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Tag No.: A0147
Based on observations, interview and record review, the hospital failed to assure the patient's right to confidentiality of his or her clinical records were consistently maintained. Findings include:
Per observation on 4/5/17 at 10:45 AM, patient records were left unattended and potentially visible to the public. During a tour of the facility environment accompanied by the Engineering and Maintenance Director and Manager, four large barrels containing diagnostic imaging records were in an exterior loading/unloading area without staff in sight. The records were protruding from the top of the barrels and patient personal health information (PHI) was clearly visible from a distance of approximately 3 feet. The loading area was unsecured and accessible from parking lots. The barrels primarily contained mammography records including patient name and diagnostic images. The observation was confirmed at the time by the accompanying staff. The facility Medical Records Management policy dated 3/1/17 states that " the Health Information Manager, appropriate Department Directors or appropriate Outpatient Department leaders will ensure medical records are stored and maintained in locations where the records are secure and that protect them from fire, water damage and other threats to the best degree possible".
Tag No.: A0397
Based on observation, interview and record review, the hospital failed to assure annual competencies and the "Right to Know Sign Off Sheet" for hazardous drugs were reviewed for 1 applicable registered nurse (RN) who was responsible for safe handling and administration of hazardous drug BCG (Bacillus Calmette-Guerin, a strain of Mycobacterium Bovis) used in the treatment of bladder cancer in the Urology out-patient clinic. (RN #1). Findings include:
Per interview on 4/5/17 at 8:55 AM, the Vice President of Clinical Services confirmed that RN #1 was handling and administering BCG in the Urology out-patient clinic, and had not completed an annual competency concerning safe handling and administration of BCG since 2014.
Per interview and record review on 4/5/17 at 8:48 AM, the Director of Pharmacy confirmed that BCG is a hazardous drug that should be classified as a Class A drug per the "Hazardous Drug Handling Policy" approved 11/13/15 and requires personal protective equipment be worn by staff. Per review of the BCG manufacturer's drug package information and confirmed by the Director of Pharmacy on 4/5/17 at 8:54 AM, the manufacturer's information states BCG is a biohazard material and "if preparation can not be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin".
In addition, per record review and interview on 4/5/17 at 4:25 PM, the Director of Pharmacy confirmed that RN #1 did not initial/sign/date the "Right to Know Sign Off Sheet" which indicates there are risks in handling hazardous drugs and this sheet should be completed as part of the annual competency.
Tag No.: A0405
Based on interview and record review, the hospital failed to develop a policy and procedure for safe handling and administration by nursing staff of the hazardous drug BCG (Bacillus Calmette-Guerin, a strain of Mycobacterium Bovis) used in the treatment of bladder cancer in the Urology out-patient clinic. Findings include:
Per interview on 4/5/17 at 8:55 AM, the Vice President of Clinical Services confirmed that there is no policy and procedure for the safe handling and administration of BCG by nursing staff who are presently administering BCG in the Urology out-patient clinic.
Per interview and record review on 4/5/17 at 8:48 AM, the Director of Pharmacy confirmed that BCG is a hazardous drug that should be classified as a Class A drug per the "Hazardous Drug Handling Policy" approved 11/13/15 and requires personal protective equipment be worn by staff. Per review of the BCG manufacturer's drug package information and confirmed by the Director of Pharmacy on 4/5/17 at 8:54 AM, the manufacturer's information states BCG is a biohazard material and "if preparation can not be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin".
Tag No.: A0413
Based on observation, interview and record review, nursing staff failed to implement hospital polices/procedures related to a patient's use of medications brought from home to be self-administered in the hospital for 1 of 30 patients in the total sample. (Patient #5). Findings include:
Per observation during a medication pass to Patient #5 on 4/3/17, an open vial of Insulin R, U 500 was observed on the patient's bedside table. The patient and the RN confirmed that the patient had an insulin pump and was dosing his/her insulin independently, as well as performing scheduled Blood Sugar testing. The patient was being transferred to another area of the hospital for a procedure. The RN present stated that the insulin should not be kept at the patient bedside and should be locked in the unit's medication room until needed by the patient for administration. The procedure is to notify the pharmacy on the date of admission that there are home medication with provider orders for the patient to self administer the medication. The medication is then sent to the pharmacy to be labeled and sent back to the unit for use. The patient was admitted from the Emergency Department to the unit on 3/22/17, and there had been no notification to the pharmacy of the insulin use by the patient.
