HospitalInspections.org

Cross refer to:

A0050
A0057

Cross refer to:

A0621

Cross refer to:

A0701
A0726

Cross refer to:

A0748

Based on a review of documentation and interview, the facility failed to ensure the the privileging of medical staff took into consideration the criteria for selection of individual character, competence, training, experience, and judgement, as evidence by failing to maintain a current privileging form for physicians.

Findings included:

The facility based bylaws stated that re-appointment and privileges are granted for a two year period of time.

The "Bylaws of the Medical Staff of Hamlin Memorial Hospital" stated in part,
". Terms of Appointment....
b. Appointments shall be for a two (2) year period....

3. Reappointment Process....
c At least thirty (30 days prior to the final scheduled Governing Body meeting in the Medical Staff year, the Medical Staff shall make written recommendation the Governing Body, through the Administrator, concerning reappointment of each member to the medical staff, including the specific privileges to be granted to each re-appointee for the ensuing period."

Review of the credentialing files for staff member #12 and 13 revealed both physicians submitted applications for re-appointment to the medical staff in 2013. The last documented request for specific privileges for these two physicians were dated 09/05/2012. This was over two years ago, past the time permitted by the facility bylaws.

In an interview on 03/10/15, staff members #11 and 18 confirmed both physicians had been re-appointed to the medical staff during a governing body meeting. Staff member #18 stated the physician may have "misdated the form".

Based on interviews, a review of documentation and a tour of the facility, the governing body failed to appoint a chief executive officer responsible for managing the hospital and enforcing facility policies and procedures necessary for patient safety and well-being.

Findings were:

Facility dietary policy titled "Purchasing and Storage" states, in part:
"Food shall be properly stored to preserve flavor, nutritive value, appearance and safety. Adequate dry area for food storage shall be provided. Dry or staple food items shall be stored off the floor in a cool, ventilated room not subject to sewage or waste water back flow, or contamination by condensation, leakage, rodents, or vermin.
2. A reliable thermometer will be used to check the temperature of each refrigerator and freezer daily to insure that the following temperatures are maintained:
· Refrigerated perishable foods: 33 degrees to 40 degrees Fahrenheit
· Frozen foods: -10 degrees to 0 degrees Fahrenheit."

During a tour of the kitchen area on 3-11-15, the following observations were made:
· A metal, institutional, triple sink (verified as not being in use by dietary staff #10) was being used for storage of various items including staple foods, such as jars of salt and pepper as well as zippered plastic bags of artificial sweeteners. The drains in each sink were obscured by these items and could not be seen. Pots and pans hung from a rack above the sinks. Storage of items (considered clean and ready for use) in an inappropriate storage area and container (such as an unused sink) allows for contamination from the sink drain, infestation of vermin, possible spills and water damage. Reaching over the items stored in the sinks to obtain a pot or pan from the hanging rack exposes the items to falling debris.
· In the dry goods storage room, 3 external shipping boxes were located on shelves above food, including open bins of vegetables and paper kitchen goods. External shipping boxes stored in a food storage area introduce bacteria and other contaminants into the food supply.
· In the dry goods storage room, 3 visibly-soiled, white "chef" coats on wire hangers were found hanging from the metal shelving units above open bins of vegetables and paper kitchen goods. Storage of personal clothing items in a food storage area introduces bacteria and other contaminants into the food supply.
· A document titled "REFRIGERATOR/FREEZER TEMPERATURES" was fastened to the door of the freezer and was labeled for March 2015. The document gave no indication of target temperature ranges. No temperatures had been recorded for March 1st or March 2nd. In an interview with dietary staff #16, dietary staff #16 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #16 stated the proper freezer temperature range to be "0 to negative 10 degrees" and the proper refrigerator temperature range to be "38 to 40 degrees." In an interview with dietary staff #10, dietary staff #10 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #10 stated the proper freezer temperature range to be "negative 10 degrees to 20 degrees" and the proper refrigerator temperature range to be "32 to 40 degrees." The inability of the dietary staff to state proper temperatures for the refrigerator and freezer as well as the absence of target temperature ranges on the temperature documentation sheet allows for the possibility of food being stored at improper temperatures that would jeopardize food storage safety and allow food spoilage.

