HospitalInspections.org

Based on interview and record review, the facility failed to ensure the physician was "immediately" available when a sampled patient (Patient 2) was a previous cesarean section delivery times two and was admitted to the facility in active labor with a subsequent pregnancy. This resulted in a nurse attended vaginal delivery and the physician not being "immediately" available to provide emergency care to Patient 2 if necessary.

Findings:

According to The American College of Obstetricians and Gynecologists (ACOG), Practice Bulletin, Number 115, dated August 2010, revealed "... Because of the risks associated with TOLAC (trial of labor after previous cesarean delivery) and that uterine rupture and other complications may be unpredictable, the College recommends that TOLAC be undertaken in facilities with staff immediately available to provide emergency care. ..."

On June 10, 2013, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on June 8, 2013, with diagnoses of term pregnancy, rupture of membranes (bag of water surrounding the infant) with meconium (infant bowel movement), and active labor. This was Patient 2's seventh pregnancy and Patient 2's last two infants had been delivered by cesarean section (abdominal delivery of an infant).

The "LD (Labor and Delivery) - Flowsheet" dated June 8, 2013, indicated:
- At 11:19 p.m., Patient 2's vaginal exam was 4 centimeters dilated (10 centimeters equals complete dilatation), 70 percent effaced (100 percent equals complete effacement), and a minus two station.
- At 11:30 p.m., Patient 2's contractions were every two to three minutes, lasting 30 to 40 seconds and were "strong."
- At 11:49 p.m., the physician was called on his cellular telephone and given a report on Patient 2's condition.
- At 11:53 p.m., the physician was informed of Patient 2's desire to refuse a repeat cesarean section (c/s), and "MD (physician) states pt (patient) will have to sign c/s refusal and be informed of all risks involved."

The "LD - Flowsheet" dated June 9, 2013, indicated:
- At 12:18 a.m., "C/S refusal signed by pt after much explanation and discussion with husband and RN (Registered Nurse)."
- At 12:48 a.m., Patient 2's vaginal exam was 6 centimeters dilated, 80 percent effaced, and a minus two station.
- At 2:28 a.m., Patient 2's vaginal exam was completely dilated, 100 percent effaced, and a zero station.
- At 2:29 a.m., the physician was called on his cellular telephone, was requested to come to the facility for delivery, and "MD states he is on his way in."
- At 2:50 a.m., Patient 2 had a vaginal delivery of a baby girl which was attended by the RN.
- At 3:03 a.m., the physician was "at bedside."

The physicians History and Physical (H&P), dated June 9, 2013, indicated "... On my end, I proceeded to call [name] via telephone, who is anesthesia on-call tonight and office of the medical staff. Since the patient has decided against my medical advice at that point, we felt no obligation to remain in house and we would come in for emergency, however. ..."

During an interview with the Director Obstetrical Services (DOS) on June 10, 2013, at 11:45 a.m., she stated the facility did not electively do "Vaginal Birth After Cesarean (VBAC)" deliveries. The DOS stated if a VBAC could not be safely transferred to another facility, anesthesia and the Operating Room (OR) staff would be notified of a possible cesarean section. The DOS stated the facility did not have a requirement that the physician be in the facility or "immediately" available. In addition, the DOS stated all RN attended deliveries were reviewed.

During an interview with the DOS, the Performance Improvement Coordinator (PIC), and the Chief Nursing Officer (CNO), on June 12, 2013, at 10:20 a.m., the CNO stated Patient 2's record/case would be referred to peer review.

