HospitalInspections.org

Based on observation, review of policy and procedures and interview with staff, in 2 of 2 staff (A and B) interviewed, the facility failed to ensure safe injection practices to prevent potential cross contamination.

Findings include:

Facility policy titled 8.17 Medication Administration, dated 5/1/09, does not include reference to one syringe-one patient.

APIC (Association for Professionals in Infection Control and Epidemiology) position paper dated 2010 advises to a standard of practice of one syringe for one patient.

Per surveyor 18816 interview with RN A on 8/6/10 at 1:00 PM she confirmed a syringe used on Pt #1 was also used on Pt #2. Per RN A on 7/26/10, while in the Block Room (BR), she dosed Pt #1 with a bolus of Fentanyl (pain medication) 50 mcg (micrograms) from a needleless syringe containing 100 mcg of Fentanyl, into the stop cock of the IV (intravenous tubing). RN A stated she usually places a pt name label on the syringe and then places the syringe in a baggie to be disposed of in pharmacy. RN A stated she does not remember exactly what she did with the syringe, but stated she was called to an Operating Room to assist staff.

RN A stated, when she returned to the BR, RA B was finishing giving a Fentanyl 50 mcg bolus dose to Pt #2 and asked her when did pharmacy change the doses in the syringe. RN A said she looked in the baggie of used syringes and noticed the one she used on Pt #1 was not in the baggie, and the syringe used for Pt #2 did not have a pt label.

Interview with RA B on 8/9/10 at 2:15 PM revealed he removed a syringe of Fentanyl from the clean medication box, noted the red cap was on the syringe and the red ring was still attached. RA B stated he did not have to break the seal, but since the syringe was in the box, assumed it was clean and available for use. RA B said he noted there was 50 mcg in the syringe, although he knew it usually would have 100 mcg of Fentanyl.

Per surveyor 18816 observation on 8/9/10 at 11:30 AM, the Pharmacy Department prepares Fentanyl in 100 mcg syringes. The syringes are clearly labeled "Fentanyl 50/mcg/ml (milligrams)". The syringe observed had a red barrel cap that has a three prong breakaway ring that remains on the syringe, indicating the syringe is opened.

Per RN A on 8/9/10 at 11:30 AM, the syringes come in 2 ml doses, totaling 100 mcg, and staff must twist and/or pull the red barrel cap off the syringe to break the seal. RN A added during the interview, the ring remaining on the syringe is no indication the syringe is safe to use.

Based on observation, review of medical records, review of policy and procedures, review of facility documents, and interview with staff, in 2 of 2 staff (A and B) interviewed, the facility failed to ensure staff followed policy to ensure the safety of patients regarding administration of medications.

Findings include:

In 2 of 2 staff, the facility failed to ensure staff follow safe injection practices regarding the use of one syringe for one patient. See tag A404.

In 1 of 1 staff, the facility failed to ensure reconciliation of narcotics includes review of administration and waste per patient. See tag A494.

In 2 of 2 staff, the facility failed to ensure policy is followed regarding used syringes. See tag A505.

In 1 of 1 staff, the facility failed to ensure the correct documentation and procedure of wasting syringes containing narcotics is followed. See tag A505.

In 1 of 1 staff, the facility failed to report medication errors per policy. See tag 508.

The cumulative affect of the above failures results in potential harm to all patients at the facility.

Based on observation, review of policy and procedures, facility documents and interview with staff, in 1 of 1 staff (D) interviewed, the facility failed to ensure the narcotic reconciliation process would identify inaccurate documentation of narcotic use and the return of an accurate number of syringes used.

Findings include:

Facility policy titled Controlled Substances-OSC (Outpatient Surgery Center) and AFCH OR (American Family Children's Hospital Operating Room) Procedures #7.11, revised 3/10, states under IV.A.4. "As drugs are used during the case, the AP will record the appropriate information on the pink and yellow copies of the sign-out sheet including patient name, MR#, amount used, and amount to be wasted." Under IV.A.6. "Medications requiring wasting will be labeled with drug name and concentration, drawn up into a syringe, placed in a second (provided) separate bag with the yellow copy of sign out sheet, and dropped into the locked CS waste medication box (mounted on wall)." Under IV.B.4. "The Central Pharmacist will compare the returned waste with corresponding waste documentation to validate accuracy of waste documentation." Under IV.C.1. "The PT (pharmacy technician) will reconcile with white, pink and yellow copies of the CS (controlled substance) Sign Out Sheet ensuring that there is a complete accounting of the controlled substances issue to the AP (Anesthesia Provider). a. The amount received by the AP must equal the sum of the amount administered, returned and wasted."

