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Based on record review and staff interview, the facility failed to ensure that orders were implemented as written, when patients (Patient 60 and Patient 61) receiving pain medications were not monitored for the effectiveness or for the side effects of medications as ordered by the prescriber or as required by the facility's guidelines.
Such failure has the potential to put patients at increased risk of suffering in pain or developing side effects that could lead to breathing stop, coma, or death.

Findings:

1. On 4/24/18, at 3:30 p.m., the record for Patient 60 was concurrently reviewed with a facility pharmacist 4 (PharmD 4). Patient 60 was 17 year old who was prescribed morphine for pain to be administered as injections on demand by the patient through a computerized pump called the Patient-Controlled Analgesia (PCA). The PCA pump contains the prescribed pain medication and is connected directly to a patient's IV (intravenous-) line. The morphine PCA order for Patient 60, dated, 4/21/18 at 1628, was for 1 mg/ml (milligram in each milliliters) concentration to be administered as continuous infusion of 0.5 mg every hour. In addition, the order included intermittent doses of 2 mg every 10 minutes as needed, but not to exceed 4.5 mg per hour.
The order contained specific instructions to monitor for respiratory rate, sleepiness, oxygen saturation and to notify the physician if any of the monitored values for Patient 60 fell below the certain parameters specified in the order.
The facility's Guidelines titled, Guidelines for the PCA ... Flowsheet, revised on 1/2018 included the following:

PCA Assess

1. Record the "Number of Doses Given" every hour.
2. Record the "Number of Attempts" every hour.
3. Record the "Total Hourly Dose (mg)" every hour.
4. Record the "Hourly Volume Infused (mL)" every hour.
5. At the end of every shift double-check and record the "reservoir Volume (mL)
6. Document "Handoff" of PCA with volume given (infused) and volume remaining with RN (Registered Nurse) cosign in the MAR (Medication Administration Record).
7. Document any PCA side effects (i.e, observation) and notify MD as ordered.

Vitals

1. Assess and record "Heart Rate" and "Respiratory Rate" every hour.
2. Document "PCA Pain Assessment too" used to assess pain every shift and with changes.
3. Assess and record patient pain level (score) every hour.

The electronic record for Patient 60 was concurrently reviewed with PharmD 4. The record review showed that documentation of the required parameters ordered by the prescriber or required by the facility's guidelines were not consistently done or documented .

The flowsheet from 4/21/18 at 1842 (start PCA) until 4/23/18 at 0500 when the first cassette (container) was infused, should have included 34 hourly documentation, excluding any hand off and end of shift documentation. Data were not documented for 10 of the 34 hours; more than 29 % of the time data were not capture or documented. Partially documented/missed data were not included in the calculation of the 29%, which mean this was a very low estimate of the missing data. The missing information were either for the PCA assess, or the PCA vitals or both; that could mean that Patient 60 was not monitored or assessed 29 % of the time. The findings were validated by PharmD 4 and Registered Nurse 16 (RN 16).
There was not clinical justification or documented rational for the missing documentation.



2. On 4/25/18, at 3:55 p.m., the record for Patient 61 was concurrently reviewed with Pharmacist 4 (PharmD 4). Patient 61 was 16 year old and was prescribed hydromorphone for pain. This medication is very potent pain medication- stronger than morphine.

Hydromorphone is considered a high-risk medication and has a boxed warning, which is the most serious warning required by the Food and Drug Administration to be placed in the product labeling for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for hydromorphone included that the medication had the highest potential for abuse and risk of producing respiratory depression. Other central nervous system depressants (medications of the same class or have the similar effects) can potentiate the respiratory-depressant effects of hydromorphone and increase the risk of adverse outcomes, including death.

The hydromorphone PCA order for Patient 61, dated, 4/12/18, was for a concentration of 0.2 mg/mL ( milligrams per milliliters) and ordered to be administered by the patient when needed at 0.13 mg does every 10 minutes, but not to exceed 0.66 milligrams per hour. The order contained specific instructions to monitor for respiratory rate, sleepiness, oxygen saturation and end tidal CO2 ( the amount of CO2- carbon dioxide- in the expired breath) to notify the physician if any of these values fell below certain parameters for Patient 61.

