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Based on observation, interviews, and record review, the hospital failed to delivery pharmaceutical services to meet the needs of the patients when medications were not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Failure to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 81, 82 and 83 were prescribed and administered fentanyl transdermal patches not in accordance with Boxed warning issued by the FDA and the manufacturer's prescribing information. In addition, pharmacy staff and nursing staff failed to demonstrate competency in safe use of fentanyl patches

2. Failure to ensure that pre-printed medication orders approved by the pharmacy and therapeutics committee were developed to ensure patient safety. Medication orders for acetaminophen and acetaminophen containing products exceeding the maximum daily dose of acetaminophen were available for ordering on preprinted order forms.

3. Failure to ensure the safe and effective distribution of controlled substances. Controlled substances were stored in nursing station as floor stock and could be administered to patient prior to pharmacist review of order.

4. Failure to ensure that medication orders were reviewed for appropriateness by a pharmacist before the first dose was dispensed. Medication orders written when the pharmacy was closed were not reviewed prior to the first dose being administered and medications ordered on Saturday might take up 16 hours before review by a pharmacist for appropriateness.

5. Failure to ensure that emergency drug supply was sealed by pharmacist in such a manner that a seal must be broken to gain access to the drugs.

Findings:

1a. A review of Patient 81's clinical record with the hospital director of pharmacy (DOP) showed that the patient was admitted to the hospital on 11/12/11 for abdominal pain. Patient 81's medication list indicated that the patient was not on any narcotic (opioid) pain medication prior to admission. Patient 81 was ordered and administered Fentanyl Transdermal Patch 25 mcg/hr (micrograms per hour, delivery rate) on 11/18/11. Patient 81's usage of narcotic (opioid) medications for pain control was as follow:

On 11/12/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/13/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/14/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of Vicodin (Hydrocodone/Acetaminophen 5/500 mg) one tablet by mouth

On 11/16/11, Patient 81 was administered a total daily dose of morphine 8 mg by intravenous route

On 11/17/11, Patient 81 was not administered any narcotic pain medication until 6:00 p.m. when Fentanyl patch 25 mcg/hr was ordered and administered.

Based on the opioid usage prior to the administration of the fentanyl patch, Patient 81 was prescribed and administered fentanyl transdermal patch not in accordance with the manufacturer's prescribing information to minimize potentially fatal side effects of the medication. Patient 81 had been on low dose of opioid analgesics for 6 days (11/12/11 to 11/17/11) prior to the initiation of fentanyl patch on 11/18/11. Patient 63 was not opioid tolerant based on the manufacturer's prescribing guidelines prior to the administration of the fentanyl patch on 11/18/11.

1b. A review of Patient 82's clinical record with the DOP showed that the patient was admitted to the hospital on 10/12/11 for shortness of breath and epigastric (upper/mid abdominal region) pain. Patient 82's medication list showed that the patient was on Vicodin 1 to 2 tablets 3 times daily as needed prior to admission with no indication of usage history. Patient 82 was ordered and administered Fentanyl Transdermal Patch 12 mcg/hr on 10/12/11. Patient 82's fentanyl patch dose was increased to 37mcg/hr on 10/14/11 and to 50 mcg/hr on 10/16/11. A review of Patient 82's medication administration record (MAR) showed that no additional pain medications was administered for pain control from 10/12/11 to 10/16/11 to justify the frequency increase in fentanyl dosage.

Lexi-Comp, a national drug information provider to health care professional, indicated that dosage of fentanyl transdermal patch should not be titrated more frequently than every 3 days after the initial dose or every 6 days thereafter. Patients should wear a consistent fentanyl dosage through two applications (6 days) before dosage increase based on supplemental opiate dosages can be estimated.

1c. A review of Patient 83's clinical record with the DOP showed that the patient was admitted to the hospital on 11/6/11. Patient 83's medication reconciliation form indicated that the patient was not on any narcotic medications prior to admission. Fentanyl patch 25 mcg/ hr was ordered by the physician on 11/8/11. Patient 83's medication administration record (MAR) showed that the patient did not receive any narcotic medication on 11/6/11 and 11/7/11 prior to the initiation of fentanyl patch.