The facility policy and procedure titled "Vaginal Birth After Cesarean (VBAC)" last reviewed December 2011, revealed "... If time, patient condition or EMTALA (Emergency Treatment and Labor Act) guidelines prohibit a safe transfer to another facility, care will be provided to the best of the hospital's ability ... "

Based on interview and record review, the facility failed to ensure an organized nursing service was provided to all patients by failing:

1. To ensure one sampled patient (Patient 8), who was receiving treatment for hyperbilirubinemia (a condition of newborns when red blood cells break down causing an excess of bilirubin in the blood that can lead to severely disabling brain damage or death), was transported to a higher level of care in a safe manner. (Refer to A392);

2. To ensure the staff recognized the newborns bilirubin fell in the "High Risk" and/or "High Intermediate Risk" Zones, and the physician was informed of the risk zone associated with the bilirubin level for two sampled patients (Patients 3 and 9). (Refer to A392);

3. To ensure the newborns discharge instructions and follow-up care were appropriate based on the facility's policy and procedure and the American Academy of Pediatrics (AAP) guidelines for two sampled patients (Patients 3 and 9). (Refer to A392);

4. To ensure laboratory tests were not drawn without a physician's order for one sampled patient (Patient 3). (Refer to A392);

5. To ensure an individualized plan of care was developed and maintained for one sampled patient (Patient 8) who developed hyperbilirubinemia (a condition of newborns when red blood cells break down causing an excess of bilirubin in the blood that can lead to severely disabling brain damage or death). (Refer to A396).

The cumulative effects of these systemic problems resulted in the failure of nursing services to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed:

1. To ensure one sampled patient (Patient 8), who was receiving treatment for hyperbilirubinemia (a condition of newborns when red blood cells break down causing an excess of bilirubin in the blood that can lead to severely disabling brain damage or death), was transported to a higher level of care in a safe manner. This resulted in Patient 8 being transported via private vehicle to Facility B's Neonatal Intensive Care Unit (NICU).

2. To ensure the staff recognized the newborns bilirubin fell in the "High Risk" and/or "High Intermediate Risk" Zones, and the physician was informed of the risk zone associated with the bilirubin level for two sampled patients (Patients 3 and 9); and

3. To ensure the newborns discharge instructions and follow-up care were appropriate based on the facility's policy and procedure and the American Academy of Pediatrics (AAP) guidelines for two sampled patients (Patients 3 and 9).

This had the potential to result in a delay in follow-up care and treatment.

4. To ensure laboratory tests were not drawn without a physician's order for one sampled patient (Patient 3). This resulted in Patient 3 having a blood draw and laboratory tests done without a physician's order.

Findings:

1. On June 11, 2013, the record for Patient 8 was reviewed. Patient 8 was admitted to the facility on May 2, 2013, at 1:11 p.m.,with a diagnosis of newborn infant.

Patient 8's "Total Bilirubin" on May 4, 2013, at 5:15 a.m., was 12.1 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 8 was "High Intermediate Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 12.1 mg/dL at 40 hours of age.

The "Physicians Orders" dated May 4, 2013, at 11 a.m., indicated "Initiate double light phototherapy (treatment of hyperbilirubinemia through light exposure) for 6 hours. Recheck bilirubin."

Patient 8's "Total Bilirubin" on May 4, 2013, at 6 p.m., was 14.8 mg/dL.

The "BiliTool" used by the facility indicated Patient 8 was "High Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 14.8 mg/dL at 53 hours of age.

The "Physicians Orders" dated May 4, 2013, at 6:50 p.m., indicated "Re-start double phototherapy. Re draw baby Q (every) 12? (hours)."

The "Newborn - Nursing Comments" dated May 4, 2013, at 7:25 p.m., indicated the physician had arranged admission to Facility B's NICU and had spoken with the accepting physician. Patient 8 was to be discharged home with parents "with strict instructions to drive directly over to [Facility B] NICU ... for admission."

The "Patient Discharge Instructions" dated May 4, 2013, indicated "Discharge to [Facility B] NICU ... Upon departure from [Facility A] drive infant to [Facility B] and check in to NICU."

Patient 8 left Facility A on May 4, 2013, at 8:10 p.m., and arrived at Facility B on May 4, 2013, at 9 p.m., for admission to Facility B's NICU.

During an interview with the Director Obstetrical Services (DOS) on June 11, 2013, at 2:35 p.m., she stated it was not the facility's practice to send patients to another facility via private vehicle. The DOS stated Patient 8 should have been transferred to a higher level of care via an ambulance.

