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Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) surgical services management failed to ensure the policies reflected the manufacturer's recommendations for testing of the cardiac defibrillator at least once a week, so the surgical services staff tested and documented the testing results for 1 (of 1) cardiac defibrillators in the Post-Anesthesia Recovery Room at least weekly. The CAH surgical services staff reported performing 76 surgical procedures during July 2010.

Failure to test the cardiac defibrillator according to the manufacturer's directions could potentially result in the defibrillator failing to function properly or failing to deliver the required electrical current when needed by the patient.

Findings include:

1. Observations during a tour of the Post-Anesthesia Recovery Room on 8/24/10 at approximately 1:30 PM revealed 1 Medic 5 Defibrillator/Monitor on the emergency cart.

2. Review of the manufacturer's instructions for the Medic 5 Defibrillator/Monitor, dated 1994, revealed in part, "The defibrillator should be tested at least once a week."

3. Review of the policy "EMERGENCY CRASH CART SECURITY AND ACCOUNTABILITY", dated 8/01, revealed in part, "The defibrillator will be checked once a month." On further review of the policy, the text "a week" was crossed out and a handwritten entry "a month" replaced the printed "a week".

4. Review of the "Audit Record" on the emergency cart revealed the surgical services staff documented testing the defibrillator once per month, from July 2008 to July 2010, as the altered policy directed.

5. During an interview at the time of the tour, the Surgery Director stated surgical staff tested the defibrillator only once a month, and did not follow the manufacturer's recommendations to test the defibrillator once per week. The Surgery Director stated surgical staff would begin testing the defibrillator at least weekly.

Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure anesthesia staff labeled 8 of 8 syringes with pre-drawn medication with the time, date, and the initials of the staff member that drew up the medication according to policy. The CAH surgical staff reported they performed 45 procedures required anesthesia during July 2010.

Failure to properly label syringes could potentially result in anesthesia staff drawing up medication, and using the medication after the medication was no longer safe for patient use or potentially resulting in decreased efficiency of the medication.

Findings include:

1. Observations during a tour of Operating Room #1 on 8/24/10 at 12:01 PM revealed:

a. 1 of 1 syringe, filled with propofol (medication used to induce sleep in surgery), lacked documentation that included the drug name, strength, date, time, and the initials of the staff member that drew up the propofol.

b. 1 of 1 syringe, labeled fentanyl, lacked documentation that included the date, time, and the initials of the staff member that drew up the fentanyl.

c. 1 of 1 syringe, labeled midazolam (medication used to cause patients to relax during surgery), lacked documentation that included the date, time, and the initials of the staff member that drew up the midazolam.

d. 1 of 1 syringe, labeled ondansetron (medication used to prevent nausea after surgery), lacked documentation that included the date, time, and the initials of the staff member that drew up the ondansetron.

e. 1 of 1 syringe, labeled atropine (medication used to raise a patient's heart rate), lacked documentation that included the date, time, and the initials of the staff member that drew up the atropine.

f. 2 of 2 syringes, labeled succinylcholine (medication used to paralyze patients during surgery), lacked documentation that included the date, time, and the initials of the staff member that drew up the succinylcholine.

2. Review of the policy "LABELING STANDARDS", revised 6/06, revealed in part, "... labels shall include at a minimum: ... Prepared date/time..." and include the initials of the staff member who prepared the solution.

3. During an interview on 8/25/10 at 9:40 AM, the Pharmacist reported expecting staff to label syringes with pre-drawn medication, and the label should include the date, time, and initials of the staff who drew up the medication.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure surgical services staff developed policies and procedures consistent with accepted professional standards, and modify policies and procedures after a medication error occurred, involving 1 (of 1) surgical patients (patient #1), in order to prevent medication overdoses from recurring. The CAH surgical services staff performed 76 surgical procedures during July 2010.

Failure to review and modify policies and procedures as needed, after a medication error could potentially result in surgical staff making a similar medication error on other patients, resulting in life threatening disability, and/or death.

