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Based on observation, a review of documentation, interviews with staff and a tour of the facility, the facility failed to ensure that the provision of services requirements were met as evidenced by failing to ensure proper medication storage and security as well as the failure of nursing staff to administer medications in accordance with acceptable standards of practice.

Findings were:

Cross Refer To:
C0276
C0294
C0297

Based on observation, review of documentation, interviews with staff and a tour of the facility, the facility failed to establish rules for the storage, handling, dispensation and administration of drugs and biologicals, including a drug storage area administered in accordance with accepted professional principles.

Findings were:

During a tour of the patient care area on 8-6-14, a review of the unit medication storage area was conducted. The medication storage area was contained in a room separated from the nurse's station by a half-door. The medication storage area contained other items including (but not limited to) a patient medication cart, copy machine, respiratory supplies and glucometer supplies. The door contained no locking mechanism.

Facility pharmacy policy titled "Security" states, in part, "3. All pharmaceuticals and biologicals will be stored securely in the pharmacy, nurse's station and emergency department and not available to the general public."

A review of the contents of the patient medication drawers in the cart revealed the following 24 oral medications in stock supply bottles, not labeled with individual patient names:
Phenergan 25 mg
Paxil 20 mg
Metronidazole 250 mg
Verapamil ER 240 mg
Simvastatin 80 mg
Hydrochlorothiazide 25 mg
Bupropion 150 mg
Protonix 40 mg
Namenda 10 mg
Aricept 10 mg
Metoclopramide 10 mg
Pravastatin 40 mg
Prenatal Multivitamins
Celebrex 20 mg
Aricept 5 mg
Nexium 40 mg
Plavix 75 mg
Losartan Potassium 50 mg
Hydroxyzine 25 mg
Keppra 500 mg
Seroquel 200 mg
Venlafaxine HCl 150 mg
Calcitrol 0.25 mcg
Norvasc 10 mg

In an interview with staff members #10 and #21, the staff was asked why stock medication bottles with no patient names were present in patient medication drawers. The staff explained that, when a medication was ordered for a patient and the order reached the pharmacy, the stock supply of the medication was sent to the unit, kept in that patient's medication drawer and dosages were obtained from the stock supply bottle. When asked the procedure if ANOTHER patient received an order for the same medication, staff stated that they could remember whether or not the stock supply bottle was already in the cart for another patient and would administer the 2nd patient's dose from the same stock supply bottle. When asked how they avoided contamination of the stock supply bottle or its contents, staff stated that the medications were pre-poured into a medication cup (without touching the tablets or capsules) and that the medication bottle was not taken into the patient's room. Asked if an inventory was kept of the number of tablets in each stock supply bottle, staff stated that no inventory was kept. When asked the disposition of any stock supply medication once no more patients had an order for it, staff stated that the bottle was sent back to the pharmacy.


In an interview with staff #22, the staff member was asked why the medications in the stock supply bottles were not delivered to the unit (for each individual patient with an order for that medication) in unit-dose form, the staff explained that not all medications were available in unit-dose form but that the staff ordered them in unit-dose form whenever available. When asked what would happen to the stock supply bottles and their respective contents when they returned to the unit, the staff member stated that the medication would then be sent back to the unit when another order was received on a patient for the same medication. When the staff member was asked why medications contained in stock supply bottles were not packaged into unit-dose form packaging by the pharmacy, the staff member stated that the pharmacy did not have the supplies to perform unit dose packaging. When asked if the medications contained in the stock supply medication bottles were inventoried (before sending the bottle to the unit and after the bottle was returned to the pharmacy), the staff member stated that they were not.

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 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 patient safety in medication through proper storage and distribution of medications. 1. The pharmacy will include a program for the control, security and accountability of drug products throughout the hospital. 5. The pharmacy will provide a unit-dose, medication cart medication delivery system. This will include direct copies of the physician order, pharmacy patient profile, routine filing of the medication cart patient drawers, and a reconciliation function between the patient profile and the nurses' medication administration record."

Facility pharmacy policy titled "DUTIES OF PHARMACY PERSONNEL" states, in part, "1. Pharmacist-in-charge: b. Ensuring that drugs and/or devices are prepared for distribution safely and accurately as prescribed. t. Maintaining pharmacy records of all receipt and distribution of medications."

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. This will also include the periodic checking of floor stock."

The above information was confirmed in an interview with the Chief Executive Officer and the Director of Quality Services on the afternoon of 8-7-14 in the facility conference room.





