HospitalInspections.org

Based on observation, patient and staff interviews, clinical and administrative document review the hospital failed to ensure policy and procedures were followed for "Pain Management when one of one sampled patients (Patient 1) experienced pain of 8-10 (pain is measured on a scale of 0-10 with 0 being no pain and 10 being the most severe pain) on consecutive assessments, without considering additional resources to address the pain.

This failure resulted in Patient 1 unnecessarily experiencing inadequately controlled pain for a nine day period.

Findings:

Patient 1 was a 33 year old female admitted 3/30/16 with a diagnosis of sickle cell crisis. (Sickle cell anemia is an inherited form of anemia - a condition in which there aren't enough healthy red blood cells to carry adequate oxygen throughout the body. Normally, red blood cells are flexible and round, moving easily through blood vessels. In sickle cell anemia, the red blood cells become rigid and sticky and are shaped like sickles or crescent moons. These irregularly shaped cells can get stuck in small blood vessels, which can slow or block blood flow and oxygen to parts of the body. Periodic episodes of pain, called crises, are a major symptom of sickle cell anemia when sickle-shaped red blood cells block blood flow through tiny blood vessels) Patient 1 was admitted with severe pain to both knees.

On 4/7/16 at 9:30 a.m., during an observation and interview, Patient 1 was observed to be grimacing and groaning and had sweat breaking out on her forehead. Patient 1 stated she had not had adequate pain relief since her admission on 3/30/16.

On 4/7/16 at 10 a.m., during an interview, the Nurse Manager for the Acute Rehab floor stated, "Oh yeah, we could have called pain management. I wonder why we didn't."

On 4/11/16 at 11:30 a.m., during a phone interview, Patient 1's doctor (MD3) stated, "Patient said she was getting relief and getting better. I increased the medication about every 2 days. That would indicate pain relief was inadequate. I did not call a pain management specialist because I thought we could handle it."

A review of Patient 1's clinical record indicated that her care plan included pain as a problem. The intervention of "Report pain as Relieved or Controlled" was not met twice during her initial week of therapy. There was no intervention for contacting pain management on the care plan. Patient 1 reported a pain level between 8 and 10. After being medicated, Patient 1 reported her pain level as a 5. Patient 1 had listed her FPG, (Functional Pain Goal- This is the level of pain patient says is an acceptable level) as a 2.

The hospital policy and procedure entitled, "Pain Management" dated 2/16, indicated, "If (patient goes more than) 24 hours without meeting FPG, consider additional resources such as Pain Management or Palliative Care consult as additional Pain Management resources."

Based on staff interview, clinical record and administrative document review, the hospital failed to ensure the accountability for disposition of controlled drugs when 2 of 3 patients reviewed had missing documentations which were not investigated and resolved in a timely manner. There were no documented records for disposition of the remaining fentanyl drip (a powerful opiate used to treat pain that is infused into patient through the vein) that had not been administered to Patient 14 and Patient 15.
These failures had the potential to result in diversion of controlled drugs.

Findings:
Review of the hospital's Policy and Procedure (P&P) titled, "Controlled Medications" dated 5/14, read in part, "...Disposition and documentation of controlled medications must be accounted for by the pharmacy and patient care areas ...The nurse will document drug administration and wastage on the controlled substance administration record and return completed document to pharmacy. The pharmacist will reconcile all documented controlled substance administration records ..."

On 4/4/16 at 1:15 p.m., during an observation in the pharmacy department, several controlled substance administration records (CSAR) for fentanyl drip were identified. Three patients' CSARs review were initiated in the presence of the Pharmacy Supervisor, Pharmacy Manager 1, RN 14 and RN 15 on 4/4/16 at 1:50 p.m. The initial review of the CSARs showed fentanyl drip bags sent to the patients were not fully accounted for in 2 of the 3 patients.

On 4/6/16 at 1:35 p.m., Patient 14 and Patient 15's fentanyl drip CSARs and related medical record were reviewed in the presence of the Clinical Nurse Specialist, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director Pharmacy/Lab services.