The facility's Guidelines titles, Guidelines for the PCA ... Flowsheet, revised on 1/2018 included the following:

PCA Assess

1. Record the "Number of Doses Given" every hour.
2. Record the "Number of Attempts" every hour.
3. .Record the "Total Hourly Dose (mg)" every hour.
4. Record the "Hourly Volume Infused (mL)" every hour.
5. At the end of every shift double-check and record the "reservoir Volume (mL)
6. Document "Handoff" of PCA with volume given (infused) and volume remaining with RN (Registered Nurse) cosign in the MAR (Medication Administration Record).
7. Document any PCA side effects (i.e, observation) and notify MD as ordered.

Vitals

1. Assess and record "Heart Rate" and "Respiratory Rate" every hour.
2. Document "PCA Pain Assessment too" used to assess pain every shift and with changes.
3. Assess and record patient pain level (score) every hour.

Continued review of Patient 61 electronic medical record, on 4/25/18, with Pharmacist 4 (PharmD 4) showed the following:
The first dose of hydromorphone was documented to have started on 4/12/18 at 1800.
The monitoring and monitoring data were not documented consistently. The documentation of the required parameters ordered by the prescriber or required by the facility's guidelines were not consistently documented. From 4/12/18 at 1800 until 4/15/18 at 1220, twelve times out of 66 potential hourly documentation, excluding any hand off and end of shift documentation, were missing. The absence of 12 out of 66 (19.7%) the monitoring data could mean only that: lack or documentation; or, it could also mean that the patient was not assessed about 20 % of the time.

Incomplete documentation could lead to incomplete and inaccurate pain assessment in response to the medication used or administered. Evaluation the number of time a patient tried to administer the medication is very helpful indication of control, lack of pain control, or potentially the presence of side effect. Monitoring for efficacy and side effects is tailoring therapy so that the patient does not remain in pain or become overmedicated and put patient at risk of respiratory depression, coma, or death.

Based on observation, staff interview, and document review, the facility failed to ensure safe use of medications by:

1. The facility did not have cleanable, disinfect-able surfaces in the medication preparation area of the IV room (area used to compound sterile medications for injections into blood vessels).

2. Not establishing written policy and procedures to ensure staff knew the correct process for evaluation of medication drawer tamper evident seals. Seven of ten interviewed staff (Nurse Manager 2, Nurse Educator 1, Registered Nurse 13, Registered Nurse 9, Registered Nurse 7, Registered Nurse 15, and Radiology Nurse Manager) were unable to verbalize the correct process for evaluation of tamper evident seals on the medication drawer of the Emergency Cart.

These failures had the potential for causing patient harm by providing potentially contaminated IV medications. In addition, the staff inability to recognize unauthorized access to the medication drawer had the potential to result in medication diversion or medication tampering, and delay of patient care.

Definitions:

Tamper evident seal: An adhesive label providing physical evidence of access to secured areas, such as a medication drawer.

Emergency Cart: a wheeled cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during medical emergencies.

Findings:

1. United States Pharmacopoeia (USP), Chapter 797 "Pharmaceutical Compounding - Sterile Preparations" sets the standards for sterile compounding, states under Appendix I the following: " ...That Are Required ( + "shall") ...
The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the buffer area shall be smooth, impervious, free from cracks and crevices, and nonshedding, thereby promoting cleanability, and minimizing spaces in which microorganisms and other contaminants may accumulate.

The buffer area shall not contain sources of water (sinks) or floor drains. Work surfaces shall be constructed of smooth, impervious materials, such as stainless steel or molded plastic, so that they are easily cleaned and disinfected.

During an observation, on 4/23/18 at 2 p.m., during inspection of the pharmacy, the IV room, had laminate wooden cabinets and drawers. these shelving had narrow areas (sides) that were unfinished, porous surfaces, and contained holes. In a concurrent interview, the Director of Pharmacy (DPH) said the surfaces are wipe-able and cleanable. When the unfinished sides were pointed out, DPH added that there were plans for a new pharmacy to ensure compliant with current standards.


