The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
|BALDPATE HOSPITAL||83 BALDPATE ROAD GEORGETOWN, MA||Nov. 15, 2012|
|VIOLATION: PHARMACEUTICAL SERVICES||Tag No: A0490|
|Based on review of documents, interviews and observations, the Hospital failed to ensure that:
1.) All aspects of the contract between the Hospital and the local Pharmacy were in compliance with Pharmacy regulations for hospitals.
2.) Drug storage areas were administered in accordance with accepted professional principles.
3.) The consulting pharmacist was responsible for developing, supervising, and coordinating all the activities of the pharmacy services.
4.) Records were kept for the disposal of destroyed scheduled medications.
5.) Proper ventilation, light, and temperature controls in pharmaceutical areas were maintained in all pharmaceutical areas.
Tag # A-491 (Medication storage)
Tag # A-492 (Pharmacist responsibilities)
Tag # A-494 (Medication receipt and distribution of scheduled drugs)
Tag # A-276 (Physical plant)
|VIOLATION: CHIEF EXECUTIVE OFFICER||Tag No: A0057|
|Based on interviews with the Complainant and Hospital staff, the Hospital failed to ensure that the Chief Executive Officer (CEO)/Owner effectively managed the Hospital because: 1.) the CEO gave her personal prescribed medication to an employee and 2.) the CEO employee dispose of medications in a manner that was not in accordance with acceptable practice standards.
1.) The correspondence from the Complainant received by the Department of Public Health on 11/7/12 indicated that "the CEO/Owner has been stealing prescription medication and feeding me for years". "Mostly Lisinopril for my blood pressure."
The CEO/Owner was interviewed on 11/15/12 at 1:05 P.M. The CEO/Owner said that she gave the Complainant Lisinopril from her personal supply of prescribed medications.
The Complainant was interviewed on 11/14/12 at 12:50 P.M. The Complainant said that the CEO provided him/her with Lisinopril.
105 Code of Massachusetts Regulations (CMR): Department of Public Health (DPH) 700.0000 indicated that dispensing of a controlled substance, Lisinopril, a scheduled VI medication, without a registration was a violation.
2.) The Complainant also indicated that the CEO/Owner had the Facility's Maintenance Assistant and the Complainant "destroy dozens of garbage bags full of narcotics in the garage so she wouldn't have to pay nurses to do it". The Complainant said "We ran everything through a shredder and poured the medications into a bucket of cat litter". The Complainant indicated the (former) Director of Nursing was in the CEO/Owner's office and witnessed the destruction of the medications and witnessed the Complainant and the Facility's Maintenance Assistant lug bag after bag of pills down the stairs (from the CEO/Owner's office) into the bed of the work truck.
The Complainant said that he/she and Facility's Manager destroyed dozens of garbage bags full of medications that were stored in the CEO/Owner's office.
The CEO/Owner said that the medications were collected, accumulated and stored in her office because the Hospital was conducting a study. The CEO/Owner said that the study was done because a lot of medications were wasted due to over ordering. The CEO/Owner said that some of the medications in the study were Bentyl (used to treat irritable bowel syndrome), Catapres (used to treat high blood pressure), Tigan (used to treat nausea) and Gabapentin. The CEO/Owner said that there were numerous cards (blister packaging containing medications which pop out of the blister) completely filled with medications that were stored in a locked room in her office. The CEO/Owner said that when the study was finished, the Complainant was directed to put the medications into red biohazardous bags, remove the bags of medications from her office and take the bags away for disposal. The CEO/Owner said that the medications in the red biohazardous bags were non-accountable medications (medications that are not narcotics, not anti-psychotics, not-Benzodiazepines, or other medications that by regulations the Hospital must keep accurate numerical records).
3.) Refer to Tag 494, #1 and #2 regarding interviews with Nurse #1, #2, and #3 regarding the procedure for medication disposal and confirmation that wasted medications were placed in the trash for disposal.
4.) Refer to Tag A 083, regarding the interview with the Waste Management Company Representative indicating the Hospital has no contract for the disposal of medications.
|VIOLATION: CONTRACTED SERVICES||Tag No: A0083|
|Based on review of Hospital contracts and interviews, the Hospital failed to ensure that 1.) the contract between the Hospital and the Pharmacist complied with the Condition of Participation of Pharmacy Services and 2.) the Hospital had a contract for the disposal of medications.
