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Based on observation, interview and record review, the Governing Body of the hospital failed to ensure the pharmacy services performed under contract (Pharmacy 1) followed USP<797> for the compounding (mixing) of the drug, 6mix Gati-Lid-Phen-Trop-Flur-Cycl (compounded preparation of 6 drugs). The hospital failed to demonstrate Pharmacy 1 followed USP<797> prior to signing the pharmacy services agreement. The hospital failed to provide documented support for the Beyond Use Date assigned to the medication compounded by Pharmacy 1.

These failures resulted in approximately 992 patients, over the past year, to be exposed to sterile eye drops that were not compounded to meet all the standards of USP<797>.

Findings:

During a concurrent observation and record review, on 8/7/17 at 10:40 am, in the pre-operative area (area dedicated to prepping patients prior to surgery), the medication refrigerator was identified. Inspection of the refrigerator showed it contained a bag of medication syringes. Inspection of the syringe label showed, "Pharmacy 1...8/3/17...6mix Gati-Lid-Phen-Trop-Flur-Cycl ...For office use at [hospital] 8/10/17...Date made 8/3/2017...Lot#08032017@15...Refrigerate...Rx# 140609...BUD 8/12/17 (nine days)...For the Eye."

During an interview, on 8/7/17 at 2 pm, Pharmacist in Charge (PIC) was requested to describe the hospital's relationship with Pharmacy 1. Her description included that Pharmacy 1 compounded sterile medications for the hospital. She further stated that Pharmacy 1 had provided compounded sterile medications for greater than 1 year. PIC was requested to provide the stability data supporting the assignment of a nine day BUD to Lot#08032017@15.

During an interview, on 8/9/17 at 10:15 am, PIC was requested to describe the hospital's expectations for the compounding of sterile IV medications. Her description included that the hospital followed USP<797>.

During an interview, on 8/10/17 at 8 am, PIC was requested to provide the hospital's records, for the past year, for the purchase of sterile compounded eye drops from Pharmacy 1c. She was also requested to provide the number of patients who had received compounded eye drops from Pharmacy 1.

During an interview, on 8/10/17 at 12:46, PIC stated the hospital did not have documentation showing Lot#08032017@15 was stabile for the assigned BUD (nine days). In addition, PIC stated the hospital administered 6mix Gati-Lid-Phen-Trop-Flur-Cycl eye drops to 992 patients in the past year.

An administrative record review, of the hospital's policy and procedure for Outside Compounding Pharmacy Agreement (PH.014, Approved by Board: 19-Jul-16) showed, Procedure:, The following procedure must be completed prior to using an outside compounding pharmacy and reviewed by the pharmacy consultant:, 1. "The Outsourcing Sterile Products Preparation Contractor Assessment Tool must be completed on line at http:www.ashpfoundation.org/sterileproductstool, provided by the American Society of Health-System Pharmacists (ASHP)."

A review of the American Society of Health-System Pharmacists (professional association of pharmacists to improve medication use and enhance patient safety) website at
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines-compounding-sterile-preparations.ashx?la=en&hash=9C5A38163C607EDBFCF620F4B8E25D12A2F1C441 showed,
ASHP Guidelines on Compounding Sterile Preparations (Approved by the ASHP Board of Directors on June 2, 2013), Other Compounding-Related Guidelines, "ASHP provides several guidelines for safe compounding practices and a discussion guide on USP chapter 797 and has recognized USP chapter 797 as a relevant practice standard in the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals."

The United States Pharmacopeia Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING (mixed)-STERILE (germ free) PREPARATIONS (CSP) documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." [Adherence to these practice and quality standards allows the hospital to assign beyond use dates (date beyond which a CSP cannot be started) to CSPs as described in USP <797>.]

An administrative record review, of the 2017 USP Compounding Compendium, Current with USP 40-NF 35 (Feb 2017, page 41) showed, Responsibility of Compounding Personnel, "Compounding supervisors shall ensure, through either direct measurement or appropriate information sources, that specific CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% if not specified, until their BUDs."

