HospitalInspections.org

Cross refer to:

C0224
C0225

Based on a tour of the facility and interviews with staff, the facility failed to provide a preventive maintenance program to ensure that drugs and biologicals were appropriately stored.

Findings were:

Facility pharmacy policy titled "Pharmacy Purpose" states, in part:
"The pharmacy will serve to provide for professional and administrative functions of the pharmaceutical service, as required to insure petient safety in medication through proper storage and distribution of medications.
1. The pharmacy will include a program for the control and accountability of drug products throughout the hospital.
...
5. The pharmacy will provide a unit dose medication delivery system."

Facility pharmacy policy titled "Definition of Terms" states, in part:
"14. Practice of Pharmacy:
...
e. Responsibility for:
...
iii. Proper and safe storage of drugs and devices.
iv. Maintenance of proper records for drugs and devices."

Facility pharmacy policy titled "Outdated Drugs" states, in part:
"1. It is the responsibility of the pharmacy to make sure that all medication used in the hospital are in date and acceptable quality.
2. The pharmacy will remove all medications which will expire by the end of or before end of the current month. Out of Date check(sic) swill(sic) be made near the end of the preceding month so that out dated drugs will not be available for use.
3. Medications that have been pulled for expiration will be stored in a secure area away from othe pharmaceutical plainly marked "Out of Date" so they will not be used."

Facility pharmacy policy titled "Storeroom and Inventory Management" states, in part:
"Inventory will be constantly monitored by the pharmacy personnel so as to be sure that the pharmacy is neither over or understocked."

Facility pharmacy policy titled "Unit Dose System" states, in part:
"Whenever possible, all medications will be provided by the pharmacy in unit dose or 'unit of use' containers."

Facility job description for "Pharmacy Technician" states, in part:
"Essential Duties and Responsibilities
A. Fill physician orders
1. Prepares pharmnaceuticals for dispensing.
...
C. Performs stock control and issuing duties under the supervision of a Pharmacist.
2. Assists in stock control and issues supplies to other departments.
D. Inventories and keeps the required stock lebvels of pharmaceuticals.
E. Performs inventories all over the hospital to ensure that medications are properly stored and maintained.
1. Monitors MAR, Narcotic cart, and pharmacy sign out sheets to make sure that every medication given in the hospital is the correct medication, and that all rules or regulations or stated or federal law are met."

Facility job description for "Pharmacy Consultant" states, in part:
"Essential Duties and Responsibilities
A. Determines items to be stocked and assumes the required stock levels of pharmaceuticals.
1. Determines the amount of pharmaceuticals to be ordered for the hospital.
...
5. Establishes and operates the stocking and storing methods of the pharmacy.
B. Manages the pharmacy system of the hospital
...
5. Monitors all areas of the hospital where drugs are stored or dispensed.
...
D. Manage department functions and supevises department personnel.
1. Initiates department policies, procedures, and practices consistence(sic) with hospital policies and Medicare requirements and to assure the proper use and control of every medication used in the hospital.
2. Establishes management control procedures to create efficient and effective control, issue, and sales of pharmaceuticals.
3. Supervises pharmacy technician in prepackaging, delivering, dispensing, and stocking of pharmaceuticals and supplies."

During a tour of the pharmacy on 4-14-16, survey staff were told by staff members #4 and #15 that, during daytime hours, the nurse administering medications had key access to the pharmacy and would enter the pharmacy as needed to obtain medications for all inpatients. The pharmacy contained a video surveillance camera mounted in a high corner of the room. Medications were stored on shelves in their stock supply bottles. Staff #4 and #15 stated that the nurse administering medications would enter the pharmacy (unaccompanied by another nurse), obtain the necessary medications from the stock supply bottles (placing the medications in a plastic cup) and then take the medications to the patients' rooms and administer them. When asked how the administered medications were tracked, staff #15 stated that they were documented on a clipboard on the outside of the pharmacy door. When asked if the medications obtained (as shown on the camera footage) were then compared to the medications recorded on the clipboard, staff #15 stated that they were not. When asked if the medications in the pharmacy were ever inventoried to make sure the amounts present were the proper amounts, staff #15 stated that they were not.

