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Tag No.: A0438
Based on staff interview and record review, the hospital failed to assure medical records were accurately written and complete for 4 of 11 applicable records. (Patient #1, 2, 3 7) Findings include:
1. On 10/29/15 in the Special Care Unit (SCU) at approximately 8:45 AM Patient #1 required a rapid sequence intubation due to respiratory compromise requiring an anesthesiologist to insert an endotracheal tube into the patient's trachea through the patient's mouth. Per review of physician progress notes, the anesthesiologist failed to complete any documentation of the intubation procedures. Per interview on 4/26/16 at 1:15 PM, the anesthesiologist confirmed s/he had not completed the documentation. The Chief of Anesthesia confirmed on 4/26/16 at 1:25 PM it was his/her expectation that the staff anesthesiologist should have completed a progress note in Patient #1's record regarding the emergent intervention.
2. Per record review, Patient #7 required an emergent laparoscopic appendectomy on 2/23/16 and received general anesthesia for the surgery. Review of the Anesthesia Record used during the surgical procedure the anesthesiologist documented medications administered, vital signs and other required monitoring but failed to complete documentation under "Intubation" to include what size Endotracheal tube, number of attempts made to intubate, type of blade used to intubate and other monitoring. The omission of documentation was confirmed at 1:30 PM on 4/27/16 with the Peri-operative Nurse Manager.
3. Per record review Patient #2 had left lower quadrant pain. A CT scan ( A computerized tomography scan that combines a series of x-ray images taken from different angles and uses computer processing to create cross-sectional images, or slices, of the bones, blood vessels and soft tissues inside of your body.) of the abdomen and pelvis were performed on 4/15/16. Per review of the radiologist's report, " It is noted the patient experienced a mild contrast (a substance injected into the body that illuminates certain structures that would otherwise be hard to see on the film) reaction consisting predominantly of rash and itching but this resolved spontaneously without medication. The patient was observed for a short time in the ER " (Emergency Room). Per record review on 4/26/16 and 4/27/16, there was no documentation of the intravenous dye and contrast allergy for Patient #2 in the EMR (Electronic Medical Record). Per interview on 4/26/16 at 3:16 PM, with the Lead Cross-sectional Anatomy Technologist, s/he confirmed that Patient #2's allergy to intravenous dye and contrast was not documented in the EMR. Per interview on 4/27/16 at 9:02 AM with the Director or Pharmacy, s/he stated that patient allergies should be entered in the EMR as soon as possible when they are known.
4. Per record review Patient #3 had visited the ER for scrotal swelling on 3/18/16. The patient had a CT scan performed while in the ER on 3/18/16. Per the ER nurse's notes, an allergy to Tramadol (prescription pain reliever) was listed. Per record review of the radiology patient questionnaire/consent form, Tramadol was documented as an allergy for Patient #3. Per review of the EMR on 4/26/16 and 4/27/16, Patient #3's allergy to Tramadol was not documented in the EMR. Per interview on 4/26/16 at 3:16 PM with the Lead Cross-sectional Anatomy Technologist, s/he confirmed that the EMR did not have Patient #3's allergy to Tramadol documented. Per interview on 4/27/16 at 9:02 AM the Director of Pharmacy also confirmed that Patient #3's allergy to Tramadol was not documented in the EMR.
Tag No.: A0508
Based on staff interview and record review, the hospital failed to develop and define within their present Adverse Drug Events policy the circumstances and expectation of staff for assuring accurate and current information regarding adverse drug reactions is recorded within the patient's Electronic Medical Record (EMR). Findings include:
Although the Pharmacy Department has an established policy Adverse Drug Events last revised 1/13, there is a lack of clarity who is responsible for documenting in the EMR under "Allergies" the drug which has been identified to have been the source of an adverse drug reaction whether occurring during hospitalization or an outpatient procedure. Per interview on 4/27/16 at 9:00 AM the Director of the Pharmacy stated if a patient experienced a "..suspected reaction to a medication.....this should be entered into Quantros..." (Safety Event report system) by the individual who has identified the adverse drug reaction. The Director further stated the same individual would also be responsible for documenting the drug allergy in the EMR "Allergy" list, thus creating further safeguards to assure their is an awareness of the newly recognized drug allergy. The Director stated by entering the adverse drug reaction within the Quantros system, this would then trigger a review by Pharmacy, and depending on the severity of the adverse drug reaction/event, a reporting and review process would be followed which incorporated the Medical Safety Committee.