Facility policy titled "INSPECTION OF NURSING STATIONS AND OTHER AREAS WHERE DRUGS ARE STORED, ADMINISTERED, OR DISPENSED" states, in part:
"...Any drug bearing an expiration date may not be distributed beyond the expiration date listed on the product label. Outdated and other unusable drugs are removed from stock and shall be quarantined together until such drugs are sent to the Return Drug Companies."

Facility policy titled "EXPIRED MEDICATIONS" states, in part:
· "ALL EXPIRED MEDICATIONS ARE RETAINED IN PHARMACY IN A BOX LABELED EXPIRED MEDS. A REPRESENTATIVE FROM AN EXPIRED PHARMACEUTICAL RETURN COMPANY COMES EVERY THREE MONTHS OR WHEN NEEDED TO PACKAGE MEDS FOR SHIPMENT."

During a tour of the emergency department on 3-11-15, the following observations were made:
· In the ER room #2 crash cart, 1 of 1 2ml vial of verapamil had expired 3-1-15 but was still available for patient use.
· In the ER room #2 crash cart, 1 of 1 1ml vial of Vitamin K had expired 3-1-15 but was still available for patient use.

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.



30250

Facility Nursing policy titled "MEDICATION ADMINISTRATION" states, in part:

"PROCEDURE...
* Never leave the medication cart unlocked when not in use."

During a tour of the facility on 03/11/15 the following observation were made:
* A respiratory cart was observed unattended in the patient hallway. A drawer was found unlocked containing: 1 box of Albuterol Sulfate Inhalation Solution 0.083%, 1 box Ipratropium Bromide Inhalation Solution 0.02%, and 1 box Levalbuterol 1.25 mg/3 ml.
* A crash cart was observed in the patient hallway unattended. A drawer was found unlocked that contained 2 boxes of Labetalol Hydrochloride injections 100 mg/20 ml, 2 vials of Lopressor 5 ml, 2 vials Benadryl 50 mg, 2 vials of Dilantin 100 mg/2 ml, 1 vial of Heparin 500 mg/ml, 1 vial of Ephedrine 50 mg/ml and 1 box of Naloxone Hydrochloride 1 mg/ml.
* In Emergency Room #1 a medication refrigerator was observed with no lock in place, unlocked. The refrigerator contained various medications including 25 vials of Succinylcholine Chloride 200 mg, 8 syringes of Bicillin injection, 6 suppositories of Phenadoz 25 mg, 8 suppositories of Phenadoz 12.5 mg, and 13 vials of Diltiazem hydrochloride. Succinylcholine Chloride is skeletal muscle relaxant.


In an interview on 03/11/15 staff members #2 and 8 confirmed the medication refrigerator in Emergency Room #1 did not have a lock in place. Staff member #2 stated the refrigerator did not have a lock or key "that I am aware of". Staff member #8 stated this refrigerator containing medication had not been locked "as long as I've been here". Staff member #8 has been employed at the facility for 18 years.

The above unsecured medications were confirmed with staff member #11 on 03/11/15.

Based on observation and review policies and procedures, the facility failed to ensure that all drugs and biologicals were must be kept in a secure area, and locked when appropriate. Unsecured medication could be accessed by unauthorized personnel, diverted by staff, or compromised placing patients at risk.

Findings included:

Facility Nursing policy titled "MEDICATION ADMINISTRATION" states, in part:

"PROCEDURE...
* Never leave the medication cart unlocked when not in use."

