HospitalInspections.org

Referenced code: Title 42 CFR 485.623(a)

Based on observation it was determined the Facility failed to maintain the building physical structure, environment and equipment in a state of good repair in two [the Geriatric Psychiatric Unit (Generations) and the Critical Care Unit (CCU)] of seven areas observed. The failed practice had the potential to affect all patients, staff, and visitors due to the potential for infection control issues. Findings follow:

A. While on tour of the facility on 05/09/17 at 0900, it was observed scuff marks on the wall in Patient Room 7 near the recliner in the Generations Unit.
B. While on tour of the facility on 05/09/17 at 0900, it was observed a scuff marks on the door and chipping paint on the door frame of room C119 Soiled Utility-in the Generations Unit.
C. While on tour of the facility on 05/09/17 at 0935, it was observed a crack in the ceiling of room CCU-3 in CCU.
D. While on tour of the facility on 05/09/17 at 0935, it was observed a chip in the ceiling tile near room C102 in CCU.
E. While on tour of the facility on 05/09/17 at 0935, it was observed rust on the supply air vent in room CCU-3 in CCU.
F. While of tour of the facility on 05/10/17 at 1000, the Senior Maintenance Mechanic verified the failed practices in A-E.

Referenced code: Title 42 CFR 485.623(c) and (d)

Based on observation and interview, it was determined the facility failed to maintain the fire and smoke rated barrier in one (above the fire-rated doors near the Chapel, Room C100) of six areas observed by protecting penetrations in the barrier with a system or material capable of limiting the transfer of smoke. The failed practice had the potential to affect all patients, visitors, and staff because it could not be assured that smoke would not spread from one side of the barrier to the other in the event of a fire and smoke event. Findings follow:

A. While touring the facility with the Senior Maintenance Mechanic on 05/10/17 at 1330, one penetration in the fire-rated barrier above the fire-rated doors near the Chapel was not sealed with a system or material capable of limiting the transfer of smoke from one side of the barrier to the other.
B. During the tour, the Senior Maintenance Mechanic verified the penetration was not sealed with a material capable of limiting the transfer of smoke from one side of the barriers to the other.
C. See K300.


Based on interview with the Maintenance Supervisor, there was no evidence for review the required 4-hour load test had been performed on the Essential Electrical System (EES) emergency generator and all ancillary equipment within the previous 36 months. The failed practice had the potential to affect all patients, visitors, and staff because it could not be assured the EES would function as required during a loss of utility supplied power. Findings follow:

A. Review of the emergency generator maintenance logs on 05/09/17 at 0900 revealed no evidence was presented to verify the required 4-hour load test had been performed on the EES for the prior 36 months.
B. During an interview with the Engineering Department Manager on 05/09/17 at 0900, it was verified the required test had been performed within the prior 36 month period.
C. See K918.

Based on observation and interview, it was observed the electrical equipment in two (electrical cage in the boiler room and the room for Air Handler #6) of six areas observed did not have a minimum of 36 inches (three feet) working space in front of the equipment because of items stored in those areas. The failed practice had the potential to affect all patients, visitors, and staff because rapid access to the panels could not be gained in the event of an emergency. Findings follow:

A. While touring the facility on 05/10/17 at 0940, it was observed a door leaning against an electrical switchboard in electrical cage inside the boiler room.
B. While touring the facility on 05/10/17 at 0955, it was observed negative air machines in front of two electrical panels in the room for Air Handler #6.
C. During the tour, the Senior Maintenance Mechanic verified the equipment did not have the required clearance.
D. See K932.


Based on observation and interview, it was determined the facility failed to maintain electrical wiring and equipment in accordance with NFPA 70 (Nation Electric Code) in two (above the drop down ceiling near the Mail Room and on the wall of the first floor Communications Room) of twelve areas observed by not maintaining covers on electrical boxes. The failed practice had the potential to affect all patients, visitors, and staff because uncovered electrical boxes were a potential fire hazard. Findings follow:

A. While touring the facility on 05/10/17 at 0945, it was observed an electrical box did not have a cover and electrical wires were exposed on the wall in the first floor Communications Room (165).
B. While touring the facility on 05/10/17 at 1330, it was observed an electrical box did not have a cover and electrical wires were exposed above the drop down ceiling near the Mail Room (B114).
C. During the tour, the Senior Maintenance Mechanic verified the electrical boxes did not have covers.
D. See K932.

