HospitalInspections.org

Based on review and interview, the facility failed to provide data, quality indicators that measured any success, or track performance to ensure that improvements are sustained.

Review of the Quality Assessment Performance Improvement (QAPI) revealed the facility had PI projects for the following:

7/5/19
The ED in tracking arrival and departure of the patient.

Accuracy of diet provided to patient and to track TAT for dietician consult.

Annual completion of N95 fit test by respiratory services.

Hire a Quality Director.

7/1/19
Add time frames to patient care plans.

Provide education for time frames.

Revise care plans as treatment plan changes.

Audit adequate completion of care plans.

5/1/19
Perform EOC infection control audits.

EVS Training.

6/1/19
HIPPA Compliance.

Monitoring expired drugs.

Audit crash carts for expired medications.

Implementation of automatic dispensing system.

Staff #42 failed to provide any data or monitoring for the PI projects in place.

Based on review of records, interviews, and observation, the facility failed to:

A) adequately monitor 3 out of 3 hospital drug storage areas (main pharmacy, Emergency Department medication room, Medical Surgical medication room) at the Texas Emergency Hospital location for appropriate temperature and humidity,

B) develop an alternate process for monitoring temperature and humidity when the primary program for monitoring was unavailable (e.g., computer system unavailable, monitoring equipment failure),

C) develop an action plan in the event that drugs were stored out of range (unacceptable excursion).

Findings:

On the afternoon of 7-16-2019, a tour of the Medical Surgical floor at Texas Emergency Hospital was made with Staff #23. Upon entering, the locked medication room across from the nursing station felt very warm and humid. Staff #23 was asked about the process for monitoring the temperature and humidity. Staff #23 stated, there was an electronic monitor in place that reported temperature and humidity to the pharmacy staff. Staff #23 stated that nursing staff did not monitor temperature and humidity of the room.

The monitoring equipment showed that the temperature at the time of the tour was 71.1 degrees Fahrenheit and 74% humidity.

The pharmacist, Staff #26, arrived to the medication room during the tour. Staff #26 was asked about temperature and humidity monitoring. Staff #26 stated that the temperature and humidity was monitored electronically through a contract. Temperature logs and alerts to temperature and humidity excursions (out of range) were provided electronically.

Staff #26 stated that he had been receiving email alerts from the contracted company up until "a few weeks ago," but the subscription had run out. Staff #26 stated that once the subscription had been paid, services would be restored. Staff #26 was asked what the predetermined ranges of storage were and if the current room temperature and humidity were within the Unites States Pharmacopeia (USP - national standard and guidelines followed by pharmacies) guidelines for storage of medications. Staff #26 was not able to provide the predetermined ranges that the hospital had established and was monitoring for. Staff #26 was unable to access the computer program on the hospital computer or through his smart-phone to obtain the requested information or access current temperature logs. Staff #26 stated, he had some copies of printed reports and provided records for temperature and humidity monitoring up to the afternoon of 7-13-2019. No records of medication storage temperature ranges were available for 7-14 2019 to the time of the findings on the afternoon of 7-16-2019. Staff #26 confirmed that no other process for monitoring temperature or humidity was in use while the contracted services could not be accessed.


Review of USP 36, General Information, <1079> Good Storage and Distribution Practices for Drug Products included the following information:

"Introduction
This general information chapter describes good storage and distribution practices to ensure that drug products (medicines) reach the end user (practitioners and patient/consumers) with quality intact.
...

Storage Management System

Storage Locations and Processes

It is important that each entity define their appropriate storage locations to ensure that adequate controls are in place. These locations include buildings and facilities for drug product storage (e.g., warehouses, storage or hold area, the original manufacturer's warehouses, contractor warehouses, wholesale distribution warehouses, mail order or retail pharmacy storage area, hospital or nursing home pharmacy storage areas; and border Customs storage areas).

Drug product storage areas are required to maintain the product temperature between the limits as defined on the product label. Buildings and facilities used for the warehousing, storage, and/or holding of drug products should be of adequate size for their intended use.
...

Environmental monitoring devices should be calibrated for their range of operation. The monitoring devices used should provide an alert mechanism if the preset ranges are breached. The following practices and controls are examples of appropriate measures that should be put in place to ensure environmental control (see also Monitoring Devices-Time, Temperature, and Humidity <1118>):

Temperature-monitoring equipment, a monitoring device, a temperature data logger, or other such device that is suitable for its intended purpose should be used.