During a tour of the facility on 03/11/15 the following observation were made:
* A respiratory cart was observed unattended in the patient hallway. A drawer was found unlocked containing: 1 box of Albuterol Sulfate Inhalation Solution 0.083%, 1 box Ipratropium Bromide Inhalation Solution 0.02%, and 1 box Levalbuterol 1.25 mg/3 ml.
* A crash cart was observed in the patient hallway unattended. A drawer was found unlocked that contained 2 boxes of Labetalol Hydrochloride injections 100 mg/20 ml, 2 vials of Lopressor 5 ml, 2 vials Benadryl 50 mg, 2 vials of Dilantin 100 mg/2 ml, 1 vial of Heparin 500 mg/ml, 1 vial of Ephedrine 50 mg/ml and 1 box of Naloxone Hydrochloride 1 mg/ml.
* In Emergency Room #1 a medication refrigerator was observed with no lock in place, unlocked. The refrigerator contained various medications including 25 vials of Succinylcholine Chloride 200 mg, 8 syringes of Bicillin injection, 6 suppositories of Phenadoz 25 mg, 8 suppositories of Phenadoz 12.5 mg, and 13 vials of Diltiazem hydrochloride. Succinylcholine Chloride is skeletal muscle relaxant.


In an interview on 03/11/15 staff members #2 and 8 confirmed the medication refrigerator in Emergency Room #1 did not have a lock in place. Staff member #2 stated the refrigerator did not have a lock or key "that I am aware of". Staff member #8 stated this refrigerator containing medication had not been locked "as long as I've been here". Staff member #8 has been employed at the facility for 18 years.

The above unsecured medications were confirmed with staff member #11 on 03/11/15.

Based on observation and a tour of the facility, outdated and unusable drugs were available for patient use. Failing to remove outdated items from available stock increases the likelihood of the drug being administered to the patient with possibly dangerous results.


Findings were:


During a tour of the emergency department on 3-11-15, the following observations were made:
· In the ER room #2 crash cart, 1 of 1 2ml vial of verapamil had expired 3-1-15 but was still available for patient use.
· In the ER room #2 crash cart, 1 of 1 1ml vial of Vitamin K had expired 3-1-15 but was still available for patient use.

Facility policy titled "INSPECTION OF NURSING STATIONS AND OTHER AREAS WHERE DRUGS ARE STORED, ADMINISTERED, OR DISPENSED" states, in part:
"...Any drug bearing an expiration date may not be distributed beyond the expiration date listed on the product label. Outdated and other unusable drugs are removed from stock and shall be quarantined together until such drugs are sent to the Return Drug Companies."

Facility policy titled "EXPIRED MEDICATIONS" states, in part:
· "ALL EXPIRED MEDICATIONS ARE RETAINED IN PHARMACY IN A BOX LABELED EXPIRED MEDS. A REPRESENTATIVE FROM AN EXPIRED PHARMACEUTICAL RETURN COMPANY COMES EVERY TJHREE MONTHS OR WHEN NEEDED TO PACKAGE MEDS FOR SHIPMENT."

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.

Based on observation, interviews and a tour of the facility, the facility failed to employ a qualified dietitian that observed and adhered to professional standards of practice regarding food storage and sanitation. Failure to adhere to these professional standards compromises patient safety and increases the likelihood of infections caused by improper sanitation and improper food storage.


Findings were:


During a tour of the kitchen area on 3-11-15, the following observations were made:
· A metal cart containing 6 shelves of folded linen was located in a hallway outside the kitchen entrance. Dietary staff #10 verified that the linen was clean and currently being used in the kitchen. Along with clean linen that was ready for use, shelf #1 contained an empty glass coffee carafe. Shelf #2 contained an empty, 8 oz, plastic parmesan cheese container. Shelf #4 contained magazines and empty glass jars. Shelf #5 contained an open box of hairnets. Storing clean linen on shelving with these items contaminates the linen and the contamination is then introduced into the food preparation area.
· A personal cell phone, verified as belonging to dietary staff #16 lay charging in a food preparation area approximately 1" from several stacks of clean, plastic plate covers that were stacked with the open side facing up. An open toaster was located on the other side of the cell phone. Personal items in the food preparation area introduce contamination into the area.
· A personal radio was located in the food preparation area, on a shelf above the warming tray. Personal items in the food preparation area introduce contamination into the area.
· A metal, institutional, triple sink (verified as not being in use by dietary staff #10) was being used for storage of various items including Styrofoam bowls, plates, paper sleeves (such as a sleeve used to contain a hamburger or sandwich), plastic, metal and glass bowls that were deemed clean and ready for use, serving trays, glass baking pans, jars of salt and pepper, a large stack of paper serving tray liners, zippered plastic bags of artificial sweeteners and a box of straws. The drains in each sink were obscured by these items and could not be seen. Pots and pans hung from a rack above the sinks. Storage of items (considered clean and ready for use) in an inappropriate storage area and container (such as an unused sink) allows for contamination from the sink drain, infestation of vermin, possible spills and water damage. Reaching over the items stored in the sinks to obtain a pot or pan from the hanging rack exposes the items to falling debris.
· A document titled "REFRIGERATOR/FREEZER TEMPERATURES" was fastened to the door of the freezer and was labeled for March 2015. The document gave no indication of target temperature ranges. No temperatures had been recorded for March 1st or March 2nd. In an interview with dietary staff #16, dietary staff #16 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #16 stated the proper freezer temperature range to be "0 to negative 10 degrees" and the proper refrigerator temperature range to be "38 to 40 degrees." In an interview with dietary staff #10, dietary staff #10 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #10 stated the proper freezer temperature range to be "negative 10 degrees to 20 degrees" and the proper refrigerator temperature range to be "32 to 40 degrees." The inability of the dietary staff to state proper temperatures for the refrigerator and freezer as well as the absence of target temperature ranges on the temperature documentation sheet allows for the possibility of food being stored at improper temperatures that would jeopardize food storage safety and allow food spoilage.
· In the dry goods storage room, 3 external shipping boxes were located on shelves above food, including open bins of vegetables and paper kitchen goods. External shipping boxes stored in a food storage area introduce bacteria and other contaminants into the food supply.
· In the dry goods storage room, 3 visibly-soiled, white "chef" coats on wire hangers were found hanging from the metal shelving units above open bins of vegetables and paper kitchen goods. Storage of personal clothing items in a food storage area introduces bacteria and other contaminants into the food supply.

Facility dietary policy titled "Purchasing and Storage" states, in part:
"Food shall be properly stored to preserve flavor, nutritive value, appearance and safety. Adequate dry area for food storage shall be provided. Dry or staple food items shall be stored off the floor in a cool, ventilated room not subject to sewage or waste water back flow, or contamination by condensation, leakage, rodents, or vermin.
2. A reliable thermometer will be used to check the temperature of each refrigerator and freezer daily to insure that the following temperatures are maintained:
· Refrigerated perishable foods: 33 degrees to 40 degrees Fahrenheit
· Frozen foods: -10 degrees to 0 degrees Fahrenheit."

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.

Based on observation and a tour of the facility, the physical plant and overall hospital environment were not maintained in such a manner that the safety and well-being of patients was assured.


Findings were:


During a tour of the emergency department on 3-11-15, the following observations were made:
· ER room #6 contained 6 bottles of hazardous cleaners, stored underneath the sink in an unlocked cabinet. Improperly stored, hazardous cleaners can be ingested and cause harm to patients and/or family members in the emergency department.
· In the bathroom located within ER room #3, 5 cans of hazardous cleaners were found. Improperly stored, hazardous cleaners can be ingested and cause harm to patients and/or family members in the emergency department.

During a tour of the physical therapy department on 3-11-15, the following observations were made:
· 1 of 1 waist-high therapy table had a 2" tear in the vinyl covering. Improperly maintained equipment presents a safety hazard for patients.