2. Review of the hospital policy, "Emergency Response: Code Blue and Med Stat (Rapid Response)," revised 3/2018 indicated, "Verify the integrity of the top medication tray seal. If a seal is broken, report it to the pharmacy ...."
The policy did not specify what type of seal was used or how to determine if a seal is broken or intact.

During an observation 4/23/18 at 11:40 a.m., with the Director of Pharmacy (DPH) and the Nurse Manager for the Radiology area (RadNM), there was an unlocked emergency cart in the Diagnostic Imaging unit. The medication drawer was secured with a tamper evident seal, which did not provide the security of a lock, to prevent unauthorized access. The seal edges covered both the tray cover, and body of the tray.

During a concurrent interview, DPH said if the seal had been removed from the medication tray (at the body of the tray), the color of the seal would change. The changed area on the sticker below the barcode, attached to the body of the tray measured only 1/16th of an inch and was difficult to visualize. DPH pulled the seal off the cover of the medication tray, and demonstrated how the color of the tape changed to show a red and white pattern, instead of solid red. When DPH completely removed the tape, the tape showed the word "void," written in white letters across a red background. RadNM said that he had not known the seal changed color to indicate tampering.

During an observation at Campus B, an offsite, inpatient care unit, on 4/24/18 at 10:10 a.m., the emergency cart was inspected with DPH, Interim Nurse Manager (RN 7), and Registered Nurse (RN 15). RN 15 said a nurse inspected the cart every shift to ensure the medications are intact and available for use in emergencies. RN 15 said she would know if there had been medication tampering if the tamper evident seal was cracked; RN 15 did not make any comments about change in seal color or the word "void."


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During an observation in the Pediatric Intensive Care Unit (PICU) on 4/23/18 at 11:40 a.m., the emergency cart contained a drawer of medications for emergency use. The medication drawer had a red adhesive patch labeled "tamper evident seal" across the edges of both the tray lid, and the tray body. A review of the Emergency Cart Checklist reflected the day shift nurse Registered Nurse 13 (RN 13) had checked the cart that day, and had written the number of the tamper evident seal on the checklist as an indication the seal was present and secure. Nurse Manager 2 (NM 2) and Nurse Educator 1 (NE 1) witnessed opening of the medication tray lid from the tray body; the tamper evident seal remained intact, but detached from the tray body. During a concurrent interview, NM 2 and NE 1 said the tamper evident seal should have ripped to indicate opening of the medication tray.

During an observation in PICU on 4/23/18 at 11:45 a.m., Pharmacist 5 (PharmD 5) replaced the opened medication tray in the emergency cart, with a new red tamper evident seal. In a concurrent interview, PharmD 5 said when the seal adhesive detached from the tray cover or body, the seal changed color to indicate opening of the tray lid: the seal changed from red, to mottled red and white. PharmD 5 said the mottling was difficult to see on the small bottom portion of the seal (connected to the body of the tray), but was clearly visible on the larger upper portion (connected to the cover) of the label. Observation of the seal's detached bottom portion revealed a color change to a mottled red and white, 1/16 of an inch in width.

During an interview on 4/23/18 at 11:55 a.m., RN 13 confirmed he had checked the emergency cart today. RN 13 said the tamper evident seal would be torn or ripped after opening of the medication drawer.

During an interview 4/25/18 at 9:20 a.m., in the Neonatal Intensive Care Unit (NICU), RN 9 said she had checked the emergency cart that morning. RN 9 said she did not know the red tamper evident seal on the medication drawer changed color if peeled off the tray; she thought a torn seal indicated opening of the tray.

Review of the hospital policy, Medication Security, revised 5/2017, indicated, "Medication storage is designed to assist in maintaining medication integrity, promote the availability of medication when needed, minimize the risk of medication diversion ...Crash cart (Emergency Cart) drugs will be stored in coded-entry locked carts with the medication tray secured with seals ...to determine if the package has been opened ..."

