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Based on observation, interview, and record review, the facility failed to ensure that equipment and supplies were stored and maintained to maintain a level of safety and quality as evidenced by:

1. Unlabeled liquid was present in the surgery department;

2. Pliers were not sterilized in an open position; and

3. Patient care supplies were stored within 18 inches of the ceiling.

These failures had the potential for infections, errors in use, and ineffective sprinkler range in the event of a fire which could negatively impact a patient's health status.

Findings:

1. On 8/20/13 at 12:05 pm, the surgery department housekeeping closet was observed to have an unlabeled bottle with clear liquid. In a concurrent interview, Licensed Nurse (LN) I, who supervised the surgeries, stated the bottle contained floor cleaner and should be labeled when it was filled.

The hospital policy, titled, "Hazardous Chemical Program," last reviewed 2/13, indicated that all containers should be labeled with the contents.

2. On 8/20/13 at 12:10 pm, the surgical supply closet was observed. The supply closet contained a orthopedic (bones) cart. This cart contained a sterile package of surgical pliers that were processed in the closed position.

In a concurrent interview, LN I stated the hospital followed AORN standards (Association of periOperative Registered Nurses). LN I acknowledged that the package should have been processed in the open position.

On 8/26/13, the AORN recommended practice for cleaning surgical instruments, recommendation XXII, read, "Cleaned surgical instruments should be organized for packaging in a manner to allow the sterilant to contact all exposed surfaces...Instruments should be open and unlocked position..."

3. On 8/20/13 at 12:20 pm, the supply room for the surgical suite was observed to have patient care supplies stacked within two inches of the ceiling.

When asked if the storage of these supplies was compliant with their policy, in a concurrent interview, LN I responded that the supplies must not be within 18 inches of the ceiling.

Fire suppression sprinklers must have a spray pattern that is not impeded. Storing items with an eighteen inch clearance from the ceiling ensures the sprinklers have an effective spray pattern to suppress a fire.

On 8/21/13 at 3:40 pm, the Director of Nurses acknowledged the above findings should not have occurred.

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Based on interview and record review, the facility failed to have a governing body that assumes full legal responsibility for determining, implementing, and monitoring policies governing the hospitals total operation and for ensuring that those policies were administered so as to provide quality health care in a safe environment as evidenced by:

1. Failure to ensure the surgical services standards were met. (Refer to C 320)

2. Failure to ensure the provision of services standards were met. (Refer to C 270)

3. Failure to provide periodic evaluation and quality assurance review of all services provided directly and by contracted services. (Refer to C 330)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services, were in compliance with the statutorily mandated Condition of Participation: Organizational Structure.

Based on observation, interview, and record review, the hospital failed to ensure that the provision of services was done in a safe manner, as evidenced by.

1. The facility did not ensure that patient care services were provided in accordance with State laws. (Refer to C 271);

2. The facility did not have adequate pharmacy oversight as evidenced by not ensuring that their Consultant Pharmacist perform first dose Medication Regimen Reviews (MRR) in an adequate and timely manner. (Refer to C 276, finding 1);

3. Numerous medications were not given and noted to be unavailable or out of stock. (Refer to C 276, finding 2);

4. A multidose medication vial was not properly labeled. (Refer to C 276, item 3);

5. Multiple pain medications were ordered, each with a dosage range without specific indications for administration. Nursing staff failed to follow the policy for pain medication management related to medication dose ranges. (Refer to 276, item 4);

4. The facility did not develop an effective system for preventing infections of patients. (Refer to C 278, items 1-3);

5. The facility failed to ensure adequate monitoring and evaluation of its pharmacy contract services. (Refer to C 293);

6. Failure to adequately assess and meet the needs of patients. (Refer to C 294, items 1-3); and

7. The facility did not develop care plans that met the needs of the patients. (Refer to C 298, items 1-4)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of services were in compliance with the statutorily mandated Condition of Participation: Provision of Services.




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Based on interview and record review, the facility failed to ensure that patient care services were provided in accordance with State laws, when a Fentanyl (narcotic pain reliever) patch was dispensed without proper labeling or in a childproof container, upon discharge, to one of 25 sampled patients. This had the potential to result in a medication error and/or accidental overdose. (Patient 117)

Findings:

A review of Patient 117's record disclosed that she presented to the Emergency Department (ED) on 8/17/13 at 9:41 am, with a complaint of "out of medication." The ED physician's (MD) assessment was, "medication refill for management of chronic pain syndrome." The ED MD noted that Patient 117 had used her last Fentanyl patch, and the patch was due to be changed on 8/17/13. The ED MD ordered a Fentanyl patch to be given to Patient 117 upon discharge. The nurse noted that the Fentanyl patch was given to the patient upon discharge. Discharge instructions to Patient 117 did not mention the Fentanyl patch. There was nothing in the record to indicate that proper labeling of the Fentanyl patch was done or that it was placed in a childproof container.

