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Based on staff interviews and review of facility documents, the hospital failed to ensure that the contracted services for clinical dieticians, laboratory services and pharmaceutical services were provided in a safe and effective manner.

Findings:

1. Clinical Dieticians:

Reference Tag A 621 for findings related to the hospital failure to ensure that dietary consultation was readily available for patients, because the facility did not have a dietary consultation policy and staff were unaware that dietary consultation services were available through a contract executed in May, 2008.

2. Laboratory Services:

Reference Tag A 724 for findings related to the hospital's failure to ensure that contract Laboratory Services supplies were maintained in a safe and effective manner.

3 Pharmaceutical Services:

Reference Tag A - 492 for findings related the hospital's failure to ensure that the contract Pharmacist developed, supervised, and coordinated the activities of the pharmacy services.

Based on tours/observations, staff interviews and review of Facility documents, the Hospital failed to ensure that staff had training in use and ready access to leather-grade shears in order to be able to quickly extract a patient from leather restraints in a medical or other emergency situation.

This failure created the potential for delay in responding to an emergency.

Findings:

1. The Facility did not have leather grade shears available.

a. On 10/31/12 at approximately 9 a.m., during a tour of Building C, the Director of Nursing (DON) and a Team Lead for the Mental Health Workers were interviewed about the use of seclusion and restraints in the facility. They confirmed that they utilized traditional leather cuff and strap restraints on the rare occasion that restraints were utilized.

When asked about availability of leather-grade shears for rapid extraction of a patient from restraints in an emergency situation, the Team Lead stated that they did have leather-grade shears, they were kept in the bag for the restraints, in the side pocket, along with the keys. S/he stated that the staff were all trained and familiar with the use of the shears as a part of their regular restraint training program. When asked if the staff had the opportunity to try use of the shears as a part of the training, s/he stated that they did.

b. On 10/31/12 at approximately 10 a.m., during a tour of Building C, the medication room was toured. Located in the room was a cart with emergency equipment, including the restraint bag. Staff present were asked to open the bag and locate the leather-grade shears. Staff were unable to locate the shears in the bag. When asked where the shears were, if not in the bag, a nurse went to the medication cart and got two pair of regular office shears that were not designed to cut leather. When asked if they had ever seen or been trained to use leather-grade shears for emergency patient extraction from leather restraints, they all stated that they had not.

c. During subsequent discussions with the Director of Nursing and the Administrator, they were unable to provide any leather-grade shears that were available for emergency use. They began to search on the internet for leather-grade shears and sent their plant operations manager to a local hardware store to attempt to obtain shears or another cutting instrument capable of cutting through the leather restrain straps for emergency patient extraction from restraints.

At the time of exit from the survey on 11/2/12, they had ordered several pairs of leather-grade shears from an internet supplier. They stated that they would train staff to use the shears, once they arrived and establish a routine check of the restraint bags, to ensure that the shears were always available in an emergency. They also stated that the use of shears for emergency extraction would be incorporated into their restraint/seclusion policy.

Based on observation, and interviews the Facility failed to ensure that medications were prepared and administered in accordance with acceptable standards of practice.

This failure created the potential for administration of contaminated medications.

FINDINGS:

1. The Facility did not label multidose vials to reflect the penetration date so that the medication could be discarded after 28 days.

The United States Pharmacopeia (USP) General Chapter 797 recommends that multi-dose vials should be discarded whenever sterility is compromised or questionable. If a multi-dose vial is accessed the vial should be dated and discarded within 28 days or according to manufacturer's instructions. http://www.cdc.gov/injectionsafety/provider/provider_faqs_multivials.html.

a) During a tour of the Facility's nurses station on 10/31/12 at 9:30 a.m., an inspection of the patient medications was conducted. Five multi-dose vials of insulin were found in the medication refrigerator that were open and penetrated. The vials were not labeled with patient names and were not dated to reflect when they were initially penetrated.

b) The Facility policy "Medication Administration" stated that multi-dose vials were to be labeled with the date opened and discarded "according to manufacturer's instruction or after 30 days from the date opened." During a subsequent interview the Director of Nurses and the Quality manager acknowledged that the Facility's policy of discarding multi-dose vials after 30 days was did not meet the national 28 day standard of practice.

c) During an interview on 10/31/12 at 9:30 a.m., 2 Registered Nurses (RN) acknowledged that the multi-dose vials were not dated and admitted that they knew that multi-dose vials were required to be dated when opened. A second inspection was conducted on 11/02/12 at 9:30 a.m., the multi-dose vials had not been discarded and were not dated.

