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Based on interview and record review the facility's governing body had not monitored policies governing the Critical Access Hospital's (CAH's) total operation, in that, their Adverse Drug Reaction Reporting policy, and their quality assurance (QA) policy, had not been implemented when a quality health care issue occurred for 1 of 1 patients (Patient # 1).

Findings included:

Medical Record review of the medication administration record (MAR) for Patient # 1, showed that she had received Phenergan 25 mg. IVP (IV push) at 3:50 PM on 07/31/10. Nurse's notes recorded at 5:10 PM that "redness noted around IV site. Positive blood return. IV site dc'd (discontinued) with catheter intact."

In an interview at 9:30 AM on 02/08/11 with the RN (Personnel # 4), she confirmed that during an Emergency Department (ED) visit on 07/31/10 she had noticed there was redness around the intravenous (IV) site of Patient #1, 1 hour and 20 minutes after she had given Phenergan by IV push. She stated that she had informed the physician and received an order to discontinue the IV at that time. When asked if she had completed an incident report or reported the redness at the IV site to anyone other than the ED physician, she said "no."

In an interview at 10:30 AM on 02/08/11 with the Director of Nurses (DON), (Personnel # 3), he said that Patient #1 had returned to the hospital on 08/02/10, and voiced her complaints that her left hand was red and swollen after receiving IV Phenergan in the ED on 07/31/10. The DON stated that her left hand had "looked like an IV infiltrate, but it wasn't bad." He was asked if this identified issue had been sent to the Pharmacy as a possible adverse drug reaction, or through the quality assurance (QA) process from the ED, and he said "no."

The facility's "Adverse Drug Reaction Reporting" policy, effective date 03/28/03, noted the following:

-"As part of (the facility's) overall medication management program, all significant adverse drug reactions (ADR's) will be reviewed by the Pharmacy and Therapeutic (P&T) Committee."
-"(The facility's) ADR monitoring and reporting process will include a concurrent surveillance system: Based on the reporting of suspected adverse drug reaction by pharmacists, physicians, nurses or patients..."
-"All concurrently reported potential adverse drug reaction reports will be investigated by a pharmacist" and "can be submitted by telephone...or in writing..."
-"The pharmacist will assign a severity rating to each adverse drug reaction report according to a scale" including as "Significant: An adverse drug reaction which results in hospital admission, increases length of stay, requires medical treatment or requires discontinuation of therapy."

In a later telephone interview at 2:30 PM on 02/10/11 with the Chief Operating Officer (CEO), (Personnel # 1), she verified that this identified issue of a suspected adverse drug reaction had not been reported to the Pharmacy, and had not gone through the facility's Pharmacy & Therapeutics (P&T) Committee. She confirmed that the facility had not followed their policy & procedure for reporting adverse drug reactions for Patient # 1.

The facility's "Quality Assurance Reporting" policy, last reviewed 03/01/05, noted that "each department of the facility is required to report to the Quality Assurance Committee every other month"...and "these departmental reports will be submitted to the Governing Board every other month."

In an interview at 2:30 PM on 02/08/11 with the Quality Assurance Coordinator (Personnel # 7), she was asked if Patient # 1's quality of care issue related to an IV infiltrate, causing redness and swelling, and further medical treatment after discharge, had been identified and gone through the facility's QA process, and she said "no." She provided QA meeting minutes for 2010, and verified that this issue was not discussed or documented in their records, and therefore, had not been reported to the governing board.

Based on interview and record review, the facility had not followed their policy and procedure for reporting adverse drug reactions, in that, the facility had no documentation of the suspected adverse drug reaction for 1 of 1 patients (Patient #1), who required follow-up medical treatment after receiving intravenous (IV) Phenergan in the Emergency Department (ED) on 07/31/10.

Findings included:

Medical Record review of the medication administration record (MAR) for Patient # 1, showed that she had received Phenergan 25 mg. IVP (IV push) at 3:50 PM on 07/31/10. Nurse's notes recorded at 5:10 PM that "redness noted around IV site. Positive blood return. IV site dc'd (discontinued) with catheter intact."