The facility policy and procedure titled "Transfer of Patients to Other Facilities" last reviewed November 2011, revealed "To provide timely, safe and efficient transfer of patients to other health care facilities to maintain continuity of care."

2a. On June 10, 2013, the record for Patient 3 was reviewed. Patient 3 was admitted to the facility on June 9, 2013, at 2:50 a.m., with a diagnosis of term newborn infant.

Patient 3's "Total Bilirubin" on June 10, 2013, at 2 a.m., was 7.4 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 3 was "High Intermediate Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 7.4 mg/dL at 23 hours of age... "recommended follow-up visit and/or a recheck bilirubin value is recommended within 24-48 hours."

There was no indication in the record the staff recognized the "Total Bilirubin" for Patient 3 was in the "High Intermediate Risk" zone. There was no indication in the record the physician was informed of the risk zone associated with the bilirubin level for Patient 3.

During an interview with Licensed Vocational Nurse (LVN) 1, Patient 3's nurse, on June 10, 2013, at 3 p.m., she stated she did not do a "BiliTool" for Patient 3. LVN 1 stated she thought Patient 3 was two days old not one day old, and she misread the laboratory results when she documented the "Total Bilirubin" was 7.0 mg/dL rather than 7.4 mg/dL. LVN 1 stated she should have accessed the "BiliTool" to determine Patient 3's risk for developing hyperbilirubinemia, and she should have told Patient 3's mother that the infant needed to be seen by the pediatrician within two days based on the "Total Bilirubin" results and the facility's policy and procedure.

The facility policy and procedure titled "Hyperbilirubinemia, Management of" last reviewed August 2012, revealed " ... Risk assessment, management, documentation and follow-up are key elements in recognition and treatment of this condition. ... Any newborn discharged in less than 48 hours after birth will be referred for follow-up by a health care professional in an office, clinic or at home within 2 days of discharge."

b. On June 11, 2013, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on May 21, 2013, at 1:07 p.m., with a diagnosis of term newborn infant.

Patient 9's "Total Bilirubin" on May 22, 2013, at 2 p.m., was 8.3 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 9 was "High Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 8.3 mg/dL at 25 hours of age..."recommended follow-up bilirubin is recommended in 6-12 hours if known hemolysis by direct Coomb's or ETCO (end-tidal carbon monoxide) and otherwise recommended within 24 hours (high risk)."

There was no indication in the record the staff recognized the "Total Bilirubin" for Patient 9 was in the "High Risk" zone. There was no indication in the record the physician was notified of the risk zone associated with the bilirubin level for Patient 9.

The "Patient Discharge Instructions" dated May 22, 2013, indicated the "Total Bilirubin" was 8.3 mg/dL, and "Follow Up Appointment - 1 week - Make appt. (appointment) for Friday (May 24, 2013 - 48 hours after discharge).

During an interview with Registered Nurse (RN) 4, on June 12, 2013, at 9:15 a.m., she stated the physician was given the "Total Bilirubin" results as a number and the staff do not report a "Risk Zone." When RN 4 was asked which "Risk Zone" a "Total Bilirubin" of 8.3 mg/dL would be associated with, she stated a "Total Bilirubin" of 8.3 mg/dL was within parameters, the patient could go home, and the result was in the "Intermediate Risk" zone. RN 4 did not utilize the "BiliTool" to reach this conclusion. When RN 4 was told the "Total Bilirubin" of 8.3 mg/dL indicated Patient 9 was "High Risk" for developing severe hyperbilirubinemia, she stated she was surprised the "Risk Zone" was so high. RN 4 stated if Patient 9's "Total Bilirubin" was in the "High Risk" zone, the patient should have been seen/re-evaluated within 24 hours. In addition, RN 4 stated she had not had any ongoing education with regards to hyperbilirubinemia.

3a. On June 10, 2013, the record for Patient 3 was reviewed. Patient 3 was admitted to the facility on June 9, 2013, at 2:50 a.m., with a diagnosis of term newborn infant.

Patient 3's "Total Bilirubin" on June 10, 2013, at 2 a.m., was 7.4 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 3 was "High Intermediate Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 7.4 mg/dL at 23 hours of age... "recommended follow-up visit and/or a recheck bilirubin value is recommended within 24-48 hours."