There was no documented record indicating that Patient 83 was opioid tolerant in accordance with the manufacturer ' s guidelines prior to the initiation of the fentanyl patch.

According to the manufacturer's prescribing information, a boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

During an interview at approximately 1:30 p.m. on 12/15/11, Registered Nurse 61 was unable to state the boxed warning of fentanyl transdermal patch.

During an interview at approximately 2:07 p.m. on 12/15/11, Pharmacist 1 stated that patients who had been on short acting opioid (dose and duration not specified) were candidate for fentanyl patch. When being asked by the surveyor how to handle a situation of a patient who had been receiving opioid for 3 days prior to physician ' s order for fentanyl patch 25 mcg/hr, Pharmacist 1 responded that she would contact the prescribing physician and if the prescribing physician considered the patient to be opoid tolerant, she would dispense the medication as ordered.

2. During an interview at approximately 4:00 p.m. on 12/14/11, the hospital Director of Pharmacy (DOP) stated that general and physician specific preprinted orders were used in the hospital and such forms were approved by the hospital Pharmacy and Therapeutics Committee for use in the hospital.

A sampled review of the preprinted medication order forms used in the hospital showed that 3 preprinted order forms contained medication orders which were unsafe for patient administration as follow:

Same Day Surgery GYN post-operative order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 3 hours as needed for moderate pain and Acetaminophen/Codeine 325/30 mg 2 tablets every 3 hours as needed for mild pain. Both orders, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg

Post-operative inpatient GYN order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 4 hours as needed for pain. The order, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg

Post-operative Shoulder/Knee order form for Physician 61 contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 3 hours for severe pain. The order, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg.

Acetaminophen overdose is the leading cause of acute liver failure in the United States and in some cases may require liver transplant. Lexis-Comp, a national drug information provider to health care professional, indicated that the maximum dose of acetaminophen should not exceed 4000 mg per day.

3. During an inspection of the medication storage cart on the third floor with Registered Nurse 61 (RN 61) at approximately 3:15 p.m. on 12/13/11, over 400 doses of over 20 different controlled substances were found in a locked compartment of the medication storage cart. RN 61 stated that the identified controlled substances were floor stock for that nursing station. RN 61 stated that access to the locked compartment was by a key which was shared between nurses but there was no mechanism to track individual access to the compartment in the event of drug diversion. RN 61 further explained that controlled substances ordered by physicians could be administered at once without having to wait for the pharmacist to review orders because the medications were readily available at the nursing station.

The SPH (American Society of Health System Pharmacists) published guidelines on minimum standard for pharmacies in hospitals indicated that floor stocks of medications generally shall be limited to medications for emergency use and routinely used safe items (e.g., mouthwash, antiseptic solutions). The potential for medication errors and adverse effects must be considered for every medication allowed as floor stock.

During an interview at approximately 3:25 p.m. on 12/13/11, the DOP stated that because of the fact that the controlled substances were stored at the nursing station, there was no mechanism to ensure that such medications would be not administered prior to pharmacist review of the physicians ' orders.

4. During an interview at approximately 10:00 a.m. on 12/13/11, the DOP stated that the inpatient pharmacy was staffed from 8 a.m. to 8 p.m. Monday to Friday and 9 a.m. to 5 p.m. on Saturdays and Sundays. Medication orders written by physicians when the pharmacy was closed would be not reviewed by a pharmacist until the next morning while medications could be obtained for administration from the night medication cart or floor stock.

During an interview at approximately 1:30 p.m. on 12/15/11, RN 61 stated that evening medication orders were not reviewed for appropriateness until the pharmacy opened the next day. RN 61 added that medications could be obtained by accessing the medications in the night cart by the nursing supervisors. RN 61 also stated that patients admitted to the hospital on a Saturday at 5:00 p.m. might not have his/her admission orders reviewed by a pharmacist until the pharmacy reopened at 9:00 a.m. on Sunday, a 16 hours delay.

ASH (The American Society of Health System Pharmacists) published guidelines on minimum standards for pharmacies in hospitals indicated that all prescribers' medication orders (except in emergency situations) must be reviewed for appropriateness by a pharmacist before the first dose is dispensed. Any questions regarding the order must be resolved with the prescriber at this time, and a written notation of these discussions must be made in the patient's medical record or pharmacy copy of the prescriber's order. Information concerning changes must be communicated to the appropriate health professional.