In an interview at 9:30 AM on 02/08/11 with the RN (Personnel # 4), she confirmed that she had diluted the 25 mg. of Phenergan in 6 cc's of diluent, as this was her usual routine when giving it by IVP. She said she had noticed there was redness around the IV site, only after she had given Ativan by IVP at 5:10 PM, which was 1 hour and 20 minutes after she had given the IV Phenergan. She stated that she had informed the physician and received an order to discontinue the IV at that time. When asked if she had completed an incident report or reported the redness at the IV site to anyone other than the ED physician, she said "no."

In an interview at 10:30 AM on 02/08/11 with the Director of Nurses (DON), (Personnel # 3), he was asked when he became aware of Patient #1's complaint that her left hand was red and swollen after her ED visit on 07/31/10. He said that Patient #1 had returned to the hospital on 08/02/10, and voiced her complaints that her left hand was red and swollen after receiving IV Phenergan in the ED on 07/31/10. The DON stated that her left hand had "looked like an IV infiltrate, but it wasn't bad," and he had taken the patient back to the ED for evaluation and assessment by the physician. He was asked if this identified issue had been sent to the Pharmacy as a possible adverse drug reaction, and he said "no."

Medical Record review of a return visit to the ED by Patient #1 on 08/02/10, documented an X-ray of left hand and wrist, with a chief complaint of "swelling and redness to left hand," with physician progress notes stating "history of ED visit and subsequent pain and swelling back of left hand and forearm...(back of hand)-phlebitis (inflammation of the vein)," ED physician had spoken to clinic physician (FMC Personnel #1), who had placed Patient #1 on oral antibiotics, given an IM (intramuscular) shot, ordered rest and elevation of left arm which had been placed in a sling. The patient was discharged with a diagnosis of "Cellulitis," and instructed to elevate left arm, apply ice, and to return to ED if concerned.

The facility's "Adverse Drug Reaction Reporting" policy, effective date 03/28/03, noted the following:

-"As part of (the facility's) overall medication management program, all significant adverse drug reactions (ADR's) will be reviewed by the Pharmacy and Therapeutic (P&T) Committee."
-"(The facility's) ADR monitoring and reporting process will include a concurrent surveillance system: Based on the reporting of suspected adverse drug reaction by pharmacists, physicians, nurses or patients..."
-"All concurrently reported potential adverse drug reaction reports will be investigated by a pharmacist" and "can be submitted by telephone...or in writing..."
-"The pharmacist will assign a severity rating to each adverse drug reaction report according to a scale" including as "Significant: An adverse drug reaction which results in hospital admission, increases length of stay, requires medical treatment or requires discontinuation of therapy."

In a later telephone interview at 2:30 PM on 02/10/11 with the Chief Operating Officer (CEO), (Personnel #1), she verified that this identified issue of a suspected adverse drug reaction had not been reported to the Pharmacy, and had not gone through the facility's Pharmacy & Therapeutics (P&T) Committee. She confirmed that the facility had not followed their policy & procedure for reporting adverse drug reactions for Patient #1.

Based on interview and record review, the registered nurse (RN),((Personnel # 4) had not followed the facility's reference used as a standard of practice for diluting a medication, in that, Phenergan 25 milligrams (mg.) was diluted in 6 cc's (cubic centimeters), instead of the 9 cc's of diluent as recommended, before administering it to 1 of 1 patients (Patient #1), by intravenous (IV) push injection.

Findings included:

Medical Record review of the medication administration record (MAR) for Patient # 1, showed that she had received Phenergan 25 mg. IVP (IV push) at 3:50 PM on 07/31/10. Nurse's notes recorded at 5:10 PM that "redness noted around IV site. Positive blood return. IV site dc' d (discontinued) with catheter intact."

