HospitalInspections.org

Based on observation and interview it was determined the Facility failed to assure outdated medications were not available for use on patients in the Surgery Recovery Room. Failure to remove outdated and expired medications did not assure the integrity, safety and efficacy of the medications. The failed practice was likely to affect all patients who received care in the Recovery Room. The findings were:

A. Observation on 11/08/16 at 0945 of the Recovery Room revealed the following expired medications:
1) Heparin Flush prefilled 3 ml (milliliter) syringes (12) expired on 06/11/16 (7); 09/15/16 (3) and 10/21/16 (2)
2) Erythromycin 500 mg (milligram) vial two of two expired on 08/01/16
3) Flumazenil 1 mg two of two 10 ml vials expired 03/16
4) Naloxone Hcl (hydrochloride) 0.4 mg/ml six of six expired 08/16
5) Pitressin 20 units (u)/ml three of three 1 ml expired 05/16
6) Clonidine Hcl 0.1 mg five of five expired 08/16
7) Lidocaine Hcl 40 mg/ml, three of three expired 09/01/16
8) BioPatch Protective Disk with CHG 2.5 cm (centimeters) 10 of 10 expired 01/16
9) Hibiclens 4 fluid ounces one of three expired 05/15
10) Perrigo Triple Antibiotic (Bacitracin/Neomycin) 0.9 grams each, 25 of 25 expired 07/16
11) Sensorcaine 10 ml 0.25% 3 of 3 expired 05/16

B. The Director of Surgical Services verified the findings of expired drugs as listed in A. at the time of observation on 11/08/16 at 0945.

C. Documentation of the physical inspection by the Pharmacy was provided on 11/08/16 and revealed Pharmacy inspection was not documented as performed in the Operating Room/Recovery room for 04/16, 05/16, and 06/16. This was confirmed by the Director of Surgical Services on 11/08/16 at 1730.

Based on observation, review of Operating Room policies and interview, it was determined the Facility failed to assure sterile fields were constantly monitored once created in one of one operating room (#2) observed. Failure to constantly monitor a sterile field did not assure a breach in sterility would be identified to prevent patient exposure to contaminants. The failed practice was likely to affect one patient awaiting surgery at 1028 in OR #2 on 11/08/16. The findings were:

A. Observation on 11/08/16 at 1028 of OR #2 revealed opened sterile instruments on two side tables and back table that were not covered. There was no staff present in the room to monitor the prepared sterile field. The Director of Surgical Services stated at the time of observation, "there should be someone in here. We don't leave the room set-up without someone watching it." Scrub Technician #1 was located by the Director of Surgical Services and returned to the room. The Director of Surgical Service instructed Scrub Technician #1 to remove the opened packs in OR #2 and then set-up the sterile field with unopened surgical instruments.

B. A policy and procedure was requested 11/08/16 for not leaving maintaining the sterile field once created. The Surgical Services policies provided on 11/08/16 did not include a requirement to constantly monitor the sterile field once prepared.

C. The Facility references AORN standards for practice. Review of the AORN (Association of Operating Room Nurses) Guidelines for Perioperative Practice, Volume 1, 2016, Recommendation VII revealed "the sterile field is subject to unrecognized contamination by personnel, vectors or breaks in sterile technique if left unobserved.(VII.a.) Once created a sterile field should not be left unattended until the operative or other invasive procedure is completed."

D. The finding in A. was confirmed by the Director of Surgical Services on 11/08/16 at 1010. The findings in B. was confirmed by the Director of Surgical Services on 11/08/16 at 1730.



Based on observation, review of policies and procedures and interview, it was determined the Facility failed to document quality tests for Revital-Ox Resert solution (used for high level disinfectant) and failed to discard water used to rinse the endoscopes after each use per manufacture's directions. The effectiveness of the high level disinfection process could not be assured without adherence to manufacturer's instructions. The failed practice was likely to affect all surgical patients. The findings were:

A. Observation on 11/08/16 from 1100-1125 of the scope processing room revealed three containers on the counter. Contents of one of the containers was reported by the Director of Surgical Services to be Revital-Ox Resert solution in use at the Facility as a high level disinfectant. The solution was dated to expire 11/16/16.
B. The second container on the counter was green. The Director of Surgical Services stated at the time of observation the green container held water and alcohol used to rinse the scopes after high level disinfection. The contents of the green container was changed once per day.
C. Review of the Steris Revital-Ox Resert instruction for use revealed "Quality Test for Revital-Ox Resert Solution Test Strip". "Upon receipt of each shipment, test each lot in the shipment." The Director of Surgical Services stated on 11/8/16 at 1125 there was no documentation of quality testing for each shipment and new lot number.
D. Review of the manufacturer's instructions for use of the Revital-Ox Resert for high level disinfection, Step 3 high level disinfection revealed (after high level disinfection): "Thoroughly rinse the device by immersing it completely in water ...remove device and discard rinse water." Surgical Technician #2 was interviewed at 1125 on 11/08/16 and confirmed scopes are rinsed in the green bin that contains water and alcohol. The water is changed one time per day.