1.) The contract between the Hospital and the local Pharmacy, signed on 3/19/12, indicated that the services provided will be in compliance with the Joint Commission, Center for Medicare and Medicaid Services (Federal Hospital Regulations), Department of Mental Health, Department of Public Health and other accrediting body's standards.
The Pharmacist was interviewed on 11/13/12 at 12:30 P.M. The Pharmacist said that his responsibilities included filling patient prescriptions, delivering prescription medications and attending Pharmacy and Therapeutics Committee meetings. The Pharmacist said that he did not have responsibility for medication policy development or review of such policies, storage of medications or ordering over-the-counter medications. The Pharmacist did not know how the Hospital was disposing of medications, including narcotics. The Pharmacist said that he thought the Hospital had a contract with a Waste Management Company for destroying medications, but was not aware of the details.
2.) The Hospital did not have written policies or procedures for the disposal of any category of medications, including narcotics.
The contracted Waste Management Company Customer Service Representative was interviewed on 11/20/12 at 1:05 P.M. The Customer Service Representative said that the Hospital's disposal contract did not include any medication disposal services. The Customer Service Representative said that medication disposal services are provided at an additional cost.
|VIOLATION: PHARMACY ADMINISTRATION||Tag No: A0491|
|Based on observations, review of documents and interviews, the Hospital failed to ensure that all areas where pharmaceuticals were stored were under the oversight of the contracted Pharmacist.
1.) Observations made on 11/13/12 at 9:40 A.M. of the maintenance department building, commonly known as the "garage", revealed that the building was a very old wooden structure. On entry, the building was dark, cluttered and contained wooden work benches, tools and supplies for building maintenance. The room had a musty smell. Inside the work room, to the left, and up a wooden ramp were two additional rooms. The room on the left, at the top of the ramp contained a smaller locked room. The Facility Manager unlocked the door and the Surveyors observed a supply of medications stored on shelves. The medications observed by the Surveyors included aspirin, vitamins, Tums, Zantac, calcium, Maalox, Milk of Magnesia, and cough medicines.
2.) The Surveyor observed on 11/14/12 at 3:00 P.M. antibiotics, anti-seizure, anti-psychotic, and other over-the-counter medications stored in a locked closet in the former Director of Nursing's office.
3.) The Hospital policy titled Medication Storage indicated that the pharmacist will conduct monthly inspections of all medication areas and complete an inspection report.
4.) The Pharmacist was interviewed on 11/13/12 at 12:30 P.M. The Pharmacist said that he was not aware of, nor was he responsible for the oversight of the storage of over-the-counter medications.
5.) The monthly Inspection Reports for 2012 completed by the Contracted Pharmacist, indicated that only two inspection reports were completed. One report was dated 4/10/12 and the second report's date was illegible. The reports indicated that the storage area in the garage and the former Director of Nursing's office, where medications were observed, were not included on the monthly inspection reports as required by Hospital policy.
|VIOLATION: PHARMACIST RESPONSIBILITIES||Tag No: A0492|
|Based on review of documents and interviews, the Hospital failed to ensure that: 1.) the contracted pharmacy service was responsible for developing, supervising and coordinating all the activities of the pharmacy services and 2.) all elements of the contract were implemented, including the storage and disposal of medications.
1.) The Pharmacist was interviewed on 11/13/12 at 12:30 P.M. The Pharmacist said that his responsibilities included filling medication orders for patients, checking for allergies, contraindications, interactions, and delivery of the prescription medications that were ordered. The Pharmacist said that he attends the Pharmacy and Therapeutics Committee meetings which are held every three months. The Pharmacist said that he had no other responsibilities for pharmacy services.
2.) The Pharmacist had no knowledge of the Hospital's medication waste or disposal procedures, reversed distribution (disposal procedures), or medication storage procedures at the Hospital. The Pharmacist said that he did not have responsibility for medication policy development or the review of any existing policies and procedures. The Pharmacist did not know who was responsible for ordering the Hospital's over-the-counter medications, nor was he responsible for overseeing the administration, waste or disposal of medications. The Pharmacist said that he did not know if the Waste Management Company was responsible for the disposal of narcotics.
