HospitalInspections.org

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Based on observation, interview, and document review, the Critical Access Hospital failed to meet the requirements for the Condition of Participation for Provision of Services.

Failure to meet established service requirements and responsibilities for Pharmacy services impaired the hospital's ability to provide quality care in a safe environment.

Findings included:

The hospital pharmacy failed to establish and implement processes for procurement, distribution and maintenance of a system of accountability for all drugs, failed to provide a pharmacy review of patient own medications, and failed to ensure that staff completed a monthly inspection of all nursing care units or other areas of the hospital where medications are dispensed, administered or stored.

Cross Reference: C0271

The hospital failed to implement a processes to provide a pharmacy review of patient own medications, failed to ensure that staff completed a monthly inspection of all nursing care units or other areas of the hospital where medications are dispensed, administered or stored, and failed to develop and implement a process for periodic monitoring of controlled substances records.

Cross Reference: C0276

The hospital failed to establish and implement processes for procurement, distribution and maintenance of a system of accountability for all drugs, failed to establish effective procedures and maintain adequate records regarding use and accountability of controlled substances, and failed to ensure that medications were kept under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security.

Cross Reference: C0297

The hospital failed to ensure that medications were administered on the order of a licensed independent practitioner and failed to ensure nursing staff administered medications as directed by the order of a licensed independent practitioner.

Due to the cumulative effect of these findings, the Condition of Participation at 42 CFR 485.635 Provision of Services was NOT MET.

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Based on observation, interview, and document review, the hospital failed to implement a processes to provide a pharmacy review of patient own medications 20 of 22 patients (Patient #501, #502, #503, #504, #505, #506, #507, #508, #509, #510, #511, #512, #513, #514, #515, #516, #517, #518, #519, and #520) (Item #1), failed to ensure that staff completed a monthly inspection of all nursing care units or other areas of the hospital where medications are dispensed, administered or stored (2 of 2 storage locations) (Item #2), and failed to develop and implement a process for periodic monitoring of controlled substances records (Item #3).

Failure to ensure that medications management quality processes for control, preparation, distribution, storage, security, and use are implemented puts patients at risk of serious harm.

Findings included:

Item #1 Pharmacy Review of Patient Own Medications

Reference: WAC 246-873-070-(3) Patient's drugs. The hospital shall develop written policies and procedures for the administration of drugs brought into the hospital by or for patients.
(a) Drugs brought into the hospital by or for the patient shall be administered only when there is a written order by a practitioner. Prior to use, such drugs shall be identified and examined by the pharmacist to ensure acceptable quality for use in the hospital.

1. Document review of the hospital's policy and procedure titled, "Patients Own Medications (Usage in the LTC Setting)," no policy number, reviewed 03/19, showed that a remote hospital site pharmacist or on-site consultant pharmacist must examine, positively identify, and evaluate the integrity of the medication. For medication refills or newly ordered medications, the nurse will send all needed information to the pharmacy of choice for the patient to be sent to the hospital. These medications will not need to be verified by medication review as they are sent directly from a licensed pharmacy."

2. On 06/25/19 at 10:50 AM, Surveyor #5, a Registered Nurse (Staff #503), and the Director of Clinical Services (Staff #501) inspected the hospital's Pharmacy. Surveyor #5 observed 5 bins located on a shelf that contained bottles of prescription medications for patients #501, #502, #503, #504, and #505. An outside community pharmacy label was affixed to each bottle.

3. At the time of the observation, during interview with Surveyor #5, Staff #501 stated that for all the swing bed patients, the medications were treated as "patient own medications." She stated that because the medications came from another pharmacy, the hospital's pharmacy did not need to identify or examine the medications. Staff #501 confirmed this included all 20 patients in the swing bed program. Staff #501 stated that the hospital did not have a contract with any outpatient pharmacy to provide these services.

Item #2 Monthly Inspection

Reference: WAC 246-873-080- Drug procurement, distribution, and control (1) (b) A monthly inspection of all nursing care units or other areas of the hospital where medications are dispensed, administered or stored. Inspection reports shall be maintained for one year.

