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Due to the nature of the deficiency, the hospital failed to comply with the Condition of Nursing Services. The hospital failed to ensure that nursing care, in the form of medications and treatments provided to their patients, was provided by qualified and adequately trained nurses, operating with policies and procedures appropriate to the needs of the patients.

The facility failed to meet the following standards under the Condition of Nursing Services:

A 398 - Nursing Services - Supervision of Contract Staff
The hospital's Director of Nursing failed to ensure that personnel files, which included evidence of qualifications, current licensure and evidence of in-house evaluation of the clinical performance was maintained for agency nurses that were on a list of staff that could immediately come to work in the facility, if needed.

A 405 - Nursing Services - Administration of Drugs
The hospital failed to ensure that a hazardous chemotherapy drug was prepared and administered in compliance with accepted standards of practice and in full compliance with approved policies and procedures.

Based on review of personnel files and staff interviews, the Director of Nursing failed to ensure that there was a system for adequate supervision and evaluation of the clinical activities of non-employee nursing personnel which occurred within the responsibility of the nursing services. The failure created the potential for negative patient outcomes.

Findings;

The hospital's Director of Nursing failed to ensure that personnel files, which included evidence of qualifications, current licensure and evidence of in-house evaluation of the clinical performance was maintained for agency nurses that were on a list of staff that could immediately come to work in the facility, if needed.

a. During the entrance conference on 04/08/13 at approximately 12:00 p.m., the Director of Nursing was asked about the use of agency or traveler nurses in the facility. S/he initially stated that they did not use agency or traveler nurses, but did acknowledge that they sometimes resorted to using an agency nurse to fill a shift if there was a call-in from regular staff. The Director was asked to provide a list of agency nurses that had been oriented to the facility and were considered qualified to come if they needed to fill a shift.

b. A list of agency nurses that could work in the facility was provided by the end of the first day of the survey (04/08/13). The list entitled, "Contract Labor," included 6 names, including 2 Registered Nurses (RN's), 3 Patient Care Technicians (PCT's), and 1 Occupational Therapist (OT). The personnel were listed as being affiliated with 3 different staffing agencies. The two RN's were selected for the sample of Human Resources (HR) records that were reviewed as a part of the survey process.

c. A review of the contract list requested from the facility at the entrance conference revealed that the facility had 9 current contracts in place to provide "Clinical Contract Labor."

d. Review of the personnel file provided for the first agency nurse selected for the sample revealed the following findings:
- no job job description outlining the duties of a nurse operating in the facility,
- no resume or application, which provided evidence of previous professional work experience and academic training related to nursing,
- the immunization record/titers, and TB testing were such poor copies that they were unreadable,
- no evidence of in-house evaluation of the nurse's performance of clinical duties.

e. Review of the personnel file provided for the second agency nurse selected for the sample revealed the following findings:
- no job job description outlining the duties of a nurse operating in the facility,
- no evidence of in-house evaluation of the nurse's performance of clinical duties.
- the nurse's RN license was from an adjacent compact state, but the licence had expired on 10/31/12.
These findings were confirmed on 04/11/13 at approximately 3 p.m. with the HR manager. A request for information about when the nurse had last worked at the facility was made at that time, in order to determine in the nurse had worked at the facility with and expired license on file. That information was not provided prior to the end of the survey, but the review did identify that this nurse, who was identified as a nurse that have been called in to work that day if there was a need, had an expired nursing license on file in the facility records.

f. Review on 04/10/13 of the facility policy/procedure entitled "Contracted Clinical Services" revealed the following, in part:
"I. PURPOSE
It is policy of the hospital to ensure that contracted patient care services meet the standard of care established for the hospital. The hospital retains full responsibility for patients receiving the services through contractual agreements.
II. POLICY
B. SERVICE PROVIDED WITHIN THE HOSPITAL
2. PRIOR to services being provided, verification of the following as related to each individual service provider will be obtained from the service provider:
a) Licensure/registration of each service provider, as required
b) Job descriptions performed by services providers
c) Current CPR, as applicable
d) Job or Department specific knowledge/skills checklist
e) Evidence of Hepatitis B status/verification of offer of vaccine
f) Evidence of PPD testing (TB) in past year"

Based on review of medical records and facility documents, staff interview and tours/observations, the hospital failed to ensure that a hazardous chemotherapy drug was prepared and administered in compliance with accepted standards of practice and in full compliance with approved policies and procedures. The failure created the potential for contamination of the medication preparation areas in the medication rooms and the patient's room, with possible exposure of nursing staff, all patients and their medications and to visitors to the room of the sample patient that was receiving the medication (#4 and #13).