An appropriate number of temperature monitors or some other form of recordation or proof of temperature control. Temperature monitor(s) should be used with every distribution process unless another process has put in place to ensure specified temperature ranges.

Electronic temperature monitors should be calibrated to National Institute of Standards and Technology (NIST) or other suitable standard.

Chemical temperature indicators may be used as appropriate.

Predetermined temperature ranges should be set for all applicable areas, as well as a plan of action in the event of an unacceptable excursion."

Based on observation and interview, the facility failed to ensure that controlled medications stored in one of two medications storage areas observed (2nd floor Medical Surgical at Texas Emergency Hospital location) were locked and/or secured inside of the locked medication room.

On the afternoon of 7-16-2019, a tour of the Medical Surgical floor at Texas Emergency Hospital was made with Staff #23. Upon entering the locked medication room, it was observed that there was a metal storage box marked as an Intubation Box sitting on top of the wall-mounted narcotic lock-box. The Intubation Box had a key in the lock for the box. The box was opened and found to contain the following controlled substances:

Etomidate 20 milligram vial (3 vials total)

Fentanyl 100 microgram vial (3 vials total) Schedule II drug

Ketamine 500 milligram vial (3 vials total) Schedule III drug

Propofol 1% 10 milligram vial (3 vials total) Schedule IV drug


The inventory directed staff that Lorazepam 2 mg vial (3 each vials) Schedule IV drug was kept in the medication refrigerator. When the medication refrigerator was checked, a clear, small plastic box that was locked was observed. The box contained 3 vials of Lorazepam. The box could be easily removed from the refrigerator. Even though the box was locked, it was small enough to be concealed. This allowed the potential for an unauthorized individual to remove it from the medication room without other staff seeing it removed. The plastic box could then be broken and drugs accessed.

The pharmacist, Staff #26, arrived to the medication room during the tour. The Staff #26 stated, he was not aware that staff were leaving the key in the Intubation Box. Staff #26 stated, he did not believe the plastic box in the refrigerator with the 3 vials of Lorazepam was a problem since there were cameras in the medication room. Staff #26 stated that if anyone took the plastic box from the refrigerator or drugs from the intubation box, they could be identified later by review of the camera recordings after the drug diversion had been discovered. Staff #26 failed to recognize that this did not prevent the diversion of scheduled drugs and was only effective if the camera system was working at the time and the recording was retrievable.

Based on interview, the facility failed to ensure a written procedure was in place for the tracking of On Staff and Patients during an emergency event when staff and patients are relocated in 5 (CEH, TEH, Porter HOPD, Woodlands HOPD, and Deerbrook HOPD) of 5 locations.

This deficient practice had the likelihood to cause harm to all patients and staff.

Findings:

An interview was conducted on 07/17/2019 with Staff #1 after 9:00 AM. Staff #1 was asked if the documentation provided to this surveyor was the entire EPP and if she had any additional documentation to provide for review. Staff #1 replied, "That is all that I have. This is our EPP." No further documentation was presented for review.


Staff #1 confirmed the findings.

Based on interview and document review, the facility failed to ensure the Emergency Plan Training Program was complete for all new hires and annually for all existing employees at 5 (CEH, THE, Porter HOPD, Deerbrook HOPD, and Woodlands HOPD) of 5 locations.

This deficient practice had the likelihood to cause harm to all patients and staff.

Findings:

A review of the documentation presented titled, "EMERGENCY HOSPITAL SYSTEM, LLC DISASTER PLAN AND DISASTER PREPAREDNESS" revealed employee sign in sheets for annual and new hire training at 5 (CEH, THE, Porter HOPD, Deerbrook HOPD, and Woodlands HOPD) of 5 locations.

A review of the documentation titled, "Emergency Hospital Systems, Inc, Disaster Plan and Disaster Preparedness Training" provided by Staff #1 revealed a list of all current employees at Emergency Hospital Systems, Inc. Further review of the document revealed only 99 of the 297 employees had been trained on the EPP at 5 (CEH, THE, Porter HOPD, Deerbrook HOPD, and Woodlands HOPD) of 5 locations.


Staff #1 confirmed the findings.