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.

CENTENNIAL PEAKS HOSPITAL 2255 S 88TH ST LOUISVILLE, CO July 21, 2016
VIOLATION: PHARMACEUTICAL SERVICES Tag No: A0490
Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation 482.25, PHARMACEUTICAL SERVICES was out of compliance.

A-494 - Standard: Current and accurate records must be kept of the receipt and disposition of all scheduled drugs. The facility failed to ensure nursing staff followed policy and procedures intended to minimize scheduled drug diversion. This failure created the potential for drug diversion and had the potential to negatively affect patients within the facility.

A-500 - Standard: In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. The facility failed to ensure medications were available to meet a patient's chronic illness needs. This failure resulted in a patient not receiving medications ordered for treatment of a chronic illness.

A-506 - Standard: When a pharmacist is not available, drugs and biologicals must be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with Federal and State law. The facility failed to have a clear system in place that accurately documented the removal of medications from the after hours supply. Furthermore, the facility failed to ensure pharmacist and non-pharmacist staff followed quality control procedures when retrieving medications from the after hours medication cabinets. These failures created the potential for medication retrieval errors.

A-508 - Standard: Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital's quality assessment and performance improvement program. The facility failed to ensure nursing staff notified patients' physicians after a medication error occurred and documented the notification in the patient's medical record. Additionally, the facility failed to ensure nursing staff documented in the medical record the description of the medication given, nursing follow-up, and patient response to the medication error. These failures resulted in inaccurate patient medical records.
VIOLATION: PHARMACY DRUG RECORDS Tag No: A0494
Based on interviews and document review, the facility failed to ensure nursing staff followed policy and procedures intended to minimize scheduled drug diversion.

This failure created the potential for drug diversion and had the potential to negatively affect patients within the facility.

FINDINGS:

POLICY

According to the policy, Controlled Substances, an audit of all formulary Schedule II, III, IV, and V drugs will be performed at the end of each shift by the off-going and on-coming medication nurse. This count will be recorded on the controlled substance record. If a narcotic medication is to be destroyed/wasted, the procedure must be observed by two licensed nurses or a licensed nurse and the pharmacist. Destruction of the medication will be recorded on the Controlled Substance Record and signed by both individuals.

1. The facility failed to ensure all drug records were in order and maintained in a manner to minimized potential loss or diversion of a scheduled drug.

a) On 07/20/16 at 10:10 a.m., a tour of the Electroconvulsive Therapy (ECT) department was conducted with the Director of Nursing (Director #5). Review of the ECT department's Controlled Substance for Fentanyl 100 micrograms (mcg)/milliliters (ml) revealed the morning count done the day of the tour was signed off by only one Registered Nurse (RN). This was in contrast to policy.

Review of additional logs for the months of May, June, and July of 2016 revealed 11 incidents where night shift counts of controlled medications did not possess a second RN verification. These incidents were as follows:

-Sufentanil 250 mcg /5 ml on 05/25/16

-Alfentanil 500 mcg/ml on 05/06/16

-Brevital 500 mg/vial on 06/27/16

-Ketamine 500 mg/20 ml on 05/06/16 and 06/27/16

-Midazolam 2 mg/ml on 05/25/16

-Morphine Sulfate 10 mg/ml on 05/09/16 and 06/27/16

-Fentanyl 100 mcg/2 ml on 05/09/16 and 06/27/16

-Lorazepam 2 mg/ml on 05/27/16

Additionally, 10 morning counts were missing the second RN verification. The counts missing a second RN verification were as follows:

-Alfentanil 500 mcg/ml on 06/01/16 and 06/29/16

-Brevital 500 mg/vial on 07/06/16

-Midazolam 2 mg/ml on 06/01/16, 06/06/16, 06/30/16, and 07/18/16

-Fentanyl 100 mcg/2 ml on 06/15/16 and 07/11/16

-Lorazepam 2 mg/ml on 05/27/16

b) Review of the Controlled Substances Logs for each inpatient unit, dated 06/30/16-07/20/16, revealed the following discrepancies:

-8 shift counts on the 800 unit logs were missing the 2nd RN verification.