Based on observation, interview, and record review, the hospital failed to ensure the collection and analysis of quality assurance (maintenance of quality) indicators (data) from Pharmacy 1. The hospital had a contract with Pharmacy 1 for the sterile (germ free) compounding (mixing) of medications. Pharmacy 1 provided sterile compounded 6mix Gati-Lid-Phen-Trop-Flur-Cycl (compounded mixture of 6 drugs) eye drops to the hospital for the past year. The hospital did not collect and analyze quality assurance data to ensure the 6mix Gati-Lid-Phen-Trop-Flur-Cycl eye drops were safe and effective.

These failures resulted in the potential for approximately 992 patients, over the past year, to be exposed to medications that were not compounded to meet all the standards of USP<797>.

Findings:

During a concurrent tour and record review, on 8/7/17 at 10:40 am, in preop (pre-operative area or before surgery), the medication refrigerator was identified. Inspection of the refrigerator showed it contained a bag of medication syringes. Inspection of the syringe label showed, "Pharmacy 1...8/3/17...6mix Gati-Lid-Phen-Trop-Flur-Cycl...For office use as [hospital] 8/10/17...Date made 8/3/2017...Lot#08032017@15...Refrigerate...Rx# 140609...BUD 8/12/17 (nine days)...For the Eye."

During an interview, on 8/7/17 at 2 pm, Pharmacist in Charge (PIC) was requested to describe the hospital's relationship with Pharmacy 1. Her description included that Pharmacy 1 compounded sterile medications for the hospital. She further stated that Pharmacy 1 had provided compounded sterile medications for greater than 1 year. PIC was requested to provide the stability data supporting the assignment of a nine day BUD to Lot#08032017@15.

During an interview, on 8/9/17 at 10:15 am, PIC was requested to describe the hospital's expectations for the compounding of sterile medications. Her description included that the hospital followed USP<797>.

During a group interview, on 8/9/17 at 3:20 pm, Chief Nursing Officer (CNO) and Director of Risk (Dir 1) were asked to describe the quality assurance data that was used to monitor the performance of Pharmacy 1 to meet the hospital's requirements for compounding of sterile medications. DON and Dir 1's description did not include Pharmacy 1's quality assurance data was reviewed to monitor the provision of sterile compounding pharmacy services.

During an interview, on 8/10/17 at 8 am, PIC was requested to provide the hospital's records for the purchasing of sterile compounded eye drops from Pharmacy 1. PIC was also requested to provide the number of patients who had received compounded eye drops from Pharmacy 1.

During an interview, on 8/10/17 at 12:46 pm, PIC stated the hospital did not have documentation showing Lot#08032017@15 was stabile for the assigned BUD (nine days). In addition, PIC stated the hospital administered 6mix Gati-Lid-Phen-Trop-Flur-Cycl eye drops to 992 patients in the past year.

A review of the American Society of Health-System Pharmacists (professional association of pharmacists to improve medication use and enhance patient safety) website at
https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines-compounding-sterile-preparations.ashx?la=en&hash=9C5A38163C607EDBFCF620F4B8E25D12A2F1C441 showed,
ASHP Guidelines on Compounding Sterile Preparations (Approved by the ASHP Board of Directors on June 2, 2013), Other Compounding-Related Guidelines, "ASHP provides several guidelines for safe compounding practices and a discussion guide on USP chapter 797 and has recognized USP chapter 797 as a relevant practice standard in the ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals."

The United States Pharmacopeia Convention (USP) is a scientific nonprofit organization that sets standards for the quality, purity, identity, and strength of medicines. USP's drug standards are enforceable in the United States by the Food and Drug Administration and are published in the United States Pharmacopeia/National Formulary (USP 35/NF 30). The USP revised general chapter <797> entitled PHARMACEUTICAL COMPOUNDING (mixed)-STERILE (germ free) PREPARATIONS (CSP) documents in the Introduction that "The objective of this chapter is to describe conditions and practices to prevent harm, including death, to patients that could result from (1) microbial contamination (nonsterility), (2) excessive bacterial toxins..." [Adherence to these practice and quality standards allows the hospital to assign beyond use dates (date beyond which a CSP cannot be started) to CSPs as described in USP <797>.]

