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.

CLARION HOSPITAL ONE HOSPITAL DRIVE CLARION, PA 16214 July 2, 2018
VIOLATION: PATIENT SAFETY Tag No: A0286
Based on review of facility documentation and employee interviews (EMP), it was determined that the facility failed to implement the established facility policies regarding medical errors for two of two identified Cancer Clinic medication errors (MR11 and MR12).

Findings include:

Review, at approximately 11:11 AM on June 27, 2018, of the "Clarion Hospital Patient Safety Plan," no review/revise date provided, revealed, "... Internal Reporting: All departments within the organization are responsible for reporting patient safety occurrences and potential occurrences to the Patient Safety Officer, who will aggregate occurrence information utilizing a computerize [sic] database and will present a report to be shared with the Patient Safety Committee, Quality & Performance Improvement Committee, EOC Committees as appropriate, Pharmacy & Therapeutics Committee, the Board of Directors and Medical Staff. ... The Patient Safety Committee will review reports to identify trends, determine cause, and whether the error presents a systematic problem, a periodic occurrence, or an isolated incident. Resolution and actions taken shall involve those involved in the process as well as individuals involved in the occurrence. Root cause analysis will be conducted on all critical occurrences and as deemed appropriate. Results and action plan will be shared as appropriate. ..."

1. At approximately 12:58 PM on June 28, 2018, a review of facility documentation regarding MR11, revealed, "... 01/24/2018 ... Name of Patients Physician [EMP12] ... Received testosterone [sic] open greater then [sic] 28 days ... Brief Factual Description ... Patient received a doses [sic] of testosterone on 1/10/18 & 1/24/18 from a vial that was dated to not be used past 1/3/18. This was brought to medical assistance [sic] attention and [he/she] was instructed to not administer from this vial as it could contain bacteria on 1/24/18 by this writer. The facility policy was also explained to the medical assistant but the medication was still administered. ... Who Was Notified? ... Manager ... [EMP9] ... Type of Person Notified Pharmacist ... [EMP10] Time 07:15 Date 01/25/2018 Notes Per [EMP10], Patient should be notified that [he/she] received a potential contamination and education should be provided on monitoring for infection ..."

2. Review, at approximately 1:15 PM on June 28, 2018, of facility documentation regarding MR12, revealed, "... 01/24/2018 ... Name of Patients Physician [EMP12] ... testosterone vial was labeled to not be used ... Patient received a doses [sic] of testosterone on 1/24/18 from a vial that was dated to not be used past 1/3/18. This was brought to medical assistance [sic] attention and [he/she] was instructed to not administer from this vial as it could contain bacteria on 1/24/18 by this writer. The facility policy was also explained to the medical assistant but the medication was still administered. Number of doses affected 1 ... Who Was Notified? ... Manager ... [EMP9] ... 01/24/2018 ... Pharmacist ... [EMP#10] ... 01/25/2018 ... Per [EMP10], Patient should be notified that [he/she] received a potential contamination and education should be provided on monitoring for infection. ..."

3. At approximately 2:32 PM on June 28, 2018, when asked if MR11 or MR12 had been notified, regarding receiving expired Testosterone on January 24, 2018, as per EMP10's recommendation, EMP3 stated, "We could not find evidence that either patient was notified." When asked why the patients had not been notified, EMP3 was unable to provide an answer.

4. Review, between 11:20 AM and 11:40 AM on June 29, 2018, of January-May 2018 Patient Safety Committee minutes, did not reveal documentation of discussions regarding MR11 and/or MR12.

5. Review, between 12:00 and 12:20 PM on June 29, 2018, of MR11 and MR12 did not reveal documentation that the patients received medication that was beyond the identified Beyond-Use-Date identified on the medication vial.

6. When asked, at approximately 12:25 PM on June 29, 2018, if there would be a way to track patients who received medication beyond a vial's Beyond-Use-Date, without a documented event or finding a vial in a treatment area beyond the vial's Beyond-Use-Date, EMP10 stated, "... There's really no way to track that. From the event report we would know when the expiration date [Manufacturer] is. There really would be no way to track it. ..."