The facility's policy, "Discharge Medications," approved 2/2013, was reviewed. It read as follows: No drugs supplied by the hospital shall be taken from the hospital unless a prescription or medical record order has been written for the medication. The medication must be properly labeled and prepared by the pharmacist or ER (Emergency Room) physician in accordance with State and Federal Laws for use outside the hospital.

California Business & Professions Code: 4170. Dispensing by Prescriber: Requirements and Restrictions; Enforcement
(a) No prescriber shall dispense drugs or dangerous devices to patients in his or her office or place of practice unless all of the following conditions are met: (4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.

4076. Prescription Container - Requirements for Labeling
(a) A pharmacist shall not dispense any prescription except in a container that meets the requirements of state and federal law and is correctly labeled with all of the following:
(1) Except where the prescriber or the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to either Section 4052.1 or 4052.2 orders otherwise, either the manufacturer's trade name of the drug or the generic name and the name of the manufacturer. Commonly used abbreviations may be used. Preparations containing two or more active ingredients may be identified by the manufacturer's trade name or the commonly used name or the principal active ingredients.
(2) The directions for the use of the drug.
(3) The name of the patient or patients.
(4) The name of the prescriber or, if applicable, the name of the certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, the nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, the physician assistant who functions pursuant to Section 3502.1, the naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, or the pharmacist who functions pursuant to a policy, procedure, or protocol pursuant to either Section 4052.1 or 4052.2.
(5) The date of issue.
(6) The name and address of the pharmacy, and prescription number or other means of identifying the prescription.
(7) The strength of the drug or drugs dispensed.
(8) The quantity of the drug or drugs dispensed.
(9) The expiration date of the effectiveness of the drug dispensed.
(10) The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.

This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration (FDA) to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The following information includes a portion of the FDA boxed warning regarding concerns related to the accidental misuse of patches by children.

Accidental Exposure
Death and other serious medical problems have occurred when children and adults were accidentally exposed to Fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure.

During an interview on 8/28/13 at 10 am, the Director of Nurses stated she did not know what kind of container the Fentanyl patch was placed in before being provided to the patient. She also stated that the necessary labeling and instructions regarding the medication were not provided to Patient 117.

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Based on observation, interview, and record review, the facility did not have adequate pharmacy oversight for nine of 25 sampled patients as evidenced by:

1. The hospital did not ensure that their Consultant Pharmacist perform first dose Medication Regimen Reviews (MRR) in an adequate and/or timely manner for eight of 25 sampled patients (Patients 113, 114, 115, 116, 122, 123, 124, and 125);

2. Numerous medications were not given and noted to be out of stock for one of 25 sampled patients. (Patient 115);

3. A multi-dose vial of neostigmine methylsulfate (used to stimulate muscles, reversal used in anesthesia) was not dated when it was opened; and

4. Orders for multiple pain medications were not clarified with the physician and pain medications with range orders were not administered according to policy for one of 25 sampled patients. (Patient 101)

This had the potential to result in medication errors and other unsafe conditions for all patients in the hospital as well as a significant decline in their health status.

Findings:

1. The facility's policy, "Medication Management: Administration," approved on 2/2013, was reviewed. It read as follows: Medication may only be administered based on an order from a Provider and a first dose review by the Pharmacist via fax to the "Pharmacy Consultant". The Pharmacist's first dose review may not occur in the event of an emergency or when there is a Provider present who is in direct control of the medications being administered.

The facility's "Pharmacy Services Agreement" was reviewed. It read as follows under "Obligations of the Pharmacy", section B, "Pharmacy shall have a licensed pharmacist available 24 hours each day, seven days per week to respond to Customer's requests for pharmacist consultation."

a. A review of Patient 115's record disclosed that she was admitted on 8/16/13, with a diagnosis that included Parkinson's Disease (affects the nerves with characteristic tremor of resting muscles and slowing of voluntary movements). Her admission orders, signed by the Emergency Department physician on 8/15/13 at 11:50 pm, included an order for Lasix (a diuretic medication that causes a patient to urinate excess fluid) 20 milligrams, one to two tablets daily. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/16/13 at 4:17 am. This included the physician's orders and Medication Reconciliation Sheet. The Medication Reconciliation Sheet (MRR) included a list of the patient's home medications and dosages, whether the physician wanted to continue these medications in the hospital, and if the medications were available in the hospital.

The admission MRR was returned to the facility via fax on 8/21/13 at 4:47 pm, more than five days after it had been sent to the pharmacist for review. The MRR did not include a recommendation to clarify the Lasix dosage.

During an interview on 8/21/13 at 3:30 pm, Pharmacist A stated that if he saw an order for Lasix 20 mg, one to two tablets, he would recommend a clarification order. He stated that you need a specific dosage and cannot have a range. Pharmacist A stated he had not reviewed these orders and suggested a call be made to Pharmacist B to see "why this order fell through the cracks."

During an interview on 8/21/13 at 3:50 pm, Pharmacist B agreed with Pharmacist A that a specific order for the dosage of Lasix was needed and would have recommended a clarification order had she reviewed these orders. Pharmacist B stated that another pharmacist had reviewed these orders, Pharmacist C.