Based on observation, interview, review of policies and procedures, and manufactures directions for use, it was determined the facility failed to have a policy and procedure in place to assure laryngoscope blades, used for examination and for placement of an endotracheal tube, were reprocessed according to manufacturer's instructions. Failure to have a policy and procedure did not assure manufacturer's instructions would be followed for reprocessing and did not assure patients would be protected from likely sources of infection. The failed practice affected any patient who required the use of the laryngoscope blade for examination or placement of an endotracheal tube. The findings were:

A. Surgical Services
1) Observation of the ante-room between Operating (OR) #1 and OR #2 on 05/09/17 from 1441-1452 revealed a container of liquid labeled "expires 05/13/17". Certified Registered Nurse Anesthetist (CRNA) #1 stated at the time of observation the laryngoscope blades were cleaned with a brush and hot water and then soaked for 30 minutes in the solution. Registered Nurse (RN) #3 identified the solution as Cidex OPA and retrieved a partially used one gallon container of Cidex OPA. The partially used container of Cidex OPA was not dated when opened and was not labeled with the expiration date of the solution once opened. There was no evidence the Cidex OPA Solution temperature was monitored. This was confirmed by RN #3 and CRNA #1 on 05/09/17 at the time of observation.
2) Review of manufacturer's instructions label directions for Cidex OPA on 05/09/17 revealed: "Do not reuse beyond 14 days or sooner as indicated by Cidex OPA Solution Test Strips. Once opened, the unused portion of the (Cidex OPA) solution may be stored in the original container for up to 75 days until used." The facility failed to follow the manufacturer's instructions for use of the germicide in that the date the Cidex OPA container was opened and the 75 day expiration from the date opened could not be determined. Therefore, the effectiveness of the solution could not assured.
3) A bottle of Cidex OPA Solution Test Strips was provided on 05/09/17 and identified by RN #3 and CRNA #1 as used for testing the Cidex OPA Solution one time per day. The expiration date on the bottle was 03/28/17 and was in use 42 days after expiration. In addition to being expired, the solution test strip bottle was not dated when opened and did not have a "do not use after" date. The facility was unable to provide documentation of MEC (minimum effective concentration) testing of Cidex OPA Solution prior to each use. This was confirmed on 05/09/17 at the time of observation by RN #3 and CRNA #1.
4) Review of Cidex OPA Solution Test Strip manufacturer's label directions for use on 05/09/17 at the time of observation revealed the following statement: "Test solution before each usage to guard against dilution, which may lower the ortho-phthalaldehyde level of the solution below its MEC. Test solution before immersing instruments." The storage instructions for the test strips included the statement "Keep cap tightly closed. Store bottle at controlled room temperature 15-30 degrees Celsius (59-86 degrees Fahrenheit) and in a dry place. Caution: Do not use after 90 days of opening the bottle." The facility failed to follow the manufacturer's instructions for use for testing the solution of Cidex OPA prior to each usage; failed to label the test strip bottle with the date opened/do not use after date and failed to assure the bottle in use was not past the manufacturer's expiration date.
5) A policy/procedure for reprocessing laryngoscope blades and the use of Cidex OPA (ortho-Phthalaldehyde) solution was requested on 05/09/17 from RN #3 and RN #4. No policy was provided. Review of Policy and Procedures provided by facility staff on 05/09/17 at 1441 revealed "All Equipment and instruments used that cannot withstand steam autoclaving and/or when time does not allow for gas sterilization, must be disinfected with activated glutaraldehyde prior to their use in a procedure." The facility policy did not include the use of ortho-Phthalaldehyde products or describe storage of laryngoscope blades after high level disinfection. The Director of Surgical Services confirmed on 05/11/17 at 0940 there was not a specific policy for the Cidex OPA in use at the facility for high level disinfection.
