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.

ST JOHN MEDICAL CENTER 29000 CENTER RIDGE ROAD WESTLAKE, OH 44145 June 23, 2016
VIOLATION: DIRECTOR OF DIETARY SERVICES Tag No: A0620
Based on observation, staff interview and policy and procedure review, the hospital kitchen staff failed to ensure safety practice for food handling. This has the potential to affect all patients receiving food from the hospital kitchen. The hospital census was 118.

Findings include:

Review of policy and procedure for Food Safety Program, Food Safety Standards, and Requirements revealed all food prepared in operation must be covered and labeled as to the contents and date of preparation prior to stage in refrigerators and freezers.

During tour of the kitchen on 06/20/16 at 11:45 AM revealed an observation of a refrigerator with four desserts and eight trays of prepared jello noted on large trays which were uncovered. Observation of another refrigerator revealed chicken and egg rolls on large trays which were noted to be uncovered. Observation of a freezer revealed breaded chicken strips, breaded fish, and breaded chicken on large trays which were noted to be uncovered.

Interview with Staff I during the tour confirmed the above findings.
VIOLATION: PHYSICAL ENVIRONMENT Tag No: A0700
Based on the life safety code survey conducted 06/20/16 through 06/23/16, the facility failed to ensure the building construction was maintained to ensure the safety of the patients by the facility's failure to ensure that the steel was protected throughout the facility, that corridors were separated from use areas by walls constructed with at least 1/2 hour fire resistance rating. In fully sprinklered smoke compartments, partitions are only required to resist the passage of smoke, that corridor room doors resisted the passage of smoke as required by the code at 19.3.6.3.1 and NFPA 80, 2.3.1.7. and there was no impediment to the closing of the doors, that stairways, elevator shafts, and ventilation shafts maintained the identified fire resistance rating as required in the code at 8.2.5., that fire doors located in the egress stairwells latched into the frame when tested in accordance with the code at 8.2.5.,and failed to provide evidence of the fire resistance rating on a stairwell doors., that smoke barriers were constructed to provide at least a one half hour fire resistance rating and constructed in accordance with 8.3, that door openings in smoke barriers had at least a 20-minute fire protection rating. Non-rated protective plates that do not exceed 48 inches from the bottom of the door are permitted, that one hour fire rated construction (with 3/4 hour fire-rated doors) or an approved automatic fire extinguishing system in accordance with 8.4.1 and/or 19.3.5.4 protected hazardous areas, smoke detectors were located at least 36 inches from air movement devices in accordance with the code at 9.6.1.4 and NFPA 72, 2-3.5.1., that sprinkler heads were of the same response type in a smoke compartment, that quarterly testing of the sprinkler system was completed, sprinkler heads were free of debris, and a sprinkler box with spare heads and wrench were located at the sprinkler riser, that heating and air conditioning complied with the provisions of section 9.2 and were installed in accordance with the manufacturer's specifications, that medical gas storage and administration areas were protected in accordance with NFPA 99, Standard for Health Care Facilities. That oxygen storage locations of greater than 3,000 cu.ft. were enclosed by a one-hour separation and that locations for supply systems of greater than 3,000 cu.ft. were vented to the outside and that single station smoke detectors were tested in accordance with NFPA 72., that fire drills were held periodically at unexpected days and times, that doors in the vertical stairwell closed to latching position, that battery operated lighting in the exit egress functioned appropriately and were tested monthly and annually as per NFPA 101; that lighted exit signage functioned appropriately in the exit egress path and that safe access to public way, as per NFPA 101 section 38.2.7 in accordance with section 7.7.1. (A710)
VIOLATION: FORM AND RETENTION OF RECORDS Tag No: A0438
Based on observation and staff interview the hospital failed to maintain medical records in a manner which protected from potential sprinkler water damage if activated in the event of fire. This had the potential to affect all medical records stored in medical records areas. The hospital census was 118.

Findings include:

The tour of medical records department on 06/21/16 at 9:20 AM revealed medical records filed on multiple open unprotected shelving units throughout the medical records office. A sprinkler system was noted above the shelving units.

The tour of the medical record storage room on 06/21/16 at 9:30 AM revealed multiple open unprotected shelving units which stored two years of medical records. A sprinkler system was noted above the shelving units.

Interview with Staff H on 06/21/16 during the tour, confirmed the medical records located in the medical record room were stored on open shelving which would not be protected from sprinkler water damage if activated. Staff H confirmed the medical records located in the medical record storage room were records the hospital maintained for two years prior to sending them to an offsite location.