Findings:

The hospital's Director of Nursing and Director of Pharmacy failed to ensure that the hazardous chemotherapy drug, that was being administered to sample patient #4 and #13, was being prepared and administered in safe and constant manner to prevent contamination of work and medication preparation surfaces, other patient's medication prepared in those same areas, the nurses preparing the medication, the secondary medication preparation area sometimes used in the patient's bathroom, and staff and visitors that entered that patient bathroom, from contamination by the dust created by crushing the medication, and the supplies and surfaces contaminated in the process of preparation and administration of the medication.

a. Review of a facility report on 04/08/13 revealed that on 03/03/13, a nurse had identified concerns that a patient (#4 and #13) was being administered a hazardous chemotherapy drug "without proper protective equipment or precautions."

b. Review of a follow-up report on this identified concern, dated 03/12/13, revealed the following administrative action plan:
"Quality, Nurse manager and pharmacy developed protocol/precautions for RN's to use when administering this medication when patient was admitted. These precautions were posted in med rooms and outside patient's room. There is no information available on crushing the drug because it states not to crush the med therefore we do not know if the drug is aerosolized."

c. Review on 04/09-10/13 of the medical records for the patient (#4, #13) receiving the chemotherapy drug revealed the following findings:

The patient was an adult patient with a melanoma with brain metastases, respiratory failure, dysphagia, tracheostomy, and stomach tube for nutrition and medication. The patient was initially admitted to the hospital on 02/27/13 and discharged on 03/27/13 to be transferred to another hospital for surgery. That hospitalization was documented in sample record #13. The patient was readmitted on 04/02/13 and discharged to a skilled nursing facility on 04/11/13. That hospitalization was documented in sample record #4.

Review of dietary consult and physician orders and progress notes revealed that the patient was NPO (nothing by mouth) orders and received medications and liquid nutritional supplements via the stomach tube, because of a swallowing problem and history of aspiration pneumonia.

Review of the History and Physical (H&P) for the initial hospitalization (#13) revealed that the patient was "on an oral chemotherapy provided by the patient's family." Review of the "Current Medications" listed on the H & P revealed the following: " 13. Vemurafenib."

Review of the MAR revealed that Vemurafenib was also listed on the Medication Administration Record (MAR) as "Zelboraf 240 mg tablets, 4 tablets (960 mg) twice daily, DO NOT CHEW OR CRUSH TABLETS."
The MAR further stated "This pt own med is in bin. Please verify correct patient and correct drug every time, USE CHEMO PRECAUTIONS*****"

Review of the MAR for 03/13/13 revealed a note to the side of the Zelboraf entry for that date with the "Use Chemo Precautions," "4 tablets (960 mg) BID," and "Do Not Chew or Crush Tablets" all circled. To the right of these instruction the nurse had written in the statement "Per (name of pharmacist), administer by crushing at bedside despite note to left." The MAR entry also stated that the route was "per tube."

Review of the MAR for 03/02/13 revealed again that a note to the side of the Zelboraf for that date with the instructions Use Chemo Precautions," "4 tablets (960 mg) BID," and "Do Not Chew or Crush Tablets" was also circled. In this case, in previous MAR's for this medication, the route was listed as "Oral," even though the patient was NPO and was receiving normally oral medications and nutrition via the stomach tube. To the right of these instructions the nurse had written in the statement "Admin by crushing at bedside per (name of) pharmacist instructions in contradiction to circled instructions not following written(?) instructions."