1 Document review of the hospital's policy and procedure titled, "Floor Stock," no policy number, reviewed 03/19, showed that the remote hospital site will inspect all floor stock supplies on a weekly basis as outline in their policies and the Pharmacy Department will maintain the report of inspection. Drug supply dating in the remote hospitals automatic dispensing machine will be electronically monitored by the Pharmacy Department Electronic printouts of al medications that will outdate within the next two days are encouraged.

2. On 06/26/19 at 9:30 AM, Surveyor #5 asked for the pharmacy monthly unit inspection records. Surveyor #5 reviewed the records and observed that the records did not include medication preparation, administration, or storage areas for patients in the hospital's swing bed program.

2. At the time of the observation, the Director of Pharmacy (Staff #505) stated that he did not inspect areas where "patient own medication" are prepared, stored, or administered, or the refrigerator located in the long-term care area (patients admitted to the hospital's swing bed program).

Item #3 Controlled Substance Audits

Reference: WAC 246-873-080-(f) Periodic monitoring of controlled substances records shall be performed by a nurse or a pharmacist to determine whether the drugs recorded on usage records have also been recorded on the patient's chart.

1. Document review of the hospital's policy and procedure titled, "Medication Management Program," showed that the hospitals pharmacy and designated members of the institution work together to develop, implement, and evaluate the hospital wide medication management assessment and evaluation program. The core medication management processes carried out by the organization include selection and procurement, storage, and ordering. In addition, transcribing, preparing and dispensing, administration, and monitoring effects and side effects on patients. This data is collected on all the stated processes over time.

2. On 06/27/19 at 9:00 AM, Surveyor #5, the Director of Clinical Services (Staff #501), and the Hospital Administrator (Staff #502) reviewed the hospital's quality program including the pharmacy quality program. Surveyor #5 found no evidence that pharmacy or nursing staff conducted periodic monitoring of controlled substances records were performed to determine whether the drugs recorded on usage records have also been recorded on the patient's chart.

3. At 9:45 AM, the Director of Pharmacy (Staff #505) joined the review to discuss the hospital's process for controlled substance monitoring related to the prior observation that acquisition and control of medications including narcotics for patients admitted to the hospital's swing program were not under the purview of the hospital's pharmacy. At this time, Staff #505 stated that he audited the acute care patients but did not keep record of the audits. Staff #501 stated that she audited for the swing bed program but did not keep any records or patient names for the audits.

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Based on observation, interview, and document review, the hospital failed to establish and implement processes for procurement, distribution and maintenance of a system of accountability for all drugs for 20 of 22 patients (Patients #501, #502, #503, #504, #505, #506, #507, #508, #509, #510, #511, #512, #513, #514, #515, #516, #517, #518, #519, and #520)(Item #1), failed to establish effective procedures and maintain adequate records regarding use and accountability of controlled substances for 9 of 9 patients (Patient #501, #506, #507, #509, #512, #515, #516, #519, and #520) (Item #2), and failed to ensure that medications were kept under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security (Item #3).

Failure to ensure that medications management quality processes for control, distribution, storage, and security are implemented puts patients at risk of serious harm.

Findings included:

Item #1 Procurement, Preparation, Control, Storage, and Distribution of all Medications

Reference:

WAC 246-873-080- Drug procurement, distribution, and control 1) General. Pharmaceutical service shall include: (a) Procurement, preparation, storage, distribution and control of all drugs throughout the hospital.

WAC 246-873-080- Drug procurement, distribution, and control (3) The director shall be responsible for establishing specifications for procurement, distribution and the maintenance of a system of accountability for drugs, IV solutions, chemicals, and biological's related to the practice of pharmacy.

1. Document review of the hospital's policy and procedure titled, "Medication Management Program," no policy number, reviewed 08/18, showed that a medication management assessment and evaluation program identifies risk points (including medication errors and adverse drug reactions) and areas to improve patient safety as well as the overall use of medications throughout the organization. The hospitals Pharmacy Department will provide fundamental functions as well as key oversight responsibilities and activities in the system of medication management. The following functions and activities will be performed by the Pharmacy Department including:

-Medication selection and procurement;

-Medication storage;

-Adequate medication inventory space;

-Oversight of ordering and transcribing processes;

-Medication preparations;

-Dispensing of medications;

-Direct and indirect scheduled medication security and control;

-Drug floor stock distribution;

-Monitoring and evaluation of drug utilization.