During the same tour of the pharmacy on 4-14-16, a quantity of 12 prescription pads (in the name of a physician who had not been on staff with the hospital in 1 year) were located in an unlocked pharmacy cabinet. Also located were 14 vials of furosemide 20mg injectable solution, which had expired 6-1-15 but were still in an area available for patient use.

The above was verified in an interview with the Chief Executive Officer and the Nursing Director on the afternoon of 4-14-16.

Based on a tour of the facility and staff interview, the facility failed to ensure the premises were maintained, clean and orderly.

Findings were:

During a tour of the hospital on the morning of 4/14/16 with the Chief Executive Officer and Director of Nursing, the following items were noted which compromised the hospital's sanitary environment:

a. Substantial chipped laminate on furniture in patient rooms throughout the facility. Chipped and broken laminate exposes permeable wood underneath which cannot be thoroughly cleaned and poses an infection control problem.
b. The bathtub in the shared bathroom of rooms 103 and 105 contained what appeared to be dirt clumps. The room was described by the CEO as cleaned and ready for patient use.
c. Patient night stands throughout the facility were stained and contained debris and dust.
d. In the laboratory, a desk had large areas of missing laminate.
e. In the lab patient area where patient blood draws were performed, furniture items included areas of broken laminate.

These findings were confirmed during the tour with the CEO and Director of Nursing on 4/14/16.

Cross refer to:

C0271
C0276

Based on a review of documentation, a tour of the facility and staff interviews, the facility failed to ensure that:

A. Staff was competent in cardio-pulmonary resuscitation (CPR) in accordance with state regulatory requirements as delineated in 25 TAC133.41(c)(3)(E) and consistent with facility policies as there was no documented evidence of registered nurses having ACLS training as required by the facility. In addition, the hospital allowed online CPR training. Online training does not include hands-on skills practice and in-person assessment and demonstration of skills. This presented a risk that staff may not be competent to respond in a medical emergency.

B. Fire drills were conducted in accordance with regulatory requirements for hospitals in the State of Texas as delineated in 25 TAC §133.141(g). In addition, the facility could provide no evidence of a policy regarding fire drills. This presented a risk that staff may not be competent to respond appropriate in an actual fire emergency.

C. Patient instruments were sterilized in accordance with regulatory requirements for sterile processing for hospitals in the State of Texas as delineated in 25 TAC §133.41(v). The facility had no written policies related to the sterile processing of instruments, and was not following state requirements. This placed patients at risk for infection due to improper or inadequate sterilization practices.

Findings were:

A. A review of facility job descriptions for the positions of Licensed Vocational Nurse and Registered Nurse revealed the following requirements:
1. Licensed Vocational Nurse
"D. Experience:...2. Technical Training: Current CPR certification..."
2. RN/Head Nurse/Charge Nurse
"C. Licensure, Registry or Certification: BCLS Certification and ACLS preferred...
D. Experience:...2. Technical Training: Current CPR certification..."

In an interview with the Director of Nurses on the afternoon of 4/13/16 in the facility meeting room, she stated current CPR certification was required of all nursing positions. In addition, she stated RNs were also required to be certified in ACLS, though the RN job description only stated that ACLS was preferred. She said, "I was trying to wait for one day when we could all take it at once, but that's been hard to schedule." She also stated that the facility employed only three RNs and that each provided care in the emergency department.

Review of staff personnel files revealed 1 of 3 LVNs providing direct patient care [Staff #7] had no current certificate of completion for CPR. Staff #2 and #5, 2 of 3 RNs providing direct patient care, could provide no documented evidence of acceptable current certification in CPR, ACLS or PALS. The personnel file of Staff #2 did include a CPR certificate from an online training facility, the American Academy of CPR & First Aid, Inc., with expiration date of 9/9/16. However, there was no evidence of her having been provided with hands-on practice and skills or competency evaluation.

Review of the Health & Safety Institute and the National Safety Council website found at http://news.hsi.com/onlineonlycpr revealed that, "No major nationally recognized training program in the United States endorses certification without practice and evaluation of hands-on skills. According to the Occupational Safety and Health Administration (OSHA) online training alone does not meet OSHA first aid and CPR training requirements." Further guidance can be found at https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=28541.

