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Based on document review, interview, and policy and procedure review, the hospital failed to ensure that the after-hour contract pharmacy service was evaluated quarterly to readily identify system variations, to proactively prevent and/or identify medication errors to be incorporated into the Quality Assurance and Performance Improvement (QAPI) program, and to ensure the Governing Body monitored the effectiveness of pharmacy services. This failure had the potential to cause concerns with the off-hours pharmacy and patient pharmacy needs to go un-noted and unmet.

Findings:

A review of the after-hour contract agreement between the hospital (Client) and contract provider of pharmaceutical services (Agency) (titled, "Remote Order Entry Service Agreement" on 9/21/11 approximately 11:35 AM revealed that the 'Scope of Services' are as follows:

-Remote order entry of physician medication orders.
-Information and clinical support to staff by pharmacist via telephone during hours of service.
-Provide end of shift (ESR) briefing at the end of each shift to Director of Pharmacy and pharmacy staff.

Per the contract, the Agency hours of services are 9 PM to 6 AM daily. The hospital's pharmacy hours are 7 AM to 9 PM. The Agency would process orders during the non-pharmacy hours, i.e., 9 PM to 6 AM. The Agency would prospectively review new medication orders, evaluate for appropriateness of dosing, allergies, therapeutic duplication, potential drug interactions, contraindications, then enter the orders into the hospital's order entry system which would generate a label to be affixed to an intravenous medication to be released for use by nursing.

Further review of the contract revealed that the end of shift (ESR) briefing events such as, RN (registered nurse) follow up issue, RN name, date/time, and pharmacist initials noted that the Agency reported medication therapy ordered during the shift. A review of the Agency's ESR dated 9/19/11 - 9/20/11 on 9/23/11 at 3 PM revealed the data (documentation) provided to the hospital was inconsistent with the information required in the designated columns. The ESR lacked drug name, RN names for 6 of 7 events, 4 of 7 events lacked times.

In an interview, on 9/21/11 at approximately 11:35 AM, the acting Pharmacist-in-Charge (DIR F) reported the regulatory requirement stipulates that the pharmacy service evaluate all aspects of the services, including identification of actual or potential medication errors, and report on a quarterly basis to the Pharmacy and Therapeutics Committee. This information is sent to the leadership for approval. The contract did not indicate a quarterly evaluative summary review of the services would be provided to the hospital to be incorporated into the Quality Assurance Performance Improvement program.

When asked, how the after-hour Agency identified and reported actual or potential medication errors, the DIR F was unable to provide an evaluation of the quality of after-hour pharmaceutical services to be incorporated into the QAPI program since the contract was implemented 4/4/11.



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During an interview with the Director of Pharmacy Services on 9/22/11, at 11:30 AM, he indicated a new off-hours pharmacy had just started servicing the hospital in July of 2011. He indicated he did not have a system to evaluate the services the new pharmacy was providing. When questioned further regarding the quality of services provided by the contracted off hour pharmacy, he stated he relied on staff to tell him of any problems. He also indicated he had no system for quantifying the quality of care. He stated "I just quantify in my brain."

During an interview with the Director of Performance Improvement on 9/22/11 at 2:05 PM, she stated any new process started in the hospital should be monitored for effectiveness.

Based on interview and record review, the hospital failed to ensure medication errors were reviewed and investigated by the Director of Pharmacy, which had the potential for patients to receive incorrect medications.

Findings:

During an interview with the Director of Pharmacy Services on 9/22/11, at 11:30 AM, he indicated he did not have a system to evaluate the medication errors made by the off-hour pharmacy. When questioned further regarding the quality of services provided by the contracted off hour pharmacy, he stated he relied on staff to tell him of any problems. He also indicated he had no system for quantifying the quality of care. He stated, "I just quantify in my brain."

During a random review of the hospital's medication errors, on 9/23/11 at 11:20 AM, it was noted the Pharmacy Director did not investigate a medication error involving Patient 3. The report indicated Patient 3 had been ordered Claforan (an antibiotic) to be given every 12 hours. However, the Medication Administration Record indicated the medication was to be given every 6 hours. The error report indicated it was sent to the Director of Pharmacy. There was no documented evidence the error was reviewed or investigated by the Director of Pharmacy. An attempted interview with the Director of Pharmacy was unsuccessful, as he had gone home ill.