Staff H stated those medical records were not records that were scanned to an electronic system but were the original documents. Staff H confirmed the medical records were stored on shelving units which would not be protected if the sprinkler located above activated in the vent of a fire.
VIOLATION: SECURE STORAGE Tag No: A0502
Based on observation, policy review and staff interview, the hospital failed to ensure medication carts in the operating rooms were locked at all times when not in use. This affected one (Room #8) of eight operating rooms. This had the potential to affect all patient's receiving surgical services. The hospital has eight functional operating rooms.

Findings include:

Review of policy, "Inventory Control-Security of Medication Storage Areas", last revision date of September, 2013, was reviewed on 6/22/16. Item # 2 reads, "All medication carts shall remain locked at all times when not in use".


Tour of the surgery unit was conducted on 6/21/16 at 8:20 AM. At 9:12 AM, operating room eight was noted to have an unlocked anesthesia cart with a variety of medications in the top drawer. Staff I who was present during the tour confirmed the cart should be locked at all times the room is not in use. Staff I also confirmed the room was last used on 6/20/16 for an open heart surgery.
VIOLATION: LIFE SAFETY FROM FIRE Tag No: A0710
Based on review of the facility schematic, tour of the facility, review of facility documentation and staff interview, the facility failed to meet the applicable provisions of the Life Safety Code of the National Fire Protection Association. Potentially all 118 patients could be adversely affected.

Findings include:

On 06/20/16 through 06/23/16 a life safety code survey was conducted throughout the facility and in a sampled selection of offsite locations.

K12, which addressed the facility failure to ensure the steel was protected throughout the facility.

K17, which addressed the facility failure to ensure corridors were separated from use areas by walls constructed with at least 1/2 hour fire resistance rating. In fully sprinklered smoke compartments, partitions are only required to resist the passage of smoke.

K18, Which addressed the facility failure to ensure that corridor room doors resisted the passage of smoke as required by the code at 19.3.6.3.1 and NFPA 80, 2.3.1.7. and there was no impediment to the closing of the doors.

K20, which addressed the facility failure to ensure stairways, elevator shafts, and ventilation shafts maintained the identified fire resistance rating as required in the code at 8.2.5.

K21, which addressed the facility failure to ensure fire doors located in the egress stairwells latched into the frame when tested in accordance with the code at 8.2.5.,and failed to provide evidence of the fire resistance rating on a stairwell doors.

K25, which addressed the facility failure to ensure that smoke barriers were constructed to provide at least a one half hour fire resistance rating and constructed in accordance with 8.3.

K27, which addressed the facility failure to ensure that door openings in smoke barriers had at least a 20-minute fire protection rating. Non-rated protective plates that do not exceed 48 inches from the bottom of the door are permitted.

K29, which addressed the facility failure to ensure that one hour fire rated construction (with 3/4 hour fire-rated doors) or an approved automatic fire extinguishing system in accordance with 8.4.1 and/or 19.3.5.4 protected hazardous areas.

K52 which addressed the facility failure to ensure smoke detectors were located at least 36 inches from air movement devices in accordance with the code at 9.6.1.4 and NFPA 72, 2-3.5.1.

K56, which addressed the facility failure to ensure sprinkler heads were of the same response type in a smoke compartment.

K62, which addressed the facility failure to ensure quarterly testing of the sprinkler system was completed, sprinkler heads were free of debris, and a sprinkler box with spare heads and wrench were located at the sprinkler riser.

K67, which addressed the facility failure to ensure that heating, ventilating, and air conditioning complied with the provisions of section 9.2 and were installed in accordance with the manufacturer's specifications.

K76, which addressed the facility failure to ensure that medical gas storage and administration areas were protected in accordance with NFPA 99, Standard for Health Care Facilities. That oxygen storage locations of greater than 3,000 cu.ft. were enclosed by a one-hour separation and that locations for supply systems of greater than 3,000 cu.ft. were vented to the outside.

K130, which addressed the facility failure to ensure single station smoke detectors were tested in accordance with NFPA 72., failure to ensure fire drills were held periodically at unexpected days and times, failure to ensure doors in the vertical stairwell closed to latching position, failure to ensure battery operated lighting in the exit egress functioned appropriately and were tested monthly and annually as per NFPA 101; failure to ensure lighted exit signage functioned appropriately in the exit egress path and failure to provide safe access to public way, as per NFPA 101 section 38.2.7 in accordance with section 7.7.1.

Please see the Life Safety Code report for more specific details.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, staff interview and review of policies and procedures, the facility failed to ensure infection control procedures were followed for hand hygiene, disinfection of blood glucose meters and administration of intravenous fluids and injectable medications. This affected two of 36 patients reviewed. (Patient #36 and Patient #38) This has the potential to affect all 118 patients in the hospital.