Review of a Nursing Progress Note dated 03/02/13 at 0900 (9:00 a.m.) revealed the following, in part:
"This RN calls (hospital where chemo drug initially prescribed and administered) Inpatient Pharmacy, speaks with pharmacist (name and number) regarding chemo drug administration. (Name of pharmacist) states (other hospital) authorized to crush Zelboraf 240 mg under bedside vent hood, then immediately into water or applesauce for medication administration. (Name of pharmacist) advised crushing medication will aerosolize medication, risking contact with any mucous membranes is dangerous. RN notifies (name of pharmacist) at (name of hospital) pharmacy. The only vent hood at the facility not available for chemo. RN obtains goggles and TB mask for (staff name) Respiratory Therapist due to the aerosolized nature of drug. RN request patient's husband leave room during administration for safety. Administered medication wearing double gloves, goggles, TB mask and blue isolation gown. RN notifies charge nurse and medical director regarding lack of adequate chemo precautions and absence of appropriate equipment. No chemo disposal available for linen or trash."

Review of the medical record for both hospitalizations revealed that the patient remained on "Chemo Precautions," which were listed on the MAR's and the Flow Sheet's. On the second admission record, the directions "Do Not Chew or Crush Tablets" were no longer present on the MAR's.

d. On 04/10/13 at approximately 9:15 a.m., an observation of the medication administration for sample patient #4 was observed. The nurse administered 9:00 a.m. medications, including the chemotherapy medication Zelboraf. Observation related to preparation and administration of the Zelboraf revealed that the nurse confirmed the medication order, including route through the gastric tube, "Chemo Precautions," and the fact that it was the patient's own medication supply provided . In the medication room, the nurse applied one set of gloves and accessed the patient's supply of Zelboraf 240 mg in the patient's bin in a cabinet above the main medication preparation area. The nurse took took a small thin plastic zip-lock bag, that was there for destroying other special-categories of medication, and utilized that to enclose the 4 tablets of Zelboraf to contain the dust when it would be crushed. S/he stated that s/he would not use the crusher in the medication room to crush the medication, because there was a crusher in the patient's room. S/he placed the bag with the Zelboraf in a separate plastic cup and carried all medications to the patient's room with the MAR. Upon entering the room, the patient was in bed and the patient's family member was at the bedside.

There was an over-the-door station containing personal protective equipment (gloves and gowns) and a laminated sign on the door about droplet precautions. There were no signs in the room, or previously in the medication room, with any instructions about "Chemo Precautions" or any protocol for crushing and administering the chemotherapy medication. When the nurse was asked about how s/he knew what to do to comply with "Chemo Precautions," s/he stated that there was a policy about that, but s/he was not sure about the name of the policy or it's exact contents. S/he confirmed that it was not in the room or the medication room, and that it could be accessed on-line, if needed.

The nurse proceeded to put on a blue, thin plastic, isolation gown, gloves and was directed by the patient's family member to the location of a box of masks that were located on the other side of the patient's bed on a table. The mask was a simple isolation mask with a clear plastic eye shield sewn to to top of the mask. S/he stated that the crusher for the pills and the plastic pitcher and syringe for administering the medications via the gastric tube were in the bathroom. When asked, s/he told the surveyor that s/he should also put on the gown, mask and gloves if s/he was going to go into the bathroom to watch the crushing and final preparation of the medications. The surveyor observed these processes in the bathroom with the RN, both of them wearing protective equipment as previously described. The nurse placed the sealed plastic bag containing the Zelboraf tablets in another open plastic sleeve provided with the crusher, to crush the tablets. S/he then placed some water in the bottom of a plastic cup and then opened the zip-lock bag and poured the crushed Zelboraf tablets into the water. S/he stated that s/he poured the crushed tablets into water to control the risk from the dust in the bag. She disposed of the plastic crushing bags by putting them in a closed, red biohazardous waste container. After all medications were prepared, the RN went to the patient's bedside and administered the medications through the gastric tube by drawing up large quantities of the dissolve medication in a large syringe (approximately 50 cc) and inserting it into the port of the gastric tubing. S/he did this repeatedly until all medications were administered with extra water to flush the tube. The plastic cups were placed in the regular trash and the pitcher and large syringe were taken back to the bathroom to be kept there for subsequent tube feedings/medication administration. The pitcher and syringe were not rinsed after use and the sink, crusher and prep area around the sink were not cleaned up in any way. The protective equipment was removed and discarded in the lidded trash receptacle in the patient's room.

