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Tag No.: A0951
Based on observation and interview, it was determined the facility failed to have a mechanism in place to ensure hand scrubbing technique were performed for the time required as per facility policy. The failure to ensure there was a mechanism in place to time hand scrubs did not assure hands were scrubbed for the specific time required. The failed practice had the potential to affect all patients who had a surgical procedure in the Cardiovascular Operating Room (CVOR). Findings follow:
A. Tour of the CVOR was conducted on 09/24/12 at 1000-1100 with the Director of Quality, Vice President of Patient Care Services and the Compliance Director. The clock on the wall above the dual scrubs sinks at the entrance of CVOR #1 was malfunctioning and the entrance of CVOR #2 did not contain a mechanism to time hand scrub techniques.
B. The Charge Nurse stated in an interview on 09/24/12 that hand scrubs were performed for 3-5 minutes.
C. Review of the Surgical Scrub policy and procedure on 09/24/12 revealed "... Initial hand scrub should last five minutes. Complete a surgical hand scrub/rub: Three minute long version of the surgical hand scrub."
Based on observation, review of the "Anesthesia Protocol for Possible Malignant Hyperthermia Cases" policy and procedure and interview, it was determined the facility failed to ensure an approved policy and procedure governing the care of Malignant Hyperthermia was in place. The failure to ensure an approved policy was in place did not allow staff guidance in caring for a patient with Malignant Hyperthermia or possible Malignant Hyperthermia in accordance with acceptable standards of medical practice and surgical patient care. The failed practice had the potential to affect all patients scheduled for a surgical procedure in the Cardiovascular Operating Room (CVOR). The findings were:
A. A policy was provided on 09/25/12 entitled "Anesthesia Protocol for Possible Malignant Hyperthermia Cases UAMS Department of Anesthesia" which contained a statement "Effective Date: Not Approved Yet".
B. The above findings were confirmed by the Vice President of Patient Care Services on 09/25/12.
Based on observation and interview, it was determined the facility failed to ensure the policy and procedure "Infection Control Guidelines Section F.2.d" was followed. Failure to follow the policy and procedure "Infection Control Guidelines" created an environment for possible infection control breaches. The failed practice had the potential to affect all patients who were admitted to CVOR for a surgical procedure. Findings follow:
A. Review of the Infection Control Guidelines Policy and Procedure on 09/25/12 revealed in Section F.2.d, "Spots on walls or equipment are wiped off with a disinfectant ..". Section 3 "Daily Terminal Cleaning" revealed "At the conclusion of the day's schedule, all operating rooms, furnishing and equipment should be terminally cleaned. All furniture and equipment, including casters and wheels, will be thoroughly cleaned with a disinfectant, using mechanical friction. Walls are washed daily with a disinfectant solution ... All cabinet exterior surfaces, including handles, will be cleaned daily.
B. The Director of CVOR on 09/24/12 at 1045 stated in an interview that operating rooms were terminally cleaned weekly.
C. Tour of the CVOR #1 was conducted on 09/24/12 at 1030-1100 with the Director of Quality, Vice President of Patient Care Services and the Compliance Director. The following was observed and confirmed at the time of observation by the Vice President of Patient Care Service:
1) The Bypass machine contained blood spats and a six inch tear in the outer coating which exposed an accumulation of rust.
2) The top of the Perfusionist connector cart contained rust.
3) The Hemotherm cooler/heater machine contained blood spats.
4) The wall behind the Hemotherm cooler/heater machine contained blood spats.
5) The Pxysis Anesthesia System contained an accumulation of a white chalky powder residue and dust.
6) The electronic monitor on the wall contained white chalky powder residue and dust.
7) The anesthesia stool contained a three inch tear exposing the porous fabric which could not be disinfected.
D. Tour of the CVOR #2 was conducted on 09/24/12 at 1000-1030 with the Director of Quality, Vice President of Patient Care Services and the Compliance Director. The following was observed and confirmed at the time of observation by the Vice President of Patient Care Service:
1) There was an accumulation of dust on the base of the computer on wheels (COW).
2) The top of the Perfusionist connector cart contained rust.
3) The Anesthesia cart contained dried blood spats, white chalky residue, rusty wheel casters and an accumulation of dust.
4) The Auto Transfusion machine contained spats of dried blood.
5) Two of two blue lab bins utilized for storing lab tubes contained a surgical towel in the bottom of the bins which contained spats of blood.
6) The Hemostasis Management System contained an accumulation of dust and spats of dried blood.
7) The Blood Gas machine contained an accumulation of dust.
8) The Bypass (heart-lung) machine contained an accumulation of dust and a stained surgical towel.
9) The Hemotherm cooler/heater machine contained blood spats.
10) The Extracorporeal membrane oxygenation (ECMO) machine contained dried blood spats and an accumulation of dust.
