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5515 PEACH STREET

ERIE, PA 16509

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility failed to ensure that medical records were properly filed and retained in order to protect medical records from water damage and unauthorized access.

Findings include:

Review, at approximately 12:00 PM on November 15, 2017, of Medical Records Policy: 3, "General Guidelines for Storage Medical Records," effective September 19, 2016, revealed, "... Procedure: ... 6. Medical Records protects from unauthorized access of hard copy records by ensuring someone is at the reception area [Medical Records Department] during hours of operations. ..."

1. During a tour of the Radiology Department, at approximately 11:45 AM on November 14, 2017, an open room was observed behind the Radiology reception area. Observation of the room revealed 377 boxes, containing miscellaneous facility medical records dating back from current to five years, approximately twelve inches by ten inches by fifteen inches, that were stored, exposed to the installed sprinkler system. The boxes were stacked upon one another around the perimeter of three walls, then stacked upon one another in six rows within the center of the room, with walk ways between the rows.

Upon entering the room, EMP31 stated, "Those [medical records] aren't mine [Radiology]." EMP31, present during the tour, confirmed the above findings at the time of observation.

2. When presented with the findings above, at approximately 12:00 PM on November 14, 2017, EMP14 stated, "Those have been there since before I came. Those have all been scanned. ... We keep them ... in case something is missing [from the scanned record]." EMP14 confirmed that the facility has an active contract with an offsite medical records storage facility.

3. During a subsequent tour of the same storage room referenced in finding number one, in the Radiology Department, at approximately 11:24 AM on November 15, 2017. Observation of the room now revealed 393 cardboard boxes, containing miscellaneous facility medical records dating back from current to five years, approximately twelve inches by ten inches by fifteen inches, that were stored, exposed to the installed sprinkler system. The boxes were stacked upon one another around the perimeter of three walls, then stacked upon one another in six rows within the center of the room, with walk ways between the rows.

EMP20 confirmed the findings and box count during the observation at 11:24 AM on November 15, 2017.

UNUSABLE DRUGS NOT USED

Tag No.: A0505

Based on review of facility documentation, facility tour, and employee interviews (EMP), it was determined that the facility failed to ensure outdated, mislabeled, or otherwise unusable drugs and biologicals were not available for patient use.

Findings include:

Review at approximately 12:13 PM on November 15, 2017, of "Expiration of Medications and Stock Supplies," effective date February 28, 2017, revealed, "... Vials: ... For multi-dose medication vials with antimicrobial preservatives which have been opened or entered (e.g., needle-punctured), the USP standard is that the BUD is 28 days, unless otherwise specified by the manufacturer. ... Medications will be discarded according to expiration date guidelines or according to the Manufacturer's expiration date, whichever comes first. ..."

1. At approximately 11:23 AM on November 15, 2017, three, open, medication vials were identified with no open and/or beyond use date (BUD), in the Unit 3 Medication Room. The medications were identified as: Xylocaine 1% 200 mg [milligrams]/20 mL [milliliters]; Lantus 100 Units/mL; and Humulin R 100 Units/mL.

EMP15 provided confirmation of this finding at the time of observation and further stated, "The vials do not have a date. They are good for 30 days, I think. I'm sure they are good for 30 days."

At approximately 11:45 AM on November 15, 2017, EMP20 confirmed that the facility utilizes a BUD of 28 days for expiration of multi-dose vials.

PHYSICAL ENVIRONMENT

Tag No.: A0700

The Condition for Physical Environment was found to be out of compliance during a Life Safety Survey completed on November 29-30, 2017. Further details are outlined in that Division of Life Safety Survey Report.

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on review of facility documentation, observations, and employee interviews (EMP), it was determined that the facility failed to ensure supplies were maintained to ensure an acceptable level of safety and quality.

Findings include:

Review, at approximately 12:30 PM on November 16, 2017, of Nursing Policy C-26, "Crash Cart Checking," effective March 1, 2016, revealed, "... Policy: ... Long Form Check: 1. The long form check list is to be done on the first day of every month and after each code blue to check all drug expirations dates and insure cart is stocked. 2. The long form check list is to be done any time the lock is broken and changed. ..."

Review, at approximately 12:45 PM on November 16, 2017, of Materials Management Policy 37, "Expiration of Sterile Manufactured Supplies," effective August 2014, revealed, "... Procedure: 1. All sterile items throughout the storeroom and hospital must be checked for expirations dates on a routine basis. This is the responsibility of the storeroom distribution clerks. 2. Items that have reached the marked expiration date will be immediately removed from the storeroom shelves and taken to the Material Management Manager. ..."

Review, at approximately 12:50 PM on November 16, 2017, of Materials Management Policy, 39, "Managing Outdates," effective August 2014, revealed, "... Procedure: 1. Many products used for patient care are labeled with an expiration date. This is the date after which the product is no longer considered safe for use. 2. Expiration dates are normally expressed as a month and year. Goods so labeled are considered safe to use through the last day of the month. ..."