5. During a tour of the surgical department at approximately 2:30 p.m. on 12/13/11, malignant hyperthermia supplies were observed being stored in a cart with no tamper-proof seal on the cart to indicate to staff if the cart had been opened or if inspection and/or replacement of supply was warranted.

California Code of Regulations Title 22 70263 (Hf) (2) stipulates that emergency drug supply shall be stored in a clearly marked portable container which is sealed by the pharmacist in such a manner that a seal must be broken to gain access to the drugs. Such system allows the hospital to know if supplies have been removed from the emergency supply which warrants inspection by appropriate staff and replacement of removed supply.

Based on observations, staff interview, and the hospital's policy and procedure review, the hospital failed to follow the hospital's laboratory service procedures when the discard date (the new expiration date) of the blood glucose control test solutions could not be determined and they were ready for use. This failure had the potential for the blood glucose checking system giving unreliable results, which could affect the patient's treatment plan and put the patient(s) at risk.

Findings:

During an observation and a concurrent interview with the registered nurse (RN 8) in the Intensive Care Unit (ICU) on 12/14/11 at 2:45 p.m., the printed manufacturer's specification on the blood glucose control test solution vials (high and low levels) indicated the control test solutions were good for 90 days after first opened. There was no discard date or first open date labeled on the control test solution vials and the vials were ready for use in the nurse station. The RN 8 confirmed that she could not determine the discard date of the blood glucose control test solutions with no information of the first open date.

On 12/15/11 at 9 a.m., review of the hospital's policy and procedure (number: 6170 - 3.02) titled "Policy and Procedure for Quality Control (QC) Testing of the Blood Glucose Meter" dated 7/11 (review/revision date) indicated "High and low levels of control solutions are used for quality control tests...Quality control (QC) solution has an open vial stability of 90 days. Upon opening, label the open vial's expired/discard date. Dispose properly any outdated vials or expired solution (open vial over 90 days), whichever comes first."

Based on observations, staff interviews, and document review, the hospital failed to maintain the relative humidity and temperature in the operating suite and the endoscopy suite as well as the air exchanges in the endoscopy suite and perioperative areas such as the sterile storage, sterile processing area and PACU (Post Anesthesia Care Unit) within acceptable standards in accordance with nationally recognized infection control guidelines when:

1. There were no humidity, temperature and airflow exchanges monitoring/control in the endoscopy suite and majority of the operating suite;

2. The recorded humidity levels for the Operating Room (OR) 1 and OR 2 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances in accordance with the hospital's protocol;

3. The recorded temperatures for the PACU were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances.

These failures had the potential for putting the patient(s) at risk due to posing a fire hazard in an oxygen-enriched environment or conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection.

Findings:

1. During the initial tour in the operating suite on 12/13/11 starting 11 a.m., there was no device for monitoring temperature and humidity observed in the sterile storage; the sterile processing area; and the area where the hand scrub sinks located.

During an interview with the Surgical Services Unit Coordinator (SCUC) on 12/13/11 at 11:50 a.m., the SCUC stated the temperature and humidity were monitored only in the OR 1 and OR 2, but were not monitored in the sterile storage, the sterile processing area; and the hand scrub sink area.

During an observation and a concurrent interview with the registered nurse in charge of the endoscopy suite (RN 5) in the small endoscopy room on 12/13/11 at 11:55 a.m., there was no device for monitoring temperature and humidity observed. RN 5 stated the temperature and humidity were not monitored in the endoscopy suite.

During an observation in the decontamination room of the central supply department on 12/13/11 at 3:15 p.m., there was no device for monitoring temperature and humidity observed.

During an interview with the Central Sterilization Staff (CSS M) in the sterile processing area at the central supply department on 12/13/11 at 4:10 p.m., the CSS M confirmed that there was no monitoring of humidity and temperature in the central supply department including the decontamination room, the sterile processing area and the sterile storage area.