Per review, the pharmacy policy, Medication Management stated under Storage, #3, "Medications brought from home will be .....stored in the pharmacy."
Step 1 - "Pharmacy will receive a notification at the time of admission.....that there are home meds...."
Step 3 - "Dispensing patient's own medications; Pharmacist identifies the medication for dispensing and affixes a sticker in the bottle with a label, R.Ph's initial and date."
During interview on 4/3/17, the pharmacist confirmed that they had not received any notification of Patient #5's insulin prior to 4/3/27 after it was noticed by the surveyor and the RN on the bedside table.
Tag No.: A0441
Based on observation and staff interview, the hospital failed to protect medical records in a secure manner when transporting records to storage facility. Findings include:
Per observation on 4/5/17 at 10:45 AM, patient records were left unattended and potentially visible to the public. During a tour of the facility environment accompanied by the Engineering and Maintenance Director and Manager, four large barrels containing diagnostic imaging records were in an exterior loading/unloading area without staff in sight. The records were protruding from the top of the barrels and patient personal health information (PHI) was clearly visible from a distance of approximately 3 feet. The loading area was unsecured and accessible from parking lots. The barrels primarily contained mammography records including patient name and diagnostic images. The observation was confirmed at the time by the accompanying staff. The facility Medical Records Management policy dated 3/1/17 states that " the Health Information Manager, appropriate Department Directors or appropriate Outpatient Department leaders will ensure medical records are stored and maintained in locations where the records are secure and that protect them from fire, water damage and other threats to the best degree possible". In a subsequent interview, the Diagnostic Imaging Director (DID) stated that the facility had an outside contract to remove, store and eventually destroy the aforementioned records. The DID confirmed that the records were indeed moved in the manner described above, utilizing the large barrels.
Tag No.: A0501
Based on interview and record review, the hospital pharmacy services failed to provide supervision of 1 applicable registered nurse (RN) in the Urology out-patient clinic and have written policies and procedures for the mixing/reconstitution of the hazardous drug BCG (Bacillus Calmette-Guerin, a strain of Mycobacterium Bovis) used in the treatment of bladder cancer in the Urology out-patient clinic. (RN #1). Findings include:
Per interview on 4/5/17 at 8:48 AM, the Director of Pharmacy confirmed that RN #1 was mixing/reconstituting BCG in the Urology out-patient clinic and was not under the supervision of the pharmacy. In addition, the Director of Pharmacy confirmed on 4/5/17 at 8:48 AM there were no written policies and procedures for nursing staff concerning mixing/reconstituting BCG in the Urology out-patient clinic.
Per interview and record review on 4/5/17 at 8:48 AM, the Director of Pharmacy confirmed that BCG is a hazardous drug that should be classified as a Class A drug per the "Hazardous Drug Handling Policy" approved 11/13/15 and requires personal protective equipment be worn by staff. Per review of the BCG manufacturer's drug package information and confirmed by the Director of Pharmacy on 4/5/17 at 8:54 AM, the manufacturer's information states BCG is a biohazard material and "if preparation can not be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin".
Per review of the Hazardous Drug Handling Policy approved 11/13/15, the Director of Pharmacy confirmed on 4/5/17 at 9:05 AM, that the policy states, "Pharmacy personnel will be responsible for proper mixing and dispensing of hazardous drugs, and the disposal and documentation of the disposal of hazardous drug waste; Nursing personnel will be responsible for proper administration of hazardous drugs and the disposal and documenting the disposal of hazardous drug waste". In addition, the Hazardous Drug Handling Policy procedure states, "Class A Drugs must be mixed/drawn up in a Biological Safety Cabinet in the Foley Cancer Center".