Patient 14's fentanyl drip 10 mcg/ml (micrograms per milliliter) 100 ml was initiated on 4/2/16 at 4:50 p.m. and the second fentanyl drip bag was started on 4/3/16 at 3:42 a.m. The electronic medication administration record (eMAR) showed 77.5 ml was administered from bag #1, however there was no documentation of disposition of the remaining solution not administered as required by the hospital's P&P. The hospital was unable to account for remaining fentanyl solution.

Patient 15's fentanyl/ropivacaine drip (2 mcg/ml/1%) 250 ml (for the production of local or regional anesthesia for surgery and for acute pain management) was initiated on 3/31/16 at 2:15 p.m. Fentanyl/ropivacaine drip bag #2 was started on 4/1/16 at 9:21 a.m. and bag #3 was started on 4/2/16 at 2:35 a.m. The eMAR showed 205.5 ml was administered from bag #2; however there was no documentation of disposition for the remaining solution not administered. The hospital was also unable to account for this contrary to their P&P.

During the concurrent staff interview, the Clinical Nurse Specialist, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director Pharmacy/Lab services acknowledged the missing documentations. The Director Pharmacy/Lab services stated she had been aware of the missing documentations and had been working with the nursing services and information technology department to make it possible to document controlled drug drips wastage on the electronic medication administration record.

Based on observation, staff interview, and document review, the hospital failed to ensure emergency medications list posted on the outside of the pediatric emergency crash carts and the malignant hyperthermia (MH-Malignant Hyperthermia is a life-threatening inherited disorder that is triggered by exposure to the volatile anesthetics [used for general anesthesia] and succinylcholine [used as neuromuscular blocking agent] cart matched medications which were inside the carts. (The MH cart is used for storing medications and medical supplies needed during an MH emergency.) The emergency crash cart is used for storing medications and medical supplies needed during a medical emergency.


These failures had the potential to result in emergency medication not available in a timely manner, leading to delayed treatment in an emergency.

Findings:

a. Review of the hospital's Policy and Procedure titled "Code Blue, Code White, and Rapid Response Team (Adult and Pediatric) Response and Equipment Management" dated 2/16; read in part, "...Pharmacy will maintain the medication drawer and the IV (intravenous) solution box for correct medications and expirations. Pharmacy will maintain the lists of Crash Cart Medications and IV solutions, and a list included with each medication tray ..."

On 4/5/16 at 3:05 p.m., the emergency department (ED) was toured in the presence of the ED Nurse Manager, Pharmacy Supervisor, Pharmacy Manager 1, the Director Pharmacy/Lab services and the Director Clinical Partnerships. An inspection of the pediatric crash cart showed the medication list posted outside the crash cart did not match the medications which had been stored inside the crash cart. One vial of lidocaine 1% 10 mg/ml (milligrams per milliliter) 20 ml (milliliters) was listed outside the cart and there was none inside the crash cart. The ED Nurse Manager, the Pharmacy Supervisor, Pharmacy Manager 1, the Director Pharmacy/Lab services and the Director Clinical Partnership acknowledged the missing lidocaine vial.

On 4/6/16 at 8:30 a.m., during an observation in the pediatric unit, inspection of the pediatric crash cart showed the medication list posted outside the crash cart did not match the medications which had been stored inside the crash cart. One vial of lidocaine 1%10 mg/ml 20 ml was listed outside the cart but was not found inside the crash cart. The Pharmacy Supervisor, Pharmacy Manager 1, and the Director of Pharmacy/Lab services acknowledged lidocaine 1% vial was not inside the crash cart. The Director of Pharmacy/Lab services stated the updated pediatric medication list did not include lidocaine 1% vial, however the hospital was unable to provide documented evidence the updated pediatric emergency medication list had been approved by the hospital's Pharmacy and Therapeutic committee.

b. On 4/5/16 at 1:45 p.m., during an observation of the operating room (OR) suites, the malignant hyperthermia (MH) cart was identified in the presence of the OR Supervisor, the Pharmacy Supervisor and Pharmacy Manager 1. The inspection of the MH cart showed the medication list which had been posted outside the MH cart did not match the medications which had been stored inside the cart. Four syringes of sodium bicarbonate 44.6 mEq ( Milliequivalent-one thousandth of a chemical compound which is an expression of the chemical combining power) /50 ml were listed outside the MH cart; however four syringes of sodium bicarbonate 50 mEq/50 ml were found inside the MH cart. The Pharmacy Supervisor and Pharmacy Manager 1 acknowledged the medication list outside the MH cart did not match the medications inside the MH cart.