An administrative record review, of the 2017 USP Compounding Compendium, Current with USP 40-NF 35 (Feb 2017, page 41) showed, Responsibility of Compounding Personnel, "Compounding supervisors shall ensure, through either direct measurement or appropriate information sources, that specific CSPs maintain their labeled strength within monograph limits for USP articles, or within 10% if not specified, until their BUDs."

A review of the American Society of Health-System Pharmacists website at https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines-outsourcing-sterile-compounding-services.ashx?la=en&hash=41D91905261CDE5983EE0AB5630B5366E7053BAA showed, ASHP Guidelines on Outsourcing Sterile Compounding Services (2015), Handling Performance or Quality Issues, "The contractor should provide the healthcare organization with information at least quarterly on its compliance with contract requirements and other information needed for the organization's quality-assurance programs."

Based on observation, interview, and record review, the hospital failed to ensure the safe administration of medications as evidenced by:

1. Six of eight patients (Patients 10, 11, 20, 27, 28 and 29) in the Surgical Nursing Unit (SNU) were administered patient's own medication without the benefit and contrary to the hospital policy for a pharmacist to identify and visually evaluate the integrity of the medication prior to administration. The patients' own medications were not labeled to show they were checked by a pharmacist. This failure resulted in the potential for patients to be exposed to avoidable medication errors.

2. Five fentanyl (narcotic pain reliever) patch patients (Patients 25, 26, 32, 33 and 34) did not meet the prior daily usage requirement of 60 milligram (mg) of morphine (narcotic) (or equivalent) before administration of the drug in accordance with hospital policy and guidelines issued by the Institute for Safe Medication Practices (ISMP). The hospital did not document the total daily dose of opioids (narcotic) for the previous 7 days before administration of a fentanyl patch. This failure resulted in the potential for patients to be exposed to the adverse effects of a fentanyl patch (respiratory depression, depressed breathing).

3. Sedation scores (measurement of wakefulness) were not documented for five fentanyl (narcotic pain reliever) patch patients (Patients 25, 26, 32, 33 and 34) in accordance with hospital policy. The hospital did not document the sedation scores for each of the five patients. This failure resulted in the potential for patients to be exposed to the adverse effects of a fentanyl patch (respiratory depression, depressed breathing).

4. A fentanyl (narcotic pain reliever) patch was ordered only by using the PO.0040 Fentanyl Duragesic (fentanyl) Patch Order.pdf (order form) in accordance with hospital policy. The hospital administered a fentanyl patch to five patients (Patients 25, 26, 32, 33 and 34). The PO.0040 Fentanyl Duragesic Patch Order.pdf was not used to order a patch on the five patients. This failure resulted in the potential for patients to be exposed to the adverse effects of a fentanyl patch (respiratory depression, depressed breathing).

Findings:

1. During a concurrent observation, interview, and medical record review, on 8/9/17 at 8:15 am, in SNU, Registered Nurse (RN) 1 stated she was preparing medications for Patient 11. Inspection of the medications showed niacin (vitamin medication) 750 mg (milligram) tablet. The niacin tablet was taken from Patient 11's own medication supply (brought in from home). RN 1 proceeded into Patient 11's room and administered his niacin tablet.

During a concurrent observation, interview, and medical record review, on 8/9/17 at 8:45 am, in SNU, RN 1 stated she was preparing medications for Patient 20. Inspection of the medications showed galantamine (medication for Alzheimers) 8 mg capsules. The galantamine was taken from Patient 20's own medication supply. RN 1 proceeded into Patient 20's room and administered his galantamine capsule.

During a concurrent observation, interview, and medical record review, on 8/9/17 at 9 am, in SNU, Pharmacist in Charge (PIC) identified Patient 11's niacin container and Patient 20's galantamine container. Inspection of the two containers did not show documentation the medications were approved by the hospital's pharmacist for administration to the patients. PIC inspected the prescription containers and acknowledged they did not show documentation they were approved by the hospital's pharmacist for administration to each patient.

