HospitalInspections.org

25730

Based on observation, interview, and record review, the hospital failed to demonstrate that the Board of Trustees exercised sufficient oversight of hospital operations to ensure they were performed in such a way as to enhance the quality of patient care and to minimize the risks and hazards for patients and staff as evidenced by:

1. Failure to ensure that single use medication vials were not used for multiple patients to prevent infection and transmission of bloodborne diseases. Single use medication vials were used for multiple patients in the surgery department by three of three anesthesiologists of the hospital, (Refer to A 500)

2. Failure to ensure the proper review of medication orders by pharmacists to ensure patient safety. Drug interaction was not identified and acted upon by pharmacist to avoid undesired therapeutic outcomes. Patient 101 was administered ciprofloxacin (an antibiotic) and iron supplement concomitantly which might significantly reduce the absorption of ciprofloxacin, (Refer to A 500)

3. Failure of the pharmacy department to ensure compliance with established medication-related policies and procedures. The hospital pharmacy department did not maintain oversight of medication use in the surgery department to ensure medication safety (Refer to A 491)

4. Failure to develop and implement a plan of correction when the temperature was consistently above the recommended range in the decontamination area, (Refer to A 726)

5. Failure to develop and implement a plan of correction when the humidity was occasionally below the recommended range in the Operating Rooms and the PACU (Post Anesthesia Care Unit). (Refer to A 726)

6. Failure to monitor temperature and humidity in the perioperative and the sterile/clean supply area, (Refer to A 726)

7. Failure to develop and implement a plan of action for the Engineering Department for their response to reports that temperature and/or humidity were out of range, (Refer to A 726), and

8. Failure to develop a hospital-wide policy and procedure for tuberculosis screening consistent with the nationally recognized infection control guidelines (CDC).

25093

Based on observation, interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care that met the needs of the patients as evidenced by:

1. Failure to ensure that single use medication vials were not used for multiple patients to prevent infection and transmission of bloodborne diseases. Single use medication vials were used for multiple patients in the surgery department by three of three anesthesiologists of the hospital. (Refer to A 500)

2. Failure to ensure the proper review of medication orders by pharmacists to ensure patient safety. Drug interaction was not identified and acted upon by pharmacist to avoid undesired therapeutic outcomes. Patient 101 was administered ciprofloxacin (an antibiotic) and iron supplement concomitantly which might significantly reduce the absorption of ciprofloxacin. (Refer to A 500)

3. Failure of the pharmacy department to ensure compliance with established medication-related policies and procedures. The hospital pharmacy department did not maintain oversight of medication use in the surgery department to ensure medication safety (Refer to A 491)


An immediate jeopardy situation was declared pertaining to the failure of the hospital to consistently implement the policy and procedure on the use of single use medication vials to ensure patient safety at 4:30 PM on 4/2/12 in the presence of the hospital's Chief Operating Officer, Nurse Manager 101, Risk Manager, Director of Pharmacy, and Nurse Educator.

The immediate jeopardy was abated at 7:50 AM on 4/3/12 after an immediate corrective action plan was implemented and accepted by the Department.

The cumulative effects of these systemic problems resulted in the inability of the hospital to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

25093

Based on observation, interviews and record review, the hospital Director of Pharmacy (DOP) failed to ensure compliance with established medication-related policies and procedures. The hospital pharmacy department did not maintain oversight of medication use in the surgery department to ensure medication safety.

Findings:

During a tour of Operating Room 1 on 4/2/12 at 10:20 AM, single use vials of fentanyl 250/ml (milliliters), midazolam 2 mg (milligram)/2 ml, and normal saline 10 ml with phenylephrine 1 mg/ml were observed opened and lying on the top of the anesthesia cart. The Infection Control Practitioner (ICP) verified the three opened medications and listened to Physician 4's (MD 4) explanation for using single dose vials on more than one patient.

MD 4 stated he had used these vials on the two preceding surgical cases and he was planning to use them on the third surgical case of the day. MD 4 stated it was wasteful to only use single dose vials once and he added that all of these wasted drugs were contaminating the environment and getting into our water supply.