Based on observation, interview, and record review, the hospital failed to ensure medications were only accessible to authorized personnel when emergency carts containing medications were not locked. These failures had the potential to result in medication tampering or diversion, with resultant harm or injury to patients from misuse or unavailability of needed medications in an emergent situation.

Definitions:

Emergency Cart: a wheeled cart stocked with emergency medical equipment, supplies, and drugs for use by medical personnel during medical emergencies.

Findings:

Review of hospital policy and procedure, Medication Security, revised 5/17, reflected, "All drugs and biologicals, including medications for crash cart use, will be stored in lockable containers or areas."


16276

During an observation 4/23/18 at 11:40 a.m., with the Director of Pharmacy (DPH), the Diagnostic Imaging area's emergency medication cart was in a hallway behind a short wall. The cart was unlocked. The top drawer contained a medication tray. The tray cover only had an adhesive label across the clear cover and body of the tray, which did not provide the security of a lock to prevent unauthorized medication access in an unlocked cart.

On 4/23/18 at 4:30 p.m., accompanied with the Director of Pharmacy (DPH) the medication storage in the surgery area was inspected. The emergency medication cart was found to be unlocked. The observation was confirmed by Director of the Perioperative Services (DPS) was and the DPH.

On 4/23/18 at 4:30 p.m., accompanied with the Director of Pharmacy (DPH) and the Director of the Perioperative Services (DPS), medication storage in Operating Room 3 (OR 3) was inspected. The anesthesia cart in OR 3 was unlocked.

The facility's policy titled, "Medication Management" revised on 5/17 was reviewed. The purpose of the policy was stated as "Medication storage is designated to assist in maintaining medication integrity, promote the availability of medication when needed, minimize the risk of medication diversion ..."
The policy also included "All drugs and biologicals stored in this hospital shall be kept in a staffed secure area, or locked when appropriate and accessible only to authorized staff."

The fancily's policy is permissive. A staffed area does not ensure secure medications. In a staffed area there are staffs that are not authorized to access medications. Additionally, in a staffed area, staffs have to come and go to do their jobs. Staffed area does not mean the presence of a designated person ensuring security of medications. Furthermore, patients, family members, and unauthorized staffs are allowed into these secure areas. Leaving the carts unlocked in "secure area" allows some patients, family members, and unauthorized staff access these medications.


31693

During a tour of the fourth floor medical surgical unit, on 4/23/18 at 10:30 a.m., the surveyor found an unlocked emergency cart in the hallway. The surveyor opened the unsecured medication drawer of the cart; all medications were accessible. In an interview at 10:35 a.m., Registered Nurse 14 (RN 14) said she had not ensured the cart re-locked, after she opened it for the required shift check of the medication drawer tamper evident seal. (A tamper evident seal is an adhesive label providing physical evidence of access to secured areas, such as a medication drawer.)

Review of the facility policy and procedure, Emergency Response: code Blue and Med Stat (Rapid Response), Emergency Cart Checks and Maintenance, revised 4/2018, indicated, "To maintain the integrity of the Emergency Cart contents, the cart will be locked when not in use ...Once all supplies and equipment are replaced, the cart itself must be locked."

Based on observation, interview and document review, the facility failed to ensure availability of usable equipment for handling medical emergencies when expired monitors and laboratory test tubes were available for use. This failure put patients at risk of death when expired equipment or reagents are used to evaluate and monitor patients in medical emergencies.

Findings

On 4/23/18 at 11:40 a.m., during inspection of Diagnostic Imaging medication storage, accompanied with the Director of Pharmacy (DPH), the emergency medication cart was observed in the hallway behind a short wall. The cart contents were inspected in the presence of the DPH and the Nurse Manager for the Radiology area (RadNM). In the cart, the following items were found to be expired.

1. Five sets of colored caps test tubes, two each, were expired. All ten tubes had 10-2017 for the expiration date. These test tubes are used to check blood gases in emergency situation among other uses.