The policy does not contain instruction to place a patient name label on the used syringe as stated by RN A who does so as her current practice. Per interview on 8/9/10 at 11:30 AM with DSS G, and confirmed with 8/9/10 interviews of staff L at 11:35 AM, N at 11:55 AM and O at 12:05 PM, patient labels are not placed on used syringes.

Facility policy titled Storage, Handling, Security and Disposition of Medications #1.43, effective 1/2008, states under V.b.xi.b.ii. "All controlled substance removed from their original tamper-proof package or protective plastic over-wrap, and /or not suitable for use with another patient must be wasted and documented as waste by two licensed nurse/practitioners...The dose actually administered to the patient must be documented on the emir (medication record), but waste should only be documented in AcuDose or on the appropriate controlled substance proof-of-use record in areas without AcuDose."

The OSC CS dated 7/26/10 revealed there were 15 syringes of Fentanyl 100 mcg (micrograms), a total 1500 mcg, issued for use in the Block Room.

The record sheet indicated Pt #1 was administered Fentanyl 50 mcg and the waste column has a number scribbled out and a zero waste is noted.

The record indicates Pt #2 was administered Fentanyl 50 mcg (a partial dose of a full syringe) and there is zero waste noted.

There were four other Pts listed receiving Fentanyl that day. They received full doses of 100 mcg, and the form documented no waste, or they received a partial dose and there was corresponding waste for the remaining Fentanyl in the syringe.

The pharmacy reconciled the sign out sheet identifying that the total Fentanyl administered was 650 mcg, total wasted Fentanyl is 50 mcg and the amount of Fentanyl returned unused was 800 mcg. This reconciliation accurately totals 1500 mcg. of Fentanyl.

Per facility policies noted above for each Pt #1 and 2, the records should have indicated that 50 mcg of Fentanyl was used and 50 mcg of Fentanyl was waste. For each Pt #1 and 2, there should have been one partially filled syringe returned to pharmacy for each pt. If this had been done accurately, the pharmacy would have then received 3 partial syringes for waste and 7 unused syringes; for a total of 10 syringes returned to pharmacy.

The pharmacy reconciliation process in this case did not capture the inaccurate documentation or the inaccurate number of syringes returned.

Per interview with P D on 8/6/10 at 2:40 PM, reviewing the OSC CS sheet, P D stated the reconciliation only involves the number of syringes returned compared to the number administered. P D said they do not reconcile the number of Pts receiving medications and the number of syringes used, adding sometimes staff will divide a syringe between two syringes for two separate Pts.

Per follow-up interview with RN A on 8/6/10 at 3:00 PM, no one in the BR divides syringe doses into two syringes.

Based on observation, review of medical records, review of policy and procedures, and interview with staff, in 2 of 2 staff (A and B) interviewed, the facility failed to ensure policies are followed regarding the use of used syringes containing medications.

Findings include:

Facility policy titled Controlled Sub.-Ambulatory Room Operating Rm. Procedures #7.11, effective 3/1/2010, states under IV.A.4. "As drugs are used during the case, the AP (Anesthesia Provider) will record the appropriate information on the pink and yellow copies of the sign-out sheet (CS) including patient name, MR#, amount used, and amount to be wasted." Under IV.A.6. "Medications requiring wasting will be labeled with drug name and concentration, drawn up into a syringe, placed in a second (provided) separate bag with the yellow copy of sign out sheet, and dropped into the locked CS (controlled substance) waste medication box (mounted on wall). "

Per interview on 8/9/10 at 11:30 AM with DSS G, and confirmed with 8/9/10 interviews of staff L at 11:35 AM, N at 11:55 AM, and O at 12:05 PM, patient labels are not placed on used syringes.