In an interview with the Director of Pharmacy (DOP) on 4/2/12 at 2:30 PM, the DOP stated the pharmacy reviews the daily narcotic reconciliation and occasionally audits the amounts given by the anesthesiologists using the patients' records and comparing amounts given with the amounts signed out. The DOP thought this was done quarterly but later reconsidered and thought it might be done once or twice/year. The DOP stated the pharmacy did not compare the number of vials ordered with the number of surgical cases performed.

In an interview on 4/2/12 at 3:15 PM, the Unit Coordinator for Surgical Services (SCU C) stated the Circulating Registered Nurse removed the narcotics (fentanyl and midazolam) from the locked narcotic box in the morning. SCU C said they took out as many vials as the anesthesiologist requested and at the end of the day the nurse recorded the amount the anesthesiologist returned to be wasted. SCU C said the nurses never questioned the anesthesiologists when they requested fewer vials that the number of cases.

A review of the operating room controlled substance records and anesthesia controlled substance records showed discrepancies between the number of single dose medication vials removed and the number of patients who received the medications indicative of the misuse of single use vials in multiple patients in the surgery department as follow:

On 4/2/12, MD 4 used two fentanyl 250/5 ml single use vials for three patients.

On 3/30/12, Physician 3 (MD 3) used four fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for seven patients.

On 3/27/12, MD 4 used one fentanyl 250/5 ml single use vials and four midazolam 2 mg/2 ml single use vials for five patients.

On 3/26/12, MD 3 used three fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for ten patients.

On 3/23/12, MD 4 used two fentanyl 250/5 ml single use vials and four midazolam 2 mg/2 ml single use vials for five patients.

On 1/11/12, MD 4 used three fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for eleven patients.

On 1/10/12, MD 3 used two fentanyl 250/5 ml single use vials and three midazolam 2 mg/2 ml single use vials for five patients.

On 1/4/12, Physician 5 (MD 5) used three fentanyl 250/5 ml single use vials and six midazolam 2 mg/2 ml single use vials for eleven patients.

Review of facility policy and procedure tiled, "Expiration date of Medications" date/revised 6/11, indicated,"All medication storage areas are inspected by pharmacy at least once a month....... 2. All single dose vials are for one (1) time use only and any unused portions will be discarded after use."

Based on observation, interviews and document reviews, the hospital failed to ensure the provision of pharmaceutical services and care in accordance with applicable standards of practice to ensure patient safety as evidenced by:

1. Single use vials of fentanyl, midazolam and phenylephrine were used in multiple patients in the surgery department, contrary to hospital policy and procedures and established professional standards of practice.

2. Medication orders were not appropriately reviewed by pharmacists to ensure optimal medication therapy. Pharmacist failed to identify drug-drug interaction in Patient 101 ' s medication therapy to ensure proper absorption of ciprofloxacin (an antibiotics)

Findings:

During a tour of Operating Room 1 at 10:20 AM on 4/2/12, the following medications were observed on the anesthesia cart:

One opened 2-ml (milliliters) single use vial of midazolam 2 mg/2 ml (milligrams per milliliters, concentration unit)
One opened 5-ml single dose vial of fentanyl 250 mcg/5 ml (micrograms per milliliter, concentration unit)
One opened single use vial of phenylephrine in 10 ml normal saline labeled with preparation date of 4/2/12 and the concentration of 1 mg/1 ml.

The Infection Control Practitioner (ICP) verified the three opened medications and listened to Physician 4's (MD 4) explanation for using single dose vials on more than one patient.

MD 4 stated he had used these vials on the two preceding surgical cases and he was planning to use them on the third surgical case of the day. MD 4 stated it was wasteful to only use single dose vials once and he added that all of these wasted drugs were contaminating the environment and getting into our water supply. MD 4 stated all anesthesiologists in the hospital adopted the practice of single dose vials use in multiple patients.

A single-dose or single-use vial is a vial of liquid medication intended for parenteral administration (injection or infusion) that is meant for use in a single patient for a single case/procedure/injection to minimize infection from microbial contamination. Single-dose or single-use vials are labeled as such by the manufacturer and typically lack an antimicrobial preservative. According to CDC (Center for Disease Control), multiple outbreaks with transmission of bloodborne viruses including Hepatitis C have resulted from healthcare personnel using single-dose or single-use vials for multiple patients.

