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88 LEWIS BAY ROAD

HYANNIS, MA 02601

QAPI

Tag No.: A0263

Based on review of Patient Safety and Quality Committee Minutes, the 2012 Annual Report of Quality and Safety, staff interviews, and the Quality Assurance/Performance Improvement (QAPI) Plan, the Hospital failed to document QAPI projects were being conducted on contract services that included the reason(s) for implementing the project, a description of the project's results and on-going quality monitoring of contract services including neurosurgical and orthopedic instrument vendors for safety and effectiveness.

Please see tag A-0273

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on document review, the Patient Safety Quality Committee Minutes, the 2012 Annual Report of Quality and Safety and the QAPI Plan, and interview, the Hospital failed to implement and maintain an on-going, data driven, quality assessment and performance improvement (QAPI) program that included quality activities for contracted services of the Hospital. Findings include:

On 9/10/13, review of the QAPI Plan, the Patient Safety Quality Committee minutes and the 2012 Annual Report of Quality and Safely, indicated the reports lacked documentation of improvement projects or studies for contracted services including neurosurgical and orthopedic instrument vendors.

The Surveyor interviewed the Director of Quality and Regulatory Department at 3:50 P.M. on 9/10/13 and again on 9/11/13. The Director of Quality and Regulatory Department said there was no QAPI program for any of the instrument vendors contracted to provide surgical instruments to the Hospital.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on observation and interview, the Hospital failed to consistently meet the standard of care or to adhere to the Hospital's Exposure Control Plan, for transport of soiled equipment.

Observations in the Decontamination Area of the Sterile Processing Department (SPD) at 10:05 A.M. on 9/10/13 included reprocessing of the Transesophageal Echocardiography (TEE) scope. The TEE probe is a long flexible instrument with an ultrasound sensor located at the tip. The probe is passed through the patient's mouth, down the back of the throat, and into the esophagus and stomach. The Surveyor interviewed the SPD Technician at 10:00 A.M. on 9/10/13. The SPD Technician said the TEE probe was transported to the SPD Department to be reprocessed. During observation, it was noted that the TEE probe was placed in a clear container lined with a plastic pad. The SPD technician said this was the routine procedure for transporting soiled TEE scopes.

Review of the Hospital's Bloodborne Pathogen Exposure Control Plan 2013-2014, indicated biohazardous labels must be affixed on containers/bags that transport OPIM (other potentially infective material). The soiled TEE probe was not transported in a manner that would comply with Hospital requirements, nor was a visual warning label affixed to the container (i.e., biohazard label or red bag), to reduce the risk of exposure to employees or patients to equipment that has not been disinfected.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation and interview, the Hospital failed to consistently maintain the environment of the Operating Room according to acceptable standards of care.

Observations were made in Operating Room (OR) #6, during the OR tour 8:15 A.M. to 9:20 A.M. on 9/10/13. A large a multi-compartment carry-all-bag (approximately 18 inches by 18 inches) was observed in the chair adjacent to the Anesthesia equipment. The bag was a print fabric with patent leather trim. The Surveyor interviewed the Nurse Director of Perioperative Services during the OR tour and again at 8:45 A.M. on 9/11/13. The Nurse Director of Perioperative Services said the bag belonged to the Certified Registered Nurse Anesthetist (CRNA) and personal items are not allowed in the OR suites.

According to Association of Perioperative Registered Nurses (AORN) standards, personal items (i.e. handbags, briefcases, laptops, fanny packs, and backpacks) should not be taken into semi-restricted or restricted areas of the OR.