During a concurrent observation, interview, and medical record review, on 8/9/17 at 9:10 am, PIC identified 6, out of the hospital's SNU census of 8, patients who were receiving medications that were brought into the hospital from home. PIC identified Patient 27's Premarin (estrogen medication) 1.25 mg tablet, Patient 29's Atorvastatin (cholesterol lowering medication) 80 mg tablet, Patient 10's erythromycin (antibiotic medication ) 250 mg tablet, and Patient 28's Bystolic (medication to treat high blood pressure) 10 mg tablet, as medications brought from home. Inspection of each patient's medication container did not show documentation they were approved by the hospital's pharmacist for administration. PIC inspected each container and acknowledged they were not labeled as approved by a pharmacist for administration.

An administrative record review, of the hospital's policy and procedure for Patient's own Medication Usage and Self Administration (PH.026, Revision Date: 1-Mar-16) showed, Policy:, A. "If it is necessary for a patient to continue therapy on a medication that is not normally available from the pharmacy (i.e., a non-formulary drug), the patient's own supply may be used provided each of the conditions below are met: ..iii. A pharmacist must identify the medication and visually evaluate the medication's integrity before use or administration of a patient's own medication.)

2. During a concurrent interview and medical record review, on 8/8/16 at 8:25 am, Pharmacist in Charge (PIC) identified Patient 32's electronic (computer) medical record (EMR). Review of the EMR showed Patient 32 was admitted on 7/5/16. Further review showed a physician's order, dated 7/5/16 at 22:24 (10:24 pm), for NF-fentaNYL Transdermal (TD, skin) Patch 50MCG (microgram)/HRS (hour) every 72 HRS. The hospital dispensed and applied the first patch on 7/6/17 at 08:30 (8:30 am). Continued review of the EMR for Patient 32 showed a nurse's note, dated 7/5/17 at 1916 (7:15 pm), "Pt has fentanyl patch (patient's own medication) to right abd (abdomen) states needs to be changed in the morning at 9 am ..." Further review did not show documentation of the strength of the patient's own fentanyl patch. PIC reviewed the EMR and stated the expectation was for the strength of the medication patch to be documented.

During a concurrent interview and medical record review, on 8/8/17 at 11:10 am, PIC identified Patient 26's EMR. Review of the EMR showed Patient 26 was admitted on 2/28/17. Further review showed a physician's order, dated 2/28/17 at 08:45 (8:45am), for NF-Fentanyl 50MG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 3/1/17 at 20:04 (10:04 pm). Review of the EMR did not show documentation of a pre-existing (patient's own medication) patch before 3/1/17 at 20:04. Registered Nurse (RN 2) and PIC reviewed the EMR and acknowledged the medical record did not document a pre-existing patch before 3/1/17 at 20:04.

During a concurrent interview and medical record review, on 8/8/17 at 3 pm, PIC identified Patient 25's EMR. Review of the EMR showed Patient 25 was admitted on 4/27/17. Further review showed a physician's order, dated 4/27/17 at 10 am, for NF-Fentanyl 50MCG/HR TD Patch every 72 hours. The hospital dispensed and applied the first patch on 4/28/17 at 08:55 (8:55 am). Review of the EMR did not show documentation of the strength of the patient's own fentanyl patch. RN 2 and PIC reviewed the EMR and acknowledged it did not document the strength of a pre-existing patch before 4/28/17 at 08:55.

During a concurrent interview and medical record review, on 8/8/17 at 3:05 pm, PIC identified Patient 33's EMR. Review of the EMR showed Patient 33 was admitted on 12/7/16. Further review showed a physician's order, dated 12/7/16 at 11:41 am, for NF-Fentanyl 25MCG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 12/7/16 at 18:07 (6:07 pm). Review of the EMR did not show documentation Patient 33 received an equivalent dose of narcotic equal to 60 mg of morphine by mouth daily for a week or longer prior to the fentanyl administration. PIC reviewed the EMR and acknowledged the medical record did not document the amount of narcotic Patient 33 received each day for the 7 days preceding 12/7/16 at 18:07.