Based on interview and record review, the hospital failed to develop a nursing care plan for one of 31 (7) sampled patients which had the potential to result in lack of consistency of care to meet patient needs.

Findings:

The clinical record for Patient 7 was reviewed on 9/21/11. There was no nursing care plan found in the clinical record.

During an interview with the Director of Maternal Child Health/Pediatrics on 9/21/11 at 3 PM, she reviewed the clinical record and was unable to find documentation of a nursing care plan.

Based on interview and record review, the hospital failed to follow the policy and procedure for medication administration for five of 31 sampled patients (1, 6, 10, 21, and 31) and failed to ensure medication administration policies and procedures were consistent across all disciplines which had the potential to result in unsafe medication administration practices.

For Patient 1, the hospital failed to perform and document a double check by two licensed staff prior to the administration of a medication which contributed to an overdose of medication above the therapeutic level.

For Patients 6, 10, and 31,the hospital failed to perform a double check by two licensed staff prior to the administration of a medication which had the potential to result under or over treatment of the medical condition.

For Patient 21, the hospital failed to correctly transcribe a physician's medication order and failed to perform a double check by two licensed staff prior to the administration of a medication which resulted in an overdose of medication that required monitoring of the patient's clinical condition.

Findings:

1. The clinical record for Patient 1 was reviewed on 9/21/11. The physician orders, dated 8/18/11, indicated Acyclovir (a medication used to treat viral infections) 20 milligrams per kilograms of weight was to be administered every eight hours. The Medication Administration Records (MAR) dated 8/18/11 through 8/21/11 indicated nine doses of the medication were administered with no documentation of the double check with another licensed staff member to ensure the correct dose and patient was found.

During an interview with Registered Nurse (RN) A on 9/21/11 at 9:50 AM, she stated that all medications administered to pediatric patients are double checked prior to administration with another nurse to ensure the drug and dosage was correct.

During an interview with the Director of Maternal Child Health Services (DIR A) on 9/21/11 at 3 PM, she stated the medication was administered at the incorrect dosage due to mislabeling by staff in the pharmacy department. DIR A stated during the review of the incident, staff were not documenting the double check of medications prior to administration.

2. The clinical record for Patient 6 was reviewed on 9/21/11. The record indicated Patient 6 was a pediatric patient. The MAR, dated 9/17/11, indicated Patient 6 received Solumedrol (a medication used to reduce inflammation) 25 milligrams intravenously at 8:22 AM. There was no double check of the drug and dosage by another licensed staff prior to administration found in the clinical record.

During an interview with DIR A on 9/21/11 at 3 PM, she reviewed the clinical record and was unable to find documentation that the double check was performed.

3. The clinical record for Patient 10 was reviewed on 9/22/11. The record indicated Patient 10 was a pediatric patient. The MAR dated 8/20/11 indicated acetaminophen (a medication used to treat pain and fever) 210 milligrams was administered at 4:47 PM. There was no double check of the medication.

During an interview with the Director of Emergency Services (DIR B) on 9/22/11 at 10:15 AM, she reviewed the clinical record and was unable to find documentation of the double check performed prior to medication administration.

4. The clinical record for Patient 31 was reviewed on 9/21/11. The record indicated Patient 31 was a neonate (newborn). The MAR dated 9/10/11 indicated Patient 31 received gentamycin (a medication used to treat infection) 16 milligrams at 8 PM. There was no double check of the drug and dosage by another licensed staff prior to administration found in the clinical record.

During an interview DIR A on 9/23/11 at 11:40 AM, she reviewed the clinical record and was unable to find documentation of the double check performed prior to medication administration.

5. The clinical record for Patient 21 was reviewed on 9/23/11. The record indicated Patient 21 was a neonate. The telephone physician orders dated 9/4/11 at 2:30 PM, indicated to give dextrose (an intravenous solution which supplies fluid and calories) 10 mgs/kg (milligrams per kilogram) over 20 to 30 minutes. The physician orders dated 9/5/11 at 10 AM, clarified the original order to give dextrose 2 cc (cubic centimeters) IV (intravenously) push (via syringe). The medication administration record dated 9/4/11, indicated 10 mgs/kg was administered at 2:20 PM. There was no double check of the drug and dosage by another licensed staff prior to administration found in the clinical record.