B. Respiratory Therapy
1) Observation on 05/11/17 from 1506-1534 of the Respiratory Department revealed a large bin containing a solution in the workroom dated 05/11/17 and identified by the Respiratory Therapy Department Manager as Cidex OPA. The Respiratory Therapy Department Manager stated the fiberoptic laryngoscope blades are cleaned with a cavi-wipe and other blades would be soaked in Cidex OPA and stated the fiberoptic laryngoscope blades could not be placed in the Cidex OPA solution.
2) The manufacturer's instructions for cleaning laryngoscope blades and the use of the Cidex OPA for high level disinfection was requested from the Respiratory Therapy Department Manager and received on 05/11/17 at 1516. Review of the care and maintenance of the manufacturer's instructions for the laryngoscope revealed: "Cleaning Procedure: Almost immediately after use, the Laryngoscope should be washed with tap or detergent water by using clean cotton wool or a soft nylon brush." After cleaning the blade should be rinsed and dried at 65 degrees Celsius to eliminate moisture." "Disinfection: soak blades in disinfecting solutions or disinfect thermo-chemically in a washer/sterilizer at up to 65 degrees Celsius. Manufacturer's instructions regarding duration and concentration of solutions should be strictly adhered to. After disinfection, rinse thoroughly in sterile water and wipe dry with a sterile cloth. Blades can be disinfected up to 95 degrees Celsius without chemical additives." "Sterilization: Before performing any of the procedures, the blade should be cleaned as described in the cleaning procedure. It is recommended that the fiber optic light guide be removed from the blade before sterilization." The methods listed for sterilization included gas sterilization by ethylene oxide, steam autoclaving, and cold soak solution, such as Cidex. The handle cleaning/sterilization stated "handles will withstand the same cold soak solution and autoclave ranges outlined in the laryngoscope blade section." There was no evidence the facility considered and followed the manufacturer's instructions for cleaning and disinfection of the laryngoscope blades or handles. The Respiratory Therapy Department Manager confirmed on 05/11/17 at the time of observation the manufacturer's instructions for cleaning and disinfecting the laryngoscope blades and handles.
3) Review on 05/11/17 of the Respiratory Therapy Department Cidex OPA log for 2017 revealed on 01/08/17 and 05/08/17 "pass" was documented. There was no additional documentation on the log. The Respiratory Therapy Department Manager confirmed the lack of documentation on the log and stated "The pass and date is when the solution is changed and the MEC is checked. That is documented on the form. We don't use it very often." There was no evidence the Cidex OPA Solution was discarded after 14 days. The MEC was not documented as checked prior to each use. The Cidex OPA bottle was not dated when opened or had a discard date. There was no evidence the temperature of the Cidex OPA Solution was monitored.
4) Review of manufacturer's label directions for Cidex OPA on 05/11/17 revealed: "Do not reuse beyond 14 days or sooner as indicated by Cidex OPA Solution Test Strips." Review of Cidex OPA Solution Test Strip manufacturer's label directions for use on 05/11/17 at the time of observation revealed the following statement: "Test solution before each usage to guard against dilution, which may lower the ortho-phthalaldehyde level of the solution below its MEC. Test solution before immersing instruments." The storage instructions for the test strips included the statement "Keep cap tightly closed. Store bottle at controlled room temperature 15-30 degrees Celsius (59-86 degrees Fahrenheit) and in a dry place. Caution: Do not use after 90 days of opening the bottle." The facility failed to follow the manufacturer's instructions for use in that there was no evidence the Cidex OPA solution was not used beyond 14 days; failed to assure MEC testing of the Cidex OPA solution prior to each usage and failed to label the test strip bottle with the date opened/do not use after date. The Respiratory Therapy Department Manager confirmed the findings in 3 and 4 on 05/11/17 at the time of observation.