Findings include:

1. Review of patient #1's medical record revealed:

a. The consultation report by Surgeon A, from 8/5/10 (7 days before surgery), showed that Patient #1's heart and lungs were normal. Surgeon A recommended Patient #1 undergo a laparoscopic hysterectomy. The pre-operative History and Physical on 8/9/10 (3 days before surgery), by Physician Assistant G showed Patient #1's heart and lungs were normal. The report revealed Patient #1 had an EKG several months earlier, and the EKG did not reveal any abnormalities. Registered Nurse (RN) H documented an Initial Physical Assessment on 8/12/10 (the day of surgery) at 10:49 AM. The assessment showed Patient #1 denied any difficulty breathing. RN H listened to patient #1's lungs with a stethoscope, and documented Patient #1's lungs were clear.

b. Review of the Perioperative Nursing Record revealed Circulator Nurse D documented surgical staff brought Patient #1 to the operating room at 12:05 PM. At 1:25 PM, Surgeon A injected 22 mL (milliliters) of Epinephrine into Patient #1's vagina. The documentation lacked identification of the strength of Epinephrine the surgeon administered to Patient #1.

c. Upon arrival to the Post-Anesthesia Care Unit at 2:29 PM, RN H documented Patient #1's vital signs as: Blood Pressure 69/46 mmHg (millimeters of mercury), Pulse 82 bpm (beats per minute), and Pulse Ox 80%. At 2:57 PM, the patient had a cough, and stated she could not catch her breath. RN H documented the patient experienced relief of the shortness of breath after receiving a nebulizer treatment. RN H failed to document s/he notified CRNA B regarding the patient's difficulty breathing. RN H documented s/he transferred the patient to an inpatient room at 2:57 PM, and documented patient #1's vital signs as: Blood Pressure 81/63 mmHg, Pulse of 112 bpm, and Pulse Ox of 88%.

d. Documentation in the inpatient nurses notes revealed, at 4:03 PM RN I notified RN H that Patient #1 still had low blood pressure (77/44 mmHg). CRNA B ordered RN I to give the patient 1 liter of Normal Saline Intravenously. At 4:22 PM, Surgeon A saw the patient in the inpatient room. At 5:27 PM, the patient had crackles in her right lung, occasionally had a cough, and a blood pressure of 78/52 mmHg. At 5:45 PM, CRNA B ordered laboratory staff to check the Troponin level in Patient #1's blood. At 6:05 PM, CRNA B notified Surgeon A of the patient's condition. At 6:37 PM, CRNA B told the patient about her elevated Troponin level. At 7:03 PM, Surgeon A called and spoke with patient #1's spouse about transferring the patient to Hospital B. RN I documented the patients vital signs as: Blood Pressure 87/59 mmHg and a pulse of 97 bpm. At 7:00 PM, Surgeon A ordered nursing staff to transfer Patient #1 to Hospital B for a higher level of care.

At 7:48 PM, CAH staff had Patient #1 emergently transferred by ambulance with advanced life support capabilities to Hospital B's Intensive Care Unit for a higher level of care. At the time of transfer the patient's Blood Pressure was 85/53 mmHg.

2. During an interview on 8/24/10 at 5:15 PM, Circulator Nurse D, RN, stated Surgeon A requested Epinephrine. Circulator Nurse F got a bottle of Lidocaine with Epinephrine (Epinephrine concentration 1:100,000), and Circulator Nurse D got a multi-dose vial of Epinephrine (Epinephrine concentration of 1:1,000, over 100 times more Epinephrine than the 1:100,000 concentration vial of Epinephrine) from the medication cupboards in the operating room. Circulator Nurse D verified with Surgeon A s/he wanted the Epinephrine. Circulator Nurse D did not verify the concentration of the Epinephrine with Surgeon A. After Surgeon A verified s/he wanted Epinephrine, Circulator Nurse D took the bottle of Epinephrine (1:1,000 ) to Scrub Tech E.

3. During an interview on 8/25/10 at 11:10 AM, Scrub Tech E stated Circulator Nurse D brought the bottle of Epinephrine to him/her and showed the name of the medication and expiration date of the medication to him/her. Circulator Nurse D and Scrub Tech E both did not verbally verify the concentration of Epinephrine (1:1,000) prior to drawing up the medication. Scrub Tech E drew up the Epinephrine, and handed it to Surgeon A. Scrub Tech E verified with Surgeon A s/he wanted Epinephrine, but did not verify the concentration of Epinephrine (1:1,000) with Surgeon A prior to handing him/her the syringe with Epinephrine. Surgeon A injected 12 mL of Epinephrine (1:1,000) into patient #1. Surgeon A handed Scrub Tech E the empty syringe, and asked Scrub Tech E to refill the syringe. Scrub Tech E refilled the syringe with Epinephrine (1:1,000), and handed it to Surgeon A, again without verifying the concentration of the Epinephrine with Surgeon A. Surgeon A then injected an additional 10 mL of Epinephrine (1:1,000) into patient #1.

