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.

BERKSHIRE MEDICAL CENTER INC - 1 725 NORTH STREET PITTSFIELD, MA 01201 Oct. 31, 2018
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, records reviewed and interview the Hospital failed to consistently adhere to its policies and infection control standards of care related to biohazard transport and storage, multi-dose vial labeling, temperature monitoring of perishable patient foods, sharps reduction, reprocessing of equipment and separation of clean and soiled storage.

1.) According to the Hospital's Exposure Control to Bloodborne Pathogens Plan, dated 4/30/2017, all Hospital campuses adhere to the handling of regulated waste (including contaminated sharps and other potentially contaminated waste) by using leak proof red containers with the appropriate biohazard warning label.

The Surveyor toured the Intensive Care Unit at 10:35 A.M. on 10/29/18. The Surveyor observed a red container on the bronchcoscopy cart. The Charge Nurse in the Intensive Care Unit said that the red container was used to transport the bronchoscope after use to be reprocessed. The red container lacked the required biohazard sign.

The Surveyor toured the Central Sterile Reprocessing Department on the Pittsfield Campus at 10:25 AM on 10/30/18. Multiple red containers were stacked in the decontamination area of the department. Ten of the red containers lacked the required biohazard sign. The Director of the Central Sterile Reprocessing Department said the stickers often wash off of the containers during reprocessing.

2.) The Surveyor toured the Post Anesthesia Care Unit (PACU) at 8:30 A.M. on 10/30/18 and interviewed PACU RN #1 about the use of multi-dose vial medications. PACU RN #1 said that the vials were used for 28 days after opening. PACU RN #1 retrieved a multi-dose Insulin vial from the medication refrigerator. The multi-dose Insulin medication vial was labeled as 10/24/18. PACU RN #1 said she was not sure if that was the date the vial was opened or the expiration date.

3.) The Surveyor toured the Preop Care Unit (PCU) at 8:15 A.M. on 10/30/18 and interviewed PCU RN #. PCU RN #1 said that the PCU was open Monday through Fridays and closed for the weekend and holidays. PCU RN #1 said that the Patient's refrigerator temperature was monitored and logged during the times that the PCU was opened. The refrigerator contained numerous perishable items i.e. milk and cream that would go unmonitored for two or even three days.

4.) According to the Occupational Safety and Health Administration (OSHA), engineering controls are the primary means of eliminating or minimizing employee exposure and include the use of safer medical devices, such as needleless devices and shielded needle devices.

The Surveyor toured the sterile core of the Operating Room at 9:00 A.M. on 10/30/18 and interviewed the Director of OR Services. There were numerous non-safety needles available for use i.e. 21 gauge x 1 1/2 inch, 25 gauge x 1/2 inch, 20 gauge x 1 inch and 25 gauge x 5/8 inch. The Director of OR Services said there was a waiver process to allow use of these items when a safety alternative did not work for the procedure.

The Surveyor reviewed the sharps waiver log on 10/30/18. The sharps waiver log indicated that there were waivers to allow providers to use these non-safety products; however, as a reason to request the waivers all of the Radiology Department had cited "Physician Preference" which is not an acceptable reason not to use a safety alternative product.

5.) The Surveyor toured the Anesthesia Workroom at 9:10 A.M. on 10/30/18 and interviewed OR Tech #1. The Surveyor observed laryngoscope handles being stored in an open bin ready for use. According to the manufacturer's directions for use, these handles require high level disinfection (a process of complete elimination of all microorganisms on a device, with the exception of small numbers of bacterial spores) and storage. An open bin with uncovered handles would be inadequate storage after reprocessing.

6.) The Surveyor observed at 9:35 A.M. on 10/30/18, in the Semi-restricted area of the Operating Room (OR) Suite, a storage cabinet with approximately 20 boxes of implantable knee replacement equipment. Vendor #1 was stocking the orthopedic cabinet with the implantable knee equipment. Vendor #1 dropped one clean box containing the implantable knee equipment on the dirty floor, picked up the contaminated box and put it in the clean storage cabinet without disinfecting the box, thereby contaminating the storage cabinet and other stored boxes of implantable knee equipment.


The Surveyor interviewed Vendor #1 at 9:35 A.M. on 10/30/18, Vendor #1 said that, because there was a cellophane wrapping on the implantable knee equipment box that he dropped on the floor, the box did not need to be disinfected prior to him placing it in the orthopedic storage cabinet. Vendor #1 was not aware of the significance of his infection control breech to ensure patient safety.