During an interview on 8/21/13 at 4:30 pm, Pharmacist C stated that she would not have pointed out the need for a clarification order for the Lasix. When asked about the length of time it took for her to complete the admission MRR, she stated that they have three business days to complete the MRR.

b. A review of Patient 114's record disclosed that he was admitted on 8/18/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/18/13 at 6:43 pm. This included the physician's orders and Medication Reconciliation Sheet. There were three medications listed on the Medication Reconciliation Sheet that were noted to be unavailable as hospital stock.

During an interview on 8/21/13 at 4:30 pm, Pharmacist C stated that she would not make a recommendation as to a substitute medication unless asked to do so because she does not know the availability of all medications at the hospital.

The admission MRR was returned to the facility via fax on 8/21/13 at 6:14 pm, three days after it had been sent to the pharmacist for review. The MRR did not include recommendations for substitute medications even though three medications were noted to be unavailable as hospital stock on the Medication Reconciliation Sheet.

c. A review of Patient 122's record disclosed that she was admitted on 8/15/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/16/13 at 4:26 am.

The admission MRR was returned to the facility via fax on 8/21/13 at 5:27 pm, more than five days after it had been sent to the pharmacist for review, and after Patient 122 had already been discharged home.

d. A review of Patient 123's record disclosed that he was admitted on 8/15/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/15/13 at 8:06 pm.

The admission MRR was returned to the facility via fax on 8/21/13 at 5:27 pm, almost six days after it had been sent to the pharmacist for review, and after Patient 123 had already been discharged home.

e. A review of Patient 124's record disclosed that he was admitted on 8/16/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/16/13 at 5:36 am.

The admission MRR was returned to the facility via fax on 8/21/13 at 5:26 pm, more than five days after it had been sent to the pharmacist for review, and after Patient 124 had already been discharged home.

f. A review of Patient 125's record disclosed that she was admitted on 8/15/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/15/13 at 8:05 pm.

The admission MRR was returned to the facility via fax on 8/21/13 at 5:26 pm, more than five days after it had been sent to the pharmacist for review, and after Patient 125 had already been discharged home.

g. A review of Patient 116's record disclosed that she was admitted on 8/21/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 8/21/13 at 5:28 am. The admission MRR was returned to the facility via fax on 8/21/13 at 6:15 pm, more than 12 hours after admission.

h. A review of Patient 113's record disclosed that he was admitted on 7/25/13. A "Medication Review Facsimile Cover Sheet" was faxed to the pharmacy on 7/25/13 at 2:41 am.

The admission MRR was returned to the facility via fax on 7/29/13 at 10:05 pm, more than four days after it had been sent to the pharmacist for review, and after Patient 113 had already been discharged home on 7/28/13.

During an interview on 8/22/13 at 9 am, Nurse Manager G confirmed that their practice was not to wait to start medications until the first dose medication review was completed by their pharmacy consultant, because they have a physician in the facility.

The above pharmacy issues were discussed with the DON on 8/22/13 at 9:20 am, who confirmed the above response times were unacceptable.

2. A review of Patient 115's record disclosed that she was admitted on 8/16/13, with a diagnosis that included Parkinson's. A review of the Medication Administration Record (MAR) disclosed that the following note, "not in stock" or "unavailable" was made next to the following medications, Ferrous Sulfate (iron), Lasix, Montelukast (treats asthma), Prilosec (treats stomach problems) on 8/17/13.

During an interview on 8/21/13 at 11:55 am, the Pharmacy Tech stated that those medications listed above would have been available in the hospital.

During an interview on 8/21/13 at 1:30 pm, the Director of Nurses(DON) confirmed that those medications were not given but should have been given.


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3. On 8/20/13 at 12:40 pm, the anesthesia cart was observed during the tour of the operating room. The cart contained an opened multi-dose vial of neostigmine methylsulfate. The vial did not have a date for when it was opened.

In a concurrent interview, LN I stated that all multidose vials need to be dated and expire, 28 days after the first use. LN 1 could not account for how long the vial had been opened.

On 8/20/13, the hospital policy, titled, "Multidose Vials and Single Dose Vials," dated 2/13, read, "Multi-dose vials must be dated when opened... will expire 28 days of being punctured."

On 8/21/13 at 3:40 pm, the DON and Licensed Nurse (LN) I stated they usually do not get into the anesthesia carts. They further confirmed that the pharmacy technician stocks the carts and monitors the expiration dates. DON and LN I stated that the CRNA (Certified Nurse Anesthetist) was responsible for dating her own vials and there was no oversight process in place to assure this occurred.

4. On 8/20/13, Patient 101's record was reviewed. Patient 101 was admitted for surgery on 7/24/13 and stayed overnight for observation. Patient 101's record contained postoperative orders, dated 7/24/13 and not timed, that read:

Morphine (for pain) 1-4 mg (milligrams) IV (intravenous) q (every) 1 hr (hour) prn (as needed)
Norco 5/325 1-2 po (by mouth) q 6 hrs prn pain

Patient 101's morphine order did not contain an indication for when to use the morphine (i.e. for pain). The morphine (MS) and Norco orders do not instruct the nurse how to determine how much medication should be used. The order did not contain instructions for the nurse to know which medication should be used or if using both medications was the intention.