During an interview with the Infection Control Practitioner (ICP P) on 12/14/11 at 9 a.m., the ICP P confirmed that the staff monitored the humidity in OR 1 and OR 2 only, but not the decontamination room, sterile processing area, sterile storage, the endoscopy suite and the central supply department.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology) guidelines as references for infection control practice. The ICP P confirmed that there was no air exchange monitoring in the perioperative areas except OR 1 and OR 2 (the perioperative areas with no air exchanges monitoring included the sterile processing area, the sterile storage, and the PACU) as well as the endoscopy suite. The ICP P also stated there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite and there was no specific policy and procedure concerning the air exchanges monitoring in the sterile storage, decontamination room, sterile processing area, PACU and the endoscopy suite.

On 12/15/11 at 2:42 p.m., the hospital's policy and procedure titled "Hospital's name utility systems failure responses: Hospital air quality policy" dated 7/07 indicated "Test...and positive pressure room balance in OR Room 1 & 2 - Annually record data on P.M. (performance maintenance) sheet..." Air exchanges monitoring in the sterile processing room, sterile storage, decontamination room, PACU, and the endoscopy suite was not addressed.

On 12/15/11 at 2:45 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 215, direction was given that, "Recommended practices for a safe environment of care...These practice settings include traditional operating rooms...endoscopy suites...and all other areas where surgery may be performed." On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F (Fahrenheit) to 73 degrees F within the operating room suite and general work areas in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows...Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Postanesthesia care unit: Six air exchanges per hour...Sterile storage area: four air exchanges per hour. Under Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

2. During an observation and a concurrent interview in OR 1 on 12/13/11 at 12 p.m., the device on the wall indicated the temperature was 68 degrees F and the humidity was 78 percent (%). The SCUC confirmed the humidity in OR 1 was 78%.

On 12/13/11 at 2:20 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated July 2011 through December 2011 with the SCUC and a concurrent interview was performed. The documented humidity levels in OR 1 were ranging from 72% to 92% while the documented humidity levels in OR 2 were ranging from 64% to 88%. When asked the normal humidity level in the OR, the SCUC stated she did not know the normal range of humidity level in OR; it should not below 50%. The SCUC further indicated that it would be "OK" if the humidity was 78% to 80%.

On 12/13/11 at 2:25 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated December 2011 with the ICP P and a concurrent interview was conducted. The aforesaid document indicated "Notify engineering when needed." When asked to explain "when needed" per protocol, the ICP P stated he did not know the meaning of "when needed" and the document should have addressed the criteria of notifying the engineering. The ICP P further stated he did not know the normal humidity range in the OR, and the engineering should know.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN, CDC, and APIC guidelines as references for infection control practice. The ICP P also stated that the humidity monitors in OR 1 and OR 2 did not function, and the hospital did not have a system to monitor the humidity and temperature in order to meet the infection control standard. The ICP P confirmed that there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite.


On 12/15/11 at 10 a.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms..."

3. On 12/14/11 at 8:35 a.m., review the PACU temperature recorded on the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated July 2011 through December 2011. There were 4 recorded temperatures higher than 75 degrees F (3 days in September 2011; 1 day in November 2011) and 14 recorded temperatures lower than 70 degrees F (2 days in October 2011; 5 days in November 2011; and 7 days in December 2011).

During an interview with the ICP P on 12/14/11 at 9 a.m., the ICP P stated he did not know the normal temperature range in the PACU.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN, CDC, and APIC guidelines as references for infection control practice. The ICP P also stated the hospital did not have a system to monitor the temperature and humidity in order to meet the infection control standard. The ICP P confirmed that there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite.

On 12/15/11 at 10 a.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 219, under Recommendation V.c.3., direction was given that, "A temperature of 70 degrees F to 75 degrees F should be maintained in recovery areas and cardiac catheterization rooms."

Based on observations, staff interviews, and document review, the hospital failed to maintain the relative humidity and temperature in the operating suite and the endoscopy suite as well as the air exchanges in the endoscopy suite and perioperative areas such as the sterile storage, sterile processing area and PACU (Post Anesthesia Care Unit) within acceptable standards in accordance with nationally recognized infection control guidelines when:

1. There were no humidity, temperature and airflow exchanges monitoring/control in the endoscopy suite and majority of the operating suite;

2. The recorded humidity levels for the Operating Room (OR) 1 and OR 2 were out of normal range on multiple occasions with no documented evidence of notification or correction for variances in accordance with the hospital's protocol;

3. The recorded temperatures for the PACU were out of normal range on multiple occasions with no documented evidence of notification or correction for the variances.