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.



30250

During a tour of the sterilization area on 03/11/15, the following physical plant issues were noted:

* The counter under the sterilizer had an area of missing laminate, approximately 2 inches in size. The laminate is bubbled up separating from the press board visible underneath. This damage appears to be the result of water damage. Staff member #7 confirmed this was a result of water leaking out of the steam sterilizer. The presence of water damage indicates the area could become contaminated with bacterial growth due to the moist environment.
* In the sink area utilized in sterilizing instruments, the counter was observed to have an 8" by 2" inch area of laminate missing to the counter edge.


The above findings were confirmed with staff member # 7 on 03/11/15.

Based on observation, interviews and a tour of the facility, there was not proper temperature control in the food preparation area. Failure to maintain proper food temperature increases the likelihood of foodborne illnesses for the patients.


Findings were:


During a tour of the kitchen area on 3-11-15, the following observations were made:
· A document titled "REFRIGERATOR/FREEZER TEMPERATURES" was fastened to the door of the freezer and was labeled for March 2015. The document gave no indication of target temperature ranges. No temperatures had been recorded for March 1st or March 2nd. In an interview with dietary staff #16, dietary staff #16 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #16 stated the proper freezer temperature range to be "0 to negative 10 degrees" and the proper refrigerator temperature range to be "38 to 40 degrees." In an interview with dietary staff #10, dietary staff #10 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #10 stated the proper freezer temperature range to be "negative 10 degrees to 20 degrees" and the proper refrigerator temperature range to be "32 to 40 degrees." The inability of the dietary staff to state proper temperatures for the refrigerator and freezer as well as the absence of target temperature ranges on the temperature documentation sheet allows for the possibility of food being stored at improper temperatures that would jeopardize food storage safety and allow food spoilage.

Facility dietary policy titled "Purchasing and Storage" states, in part:
"Food shall be properly stored to preserve flavor, nutritive value, appearance and safety. Adequate dry area for food storage shall be provided. Dry or staple food items shall be stored off the floor in a cool, ventilated room not subject to sewage or waste water back flow, or contamination by condensation, leakage, rodents, or vermin.
2. A reliable thermometer will be used to check the temperature of each refrigerator and freezer daily to insure that the following temperatures are maintained:
· Refrigerated perishable foods: 33 degrees to 40 degrees Fahrenheit
· Frozen foods: -10 degrees to 0 degrees Fahrenheit."

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.

Based on observation, interviews, a review of documentation and a tour of the facility, the infection control officer failed to develop and implement adequate policies governing control of infections and communicable diseases. Failure to develop and implement adequate policies increases the likelihood of disease and illness within the facility.


Findings were:


During a tour of the kitchen area on 3-11-15, the following observations were made:
· A metal cart containing 6 shelves of folded linen was located in a hallway outside the kitchen entrance. Dietary staff #10 verified that the linen was clean and currently being used in the kitchen. Along with clean linen that was ready for use, shelf #1 contained an empty glass coffee carafe. Shelf #2 contained an empty, 8 oz, plastic parmesan cheese container. Shelf #4 contained magazines and empty glass jars. Shelf #5 contained an open box of hairnets. Storing clean linen on shelving with these items contaminates the linen and the contamination is then introduced into the food preparation area.
· A personal cell phone, verified as belonging to dietary staff #16 lay charging in a food preparation area approximately 1" from several stacks of clean, plastic plate covers that were stacked with the open side facing up. An open toaster was located on the other side of the cell phone. Personal items in the food preparation area introduce contamination into the area.
· A personal radio was located in the food preparation area, on a shelf above the warming tray. Personal items in the food preparation area introduce contamination into the area.
· A metal, institutional, triple sink (verified as not being in use by dietary staff #10) was being used for storage of various items including Styrofoam bowls, plates, paper sleeves (such as a sleeve used to contain a hamburger or sandwich), plastic, metal and glass bowls that were deemed clean and ready for use, serving trays, glass baking pans, jars of salt and pepper, a large stack of paper serving tray liners, zippered plastic bags of artificial sweeteners and a box of straws. The drains in each sink were obscured by these items and could not be seen. Pots and pans hung from a rack above the sinks. Storage of items (considered clean and ready for use) in an inappropriate storage area and container (such as an unused sink) allows for contamination from the sink drain, infestation of vermin, possible spills and water damage. Reaching over the items stored in the sinks to obtain a pot or pan from the hanging rack exposes the items to falling debris.
· A document titled "REFRIGERATOR/FREEZER TEMPERATURES" was fastened to the door of the freezer and was labeled for March 2015. The document gave no indication of target temperature ranges. No temperatures had been recorded for March 1st or March 2nd. In an interview with dietary staff #16, dietary staff #16 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #16 stated the proper freezer temperature range to be "0 to negative 10 degrees" and the proper refrigerator temperature range to be "38 to 40 degrees." In an interview with dietary staff #10, dietary staff #10 was asked to state the proper temperature ranges for both the refrigerator and freezer. Dietary staff #10 stated the proper freezer temperature range to be "negative 10 degrees to 20 degrees" and the proper refrigerator temperature range to be "32 to 40 degrees." The inability of the dietary staff to state proper temperatures for the refrigerator and freezer as well as the absence of target temperature ranges on the temperature documentation sheet allows for the possibility of food being stored at improper temperatures that would jeopardize food storage safety and allow food spoilage.
· In the dry goods storage room, 3 external shipping boxes were located on shelves above food, including open bins of vegetables and paper kitchen goods. External shipping boxes stored in a food storage area introduce bacteria and other contaminants into the food supply.
· In the dry goods storage room, 3 visibly-soiled, white "chef" coats on wire hangers were found hanging from the metal shelving units above open bins of vegetables and paper kitchen goods. Storage of personal clothing items in a food storage area introduces bacteria and other contaminants into the food supply.

During a tour of the emergency department on 3-11-15, the following observations were made:
· ER room #6 contained dust on high, horizontal surfaces including the overhead exam lamp.
· In ER room #2, a dust-covered pad was found on top of the crash cart.
· In ER room #3, a ceiling fan was present and the blades were coated with dust.

During a tour of the physical therapy department on 3-11-15, the following observations were made:
· 1 of 1 waist-high therapy table had a 2" tear in the vinyl covering. A torn covering prevents the surface from being properly cleaned and can harbor dangerous bacteria.

The above was verified in an interview with the Chief Executive Officer, the Chief Financial Officer and the Administrative Assistant on the afternoon of 3-11-15 in the facility conference room.



30250

The facility failed to ensure that articles to be sterilized were arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature.

The Centers for Disease Control and Prevention (CDC) article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: , states on page 74 that "hinged instruments and instruments that are closed should be opened during the process of sterilization."

During a tour of Emergency Room #1 on 03/11/15, 3 of 9 hinged instruments with a locking mechanism that had been sterilized and stored were observed with the locking mechanism in a closed and clamped position. The locking mechanism is a series of interlocking teeth on each handle that clamps and holds the handles in place with tension. It could not be determined that these surfaces were appropriately cleaned. When instruments are closed, the sterilizing agent cannot penetrate all surfaces to ensure complete sterilization of all surfaces of the instruments.

In an interview on 03/11/15, staff member #8 confirmed the the locking mechanism on the 3 sterilized instruments were in a closed and clamped position.

The facility failed to ensure that a log was maintained with external chemical indicator biological indicators results for the sterilizer at the facility. Failing to record the external chemical indicator and biological indicators results, indicates the facility is not ensuring the sterilizer is appropriately and consistently sterilizing instruments.

In the sterilization room a log book entitled, "3M Sterilizer Record Keeping" was observed. In an interview on 03/11/15, staff member #7 confirmed this is where documentation related to sterilization of medical instruments is logged.