Please also see Tag # A-491
|VIOLATION: PHARMACY DRUG RECORDS||Tag No: A0494|
|Based on review of documentation, observations and interviews, the Hospital failed to:
1.) develop a policy and procedure for the disposal of wasted narcotics
2.) develop and policies and procedures for the wasting and disposal of accountable medications (medications including narcotics that have a potential for abuse or addiction, held under strict governmental control, as delineated by the Comprehensive Drug Abuse Prevention & Control Act) and
3.) maintain accurate disposal records of controlled medications.
Interviews with Nurse #1, #2, and #3 indicated inconsistent methods for the disposal of scheduled medications. For example:
1.) Nurse #1 was interviewed on 11/13/12 at 1:20 P.M., Nurse #2 was interviewed during a tour of the Hospital Unit on 11/13/12 at 10:15 A.M. and Nurse #3 was interviewed on 11/13/12 during a second tour of the Hospital Unit at 11:30 A.M.
During a tour of the Hospital Unit on 11/13/12 at 10:00 A.M. a locked-slot (similar to a mail-box slot) was observed on the Nurses Station desk. This locked-slot on the nurses' desk led to a container under the desk that collected the wasted accountable medications and narcotics. Periodically, the container was unlocked by two licensed nurses with authority to destroy the medications. However, the Hospital had no policy for the destruction of these medications.
2.) Nurse #1 said that she and another nurse, either a supervisor or staff nurse, removed the accountable medications from the locked-slot container. Nurse #1 said that she and the other nurse then destroyed the medication by putting the medication in a cup of hot water, then putting the debris in a blue glove (non sterile examination glove) which she and the other nurse then put into a bucket of cat litter. The bucket of cat litter containing the destroyed medications was then removed by the maintenance department for disposal in the Hospital trash. However, the Hospital had no policy for the destruction of these medications. Nurse #1 said that she did not know the final disposition of the trash.
Nurse #2 said that when accountable medications were no longer needed for a patient, the accountable medications were placed into the locked-slot until the medication was destroyed. Nurse #2 said only the nursing supervisors have access to the locked container of medications.
Nurse #3 said that she was the Charge Nurse of the Hospital Unit. Nurse #3 said that she destroyed non-narcotic and non-accountable medications that were no longer needed. Nurse #3 said that she melts the non-narcotic, non-accountable medications in hot water and then pours the debris into a glove. Nurse #3 said she then placed that glove inside another glove and placed it in the red biohazardous square box located in a locked closet on the nursing unit. Nurse #3 said that the maintenance department empties the red biohazardous boxes.
The Hospital's policy titled Narcotic Waste included a process for wasting narcotics. However, there was no policy for disposal of wasted narcotics.
The Hospital policy titled Accountable Drugs did not include a process for wasting accountable medications and did not include a process for the disposal of accountable drugs.
|VIOLATION: VENTILATION, LIGHT, TEMPERATURE CONTROLS||Tag No: A0726|
|Based on observation of the maintenance department building, commonly known as the "garage", on 11/13/12 at 9:40 A.M., the Hospital failed to store sterile supplies and hospital pharmaceuticals according to the manufactures recommendations and ensure there was proper lighting, ventilation, and temperature controls.
1.) During a tour of the maintenance department "garage" on 11/13/12 at 9:40 A.M., the Surveyors did not observe any humidity or temperature control mechanisms. There was no tracking log maintained to ensure that appropriate temperature and humidity levels were maintained. The Surveyors observed the following stored in the garage
a.) sterile supplies, syringes, hypodermic needles and lancets (blood testing equipment), bandages, gauze and suture removal kits
b.) non-sterile supplies, including examination gloves, face masks, hydrogen peroxide, rubbing alcohol, nebulizers and oxygen tubing for respiratory treatments, also stored on shelves.
c.) non medical supplies such as grout cleaner, toilet paper and plastic eating utensils, stored in the same room with over-the-counter medications.
d.) a pink plastic bucket on the top shelf used to collect water from a leaking ceiling. The leaking ceiling is a venue for water contamination and places the items in the storage room at risk for contamination.
e.) Hospital patient mattresses, covered in plastic were in a second room at the top of the wooden ramp. The room was dark, cluttered and smelled musty. Other tools and maintenance department supplies were stored in this room.
2.) The Facilities Manager was interviewed on 11/13/12 at 9:40 A.M. The Facilities Manager denied problems with insects or mice, however, he said that he needed to patch holes in the garage because in the Spring, squirrels were getting in.
Please refer to Tag # A-491.