Based on observation, document review and interviews, the Facility failed to ensure that the Pharmacist developed, supervised, and coordinated the activities of the pharmacy services.

This failure created the potential for unsafe medication use processes.

FINDINGS:

1. The Facility did not ensure the implementation of the Pharmacist's responsibilities.

a) During a tour of the nurse's station, which contained the patient medications, five open multidose vials of injectable insulin were observed in the medication refrigerator. The multidose vials had not been marked with the date that the vial was opened, or with any patient's name. The medication refrigerator also contained medications from patients that had been discharged in September of 2012.

One of the medications belonged to a former patient who returned to the Facility to have the medication administered. During an interview on 10/31/12 at 9:30a.m., a staff Registered Nurse (RN) stated that the medication was kept for a former patient who would come to the Facility to be escorted to an affiliated mental health center for administration of the medication.

b) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3. B. stated that the Pharmacist would check the medication storage facilities and medication carts "at least quarterly" for proper storage of medications, and removal of expired medications.

The agreement between the Facility and the Pharmacy stated that the Pharmacy would provide the services of a "Consultant Nurse". The Consultant Nurse would be responsible for performing monthly medication room reviews, medication cart reviews and medication pass review. Written reports were to be submitted to the Facility monthly.

The Pharmacy's policy "Expired medications and Medications with Shortened Expiration Dates" stated that the Pharmacist's nurse consultant would review the medication system monthly.

A review of the nurse consultant's "Medication Cart Review" documentation revealed that the Nurse Consultant reviewed the medication cart in September, October, November and December of 2011. S/he reviewed the medication cart in May and August of 2012. The reports do not indicate what action the Consultant Nurse took regarding issues discovered during the Medication Cart Review.

2. The Pharmacist did not follow the Pharmacy's policies related to service requirements.

a) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3.L. stated that the Pharmacist would assist the Administrator and Pharmaceutical Subcommittee in "developing, implementing, and monitoring policies and procedures" for safe and effective distribution, control and use of medications.

There was no evidence that the Pharmacist assisted the Administrator in developing, implementing and monitoring Facility policies. The Facility provided a book of the Pharmacy's corporate policies for review. There was no evidence that the policies had been reviewed or approved by the medical staff for incorporation into the Facility's policy and procedure system. The corporate policies are kept in a binder in an administration office and are not available to staff.

b) The Pharmacy's policy "Consultant Pharmacist Quarterly Report" stated that the Pharmacist would prepare quarterly written reports on the status of the Facility's pharmaceutical services and nursing staff performance related to medication therapy. The policy further stated that the Pharmacist's report would include recommendations for improvements to the medication systems, pharmaceutical service and ways to correct or prevent noncompliance related to medication administration. The report would summarize medication statistics for the period and render an assessment of nursing staff compliance and pharmacy services.

The Pharmacy's "Facility Pharmacy Inspection Report" was reviewed. The document did not contain documentation of a medication statistical summary, evaluation of the medication systems, assessment of nursing staff compliance or recommendations for improvements. The document does not acknowledge or address the findings of the Nurse Consultant and no action was documented that addressed patterns of improperly tabled, expired or discharged patient medications.

c) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3. N. stated that the Pharmacist would serve on Facility committees as required or requested, "including but not limited to Quality Assurance Committee."

In an interview on 11/01/12 at 2:00 p.m., the Pharmacist stated that he spent one hour at the Facility quarterly and attended the Pharmacy and Therapeutics committee meetings, however, s/he admitted that s/he did not attend the Facility's Quality Committee meetings.

d) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3. K. stated that the Pharmacy would assist in the destruction of unused controlled substances and non-controlled substances.

During a tour of the nurses station, patient medications were observed in the pyxis and in the medication refrigerator.

In an interview on 10/31/12 at 9:00 a.m., the Director of Nurses (DON) stated that s/he routinely destroyed medications and was in the process of developing an agreement with a company to assist with the destruction of medications.

e) A review of the Board Meeting Minutes from 09/13/12 revealed that critical incident reports from the 4th quarter Quality Assurance Committee report showed a high number of medication errors had been reported. The report states that medication errors may have contributed to a patient's length of stay due to "missed doses, and delayed delivery of drugs by pharmacy."