On 8/22/13, the hospital policy, titled, "Medication Management," 2/13, indicated guidelines for how the nurse was to determine how much medication was to be used when a range was used for pain medication. This policy did not include instructions for how to determine which medication to use when two pain medications were ordered.

The above policy read, "Medications ordered with a dose range will be administered as follows:
Mild pain (1-3): Use lowest dose of ordered range
Moderate pain (4-6)/ Severe pain (7-10): Use mid-point of ordered dose range.
If desired effects are not achieved with medication dose administered for pain, the same initial dose may be repeated at the following time interval:
- Medication ordered IV, may repeat in 15 minutes...
- Medications ordered PO, may repeat in 1 hour..."

Patient 101's record contained a MAR that listed the following pain medication administrations with the pain score:
7/24 4:54 pm MS 4 mg Pain only listed as incisional pain
7/24 11:24 pm MS 4 mg Pain = 9
7/24 2:59 pm Norco 2 tabs Pain = 7
7/24 8:26 pm Norco 2 tabs Pain = 7
7/25 2:06 am Norco 2 tabs Pain = 8
7/25 9:33 am MS 4 mg Pain = 9
7/25 5:17 am MS 4 mg Pain = 8

On 8/21/13 at 3:40 pm, DON reviewed Patient 101's record and acknowledged that the above order was not clear and the nurse should have contacted the physician to clarify his intentions with the order. DON further acknowledged the policy was not followed for pain medication administration.

Based on observation, interviews, and document review, the facility did not develop an effective system for preventing and controlling infections of patients. This was evidenced by:

1. The facility did not ensure that Patient 114's bedside table was cleaned prior to placing his lunch tray on it;
2. The facility did not ensure that the Dexa (x-ray bone scan) Room had the appropriate cleaning wipes available for staff to clean the table between patients; and
3. The facility's anesthesia cart contained uncapped needles that were available for patient use.

These failures had the potential to result in infections for numerous patients.

Findings:

1. During the initial tour on 8/20/13 at 11:20 am, a urinal containing urine was observed sitting on top of the bedside table in Patient 114's room. During a subsequent observation on 8/20/13 at 11:55 am, Certified Nursing Assistant (CNA) AA removed the urinal from the bedside table and placed Patient 114's lunch tray on it without first cleaning the bedside table.

During an interview on 8/20/13 at 12 pm, CNA AA confirmed that she had not cleaned Patient 114's bedside table before placing his lunch tray on it.



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2. On 8/20/13 at 11:48 am, the DEXA (dual energy x-ray - used to measure bone density or in DPS) room was observed. There was no disinfectant available for staff to clean the patient care equipment between patients.

On 8/22/13, the hospital policy, titled, "Infection Control - Patient Equipment," dated 11/20/13, read, "All equipment must be cleaned in between patient use by wiping down with Neutral Disinfecting Solution.

In a concurrent interview, Radiology Manager U acknowledged that the Dexa room did not have the proper disinfectant for staff to use between patients.

3. On 8/20/13 at 12:37 pm, the anesthesia cart in the operating room was observed to have two capped disposable syringe needles in the upper drawer that were not in their packaging.

On 8/22/13, the hospital policy, titled, "Needle Safe System," dated 2/13, read, "Any and all contaminated Sharps (such as the above needles) must be discarded into biohazardous containers."

The online AORN (Association of PeriOpertive Nurses) standards indicate that "Single-use items (....needles...) should be used once and discarded...."

In a concurrent interview, Licensed Nurse I acknowledged that the unpackaged needles should have been discarded after use.

Based on interview and record review, the facility failed to ensure adequate monitoring and evaluation of its pharmacy contract services. The pharmacy consultants did not adhere to provisions set forth in the facility's pharmacy contract regarding availability of services 24 hours per day. This resulted in non-compliance of pharmacy related regulations as well as facility policy. (Refer to C 276, Finding 1)

Findings:

Records of eight patients were reviewed to determine the response time of the Consultant Pharmacist for the first dose medication regimen review. The first dose medication review response time for seven of the eight patients ranged from three to more than five days, and was greater than 12 hours for the other patient.

The facility's policy, "Medication Management: Administration," approved on 2/2013, was reviewed. It read as follows: Medication may only be administered based on an order from a Provider and a first dose review by the Pharmacist via fax to the "Pharmacy Consultant". The Pharmacist's first dose review may not occur in the event of an emergency or when there was a Provider present who is in direct control of the medications being administered.

The "Pharmacy Services Agreement" was reviewed. It read as follows under "Obligations of the Pharmacy", section B, "Pharmacy shall have a licensed pharmacist available 24 hours each day, seven days per week to respond to Customer's requests for pharmacist consultation."

During an interview on 8/22/13 at 11:20 am, the Quality Nurse W stated they currently had no way to evaluate the performance of the pharmacy contract services. She confirmed that it was necessary to evaluate the services to determine if the pharmacy performed in an acceptable manner.