In an interview with the facility chief executive officer and director of nursing on the afternoon of 4/13/16 in the facility meeting, the CEO stated she had wondered whether online CPR certification met current requirements. The Director of Nursing identified the American Academy of CPR & First Aid, Inc. as an online CPR program. In addition, they confirmed that several nurses were not currently certified in cardiopulmonary resuscitation.

B. Fire drill documentation for 2015 and 2016 was reviewed. Though the facility was performing one fire drill per shift per quarter, drill documentation included no information that staff had demonstrated the use of fire-fighting equipment or that simulation of evacuation of patients and other occupants was performed as required according to 25 TAC §133.141(g).

The above findings were confirmed in an interview with the Chief Executive Officer and the Director of Nursing on the afternoon of 4/14/16 in the facility meeting room.

C. A review of the personnel record for staff member #4, the individual identified as responsible for sterile processing for the facility, revealed this employee had not completed any specialized training for the sterile processing of instruments.

In an interview with Staff #4 during a tour of the facility on the morning of 4/14/16, she stated she had never received any training in sterile processing. She said, "The woman who was doing this before me was the only one who knew how to do it. She just told us one Friday afternoon that she wouldn't be back. So I've been doing it since then. That was about a year ago ...We only do [process] about one load per month." When asked for facility policies related to sterile processing, she stated, "We don't really have any. There is only a small entry related to it in the policy about environmental culturing."

A review of hospital policy entitled Environmental Culturing, no effective date, included only the following related to the sterilization of instruments:
"4. Monthly spore-strips of autoclaves will be done."

The Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, states in part, "Chemical indicators are affixed on the outside of each pack to show that the package has been processed through a sterilization cycle, but these indicators do not prove sterilization has been achieved. Preferably, a chemical indicator also should be placed on the inside of each pack to verify sterilant penetration. Chemical indicators usually are either heat-or chemical-sensitive inks that change color when one or more sterilization parameters (e.g., steam-time, temperature, and/or saturated steam; ETO-time, temperature, relative humidity and/or ETO concentration) are present. Chemical indicators have been grouped into five classes based on their ability to monitor one or multiple sterilization parameters ...If the internal and/or external indicator suggests inadequate processing, the item should not be used ... An air-removal test (Bowie-Dick Test) must be performed daily in an empty dynamic-air-removal sterilizer (e.g., prevacuum steam sterilizer) to ensure air removal ..."

In an interview with Staff #4 during a tour of the hospital on the morning of 4/14/16 she was asked if chemical indicators were used to ensure proper sterilization of instruments was achieved. She said, "No. I'm not sure what those are." When asked for facility policies related to the use of chemical indicators during sterile processing, she stated, "We don't really have any policies about sterile processing."

Also during the hospital tour on the morning of 4/14/16, Staff #4 was asked if there was record of the mechanical indicators, including pressure, temperature, and time, for each sterilizer load. She stated the sterilizer had no print-out as "There's no tape in the machine" and that there were no documented performance records which included mechanical indicators for sterilizer loads.

The Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, from the Centers for Disease Control and Prevention, available at http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html includes the following:
"Like other sterilization systems, the steam cycle is monitored by mechanical, chemical, and biological monitors. Steam sterilizers usually are monitored using a printout (or graphically) by measuring temperature, the time at the temperature, and pressure. Typically, chemical indicators are affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature ... Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics...These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators ... "

Additionally, during the hospital tour with the CEO and Staff #4 on the morning of 4/14/16, Staff #4 identified a Midmark M9/M9D, M11/M11D Self-Contained Steam Sterilizer as the one used by the facility for the sterilization of patient care instruments.

The manual for the Midmark sterilizer included weekly and monthly maintenance tasks to be completed, as well as several tasks that were non-scheduled and to be completed as needed. In an interview with Staff #4 during the tour, she stated she believed she was completing these tasks. However, when asked for maintenance logs or records documenting that the tasks were completed, the facility could provide no such documentation. When asked if the sterilizer ever received scheduled maintenance by a qualified professional, she stated, "No."

All the above findings were confirmed a final time in an exit interview with the Chief Executive Officer and Director of Nursing on the afternoon of 4/14/16.

Based on a tour of the facility and interviews with staff, the facility failed to provide and enforce rules for the storage, handling, dispensation and administration of drugs and biologicals.