7. When asked, at approximately 1:08 PM on June 29, 2018, if the events were reviewed by the Patient Safety Committee, EMP10 stated, "... I don't believe so. I don't recall it being discussed. . ..."

8. When asked, at approximately 1:10 PM on June 29, 2018, why the events were not reviewed by the Patient Safety Committee, EMP10 stated, "... I actually believe EMP13 and I discussed it privately. Based on responses my thought process was that it wasn't a serious event. ..."
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on review of facility documentation, medical records (MR), and personnel files (PF), as well as employee interviews (EMP), revealed that the facility failed to ensure that all drugs were administered in accordance with State regulations for two of two Cancer Clinic medical records reviewed (MR11 and MR12).

The facility was found to be noncompliant with the following State Regulation:

"28 PA Code Part IV. Health Facilities Subpart B. General and Special Hospitals Chapter 107. Medical Staff," revealed, "107.64. Administration of drugs. Drugs shall be administered only upon the proper order of a practitioner acting within the scope of his license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practice nurse with pharmacy training. Graduate practical nurses, graduate nurses, and students in approved schools of nursing may be authorized to administer drugs, but only under the supervision of a registered professional nurse or a physician under 49 Pa Code 21.14 (relating to administration of drugs). A paramedic may be permitted to administer drugs only under 117.30 (relating to emergency paramedic services) and Chapter 2, Subchapter A (relating to emergency medical technicians). Further policies on the administration of drugs shall be established by the medical staff in conjunction with the pharmacy committee."

Based on review of facility documentation, medical records (MR), and personnel files (PF), as well as employee interviews (EMP), it was determined that the facility failed to ensure that medications administered in the Cancer Clinic were administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practice nurse with pharmacy training.

Findings include:

Review, at approximately 12:09 PM on June 27, 2018, of Policy 43, "Medication Administration," revised November 2016, revealed, "... II. Responsible Staff: RN/GN/LPN/GPN/Respiratory Therapist ... IV. Text: General Information A. Nursing is responsible to assure accurate and efficient administration of medications to patients on all nursing units. ... D. Medications are to be administered by RNs, LPN, Respiratory Therapy, and Dialysis RNs ... Medication Administration A. General Information ... Drugs and Biologicals must be ... administered in accordance with federal and state laws ... and acceptable standards of practice. ..."

Review, at approximately 1:48 PM on June 28, 2018, of the "Clarion Hospital Job Description," for "Medical Office Assistant," revised March 1, 2011, did not reveal medication administration to be included in the responsibilities of a medical office assistant.

1. At approximately 12:58 PM on June 28, 2018, a review of facility documentation revealed a medical assistant administered medication to the MR11 patient.

2. Review, at approximately 1:15 PM on June 28, 2018, of documentation regarding MR12, revealed a medical assistant administered medication to the MR12 patient.

3. When asked, at approximately 2:20 PM on June 28, 2018, if medical assistants were allowed to administer medication to patients, EMP9, stated, "Yes. They administer B12, Vaccines, and testosterone, but EMP14 would know more. ..."

4. When asked, at approximately 2:24 PM on June 28, 2018, if medical assistants were allowed to administer medication to patients, EMP14, stated, "Yes. They would administer B12, Testosterone, flu vaccine, and pneumonia vaccine. EMP7 hasn't done it yet, because [he's/she's] a float, but EMP11 has. However, [he's/she's] no longer with us. [He's/She's] been doing it for at least 14 to 15 years. ..."
VIOLATION: UNUSABLE DRUGS NOT USED Tag No: A0505
Based on review of facility documentation and employee interviews (EMP), it was determined that the facility failed to ensure that outdated or otherwise unusable drugs were not available for patient use to patients receiving care in the Cancer Clinic.

Findings include:

Review, at approximately 12:09 PM on June 27, 2018, of Policy 43, "Medication Administration," revised November 2016, revealed, "... Medication Administration A. General Information ... Drugs and Biologicals must be prepared and administered in accordance with federal and state laws, the orders of the practitioner, and acceptable standards of practice. ..."

