HospitalInspections.org

Based on observation, and interview, the facility failed to ensure medications were stored in a manner consistent with acceptable standards of professional practice in the operating room.

Findings include:

The surgical suite #2 contained stock pharmaceuticals that were outdated.

During a tour of the surgical suite #2 on 9/9/10, at 9:45 a.m. it was noted there were seven packages of Ceftin which is an antibiotic that had expiration dates from 5/2010 and 7/2010. It was also noted that there had been one multi-use vial of lidocaine 1% and a vial of epinephrine that had an open date of 7/22/10, but was not removed from service after the 30 day expiration date of 8/21/10. During an interview with the operating room clinical manager on 9/9/10, at 9:45 a.m. she stated that outdated meds were to be checked every week on Monday's. She also confirmed that Ceftin, lidocaine, and epinephrine were outdated in the operating room suite #2.

Based on the revocation of the Clinical Laboratory Improvement Act (CLIA) certificate the facility failed to ensure laboratory services are provided as " direct services. "

Findings included:

1). On June 17, 2010 CMS revoked the CLIA certificate for St. Elizabeth ' s hospital therefore; St. Elizabeth ' s Medical Center failed to ensure basic laboratory services are provided as " direct services. "

2). The Critical Access Hospital (CAH) must have a current CLIA certificate to perform all tests.

Based on record review and staff interview, the facility failed to ensure that each patients medical record entry had been authenticated by the author with a timed and dated entry 14 of 25 patient records reviewed (P1, P2, P3, P4, P5, P6, P8, P9, P12, P7, P10, P13, P14, P15) reviewed in the sample.

Findings include:

P1, P2, P3, P4, P5, P6, P8, P9, and P12 were inpatient records reviewed. The following entries were noted to not have a date nor time of entry: Dated and timed physician signatures were lacking on Discharge Summaries, Progress Notes (including lack of electronic signatures) , Physician orders (including verbal and telephone orders), Standing Orders, and Specific care protocols, and/or History and Physical Examinations.

P7 and P10 were surgical records that were reviewed and they lacked authentication of entries by the physician and/or surgeon. Entries lacking proper authentication included: pre and post operative orders, and standing surgical physician orders.

P13, P14, and P15 were emergency patients and they lacked physician orders that contained the date and time of entry.

P13, seen in the emergency department (ED) 9/6/10; P14, seen in ED on 9/4/10; and P15, seen in the ED on 8/26/10; Emergency room documents lacking proper authentication included physician handwritten notes and medication orders, patient transfer forms, and dictated emergency room notes.

A facility policy titled Physician/Practitioner Orders dated 9/16/2009 was reviewed. It stated, "The physician/practitioner will date and time the orders."


Interviews were conducted with the director of patient services at 8:45 a.m. and 10:00 a.m. on 9/10/2010, and with the vice president of patient services on 9/8/2010, at 1:00 p.m. They both verified that entries in the medical records reviewed lacked consistent authentication of entries that were dated and timed by the author. Also it was learned that this issue was discussed during the performance improvement program in the past. However, it remained an ongoing problem.

Based on interview and record review, the facility failed to ensure they had developed a quality assurance committee with members from departments of the hospital that meet and evaluated the overall ongoing quality and improvement of patient care and services in the critical care hospital (CAH).

Findings include:

Even though the facility had each department identify their own quality improvement concerns this information may not have been shared with the other departments so the quality improvement projects could be implemented and reviewed for effectiveness by all departments involved with patient care and services.

During the entrance conference on 9/7/10, at 3:00 p.m. the quality assurance program meeting minutes were requested, however the vice president of clinical services stated that each department had their own quality assurance activity and there was not a hospital wide functioning committee where each department head came together to discuss ongoing quality assurances projects related to patient treatment and services furnished by the CAH.

Review of the facilities "QUALITY PLAN" revealed the following: "As part of the organization's strategic planning process, goals to further our quality improvement efforts will be established." Under the Category "ROLES AND RESPONSIBILITIES" the following was noted for Physician Leaders, Senior Leaders, and Department Managers they are to be actively " Participate on Quality Improvement (QI) Teams.

The Vice President of Clinical Services was interviewed again on 9/10/10 at 4:00 p.m., during which she confirmed that there had not been a quality assurance committee that had formal meetings related to quality improvement, but that each department completed quality improvement programs independently.

Based on interview, and record review, the facility failed to ensure that the written policy for organ procurement organization (OPO) included a definition of "imminent death."

Findings include:

The policy for tissue and eye donation dated 6/2009 was reviewed and it was noted that the policy identified cardiac death, but did not define "imminent death" as it relates to organ procurement.

The Vice President of clinical services was interviewed on 9/8/10, at 1:00 p.m. during which she confirmed that the critical access hospital policy for OPO did not include the definition of "imminent death."

Based on review of staff in-service information, review of Quality Improvement information, and on staff interview the critical access hospital (CAH) failed to ensure all patient care staff received ongoing education regarding donation issues; and failed to incorporate data related to the organ procurement organization (OPO) and tissue including eye bank into the Quality Improvement program for evaluation.

Findings include:

Review of staff education and in-service materials for the past year revealed no evidence of training related to donation issues. On interview with the vice president of clinical services on 9/8/10, at 1:50 p.m. they confirmed new staff had not been provided with information related to donation and there had been no ongoing education provided to patient care staff related to organ and tissue donation "for a couple of years."

Review of the Quality Improvement minutes revealed no integration of the OPO data into the QI Plan was noted. Although the OPO had provided documentation to the CAH related to deaths reported for potential donation, the information received from the OPO had not been reported as part of the QI program. There was no evidence that the CAH had evaluated current protocols to determine effectiveness. Interview with the vice president of clinical services on 9/8/10, at 1:50 p.m. confirmed that OPO had not been included in their Quality Improvement plans.