During a concurrent interview and medical record review, on 8/8/17 at 3:45 pm, PIC identified Patient 34's EMR. Review of the EMR showed PIC was admitted on 7/11/16. Further review showed a physician's order, dated 7/13/16 21:01 (9:01 pm), for NF-Fentanyl TD System 75MCG/HR every 72 HRS. The hospital dispensed and applied the first patch on 7/13/16 at 21:11 (9:11 pm). Further review did not show documentation of the strength of the patient's own fentanyl patch, prior to 7/13/16 at 21:11. RN 2 and PIC reviewed the EMR and acknowledged the medical record for Patient 34 did not document the strength of a pre-existing patch before 7/13/16 at 21:11.

An administrative record review, of the Institute for Safe Medication Practices (ISMP) website at http://www.ismp.org/Newsletters/acutecare/articles/20070628.asp showed Acute Care, ISMP Medication Safety Alert!, Ongoing, Preventable Fatal Events with Fentanyl Transdermal Patches are Alarming! (June 28, 2007 issue), Indication, "Fentanyl patches should ONLY be used to manage persistent, moderate to severe chronic pain that requires continuous, around-the-clock opiate administration for an extended period of time...Transdermal fentanyl should ONLY be used in patients who are already tolerant to opiate therapy, and who require a total daily dose of other opiates at least equivalent to a 25 mcg per hour fentanyl patch. Patients who are considered opiate-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily ... (or an equianalgesic [an equivalent amount for the same pain relief] dose of another opiate)."

An administrative record review, of the hospital's policy and procedure for Fentanyl Transdermal Patch (PN.048, Approved by Board: 19-Jul-16) showed, Supportive Data, 3. Contraindications to use due to risk of serious or life-threatening respiratory depression:, a. "Patients who are not opioid tolerant (opioid tolerant=patient has been taking another opioid at a dose comparable to a transdermal fentanyl patch for at least seven (7) days)."

3. During a concurrent interview and medical record review, on 8/8/16 at 8:25 am, Pharmacist in Charge (PIC) identified Patient 32's electronic (computer) medical record (EMR). Review of the EMR showed Patient 32 was admitted on 7/5/16. Further review showed physician's order, dated 7/5/16 at 22:24 (10:24 pm), for NF-fentaNYL (narcotic pain reliever) Transdermal (TD, skin) Patch 50MCG (microgram)/HRS (hours) every 72 HRS. The hospital dispensed and applied the first patch on 7/6/17 at 08:30 (8:30 am). Continued review showed a nurse's note, dated 7/5/16 at 1916 (7:16 pm), "Pt has fentanyl patch (patient's own medication) to right abd (abdomen) states needs to be changed in the morning at 9 am..." Further review did not show documentation of patient's sedation scale (score to measure wakefulness). PIC and Registered Nurse (RN 2) reviewed the EMR and acknowledged the medical record for Patient 32 did not document the patient's sedation scale. PIC stated it was her expectation that sedation scores were monitored and documented for a patient that had received a fentanyl patch.

During a concurrent interview and medical record review, on 8/8/17 at 11:10 am, PIC identified Patient 26's EMR. Review of the EMR showed Patient 26 was admitted on 2/28/17. Further review showed a physician's order, dated 2/28/17 at 08:45 (8:45 am), for NF-Fentanyl 50MG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 3/1/17 at 20:04 (10:04 pm). Review of the EMR did not show documentation of a pre-existing (patient's own medication) patch before 3/1/17 at 20:04. Further review did not show documentation of the patient's sedation scale. PIC and RN 2 reviewed the EMR and acknowledged the medical record for Patient 26 did not document the patient's sedation scale. PIC stated it was her expectation that sedation scores were monitored and documented for a patient that had received a fentanyl patch.

During a concurrent interview and medical record review, on 8/8/17 at 3 pm, PIC identified Patient 25's EMR. Review of the EMR showed Patient 25 was admitted on 4/27/17. Further review showed a physician's order, dated 4/27/17 at 10 am, for NF-Fentanyl 50MCG/HR TD Patch every 72 hours. The hospital dispensed and applied the first patch on 4/28/17 at 08:55 (8:55 am). Review of the EMR did not show documentation of the strength of the patient's own fentanyl patch. Further review did not show documentation of the patient's sedation scale. PIC and RN 2 reviewed the EMR and acknowledged the medical record for Patient 25 did not document the patient's sedation scale. PIC stated it was her expectation that sedation scores were monitored and documented for a patient that had received a fentanyl patch.