The "Patient Discharge Instructions" dated June 10, 2013, indicated the "Total Bilirubin" was 7.0 mg/dL, "Follow Up Appointment - 1 week," and "Home Visit Scheduled - No."

During an interview with Licensed Vocational Nurse (LVN) 1, Patient 3's nurse, on June 10, 2013, at 3 p.m., she stated she thought Patient 3 was two days old not one day old, and she misread the laboratory results when she documented the "Total Bilirubin" was 7.0 mg/dL rather than 7.4 mg/dL. LVN 1 stated she should have accessed the "BiliTool" to determine Patient 3's risk for developing hyperbilirubinemia, and told Patient 3's mother the infant needed to be seen by the pediatrician within two days based on the "Total Bilirubin" results and the facility's policy and procedure.

The facility policy and procedure titled "Hyperbilirubinemia, Management of" last reviewed August 2012, revealed " ... Risk assessment, management, documentation and follow-up are key elements in recognition and treatment of this condition. ... Any newborn discharged in less than 48 hours after birth will be referred for follow-up by a health care professional in an office, clinic or at home within 2 days of discharge."

b. On June 11, 2013, the record for Patient 9 was reviewed. Patient 9 was admitted to the facility on May 21, 2013, at 1:07 p.m., with a diagnosis of term newborn infant.

Patient 9's "Total Bilirubin" on May 22, 2013, at 2 p.m., was 8.3 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 9 was "High Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 8.3 mg/dL at 25 hours of age..."recommended follow-up bilirubin is recommended in 6-12 hours if known hemolysis by direct Coomb's or ETCO (end-tidal carbon monoxide) and otherwise recommended within 24 hours (high risk)."

The "Patient Discharge Instructions" dated May 22, 2013, indicated the "Total Bilirubin" was 8.3 mg/dL, and "Follow Up Appointment - 1 week - Make appt. (appointment) for Friday (May 24, 2013 - 48 hours after discharge).

During an interview on June 12, 2013, at 9:15 a.m., when Registered Nurse (RN) 4 was asked which "Risk Zone" a "Total Bilirubin" of 8.3 mg/dL would be associated with, RN 4 stated a "Total Bilirubin" of 8.3 mg/dL was within parameters, the patient could go home, and the result was in the "Intermediate Risk" zone. RN 4 did not utilize the "BiliTool" to reach this conclusion. When RN 4 became aware the "Total Bilirubin" of 8.3 mg/dL indicated Patient 9 was "High Risk" for developing severe hyperbilirubinemia, she stated she was surprised the "Risk Zone" was so high. RN 4 stated if Patient 9's "Total Bilirubin" was in the "High Risk" zone, the patient should have been seen/re-evaluated within 24 hours.

4. On June 10, 2013, the record for Patient 3 was reviewed. Patient 3 was admitted to the facility on June 9, 2013, at 2:50 a.m., with a diagnosis of term newborn infant.

The "Nursery Admission Orders" dated June 9, 2013, indicated "If large for gestational age (greater than 4000 gm [grams]) or small for gestational age (less than 2500 gm) or intra-uterine growth retardation, draw CBC [complete blood count], BMP [basic metabolic panel] and venous blood sugar at 2 hr [hours] of age."

Patient 3's weight at birth was 3290 grams.

The "Infant Maternal Data Record" dated June 9, 2013, indicated Patient 3 was a term infant and "AGA [Average for Gestational Age]."

A CBC, BMP and venous blood sugar were drawn from Patient 3 on June 9, 2013, at 5 a.m.

There was no indication in the record as to why the CBC, BMP and venous blood sugar were drawn from Patient 3.

A CBC was drawn from Patient 3 on June 9, 2013, at 2:20 p.m.

There was no physician's order for the CBC to be drawn and no indication in the record as to why the CBC was drawn from Patient 3 on June 9, 2013, at 2:20 p.m.