Findings include:

1. During observations in Surgery suite #9 on 06/21/2013 between 9:32 AM and 9:34 AM, Staff E was observed drawing up pre-operative medications Fentanyl (used in anesthesia for pain prevention), Versed (used for sedation) and Propofol (used for relaxation). After opening each vial, Staff E failed to cleanse the rubber seal with disinfectant prior to inserting the syringes and drawing up the medications. Staff E failed to perform hand hygiene prior to donning gloves and drawing up the medications and after removing the gloves.

At 10:43 AM, Staff F again was observed drawing up Propofol without first wiping the rubber seal with disinfectant and then administered the medication intravenously without first wiping the injection port with disinfectant. Staff F failed to perform hand hygiene prior to donning gloves for the procedure and after removing the gloves.

In an interview on 06/21/2013 at 11:40 AM Staff E confirmed the rubber seals were not wiped with disinfectant prior to drawing up the medications.

Review of procedures for preparing injections taken from Clinical Nursing Skills & Techniques, by Perry Potter was completed. Per Staff B, on 06/22/2016 at 8:30 AM, the Hospital uses Potter as a reference. The procedure to "to prepare vial containing a solution stated: "remove cap covering top of unused vial to expose sterile rubber seal. If a multi-dose vial has been used before, cap is already removed. Firmly and briskly wipe surface of rubber seal with alcohol swab and allow it to dry......Not all drug manufacturers guarantee that rubber seals of unused vials are sterile. Swabbing with alcohol reduces transmission of microorganisms".

Review of the Hospital policy no: 1.4 Hand Hygiene was completed. Under the indications for Hand Hygiene is listed "after removing gloves". The policy further stated
"Wash hands after removing gloves. Pathogens can gain access through small defects in gloves or by contamination of the hands during glove removal".

These above findings had the potential to affect all patients receiving anesthesia services from the Hospital.

2. On 06/23/16 at 8:15 AM, Staff J was observed performing the blood glucose test for Patient #38. Staff J carried the contaminated blood glucose meter from the patient's room to the nursing station and place it on a barrier Staff J gathered an 70% alcohol preparation pad and proceeded to cleanse the soiled machine with the alcohol and replace the machine in the machine's charging base in preparation for the next patient's use.

Review of the hospital's policy and procedure entitled Laboratory Point of Care, with a most recent revision date of 03/2016, directed to use a Super Sani Wipe to disinfect the blood glucose meter.

Interview with Staff K, on 06/23/16 at 8:31 AM, confirmed point of care devices are required to be disinfected with hospital approved cleansers or bleach based cleanser.

3. During an observation of medication administration on 06/21/16 at 9:01 AM, Staff L was observed to prepare intravenous antibiotic medication for Patient #39. Staff L was observed removing the intravenous (IV) tubing from its manufacturer's outer wrap, grasp one end of the tubing in preparation for spiking the medication bag and then toss the remainder of the tubing, which included the injection access port and the end cap (used to attach to patient's IV access device). Staff L proceeded to spike the antibiotic and to prime the entire length of the IV tubing while the tubing was observed lying in the bottom of the sink in the patient's room.

This finding was confirmed during interview with Staff M on 06/23/16 at 1:22 PM.

4. Review of the hospital's policy and procedure entitled Opened Multi-dose Vials with a revision date of 4/2015 directed at Item 6 to use multi-dose medication vials for a single patient whenever possible. The procedure indicated the risk of transmission posed by multi-dose vials has been clearly demonstrated and mandates a practice of one vial per one patient whenever possible. Infection transmission risk is reduced when multi-dose vials are dedicated to a single patient. Item 7 directed to keep multi-dose vials away from the immediate patient environment.

During an observation of insulin injection on 06/23/16 at 7:54 AM, Staff O was observed to gather Patient #38's insulin. The patient was ordered a patient specific pharmacy prepared insulin in syringes along with a routine and sliding scale doses of Humalog insulin. Staff O gathered the pharmacy prepared syringe then proceeded to access the nursing unit Pyxis (drug dispensing machine) and withdraw a three milliliter vial of Humalog insulin. Staff O then proceeded into Patient #38's room with both the prepared insulin syringes and the Humalog insulin vial and administered the medications per the physician's order.

During an observation of insulin injection on 06/23/16 at 8:36 AM, Staff N was observed to gather Patient #40's insulin. The patient was ordered a patient specific pharmacy prepared insulin along with a routine and sliding scale doses of Humalog. Staff N gathered the pharmacy prepared syringe then proceeded to access the nursing unit Pyxis (drug dispensing machine) and withdraw a three milliliter vial of Humalog. Staff N then proceeded into Patient #40's room with the both insulins and administered the medications per physician's order.

Interview with Staff N confirmed the hospital stocks multi dose vials of insulin in the Pyxis refrigerator for use for all patients who have orders for both Humalog and Humulin R.