During a concurrent interview and medical record review, on 8/8/17 at 3:05 pm, PIC identified Patient 33 EMR, Review of the EMR showed Patient 33 was admitted on 12/7/16. Further review showed a physician's order, dated 12/7/16 at 11:41am, for NF-Fentanyl 25MCG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 12/7/16 at 18:07 (6:07 pm). Review of the EMR did not show documentation Patient 33 received an equivalent dose of narcotic equal to 60 mg of morphine by mouth. Further review did not show documentation of the patient's sedation scale. PIC and RN 2 reviewed the EMR and acknowledged the medical record for Patient 33 did not document the patient's sedation scale. PIC stated it was her expectation that sedation scores were monitored and documented for a patient that had received a fentanyl patch.

During a concurrent interview and medical record review, on 8/8/17 at 3:45 pm, PIC identified Patient 34's EMR. Review of the EMR showed Patient 34 was admitted on 7/11/16. Further review showed a physician's order, dated 7/13/16 21:01 (9:01 pm), for NF-Fentanyl TD System 75MCG/HR every 72 HRS. The hospital dispensed and applied the first patch on 7/13/16 at 21:11 (9:11 pm). Further review did not show documentation of the patient's sedation scale. PIC and RN 2 reviewed the EMR and acknowledged the medical record for Patient 34 did not document the patient's sedation scale. PIC stated it was her expectation that sedation scores were monitored and documented for a patient that had received a fentanyl patch.

An administrative record review, of the hospital's policy and procedure for Fentanyl Transdermal Patch (PN.048, Approved by Board: 19-Jul-16) showed, Attachment A, Fentanyl Duragesic Patch Order, 5. Monitoring, "Sedation scale; 0=Awake, conversant, 1=Normal, sleep, 2=Drowsy, easy to arouse, 3=Somnolent, difficult to arouse, 4=Unarousable..."

4. During a concurrent interview and medical record review, on 8/8/16 at 8:25 am, Pharmacist in Charge (PIC) identified Patient 32's electronic (computer) medical record (EMR). Review of the EMR showed Patient 32 was admitted on 7/5/16. Further review showed physician's order, dated 7/5/16 at 22:24 (10:24 pm), for NF-fentaNYL Transdermal (skin) Patch 50MCG (microgram)/HRS (hours) every 72 HRS. The hospital dispensed and applied the first patch on 7/6/17 at 08:30 (8:30 am). Further review did not show the patient's fentanyl patch was ordered by the physician using the hospital's PO.0040 Fentanyl Duragesic Patch Order.pdf (electronic form). PIC reviewed the EMR and acknowledged the medical record for Patient 32 did not contain a fentanyl patch order using the fentanyl Duragesic patch order form.

During a concurrent interview and medical record review, on 8/8/17 at 11:10 am, PIC identified Patient 26's EMR. Review of the EMR showed Patient 26 was admitted on 2/28/17. Further review showed a physician's order, dated 2/28/17 at 08:45 (8:45 am), for NF-Fentanyl 50MG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 3/1/17 at 20:04 (10:04 pm). Further review did not show the patient's fentanyl patch was ordered by the physician using the hospital's PO.0040 Fentanyl Duragesic Patch Order.pdf . PIC reviewed the EMR and acknowledged the medical record for Patient 26 did not contain a fentanyl patch order using the fentanyl Duragesic patch order form.

During a concurrent interview and medical record review, on 8/8/17 at 3 pm, PIC identified Patient 25's EMR. Review of the EMR showed Patient 25 was admitted on 4/27/17. Further review showed a physician's order, dated 4/27/17 at 10, for NF-Fentanyl 50MCG/HR TD Patch every 72 hours. The hospital dispensed and applied the first patch on 4/28/17 at 08:55 (8:55 am). Further review did not show the patient's fentanyl patch was ordered by the physician using the hospital's PO.0040 Fentanyl Duragesic Patch Order.pdf . PIC reviewed the EMR and acknowledged the medical record for Patient 25 did not contain a fentanyl patch order using the fentanyl Duragesic patch order form.