Based on interview and record review, the facility did not meet the needs of patients as evidenced by:

1. The facility did not notify the physician that a prescribed medication was unavailable for more than 72 hours, and did not ask for a clarification order when a physician's order for Lasix (a diuretic medication that causes patients to urinate more to rid the body of excess fluid) did not include the exact dosage, for one of 25 sampled patients. (Patient 115)

2. The facility did not provide proper instructions to a patient after providing a Fentanyl (narcotic pain reliever) patch to take home with her. (Patient 117)

3. The facility failed to provide a complete set of discharge instructions for one of 25 sampled patients. (Patient 101)

This had the potential to result in the patients' needs to go unattended and suffer adverse health consequences.

Findings:

1 a. A review of Patient 115's record disclosed that she was admitted on 8/16/13 with a diagnoses that included Parkinson's disease (affects the nerves with characteristic tremor of resting muscles and slowing of voluntary movements). Her admission orders, signed by the Emergency Department physician on 8/15/13 at 11:50 pm, included Azilect (a medication for the treatment of Parkinson's) 0.5 milligrams twice per day. The scheduled times for this medication was at 9 am and 9 pm daily. A review of the Medication Administration Record (MAR) disclosed that Patient 115 did not receive her first dose of this medication until 9 pm on 8/19/13, more than 72 hours after being admitted. No documentation could be located in the record that stated that the nurses informed the physician that this medication was not available.

During a concurrent record review and interview on 8/21/13 at 1:30 pm, the Director of Nurses (DON) confirmed that Azilect was not started until 8/19/13, because it was not available in the hospital. The DON confirmed that Patient 115's husband brought in the medication from home. She confirmed that there was nothing in the record to indicate that the nurses notified Patient 115's physician that this medication was unavailable or ask if he wanted to order an alternative medication.

b. Patient 115's admission orders also included an order for Lasix 20 milligrams (mg), one to two tablets daily. The MAR reflected the dosage range 20 mg to 40 mg.

During a concurrent record review and interview on 8/21/13 at 1:30 pm, the DON stated this order was not acceptable as it did not give an exact dosage and the nurse should have called the physician to clarify the order.

2. A review of Patient 117's record disclosed that she presented to the Emergency Department (ED) on 8/17/13 at 9:41 am, with a complaint of "out of medication." The ED physician's (MD) assessment was, "medication refill for management of chronic pain syndrome." The ED MD ordered a Fentanyl patch to be given to Patient 117 upon discharge. The nurse noted that the Fentanyl patch was given to the patient upon discharge. Discharge instructions to Patient 117 did not mention the Fentanyl patch. There was nothing in the record to indicate that proper labeling of the Fentanyl patch was done or that it was placed in a childproof container.

The facility's policy, "Discharge Medications," approved 2/2013 was reviewed. It read as follows: No drugs supplied by the hospital shall be taken from the hospital unless a prescription of medical record order had been written for the medication. The medication must be properly labeled and prepared by the pharmacist or ER (Emergency Room) physician in accordance with State and Federal Laws for use outside the hospital.

This medication had a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration (FDA) to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The following information included a portion of the FDA boxed warning regarding concerns related to the accidental misuse of patches by children.

"Accidental Exposure
Death and other serious medical problems have occurred when children and adults were accidentally exposed to Fentanyl transdermal system. Advise patients about strict adherence to the recommended handling and disposal instructions in order to prevent accidental exposure."

During an interview on 8/28/13 at 10 am, the Director of Nurses stated she did not know what kind of container the Fentanyl patch was placed in before being provided to the patient. She also stated that the necessary labeling and instructions regarding the medication were not provided to Patient 117.



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3. On 8/20/13, Patient 101's record was reviewed. Patient 101 was admitted for surgery on 7/24/13 and stayed over night for observation. Patient 101's record contained a "Short Form Discharge Summary," dated 7/24/13 at noon, that read, "Discharge instructions given to patient: No shower until Saturday... Other instructions: Change gauze prn (as needed); empty JP drain (Jackson Pratt drain - use to drain excess fluid from surgical site) tid (three times) a day prn."

Patient 101's record contained a copy of written discharge instructions, dated and signed by Patient 101 on 7/24/13, which did not contain any evidence that the above instructions were given to Patient 101 in writing.

The written discharge instructions contained the following questions:
Ice should be applied to specified area for how many minutes?
Ice should be applied to specified area how many times per day?
At what oral temperature should the patient return to this location or see the caregiver?
At what oral temperature, not controlled by medication, should the patient call or see their physician?

On 7/21/13, the hospital policy, titled, "Discharge Instructions," dated 2/13, read, "The physician or registered nurse will verbally instruct patient and/or caregiver on specific after-care instructions...Patient or care caregiver (when appropriate) will sign after-care instruction. One (1) copy is given to patient. One (1) signed copy will be placed in the patient's medical record."

On 7/21/13 at 3:40 pm, DON reviewed Patient 101's record and stated that a computerized program is used for discharge instructions. DON stated that the questions regarding ice and oral temperature that appeared on the discharge instructions should have had specific instructions appropriate for Patient 101's care. DON confirmed that the physician's instructions were not included in the written discharge instructions.