Based on observation and review of policies and procedures, it was determined the facility failed to assure policies were reviewed at least annually for four of four (Central Sterile/Receiving, Day surgery,surgery, Post-anesthesia care unit, and Emergency Department) departments reviewed. The failed practice did not assure patients would receive care in accordance with policies and procedures that reflected facility expectations and affected all patients treated at the facility. The findings were:

On 05/09-05/11/17 review of Central Sterile/Receiving, Day Surgery, Surgery, Post-anesthesia Care Unit, and Emergency Department revealed the first page was signed and dated June 2013. The finding was confirmed by the Director of Nursing Services on 05/11/17 at 0930.

Based on observation, review of policy and interview, it was determined one of one Infant Crash Cart in the Obstetrics Unit was not stored readily accessible in that it was locked in the Medication Room and the keys were not located for 5 minutes, after it was asked to be checked. By not storing the Infant Crash Cart in a manner that made it readily accessible, the facility could not assure emergency treatment would be not be hindered or delayed. The failed practice had the likelihood to affect any infant in need of immediate emergency medical treatment. Finding follow:

A. During a tour of Obstetrics on 05/09/17 at 1012, Surveyor #4 asked where the infant crash cart was. Surveyor #4 was told it was in the Medication Room. The keys were not on a person and took until 1017 to locate where they were left.
B. Review of policy titled Infant Resuscitation- Equipment and Supplies stated "Appropriate equipment and supplies will be readily accessible to facilitate the orderly and effective resuscitation of a neonate."
C. During an interview on 05/09/17 at 10:17, the Obstetrics Nurse Manager verified the Infant Crash Cart was not readily available due to it being locked in a Medication Room and the keys were not found for 5 minutes.


Based on policy, review of annual compounding skills checklist and interview, it was determined the facility failed to ensure Gloved Fingertip Sampling was completed as part of the annual re-certification of Intravenous (IV) Admixture technique for three of three (#1-#3) Pharmacists trained to compound medications in the Laminar Flow Hood (per United States Pharmacopeia Chapter 797, 2008). By not completely evaluating the competencies of the personnel, the facility could not assure the sterility or accuracy of the medications compounded. The failed practice had the likelihood to affect all patients who received medications compounded in the Laminar Flow Hood. Findings follow:

A. Review of Pharmacy Policies and Procedures revealed a Competency Assessment for Environment Sampling that included in the checklist; Gloved Fingertip Sampling was to be completed.
B. Review of the skills checklists for Pharmacists #1-#3 revealed Gloved Fingertip Testing was not evaluated.
C. During an interview on 05/09/17 at 1320, the Director of Pharmacy verified Gloved Fingertip Testing was not being done as part of the annual re-certification of Intravenous (IV) Admixture technique.


Based on review of policy, review of Medication Error Incident Reports, review of clinical records and interview, it was determined the facility failed to:
1. Assure policies and procedures included medication errors were to be recorded along with notification to the practitioner; and
2. Assure in 24 of 24 clinical records there was evidence medication errors were recorded along with notification to the practitioner.
The failed practice did not assure the physician was aware of the medication error so that treatment, if any, could be altered. The failed practice had the likelihood to affect any patient with a medication error. The findings follow:

A. Policy titled Medication Error Definition & Reporting stated "I. All medication errors will be immediately reported to the physician. After physician notified and any order given by the physician has been completed, then a Variance Form shall be completed." There is no direction to document the medication error and the notification of the physician in the patient's clinical record.
B. Review of Medication Error Incident Reports revealed 24 medication errors dating from July 2016 through April 2017.
C. Review of the 24 Medication Errors in the clinical records revealed there was no evidence of documentation of the medication error and notification to the physician.
D. During an interview on 05/11/17 at 1500, the Director of Quality verified there would not be documentation of the medication error or notification to the practitioner in the clinical record. The documentation was on the Medication Error Incident Reports only.
E. During an interview on 05/12/17 at 0900, the Chief Nursing Officer verified there would not be documentation of the medication error or notification to the practitioner in the clinical record. The documentation was on the Medication Error Incident Reports only.


Based on observation, review of policy, review of manufacturer information on Succinylcholine and interview, it was determined the facility failed to ensure Succinylcholine had been dated with the manufacturers recommended expiration date in two (Cart #1 and #2) of three (Carts #1-#3) Anesthesia Carts observed in the Anesthesia Room while on tour. The potential existed for the medications to be used beyond manufacturer guidelines leading to a decrease in potency of the medications upon administration to patients. The practice had the likelihood to affect all patients who received the medication during surgery. Findings follow:

A. During a tour of Surgical Services on 05/09/17 from 1400 to 1445, observation revealed the following:
1) Anesthesia Cart #1 had 2 unopened vials of Succinylcholine that were not dated to indicate when they were removed from refrigeration or when they would expire; and
2) Anesthesia Cart #2 had 1 unopened vial of Succinylcholine that was not dated to indicate when it was removed from refrigeration or when they would expire.
B. Review of policy titled Storage of Zemuron, Tracrium and Succinylcholine stated "According to State Health regulations, once removed from refrigeration Zemuron, Tracrium and Succinylcholine need to be dated as follows ...Succinylcholine 14 days."
C. Review of package insert for Succinylcholine stated "The multi-dose vials are stable for up to 14 days at room temperature without significant loss of potency". There is no manufacturer information regarding beyond use dating if a facility removes the product during the day and refrigerates it at night. Therefore, once the product is removed, one can only follow the 14 day recommendation.
D. During an interview on 05/09/17 at the time of observation, Certified Registered Nurse Anesthetist #2 verified the Succinylcholine was removed from the refrigerator every surgery day (for the rooms being used) and replaced at the end of the day.

Based on observation, interview, policy and procedure review, it was determined the facility failed to control infections in that there was no policy and procedure in place to assure laryngoscope blades, used for examination and for placement of an endotracheal tube, were individually wrapped for storage to prevent contamination in seven of seven areas (Geriatric Psychiatric Unit, Critical Care Unit, Emergency Department, Obstetrics, Medical Surgical Unit, Surgical Services and the Respiratory Department) toured. Patients would not be protected from likely sources of infection due to contamination in that Laryngoscope blades were not individually packaged. The failed practice affected all patients admitted or treated at the facility. The findings were:

A. Observation revealed laryngoscope blades in the Geriatric Psychiatric Unit, Critical Care Unit, Emergency Department, Obstetrics, Medical Surgical Unit, Surgical Services and Respiratory Department were stored with multiple blades and were not individually packaged.
1) Geriatric Psychiatric Unit: Adult Emergency Cart, six blades. The finding was confirmed by Registered Nurse (RN) #1 on 05/09/17 at 0908.
2) Critical Care Unit: Adult Emergency Cart, eight blades; Pediatric Crash Cart eight blades. The findings were confirmed by RN #2 on 05/09/17 at 0939.
3) Emergency Department: Adult Emergency Cart, five blades and seven blades on a second cart; Pediatric Emergency Cart, ten blades. The findings were confirmed by the Chief Nursing Officer 05/09/17 at 1003.
4) Obstetrics: Adult Emergency Cart had 12 blades. The finding was confirmed by the Obstetrics Manager on 05/09/17 at 1020. The Anesthesia Medication Cart had five blades. The finding was confirmed by Certified Registered Nurse Anesthetist (CRNA) #3 on 05/09/17 at 1022.
5) Medical Surgical Unit: Adult Emergency Cart had four blades and was confirmed by Nursery Nurse Manager on 05/09/17 at 1040.
6) Surgical Services: Anesthesia cart, three blades and was confirmed by CRNA #1 on 05/09/17 at 1441.
7) Respiratory Department: work room, six and was confirmed by the Respiratory Department Manager on 05/11/17 at 1534.
B. The Infection Control Nurse/Medical Surgical Unit Manager stated in an interview on 05/11/17 at 1403 the facility adheres to CDC (Centers for Disease Control and Prevention), APIC (Association for Professionals in Infection Control) and AORN (Association of periOperative Nurses) standards.
C. Review of the CDC "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" revealed "Semicritical items minimally require high-level disinfection using chemical disinfectants." "After rinsing, items should be dried and stored (e.g., packaged) in a manner that protects them from recontamination."
D. A policy/procedure for the use of Cidex OPA (ortho-Phthalaldehyde) solution, used by facility to high-level disinfect laryngoscope blades, was requested on 05/09/17 from RN #3 and RN #4. No policy/procedure was provided. Review of policy and procedure "Glutaraldehyde Solution For Central Service Disinfection Of Instruments" on 05/09/17 at 1441 revealed "All Equipment and instruments used that cannot withstand steam autoclaving and/or when time does not allow for gas sterilization, must be disinfected with activated glutaraldehyde prior to their use in a procedure." The facility policy did not include the use of ortho-Phthalaldehyde products or describe storage of laryngoscope blades after high level disinfection to prevent contamination.