1. At approximately 9:30 AM on November 15, 2017, an open yankauer attached to a suction container for future use, with no patient present, was identified in the PACU.

EMP16 provided confirmation of this finding at the time of observation and further stated, "Sometimes the staff prepare for future patients, but they are not permitted to have open supplies prepared."

2. At approximately 9:40 AM on November 15, 2017, three, open, 10cc syringes with no packaging, were identified in Operating Room 1.

EMP16 provided confirmation of this finding at the time of observation.

3. At approximately 10:00 AM on November 15, 2017, one, open, syringe with needle attached and no packaging present, was identified in the Endoscopy Procedure Room.

EMP16 provided confirmation of this finding at the time of observation.

4. At approximately 10:55 AM on November 16, 2017, the following supplies with associated expiration dates were identified within the ED's crash cart: one SPO2 Sensor - September 2017; one 10FR Tube - January 2017; two 22G IV Catheters - August 2016; one Cuffless Tracheostomy tube - May 2016; one 10FR Tube - July 2013; three Arterial Blood Sampling Kits - July 2016; four 30 mL Syringes - May 2017; one 30 mL Syringe - May 2014; one Pneumothorax Kit - May 2014; one 8FR Female Cath Kit - "2016-02"; one 20G x 1" ProtectIV Plus Safety IV Catheter - "2016-09"; one 18G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2016-02"; two Sterile Disposable Safety Scalpel #10 - "11/2016"; one packet of Surgilube - "Apr15"; one four ounce bottle of 10% topical Prep Solution Antiseptic Microbicide Povidone Iodine - "09/16"; three 22G x 1" ProtectIV Plus Safety IV Catheter - "2017-02"; three BD Vacutainers with red top - "2017-05"; three BD Vacutainers with pink top - "2017-05"; three BD Vacutainers with green top - "2017-05"; three BD Vacutainers with purple top - "2017-04"; three BD Vacutainers with light blue top - "2017-03-31"; and one BD Vacutainer with gray top - "2017-05".

EMP15 confirmed the above findings at the time of observation.

5. At approximately 11:00 AM on November 16, 2017, on the wall outside of Exam Bed 1, in the ED, there were labeled containers on two shelves, approximately six feet in height, that were identified by EMP11 and EMP33, as the equivalent of a Pediatric Crash Cart. Within the containers, the following supplies with associated expiration dates were identified; two Cuffed Nasal Tracheostomy Tubes - February 2017; one 20G IV Catheter - September 2016; four 16G IV Catheters - July 2017; three 22G IV Catheters - 2016; one neonatal-adult SpO2 sensor - "2017-07"; three BD Bactec Peds Plus / F Culture Vials - "2017-08-31"; four BD Bactec Peds Plus / F Culture Vials - "2017-09-30"; eleven 16G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2017-09"; and three Triflex Sterile Latex Powdered Surgical Gloves, size 8 ½ - "2016-10".

EMP15 and EMP11 confirmed the above findings at the time of observation.

6. At approximately 11:05 AM on November 16, 2017, the following supplies and associated expiration dates were identified within Room 1 in the ED: two Manual Infant Resuscitator's - "10/2014"; and one Neonatal Adult Pulse Ox Sensor - "7/2017".

EMP15 provided confirmation of this finding at the time of observation.

7. Between 11:05 AM and 11:30 AM on November 16, 2017, the additional following supplies with associated expiration dates were identified within the ED: one 5% Dextrose Sodium Chloride, 500 mL bag - August 2015; one Adult Manual Resuscitation Bag - September 2016; one Adult/Neonatal SPO2 Sensor - July 2017; one Adult SPO2 Sensor - July 2017; one Pediatric Resuscitation Bag - August 2010; one Epistaxis Packing - April 11, 2017; two BD Bactec Peds Plus / F Culture Vials - "2017-09-30"; four BD Bactec Peds Plus / F Culture Vials - "2017-08-31"; four 16G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2017-09" one 16G x 1 1/4" ProtectIV Plus Safety IV Catheter - "2017-01"; and five 16G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2017-07".

The above findings were confirmed by EMP11 and EMP15 at the time of observation.

8. At approximately 11:22 AM on November 16, 2017, the following supplies and associated expiration dates were identified within the ED Supply Room: one Occlusive Gauze Strip - "8/2017"; one Povidone-Iodine Swab Stick - "3/2017"; and one Ammonia Capsule - no expiration date, which the staff was unable to locate at this time.

EMP15 confirmed the above findings at the time of observation, and further stated, regarding the Ammonia Capsule, "I can't tell you the date. I am not sure how to determine it."

9. At approximately 11:30 AM on November 16, 2017, the following supplies with associated expiration dates were identified within the PACU Adult Crash Cart: one Endotracheal Tube Holder - "10/2009"; one Endotracheal Tube Holder - "3/2006"; two 20cc Syringes - "4/2016"; two 20cc Syringes - "10/2016"; one 100 mL IV bag of Normal Saline - "9/2017"; one size 3.0 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "2/2017"; six size 4.0 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "7/2017"; one, open, size 4.5 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "3/2018"; five size 4.5 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "3/2017", one size 5.0 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "6/2017"; and one size 5.5 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "4/2016".

