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Based on observation, interview and document review, it was determined that the outpatient orthopedic service did not adhere to manufacturer's specifications in utilizing its autoclave.

Findings include:

Observation on 6/9/16 of the outpatient facilities revealed an autoclave machine located in the laboratory adjacent to the Orthopedic Clinic. Interview with Staff A, (Medical Assistant) on 6/9/16, revealed that Staff A does the autoclaving, e.g. for suture removal kits, and utilizes a strip that changes color on the bags, and the fluid is changed every week; Staff A confirmed that Staff A doesn't run any spores, and Staff A relates the autoclave has no gauges to monitor temperature or pressure.

The facility made available a copy of the Operating Instructions Classic Autoclave Medical Device, which reads on page 5 "Healthcare personnel should select Biological Indicators consisting of spores of Bacillus Stearothermophilus .... sterilization loads should be biologically monitored at least once a week, but preferably daily...."

Based on record review and interview, it was determined that the facility failed to ensure that consents to treat were complete and current for 3 outpatients in a survey sample of 8 off-site hospital patients. (Patient identifiers are #3, #4, and #8.)

Findings include:

Clinical record review was facilitated by the facility navigators who operated the computers for review of electronic medical records on 6/8/16 and 6/9/16. Additionally some records in paper form were provided during survey.

Patient #3
Review of this patient's clinical record revealed the patient underwent a surgical excision on 5/3/16 with specimen(s) sent to pathology. The provider's document generated 5/14/16, for the 5/3/16 visit, relates "Consent was obtained. The procedure and risks were explained in detail. Questions were encouraged and answered...." While this patient had signed a general consent to the Speare Memorial Hospital Physician Group Practices on 9/22/15, there was no document signed by the patient specific to the consented procedure and related risks for the procedure on 5/3/16.

Patient #4
Review of this patient's clinical record revealed the patient underwent a surgical excision on 5/6/16 with specimen(s) sent to pathology. The provider's note of 5/6/16 relates "Consent was obtained. The procedure and risks were explained in detail. Questions were encouraged and answered...." While this patient had signed a general consent to the Speare Memorial Hospital Physician Group Practices on 1/25/16, there was no document signed by the patient specific to the consented procedure and related risks for the procedure of 5/6/16.

Patient #8
Review of this patient's clinical record revealed the patient was seen for services at the outpatient orthopedic clinic. No general consent for treatment was evident in the clinical record.

During the review of electronic medical records for the above three patients on 6/9/16 with Staff C, navigator, Staff C confirmed, via interview, that Staff C was unable to identify and display additional consents relative to the above visits.

Based on record review and interview, it was determined that the facility failed to ensure contracts and agreements for services were properly executed and kept current.

Findings include:

Review of the facility's Master Contract List-Patient Care Related Services, dated 4/12/2016 revealed that Services included, in part, Hospitalist Program, Patient Transfer and Service Agreement, CAH Network Agreement, and Emergency and Trauma Services.

Review of the Patient Referral and Transfer Agreement between Speare Memorial Hospital and ... Medical Center, revealed it commenced on 6/1/14 and continued for a period of two years, unless sooner terminated. Interview on 6/10/16 with Staff B (Quality Manager) confirmed that the contract had expired and that the facility continued to use the Medical Center for transfers.

Review of the Professional Services Agreement By and Between ... Hospitalist Program and Speare Memorial Hospital, effective 4/1/16 reveals that it is for the two year period commencing on June 1, 2016. This was signed by Speare Memorial Hospital but lacked any signature by the Hospitalist Program provider.

Review of the Letter of Agreement Between ... [manager of emergency services and trauma] and the facility reveals "The term of this agreement is effective on the date of signature and will remain in effect for three years...." The dates of signature on the agreement were 3/28/13 and 4/1/13.

Interviews with Staff B during survey confirmed the above findings.