Another nurse in a subsequent medication administration observation of another patient receiving medication by a nasogastric tube stated that the plastic pitcher and syringe in each patient room was labeled and used for 24 hours and then discarded. S/he stated new ones were put out in the morning by the night shift staff. That nurse did rinse the pitcher and syringe with clear water and set it aside in the bathroom sink area after completing the medication administration.

e. On multiple occasions during the survey, the policy for "Chemo Precautions was requested from numerous staff. The compliance specialist finally stated on 04/10/13 that there was not a specific "Chemo Precautions" policy, but the issues were covered in the "Medication Management for Hazardous Medications" policy. Review of that policy revealed the following, in part:
"I. PURPOSE
To provide guidelines for the handling of hazardous drug dosage forms.
II. POLICY
NIOSH (National Institute for Occupational Safety and Health) defines hazardous drugs as those that pose a risk due to: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, and structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.
Employees who compound, repackage, administer, or otherwise handle hazardous drugs shall adhere to the following guidelines for safe handling of hazardous drugs. Guidelines from the American Society of Health-Systems Pharmacist and other agencies, including OSHA, are used in the development of these procedures.
'Hazardous Precautions' shall indicate the need to use personal Protective Equipment in the minimal form of one pair of chemo-approved gloves when handling a medication so labeled. Additional Personal Protective equipment may be implemented when appropriate to the situation, i.e. non-permeable gown and facemask when pouring liquids or crushing tablets not contained in packaging.
III. PROCEDURE:
A. Storage bins and containers of all hazardous drugs listed in the most up to date NIOSH List of Hazardous Drugs will be labeled with 'Caution: Handle with Hazardous Precautions.' Individual dosage units may be labeled as hazardous when feasible (i.e. package size permits as with IV piggyback bags, large disposable containers,etc.) The Medication Administration Record will also indicate those medications that are hazardous.
B. Chemo-approved gloves should be worn when unpacking shipping crates containing hazardous drugs, crushing, compounding, or otherwise preparing a dose of a hazardous drug, or administering dose of a hazardous drug.
C. Counting, pouring, crushing, repackaging, or other manipulation of hazardous drug products should occur using equipment dedicated to hazardous drug use, and equipment should be cleaned immediately after use with sterile water and 70% isopropyl alcohol.
D. Crushing, opening, or dissolving tablets or capsules and pouring or other manipulations of liquid dosage forms should be performed utilizing non-permeable gowns and facemasks in addition to the use of chemo-approved gloves.
F. Disposal of unused dosage forms and their immediate containers should be via hazardous waste containers.
G. Spills
1. Liquid forms of medications will be absorbed utilizing a chemo spill kit. The directions on the spill kit should be followed.
2. Free powders (i.e., crushed medications) will be cleaned with a wet cloth or paper towel. A broom should NOT be used to contain the spill.
3. Solids should be picked up using chemo-approved gloves and whatever PPE is appropriate, with a cleaning of the general area of the spill with a wet cloth or paper towel.
4. Disposal of the spill materials should comply with hospital policy regarding disposal of EPA defined hazardous materials."

NOTE: The policy/procedure did not contain a list of current NIOSH drugs and the medical record, including the MAR did not identify the medication ( Zelboraf) as a NIOSH medication.

f. During the last two days of the survey, 04/10-11/13, the protocol/signage referred to in the facility action plan was repeatedly requested related to the identified concerns that the patient (#4 and #13) was being administered a hazardous chemotherapy drug "without proper protective equipment or precautions." Numerous administrative, nursing and pharmacy staff stated that a protocol had been prepared and posted during the initial hospitalization, to give direction to staff, but that it could not be located. The protocol was never received during the survey.

g. During the exit conference on 04/11/13, while the lack of written protocols/direction for safe administration of the Zelboraf was being discussed, the Director of Pharmacy made the statement that the medication was "not really a chemotherapy drug, but it was a NIOSH drug." The surveyor directed him/her to the medical record in which the patient's physicians referred to the medication as a chemotherapy medication and that the MAR's instructions did not label it as a NIOSH drug, but did direct use of "Chemo Precautions."