-5 shift counts on the 700 unit logs were missing the 2nd RN verification.

-2 shift counts on the 900 unit logs were missing the 2nd RN verification.

-1 shift count on the 1000 unit logs were missing 2nd RN verification.

c) On 07/20/16 at 9:39 a.m., an interview was conducted with RN #6 who worked on the inpatient units. RN #6 stated the oncoming and offgoing RNs were responsible for the controlled substance counts each 12 hour shift. RN #6 stated 2 signatures were required for each count and the 2nd signature indicated the 2nd RN agreed the count was correct.

d) On 07/20/16 at 4:13 p.m., an interview was conducted with RN #7 who worked in the ECT department. RN #7 stated 2 RNs were expected to complete both a.m. and p.m. controlled substance counts. S/he stated this was done to ensure the count was accurate and controlled. RN #7 stated the facility expected the RNs to sign the log at the same time the count was done.

e) On 07/20/16 at 4:24 p.m., an interview was conducted with the Interim Director of Pharmacy (Director #4) who stated the prior Director of Pharmacy conducted the controlled substance log audits monthly and the units selected would be random. Director #4 stated dual signatures were required for shift counts to prevent drug diversion.

A review of the audits dated February 2016 through June 2016 showed no evidence the ECT department logs were monitored. Furthermore, from 06/30/16 through 07/20/16, the inpatient units had 16 controlled substance counts without dual RN verification. There was no evidence the facility monitored the logs during this 3 week period.

2. The facility failed to ensure two Registered Nurses wasted controlled substances and the controlled substance records were signed by both individuals.

a) Review of the ECT department's Controlled Substance Logs for the months of May, June, and July of 2016 revealed on 06/22/16 RN #8 wasted 50 mcg of the intravenous (IV) medication Fentanyl 100 mcg/2 ml. There was no evidence showing a 2nd RN witnessed the waste per policy. Additionally, on 07/18/16 RN #8 documented 50 mcg of IV Fentanyl wasted without a 2nd RN verification.

b) On 07/20/16 at 4:13 p.m., an interview was conducted with RN #7 who stated if a controlled substance was wasted, a second RN was expected to observe the waste and document the waste on the Controlled Substance Log.

c) On 07/20/16 at 4:24 p.m., an interview was conducted with Director #4 who stated dual signatures were required for a controlled substance waste. S/he stated this process was expected to be done to prevent drug diversion.

During the same interview Director #4 stated the prior Director of Pharmacy conducted the controlled substance log audits monthly and the units selected would be random. A review of the audits dated from February 2016 through June 2016 showed no evidence the ECT department logs were monitored for discrepancies.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on interviews and document review, the facility failed to ensure medications were available to meet a patient's chronic illness needs (Patient #3).

This failure resulted in a patient not receiving medications ordered for his/her treatment of a chronic illness.

FINDINGS:

POLICY

According to the policy, Use of Patient's Own Medications, when a patient is out of their own supply of medication, the pharmacist or nursing personnel is responsible for making arrangements. If the medication is not carried by the facility, the pharmacist will take appropriate actions, including but not limited to: replacement with an appropriate substitution approved by physician, or procurement from an outside pharmacy such as a nearby hospital.

1. Pharmacy staff did not make arrangements to ensure Patient #3's home medications were available to meet the patient's chronic illness needs.

a) Review of Patient #3's medical record revealed the following:

Patient #3 was admitted on [DATE]. At 07:53 a.m., Patient #3's physician ordered 2 of the patient's home medications (Truvada and Tivicay), which were prescribed prior to admission for a chronic illness, to be continued. At 05:00 p.m., the patient's physician ordered for him/her to be called if there was any delay of the patient receiving the 2 home medications. At 10:47 p.m., Patient #3's Registered Nurse (RN) documented the patient's home medications were clarified and the patient was notified that s/he would need to have the 2 medications brought into the facility. The RN documented the facility's pharmacy was unable to provide the medications.