During a concurrent interview and medical record review, on 8/8/17 at 3:05 pm, PIC identified Patient 33's EMR. Review of the EMR showed Patient 33 was admitted on 12/7/16. Further review showed a physician's order, dated 12/7/16 at 11:41 am, for NF-Fentanyl 25MCG/HR TD Patch every 72 HRS. The hospital dispensed and applied the first patch on 12/7/16 at 18:07 (6:07 pm). Further review did not show the patient's fentanyl patch was ordered by the physician using the hospital's PO.0040 Fentanyl Duragesic Patch Order.pdf . PIC reviewed the EMR and acknowledged the medical record for Patient 33 did not contain a fentanyl patch order using the fentanyl Duragesic patch order form.

During a concurrent interview and medical record review, on 8/8/17 at 3:45 pm, PIC identified Patient 34's EMR. Review of the EMR showed Patient 34 was admitted on 7/11/16. Further review showed a physician's order, dated 7/13/16 at 21:01 (9:01 pm), for NF-Fentanyl TD System 75MCG/HR every 72 HRS. The hospital dispensed and applied the first patch on 7/13/16 at 21:11 (9:11 pm). Further review did not show the patient's fentanyl patch was ordered by the physician using the hospital's PO.0040 Fentanyl Duragesic Patch Order.pdf . PIC reviewed the EMR and acknowledged the medical record for Patient 34 did not contain a fentanyl patch order using the fentanyl Duragesic patch order form.

An administrative record review, of the hospital's policy and procedure for Fentanyl Transdermal Patch (PN.048, Approved by Board: 19-Jul-16) showed Procedure, 2. Fentanyl (Duragesic) Patch Order Form, a. "Physicians shall only prescribe initial transdermal fentanyl patch by using the PO.0040 Fentanyl Duragesic Patch order.pdf (see Attachment A)."

Based on observation, interview, and administrative record review, the hospital failed to ensure the provision of pharmaceutical services and care that meets the needs of the patients as evidenced by:

1. The Governing Body of the hospital failed to ensure the pharmacy services performed under contract (Pharmacy 1) followed USP<797> for the compounding (mixing) of the drug, 6mix Gati-Lid-Phen-Trop-Flur-Cycl (compounded preparation of 6 drugs). The hospital failed to demonstrate Pharmacy 1 followed USP<797> prior to signing the pharmacy services agreement. The hospital failed to ensure there was stability (retention of properties from time of compounding [mixing]) data for 6mix Gati-Lid-Phen-Trop-Flur-Cycl to support the assignment of a 9 day beyond-use (expiration) date. The facility purchased 6mix Gati-Lid-Phen-Trop-Flur-Cycl sterile (germ free) compounded eye drops from Pharmacy 1. The compounded eye drops were labeled with a BUD of 9 days from the date of compounding. The hospital did not have documentation showing the 6mix Gati-Lid-Phen-Trop-Flur-Cycl maintained the labeled properties (strength, stability) through the BUD. (See A-0084).

2. The hospital failed to ensure the collection and analysis of quality assurance (maintenance of quality) indicators (data) from Pharmacy 1. The hospital had a contract with Pharmacy 1 for the sterile (germ free) compounding (mixing) of medications. Pharmacy 1 provided sterile compounded 6mix Gati-Lid-Phen-Trop-Flur-Cycl (compounded mixture of 6 drugs) eye drops to the hospital for the past year. The hospital did not collect and analyze quality assurance data to ensure the 6mix Gati-Lid-Phen-Trop-Flur-Cycl eye drops were safe and effective. (See A-0273).