The Association for Professionals in Infection Control and Epidemiology published position paper " Safe injection, infusion, and medication vial practices in health care " indicates that single-dose vials are to be discarded after use and never to be used for another patient. The position paper also indicated that immediate-use compounded sterile preparations (sterile products prepared outside of a clean room or ISO class 5 laminar flow hoods) should be used within 1 hour from preparation. The 1-hour limit is expected to preclude microbial population increase when accidental contamination occurs during preparation. Once microbial contamination occurs, organism replication can begin within 1 to 4 hours with exponential growth occurring rapidly afterward.

A review of the operating room controlled substance records and anesthesia controlled substance records showed discrepancies between the number of single dose medication vials removed and the number of patients who received the medications indicating the practice of single use vials used in multiple patients in the surgery department as follow:

On 4/2/12, MD 4 used two fentanyl 250/5 ml single use vials for three patients.

On 3/30/12, Physician 3 (MD 3) used four fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for seven patients.

On 3/27/12, MD 4 used one fentanyl 250/5 ml single use vials and four midazolam 2 mg/2 ml single use vials for five patients.

On 3/26/12, MD 3 used three fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for ten patients.

On 3/23/12, MD 4 used two fentanyl 250/5 ml single use vials and four midazolam 2 mg/2 ml single use vials for five patients.

On 1/11/12, MD 4 used three fentanyl 250/5 ml single use vials and five midazolam 2 mg/2 ml single use vials for eleven patients.

On 1/10/12, MD 3 used two fentanyl 250/5 ml single use vials and three midazolam 2 mg/2 ml single use vials for five patients.

On 1/4/12, MD 5 used three fentanyl 250/5 ml single use vials and six midazolam 2 mg/2 ml single use vials for eleven patients.

A review of the hospital policy and procedure titled "Expiration Date of Medications" dated/revised 06/11, indicated that all single dose vials were for one time use only and any unused portion would be discarded after use.

In an interview with the Director of Pharmacy (DOP) on 4/2/12 at 2:00 PM, the DOP stated the pharmacy reviewed the daily narcotic reconciliation forms and occasionally audited the amounts given by the anesthesiologists using the patients' records and comparing amounts given with the amounts signed out. The DOP thought this was done quarterly but during the meeting at 3:00 PM, the DOP reconsidered and thought it might be done once or twice/year. The DOP stated these audits had not been done for a long time and the pharmacy never compared the number of vials ordered with the number of surgical cases performed.

During a group interview at approximately 3:00 p.m. on 4/2/12, the hospital's ICP confirmed there were two practicing anesthesiologists at the hospital, MD 3 and MD 4.

In an interview on 4/2/12 at 3:15 PM, the Unit Coordinator for Surgical Services (SCU C) stated that before surgeries started each day, the Circulating Registered Nurse removed the narcotics (fentanyl and midazolam) from the locked narcotic box in the morning. SCU C said they took out as many vials as the anesthesiologist requested and at the end of the day the nurse recorded the amount the anesthesiologist returned to be wasted. SCU C said the nurses never questioned the anesthesiologists when they requested fewer vials than the number of cases scheduled for the day.

During an interview at approximately 1:00 p.m. on 4/3/12, the hospital COO stated that MD 5 was a relief anesthesiologist who worked in the hospital 3 to 4 times a year. The COO acknowledged that all practicing anesthesiologists of the hospital used single dose medications in multiple patients, a practice contrary to the hospital policy and standards of practice.

The use of single dose vials in multiple patients by all the anesthesiologists in the surgery department of the hospital contradicted the professional standards of practice supported by the CDC and the Association for Professionals in Infection Control and Epidemiology to ensure patient safety.

O 3/2/12 at 4:30 PM, an immediate jeopardy situation was declared pertaining to the failure of the hospital to consistently implement the policy and procedure on the use of single use medication vials to ensure patient safety in the presence of the hospital's Chief Operating Officer, Nurse Manager, Risk Manager, Director of Pharmacy, and Nurse Educator.

The immediate jeopardy was abated at 7:50 AM on 4/3/12 after an immediate corrective action plan was implemented and accepted by the Department.

2. A review of Patient 84's clinical record showed that the patient was admitted to the hospital on 3/21/12 for humerus (upper arm) fracture and dehydration. Patient 84's admission order included Ciprofloxacin 250 mg one tablet twice daily and Iron sulfate 325 mg one tablet twice daily. Patient 84's Medication Administration Record showed that the patient was administered both medications at 9:00 a.m. and 9:00 p.m. on 3/22/12, 3/23/12 and 3/24/12.