These failures had the potential for putting the patient(s) at risk due to posing a fire hazard in an oxygen-enriched environment or conducing bacterial growth which would compromise the integrity of wrapped sterile items and cause infection.

Findings:

1. During the initial tour in the operating suite on 12/13/11 starting 11 a.m., there was no device for monitoring temperature and humidity observed in the sterile storage; the sterile processing area; and the area where the hand scrub sinks located.

During an interview with the Surgical Services Unit Coordinator (SCUC) on 12/13/11 at 11:50 a.m., the SCUC stated the temperature and humidity were monitored only in the OR 1 and OR 2, but were not monitored in the sterile storage, the sterile processing area; and the hand scrub sink area.

During an observation and a concurrent interview with the registered nurse in charge of the endoscopy suite (RN 5) in the small endoscopy room on 12/13/11 at 11:55 a.m., there was no device for monitoring temperature and humidity observed. RN 5 stated the temperature and humidity were not monitored in the endoscopy suite.

During an observation in the decontamination room of the central supply department on 12/13/11 at 3:15 p.m., there was no device for monitoring temperature and humidity observed.

During an interview with the Central Sterilization Staff (CSS M) in the sterile processing area at the central supply department on 12/13/11 at 4:10 p.m., the CSS M confirmed that there was no monitoring of humidity and temperature in the central supply department including the decontamination room, the sterile processing area and the sterile storage area.

During an interview with the Infection Control Practitioner (ICP P) on 12/14/11 at 9 a.m., the ICP P confirmed that the staff monitored the humidity in OR 1 and OR 2 only, but not the decontamination room, sterile processing area, sterile storage, the endoscopy suite and the central supply department.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN (Association of periOperative Registered Nurses), CDC (Centers for Disease Control and Prevention), and APIC (Association for Professionals in Infection Control and Epidemiology) guidelines as references for infection control practice. The ICP P confirmed that there was no air exchange monitoring in the perioperative areas except OR 1 and OR 2 (the perioperative areas with no air exchanges monitoring included the sterile processing area, the sterile storage, and the PACU) as well as the endoscopy suite. The ICP P also stated there was no specific policy and procedure concerning the temperature and humidity monitoring/control in the operating suite and the endoscopy suite and there was no specific policy and procedure concerning the air exchanges monitoring in the sterile storage, decontamination room, sterile processing area, PACU and the endoscopy suite.

On 12/15/11 at 2:42 p.m., the hospital's policy and procedure titled "Hospital's name utility systems failure responses: Hospital air quality policy" dated 7/07 indicated "Test...and positive pressure room balance in OR Room 1 & 2 - Annually record data on P.M. (performance maintenance) sheet..." Air exchanges monitoring in the sterile processing room, sterile storage, decontamination room, PACU, and the endoscopy suite was not addressed.

On 12/15/11 at 2:45 p.m., the 2011 Perioperative Standards and Recommended Practices, published by AORN, was reviewed. On page 215, direction was given that, "Recommended practices for a safe environment of care...These practice settings include traditional operating rooms...endoscopy suites...and all other areas where surgery may be performed." On page 218, under Recommendation V.b., direction was given that, "Relative humidity should be maintained between 30% and 60% within the perioperative suite, including operating rooms, recovery area, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas and should be maintained below 70% in sterile storage areas." On page 219, under Recommendation V.c., direction was given that, "Temperature should be monitored and recorded daily..." Under recommendation V.c.1., direction was given that, "Temperature should be maintained between 68 degrees F (Fahrenheit) to 73 degrees F within the operating room suite and general work areas in sterile processing." Under Recommendation V.c.2., direction was given that, "The decontamination area temperature should be maintained between 60 degrees F to 65 degrees F." Under Recommendation V.d., direction was given that, "The air-exchange rate in the perioperative area should be carefully controlled." Under Recommendation V.d.1. The minimum rate of total air exchanges per hour should be maintained at a constant level as follows...Operating room: minimum of 15 air exchanges per hour with a recommended range of 20 to 25 air exchanges...Postanesthesia care unit: Six air exchanges per hour...Sterile storage area: four air exchanges per hour. Under Recommendation V.e. Air-flow patterns within the perioperative setting should be controlled and uninterrupted."