During an interview with the Director Obstetrical Services (DOS), on June 11, 2013, at 2:35 p.m., she reviewed the record and was unable to determine why the initial CBC, BMP and venous blood sugar were drawn based on the physician's order. In addition, the DOS stated there was no order for the second CBC. The DOS stated physician's orders should have been obtained prior to the laboratory tests being drawn or the test should not have been drawn if they were not ordered by the physician.

28294

Based on interview and record review, the facility failed to ensure an individualized plan of care was developed and maintained for one sampled patient (Patient 8) who developed hyperbilirubinemia (a condition of newborns when red blood cells break down causing an excess of bilirubin in the blood that can lead to severely disabling brain damage or death). This had the potential to result in a delay in care and treatment.

Findings:

On June 11, 2013, the record for Patient 8 was reviewed. Patient 8 was admitted to the facility on May 2, 2013, at 1:11 p.m.,with a diagnosis of newborn infant.

Patient 8's "Total Bilirubin" on May 4, 2013, at 5:15 a.m., was 12.1 milligrams per deciliter (mg/dL).

The "BiliTool (designed to help clinicians assess the risks toward the development of hyperbilirubinemia or "jaundice" in newborns)" used by the facility indicated Patient 8 was "High Intermediate Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 12.1 mg/dL at 40 hours of age.

The "Physicians Orders" dated May 4, 2013, at 11 a.m., indicated "Initiate double light phototherapy (treatment of hyperbilirubinemia through light exposure) for 6 hours. Recheck bilirubin. Update MD (with) results for further orders. Breastfeed on demand."

Patient 8's "Total Bilirubin" on May 4, 2013, at 6 p.m., was 14.8 mg/dL.

The "BiliTool" used by the facility indicated Patient 8 was "High Risk" for developing severe hyperbilirubinemia based on a "Total Bilirubin" of 14.8 mg/dL at 53 hours of age.

The "Physicians Orders" dated May 4, 2013, at 6:50 p.m., indicated "Re-start double phototherapy. Re draw baby Q (every) 12? (hours). Supplement after every breastfeeding with 15 ml (milliliters) - 20 ml of Enfamil."

During an interview with the Director Obstetrical Services (DOS) on June 11, 2013, at 2:35 p.m., she reviewed the record and was unable to find documentation of a plan of care being developed and maintained for Patient 8's hyperbilirubinemia. The DOS stated a plan of care should have been developed and maintained addressing Patient 8's hyperbilirubinemia.

The facility policy and procedure titled "Care Plans, Patient" last reviewed January 2011, revealed "... The Patient Care Plan will be based upon the data obtained by the RN (Registered Nurse) ... Goals shall be reflected in the Nursing documentation..."

28294

Based on observation, interview and record review, the facility failed to ensure regular insulin was available as part of the "Malignant Hyperthermia [life-threatening condition that is usually triggered by exposure to certain drugs used for general anesthesia] Cart Contents" per facility policy and procedure. This had the potential to result in the drug not being available during an emergency.

Findings:

On June 10, 2013, at 10:45 a.m., a tour of Surgical Services was conducted with RN 1.

In the medication refrigerator, an open vial of Humulin R (regular) insulin dated June 6, 2013, was observed in a container marked "For MH [Malignant Hyperthermia] Cart." There was no other insulin in the refrigerator.

During a concurrent interview with RN 1, she stated there should be two vials of Humulin R insulin in the refrigerator, one for general use and one in the container marked "For MH Cart." RN 1 stated the staff should not have used the one marked for the "MH Cart" but if the staff did so in an emergency, the staff should have immediately replaced the Humulin R insulin for the "MH Cart" with a new vial.

The facility policy and procedure titled "Malignant Hyperthermia" last reviewed September 2011, revealed "Malignant Hyperthermia Cart Contents - Regular insulin 100 units/ml (per milliliter) x (times) 1 refrigerated* - Surgery Medication Refrigerator - *Insulin kept refrigerated."

22384

Based on interview and record review, the facility failed to ensure the Director for Nutritional Services (DFNS) provided effective oversight of food services when the dietary staff failed to ensure the cooling process for potentially hazardous foods (PHF) was implemented. This failure could lead to food borne illness.