A review of the Pharmacy Therapeutics meeting minutes from 03/28/12 showed discussion related to untimely medication delivery.

In an interview on 10/31/12 at 9:00 a.m., 2 staff RN's stated that there had been complaints regarding the Pharmacy's medication delivery response, particularly during off hours.


f) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3. J. stated that the Pharmacy would assess the performance of nursing staff in medication administration through the process of medication pass observation, as requested by nursing and administration, and as necessary.

There was no documentation of medication pass observations conducted by the Consultant Nurse. There was no evidence of communication of the findings reported by the Consultant Nurse to nursing administration or quality.

Based on observation and interviews the Facility failed to ensure that outdated, mislabeled or otherwise unusable drugs and biologicals were not available for patient use.

This failure contributed to the findings of unusable and expired medication in the patient medication area.

FINDINGS:

1. The Pharmacy did not follow its policy to maintain an inspection and inventory management system sufficient to ensure that medications were properly labled, dated and removed from the medication storage area.

a) During a tour of the nurse's station, which contained the patient medications, five open multidose vials of injectable insulin were observed in the medication refrigerator. The multidose vials had not been marked with the date that the vial was opened, or labled with any patient's name. The medication refrigerator also contained medications from patients that had been discharged in September of 2012.

b) The Pharmacy's policy "Consultant Pharmacist Services-Requirements" 3. B. stated that the Pharmacist would check the medication storage facilities and medication carts "at least quarterly" for proper storage of medications, and removal of expired medications.

The Pharmacy's policy "Expired medications and Medications with Shortened Expiration Dates" stated that the Pharmacist's nurse consultant would review the medication system monthly. The Consultant Nurse would be responsible for performing monthly medication room reviews and medication cart reviews. Written reports were to be submitted to the Facility monthly.

A review of the nurse consultant's "Medication Cart Review" documentation revealed that the Nurse Consultant reviewed the medication cart in September, October, November and December of 2011. S/he reviewed the medication cart in May and August of 2012. The Consultant Nurse documented outdated medications and medications from discharged patients in the medication cart, however, the reports did not indicate what action the Consultant Nurse took regarding issues discovered during the Medication Cart Review.

Based on staff interviews and review of facility documents, the hospital failed to ensure that dietary consultation was readily available for patients, because the facility did not have a dietary consultation policy and staff were unaware that dietary consultation services were available through a contract executed in May, 2008.

FINDINGS:

Dietary Consults Availability:

a. On 10/31/12 at approximately 9 a.m., during a tour of Building C, the Director of Nursing (DON) and a Team Lead for the Mental Health Workers were interviewed about the dietary services provided by a local caterer. They were asked about the availability of a clinical dietician to provide dietary consults when needed. They both stated that the caterer had a dietician that supervised the meal planning and ensured that all diets, including special diets were supplied to the patients. They stated that the dietician did not come to the hospital to do dietary consults. The director of nursing stated that the nurse practitioners and nurses were familiar with dietary issues and were able to meet the needs of the patient. S/he reiterated that they did not have a dietician that came to do dietary consults for individual patients. The DON was unaware that there had ever been a request for a dietary consult for a patient.

b. On 10/31/12 at approximately 1 p.m., the Administrator was interviewed about dietary services and stated that the facility had a contract with a local acute care hospital to provide clinical dietary services. S/he stated that s/he was surprised to hear that the staff interviewed (including the DON), were not aware that dietary consultation services were available. S/he later provided a copy of the contract for inspection.

c. On 10/31/12, the contract for dietary services, provide by the Administrator, was reviewed. The contract was executed in May, 2008. The contract contained an addendum list of 10 registered dieticians from the acute care hospital that were available to provide dietary consultations for the hospital's patients, when needed.

d. Personnel files for the dieticians and a hospital dietary consult policy were requested from the administrator on 10/31/12 and 11/01/12. On 10/31/12, the Administrator confirmed that the hospital did not maintain personnel files on the contract dieticians. On 11/01/12, the Administrator, the DON and the Director of Quality all confirmed that the facility did not have a policy in place to notify and guide staff and physicians to obtain dietary consultations for patients, when they might have been clinically indicated.

Based on tours/observations, staff interviews and review of facility documents, the hospital failed to ensure that supplies and equipment, including lab testing supplies, emergency and biomedical equipment were maintained to ensure an acceptable level of safety and quality.