During an interview with DIR A on 9/23/11 at 12:55 PM, she reviewed the clinical record and was unable to find documentation of the double check performed prior to medication administration.

6. During an interview with Respiratory Therapist (RT) A on 9/21/11 at 10:45 AM, he stated he administered medications to pediatric patients as ordered by the physician as part of the respiratory treatment regime. RT A stated the medications are unit dosed and not checked by another licensed staff member prior to administration. He stated he was not aware of any policy and procedure for double-checking medications prior to administration for pediatric patients.

The hospital policy and procedure titled "Medication Administration Principles and Procedures, dated 6/11, indicated the affected areas and personnel responsible for implementation of this policy included all patient care areas/registered nurses, licensed vocational nurses, and respiratory therapists. The policy indicated "4. The following medications require a second nurse to verify the correct dose. The second nurse will check the dosage calculation, as applicable, and the dose that is prepared. Both nurses will initial and sign the patient's MAR a. Insulin, b. Heparin, c. All pediatric medications..."

During an interview with the Director of Respiratory Care (DIR C) on 9/23/11 at 10:45 AM, he provided a department-specific policy and procedure "Medication Management", no date, which did not have a second check indicated for pediatric medications. The DIR C stated Respiratory Therapy policies and procedures were reviewed by the Medical Director, Medical Staff, Administration, and Governing Board. He could not produce evidence that the department-specific policy and procedure was approved by administration and the governing board.

Based on observation, staff interviews, medical record reviews, document reviews, and policy and procedure reviews, the hospital failed to ensure pharmaceutical services were provided to meet patients' needs for safe, accurate and timely medication administration.

1. The content of medications orders did not clearly communicate orders for Patient 2 to nursing staff. Refer to A0500

2. Failure to ensure that evaluation of medication storage conformed with state and federal regulations by maintaining controls of oxygen canisters. Refer to A0491

3. An alert system was not available in the Automated Dispensing Cabinet (ADC) that contained medications with high alert warnings according to the Federal Drug Administration warnings. Refer to A0500

4. Failed to ensure that the after-hour contract pharmacy service was evaluated quarterly to readily identify system variations, and to proactively prevent and/or identify medication errors to be incorporated into the Quality Assurance and Performance Improvement program. Refer to A0084

5. Failed to ensure that a physician order for Acyclovir IV was appropriately labeled for dispensing and administration to Patient 1. Refer to A0500

6. Failed to ensure the hospital's intravenous preparation area complied with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions. Refer to A 501

The cumulative effects of the systemic problems resulted in the hospital's inability to ensure the provision of pharmaceutical services in a safe environment.

Based on observation, interview, and record review, the hospital failed to ensure that four (4) filled oxygen canisters were securely stored within the hospital and not available to unauthorized persons and the correct amount of the medication Dantrium (drug given in an emergency when a patient is experiencing Malignant Hyperthemia which is a life threatening medical emergency caused by a patient's reaction to general anesthesia) was available which placed patients at risk of inadequate treatment of Malignant Hyperthemia.

Findings:

1. On 9/22 /11 at 4:05 PM, four (4) oxygen canisters were observed in the hospital's lobby attached to patient wheelchairs. These wheelchairs are used during the discharge process. Inspection of the oxygen canisters revealed they were not empty.

During a concurrent observation with the Director of Radiology on 9/22/11 at 4:05 PM, oxygen canisters were observed in the lobby. He reported that the Respiratory Care Services (RCS) Manager could speak to this issue.

Interview with the RCS Manager on 9/22/11 at 4:10 PM, revealed after engineering supplied the oxygen 'tanks', the overall responsibility for security and storage of the oxygen canisters is that of the respiratory and nursing departments.



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2. During an observation on 9/23/11 at 10 AM, of the emergency cart in the surgical area it was noted only 25 vials of Dantrium were available.