On 05/21/16 at 10:50 a.m., Patient #3's physician wrote an order for the Pharmacy to call him/her as soon as possible regarding the availability of the patient's 2 home medications which were still needed and when the patient would be able to resume the medications. At 1:18 p.m., the RN documented the patient stated his/her chronic medications would be brought in on 05/22/16.

On 05/22/16 at 11:40 p.m., Patient #3's RN documented the patient's 2 chronic medications were brought in and verified. A physician order was obtained for the patient to continue the 2 medications. Both of the medications were ordered to be taken daily. Patient #3 had 5 tablets brought in for each of the 2 medications prescribed.

Patient #3 was given his/her daily dose of the Truvada and Tivicay from 05/22/16 through 05/26/16.

On 05/27/16 at 1:00 p.m., the patient's RN documented Patient #3 was out of his/her home medications for the Truvada and Tivicay and his/her last dose was taken on 05/26/16. The RN documented his/her attempts to obtain refills from an outside pharmacy, clarify the medications, and physician updates. Review of additional notes documented by RN on the same day, showed no evidence the facility's own pharmacy staff was notified or involved in obtaining the medications to meet the patient's needs. At 5:00 p.m., the RN documented s/he was still unable to resolve the issue and updated the evening RN supervisor of his/her concerns. There was no evidence in the medical record the evening supervisor addressed Patient #3's medication supply issues.

On 05/27/16 at 7:30 p.m., a physician ordered for both the Truvada and Tivacay to be discontinued.

b) On 07/20/16 at 2:09 p.m., an interview was conducted with Physician #12 who stated Patient #3 provided conflicting information about his/her home medications after the medications ran out. Physician #12 stated the patient refused to give permission for facility staff to be able to talk with outside providers in order to clarify home medication prescriptions for his/hers chronic illness. However, review of the medical record showed no documentation of Patient #3's refusal.

c) On 07/21/16 at 9:13 a.m., an interview was conducted with the Interim Director of Pharmacy (Director #4) who stated when a patient's home medication supply runs out, the facility should be able to replace it and pharmacy staff should be involved in the process of refilling the needed medication. Upon exit of the survey, Director #4 was unable to provide evidence the pharmacy staff made attempts to obtain Patient #3's home medications which were needed for the patient's chronic illness. This was in contrast to facility policy.

d) On 07/21/16 at 10:52 a.m., an interview was conducted with RN #9 who stated if a patient's home medication supply was low; the pharmacy should be called and notified prior to the medication running out. There was no evidence in Patient #3's medical record pharmacy staff were notified prior to Patient #3's home medication supply being depleted.

e) On 07/21/16 at 11:56 a.m., an interview was conducted with Physician #11 who stated if a patient's home medication supply ran out, pharmacy staff should be involved in obtaining the medications the patient needs while in the facility. Physician #11 stated s/he was aware of Patient #3's chronic illness and the risk involved if the patient did not take the medications prescribed. Physician #11 stated if the patient refused to sign a release of information needed to obtain further information, facility staff were expected to document in the medical record the refusal. Physician #11 further stated, pharmacy staff were aware of Patient #3's medication needs on 05/21/16 and had ample time to ensure the availability of the medications needed during Patient #3's hospital stay.

Patient #3 was discharged on [DATE].
VIOLATION: AFTER-HOURS ACCESS TO DRUGS Tag No: A0506
Based on interviews and document review, the facility failed to have a clear system in place that accurately documented the removal of medications from the after hours supply. Furthermore, the facility failed to ensure pharmacist and non-pharmacist staff followed quality control procedures when retrieving medications from the after hours medication cabinets.

These failures created the potential for medication retrieval errors.

FINDINGS:

POLICY

According to the policy, Medication Administration General Guidelines, nurses who have completed a competency for retrieval of after hours medication will obtain after hours medication from the allowed after hours stock. The medication must be co-signed by 2 nurses and the indications/use for each medication completed.