2. On 06/25/19 at 10:50 AM, Surveyor #5, a Registered Nurse (Staff #503), and the Director of Clinical Services (Staff #501) inspected the hospital's Pharmacy. Surveyor #5 observed 5 bins located on a shelf that contained bottles of prescription medications for patients #501, #502, #503, #504, and #505. An outside community pharmacy label was affixed to each bottle.

3. At the time of the observation, Surveyor #5 asked Staff #501 and #503 to describe the hospitals medication procurement practice. Staff #501 stated that they were the patient medications for patients in the hospital's swing bed program. She stated that the physician wrote an order for the patients "own medications," the nursing staff faxed the orders to the local pharmacy, and the local pharmacy delivered the patients "own medications" to the nursing department where the patient was located each month. Surveyor #5 asked how the hospital's pharmacy department was involved in the procurement and control of medications throughout the hospital. Staff #501 stated that the medications were treated as "patient own medications" and because the medications came from another pharmacy, the hospital's pharmacy was not responsible for these medications. Staff #501 stated that the hospital had 2 acute inpatient admissions and that the pharmacy managed the medications only for the acute inpatients.

4. On 06/26/19 at 9:15 AM, during interview with the hospital's Pharmacist (Staff #505), Surveyor #5 asked him to describe the hospital pharmacy's role in procurement, distribution, control, and accountability of patient medications throughout the hospital. Staff #505 stated that the hospital's pharmacy had no oversight of any medications prescribed for the "swing bed patients." The hospital treated these medications as 'patient own medications" and therefore the pharmacy did not - procure, store, inventory, prepare, dispense, or have oversight of control or security for any of the "patient own medications." Surveyor #5 asked for clarification that for 20 of 22 patients in the hospital, the pharmacy did not oversee medication procurement, distribution, or storage. Staff #505 confirmed this statement was correct.

5. On 06/26/19 at 10:00 AM, Surveyor #5 and a Licensed Practical Nurse (Staff #504) inspected the medication cart for the West Wing Swing Bed patients. Surveyor #5 observed 15 bins located in the medication cart that contained bottles of prescription medications for patients #506, #507, #508, #509, #510, #511, #512, #513, #514, #515, #516, #517, #518, #519, and #520. An outside community pharmacy label was affixed to each bottle.

6. At the time of the observation, Staff #504 stated that a provider writes a prescription for the patient's own medication and then nursing staff fax the prescription to an outside pharmacy to fill. The nursing staff also faxes the prescription to the hospital's pharmacy for entry into the electronic medication administration record. When the medications are received from the outside pharmacy, they are checked in by the nursing staff, and then stored in the medication cart.

Item #2 Accountability of Controlled Substances

Reference: WAC 246-873-080- Drug procurement, distribution, and control (7) Controlled substance accountability. The director of pharmacy shall establish effective procedures and maintain adequate records regarding use and accountability of controlled substances, and such other drugs as appropriate, in compliance with state and federal laws and regulations. (a) Complete, accurate, and current records shall be kept of receipt of all controlled substances and in addition, a Schedule II perpetual inventory shall be maintained. (b) The pharmacy shall maintain records of Schedule II drugs issued from the pharmacy to other hospital units, which include: (i) Date (ii) Name of the drug (iii) Amount of drug issued (iv) Name and/or initials of the pharmacist who issued the drug (v) Name of the patient and/or unit to which the drug was issued.

1. On 06/26/19 at 12:30 PM, during inspection of the hospital's pharmacy department, Surveyor #5 and the Pharmacy Director (Staff #505) reviewed and audited the hospital's perpetual narcotic inventory list. Surveyor #5 observed that the narcotic inventory included narcotic medications for patients classified by the hospital as "inpatient acute care" but did not include narcotic medications for patients the hospital classified as "long-term care" (swing bed program patients).