Per record review and interview on 4/5/17 at 4:25 PM, the Director of Pharmacy confirmed that RN #1 did not initial/sign/date the "Right to Know Sign Off Sheet" which indicates there are risks in handling hazardous drugs and this sheet should be completed as part of the annual competency.
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Tag No.: A0592
Based on staff interview and record review, the hospital failed to develop and update policies and procedures for time notification and content of notification for potential infectious blood products. Findings include:
Although 2 of 2 applicable "Lookback/Withdrawal Notification Details" demonstrated notification to the physician, who is responsible for patient notification, the laboratory's "Consignee/Recipient Notification Guidelines" failed to address the time frame for notification to patients who received potentially HIV (Human Immunodeficiency Virus) or HCV (Hepatitis C Virus) infectious blood and blood components from donors who initially tested negative on or after February 20, 2008. The policy and procedures did not address providing patient notification over a period of 12 weeks, unless the patient was located and notified, or if there were extenuating circumstances that exceeded the 12 week time frame. For donors tested prior to February 20, 2008, the policies and procedures did not address notification to patients who received potentially HCV infectious blood or blood components and complete actions within one year.
In addition, the policies and procedures failed to include notification to the patient which included, a basic explanation of the need for HIV or HCV testing; oral or written information so that an informed decision can be made about whether to obtain HIV or HCV testing and counseling; and a list of programs or places where the patient can obtain HIV or HCV testing and counseling, including any requirements or restrictions the program may impose.
This was confirmed by the Laboratory Director - Clinical Supervisor for blood services on 4/5/17 @ 9:30 AM.
Tag No.: A0620
Based on observation and record review, the Dietary Manager failed to assure that all dietary policies and procedures and dietary practices were in accordance with recognized food safety management systems related to food temperature and handling practices in all areas. Findings include:
Per observation during the initial tour of the hospital kitchen on 4/3/17 commencing at 10:30 AM, the following issues were identified:
Per review of thermometers in the refrigeration units through out the kitchen and cafeteria, many temperature recordings were above the safe storage upper range of 40 degrees F (Fahrenheit). The kitchen had recently installed an alarmed electronic thermometer system in all kitchen and dietary refrigerators and freezers. They also had manual thermometers inside some refrigeration units. Staff explained that the temperatures are read and recorded on an electronic system every 15 minutes. If a temperature is out of range for 2 consecutive recordings, the system should alarm and note the above range recording.
The problem was that for most of the observations, the temperature recorded from the inside manual thermometers did not match the electronically recorded temperatures, one of which was often above the safe range (41 - 135 degrees F.) Staff had failed to note this discrepancy and assure a system was put into place to discover the problem and address it. The dietary manager stated that staff rely on the electronic system and record the temperatures on a daily log from that information only. They were not checking the internal temperatures recorded on the manual thermometers inside the refrigerators/freezers. The electronic system was installed recently and no staff had identified that there were inconsistencies with the system they were using to assure that perishable foods were stored at safe temperatures.
Examples of unsafe and /or inconsistent temperature observations included the following: #2 reach in was 44.8 and 42 degrees F, deli cooler #2 was 42 degrees F., the meat storage walk-in cooler read 46.2 degrees, 42 degrees F. and 38 degrees with 3 thermometers in place.
Per observation of perishable foods on the cafeteria salad bar and sandwich bar, the following unsafe temperatures were observed: salad bar ham - 50 degrees F., egg salad 48 degrees F.
seafood salad 48 degrees F. The sandwich bar items included chicken salad - 48 degrees F., sliced turkey 48 degrees F.
During interview with the dietary manager, there was not a consistent policy/procedure to re-calibrate manual thermometers used in several areas of the kitchen. The dietary P/P entitled "Food Handling Safety, rev. 3/16/17, stated under D. PROCEDURE, 1. Standards of food safety will be followed according to the SERVSAFE MANAGER handbook, 6th edition, National Restaurant Association, 2012. Per review of the handbook, thermometers should be re-calibrated before every shift to assure accurate readings. During discussions with dietary staff, including the Director of Food Services, based on observations of where electronic probes were placed in the refrigeration units may be affecting the temperature recordings and this fact had not been previously reviewed.