2. During an observation and a concurrent interview in OR 1 on 12/13/11 at 12 p.m., the device on the wall indicated the temperature was 68 degrees F and the humidity was 78 percent (%). The SCUC confirmed the humidity in OR 1 was 78%.

On 12/13/11 at 2:20 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated July 2011 through December 2011 with the SCUC and a concurrent interview was performed. The documented humidity levels in OR 1 were ranging from 72% to 92% while the documented humidity levels in OR 2 were ranging from 64% to 88%. When asked the normal humidity level in the OR, the SCUC stated she did not know the normal range of humidity level in OR; it should not below 50%. The SCUC further indicated that it would be "OK" if the humidity was 78% to 80%.

On 12/13/11 at 2:25 p.m., review of the document titled "Name of Hospital: Surgical Suite Humidity Record & (and) Crash Cart & Warmer Temperature Check Sheet" dated December 2011 with the ICP P and a concurrent interview was conducted. The aforesaid document indicated "Notify engineering when needed." When asked to explain "when needed" per protocol, the ICP P stated he did not know the meaning of "when needed" and the document should have addressed the criteria of notifying the engineering. The ICP P further stated he did not know the normal humidity range in the OR, and the engineering should know.

During an interview with the ICP P on 12/15/11 at 2:40 p.m., the ICP P stated the hospital used AORN, CDC, and APIC guidelines as references for infection control practice. The ICP P also stated that the humidity monitors in OR 1 and OR 2 did not function, and the hospital did not have a system to monitor the humidity and temperature in order to meet the infection control standard. The ICP P confirmed that there was no specific policy and procedure concerning the temperature and humidity

Based on observation, interviews, and record review, the hospital failed to delivery pharmaceutical services to meet the needs of the patients when medications were not controlled and distributed in accordance with standards of practice, federal and state laws as evidenced by:

1. Failure to develop policies and procedures to ensure the safe use of fentanyl transdermal patches. Patient 81, 82 and 83 were prescribed and administered fentanyl transdermal patches not in accordance with Boxed warning issued by the FDA and the manufacturer's prescribing information. In addition, pharmacy staff and nursing staff failed to demonstrate competency in safe use of fentanyl patches

2. Failure to ensure that pre-printed medication orders approved by the pharmacy and therapeutics committee were developed to ensure patient safety. Medication orders for acetaminophen and acetaminophen containing products exceeding the maximum daily dose of acetaminophen were available for ordering on preprinted order forms.

3. Failure to ensure the safe and effective distribution of controlled substances. Controlled substances were stored in nursing station as floor stock and could be administered to patient prior to pharmacist review of order.

4. Failure to ensure that medication orders were reviewed for appropriateness by a pharmacist before the first dose was dispensed. Medication orders written when the pharmacy was closed were not reviewed prior to the first dose being administered and medications ordered on Saturday might take up 16 hours before review by a pharmacist for appropriateness.

5. Failure to ensure that emergency drug supply was sealed by pharmacist in such a manner that a seal must be broken to gain access to the drugs.

Findings:

1a. A review of Patient 81's clinical record with the hospital director of pharmacy (DOP) showed that the patient was admitted to the hospital on 11/12/11 for abdominal pain. Patient 81's medication list indicated that the patient was not on any narcotic (opioid) pain medication prior to admission. Patient 81 was ordered and administered Fentanyl Transdermal Patch 25 mcg/hr (micrograms per hour, delivery rate) on 11/18/11. Patient 81's usage of narcotic (opioid) medications for pain control was as follow:

On 11/12/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/13/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/14/11, Patient 81 was administered a total daily dose of morphine 6 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of morphine 2 mg by intravenous route

On 11/15/11, Patient 81 was administered a total daily dose of Vicodin (Hydrocodone/Acetaminophen 5/500 mg) one tablet by mouth

On 11/16/11, Patient 81 was administered a total daily dose of morphine 8 mg by intravenous route

On 11/17/11, Patient 81 was not administered any narcotic pain medication until 6:00 p.m. when Fentanyl patch 25 mcg/hr was ordered and administered.