Facility policy titled Storage, Handling, Security and Disposition of Medications #1.42, effective 1/2008, states under V.b.xi.b.ii. "All controlled substance removed from their original tamper-proof package or protective plastic over-wrap, and /or not suitable for use with another patient must be wasted and documented as waste by two licensed nurse/practitioners. The dose actually administered to the patient must be documented on the emir (medication record), but waste should only be documented in AcuDose or on the appropriate controlled substance proof-of-use record in areas without AcuDose."

Per surveyor 18816 observation on 8/9/10 at 11:30 AM, the Pharmacy Department will prepare Fentanyl in 100 mcg syringes. The syringes are clearly labeled "Fentanyl 50/mcg/ml (milligrams)". The syringe observed had a red barrel cap that has a three prong breakaway ring, that remains on the syringe, indicating the syringe is opened. Per RN A on 8/9/10 at 11:30 AM, the syringes come in 2 ml doses, and staff must twist and/or pull the red barrel cap off the syringe to break the seal; adding, the ring remaining on the syringe is no indication the syringe is safe to use.

Per surveyor 18816 interview with RN A on 8/6/10 at 1:00 PM she confirmed a syringe used on Pt #1 was also used on Pt #2. Per RN A on 7/26/10, while in the Block Room (BR), she dosed Pt #1 with a bolus of Fentanyl (pain medication) 50 mcg (micrograms) from a needleless syringe containing 100 mcg of Fentanyl, into the stop cock of the IV (intravenous tubing). RN A stated she usually places a pt name label on the syringe and then places the syringe in a baggie to be disposed of in pharmacy. RN A stated she does not remember exactly what she did with the syringe, but stated she was called to an Operating Room to assist staff.

RN A stated, when she returned to the BR, RA B was finishing giving a Fentanyl 50 mcg bolus dose to Pt #2 and asked her when did pharmacy change the dose in the syringe. RN A said she looked in the baggie of used syringes and noticed the one she used on Pt #1 was not in the baggie, and the syringe used for Pt #2 did not have a pt label.

Interview with RA B on 8/9/10 at 2:15 PM revealed he removed a syringe of Fentanyl from the clean medication box, noted the red cap was on the syringe and the red ring was still attached to the syringe. RA B stated he did not have to break the seal, but since the syringe was in the clean box, assumed it was clean and available for use. RA B said he noted there was 50 mcg in the syringe, although he knew it usually would have 100 mcg of Fentanyl.

Pt #1's MR reviewed by surveyor 18816, on 8/6/10 at approximately 1:00 PM, revealed Pt #1 was given, via IV, Fentanyl 50 mcg at 8:50 AM by RN A. This is confirmed in interview with MD K on 8/6/10 at 1:00 PM.

Pt #2's MR reviewed on 8/6/10 at approximately 1:10 PM revealed Pt #2 was given, via IV, Fentanyl 50 mcg at 12:33 PM by RA B. This is confirmed in interview with MD K on 8/6/10 at 1:00 PM.

Per surveyor 18816 interview with RN A on 8/6/10 at 1:00 PM she confirmed a syringe used on Pt #1 was also used on Pt #2.

Based on review of incidents reports, review of policy and procedures and interview with staff, in 1 of 1 staff (A) interviewed, the facility failed to ensure incident reports are completed timely per policy.

Findings include:

Facility policy titled 4.22 Event Reporting, effective 7/1/2008, states under IV. A. "Identification of an event. 1. Any employee suspecting an actual or potential events that resulted in, or had the potential to result in harm to a patient or visitor, should report the event electronically via Patient Safety Net (PSN). 2. Whenever possible events should be reported within 24 hours of the event."

Per surveyor 18816 review of incident report #71457 on 8/9/10 at 9:00 AM, reflects the incident of a syringe used on Pt #1 on 7/26/10 at 8:50 AM, to administer Fentanyl (anesthesia medication) also used on Pt #2 on 7/26/10 at 12:35 PM, was not reported until 7/28/10 at 3:22 PM, contrary to timeline established in policy.

Per interview with RN A on 8/6/10 at 1:00 PM, RN A stated she thought she completed the incident report on 7/28; adding she was too busy to compete it sooner.