2. Two adult CO2 (Carbon dioxide- gas) detectors. Both had the expiration date of Sept. 2016. There was a hand written note taped to the detector: "on order 11/4."

3. Two pediatric (for children) CO2 detectors. Both were expired on 8/2016. These also had a hand written note taped to them reading "on order 11/4."

The CO2 detectors are used to measure exhaled CO2 to help confirm tube placement into the lungs.

Review of the facility policy and procedure, Emergency Response: code Blue and Med Stat (Rapid Response), Emergency Cart Checks and Maintenance, revised 4/2018, indicated "responsible staff member will check all contents for expiration dates monthly and rotate stock as needed."

Based on observation, interview and document review, the facility failed to maintain a system for controlling sources of infections in accordance with internal policies and procedures, nationally recognized infection control practices and guidelines, and regulations, when:

1. Hand hygiene was not performed according to facility policy.
2. Employees in restricted areas did not follow facility policy or nationally recognized infection control standards for surgical attire.
3. Secondary containers of disinfectants were not labeled according to EPA requirements.
4. The operating room was not cleaned and disinfected prior to the set-up for the next case in the room.
5. Peel packages used for the sterilization of small instruments were not utilized according to manufacturer's instructions for use.
6. Terminal cleaning was not performed in required areas of perioperative services.
7. There was no certification performed to determine air exchanges in airborne isolation rooms.
8. A sharps container (A puncture-resistant and leak-proof container with a one-way top used to dispose of sharps (i.e. needles, scalpel blades, blood collection tubes.) was past the fill line. This had the potential to result in spillage of contaminated products, contamination of the environment, and spread of contamination.

These failures had the potential to result in contamination, infection, and the spread of contamination and infection.


Findings:

1. On 3/24/18 at 10:00 a.m., in Operating Room 1, during a procedure, the surgical nurse (RN 11) was observed to have removed her gloves and reapply gloves on three separate occasions without performing hand hygiene (washing hands or cleansing with alcohol based hand gel) in between.

According the facility policy entitled "Hand Hygiene Guidelines" dated July 2016, "Healthcare workers should wash hands or use a hand sanitizer before putting gloves on and after taking gloves off."

2. On 3/24/18 between 10:00 a.m. and 10:30 a.m., during the observation of Operating Room 1 (a restricted area) RN 12 was observed to have the sleeves of her scrub jacket rolled up exposing the forearms during a surgical procedure. Anesthesia Technician 1 (ATech 1) was observed in Operating Room 1 cleaning the anesthesia equipment at the end of the case wearing scrubs with short sleeves.
The facility policy entitled "Attire, Surgical" dated January 2017, indicated, "All personnel will adhere to the established dress code within the semi-restricted and restricted areas of the surgical and invasive procedure areas. All non-scrubbed persons must wear a hospital laundered, clean cloth or disposable jacket over scrub tops."

3. On 3/24/18 at 10:30 a.m., outside Operating Room 1, Environmental Services worker 1 (EVS 1) was asked what solution was in the mop bucket and the container of moistened cleaning cloths that were being used for the turnover cleaning and disinfection of the room. She stated that the solution was Virex II 256 (an EPA registered disinfectant). The Infection Control Preventionist (ICP) confirmed there were no visible labels on either container.

According to the EPA (Environmental Protection Agency), secondary containers of disinfectants (pesticides) should have labels include the following information: Product name, EPA registration number, name and percentage of active ingredient. Diluted product labeling should also include the wording, "Follow the directions for use on the pesticide label when applying this product. The product in this container is diluted as directed on the pesticide product label."

4. On 3/24/18 at 10:45 a.m., outside of Operating Room 1, RN 12 and ATech 1 were preparing the room for a surgery case. The turnover cleaning had been completed. A table against the far wall of the room was observed to have contaminated items on it from the previous case. RN 12 removed the items.