Another identified concern was related to safe food handling and storage processes. Dated foods were observed in a walk-in cooler that had been out in the cafeteria for a previous day and they were labeled with an expiration date in the future; staff confirmed that they would be going back onto the cafeteria line for lunch that day. An observation was made of the temperatures for a sample of foods on the self-serve salad bar and the sandwich station with the following temperatures found: salad bar - cottage cheese 50 degrees F., egg salad - 46 degrees F., seafood salad - 48 degrees F. The sandwich bar included chicken salad - 48 degrees F. and sliced turkey 48 degrees F.
Per review, the hospital's policy/procedure entitled "Food Dating Guidelines" under E. PROCEDURE, #6. Food Court salads = expiration 3 days."
This policy does not address any parameters to assure safe food handling. Per the SERVSAFE MANUAL, chapters 4 - 7, Food temperatures must be tested at stated frequencies to assure that items are kept in the safe temperature and should not be re-used if it cannot be assured that food is kept under 41 degrees F or above 135 degrees F. Per the system in use, with refilling of items as needed (in self service areas), the safety of foods cannot be assured and thus re-used at a later time.
Additionally foods located on an open cooler for self-service should not be re-used due to potential contamination from other sources.
Per interview with the Food Services Director, there was no hospital policy to address re-use of items from the open self-service coolers.
Tag No.: A0710
Based on interview and record review, the hospital failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association (NFPA). Findings include:
Per interview on 4/5/17 at 11:45 AM the State of Vermont Assistant Fire Marshall confirmed during inspection on 4/3/17 - 4/5/17 the hospital failed to be in compliance with all Life Safety Code requirements (NFPA 101-2000 edition) and the NFPA-99: Health Care Facilities regulations. Please refer to CMS-2786 report for identified violations.
Tag No.: A0749
Based on observation, staff interview and record review, the hospital failed to assure that the laboratory was maintained in a manner to prevent the spread of infection and communicable diseases and failed to assure that there was effective monitoring of nursing staff related to medication administration and adherence to aseptic technique during patient care. (Patient #6). Findings include:
1. During a tour on 4/3/17 beginning at 11:05 AM with the Laboratory Director, two containers of "Activate Institutional Bleach 5.25% Hospital Cleaner and Disinfectant" was outdated with a use by date of February 2015. One container was observed in the tissue grossing room and another was in the laboratory storage room. The Laboratory Director confirmed that the use by date had expired during the tour.
The floor in the autoclave room in the laboratory was soiled with multiple circular brown spots, identified as melted auger. The Laboratory Director stated that housekeeping was responsible for cleaning the floor. During observations on 4/6/17 at 10:00 AM, the floor remained soiled. The Laboratory Director confirmed that it looked like the substance could be cleaned from the floor but was unsure of housekeeping's schedule or responsibility in this area.
2. Per observation of medication administration for Patient #6, the RN failed to adhere to aseptic technique by failing to cleanse/sanitize hands and don gloves prior to administering electrolyte replacement (Potassium Sulfate) via the intravenous route (IV). The RN was observed to sanitize hands upon entrance to the patient's room, then touch multiple inanimate objects in the area, including the patient,the computer and other areas in the vicinity. The nurse then set up and administered the electrolyte solution via IV route.. The RN failed to perform hand hygiene and don clean gloves just prior to administering the IV solution. Per review, the hospital Infection Control Manual, under policy titled Infection Control - Hand Hygiene., section C. Policy, Hand Hygiene should be used in the following situations: #3 "After contact with inanimate objects in the patient's immediate environment".
Per review of the hospital's reference manual for nursing procedures, regarding IV medication administration, Skill 32-6, under #6, "Apply clean gloves." prior to IV medication administration.*
The failure to adhere to aseptic technique was confirmed with the RN immediately after the observation.
* Fundamentals of Nursing" ninth edition, , Potter and Perry, copyright 2017.