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In the medication room a large shallow cabinet, approximately 4 X 4 feet in size, was observed on the wall to the left of the half door. This surveyor asked staff members # 10 and 21 what was stored in this cabinet. Staff # 10 stated this was the "night stock cabinet". This staff member explained that the purpose of the cabinet was for the night shift nurse to obtain "stock supply" medication if ordered by the physician "since the pharmacist is not here at night".

A piece of paper on the front of this cabinet titled "Pharmacy Night Drug Cabinet List" listed the following medications:
"Albuterol UD-5
ASA 81mg Tab-5
Clonidine 0.1 mg Tab-5
Colace 100 mg Tab-5
Ipratropium UM-5
Lanoxin 0.125 mg-5
Lanoxin 0.25mg-5
Lasix 20 mg Tab-5
Lasix 40 mg Tab-5
Levaquin 500 mg Bag-5
Levaquin 750 mg Bag-5
Lisinopril 10 mg Tab-5
Phenergan mg Amp-5
Potassium Chloride 20 meq Vial-5
Pulmicort 0.5 mg UD-5
Rocephin 500 mg Vial-5
Rocephin 1 GM Vial-5
Solu Medrol 40 mg Vial-5
Solu Medrol 125 mg Vial-5
Tylenol 500 mg Tab-5
Xopenex 1.25 mg UD-5
Zithromax 500 mg Vial-5
Zofran 4 mg Vial-5"

This surveyor had staff member # 10 unlock and open this cabinet. All of the above medications were observed hanging from small hooks in the cabinet. The amount of medication observed differed from the amount indicated on the "Pharmacy Night Drug Cabinet List". A clipboard with a form entitled "Pharmacy Access Control" was observed hanging in the cabinet.

Staff member #10 stated that the "Pharmacy Access Control" sheet was to be completed any time a nurse removed a medication from the cabinet. Staff member #10 stated this form should accurately reflect which medications had been removed from the cabinet by night shift nursing staff.

The "Pharmacy Access Control" sheet stated the following medications had been removed from the cabinet since 8/1/14: Colace 10 mg, Zofran 4 mg, and Clonidine 0.1 mg.

This surveyor counted the medications contained in the cabinet. The following medication were observed to be available in amounts less than 5 per the "Pharmacy Night Drug Cabinet List": Levaquin 750 mg bag (4), Phenergan 25 mg tab (4), Tylenol 500 mg (4), Albuterol unit dose (1), Ipatropium unit dose (4), Pulmicort 0.5 mg (4), Xopenex 1.25 mg (4), Rocephin 500 mg vial (1), Rocephin 1 gm vial (2), Solu Medrol 40 mg Vial (2), Solu Medrol 125 mg Vial (2), and 1 vial Solu Medrol was mislabeled on the external bag as 125 mg (the actual dosage labeled on the vial was 40 mg). This surveyor also observed a ziplock bag labeled "Xopenex 1.25 mg" hanging empty in the cabinet.

In an interview on 8/6/14, staff member #22 confirmed this cabinet was for use by the night shift nursing staff to access stock medication supplies. This cabinet was created to, "limit nurses accessing the pharmacy at night". They were asked if the document entitled "Pharmacy Night Drug Cabinet List" should be an accurate reflection of what was contained in the cabinet and if any variation should be reflected on the "Pharmacy Access Control" form. Staff member # 22 respond "Yes it should."

They were asked how the facility tracks medication removed from this cabinet. They replied that the "Pharmacy Access Control" form was to be completed every time medication was removed form the cabinet. This staff member was shown the empty bag labeled "Xopenex". They replied, "When a bag's missing they sign it out on the book up there (pointing to the "Pharmacy Access Control" form)." They were informed this medication was not documented on the "Pharmacy Access Control". The staff member had no explanation for this discrepancy.

This surveyor showed staff member # 22 that the inventory for the cabinet did not match the "Pharmacy Night Drug Cabinet List" or "Pharmacy Access Control" form. The staff member was unable to provide an explanation for this discrepancy. Staff member # 22 was asked when this stock was inventoried and replaced. They replied, "(Staff member #17) does floor stock on close to a day to day basis."

Staff member # 22 was shown that there was mislabeled vial of Solu Medrol 40 mg in the cabinet, which would increase the risk for a medication administration error. They stated, "That is wrong".

The discrepancies in the inventory of the "Pharmacy Night Drug Cabinet List" indicate the medications are not being properly managed or stored.

The facility had no policy to address the use of the "Pharmacy Night Drug Cabinet" by nursing staff. The only facility based policy for afterhours access to medications were regarding entry into the pharmacy.