Findings:

A tour of the facility kitchen was conducted on June 10, 2013, at 11 a.m., with the Registered Dietician (RD) 1 and the DFNS.

A review of the facility document, "Food and Nutrition Services Hot Food Cooling Log," was conducted. At the bottom of the document the following was printed, "Cooling of hot foods is a two stage process:
Stage 1- hot food cooling starts from a temperature of greater than or equal to 140 degrees Fahrenheit and must be reduced to less than or equal to 70 degrees Fahrenheit within 2 hours.
Stage 2- In the next 4 hours the temperature must be reduced to less than or equal to 41 degrees. When the temperature is not achieved within the time frame, the food shall be discarded."

The following was documented on the Log:
May 12, 2013, "Eggs (boil)"- No time or temperature logged when the eggs were initially removed from the steamer.
May 22, 2013, "Eggs (boil)"- No time or temperature logged when the eggs were initially removed from the steamer.
May 25, 2013, "Egg Salad"- No documentation of the initial hot food cooling process of the eggs.
May 30, 2013, "Egg Salad"- No documentation of the initial hot food cooling process of the eggs.

A review of the facility procedure, "HACCP (Hazardous Analysis of Critical Control Point) Principals Of Safe Food Handling," (undated) was conducted. The procedure indicated, "document cooling temperatures if you are going to reuse foods; (140 degrees down to 70 degrees in two hours, 70 degrees to 41 degrees in the next 4 hours)."

An interview was conducted with the Lead Kitchen Staff (LKS) 1 on June 10, 2013, at 12:15 p.m. LKS 1 stated the process for monitoring egg cooking is as follows, place the eggs in the steamer, take the temperature, write the temperature down in the log. Cover the eggs with ice place the eggs in the walk in refrigerator. Take the temperature of the eggs again in 45 minutes to one hour. LKS 1 further stated the temperature monitoring process was not documented regarding the boiled eggs and the egg salad.

An interview was conducted with the DFNS on June 10, 2013, at 11:50 a.m., who stated more education with the staff has to be done regarding the cool down process.

22384

Based on observation and interview, the facility failed to ensure the frozen food items included in the Disaster Meal Plan were clearly labeled and readily accessible. This failure could result in a lack of food for medically fragile patients in the facility during a disaster.

Findings:

A tour of the facility's kitchen and storage areas was conducted on June 10, 2013, at 10:30 a.m., with the Director of Food and Nutritional Services (DFNS). A review of the three day "Emergency Disaster Menu (Reviewed 5/12)," was conducted. The menu included butter, macaroni and cheese, and pureed vegetables among other food items.

A concurrent interview was conducted with the DFNS who stated the butter, the macaroni and cheese, and vegetables included in the disaster menu were kept in the walk in refrigerator.

A tour of the walk in refrigerator was conducted with Cook 1 and the DFNS on June 10, 2013, at 10:45 a.m. The disaster food supply was not visible. Cook 1 was observed as he walked to the far left corner of the walk in refrigerator, knelt down, and while partially lying on the floor tile stretched out his arm in order to reach the far back corner of a food cart which was partially occluded by a second food cart, and stated the disaster foods were in this back corner.

Cook 1 then pulled out a box of butter, macaroni and cheese, and pureed green beans from the cart. The refrigerated items were labeled "disaster" on the end of each box. The labels were not visible until the items were pulled completely out of the cart.

The DFNS further stated the refrigerated disaster food items were difficult to access and not clearly marked.

28294

Based on observation, interview and record review, the facility failed:

1. To ensure surgical instruments were processed and sterilized per facility policies and procedures and in accordance with national standards of practice. This had the potential to result in surgical instruments not being sterilized appropriately following a surgical case.

2. To ensure food production practices and infection control practices were integrated as the infection control surveillance audits of food safety were not reported to the Director of Food and Nutrition Services (DFNS). This failure had the potential of promoting foodborne illness.

Findings:

1. On June 10, 2013, at 10 a.m., a tour of Surgical Services was conducted with Registered Nurse (RN) 1 and Sterile Processing Technician (SPT) 1.