4. During an interview on 8/25/10 at 8:30 AM, CRNA B stated after Surgeon A injected the Epinephrine into patient #1, patient #1's heart rate jumped to approximately 140 bpm. CRNA B had to administer Fentanyl to patient #1, to lower patient #1's heart rate.

5. Review of the Association of Surgical Technologists (the professional organization for scrub techs) publication "Guideline Statement for Safe Medication Practices in the Perioperative Area", adopted 5/05, revealed in part, "Safe Medication Practices ... The [surgical technologist in the scrub role] will announce the name of the medication and its strength as it is passed to the person who will administer it."

6. Review of the Association of Operating Room Nurses (the professional organization for nurses in operating rooms) publication, "2010 Perioperative Standards and Recommended Practices", last revised 11/05, revealed in part, "Delivering Medications to the Sterile Field ... Actively communicate the medication name, strength, dosage, and expiration date as the medication is passed to the sterile field. Verbally and visually confirm all medications delivered to the sterile field, including medication name, strength, dosage, and expiration date. Medications should be verified concurrently by the circulating registered nurse and scrub person." "Managing Medications on the Sterile Field ... Communication is a vital key to the success of the medication delivery process. Verbally and visually confirm the medication (ie: medication name, strength, dose, and expiration date) upon receipt from the circulating registered nurse... Verbally and visually confirm the medication name, strength, and dose by reading the medication label aloud while passing a medication to the licensed professional performing the procedure."

7. During an interview on 8/23/10 at 2:05 PM, Surgeon A stated s/he examined Patient #1 5 minutes prior to surgery, and believed Patient #1 could undergo surgery without undue complications. Surgeon A did not specify the strength of Epinephrine when s/he asked Circulator Nurse D and Scrub Tech E for epinephrine. Surgeon A expected to receive Epinephrine (1:100,000). Instead, Surgeon A received Epinephrine (1:1,000). Surgeon A did not verify the strength of the Epinephrine before administering it to patient #1.

8. Review of the policy "SOLUTION LABELING - UNSTERILE [and] STERILE MEDICATION TRANSFER [and] LABELING", on 8/09, revealed in part, "Medication being [put on the sterile field] will be checked by circulator [nurse and] scrub nurse." The policy failed to address what information the circulator nurse and scrub nurse checked. The policy also lacked the requirement to verify, and label medication on the sterile field with: the name; strength; dosage; and expiration date of the medication, as required by professional standards.

9. During an interview on 8/24/10 at 3:30 PM, the Surgery Director acknowledged surgical staff did not follow professional standards by verifying the concentration of medications when staff drew up medications, or when passing medications to the surgeon performing the procedure. The Surgery Director stated the patient received a dose of Epinephrine 100 times stronger than intended, potentially causing the complications after surgery.

10. During an interview on 8/25/10 at 9:40 AM, Pharmacist J stated they provided education to the surgical services staff on Epinephrine, the morning after patient #1 received the Epinephrine (1:1,000). Pharmacist J stated the pharmacy only stocked Epinephrine (1:1,000) in the operating rooms, and did not stock Epinephrine (1:100,000) in the operating rooms, or pharmacy. Pharmacist J only provided education to the surgical services staff on Epinephrine. Pharmacist J did not provide additional education on any other medications used in the operating rooms, including: the indications; usual dosages; strengths available; and safe use of the medications.

11.During an interview on 8/24/10 at 3:30 PM, the Surgery Director stated surgical services staff had not received additional education related to the medications used during surgery, including: indications, usual dosage, strengths available, and safe use of the medications.

12. During an interview on 8/24/10 at 3:30 PM, the Surgery Director acknowledged the CAH administrative staff had not changed their policies so the surgical services staff was required to verbally state and verify the strength of medications when staff initially placed medications on the sterile surgical field, or when staff handed medications to surgeons. Instead, the CAH's surgical staff moved the storage of the Epinephrine (1:1,000) from inside the operating room, to an automated medication-dispensing machine in the Post Anesthesia Care Unit. The CAH surgical staff did not take additional measures to prevent a similar error from occurring.