The policy entitled, "After Hours Entry Into the Pharmacy" stated, "There may be times when medications are ordered when pharmacy is not here. In these cases, it may be necessary for nursing personned [sic] to enter the pharmacy to retrieve medications. All medications must be signed for on the AFTER HOURS PHARMACY ENTRY LOG by the person withdrawing the medication. The nurse will withdraw no more than enough of the medication (s) to last until the next tour of duty by the pharmacy personnel. List of RN's and LVN's are on the next page that can extry [sic] pharmacy after hours. This will include typed name, signature, and initials of each nurse."

During interview, staff members # 10, 21, and 22 stated that nurses do not currently access the pharmacy after hours, instead the "Pharmacy Night Drug Cabinet" is accessed. With no policy to address the proper use, documentation of access, and inventory of this cabinet, there is an increased risk of medication error at the facility.

The storage of concentrated injectable potassium chloride in the "Pharmacy Night Drug Cabinet" also poses a risk to patient safety. Best practices indicate that concentrated potassium chloride should be segregated and stored away from other stock medication to prevent possible administration errors.

A Pharmacy and Therapeutics (P & T) article entitled, Potassium Chloride Injection Still Poses Threats to Patients, 2011, by Matthew Grissinger, RPh, FASCP, found at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3138362/ states, " Nurses have access to the pharmacy or night cabinet. In hospitals where 24-hour pharmacy services are not available, nurses may obtain medications from a night or weekend cabinet or from a discrete, secured area in the pharmacy. Vials of concentrated KCl may be available in these areas, increasing the risk that a nurse might accidentally select KCl in the attempt to obtain another medication."


Recommendations to prevent such errors included:
"Safe Practice Recommendations: Removing concentrated KCl vials from floor stock is not enough to prevent tragic errors with this high-alert medication. The following additional strategies should be considered:
1. Failure mode and effects analysis (FMEA) should be performed. An inventory should be made of all concentrated electrolytes in the organization, and an FMEA should be performed. The look-alike potential of product containers should be evaluated. When possible, concentrated electrolytes should be purchased from different vendors to avoid the potential for mixups between the two vials because of their similar appearance.
2. Nursing access to the pharmacy should be prohibited. Nurses should not enter the pharmacy when it is closed. A discrete stock of carefully selected, after-hours medications, including pre-mixed small and large volumes of KCl solutions, should be available in a secured area, preferably in a controlled-access cabinet.
3. Dispensing of vials should be prohibited. Vials of KCl should not be dispensed to prepare infusions by nurses on the patient ' s floor. Instead, the pharmacy should dispense premixed solutions or should prepare admixtures for patients as needed. Vials should not be provided as floor stock."

In an interview on 8/6/14, staff member # 22 stated they were aware that concentrated potassium chloride was available for access in the "Pharmacy Night Drug Cabinet" with no warning labels present.

This facility was not following best practices for the storage and management of concentrated potassium chloride as evidence by stocking concentrated vials in the "Pharmacy Night Drug Cabinet" in the unlocked medication room of the facility.


The above findings were confirmed in an interview with staff member # 22 on 8/6/14.

Based on observation, review of documentation, interviews with staff and a tour of the facility, the facility failed to ensure that nursing services met the needs of the patients.

Findings were:

During a tour of the patient care area on 8-6-14, a review of the unit medication storage area was conducted. The medication storage area was contained in a room separated from the nurse's station by a half-door. The medication storage area contained other items including (but not limited to) a patient medication cart, copy machine, respiratory supplies and glucometer supplies. The door contained no locking mechanism.

Facility pharmacy policy titled "Security" states, in part, "3. All pharmaceuticals and biologicals will be stored securely in the pharmacy, nurse's station and emergency department and not available to the general public."

A review of the contents of the patient medication drawers in the cart revealed the following 24 oral medications in stock supply bottles, not labeled with individual patient names:
Phenergan 25 mg
Paxil 20 mg
Metronidazole 250 mg
Verapamil ER 240 mg
Simvastatin 80 mg
Hydrochlorothiazide 25 mg
Bupropion 150 mg
Protonix 40 mg
Namenda 10 mg
Aricept 10 mg
Metoclopramide 10 mg
Pravastatin 40 mg
Prenatal Multivitamins
Celebrex 20 mg
Aricept 5 mg
Nexium 40 mg
Plavix 75 mg
Losartan Potassium 50 mg
Hydroxyzine 25 mg
Keppra 500 mg
Seroquel 200 mg
Venlafaxine HCl 150 mg
Calcitrol 0.25 mcg
Norvasc 10 mg

In an interview with staff members #10 and #21, the staff was asked why stock medication bottles with no patient names were present in patient medication drawers. The staff explained that, when a medication was ordered for a patient and the order reached the pharmacy, the stock supply of the medication was sent to the unit, kept in that patient's medication drawer and dosages were obtained from the stock supply bottle. When asked the procedure if ANOTHER patient received an order for the same medication, staff stated that they could remember whether or not the stock supply bottle was already in the cart for another patient and would administer the 2nd patient ' s dose from the same stock supply bottle. When asked how they avoided contamination of the stock supply bottle or its contents, staff stated that the medications were pre-poured into a medication cup (without touching the tablets or capsules) and that the medication bottle was not taken into the patient's room.