h. On 04/10/13 at 2:50 p.m., the hospital pharmacy was toured and interviews with the lead pharmacist and the Director of Pharmacy revealed that the lead pharmacist investigated the medication (Zelboraf) by looking on the Internet. They stated that they relied on the physician's approval of the directions (provided by the prescribing doctor/hospital), to crush the medication, even though there was no information in the literature approving crushing the medication. When asked about precautions for staff dealing with excretion of the medication, the pharmacist stated the medication was excreted primarily in urine. Both pharmacists stated that the patient had a catheter in place during the previous hospitalization (sample #13), so staff were able to protect themselves from exposure by urine. When asked to provide the information s/he had found to guide the staff in safe preparation and administration in the facility, s/he stated that s/he did not have anything to show me. When asked about the protocols being used by staff, they were under the impression that the staff were preparing the medication in the medication room utilizing personal protective equipment (PPE) located in the medication room and utilizing the open plastic sleeves, provided with the pill crusher by the manufacturer, to crush the pills. They stated that there was also PPE available in the patient's room. They were unaware that there was also a pill crusher in the patient's bathroom.

i. At the time of the tour, the pharmacists were asked to provide a copy of the protocols, that were referred to in the administrative plan, previously mentioned, which was supposed to direct staff in safe handling, preparation and administration of the medication. They stated that a protocol had been prepared during the previous hospitalization, but they did not have a copy of it. The pharmacist later brought information s/he had just printed up from the Internet. Review of the information s/he provided about Zelboraf from the Internet stated it was "Full Prescribing Information." It stated at the top of each page "Copy from GRASS PID2012-03759." Review of the information revealed the following, in part:
"INDICATIONS AND USAGE
Zelboraf is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma
2 DOSAGE AND ADMINISTRATION
Zelboraf should not be chewed or crushed
12 CLINICAL PHARMACOLOGY
Elimination
Following oral administration, approximately 94% of the doses was recovered in feces and approximately 1% was recovered in urine."

The information contained no information or direction for safe handling of the medication by nurses, safe crushing of the medication, or safe disposal of medication preparation and administration supplies, cleaning of equipment and disposal of urine and fecal contamination.

j. A subsequent tour of the medication rooms at approximately 4:00 p.m., with pharmacy and nursing staff revealed that there were no protocols or any outline of "Chemo Precautions" posted or other wise available in the medications rooms.

k. Interview conducted with another nurse on 04/10/13 revealed that s/he had prepared (crushed) the medication in the medication room, using the crusher in the medication room and was unaware that there was a crusher in the patient's bathroom.

Due to the nature of the deficiency, the hospital failed to comply with the Condition of Pharmaceutical Services. The hospital failed to ensure that adequately collaborate with nursing care, to provide the specialized pharaceutical expertice to create a protocol for safe administration of a hazardous chemotherapy drug by nurses to a patient in the facility.

The facility failed to meet the following standards under the Condition of Pharmaceutical Services:

A 492 - Pharmaceutical Services - Pharmacist Responsibilities
The Director of Pharmacy Services and other pharmacist failed provided adequate and detailed direction to nursing staff for safe handling of a hazardous medication being administered to a patient in the facility.

Based on tours/observations, staff interviews and review of facility documents, the lead pharmacist and Director of Pharmacy Services failed provided adequate and detailed direction to staff for safe handling of a hazardous medication being administered to a patient in the facility.

Findings:


The pharmacy staff failed to provide for safe handling of the hazardous chemotherapy agent Zelboraf by nurses, including safe crushing of the medication, disposal of medication preparation and administration supplies, cleaning of equipment and disposal of contaminated bodily waste and supplies, due to the patient's excretion of the medication.

Reference Tag A 405 - Nursing Services - Administration of Drugs for findings related to the failure to provide adequate information to the nurses administering the medication to ensure safety for nurses, other patients and visitors from inadvertent contamination by a hazardous medication.