According to the policy, Accessing Pharmacy When Pharmacist Not Available, the nursing house supervisors have a key to the after hours area in the pharmacy. The competency trained nurse must complete a night cabinet log for each medication that is retrieved and leave it along with a copy of the original order. The pharmacist reconciles the inventory daily. the drug inventory includes date, time, patient name, strength removed, quantity removed, physician, reason, correct dose and frequency, allergy or drug interaction.

1. Pharmacists and non-pharmacist staff did not follow after hours medication retrieval procedures.

a) Review of the Night Cabinet Logs dated 07/01/16 through 07/19/16 revealed multiple areas of documentation were not completed according to policy. The logs were missing 1 of the 2 Registered Nurse (RN) signatures required for verification. The log dated 07/05/16 showed under the column labeled "Patient MAR checked for allergies, interactions, etc" was left blank for the 3 different patients listed. Furthermore, the pharmacist who reconciled the 07/05/16 log documented 2 additional medications were pulled from the cabinet which were not signed out on the log, Gabapentin (nerve pain medication and anti-convulsant) and Bactrim DS (antibiotic).

Review of the log dated 07/07/16 revealed 2 Olanzapine (antipsychotic) 10 milligram (mg) tablets were removed from the after hours cabinet without being signed out. In addition, an order for the medication was not left with the log.

Review of the log dated 07/08/16 showed a RN removed 40mg of Celelexa (antidepressant) for a patient. There was no evidence showing the reason the medication was removed after hours; nor was there evidence showing the RN checked the Patient's MAR for allergies.

Review of the log dated 07/16/16 and 07/17/16 showed no evidence the pharmacist reconciled the medication inventory which was removed over the weekend. However, the logs dated after these dates were reconciled.

Review of logs for the months of May 2016 and June 2016, showed no evidence a second RN verification was completed when patient medications were retrieved after hours.

b) On 07/19/16 at 3:03 p.m., a tour of the pharmacy after hours area was conducted with Pharmacist #1. Pharmacist #1 stated the pharmacist should reconcile the Night Cabinet Log the following morning the medications were retrieved. Pharmacist #1 stated the logs were reconciled to maintain security of all medications and to track variances.

c) On 07/20/16 at 9:39 a.m., an interview was conducted with RN #2 who stated 2 signatures were required when medications were retrieved from the night cabinet after pharmacy hours. S/he stated the second signature was a double check. RN #2 stated s/he thought the prior Pharmacy Director (Director #3) changed the policy recently where only one signature was required for verification.

Upon exit of the survey, the facility was unable to provide evidence the policy was changed and staff were educated on the changes mentioned in RN #2' s interview.

d) On 07/21/16 at 9:13 a.m., an interview was conducted with the Interim Director of Pharmacy (Director #4) who reviewed Night Cabinet Logs for July 2016. Director #4 stated 2 signatures were required on the night cabinet log sheets since a pharmacist was not present after hours. Director #4 stated as long as the facility had a manual system, 2 signature verification would be required. S/he further stated there was a possible increase of errors if a second verification was not done. Additionally, Director #4 stated Pharmacists were responsible for reconciling the form the following day. S/he stated the Pharmacists were responsible for ensuring the form was completed and medications orders were present. S/he expected the form to be filled out completely.

Director #4 stated there was no current process for auditing the logs.

During the interview, the Director of Nursing (Director #5 ) was present. Director #5 stated s/he was not aware of any concerns regarding the incomplete and inaccurate logs.
VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING Tag No: A0144
Based on observation and interviews, the facility failed to ensure oxygen tanks used in patient care units were stored in a secure manner.

This failure created an increased risk of patient or staff harm related to a possible hazardous event.

FINDINGS:

POLICY

According to the policy, Oxygen Tanks, oxygen tanks will be stored in the rack that has been specifically prepared for that purpose.