13. Review of the Utilization Management/Continuous Quality Improvement meeting minutes, from 8/26/10, revealed the committee did not address the medication error until the meeting 14 days (2 weeks) after the incident.

I. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure surgical services staff followed the manufacturer's directions for 1 of 1 Germicidal Detergent when cleaning the operating room. The CAH surgical staff performed 76 surgical procedures during July 2010.

Failure to follow manufacturer's directions for germicidal detergents could potentially result in failure to kill all microorganisms on a surface, the microorganisms potentially infecting another patient, and causing a life-threatening infection to occur.

Findings include:

1. Review of the manufacturer's directions for Beaucoup Germicidal Disinfectant, copyright 2007, revealed in part, "APPLICATION: Use 1 ounce of BEAUCOUP per gallon of water for a minimum contact time of 10 minutes in a single application."

2. Observations on 8/24/10, of surgical staff cleaning Operating Room #1, following a surgery revealed the following.

a. At 1:37 PM, the Surgical Director applied Beaucoup Germicidal Detergent to the scrub table. Approximately 20 seconds later, the Surgical Director dried off the Germicidal Detergent, leaving the surface dry.

b. At 1:38 PM, the operating room staff applied Beaucoup Germicidal Detergent to the head pad of the operating room table. Approximately 15 seconds later, the operating room staff dried off the Germicidal Detergent, leaving the surface dry.

c. At 1:39 PM, the operating room staff applied Beaucoup Germicidal Detergent to a stool for the surgeon. Approximately 10 seconds later, the operating room staff dried off the Germicidal Detergent, leaving the surface dry.

d. At 1:40 PM, the operating room staff applied Beaucoup Germicidal Detergent to the operating room lights. Approximately 10 seconds later, the operating room staff dried off the Germicidal Detergent, leaving the surface dry.

e. At 1:41 PM, the operating room staff applied Beaucoup Germicidal Detergent to a patient security strap. Approximately 5 seconds later, the operating room staff dried off the Germicidal Detergent, leaving the surface dry.

3. During an interview at the time of the observations, the Surgical Director stated they "let [the Beaucoup Germicidal Detergent] sit for a little bit, and then we wipe it down to dry it off." The Surgical Director acknowledged operating room staff dried the Germicidal Disinfectant after less than 60 seconds during all observations.

4. During an interview on 8/25/10 at 11:45 AM, the Surgical Director acknowledged the manufacturer's directions instructed operating room staff to apply Beaucoup Germicidal Disinfectant, and required the surface to stay wet for 10 minutes to kill microorganisms.



II. Based on observation, document review, and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure surgical services staff followed the manufacturer's directions for 1 of 1 opened bottle of Steris System1 test strips, used to indicate if the System1 sterilizing solution effectively disinfected equipment in the Steris System1 sterilizer. The CAH surgical services staff performed 31 endoscopic procedures in July 2010.

Failure to follow the manufacturer's directions for the test strips could potentially result in test strips incorrectly indicating a solution appropriately disinfected endoscopes, when the solution lacked sufficient strength to fully kill all microorganisms, thus resulting in a life-threatening infection spreading between patients.

Findings include:

1. Observations during a tour of the Steris Room on 8/24/10 at 1:50 PM revealed 1 of 1 opened bottle of Steris System1 test strips. The bottle contained 18 out of 60 original test strips. The test strips expired 2/10, according to the manufacturer's expiration date on the bottle. Additionally, the bottle lacked documented evidence of when surgical services staff opened the bottle of test strips. At the time of the tour, the Surgical Director stated surgical services staff currently used only the test strips from the expired bottle. The Surgical Director also acknowledged surgical service staff failed to document the date the surgical services staff opened the bottle of test strips.

2. Review of the manufacturer's directions for the Steris System1 test strips, dated 10/08, revealed in part, "Instructions for Use: 1. Check the expiration date on the container. Do not use an indicator beyond the expiration date. If a new container is being opened, record the date it was first opened and the new 6 month expiration date on the container... Expiration Date: The shelf life is stated on the container. After first opening the container, the shelf life is 6 months, or the stated expiration, whichever is shortest. Do not use after the stated expiration date."