2. At the time of the observation, Staff #505 stated that the pharmacy did not check in or monitor narcotics for "patient own medications." Staff #505 stated that the nursing staff bring the patients prescription bottle containing the narcotics to him and he bubble packs them for single dose administration but that he does not oversee the narcotics for patients using their "own medications."

3. On 06/26/19 at 1:30 PM, Surveyor #5 and a licensed Practical Nurse (Staff #504) reviewed a narcotic log for patients in the hospital's swing bed program. The log was located on the medication cart in the hospital's west wing. Surveyor #5 observed 9 patients in the log receiving narcotic medications (Patient #501, #506, #507, #509, #512, #515, #516, #519, and #520).

4. At the time of the observation, Staff #504 stated that the patient's outside pharmacy delivered the patients medications, including narcotics if ordered, to the nursing staff in the west wing. Nursing staff checked in the narcotics and then took the patients prescription bottle containing the narcotics to the pharmacy where the pharmacist would put them into the bubble pack cards. She stated that the nursing staff completed a narcotic inventory count every shift.

Item #3 Medication Storage and Security

Reference: WAC 246-873-070-Requirements (4) Drug storage areas. Drugs shall be stored under proper conditions of sanitation, temperature, light, moisture, ventilation, segregation, and security.

1. On 06/25/19 at 2:45 PM during inspection of the hospital's west wing, Surveyor #5 observed an unsecured box of patient medications located in a "patient food" refrigerator. The box contained commingled patient specific medications including insulin vials and insulin pens for 5 patients.

2. At the time of the observation, Staff #501 stated that medications had been stored in the patient food refrigerator since she had worked there and it has never been a problem.

3. On 06/26/19 at 9:30 AM, during interview with Surveyor #5, the Director of Pharmacy (Staff #505) stated that it was bad practice to store food and medications in the same refrigerator. He stated that if the medications were under his control they would not be stored together, but that the swing bed patients medications were considered their "own medications" and the hospital pharmacy was not involved and did not oversee these medications.

4. On 06/26/19 at 11:00 AM, during inspection of the hospital's pharmacy, Surveyor #5 observed:

-Medications stored in bins directly above the water faucet of the handwashing sink;

-Medications and saline syringes stored in bins and cardboard boxes under the handwashing sink.

Prior to exiting the room, Surveyor #5 performed hand hygiene and noted that the water splashed onto the bins above the faucet possibly contaminating the boxes, vials, and bottles of medications stored in the bins.

5. At the time of the observation, Staff #505 confirmed the finding and stated that the medications should not be stored under the sink and that he would move the medications located above the faucet to a location where they would not be splashed with water during hand hygiene.

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Based on observation, interview, and document review, the hospital failed to ensure that medications were administered on the order of a licensed independent practitioner for 1 of 1 patients reviewed (Patient #515) (Item #1), and failed to ensure nursing staff administered medications as directed by the order of a licensed independent practitioner for 2 of 2 patients reviewed (Patient #508 and #516) (Item #2).

Failure to ensure that medications management quality processes for control, preparation, distribution, storage, security, and administration are implemented puts patients at risk of serious harm.

Findings included:

Item #1 Medication Administration without a Provider Order

Reference: WAC 246-873-070-Administration of Drugs- (1) General. Drugs shall be administered only upon the order of a practitioner who has been granted clinical privileges to write such orders. Verbal orders for drugs shall only be issued in emergency or unusual circumstances and shall be accepted only by a licensed nurse, pharmacist, or physician, and shall be immediately recorded and signed by the person receiving the order. The prescribing practitioner shall authenticate orders within 48 hours.

1. Document review of the hospital's policy and procedure titled, "Medication Administration," no policy number, reviewed 03/19, showed that medications will be administered only upon the order of a licensed independent practitioner (LIP) who, by their training and demonstrated skills, have been authorized by the state.

Document review of the hospital's policy and procedure titled, "Medication Orders (Telepharmacy)," no policy number, reviewed 03/19, showed that medications can only be administered pursuant to an order from a licensed independent practitioner (LIP).