Based on observation, staff interview, and document review, the hospital failed to ensure the pharmacy staff implemented safe medication use. The pharmacy staff failed to properly label compounded sterile products with a beyond use date in accordance with accepted professional standards.

A beyond use date (BUD) as defined by the USP <797> as the date or time after which a compounded sterile product shall not be administered, stored or transported.

This failure had the potential to expose patients to compounded sterile products which may no longer provide the intended benefit.

Findings:

Review of the hospital's policy and procedure titled, "Sterile Product Preparation" dated 12/15, read in part, "Each compounded sterile drug product must bear an appropriate expiration date. The date assigned must be based on currently available drug stability information and the risk level of contamination based on complexity of manufacture ...Low risk compounding, (adding no more than 3 items to a bag) may carry at a maximum an expiration of 48 hours at room temperature, 14 days refrigerated or 45 days in a frozen state ...Sterile products must be labeled with ...date prepared and expiration dating ..."

On 4/6/16 at 9:05 a.m., during an observation on the pediatric intensive care unit, one liter of dextrose 5 % normal saline with 20 mEq potassium acetate (hydration, for potassium replacement) and two syringes of levetiracetam 300 mg/60 ml (for seizure control) were observed in Patient 10's cassette without any expiration date or beyond use date noted on the containers.

During the concurrent staff interview, the Pharmacy Supervisor, Pharmacy Manager 1, and the Director of Pharmacy/Lab services acknowledged the above compounded sterile products (CSP) were not labeled with the BUDs. When asked about the hospital's policy and procedure (P&P) regarding above, the Pharmacy Supervisor checked the P&P and stated the above CSPs involved low risk compounding, and should be used within 48 hours of compounding when stored at room temperature.

32305



Based on observation, staff interview, and document review, the hospital failed to ensure expired drugs were not available for patient use. This failure had the potential to result in patients receiving outdated drugs in an emergency situation which may not provide the intended benefit.

Findings:

a. Review of the hospital's policy and procedure (P&P) titled, "Drug Inspections" dated 1/16, showed "...Medication(s) must be replaced two months prior to expiration with the exception of short dated medications ..."

Review of the hospital's P&P titled, "Storage of Medications" dated 1/13, read in part, "... Medications shall not be kept in stock after the expiration date on the label and no contaminated or deteriorated medications shall be available for use ..."

Review of the hospital's P&P titled, "Unit Dose Packaging - Repackaging Oral Solids and Liquids" dated 1/16, showed "...The Pharmacist will verify if a bulk container was opened, and contents remain inside, that the technician has labeled it with one year expiration date ..."

On 4/4/16 at 1 p.m., an observation in the pharmacy department was initiated in the presence of the Pharmacy Supervisor, Pharmacy Manager 1 and the Director Pharmacy/Lab services. An inspection of the flammable cabinet showed several pharmaceutical/chemicals which included four bottles of collodion flexible USP 100ml (used as a topical protectant) with expiration date of 7/09, and a partial bottle of glacial acetic acid 500 ml (when diluted used as bladder and wound irrigations) that was not dated with expiration date contrary to hospital's P&P. During the concurrent staff interview, the Pharmacy Supervisor, Pharmacy Manager 1 and the Director Pharmacy/Lab services were unable to verify when the glacial acetic acid bottle was opened and they acknowledged the expired collodion flexible bottles. The Director Pharmacy/Lab services stated the hospital had not used the above pharmaceuticals in a long time.


b. Review of the hospital's P&P titled, "Malignant Hyperthermia" dated 4/16, read in part "...Pharmacy is responsible for checking outdates on a monthly basis ..."