Based on observation on tour it was determined the infection control nurse failed to identify and control potential infections assure a sanitary environment was maintained in three (Geriatric Psychiatric Unit, Emergency Department, and Obstetric Department) of seven (Medical Surgical Unit, Emergency Department, Nursery, Surgical Services, Obstetrics, Critical Care Unit, and Geriatric Psychiatric Unit) areas observed. It could not be assured patients would be protected from likely sources of infection. The failed practice likely affected all patients treated at the facility. The findings were:

Observation on tour on 05/09/17 revealed the following:
A. Geriatric Psychiatric unit:
1) In the tub room, there was an accumulation of dust and soil along the floor and on top of the scales. There were three wlakers and one wheelchair in the room with an accumulation of dust. The findings were confirmed by the Unit Manager and Program Director of the Geriatric Psychiatric Unit on 05/09/17 at 0922.
2) Observation of the clean supply storage room at 0930 revealed a 3M brand electric razor with an electric blade attached that had been previously used as evidence by hair residue on the blade. The blade was confirmed by the Unit Manager at the time of observation as single use. Review of the blade package revealed it was a single use item.
B. Emergency Department:
1) The Trauma Room revealed an accumulation of dust on the computer desk and keyboard. The finding was confirmed by Emergency Department Nurse Manager on 05/09/17 at 1001.
2) The Triage Room revealed an accumulation of dust on the computer keyboard and scales. The findings were confirmed by the Emergency Department Nurse Manager on 05/09/17 at 1005.
C. Obstetrics:
Observation in Room 217 revealed an expired insulin syringe, dated 02/2017. One bin in the top drawer of the bedside had tape residue and a human hair was observed in the bin. An accumulation of dust was observed on the isolet in the room. The findings were verified by the Obstetrics Nurse Manager on 05/09/17 at 1012.

Based on policy review, Equipment Temperature Chart review, and interview, it was determined the facility failed to ensure one of one Walk-in and one of one Reach-in freezer temperatures were -10 degrees Fahrenheit (F) to 0 degrees F as stated per policy. The failed practice created the potential for frozen foods to begin to thaw and could affect any patient receiving foods from those freezers. Findings follow.

A. Review of policy titled "General Storage Procedures for Food and Non-Food Items" stated "Freezer Storage: A walk-in freezer and a reach-in freezer are maintained at a temperature of -10 (degrees) F (Fahrenheit) to 0 (degrees) F.
B. Review of Equipment Temperature Chart for the Reach-in Freezer revealed freezer temperatures were above 0 degrees F for 160 out of 183 opportunities from 03/01/17 through 04/30/17.
C. Review of Equipment Temperature Chart for the Walk-in Freezer revealed freezer temperatures were above 0 degrees F for 172 out of 183 opportunities from 03/01/17 through 04/30/17.
D. During an interview on 05/10/17 at 1028, the Dietary Manager confirmed the freezer temperatures were above 0 degrees F.

Based on review of Medication Error Incident Reports, review of clinical records and interview, it was determined the facility failed to maintain accurate records in that 24 of 24 clinical records failed to contain evidence medication errors were recorded along with notification to the practitioner. The failed practice did not assure the physician was aware of the medication error so that treatment, if any, could be altered. The failed practice had the likelihood to affect any patient with a medication error. The findings follow:

A. Review of Medication Error Incident Reports revealed 24 medication errors dating from July 2016 through April 2017.
B. Review of the 24 Medication Errors in the clinical records revealed there was no evidence of documentation of the medication error and notification to the physician.
C. During an interview on 05/11/17 at 1500, the Director of Quality verified there would not be documentation of the medication error or notification to the practitioner in the clinical record. The documentation was on the Medication Error Incident Reports only.
D. During an interview on 05/12/17 at 0900, the Chief Nursing Officer verified there would not be documentation of the medication error or notification to the practitioner in the clinical record. The documentation was on the Medication Error Incident Reports only.