Based on interview and record review the facility failed to ensure that a comprehensive nursing care plan had been developed for four of 25 sampled patients. (Patients 113, 114, 115, and 116)

1. Patient 114 had no care plan regarding his admitting diagnosis of alcoholism;
2. Patient 115 had no care plan regarding her admitting diagnosis of a skin infection;
3. Patient 116 had no care plan regarding her admitting diagnosis of pyelonephritis (kidney infection); and
4. Patient 113 had no care plan regarding his diabetes, hypertension (high blood pressure), and nausea.

This had the potential to result in the patients' needs not being met and a decline in their overall health condition.

Findings:

1. A review of Patient 114's record disclosed that he was admitted on 8/18/13, with diagnoses that included alcoholism. The physician ordered medication for Patient 114 if he showed any signs of alcohol withdrawal. A review of the care plans disclosed that there was not one that dealt with the problem of alcoholism or possible symptoms of withdrawal from alcohol.

During an interview on 8/21/13 at 9:15 am, Nurse Manager G confirmed there was not a care plan for alcoholism or alcohol withdrawal although there should have been since alcoholism was one of Patient 114's admitting diagnoses.

2. A review of Patient 115's record disclosed that she was admitted on 8/15/13, with diagnoses that included a skin infection with multiple lesions caused by a drug resistant bacteria. A review of the care plans disclosed that there was not one that pertained to skin lesions and/or drug resistant bacteria.

During an interview on 8/21/13 at 1:30 pm, the Director of Nurses (DON) confirmed that there was not a care plan for the skin infection although there should have been since her primary admitting diagnoses included the skin infection.

3. A review of Patient 116's record disclosed that she was admitted on 8/21/13, with diagnoses that included pyelonephritis. A review of the care plans disclosed that there was not one that pertained to the kidney infection.

During an interview on 8/22/13 at 9:30 am, the DON stated that an infectious process care plan should have been initiated for Patient 116 given her diagnosis of pyelonephritis.



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4. On 7/22/13, Patient 113's record was reviewed. Patient 113 was admitted on 7/25/13, through the emergency room, with diagnoses that included mild ketoacidosis (a potentially life-threatening complication in patients with diabetes), diabetes, and hypertension. Patient 113's record contained nursing notes, dated 7/27/13 at 12:05 pm, which indicated Patient 113 had nausea. Patient 113's record did not contain evidence of any care plans for diabetes, hypertension, and nausea.

On 8/22/13 at 11:40 am, DON reviewed patient 113's record and confirmed no care plans were present for the above problems. DON stated that the hospital did not have a policy in regards to care plans but acknowledged that care planning was part of the the nursing process.

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Based on interview and record review, the hospital failed to ensure that five of 25 sampled patients had complete and accurately documented records.

1. Patients 101 and 102 had entries that were not timed.
2. Patients 101, 104, and 108 had ECG (electrocardiogram) recordings that were not dated, timed, or authenticated and did not contain an interpretation of the cardiac rhythm.
3. Patient 113's record did not have a patients rights or advance directive acknowledgements completed.
4. Patient 108's preprocedure assessment did not document a complete nursing assessment.

This failure could result in miscommunication that could negatively impact a patient's health status.

Findings:

1 a. Patient 101's record contained the following entries that were not timed:
- Post-operative orders, dated 7/24/13, and
- Post-anesthesia orders, dated 7/24/13.

b. Patient 102's record contained a pre-anesthetic form, dated 7/24/13, that was not timed.

On 8/21/13 at 3:40 pm, the Director of Nurses (DON) reviewed Patients 101 and 102's records and acknowledged the above entries were not timed.

2. On 7/20/13, Patients 101, 104, and 108's records were reviewed.

a. Patient 101's record, for admission dated 7/26/13 and discharge on 7/28/13, contained two pages of "Rhythm Flowsheets" that had five different ECG strips. These flowsheets did not contain a date, time, or person who had evaluated the strips. None of the five rhythms had an interpretation of the rhythm documented.

b. Patients 104 and 108 had procedures in the operating room on 8/7/13.

Patients 104 and 108's records contained ECG strips done in the post-anesthesia recovery unit (PAR). These strips did not contain an interpretation of the cardiac rhythm or who had reviewed the strip.

On 8/21/13 at 3:40 pm, DON reviewed Patient 101, 104, and 108's records and acknowledged the above findings. DON stated she was unable to locate a policy the addressed the standards for ECG documentation.

3. On 7/22/13, Patient 113's record was reviewed. Patient 113's record contained blank forms for patients rights and advance directive acknowledgements.

On 7/22/13 at 9:30 am, DON reviewed Patient 113's record and acknowledged that the patients rights and advance directive acknowledgements had not been completed. DON could not stated what the process was for patients admitted after normal business hours.

On 7/22/13 at 11 am, the Admitting Department Manager stated that there was not a clear process to follow up that patients rights and advance directive acknowledgements were completed for admissions after normal business hours.