1. Per record review, Patient #1 was admitted on 10/20/15 with an infection on his/her right lower leg. Treatment included intravenous (IV) and oral antibiotics. Per nursing progress note at 15:05 on 10/24/15 states " PT C/O itching 'all over'. Red non-raised rash especially on back and left arm..." On 10/25/15 at 22:38 nursing progress note states " Pt. has itchy rash on torso and bright red back and buttocks...". On 10/27/15 a hospitalist documents " Drug rash most likely seems to have developed after Cefazolin was started". The antibiotic was stopped, however no report was created in Quantros and the drug was not added to Patient #1's "Allergy" list in the patient's EMR. This omission was confirmed by the Director of the Pharmacy on 4/27/16 at 9:15 AM, stating "We were not made aware".
2. Per record review Patient #2 had left lower quadrant pain. A CT scan of the abdomen and pelvis were performed on 4/15/16. Per review of the radiologist's report, "It is noted the patient experienced a mild contrast reaction consisting predominantly of rash and itching but this resolved spontaneously without medication. The patient was observed for a short time in the ER". Per record review on 4/26/16 and 4/27/16, there was documentation in the Quantros system regarding Patient #2's Adverse Drug Reaction (ADR), however, there was no documentation of the allergy to intravenous dye and contrast for Patient #2 in the EMR. Per interview on 4/26/16 at 3:16 PM, with the Lead Cross-sectional Anatomy Technologist, s/he confirmed that Patient #2's allergy to intravenous dye and contrast was not documented in the EMR. Per interview on 4/27/16 at 9:02 AM with the Director or Pharmacy, s/he stated that patient allergies should be entered in the EMR as soon as possible when they are known.
Per interview on 4/27/16 at 11:20 AM the VP of Patient Services stated due to the separate computer applications used by various inpatient and outpatient departments, access to the EMR is limited within certain departments. As a result, if a patient has been identified to have experienced a new drug allergy, it may not be recorded in the EMR, noting "...there is no crossover" between computer systems and software used within the hospital and outpatient settings. However, per interview on 4/27/16 at 2:45 PM the Executive Director for Quality, Utilization & Case Management stated ultimately there is a process for hospital staff to access the Allergy notification tab within the EMR to complete documentation of a newly identified drug allergy. But further suggested the Pharmacy Department, who has access to all Quantros reports that identify adverse drug reactions would have the best opportunity to assure a newly identified drug allergy has been added to a patient's EMR allergy list.
However, if a staff member does not complete a Quantros report when an adverse drug reaction is identified, regardless what system or department they are assigned, and does not enter the information into the EMR, the Pharmacy Department would not be directly alerted to add this important information into a patient's drug profile. When asked what happens if a drug is prescribed for a patient who has a known allergy to the drug, the Director of the Pharmacy stated the Pharmacy software system does a "Hard Stop". This prevents the drug from being prescribed until there is a review and discussion with the prescribing physician. But, if their is a failure to report and document, the Pharmacy Department will not be directly appraised of the allergy.
Tag No.: A1004
Based on staff interview and record review, Anesthesia staff failed to complete documentation in a intraoperative patient's record utilized during the process of induction of general anesthesia for 1 of 6 applicable patients. (Patient # 7) Findings include:
1. Per record review, Patient #7 required an emergent laparoscopic appendectomy on 2/23/16 and received general anesthesia for the surgery. Review of the Anesthesia Record used during the surgical procedure the anesthesiologist recorded on the intraoperative record medications administered, vital signs and other required monitoring but failed to complete documentation under "Intubation" to include what size Endotracheal tube, number of attempts made to intubate, type of blade used to intubate and other monitoring. The omission of the documentation in Patient #7's record was confirmed at 1:30 PM on 4/27/16 with the Peri-operative Nurse Manager.