Staff member #7 stated that a biologically indicator is run in the sterilizer weekly at the facility. The facility sterilizes instruments once a week. Staff member #7 was unable to provide documentation to support that biological indicators are run weekly. Staff member #7 stated a chemical indicator is included in each load sterilized. A box of Bowie-Dick test results was provided to the surveyor. Each Bowie-Dick test result sheet was dated to correspond to a load of instruments sterilized.

In the front of a the "3M Sterilizer Record Keeping" log book an instruction sheet is present. The Instructions for Use state in part, "For continuous improvement in the performance of the sterilization process, biological indicators (BIs) are placed in process challenge devices (PCD) (test or challenge pack) that is representative of the load and creates the greatest challenge...

Monitoring Frequency....

Routine Efficacy Testing: Weekly, preferably daily, or every load and quarantine to eliminate recalls and improve pateint safety...

Log sheet instructions:..
4. Check the Attest BI product used.
5. Record the BI manufacturing lot number...
12 Record the well number the BO was placed into.
13. Record the time BI was placed in the incubator and your initials.
14. Record the time BI was removed from the incubator and your initials.
15. Record the BI test results by circling the + (positive) or - (negative) results.
16. Record the BI control results by circling the + (positive) or - (negative) results."

Review of the "3M Sterilizer Record Keeping" log from 04/07/14 through 03/03/15 revealed that chemical indicators and biological indicator results were not documented or recorded in this log book. The form in this book has areas present to document "Indicator Results" and "Chemical Indicator". The form was not completed as indicated per the manufacturer instructions in the log book. Staff member #7 confirmed that chemical indicator and biological indicator results are not recorded in the log book currently.

In the front of a the "3M Sterilizer Record Keeping" log book an instruction sheet is present. The Instructions for Use state in part, "For continuous improvement in the performance of the sterilization process, biological indicators (BIs) are placed in process challenge devices (PCD) (test or challenge pack) that is representative of the load and creates the greatest challenge...

Monitoring Frequency....

Routine Efficacy Testing: Weekly, preferably daily, or every load and quarantine to eliminate recalls and improve pateint safety...

Log sheet instructions:..
4. Check the Attest BI product used.
5. Record the BI manufacturing lot number...
12 Record the well number the BO was placed into.
13. Record the time BI was placed in the incubator and your initials.
14. Record the time BI was removed from the incubator and your initials.
15. Record the BI test results by circling the + (positive) or - (negative) results.
16. Record the BI control results by circling the + (positive) or - (negative) results."


Review of the "3M Sterilizer Record Keeping" log from 04/07/14 through 03/03/15, revealed that biological indicator results were not documented or recorded in this log book. The form in this book has areas present to document "Indicator Results". The form was not completed as indicated per the manufacturer instructions in the log book.

During a tour of the sterilization area on 03/11/15, the following infection control issues were noted:

* 3 external shipping boxes were stored above the autoclaves used for sterilizing instruments. These external shipping boxes could potentially contaminate the area used for sterilization.
* The counter under the sterilizer has an area of missing laminate, approximately 2 inches in size. The laminate is bubbled up separating from the press board visible underneath. This damage appears to be the result of water damage. Staff member #7 confirmed this was a result of water leaking out of the steam sterilizer. The presence of water dame, indicates the area could become contaminated with bacterial growth due to the moist environment.
* In the sink area utilized in sterilizing instruments, the counter was observed to have an 8" by 2" area of laminate missing to the counter edge. This area cannot be effectively cleaned due to the missing laminate.
* The the sink area utilized in sterilizing instruments miscellaneous items were noted such as a radio, books, and paperwork. In an interview staff member #7 stated these items belonged to the Physical Therapy and Housekeeping departments. This sink area should be dedicated for use with sterilization, keeping clean and dirty items separate.

The above findings were confirmed with staff member # 7 on 03/11/15.