Findings were:

Facility pharmacy policy titled "Pharmacy Purpose" states, in part:
"The pharmacy will serve to provide for professional and administrative functions of the pharmaceutical service, as required to insure petient safety in medication through proper storage and distribution of medications.
1. The pharmacy will include a program for the control and accountability of drug products throughout the hospital.
...
5. The pharmacy will provide a unit dose medication delivery system."

Facility pharmacy policy titled "Definition of Terms" states, in part:
"14. Practice of Pharmacy:
...
e. Responsibility for:
...
iii. Proper and safe storage of drugs and devices.
iv. Maintenance of proper records for drugs and devices."

Facility pharmacy policy titled "Outdated Drugs" states, in part:
"1. It is the responsibility of the pharmacy to make sure that all medication used in the hospital are in date and acceptable quality.
2. The pharmacy will remove all medications which will expire by the end of or before end of the current month. Out of Date check(sic) swill(sic) be made near the end of the preceding month so that out dated drugs will not be available for use.
3. Medications that have been pulled for expiration will be stored in a secure area away from othe pharmaceutical plainly marked "Out of Date" so they will not be used."

Facility pharmacy policy titled "Storeroom and Inventory Management" states, in part:
"Inventory will be constantly monitored by the pharmacy personnel so as to be sure that the pharmacy is neither over or understocked."

Facility pharmacy policy titled "Unit Dose System" states, in part:
"Whenever possible, all medications will be provided by the pharmacy in unit dose or 'unit of use' containers."

Facility job description for "Pharmacy Technician" states, in part:
"Essential Duties and Responsibilities
A. Fill physician orders
1. Prepares pharmnaceuticals for dispensing.
...
C. Performs stock control and issuing duties under the supervision of a Pharmacist.
2. Assists in stock control and issues supplies to other departments.
D. Inventories and keeps the required stock lebvels of pharmaceuticals.
E. Performs inventories all over the hospital to ensure that medications are properly stored and maintained.
1. Monitors MAR, Narcotic cart, and pharmacy sign out sheets to make sure that every medication given in the hospital is the correct medication, and that all rules or regulations or stated or federal law are met."

Facility job description for "Pharmacy Consultant" states, in part:
"Essential Duties and Responsibilities
A. Determines items to be stocked and assumes the required stock levels of pharmaceuticals.
1. Determines the amount of pharmaceuticals to be ordered for the hospital.
...
5. Establishes and operates the stocking and storing methods of the pharmacy.
B. Manages the pharmacy system of the hospital
...
5. Monitors all areas of the hospital where drugs are stored or dispensed.
...
D. Manage department functions and supevises department personnel.
1. Initiates department policies, procedures, and practices consistence(sic) with hospital policies and Medicare requirements and to assure the proper use and control of every medication used in the hospital.
2. Establishes management control procedures to create efficient and effective control, issue, and sales of pharmaceuticals.
3. Supervises pharmacy technician in prepackaging, delivering, dispensing, and stocking of pharmaceuticals and supplies."

During a tour of the pharmacy on 4-14-16, survey staff were told by staff members #4 and #15 that, during daytime hours, the nurse administering medications had key access to the pharmacy and would enter the pharmacy as needed to obtain medications for all inpatients. The pharmacy contained a video surveillance camera mounted in a high corner of the room. Medications were stored on shelves in their stock supply bottles. Staff #4 and #15 stated that the nurse administering medications would enter the pharmacy (unaccompanied by another nurse), obtain the necessary medications from the stock supply bottles (placing the medications in a plastic cup) and then take the medications to the patients' rooms and administer them. When asked how the administered medications were tracked, staff #15 stated that they were documented on a clipboard on the outside of the pharmacy door. When asked if the medications obtained (as shown on the camera footage) were then compared to the medications recorded on the clipboard, staff #15 stated that they were not. When asked if the medications in the pharmacy were ever inventoried to make sure the amounts present were the proper amounts, staff #15 stated that they were not.

During the same tour of the pharmacy on 4-14-16, a quantity of 12 prescription pads (in the name of a physician who had not been on staff with the hospital in 1 year) were located in an unlocked pharmacy cabinet. Also located were 14 vials of furosemide 20mg injectable solution, which had expired 6-1-15 but were still in an area available for patient use.

The above was verified in an interview with the Chief Executive Officer and the Nursing Director on the afternoon of 4-14-16.