Based on the opioid usage prior to the administration of the fentanyl patch, Patient 81 was prescribed and administered fentanyl transdermal patch not in accordance with the manufacturer's prescribing information to minimize potentially fatal side effects of the medication. Patient 81 had been on low dose of opioid analgesics for 6 days (11/12/11 to 11/17/11) prior to the initiation of fentanyl patch on 11/18/11. Patient 63 was not opioid tolerant based on the manufacturer's prescribing guidelines prior to the administration of the fentanyl patch on 11/18/11.

1b. A review of Patient 82's clinical record with the DOP showed that the patient was admitted to the hospital on 10/12/11 for shortness of breath and epigastric (upper/mid abdominal region) pain. Patient 82's medication list showed that the patient was on Vicodin 1 to 2 tablets 3 times daily as needed prior to admission with no indication of usage history. Patient 82 was ordered and administered Fentanyl Transdermal Patch 12 mcg/hr on 10/12/11. Patient 82's fentanyl patch dose was increased to 37mcg/hr on 10/14/11 and to 50 mcg/hr on 10/16/11. A review of Patient 82's medication administration record (MAR) showed that no additional pain medications was administered for pain control from 10/12/11 to 10/16/11 to justify the frequency increase in fentanyl dosage.

Lexi-Comp, a national drug information provider to health care professional, indicated that dosage of fentanyl transdermal patch should not be titrated more frequently than every 3 days after the initial dose or every 6 days thereafter. Patients should wear a consistent fentanyl dosage through two applications (6 days) before dosage increase based on supplemental opiate dosages can be estimated.

1c. A review of Patient 83's clinical record with the DOP showed that the patient was admitted to the hospital on 11/6/11. Patient 83's medication reconciliation form indicated that the patient was not on any narcotic medications prior to admission. Fentanyl patch 25 mcg/ hr was ordered by the physician on 11/8/11. Patient 83's medication administration record (MAR) showed that the patient did not receive any narcotic medication on 11/6/11 and 11/7/11 prior to the initiation of fentanyl patch.

There was no documented record indicating that Patient 83 was opioid tolerant in accordance with the manufacturer ' s guidelines prior to the initiation of the fentanyl patch.

According to the manufacturer's prescribing information, a boxed warning (Black Box Warning) was issued on fentanyl patches which indicated that (1) fentanyl patch is indicated for management of persistent, moderate to severe chronic pain. (2) fentanyl patch should ONLY be used in patients who are receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to fentanyl transdermal system 25 mcg/hr. Patient who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid. (3) Fentanyl transdermal system is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

During an interview at approximately 1:30 p.m. on 12/15/11, Registered Nurse 61 was unable to state the boxed warning of fentanyl transdermal patch.

During an interview at approximately 2:07 p.m. on 12/15/11, Pharmacist 1 stated that patients who had been on short acting opioid (dose and duration not specified) were candidate for fentanyl patch. When being asked by the surveyor how to handle a situation of a patient who had been receiving opioid for 3 days prior to physician ' s order for fentanyl patch 25 mcg/hr, Pharmacist 1 responded that she would contact the prescribing physician and if the prescribing physician considered the patient to be opoid tolerant, she would dispense the medication as ordered.

2. During an interview at approximately 4:00 p.m. on 12/14/11, the hospital Director of Pharmacy (DOP) stated that general and physician specific preprinted orders were used in the hospital and such forms were approved by the hospital Pharmacy and Therapeutics Committee for use in the hospital.

A sampled review of the preprinted medication order forms used in the hospital showed that 3 preprinted order forms contained medication orders which were unsafe for patient administration as follow:

Same Day Surgery GYN post-operative order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 3 hours as needed for moderate pain and Acetaminophen/Codeine 325/30 mg 2 tablets every 3 hours as needed for mild pain. Both orders, when used at maximum allowable dose, would exceed the daily maximum dose of acetaminophen of 4000 mg

Post-operative inpatient GYN order form contained the order for Hydrocodone/Acetaminophen 5/500 mg 2 tablets every 4 hours as needed for pain. The order, when used at maximum allowable dose, would exceed the