The following hinged surgical instruments in "peel packs (see through packaging)" were observed to be closed and in the locked position:
- A "Long Right Angles" with a sticker indicating it had been processed on June 22, 2012.
- A "Basic Pack" with a sticker indicating it had been processed on October 5, 2012, and with no initials on the package to indicate who had processed the instruments.
- A "Packet of Tonsels" with a sticker indicating it had been processed on November 29, 2012, and with no initials on the package to indicate who had processed the instruments.
- A "Single Tenaculum" with a sticker indicating it had been processed on December 3, 2012, and with no initials on the package to indicate who had processed the instrument.
- A "Right Angles" with a sticker indicating it had been processed on March 27, 2013, and with no initials on the package to indicate who had processed the instrument.
- A Tonsil Clamp labeled as "Epidural" with a sticker indicating it had been processed on April 19, 2013, and with no initials on the package to indicate who had processed the instrument.
- A "Mayo/Pear Clamps" with a sticker indicating it had been processed on May 10, 2013, and with no initials on the package to indicate who had processed the instruments.
- A "Heaney Needle Holder" with a sticker indicating it had been processed on May 16, 2013, and with no initials on the package to indicate who had processed the instrument.
- A "Basic Pack" with no sticker indicating the date the instruments had been processed, and with no initials on the package to indicate who had processed the instruments.

During a concurrent interview with RN 1, she verified the instruments were in the closed and locked position. RN 1 stated the hinged surgical instruments should have been processed in the open and unlocked position, the packages should be labeled with the name of the instrument or the name of the "group" of instruments, the initials of the individual who processed the instruments should be on the "peel pack," and all processed packs should contain a sticker which indicated the date the package was processed.

The facility policy and procedure titled "Instrument Tray Assembly" last revised June 2012, revealed "... Each tray or pack is identified by name during the assembly process. A felt tip pen is used to write on a separate self-adhering label or sterilization tape and placed on the wrapper. ... A sticker reflecting the date sterilized and load number for that day ..."


The Association of Perioperative Registered Nurses (AORN) March 9, 2012:

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments.

Recommended Practices for Selection and Use of Packaging Systems for Sterilization

Recommendation VII - Packages to be sterilized should be labeled.
Packaging systems should be labeled before sterilization. The label information should include, but not be limited to, a description of the package contents, a method to identify the package assembler, and lot control number.



18918



22384

2. A tour of the facility kitchen was conducted on June 10, 2013, at 11 a.m., with the Registered Dietician (RD) 1 and the DFNS (Director for Nutritional Services).

A review of the facility document, "Food and Nutrition Services Hot Food Cooling Log," was conducted. At the bottom of the document the following was printed, "Cooling of hot foods is a two stage process:
Stage 1- hot food cooling starts from a temperature of greater than or equal to 140 degrees Fahrenheit and must be reduced to less than or equal to 70 degrees Fahrenheit within 2 hours.
Stage 2- In the next 4 hours the temperature must be reduced to less than or equal to 41 degrees. When the temperature is not achieved within the time frame, the food shall be discarded."

The following was noted in the Log:
May 12, 2013, "Eggs (boil)"- No time or temperature logged when the eggs were initially removed from the steamer.
May 22, 2013, "Eggs (boil)"- No time or temperature logged when the eggs were initially removed from the steamer.
May 25, 2013, "Egg Salad"- No documentation of the initial hot food cooling process of the eggs.
May 30, 2013, "Egg Salad"- No documentation of the initial hot food cooling process of the eggs.

A review of the facility procedure, "HACCP (Hazardous Analysis of Critical Control Point) Principals Of Safe Food Handling," (undated) was conducted. The procedure indicated, "document cooling temperatures if you are going to reuse foods; (140 degrees down to 70 degrees in two hours, 70 degrees to 41 degrees in the next 4 hours)."