Based on observation, interview, review of steam sterilizer load documentation, Association of periOperative Registered Nurses (AORN) Guidelines and policy and procedure review, it was determined the facility failed to perform surgical sterilization procedures in a safe manner in that daily biological indicators were not performed in accordance with policy 69 times from 02/17/17-05/05/17. Failure to document the results of biological monitoring of steam sterilization cycles did not assure the facility would be knowledgeable if processing was sufficient to assure no viable organisms were present after sterilization. The failed practice affected all patients who had surgery at the facility. The findings were:

A. On 05/10/17 from 1252-1340, the Surgical Services staff consisting of Licensed Practical Nurse (LPN)#1, LPN #2, Registered Nurse (RN)#3- RN#7 were interviewed with the following discussed: Process and documentation of load monitoring for steam sterilization for autoclave #1 and #2 was reviewed with all staff present. LPN #1 and LPN #2, in the presence of RN#3- RN#7, confirmed the "challenge pack" included the biological indicator (BI) and was performed one time per day and with all implants. The BI was placed in the incubator along with the control and the load was quarantined. The results of the BI and control were documented after 24 hours. The control was supposed to be "positive" and the BI "negative." The surgical staff stated there had been no biological indicator failures and that if any failures occurred, it would be reported to the surgical services director and the load would not be released.
B. Review of the "Steam Load Release" documentation revealed biological indicator results were not documented at least daily with each Challenge Pack documented a total of 69 times from 02/17/17-05/05/17. LPN #1 and LPN#2 stated on 05/10/17 at 1337 that "We always read the biological indicator results. For some reason they aren't written down all the time."
C. Review of Policy #7052 "Biological Monitoring" revealed "Biological monitoring shall be done daily on all steam sterilization loads"
D. Review of the Verify Biological/Integrator Challenge Pack instructions for use included the statement "Each challenge pack contains a Verify Self-Contained Biological Indicator and a Class 5 steam integrator."
E. Review of Association of periOperative Registered Nurses (AORN) Guidelines for Sterilization, VI.c.5. revealed "Biological indicators should be used to monitor sterilizer efficacy. Efficacy monitoring should be performed at least weekly and preferably daily."


Based on observation, interview, review of Association of periOperative Registered Nurses (AORN) Guidelines and review of policy and procedures, it was determined the facility failed to assure six of seven surgical staff observed followed their policy and procedure in that reusable surgical hats were not laundered in a health care associated laundry. The facility could not be assured of the method or effectiveness of home laundering of surgical hats in order to prevent patient exposure to microorganisms. The failed practice affected all surgical patients at the facility. The findings were:

A. Observation on 05/09/17 at 1400 revealed six of seven surgical staff wore cloth surgical hats within the Surgical Suite. The surgical staff stated their surgical hats were home laundered. Registered Nurse #3 stated "We have always washed them at home."
B. Review of policy "Attire in the Operating Room" as provided on 05/09/17 revealed "All head and facial hair is to be covered while in the restricted area of the surgical suite. The surgical hat or hood is to be clean, free of lint and confine the hair. The surgical hat or hood is changed daily. Reusable hats or hoods shall be laundered, after each use, by the laundry facility approved and monitored by Ashley County Medical Center."
C. Review of AORN "Guidelines for surgical Attire, Recommendation III.a.4, revealed " Reusable head coverings should be laundered in a health care-accredited laundry facility after each daily use and when contaminated."
D. The Surgical Services Manager stated in an interview on 05/11/17 at 0850 "I've told them to send them (cloth surgical caps) out to the facility laundry."

Based on review of Hospital Wide Performance Improvement Plan, Medical Staff Meeting Minutes and Board of Governors Meeting Minutes and interview, it was determined the facility failed to ensure Quality Assurance data was reported to the Medical Staff and the Board of Governors as required in the Hospital Wide Performance Improvement Plan from May 2016 through March 2017 . The failed practice did not ensure the Medical Staff and Board of Governors were aware of the quality indicators, and which items needed corrective action. Findings follow.

A. Review of Hospital Wide Performance Improvement Plan stated "The Board of Governors has the ultimate responsibility for performance assessment and improvement activities in the hospital and medical staff services. The Governing Body delegates the functionality of the program to the Administrative and Medical Staff leaders ...Periodically report performance monitoring results and improvement functions/activities to the Board and other appropriate committees/groups."
B. Review of Medical Staff meeting minutes and Board of Governors Meeting Minutes for May 2016 through March 2017 revealed no evidence of departmental Quality Assurance data was reported.
C. During an interview on 05/09/17 at 1510, the Director of Quality confirmed Quality Assurance had not been reported to the Board of Governors or the Medical Staff.