EMP20 provided confirmation of the findings at the time of observation.

10. At approximately 11:35 AM on November 16, 2017, the following supplies with associated expiration dates were identified in the Unit 5 crash cart: one 5FR 110cm Bipolar Electrode Catheter - "2017-08"; three 4" x 5 ½" opsite - "2017-01"; two BD Vacutainer Safety Lok - "2017-09"; five 2" x 2 ¾" Transparent Film Dressing - "2016-03"; three 3.5 metric 60mm Syneture Coated, Braided Silk - "2016-12"; one AirLife CO2 Detector - "2017-10"; one AirLife CO2 Detector - "2017-05"; one Yankauer Suction Tube - "2016/06"; one Yankauer Suction Tube - "2016/03"; two Pro-Vent Arterial Blood Sampling Kit - "2017-06"; five 14G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2017-06"; two 22G x 1 ½" BD Eclipse 3mL syringes - "2017-10"; one 22G x 1 ½" BD Eclipse 3 mL syringes - "2017-08"; and three 24G x ¾" ProtectIV Plus Safety IV Catheter - "2017-01".

EMP11 confirmed the above findings at the time of observation.

11. At approximately 11:55 AM on November 16, 2017, the following supplies with associated expiration dates were identified in the PACU Pediatric Crash Cart: one, open, size 4.5 Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "5/2015" one size 10 FR Suction Catheter - "8/2016" two pink lab tubes - "5/2017"; one Lo-Pro Oral/Nasal Tracheal Tube Cuffed - "5/2015"; one 22G IV Catheter - "10/2017"; two, open, infant oxygen masks with no packaging; and two, open, oxygen tubing with no packaging.

EMP20 provided confirmation of this finding at the time of observation.

12. At approximately 12:00 PM on November 16, 2017, the following supplies with associated expiration dates were identified in the Unit 4 crash cart: three 16G x 1 ¼" ProtectIV Plus Safety IV Catheter - "2017-07"; three 14G x 1 ¼" ProtectIV Plus Safety Catheter - "2017-06"; one 5% Dextrose Injection - "Sep17"; five 20 mL Sterile Water Inj - "1Jun2017"; three 24G x ¾" ProtectIV Plus Safety IV Catheter - "2017-09"; four Pro-Vent Arterial Blood Sampling Kit - "2017-06"; one Yankauer - "2017/04"; four BD 20 mL syringe - "2017-07"; two BD Vacutainer Safety-Lok - "2017-09"; one 4x4 Curity Gauze sponge - "2017-07"; one AirLife CO2 Detector - "2017-10"; two Vacutainer with black cap - "2017-05"; two vacutainer with green cap - "2017-09"; one BD Vacutainer with green top - "2017-04"; one BD Vacutainer with light blue top - "2016-12"; one BD Vacutainer with purple top - "2017-03"; three BD Vacutainer with red top - "2017-07"; and one BD Vacutainer with red top - "2017-03".

EMP11 confirmed the above findings at the time of observation.

13. At approximately 12:10 PM on November 16, 2017, the following supplies with associated expiration dates were identified within the Outpatient Surgery crash cart: 24 four x four Gauze Pads - "3/2017"; one AirLife Carbon Dioxide Detector - "5/2017"; four 20cc Syringes - "7/2017"; two 25G IV Catheters - "2/2016"; four tongue depressors - "4/30/2017"; and 50 Molded Surgical Masks - "4/2017".

EMP20 provided confirmation of this finding at the time of observation.

14. At approximately 12:31 PM on November 16, 2017, the following supplies with associated expiration dates were identified within the Inpatient Rehab Unit crash cart: one Adult Ambu Bag - "4/2016" and one Adult Ambu Bag - "7/2017".

EMP20 provided confirmation of this finding at the time of observation.

15. At approximately 12:00 PM on November 16, 2017, the following supplies with associated expiration dates were identified within the ICU department's crash cart: six IV covers - October 2015; five Coated Braided Silk - June 2017; five 18G IV Catheters - December 2011; one Blood Transfusion Device - December 2013; one 20 mL Syringe - October 2015; one 30 mL Syringe - October 2015; one 60 mL Syringe - January 2017; five 24G IV Catheters - October 2015; one Tracheostomy Tube - August 2016; seven Vacutainers - July 2017; and four 22G IV Catheters with what was previously the expiration date was blackened out.

When asked what had happened to the expiration dates with the four IV Catheters, EMP15 stated, "I'm not sure, maybe because it doesn't expire anymore."

EMP15 confirmed the ICU department crash cart expiration dates at the time of observation.

16. At approximately 12:20 PM on November 16, 2017, the following supplies with associated expiration dates were identified within the 3 North department's crash cart: one needle, not securely capped; four 20 mL Syringes - April 2012; and three Butterfly Safety Locks - July 2017.

EMP15 confirmed the 3 North department crash cart findings at the time of observation.