An interview was conducted with the Infection Control Assistant (ICA), on June 11, at 2013, at 8:35 a.m. The ICA stated she toured the kitchen weekly and completed a Hazardous Analysis of Critical Control Points (HACCP). A review of the infection control weekly HACCP checklist was conducted and indicated;

April 16, 2013, "Cooling down Temperatures Log review some missing entries referred to supervisor."
May 15, 2013, "Cooling down temperatures log review OK." (Documentation found did not address the egg cool down temperature omission from May 12, 2013).
May 22, 2013, "Cooling down Temperatures Log review...Some food not properly according to log food discarded."

Concurrent interviews were conducted with the DFNS and RD 1 on June 11, 2013, at 8:45 a.m. The DFNS stated he was not made aware of issues the ICA found during her weekly HACCP tours of the kitchen. RD 1 stated she was not aware the Infection Control Department was doing weekly HACCP checks.

The ICA stated the HACCP checklist was then given to her Supervisor, the Infection Control Coordinator (ICC), and was not forwarded to, or reviewed with the DFNS. The ICA was told by the ICC that after the kitchen tours were done weekly for a couple of months they will then look to see if there were any trends and will proceed from there to determine what needed to be done.

The ICA further stated documentation on the weekly log needed to be more specific overall and indicate what food(s) were targeted during her review of the kitchen due to the potential for infection from food that was not safely cooled down.

Based on observation, interview and record review, the facility failed to ensure surgical instruments were processed and sterilized per facility policies and procedures and in accordance with national standards of practice. This had the potential to result in surgical instruments not being sterilized appropriately following a surgical case.

Findings:

On June 10, 2013, at 10 a.m., a tour of Surgical Services was conducted with Registered Nurse (RN) 1 and Sterile Processing Technician (SPT) 1.

The following hinged surgical instruments in "peel packs (see through packaging)" were observed to be closed and in the locked position:
- A "Long Right Angles" with a sticker indicating it had been processed on June 22, 2012.
- A "Basic Pack" with a sticker indicating it had been processed on October 5, 2012, and with no initials on the package to indicate who had processed the instruments.
- A "Packet of Tonsels" with a sticker indicating it had been processed on November 29, 2012, and with no initials on the package to indicate who had processed the instruments.
- A "Single Tenaculum" with a sticker indicating it had been processed on December 3, 2012, and with no initials on the package to indicate who had processed the instrument.
- A "Right Angles" with a sticker indicating it had been processed on March 27, 2013, and with no initials on the package to indicate who had processed the instrument.
- A Tonsil Clamp labeled as "Epidural" with a sticker indicating it had been processed on April 19, 2013, and with no initials on the package to indicate who had processed the instrument.
- A "Mayo/Pear Clamps" with a sticker indicating it had been processed on May 10, 2013, and with no initials on the package to indicate who had processed the instruments.
- A "Heaney Needle Holder" with a sticker indicating it had been processed on May 16, 2013, and with no initials on the package to indicate who had processed the instrument.
- A "Basic Pack" with no sticker indicating the date the instruments had been processed, and with no initials on the package to indicate who had processed the instruments.

During a concurrent interview with RN 1, she verified the instruments were in the closed and locked position. RN 1 stated the hinged surgical instruments should have been processed in the open and unlocked position, the packages should be labeled with the name of the instrument or the name of the "group" of instruments, the initials of the individual who processed the instruments should be on the "peel pack," and all processed packs should contain a sticker which indicated the date the package was processed.

The facility policy and procedure titled "Instrument Tray Assembly" last revised June 2012, revealed "... Each tray or pack is identified by name during the assembly process. A felt tip pen is used to write on a separate self-adhering label or sterilization tape and placed on the wrapper. ... A sticker reflecting the date sterilized and load number for that day ..."


The Association of Perioperative Registered Nurses (AORN) March 9, 2012:

Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment

XII.c.1. Instruments should be kept in the open and unlocked position using instrument stringers, racks, or instrument pegs designed to contain instruments.

Recommended Practices for Selection and Use of Packaging Systems for Sterilization

Recommendation VII - Packages to be sterilized should be labeled.
Packaging systems should be labeled before sterilization. The label information should include, but not be limited to, a description of the package contents, a method to identify the package assembler, and lot control number.