In an interview at 9:00 AM on 02/08/11, with the RN (Personnel #4), who had administered IV Phenergan to Patient #1, she was asked how she had mixed this medication to give as an IV push injection. She stated that she always drew up Phenergan and mixed it with IV fluid in a 6 cc syringe, before giving it slow IV push. When asked what drug book was used as a reference for the Emergency Department's (ED) standard of practice for administering IV medications, she said they had a Mosby's drug book at the nurse's desk in the ED. When asked what the standard of practice was for administering IV Phenergan, she said that she thought the standard was to give no more than 25 mg. IV push.

Review of Mosby's Drug book, dated 2007, noted the process to administer Phenergan by IV route as "after diluting each 25-50 mg/9 ml (milliliters) of NaCl (Sodium Chloride) for injection; give 25 mg. or less/2 minutes." Cubic centimeters (cc's) are equal to milliliters (ml's).

In an interview at 9:30 AM on 02/08/11 with the RN (Personnel #4), she confirmed that she had diluted the 25 mg. of Phenergan in 6 cc's of diluent, as this was her usual routine, and had thought this met practice standards. When asked if she had completed an incident report or reported the redness at the IV site to anyone other than the ED physician, she said "no."

Based on interview and record review, the facility had not ensured they had an effective quality assurance (QA) program that evaluated all patient care services, in that, they had no documentation of an adverse patient outcome affecting an Emergency Department (ED) patient's health, for 1 of 1 patients (Patient # 1).

Findings included:

Medical Record review of the medication administration record (MAR) for Patient # 1, showed that she had received Phenergan 25 mg. IVP (IV push) at 3:50 PM on 07/31/10. Nurse's notes recorded at 5:10 PM that "redness noted around IV site."

In an interview at 9:30 AM on 02/08/11 with the RN (Personnel #4), she confirmed that she had diluted the 25 mg. of Phenergan in 6 cc's of diluent, as this was her usual routine when giving it by IVP. She said she had noticed there was redness around the IV site, only after she had given Ativan by IVP at 5:10 PM, which was 1 hour and 20 minutes after she had given the IV Phenergan. She stated that she had informed the physician and received an order to discontinue the IV at that time. When asked if she had completed an incident report or reported the redness at the IV site to anyone other than the ED physician, she said "no."

In an interview at 10:30 AM on 02/08/11 with the Director of Nurses (DON), (Personnel # 3), he was asked when he became aware of Patient #1's complaint that her left hand was red and swollen after her ED visit on 07/31/10. He said that Patient #1 had returned to the hospital on 08/02/10, and voiced her complaints that her left hand was red and swollen after receiving IV Phenergan in the ED on 07/31/10. The DON stated that her left hand had "looked like an IV infiltrate, but it wasn't bad," and he had taken the patient back to the ED for evaluation and assessment by the physician. He was asked if this identified quality of care issue had been reported through the QA process from the Emergency Department, and he said "no."

Medical Record review of a return visit to the ED by Patient #1 on 08/02/10, documented an X-ray of left hand and wrist, with a chief complaint of "swelling and redness to left hand," with physician progress notes stating "history of ED visit and subsequent pain and swelling back of left hand and forearm...(back of hand)-phlebitis (inflammation of the vein)," ED physician had spoken to clinic physician (FMC Personnel #1), who had placed Patient #1 on oral antibiotics, given an IM (intramuscular) shot, ordered rest and elevation of left arm which had been placed in a sling. The patient was discharged with a diagnosis of "Cellulitis," and instructed to elevate left arm, apply ice, and to return to ED if concerned.

In an interview at 2:30 PM on 02/08/11 with the Quality Assurance Coordinator (Personnel # 7), she was asked if Patient #1's quality of care issue related to an IV infiltrate, causing redness and swelling, and further medical treatment after discharge, had been identified and gone through the facility's QA process, and she said "no." She provided QA meeting minutes for 2010, and verified that this issue was not discussed or documented in their records.

The facility's "Quality Assurance Reporting" policy, last reviewed 03/01/05, noted that "each department of the facility is required to report to the Quality Assurance Committee every other month"...and "these departmental reports will be submitted to the Governing Board every other month."