During an interview with the Director Surgical Services she indicated per the hospital policy there should be 36 vials available. However, staff had removed one unusable vial as the cap to the medication was off.

Review of MHAUS (Malignant Hyperthermia Association) recommends facility's keep 36 vials available at all times.

Based on record review and interview, and policy and procedure review, the hospital failed to ensure: 1) the physician order for intravenous Acyclovir, an antiviral drug, was appropriately labeled for dispensing, accurately compounded, and administered to Patient 1; 2) the content of a medications order was clearly communicated to nursing staff for Patient 2; and, 3) provide a system whereby licensed staff would be alerted to medications that are considered high risk with or without the FDA's black box warnings retrieved from an Automated Dispensing Cabinet (ADC).

Findings:

1. During the course of Patient 1's medication therapy, a three day old neonate, the physician ordered Acyclovir 20 milligrams per kilogram per dose to be administered intravenously every 8 hours on a routine basis. Patient 1's weight was 3.29 kilograms. The telephone order was written on 8/18/11 at 8:10 PM to 'Start Acyclovir 20 mg/kg/dose every 8 hours IV (intravenous) and faxed to the after-hour contract pharmacy service (Agency) per documentation at 10:10 PM. The hospital's policy and procedure states, "The unit clerk will fax all new physician orders to Pharmacy within 30 minutes of being written".

The after-hour Agency, a contract pharmacy provides the following service during the hours of 9 PM to 6 AM daily.

-Remote order entry of physician medication orders
-Information and clinical support to staff by pharmacist via telephone during hours of service
-Provide end of shift (ESR) briefing at the end of each shift to Director of Pharmacy and pharmacy staff.

Per the contract, the Agency's pharmacist calculates the dose based on a weight of 3.29 (kg) kilograms and remotely enters the order for Acyclovir. The standard of pharmaceutical practice is to have two pharmacists verify neonatal and pediatrics doses prior to dispensing the final medication for administration.

A review of the hospital's policy and procedure titled, "Dispensing of Medications" states, 'Computer generated IV medication labels will contain all ... and the volume of the base solution, the rate, trade and/or generic name of any additives, dose/amount of any additives, bag sequence number and date and time due, date prepared & expiration date, and special instructions as required'. The policy and procedure titled, 'Medication Administration Principles and Procedures' states, nurses to verify dosage calculations ... all pediatric medications.'

A follow-up interview conducted with the current Director of Pharmacy on 9/21/11 at approximately 10:16 AM regarding the discovery of who actually entered the Acyclovir order remotely confirmed the order was entered by a pharmacy technician, not a pharmacist. The label generated did not include the concentration of Acyclovir (500 mg/10 ml equivalent to 50 mg/1 ml). The medication order did not change, therefore, the label's information would remain the same until discontinued. The hospital's policy and procedure titled, 'IV preparation and Dispensing' states, 'Labels of sterile products shall accurately reflect the contents'. 'A pharmacist shall inspect the drug & diluent and verify by initialing the above label'.

On 8/18/11, doses 1 and 2 of Acyclovir 64 mg in 10 ml normal saline (NS) were mixed by the nursing shift supervisor and administered on 8/18/11 at 11 PM, and 8/19/11 at 7 AM respectively.

On 8/19/11, the hospital Pharmacy Technician I prepared doses 3, 4, 5, and 6, which were checked by the pharmacist as correct. The label remained the same.
On 8/20/11, the hospital Pharmacy Technician II prepared doses 7 and 8 which were checked by the pharmacist as correct. The label remained the same.
On 8/21/11, the hospital Pharmacy Technician III prepared dose number 9. However, the verifying pharmacist identified the labeling error.

The Agency pharmacist's label documented 65.8 mg of Acyclovir (13.16 ml) and (13.2 ml) of NS equaled the correct dose of 20 mg/kg/dose.

An order to hold Acyclovir order was written on 8/21/11 at 10:30 AM.

Interview with pharmacy management on 9/21/11 at approximately 10:16 AM confirmed the systemic failures that included the after-hour Agency pharmacist procedures, the hospital pharmacist verification processes and nursing processes that resulted in failure to administer Acyclovir as ordered to Patient 1.