1. The facility failed to secure oxygen tanks stored on patient care units.

a) On 07/18/16 at 11:34 a.m., a tour of the 800 unit was conducted with the Director of Nursing (Director #5). An unsecured oxygen tank was observed falling on the floor in the medication room. At 11:40 a.m., a second unsecured tank was observed on the floor in the oxygen storage room.

b) On 07/20/16 at 2:49 p.m., an interview was conducted with the Registered Nurse (RN #14) who stated oxygen tanks should be secured to prevent the tanks from falling. Director #5 was present during the interview. S/he stated the oxygen tanks could explode.

c) On 07/20/16 at 3:34 p.m., an interview was conducted with RN #6 who was present at the time the oxygen tanks on the 800 unit fell on the floor. RN #6 stated oxygen tanks should be stored in carts so the tanks do not tip over. RN #6 stated s/he was unsure why the tank was not stored securely.
VIOLATION: REPORTING ADVERSE EVENTS Tag No: A0508
Based on interviews and document review, the facility failed to ensure nursing staff notified patients' (Patient #9 and Patient #11) physicians after a medication error occurred and documented the notification in the patient's medical record. Additionally, the facility failed to ensure nursing staff documented in the medical record the description of the medication given, nursing follow-up, and patient response to the medication error.

These failures resulted in an inaccurate patient medical records.

FINDINGS:

POLICY

According to the policy, Medication Errors, the purpose of the policy is to ensure that medication errors are documented and reported with follow-up action taken to protect the patient. The RN will monitor the patient for adverse reactions related to the medication error. The attending physician is notified of the occurrence. Documentation in the medical record shall include the following: description of medication given or omitted, notification of physician, any new physician order, nursing follow-up, and patient response. The patient is assessed for any possible adverse reactions and findings documented.

1. The facility failed to ensure nursing staff documented patient medication errors, nursing follow up, and the appropriate notifications in patients' medical records (Patient #11 and Patient #9).

a) Review of 12 internal reporting documents for medication errors revealed the following:

On 02/18/16, Patient #11 (14 year old) was given 0.5 milligrams (mg) of Klonopin, a sedative, instead of the prescribed dose of 0.25 mg. The event occurred in the Adolescent unit during the day shift.

On 06/03/16, Patient #9 was ordered to be given Haldol, an antipsychotic, 3 mg by mouth twice daily. The patient was given a different antipsychotic, Risperdal 3 mg, instead of the prescribed Haldol. This event occurred in the adult Intensive Treatment Unit (ITU).

Review of both Patient #11 and Patient #9's medical records revealed no evidence the medication errors (wrong dose and wrong medication) occurred, the physician was notified, the patient or patient's parent were notified, nursing follow-up, and the patients' response to the medication error. This was in contrast to policy.

b) On 07/20/16 at 3:34 p.m., an interview was conducted with Registered Nurse (RN) #6 who stated medication errors should be documented in the patients' medical records. RN #6 stated the patient should be notified or if the patient was an adolescent, the parent should be notified about the error.

c) On 07/21/16 at 10:52 a.m., an interview was conducted with RN #9 who was responsible for Patient #11's care during the day shift on 02/18/16. RN #9 stated when a medication error occurred, s/he would notify the physician, notify the patient or the patient's family member, and assess the patient for any side effects. RN #9 stated s/he would document the follow up in a progress note in the patient's medical record. After review of Patient #11's medical record, RN #9 stated s/he remembered the incident. RN #9 confirmed the medical record lacked evidence the medication error occurred. RN #9 stated s/he might have been busy that day.

d) On 07/21/16 at 11:32 a.m., an interview was conducted with both the Director of Nursing (Director #5) and the Director of Risk Management and Improvement (Director #10). Director #5 stated after a medication error, staff were expected to document the error in the patient's medical record, including: physician notification, patient or family notification, and any nursing follow up conducted. After review of Patient #9 and Patient #11's internal reporting documents, Director #5 stated s/he did not review the patients' medical records.

e) On 07/21/16 at 11:56 a.m., an interview was conducted with Physician #11 who was the facility's medical director. Physician #11 stated s/he expected a medication error, which could affect a patient, should be documented in the medical record. Physician #11 stated the facility internal reporting documents were not part the the patient's medical record.