11) The Pxysis Anesthesia System contained an accumulation of a white chalky powder residue and dust.
12) The wall telephone contained an accumulation of a white chalky powder residue and dust.
13) Two of two chairs contained a 12 inch and 18 inch tear leaving exposed foam cushion which was porous and could not be disinfected or cleaned.
14) The autoclave machine between CVOR #1 and CVOR #2 revealed two of two metal flash sterilization trays with an accumulation of rust.
Based on review of the Thrombelastograph (TEG) Analyzer Policy and Procedure, TEG Hemostasis Analyzer direction for use, TEG QC log and interview, it was determined the facility failed to assure quality controls were performed on the TEG Analyzer machine as per facility policy in four (February, June, July and August) of the eight (January -August) months. The failure to adhere to the facility policy did not assure the operational check and calibration was within acceptable ranges for that equipment. The failed practice had the potential to affect all patients admitted to CVOR who required TEG monitoring. Evidence follows:
A. Review of the TEG QC data for January 2012 to August 2012 revealed the following:
1) In January, March, April and May, there was no patient test performed prior to TEG QC or when the QC was expired after 8 hours of continued patient testing;
2) There was one patient TEG test performed with no QC on respective channel in February;
3) 4) In June, there was seven patients TEG test performed on channels with no QC on respective channel and three tests were performed after the QC expired;
5) In July, there was four TEG test performed with no QC on respective channels; and
6) In August, there was two TEG test performed with no QC on respective channels.
Based on review of the surgical log, TEG Analysis log and the TEG QC log for January -August 2012, it was determined in four (February, June, July and August) of the eight (January -August) months reviewed patient's TEG tests were performed with no QC on respective channels and/or performed after the QC expired.
B. Review of the Thrombelastograph (TEG) Analyzer Policy and Procedure on 9/25/12 revealed "Perform a maintenance check by running a baseline electronic check (eTest) on both channels. Quality control (QC) should be performed daily BEFORE patient testing and every 8 hours of continued patient testing. BOTH Level I (normal) and Level II (abnormal) controls are assayed in BOTH Channels 1 and 2 before starting patient testing. If time constraints make running controls in both channels impossible, assay both level I and level II in one channel and put tape over the uncontrolled channel so staff know this channel cannot be used until QC is performed ... However, to insure the instrument is working properly, QC in both channels should be performed everyday of patient testing and alternate methods should only be used when patient care could be compromised if testing is not performed as soon as possible (ASAP)."
C. Review of the TEG Hemostasis Analyzer direction for use on 09/24/12 revealed "Use of biological controls, which serve as the operational check and calibration verification, is the basis for monitoring quality control of the analyzer and both levels should be run each shift (or as otherwise directed by your institution's policy) before running other samples to assure that all analyzer settings are within range."
D. Interview with the Point of Care Coordinator on 9/25/12 confirmed TEGs QCs were not performed as per policy.
Based on observation and interview, it was determined the facility failed to ensure outdated medications were not available for patient use past the expiration date. Failure to ensure medications were not available for patient use past the expiration date created the potential for patients to receive expired medications and had the potential to affect all patients admitted to CVOR (Cardiovascular Operating Room). The findings were:
Tour of the CVOR was conducted on 09/24/12 at 1000-1030 with the Director of Quality, Vice President of Patient Care Services and the Compliance Director. The following pre-filled syringes of medications were observed in CVOR #2 on the anesthesia cart outdated and confirmed at the time of observation by the Vice President of Patient Care as follows:
1) Phenylephrine 100 micrograms/milliliter (mcg/ml), expiration date- 9/13/12;
2) Phenylephrine 10 mcg/ml, expiration date- 9/20/12;
3) Phenylephrine 10 mcg/ml, expiration date- 9/20/12;
4) Phenylephrine 10 mcg/ml, expiration date- 9/20/12;
5) Dopamine 320 mcg/ml 50 ml, expiration date- 9/22/12;
6) Atropine 0.4 milligram (mg) in 1 ml, expiration date- 9/24/12 at 0600; and
7) A 3 ml syringe labeled Glycopyrrolate- no expiration date.
Tag No.: A0958
Based on review of the Surgical Log provided for review and interview, it was determined the facility failed to ensure the Surgical Log included required documentation pertaining to the surgical procedures performed in the Cardiovascular Operating Room (CVOR). The failed practice inhibited the ability to immediately retrieve information that could assist in monitoring complications, infections and other negative outcomes and had the potential to affect all patients who received services in the CVOR. The findings follow:
A. Review of the CVOR Surgical Log provided for review on 09/25/12 revealed the Surgical Log lacked documentation of the following: Date of operation; total time of operation; any assistant surgeons; type of anesthesia used and person administering it; operation performed; pre and postoperative diagnoses; and age of patient.
B. The findings were confirmed in an interview with the Director of CVOR on 09/25/12 at 1455.