Based on observation and staff interview, the Critical Access Hospital's (CAH) Radiology Director failed to develop a policy addressing dosimetry badge use in the operating room, and provide dosimetry badges to all staff in the operating room during surgical procedures utilizing the C-Arm fluoroscope. The CAH staff performed 2 surgical procedures utilizing the C-Arm fluoroscope in July 2010, with 5 staff members present in the room during the procedures that utilized the C-Arm fluoroscope.

Failure to provide dosimetry badges for all staff could potentially result in repeated staff exposure to unsafe levels to unintentional, and unknown amounts of x-rays, which could cause cancer or death.

Findings include:

1. Observations during a tour of the Operating Rooms on 8/24/10 at approximately 11:05 AM revealed 1 of 1 C-Arm Fluoroscopes.

2. During an interview at the time of the tour, the Surgery Director stated the surgical staff use the C-Arm Fluoroscope during surgical procedures. The Surgery Director stated when the staff used the C-Arm Fluoroscope, the operative room contained 1 surgeon, 1 anesthesia provider, 2 circulating nurses, and 1 scrub technician. The Surgery Director stated the surgeon and anesthesia provider wore dosimetry badges, but the nurses and scrub technicians did not wear dosimetry badges.

3. During an interview on 8/25/10 at 11:00 AM, the Director of Radiology stated surgical staff had declined to wear dosimetry badges, and did not currently wear dosimetry badges when assisting with surgical cases involving the C-Arm Fluoroscope. The Director of Radiology also stated the CAH lacked a policy addressing radiation safety for the surgical staff. The current policy only addressed radiology staff.

Based on document review and staff interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure surgical staff:

Followed accepted standards of practice, and implement mechanisms to prevent additional medication errors, during surgical procedures (Refer to C-277);

Evaluated all patients for recovery from anesthesia (Refer to C-322).

Labeled syringes of pre-drawn medication with the time, date, and initials of the staff member who drew up medication (Refer to C-276);

Followed manufacturer's directions when using the germicidal detergent (Refer to C-278);

Developed a policy regarding staff requirements for dosimetry badges during the operation of the C-Arm Fluoroscope (Refer to C-283);

The cumulative effect of these systemic failures, and deficient practices, resulted in the CAH surgical staff's inability to provide surgical services in a safe manner. The CAH surgical services staff performed 76 surgical procedures in July 2010.

Based on document review and staff interview, the Critical Access Hospital (CAH) administrative staff failed to ensure anesthesia providers documented a post-anesthesia evaluation to determine the patient's recovery from anesthesia in 5 of 8 closed surgical medical records (patients #2, 3, 4, 5, and 6). The CAH surgical staff performed 45 procedures that required anesthesia during July 2010.

Failure to determine if a patient fully recovered from anesthesia could potentially allow staff to discharge patients with unrecognized complications from the anesthesia, such as changes in heart rate or rhythm, blood pressure, heart attack, or stroke.

Findings include:

1. Review of the policy "Anesthesia Responsibilities", dated 8/01, revealed in part, "Postoperative visits must be made by the anesthetist and the patient must be evaluated by a licensed independent practitioner... prior to discharge from the Post Anesthesia Care Unit."

2. Review of closed surgical medical records revealed:

a. Patient #2's medical record lacked documented evidence the anesthetist, or licensed independent practitioner, evaluated the patient after they transferred patient #2 to the Post Anesthesia Care Unit (PACU).

b. Patient #3's medical record lacked documented evidence the anesthetist, or licensed independent practitioner, evaluated the patient after they transferred patient #3 to the Post Anesthesia Care Unit (PACU).

c. Patient #4's medical record indicated the anesthetist performed the post-anesthesia evaluation approximately 2.5 hours after nursing staff discharged patient #4.

d. Patient #5's medical record lacked documented evidence the anesthetist, or licensed independent practitioner, evaluated patient #5 before nursing staff discharged patient #5.

3. During an interview on 8/25/10 at 8:15 AM, Certified Registered Nurse Anesthetist (CRNA) B acknowledged s/he did not evaluate patients that received anesthesia for recovery, except briefly when they transferred care to the Post Anesthesia Care Unit nurse. CRNA B did not see the patients after the transfer of care.

4. During an interview on 8/25/10 at 11:45 AM, the Surgery Director acknowledged the closed medical records for patients #2, 3, 4, 5, and 6 lacked documented evidence the anesthetist or licensed independent practitioner evaluated the patients for recovery from anesthesia prior to nursing staff discharging the patients.