4. On 8/20/13, Patient 108's record was reviewed. Patient 108 was admitted on 8/7/13 for a colonoscopy (to view the inside of the bowel). Patient 108's record contained a pre-procedure nursing assessment which had sections for gastrointestinal (oral cavity through to the bowels and rectum) and genitourinary (genitals and urinary systems) that were documented with a "NA" (not applicable).

On 8/21/13 at 3:40 pm, the DON and Registered Nurse I reviewed Patient 108's record and acknowledged that the documentation was incomplete.





32668

Based on observation, interview, and document review, the facility failed to provide surgical procedures in a safe manner as evidenced by:

1. Failure to ensure that three of 12 sampled patients receiving anesthesia (Patients 101, 102, and 103) had an adequate examination by a qualified anesthetist immediately before the procedure to evaluate the risk of anesthesia. (Refer to C 322, items 1-3)

2. Failure to follow hospital policy for labeling disinfectants. (C 222, item 1)

3. Failure to process sterile instruments in manner consistent with national standards. (Refer to 222, item 2)

4. Failure to properly label multidose vials to ensure safe administration. (Refer to C 276, item 3)

5. Failure to store needles according to standards of practice. (Refer to C 278, item 3)

6. Failure to monitor five of nine procedure patients in the post-recovery phase safely. (Refer to C 320, item 1)

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment, and ensure surgical services were in compliance with the statutorily-mandated Condition of Coverage: Surgical Services.

Findings:

1. On 8/20/13, Patients 104, 105, 106, 107, and 108's records were reviewed. Patients 104, 105, 106, 107, and 108 had endoscopic gastrointestinal procedures (inserting a tube with a camera to view the inside of the gastrointestinal tract) on 8/7/13. Patients 104, 105, 105, 107, and 108's record contained ECG (electrocardiogram) recordings done in the post-anesthesia recovery unit (PAR), all of which had a notation that the alarms were suspended.

On 8/20/13 at 10:45 am, the Biomedical Engineer E provided manufacturer information for the bedside monitoring equipment which read, "Clinicians should acknowledge as many alarms as possible ...All arrhythmia (abnormal heart rhythms) alarms are disabled if alarms are suspended ..."

On 8/20/13 at 3:40 pm, the Director of Nurses and Registered Nurse I reviewed Patients 104, 105, 106, 107, and 108's record and acknowledged that the ECG alarms should not be suspended because they alert the nurse to arrhythmias that require a quick response. DON and RN I stated they could not locate a hospital policy regarding alarm settings.

Based on interview and record review, the hospital failed to ensure that three of three sampled surgical patients (Patients 101, 102, 103) had an adequate examination by a qualified anesthetist immediately before the procedure to evaluate the risk of anesthesia.

This failure permitted the possibility that a patient could suffer harm as a result of unrecognized surgical or anesthesia risk.

Findings:

On 8/20/13, Patients 101, 102 and 103's records were reviewed.

1. Patient 101 had a laparoscopic cholecystectomy (removal of the gall bladder) on 7/24/13. Patient 101's record contained a form titled, "Preanesthesia Evaluation," which was not complete for the assessment of the airway/teeth/head & neck (important for successful intubation without injury) and for physical examination for cardiovascular and respiratory systems.

2. Patient 102 had an umbilical (belly button) hernia (protrusion of tissue) repair on 7/24/13. Patient 102's Preanesthesia Evaluation did not contain cardiovascular history or physical examination findings. The evaluation also did not have physical examination findings for the respiratory system even though the history indicated that Patient 102 had pneumonia in late May.

3. Patient 103 had a vein ablation (removal of varicose [enlarged] veins) on 7/24/13. Patient 103's Preanesthesia Evaluation did not contain any physical examination findings for cardiovascular and respiratory systems, nor was there evidence of a history for these systems.

On 8/20/13, the hospital policy, titled, "Assessment prior to Induction," dated 1/13, read, "All patients will have a pre-anesthesia evaluation prior to a surgical and /or invasive procedure ... with the results documented in the pre-anesthesia evaluation record." The policy further indicated that the only requirements of this evaluation were vitals signs.

The American Society of Anesthesiologists Task Force on Preanesthesia Evaluation Advisory Statements, dated 3/12, read, "For patient with low severity of disease undergoing procedures with medium or low surgical invasiveness, the initial interview and physical exam may be performed on...the day of surgery. At a minimum, a focused preanesthetic physical examination should include an assessment of the airway, lungs, and heart, with documentation of vital signs."

On 8/21/13 at 3:40 pm, the Director of Nurses reviewed Patient 101, 102, and 103's records and acknowledged that the pre-anesthesia evaluation documented was not adequate to assess the patients risk for anesthesia.