On 4/5/16 at 1:20 p.m., during an observation on the operating room (OR) suites, the malignant hyperthermia (MH) cart was identified in the presence of the OR Supervisor, the Pharmacy Supervisor and Pharmacy Manager 1. An inspection of the MH cart showed five vials of furosemide 20 mg injection with expiration date of 4/1/16. The OR Supervisor, the Pharmacy Supervisor and Pharmacy Manager 1 acknowledged the furosemide vials had expired and should not be used.

c. On 4/6/16 at 8:30 a.m., during an observation and inspection in the pediatric unit, a filter needle in the mannitol kit which had an expiration of 2/16 was identified in the pediatric crash cart. During the concurrent staff interview, the Pediatric Pharmacist acknowledged the filter needle had expired and should not be used. Pharmacy Manager 1 also acknowledged the filter needle had expired and stated the staff that checked the cart for outdates was probably not aware that needles now have expiration dates.

d. On 4/6/16 at 10:18 a.m., during an observation and concurrent staff interview in the medication room of Definitive Observation Unit (DOU), four bottles of betadine solution 8 fluid ounces were identified with the expiration date of 6/15. The Pharmacy Supervisor, Pharmacy Manager 1 and the DOU Manager acknowledged expired betadine solution bottles should not be in the patient care area.

e. On 4/6/16 at 11 a.m., during an observation and staff interview on the 4 West medical/surgical unit's medication room, 52 applicators of ChloraPrep Sepp (Chlorhexidine and isopropyl alcohol, used for preoperative and pre-injection skin preparation) were identified with the expiration date of 1/16. The 4 West Nurse Manager, Pharmacy Manager 1 and the Director Pharmacy/Lab services acknowledged the expired ChloraPrep applicators.

32306

Based on observation, staff interview and administrative document review, the facility failed to ensure staff followed hospital policy and procedures for maintaining infection control standards when:
1. Employees from different parts of the hospital were seen with the cuffs of their pants dragging on the ground.
2. Operating room personnel, including physicians and nurses, had their arms uncovered while in the operating room.
3. A surgeon did not have all of his hair covered while performing surgery.
4. An anesthesiologist ( a medical doctor responsible for putting patients to sleep during surgery) did not follow safe injection practices while providing anesthesia.
5. Four of five employees observed on a patient care floor failed to perform proper hand hygiene.
6. Circulating Nurse (responsible for keeping records, getting needed supplies and preparing patients for surgery) failed to follow infection control standards during an operation.
7. Intravenous (IV) solutions were primed up to 24 hours prior to use.
8. A multi-dose bottle of megestrol (used to treat loss of appetite, weight loss, advanced breast cancer and endometrial cancer) was taken inside Patient 11 ' s contact isolation room and then returned to the medication room after administration without being disinfected.
9. During a simulation of intravenous (IV) medication preparation, Nurse 11 did not disinfect the rubber stopper on the medication vial and the solution vial prior to use.

These failures had the potential to expose patients to avoidable infections.


Findings:

1. On 4/4/16 at 1:30 p.m., during an observation and concurrent interview in the Endoscopy Suite (Area where procedures are done involving inserting flexible scopes into either the throat or rectum for diagnostic purposes.) three employees, including the Director of Imaging, Cardiac, Gastro Intestinal, and Acute Rehab, (DICGAR) had the cuffs of their pants dragging on the floor. When cuffs were pointed out, the DICGAR stated, "Yeah, they (cuffs) start up where they should be then always slip down."

On 4/5/16 at 8:50 a.m., during an observation and concurrent interview in the Emergency department, three employees including the Emergency Department Manager (EDM) were observed with the cuffs of their pants dragging on the floor. When this was pointed out the EDM concurred and stated she would talk to the employees about it.

On 4/5/16 at 1:00 p.m., during an observation in the Surgical Department, four employees were seen with the cuffs of their pants dragging on the floor. The Director of Surgical Services (DSS) concurred and stated she would speak to the employees about it.

The Association of Operating Room Nurses (AORN) "Guidelines for Perioperative Practice" indicated, "Scrub attire that contacts the floor could become a vehicle for transferring microorganisms (germs) from the floor to perioperative patients or surfaces."

2. On 4/5/16 at 1:00 p.m., and on 4/6/16 at 7:30 a.m., during an observation and concurrent interview in the Surgical Department, 11 operating room personnel, including physicians and nurses, were observed to have their arms uncovered while in various operating rooms while surgeries were in progress. When this was pointed out, the DSS concurred and distributed jackets to all personnel whose arms were uncovered.