Findings:

1. Laboratory Supplies/Equipment:

a. On 10/31/12 at approximately 10 a.m., during a tour of Building C, the medication room was toured. In a supply cabinet, test tubes for blood draws were inspected. Three flats of test tubes, one contained blue tubes, one containing red tubes and one containing green tubes were found. with expired dates on the tubes. The oldest expiration date was 10/11. The nurses stated that the tubes had just recently been delivered by the contract acute care hospital, that received the blood samples and conducted the tests as part of a contractual agreement to provide laboratory services. A nurse on the unit immediately placed all of the expired test tubes in a sharps container, so that they would not be available for use for future blood-draws.

b. On 10/31/12 at approximately 11 a.m., the Administrator confirmed that the hospital had a contract with a local acute care hospital to provide all laboratory services for the patients, except for a few point-of-care tests, such as rapid strep, glucometer and pregnancy testing, that the nurses conducted onsite.

Inspection of the point-of-care testing supplies during the tour on 10/31/12, revealed that none of the bottles of controls or re-agents for the kits were dated when they had been opened, therefore there was no way to determine if they were still effective. When asked if they had a policy or other guidance from the laboratory about how long a control/re-agent could still be use and considered effective, they stated that they did not have a policy/guidance and were not sure how long the bottles had been opened.

2. Emergency Supplies/Equipment:

a. On 10/31/12 at approximately 10 a.m., during a tour of Building C, the medication room was toured. During the tour, a cart with emergency equipment, including an emergency bag (containing oxygen masks, tubing and personal protective equipment), an AED (automated external defibrillator), back board (for chest compressions), and a restraint bag (containing leather cuffs, straps and keys). Several oxygen tanks were on portable stands in the area of the cart. Staff stated that the suction machine was in the kitchen/dayroom area of the building. Review of the area revealed that there was no apparent check-list or regular inspection system for the emergency equipment. When asked about checking the AED, the staff said that it was not routinely checked. The DON stated that the battery had recently been replaced. The staff said that they previously had a full emergency resuscitation cart and had changed to an emergency bag. They stated that the previous system was able to keep all of the supplies for and emergency in one place.

During the tour it was also determined that the restraint bag did not contain the leather-grade shears for emergency removal of restraints. A Team Lead for the Mental Health Workers had previously stated on the tour the leather shears were to be located in the restraint bags. In addition, it was determined that the emergency suction machines were not kept with the rest of the medical equipment and not regular checked to make sure they were located where they were supposed to be and that they were functioning properly. It was also determined during the interview that the suction machines were electric with cords, so that they potentially would not have suction capability if the patient was not in close proximity to an electric outlet when emergency suction was needed or if there was a power outage during an emergency.

b. On 11/01/2012 at 11:15 a.m., the facilities manager was interviewed about the emergency generator system to supply emergency power to parts of the hospital in the event of a power outage. During the interview, it was confirmed that the sleeping wings of the two in-patient buildings (C and D Buildings) did not have red emergency outlets to supply power during an outage. S/he stated that the thought was that patients would be moved to the dayroom sections of the buildings, where there were plenty of emergency outlets, during a power outage. S/he was asked about power supply to the emergency suction machines. S/he stated that there extension cords stored in each of the buildings, but agreed that a battery-powered suction machine would be a quicker option in an emergency or power outage. S/he stated that s/he would work with the administrator to order a battery-powered suction machine for each in-patient building (C and D).

3. Biomedical Equipment:

a. On 10/31/12 at approximately 10 a.m., during a tour of Building C, the medication room was toured. During the tour, it was observed that biomedical equipment, such as vital signs machines, weight scales, suction machines and oxygen concentrators did not have a tag indicating routine preventive maintenance inspections.

b. On 11/01/2012 at 11:15 a.m., the facilities manager was interviewed about preventive maintenance. S/he stated that his/her department did not conduct biomedical equipment maintenance because the department did not have the specialized training to conduct those kinds of inspections. S/he suggested that the Director of Nursing (DON) might be aware of biomedical inspection and maintenance activities. In a subsequent interview with the DON and the administrator on 11/01/12 at approximately 2:30 p.m., they confirmed that there was no current system in place to conduct and tract routine biomedical inspections and repairs. They stated that they would institute a system for biomedical inspections going forward.