According to the Texas Administrative Code Title 22, Part 11, Chapter 217, Rule 217.11 Standards of Nursing Practice;
(1) Standards Applicable to All Nurses. All vocational nurses, registered nurses and registered nurses with advanced practice authorization shall:

(A) Know and conform to the Texas Nursing Practice Act and the board's rules and regulations as well as all federal, state, or local laws, rules or regulations affecting the nurse's current area of nursing practice;

(B) Implement measures to promote a safe environment for clients and others;

(C) Know the rationale for and the effects of medications and treatments and shall correctly administer the same;

By transporting loose medication to a patient room in a pre-poured contained, the nurse administering the medication is unable to perform a final check of the medication to be administered against the order for the medication, thus creating an unsafe environment and the potential for a medication error.

A review of facility policies and procedures revealed no current policy or procedure providing guidance or instructions on safe medication administration.

The above information was confirmed in an interview with the Chief Executive Officer and the Director of Quality Services on the afternoon of 8-7-14 in the facility conference room.

Based on observation, review of documentation, interviews with staff and a tour of the facility, the facility failed to ensure that all drugs, biologicals and intravenous medications were administered in accordance with accepted standards of practice.

Findings were:

During a tour of the patient care area on 8-6-14, a review of the unit medication storage area was conducted. The medication storage area was contained in a room separated from the nurse's station by a half-door. The medication storage area contained other items including (but not limited to) a patient medication cart, copy machine, respiratory supplies and glucometer supplies. The door contained no locking mechanism.

Facility pharmacy policy titled "Security" states, in part, "3. All pharmaceuticals and biologicals will be stored securely in the pharmacy, nurse's station and emergency department and not available to the general public."

A review of the contents of the patient medication drawers in the cart revealed the following 24 oral medications in stock supply bottles, not labeled with individual patient names:
Phenergan 25 mg
Paxil 20 mg
Metronidazole 250 mg
Verapamil ER 240 mg
Simvastatin 80 mg
Hydrochlorothiazide 25 mg
Bupropion 150 mg
Protonix 40 mg
Namenda 10 mg
Aricept 10 mg
Metoclopramide 10 mg
Pravastatin 40 mg
Prenatal Multivitamins
Celebrex 20 mg
Aricept 5 mg
Nexium 40 mg
Plavix 75 mg
Losartan Potassium 50 mg
Hydroxyzine 25 mg
Keppra 500 mg
Seroquel 200 mg
Venlafaxine HCl 150 mg
Calcitrol 0.25 mcg
Norvasc 10 mg

In an interview with staff members #10 and #21, the staff was asked why stock medication bottles with no patient names were present in patient medication drawers. The staff explained that, when a medication was ordered for a patient and the order reached the pharmacy, the stock supply of the medication was sent to the unit, kept in that patient's medication drawer and dosages were obtained from the stock supply bottle. When asked the procedure if ANOTHER patient received an order for the same medication, staff stated that they could remember whether or not the stock supply bottle was already in the cart for another patient and would administer the 2nd patient's dose from the same stock supply bottle. When asked how they avoided contamination of the stock supply bottle or its contents, staff stated that the medications were pre-poured into a medication cup (without touching the tablets or capsules) and that the medication bottle was not taken into the patient's room.

According to the Texas Administrative Code Title 22, Part 11, Chapter 217, Rule 217.11 Standards of Nursing Practice;
(1) Standards Applicable to All Nurses. All vocational nurses, registered nurses and registered nurses with advanced practice authorization shall:

(A) Know and conform to the Texas Nursing Practice Act and the board's rules and regulations as well as all federal, state, or local laws, rules or regulations affecting the nurse's current area of nursing practice;

(B) Implement measures to promote a safe environment for clients and others;

(C) Know the rationale for and the effects of medications and treatments and shall correctly administer the same;

By transporting loose medication to a patient room in a pre-poured contained, the nurse administering the medication is unable to perform a final check of the medication to be administered against the order for the medication, thus creating an unsafe environment and the potential for a medication error.

The above information was confirmed in an interview with the Chief Executive Officer and the Director of Quality Services on the afternoon of 8-7-14 in the facility conference room.