On 4/6/16 at 12:00 p.m., during an observation and concurrent interview in the Surgical Department, three operating room personnel were observed with their arms uncovered while in the operating room while surgery was in progress. The DSS concurred and opened the operating room door and instructed the personnel they must wear their jackets.

The AORN "Guidelines for Perioperative Practice" indicated, "When in the restricted areas, all nonscrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket."

3. On 4/5/16 at 3:00 p.m., during an observation in operating room 9, the surgeon (MD1) was observed performing surgery. Two inches of his sideburns were exposed, not covered by his hat or his mask.

On 4/5/16 at 4:15 p.m., during an interview, the DSS stated that all hair of all personnel should be covered while in the semi restricted and restricted areas of the Surgery Department.

The AORN "Guidelines for Perioperative Practice" indicated, "Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair."

4. On 4/5/16 at 3:00 p.m., during an observation in operating room 9, the anesthesiologist (MD2) removed the plastic cap from four vials of medication and accessed the bottles with a needle and syringe without wiping the rubber stopper with alcohol first. MD2 also accessed the bag of intravenous fluid with a needle and syringe without wiping off the rubber stopper. He then used that fluid to reconstitute a vial of antibiotics.

On 4/5/16 at 4:15 p.m., during an interview, the DSS stated that MD2 had not followed acceptable standards and she would be talking to him.

On 4/11/16 at 3:15 p.m., during a telephone interview, MD2 acknowledged that he had not followed the correct procedure for accessing the medication vials. MD2 stated, "I didn't know that was a thing."

The Centers for Disease Control and Prevention (CDC) guidelines entitled, "Medication Preparation - Safe Practices for Medical Injections" dated 3/2/11, indicated, "Parenteral (intravenous or intramuscular) medications should be accessed in an aseptic (germ free) manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum (stopper) should be disinfected with alcohol prior to piercing it."

5. On 4/6/16 at 8:30 a.m., during an observation and concurrent interview on the Orthopedic (bones) and Neuro (brain and spine) floor, Registered Nurse 1 (RN1) was observed entering a patient's room without performing hand hygiene. RN1 exited patient's room shortly after and again did not perform hand hygiene. When this was pointed out, RN1 admitted she should have performed hand hygiene when entering and exiting the patient's room.

On 4/6/16 at 8:45 a.m., during an observation and concurrent interview on the Orthopedic and Neuro floor, RN2 was observed exiting a patient's room without performing hand hygiene. When this was pointed out, RN2 admitted she should have performed hand hygiene when she exited the patient's room.

On 4/6/16 at 9:15 a.m., during an observation and concurrent interview on the Orthopedic and Neuro floor, Patient Care Assistant 1 (PCA1) was observed entering a patient's room without performing hand hygiene. PCA1 received a signal from other staff to perform hand hygiene when she exited the room. PCA1 admitted that she had not performed hand hygiene when she entered the room as she should have.

On 4/6/16 at 9:30 a.m., during an observation and concurrent interview on the Orthopedic and Neuro floor, RN3 was observed donning exam gloves without performing hand hygiene. When this was pointed out, RN3 admitted that she should have performed hand hygiene before donning gloves.

The hospital's policy entitled "Hand Hygiene" dated 11/2015 indicated, "Hands must be washed with soap and water or decontaminated using alcohol based sanitizers: A. Before and after using gloves. B. Before and after all contact with patients (including intact skin)."

6. On 4/6/16 at 10:35 a.m., during an observation in Operating Room 12 (OR12), the circulating nurse (RN4) was observed donning gloves without first performing hand hygiene.

On 4/6/16 at 10:40 a.m., during an observation in OR12, RN4 was observed removing her gloves without performing hand hygiene.

On 4/6/16 at 10:45 a.m., during an observation in OR12, RN4 was observed donning gloves without first performing hand hygiene.

On 4/6/16 at 10:47 a.m., during an observation in OR12, RN4 was observed removing her gloves without performing hand hygiene.

On 4/6/16 at 10:49 a.m., during an observation in OR12, RN4 was observed donning gloves without first performing hand hygiene.