Review, at approximately 2:05 PM on June 28, 2018, of Procurement, Storage, and Control Policy #12, "Use of MultiDose Vials," revised January 2011, revealed, "... Policy: The expiration date for multiple dose vials will be 28 days, unless otherwise stipulated by the manufacturer, from initial use, providing that there is no obvious contamination and that normal precautions have been taken. ... If contamination is suspected, a new vial is to be used. The expiration date is recorded on the vial. ..."

1. At approximately 12:58 PM on June 28, 2018, a review of facility documentation regarding MR11, revealed, "... 01/24/2018 ... Name of Patients Physician [EMP12] ... Received testosterone [sic] open greater then [sic] 28 days ... Brief Factual Description ... Patient received a doses [sic] of testosterone on 1/10/18 & 1/24/18 from a vial that was dated to not be used past 1/3/18. This was brought to medical assistance [sic] attention and [he/she] was instructed to not administer from this vial as it could contain bacteria on 1/24/18 by this writer. The facility policy was also explained to the medical assistant but the medication was still administered. ..."

2. Review, at approximately 1:15 PM on June 28, 2018, of facility documentation regarding MR12, revealed, "... 01/24/2018 ... Name of Patients Physician [EMP12] ... testosterone vial was labeled to not be used ... Patient received a doses [sic] of testosterone on 1/24/18 from a vial that was dated to not be used past 1/3/18. This was brought to medical assistance [sic] attention and [he/she] was instructed to not administer from this vial as it could contain bacteria on 1/24/18 by this writer. The facility policy was also explained to the medical assistant but the medication was still administered. ..."

3. When asked, at approximately 12:25 PM on June 29, 2018, if there would be a way to track patients who received medication beyond a vial's Beyond-Use-Date, without a documented event or finding a vial in a treatment area beyond the vial's Beyond-Use-Date, EMP10 stated, "... There's really no way to track that. From the event report we would know when the expiration date [Manufacturer] is. There really would be no way to track it. ..."
VIOLATION: FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE Tag No: A0724
Based on review of facility documentation, observation, and employee interviews (EMP), it was determined that the facility failed to ensure supplies were maintained to ensure an acceptable level of safety and quality as evidenced by having supplies with opened external packaging and opened and expired supplies located within the Cancer Center.

Findings Include:

A review at approximately 2:30 PM on June 28, 2018, of "Code Blue and CPR Procedure," revision dated December 2015, revealed, "... 15. All crash carts are to be opened at least once a month to check for appropriate supplies and outdates on supplies; ..."


Review, at approximately 9:45 AM on June 29, 2018, of Procedure IC1023, "Supply monitoring for expiration dates," revision dated June 2009, revealed, "... Procedure: All areas that stock patient care supplies will check department inventory at least annually for expired or soon-to be expired items. ... 1. By January 30th of each year, all departments will be responsible for inventorying all departmental patient-use supplies for expiration dates. The manager of each department is to designate an individual to complete this task. ... 5. All items found expired are to be removed immediately from service and sent to the central supply department. 6. The individual(s) completing the task shall forward a list of outdated or soon to be outdated supplies to the department manager. 7. A copy of the list is to be provided to the Infection Preventionist."

On June 28, 2018, a tour was conducted from approximately 2:15 PM-2:40 PM of the Cancer Center. The following findings were identified during this time:

1. Within the cupboards of the Medication Supply Room, the external packaging was not intact for five dressing changing trays.

2. Within the cupboards of the Medication Supply Room, the external packaging was not intact for one dressing changing tray with tegaderm.

3. Within the cupboards of the Medication Supply Room, one Bactec Peds Plus F Culture Vial without a cap was identified.

EMP9 stated, "That shouldn't even be in there, it doesn't have a cap."

4. Within the crash cart located in the patient care area, two lubricating jelly packets were identified with an expiration date of March 2017.

5. Within the crash cart located in the patient care area, one 10 French Slick Stylet was identified with an expiration date of June 2017.

6. All findings were confirmed by EMP1 and EMP9 at the time that the items were identified.