26611

Based on staff interview and document review, the hospital failed to ensure that requirements were met for the condition of participation: Periodic Evaluation and Quality Assurance Review as evidenced by:

1. Failure to evaluate the effectiveness of corrective action plans when deficiencies persist. (Refer to C 337, item 1)

2. Failure to have a comprehensive quality program to ensure the quality of all patient related services/processes such as respiratory services, advance directive and patient rights acknowledgements, adequacy of preanesthesia evaluation, housekeeping services, adequacy of nursing care plans, and first dose medication regiment review. (Refer to C 337, items 2 and 3)

3. Failure to maintain evidence of the evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy (disease of a bone) at the hospital. (Refer to C 340)

The cumulative effect of these systemic problems resulted in the facility's inability to comply with the statutorily mandated Condition of Participation: Periodic Evaluation and Quality Assurance Review.

Based on interview and record review, the hospital failed to have an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished, and of treatment outcomes for all patient care services and other services affecting patient health and safety as evidence by:

1. Failure to evaluate the effectiveness of the corrective action plan when deficiencies persist.

2. Failure to have a comprehensive quality program to ensure the quality of all patient related services/processes such as respiratory services, advance directive and patient rights acknowledgements, adequacy of preanesthesia evaluation, housekeeping services, adequacy of nursing care plans, and first dose medication regiment review.

The failure to evaluate patient care services resulted not only in the lack of identification of problems that may harm patients or negatively impact their health status but also resulted in a delay in the monitoring and evaluation of processes to correct problems once they were identified.

Findings:

1. On 8/22/13, the Quality Committee minutes were reviewed.

a. There was no evidence in the minutes of evaluation of the effectiveness of the actions taken on quality indicators that had not met performance thresholds.

b. There was no evidence that respiratory services, advance directive and patient rights acknowledgements, adequacy of preanesthesia evaluation, housekeeping services, and adequacy of nursing care plans were evaluated through the quality program.

On 8/22/13 at 11:30 am, Quality Nurse W confirmed that no quality indicators were developed to evaluate the effectiveness of the above services and patient-related processes. Quality Nurse W further stated that more work was needed to ensure managers understood the the quality improvement processes and acknowledged they had not yet evaluated the effectiveness of their actions.


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2. Records of eight patients were reviewed to determine the response time of the Consultant Pharmacist for the first dose medication regimen review. The first dose medication review response time for seven of the eight patients ranged from three to more than five days, and was greater than 12 hours for the other patient.

The facility's policy, "Medication Management: Administration," approved on 2/2013, was reviewed. It read as follows: Medication may only be administered based on an order from a Provider and a first dose review by the Pharmacist via fax to the "Pharmacy Consultant". The Pharmacist's first dose review may not occur in the event of an emergency or when there is a Provider present who is in direct control of the medications being administered.

During an interview on 8/22/13 at 9 am, Nurse Manager G stated that they had a problem last year with getting timely reviews. She had e-mails dating back to 10/2012, where she had contact with the facility's Consultant Pharmacist, regarding response times for first dose reviews. Nurse Manager G confirmed she did not refer this issue to the Quality Improvement Committee for further review and monitoring.

On 8/22/13 at 8:45 am, Quality Nurse W was asked what kinds of quality indicators regarding pharmacy services that the Quality Committee was monitoring. She provided a list of quality indicators for pharmacy services that did not include response times for first dose medication review.

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26611

Based on interview and document review, the hospital failed to maintain evidence that it had utilized an agreement with a hospital, QIO (Quality Improvement Organization) or other equivalent/qualified outside entity to evaluate the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital. This failure had the potential for substandard medical care to persist and negatively impact patients' health status.

Findings:

A review of the provided list of services by contract or agreement did not list a hospital, QIO or other entity that was listed as providing an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital. The list did contain one QIO, however the "Contracted Services" list, did not describe the services provided other than to read "Medicare Quality Assurance." The hospital provided no documentation to show that this QIO had been utilized to conduct an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by practitioners at the hospital.

The Administrative Policy #AD 066, titled "Quality and Performance Improvement" (Q/PI), last reviewed 4/25/13, did not specify a plan to have an outside entity evaluate the diagnoses and treatments furnished by practitioners at the hospital.

During the first revisit survey, in an interview on 5/1/13 at 12 pm, the Chief Executive Officer (CEO) stated he had contacted a QIO to complete the required service but the QIO would not start the evaluation until 5/15/13.

On 6/11/13, during the second revisit survey, a report was provided that was represented as a "QIO report". The report was dated 5/20/13 and included a review and recommendations for the hospital's quality and credentialing program. This report was done by a registered nurse who was contracted by the critical access hospital network. The report did cover the elements of the annual review but did not include the required elements of "an evaluation of the quality and appropriateness of the diagnoses and treatments furnished by doctors of medicine or osteopathy at the hospital." Appropriateness of medical care was customarily reviewed by physicians due to their expertise.

On 6/24/13 at 1:15 pm, the hospital CEO acknowledged that the report did not include the required elements for this regulation.

On 8/20/13 at 10:50 am, during the third revisit survey, the CEO stated that although they had an agreement with a member hospital of the network, they have chosen to enter into another agreement with the state critical access network (a qualified entity) to provide the evaluation of the diagnosis and treatment furnished by doctors of medicine or osteopathy. The CEO provided the signed contract, dated 7/23/13, and stated the actual review of records had not yet occurred.