According the facility policy entitled "Environmental Cleaning of the Operating Room" dated August 2017, "post case cleaning [includes] operating room equipment and furniture that are visibly soiled are cleaned with a hospital approved detergent/disinfectant agent and water. Place disposable items contaminated with blood or tissue in in a leak-proof container or bag."

During an interview with ICP on 3/24/18 at 9:00 a.m., she stated that the facility adopted the Association for Peri-Operative Nurses Guidelines for Perioperative Practice for the facility's infection control program.

According to the Association for Peri-Operative Nurses Guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning, "Items that are used during a surgical or invasive procedure should be cleaned and disinfected, including tables and Mayo stands. Reestablishing a clean environment after the patient leaves the area decreases the risk of cross-contamination and disease transmission."

5. On 3/24/18 at 11:00 a.m., during a tour of the Sterile Processing department, three instrument peel pouches (envelope containers made of paper and lightweight plastic, designed for packaging small, lightweight surgical instruments for sterilization) were examined. All peel pouches were double wrapped, and labeled with Cardinal as the manufacturer. Central Processing Manager (CPS-M) confirmed Peel Pouch 1 had an inner pouch improperly folded inside the outer pouch, and Peel Pouch 2 had less than a one-inch margin between the instrument and the outer margin of the pouch.

According to directions for use for Cardinal Health (Trademark) Sterilization Pouches and Tubing, "The pouch should only be filled 3/4 of the packing volume to allow proper air evacuation and sterilant penetration. Carefully press the excess air out of the pouch and ensure there is at least one (1) inch of area available around all four (4) sides of the enclosed items ... the pouch sizes should be selected so the inner pouch can be placed inside the outer pouch without folding."

6. On 3/24/18 at 11:15 a.m., during a tour of the Decontamination department, CPS-M said environmental services cleaned the department each day, on the evening shift.

During an interview on 3/24/18 at 3:00 p.m., with Manager of Environmental Services (EVSM), he stated that terminal cleaning is not performed in the Decontamination department on a daily basis.

During an interview with ICP on 3/24/18 at 9:00 a.m., she stated that the facility adopted the Association for Peri-Operative Nurses Guidelines for Perioperative Practice for the facility's infection control program.

According to AORN Guidelines for Perioperative Practice (2018), Guideline for Environmental Cleaning, "Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used."

7. Review of the hospital air exchange (Air exchange is a measurement of how frequently fresh air replaces all the air within a space.) documentation on 3/24/18, showed air exchange testing on 2/14/17, for the operating rooms. The documentation did not include procedure rooms, endoscopic processing rooms, or isolation rooms.

According the facility policy entitled "Tuberculosis Management Plan" dated September 2016, "the engineering department will perform the following tests and inspections [on isolation rooms]: Air balance and air exchange rates annually."

During an interview with ICP on 3/24/18 at 9:00 a.m., she stated that the facility adopted the Association for Peri-Operative Nurses Guidelines for Perioperative Practice for the facility's infection control program.

According to the Association for Peri-Operative Nurses Guidelines for Perioperative Practice (2018), Guideline for a Safe Environment of Care, Part 2, "The ACH [air changes per hour] in a restricted area should be maintained at 20 total changes per hour, with a minimum of four air changes of outdoor air per hour or at the rate that was applicable at the time of design or of the most recent renovation of the HVAC system. The ACH in a semi-restricted area are related to the function performed in that area: sterile storage-4 total and 2 outdoor air changes; decontamination room-6 total and 2 outdoor air changes. The ACH in an unrestricted area are related to the function performed in that area: post anesthesia care unit-6 total and 2 outdoor air changes; procedure room-15 total and 3 outdoor air changes; endoscopy procedure room-6 total and 2 outdoor air changes."


31693

8. On 4/23/18 at 10:45 a.m., during tour of the fourth floor treatment room, the only sharps container (a plastic container for disposal of sharp items such as needles) had waste material above the container's fill line mark.

The facility, "Medical Waste Management Plan," revised 12/2016, reflected when waste material in a sharps container reached the fill line, Environmental Services staff were to remove the filled container from use, and prevent spillage or protrusion of contents.