On 4/6/16 at 10:50 a.m., during an observation in OR12, RN4 was observed removing her gloves without performing hand hygiene.

On 4/6/16 at 10:52 a.m., during an observation in OR12, RN4 was observed touching the patient's bare skin with her bare hands, without performing hand hygiene before or after direct contact with patient.

On 4/6/16 at 10:54 a.m., during an observation in OR12, RN4 was observed donning gloves without first performing hand hygiene.

On 4/6/16 at 11 a.m., during an observation in OR12, RN4 was observed removing her gloves without performing hand hygiene.

On 4/6/16 at 11:05 a.m., during an observation in OR12, RN4 was observed picking up something from the floor. RN4 then opened a sterile pack without performing hand hygiene.

On 4/6/16 at 11:20 a.m., during an observation in OR12, RN4 was observed picking up something from the floor. After discarding the object, RN4 did not perform hand hygiene.

On 4/6/16 at 12:15 p.m., during an interview, the DSS and the Infection Control Specialist agreed that RN4 had not followed infection control guidelines while working the case in OR12.

The hospital's policy entitled "Hand Hygiene" dated 11/2015 indicated, "Hands must be washed with soap and water or decontaminated using alcohol based sanitizers: A. Before and after using gloves. B. Before and after all contact with patients (including intact skin)."

The AORN "Guidelines for Perioperative Practice" indicated, "Floors in the OR or procedure room are considered contaminated. Items placed on the floor could become vehicles for transferring microorganisms (germs) from the floor to other perioperative or external surfaces."

7. On 4/5/16 at 2 p.m., during an observation on the operating room (OR) suites, several IV solutions with attached IV tubing hanging on an IV pole were identified in the anesthesia room in the presence of the OR Supervisor, the Pharmacy Supervisor and Pharmacy Manager 1. Further inspection showed each IV solution had been labeled with the date and time 4/6/16 at 8 a.m. During the concurrent interview, the OR Supervisor stated the Anesthesia Technician set up the IV solutions. The Anesthesia Technician stated he primed the IV solutions in the mornings for possible arterial line use and labeled with an expiration time of 24 hours. He also stated he had been performing same IV set up at his previous job, and had not been cited for this practice by The Joint Commission. He did not produce any evidence to support this.

During the staff interview on 4/6/16 at 12:20 p.m. in the conference room, the infection Control Manager stated it was not acceptable to prime IV solution for up to 24 hours prior to use. IV solutions should be primed just before use.

8. On 4/5/16 at 8:40 a.m., Nurse (RN) 11 was observed during the medication administration process. RN 11 took Patient 11 ' s medications including the multi-dose bottle of megestrol suspension into the patient ' s contact isolation room while wearing personal protective garment and gloves. The nurse administered the pills to Patient 11, picked up the megestrol bottle poured the dose for patient to take and place the bottle back on the counter in the patient ' s room. After RN 11 removed her protective garment and gloves, and washed her hands, she returned the megestrol bottle to Patient 11 ' s medication cassette in the medication room. The megestrol suspension bottle was not disinfected prior to returning to the medication room.

During the concurrent staff interview, RN 11 stated she should not have taken the multi-dose megestrol bottle into Patient 11 ' s contact isolation room. RN 11 stated she usually poured the megestrol suspension dose in the medication room and had taken the exact dose inside the isolation room. She was unable to provide the reason for the change in process during this observation.

During the staff interview on 4/6/16 at 12:20 p.m. in the conference room, the infection Control Manager stated multi-dose medication should not be taken into an isolation room. The hospital's policy and procedure did not address administration of medication process in an isolation room.

9. On 4/6/16 at 9:25 a.m., during an observation and concurrent staff interview on the medical unit, RN 12 was asked to prepare promethazine injection in a patient's medication cassette for administration. Promethazine injection label from pharmacy stated to dilute prior to administration. RN 12 removed the caps of promethazine injection vial and the normal saline vial, and diluted promethazine dose with the solution without disinfecting the rubber stoppers of the vials. RN 12 acknowledged not disinfecting the rubber stoppers on the vials.

During the staff interview on 4/6/16 at 12:20 p.m. in the conference room, the infection Control Manager stated the vial stoppers should be disinfected prior to entry.