Document review of the hospital's policy and procedure titled, "Standing Orders," no policy number, reviewed 03/19, showed that the hospital staff uses standing orders for each patient that allows the nursing staff to administer medication and provide treatments for non-emergency concerns for patients admitted to the hospitals swing bed program. These include medication administration and treatment for temperatures over 101 degrees Fahrenheit, general aches and discomfort, sleeplessness, loose stools, cough, indigestion, gas, non-suturable skin tears less than 3 cm, skin tears that require edge approximation less than 3 cm, Stage 1 and Stage II decubitus ulcers, and minor or potential skin infections. The policy states the purpose of the standing order is to reduce cost to the patient and reduce the number of after-hour calls to the on-call physician.

2. On 06/25/19 at 1:50 PM, Surveyor #5 observed a Licensed Independent Practitioner (LIP) (Staff #507) approach a Registered Nurse (Staff #506) and state that Patient #515 needed medication for a headache. Staff #506 stated to Staff #507 that the patient had a "standing order" for Acetaminophen for pain. The Registered Nurse (Staff #506) looked up the patient's medication in the medication administration record and noted that there was no order for pain medication. Staff #506 stated that all patients had standing orders for certain medications and she entered an order for Acetaminophen 650 mgs into the patient record.

3. At this time, Surveyor #5 questioned the nurse about the hospital's process and policy for notifying the provider of changes in conditions or needs and for receiving physician orders for medication administration. Staff #506 reiterated to the Surveyor that the hospital had standing orders. She stated that it was not necessary to contact the physician and that the physicians usually signed the orders off by 5:00 PM the next day. Surveyor #5 noted that the patient did not have all the medications on his profile that were on the policy. Staff #506 stated that nursing could enter and administer what the patient needed off that list when the patient needed it.

4. On 06/25/19 at 3:30 PM, the Director of Clinical Services (Staff #501) stated that the medical staff approved the list of standing order medication and treatments. She stated that the nurses could administer these medications and treatments without contacting a provider because the medical staff had approved these medications in a policy.

Item #2 Medication Orders

1. Document review of the hospital's policy and procedure titled, "Medication Administration," no policy number, reviewed 03/19, showed that the patient's medication administration record and the medication order will be reviewed prior to preparation of any medication at least once per shift.

2. On 06/26/19 at 2:25 PM, Surveyor #5 and the Director of Clinical Services (Staff #501) reviewed the medical record for Patient #508 who was admitted to the hospital's swing bed program. Surveyor #5 observed:
-A physician order for blood sugar checks 4 times daily and Tier 1 blood sugar coverage that stated if the patient's blood sugar was greater than 200 mg/dl twice in 24 hours to move the patient to Tier 2 blood sugar insulin coverage (this would result in a higher dosage on insulin administration).

-The patient's blood glucose levels were documented on 06/25/19 as 379, 245, 272, and 203, documented on 06/24/19 as 263, 165, 299 and 191, and documented on 06/23/19 as 200, 279, 169 and 266. Surveyor #5 reviewed the prior 4 months of blood sugar testing data and found consistent similar values.

Surveyor #5 found no evidence that nursing staff had notified the patent's provider of the elevated blood sugars or implemented Tier 2 insulin orders as ordered by the provider.

3. On 06/26/19 at 3:18 PM, Surveyor #5 and the Director of Clinical Services (Staff #501) reviewed the medical record for Patient #516 who was admitted to the hospital's swing bed program. Surveyor #5 observed:

A physician order for blood sugar checks 4 times daily and Tier 3 blood sugar coverage that stated if the patient's blood sugar was greater than 200 mg/dl twice in 24 hours to contact the physician.

-The patient's blood glucose levels were documented on 06/25/19 as 176, 243 and 86, documented on 06/24/19 as 179, 270, 237 and 83, and documented on 06/23/19 as 237 and 222.

Surveyor #5 found no evidence that nursing staff had notified the patent's provider of the blood sugars greater than 200 as ordered by the provider.

4. At the time of the observations, Staff #501 confirmed the finding and stated that the nursing staff had not implemented the provider orders.

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