2. Patient 2 was admitted to the hospital with diagnoses that included hypertension, status post stent placement, renal disease, ASHD, (arterosclerotic heart disease).

A review of Patient 2's medical record on 9/22/11 at 1:55 PM revealed an incomplete medication order written on 9/20/11 at 1:30 PM as, "Resume home doses of Myfortic (used for prevention of organ rejection in transplant recipients), and Prograf (used for prevention of organ rejection in transplant recipients). All elements of a medication order to include dose, strength, frequency, and route (method of administration).

Policy and procedure reviews on 9/21/11 at 10:23 AM titled, "Dispensing of Medications" and "Medication Administration Principles and Procedures" document that valid medication orders written or verbally communicated must have name and strength of medication, route and frequency of administration, duration - if appropriate, indications for use - if as needed order, and other directions as appropriate.

In a concurrent interview on 9/22/11 at 1:55 PM with the nurse manage, it was confirmed the content of the medication order as written, was not clearly communicated to nursing staff for Patient 2.

3. During a tour of Emergency Department (ED) on 9/22/11 at 2:58 PM with the ED Director, a registered nurse (RN) C was asked to access the Automated Dispensing Cabinet (ADC) to demonstrate when a high risk medication such as Haldol 5 mg/ml IV, a psychotherapeutic medication, is taken from the cabinet, what precautionary statement would be seen immediately to alert the nurse that certain physiological parameters are needed before the medication can be administered.

The demonstration revealed the precautionary statement expected to be seen when the drug was removed was not printed on the ADC slip or terminal. In a concurrent interview with RN C on 9/22/11 at approximately 3 PM, she stated the new ADC system does not provide the same information as the previous system.

The hospital's policy and procedure titled 'Medication Administration Principles and Procedures' state in section 3, Black Box Warnings: The nurse will monitor the patient for any serious side effects associated with medications that have specific black box warnings. The new ADC system does not provide a precautionary statement that would be seen immediately to alert the nurse that certain physiological parameters are needed before the medication can be administered.

Based on observation, document review, and interview, the hospital failed to ensure the hospital's intravenous preparation area comply with the United States Pharmacopeia (USP) Chapter 797 Compounding-Sterile preparation, which set practice standards to ensure the safety and final quality of all products compounded under sterile conditions.

Findings:

During an inspection of the pharmacy on 9/21/11 at approximately 10:30 AM, it was observed the IV preparation area was not separated into a clean and non-clean (buffer, ante) area by a clearly defined barrier. USP 797 addresses facilities in which sterile products are prepared according to the manufacturers' labeling and where manipulations are performed during the compounding of sterile products which increase the potential for microbial contamination of the prepared products. It delineates what training is needed, how the preparation area should be designed, equipment type, and quality control program formalized in writing.

The Director of Pharmacy (DOP) was observed walking into one of the two entrances to the IV room on 9/21/11 at approximately 10:34 AM. This area is not enclosed by a barrier to the general pharmacy area. Each entrance has a red line and sign outlining the restrictions needed before crossing the red line. When asked the purpose of the red line, and why he crossed it without observing the restrictions posted over the door, the DOP stated that the red line delineates the separation between the clean and non-clean areas of the IV room. He further stated that the clean area is the Laminar Flow Hood. The hood is a partially enclosed area where sterile air flows horizontally providing a safe area for preparing intravenous (IV) admixtures. Disrupting the airflow will contaminate the preparation area. The purpose of USP 797 standards is to further prevent contamination of parenteral preparations. This IV room has two entrances that are not enclosed. Each entrance has a red line to delineate the separation between the clean and non-clean areas.

A review of the hospital's policy and procedure titled, 'IV Preparation and Dispensing' states ..Unauthorized personnel are not allowed in hood areas.' 'the purpose is to provide safe and efficient preparation of intravenous admixtures/solutions'. The policy and procedure dated 2/23/10 does not reference US Pharmacopeia which mandates the current standards for the preparation of parenteral products.

In a concurrent interview with the DOP, he acknowledged that the hospital's preparation area does not comply with the United States Pharmacopeia 797 (USP) standards for Pharmaceutical Compounding-Sterile Preparations.