were maintained in accordance with facility policies and procedures.The CAH is licensed for 25 beds and had a census of 7 acute inpatients and 1 hospice patient upon entrance. Findings include:

A. Review of 6 closed medical records revealed that 2 closed records did not include a discharge summary and time and dated physician telephone orders. Examples are:

1. Record review on 7/21/10 revealed Patient 11 presented to the Emergency (ER) on 5/15/10 with symptoms of chest pain, and shortness of breath/angina. Patient was admitted to an inpatient status and placed in ICU, with discharge date of 5/17/10. Patient 11 experienced a suspected drug reaction on 5/16/10, requiring additional medications. The medical record lacks a formal discharge summary and the physician progress note does not mention suspected adverse drug reaction or a diagnosis. Medical record also lacks dates and times on several physician telephone orders specific to 5/16/10 @ 2125, 5/16/10 @2207, 5/16/10 @ 2230, and 5/16/10 @2245 placing this medical record in a delinquent status for 52 days upon date of review.

2. Record review on 7/22/10 revealed Swingbed Patient 12 admitted through the ER on 6/9/10 and discharged on 6/10/10 with pertinent diagnoses of decubitus and failure to thrive. The medical record lacks a discharge summary or pertinent information on physician progress notes. It is noted the discharge summary for Patient 12 was completed during survey on 7/22/10. Medical record also lacks dates and times on several physician telephone orders specific to 6/9/10-no time for physician orders, 6/10/10-no time of physician orders, 6/10/10 no time for physician telephone order.

B. Interview on 7/19/10 with the Corporate Compliance Officer (CCO) revealed if the patient is in the hospital less than 48 hours the physician may use progress notes as a discharge summary and that times and dates of the physician telephone medication orders should be in the medical record.

C. Review on 7/20/10 of the Medical Staff Rules and Regulations, revised January 2010, Page 5 E reads: "Written or verbal orders may be given only by those health care physicians who have privileges to give orders with respect to the patient's care...All orders for treatment shall be in writing with date and time."

Review of the Medical Staff Rules and Regulations, Page 3. 10 reads: "A final progress note may be substituted for the discharge summary in the case of patients with minor problems who require less than forty-eight (48) hours of hospitalization, and in the case of newborns and uncomplicated obstetrical deliveries. The note should include instructions given to the patient and/or family."

Review of the Medical Staff ByLaws, page 16 F. reads: "An automatic suspension of admitting privileges shall be imposed when a Staff Member receives final notice for failure to complete medical records within the 14 days in accordance with these Bylaws and Rules and Regulations...Notice of suspensions will be delivered by the Chief Executive Officer or in his/her absence the Chief of Medical Staff. Each member of the consulting staff shall be notified of pending denial of privileges in order that he/she may complete records prior to his/her next scheduled clinic date."

D. Interview with CCO on 7/22/10 acknowledged the lack of documented discharge summaries or progress notes, the lack of dates and times on physician's telephone orders placing these medical records in a delinquent status. As of 7/22/10 no physicians had been notified of suspended privileges or pending action as noted in the Bylaws/Medical Staff Rules and Regulations pertaining to delinquent medical records.