Ciprofloxacin is a quinolone antibiotic for the treatment of bacterial infection. According to the manufacturer's prescribing information, the concurrent administration of ciprofloxacin with iron products may substantially decrease the absorption of ciprofloxacin affecting the antibacterial effect of the medication.

A review of the hospital policy and procedure titled "Pharmaceutical Care Monitoring" indicated that pharmacists should provide any interventions or recommendations in patient's drug therapy whenever the current therapy placed the patient at risk (drug interactions, allergy) or whenever an optimal therapy can be achieved.

During an interview at approximately 11:30 AM on 4/3/12, the DOP stated that medications prescribed twice a day by the physician would be scheduled to be administered at 9:00 a.m. and 9:00 p.m. by default unless clinically indicated otherwise. The DOP further stated that due to the interaction between ciprofloxacin and iron, it was his expectation that the pharmacist who reviewed the orders to override the default dosing schedule to avoid the drug interaction that could lead of poor absorption of ciprofloxacin.

Based on observation, interview, and record review, the facility failed to 1. develop and implement a plan of correction when the temperature was consistently above the recommended range in the decontamination area, 2. develop and implement a plan of correction when the humidity was occasionally below the recommended range in the Operating Rooms and the PACU (Post Anesthesia Care Unit), 3. monitor temperature and humidity in the perioperative and the sterile/clean supply area, and 4. develop and implement a plan of action for the Engineering Department for their response to reports that temperature and/or humidity were out of range.

Findings:

1. Record review of the temperature and humidity logs for the decontamination area indicated the temperature in this small room was consistently above the 60 to 65 degrees Fahrenheit recommended to minimize bacterial growth.

In an interview on 4/3/12 at 10:30 AM, the Infection Control Practitioner (ICP) stated he was aware of this situation and had discussed it with Engineering. The ICP stated the decontamination area was small and was located in the basement of the hospital. The area was at its maximum air exchange capability and there were no additional means of increasing the ventilation to remove the heat created by the machinery.

2. Record review of the temperature and humidity logs for the two Operating Rooms (ORs) and the PACU indicated that the humidity was below the recommended 30-60% range in all three areas five times during February and March, 2012. Low humidity increases the the risk of fire from anesthesia gases and the use of electrical equipment in the OR and may cause excessive drying of the surgical site.

There were notations made on the log that Engineering had been notified each time the humidity was below the acceptable range. There were no indications that Engineering had responded and/or corrected the situation.

In an interview on 4/3/12 at 10:30 AM, the ICP did not know if Engineering had a policy and procedure for dealing with low humidity situations.

3. In an interview on 4/3/12, the ICP stated the peri-operative and sterile supply areas had received thermo-hygrometers but these areas were not included on the daily monitoring logs.

4. The ICP was asked to provide Engineering policies and procedures regarding the department response when they were notified the temperature and/or humidity were out of range in any of the surgical and central supply areas. No documents were provided.

The hospital failed to fully implement their plan of correction regarding the monitoring of temperature and humidity and the maintenance of temperature and humidity within the acceptable ranges.


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27921

Based on interview and record review, the facility failed to develop a hospital-wide policy and procedure to reduce the potential for transmission of infection to or from employees when the said policy and procedure was not consistent with the nationally recognized infection control guidelines.

Findings:

Review of policy and procedure "EMPLOYEE HEALTH", dated 12/11 (revision/review date), indicated, "Each staff member shall be screened for Tuberculosis annually." The Policy and Procedure does not reflect CDC guidelines for all employees. Employees who test positive,due to receiving the BCG (bacille Calmette-Guerin) vaccine, should submit an annual Tuberculosis (TB) surveillance screening, stating that the employee had no symptoms of TB.

Review of "Core Curriculum on Tuberculosis" dated Fifth Edition 2011, a publication by CDC, indicated, "The TST(tuberculin skin test)....is not contraindicated for persons who have been vaccinated with BCG (bacille Calmette-Guerin). The TST results are used to support decisions about the diagnosis of infection with M. tuberculosis." This is not addressed in the facility's policy and procedure.
In an interview on 4/3/12, at 2:00 PM, the Infectious Control Practitioner(ICP), stated, "I will correct the policy."








28798