3. Six of eight patients (Patients 10, 11, 20, 27, 28 and 29) in the Surgical Nursing Unit (SNU) were administered patient's own medication without the benefit and contrary to the hospital policy for a pharmacist to identify and visually evaluate the integrity of the medication prior to administration. The patients' own medications were not labeled to show they were checked by a pharmacist. (see A-0405, finding 1)

4. Five fentanyl (narcotic pain reliever) patch patients (Patients 25, 26, 32, 33 and 34) did not meet the prior daily usage requirement of 60 milligram (mg) of morphine (narcotic) (or equivalent) before administration of the drug in accordance with hospital policy and guidelines issued by the Institute for Safe Medication Practices (ISMP). The hospital did not document the total daily dose of opioids (narcotic) for the previous 7 days before administration of a fentanyl patch. (See A-0405, finding 2).

5. Sedation scores (measurement of wakefulness) were not documented for five fentanyl (narcotic pain reliever) patch patients (Patients 25, 26, 32, 33 and 34) in accordance with hospital policy. The hospital did not document the sedation scores for each of the five patients. (See A-0405, finding 3).

6. The hospital failed to ensure a fentanyl (narcotic pain reliever) patch was ordered using the PO.0040 Fentanyl Duragesic (fentanyl) Patch Order.pdf (order form). The hospital administered a fentanyl patch to 5 patients (Patients 25, 26, 32, 33 and 34). The PO.0040 Fentanyl Duragesic Patch Order.pdf was not used to order a patch on the 5 patients. (See A-405, finding 4).

7. The hospital failed to ensure, in the case of a drug recall, that patients who had received a CT (computed tomography, x-ray scan) colonography (examination of the large intestine) prep (preparation) kit (bag of several drugs) could be identified and contacted in a timely (speedy) manner. The hospital did not maintain a list of patients that it had dispensed CT prep kits. These failures resulted in the potential for patients to be exposed to drugs that have been recalled (See A-0491 finding 2).

8. The hospital failed to secure all medications in the malignant hyperthermia (MH, fast rise in body temperature) emergency (contains medications and supplies for use in a life-threating emergency) cart. The hospital stored a portion of the MH cart emergency medications in a refrigerator. The refrigerator was not secured from unauthorized access. (See A-0502).

9. The hospital failed to ensure frozen normal saline (salt water) 1 liter (L) intravenous (IV, directly into a vein) bag was removed from the malignant hyperthermia (MH, fast rise in body temperature) emergency drug (medications needed in a life-threating emergency) supply. In the operating suite, the MH cart drug supply included a frozen 1 L bag of normal saline. The normal saline should not have been frozen. (See A-0505, finding 1).

10. The hospital failed to ensure the Clinic 2's fluid warmer's (cabinet to warm intravenous (IV, directly into a vein) and irrigation fluids) temperature was monitored. The temperature inside the fluid warmer was documented 25 out of 71 days. (See A-0504, finding 2).

The cumulative effects of these systemic problems resulted in the pharmacy's inability to provide pharmaceutical services and care in a safe and effective manner in accordance with the statutorily-mandated Conditions of Participation for Pharmaceutical Services.

Based on observation, interview, and record review, the hospital failed to ensure the development and implementation of policies and procedures meant to prevent, identify and minimize medication errors when:

1. No hospital policy and procedure was developed and implemented to appropriately stock and equip the pediatric emergency cart (a cart on wheels equipped with supplies and drugs meant to be used in the event of an emergency) with the most current Broselow reference tape (medical instruction tape used to determine the appropriate emergency dose for children by using the length of the child). The hospital's pediatric emergency carts were stocked with a Broselow tape labeled version 2011A. The current Broselow reference tape was 2017. These failures resulted in the potential for pediatric patients, in an emergency, to be exposed to medical instructions that did not meet the 2015 PALS (pediatric advanced life support) standards.

2. No hospital policy and procedure was developed and implemented to address patient notification in the event of a recall of the drugs used in the preparation kit for CT (computerized tomography - a specialized three dimensional x-ray) colonography (three dimensional picture of the intestines). The hospital did not demonstrate, , in the case of a drug recall, that patients who had received a CT colonography prep (preparation) kit (bag of several drugs) could be identified and contacted in a timely (speedy) manner. The hospital did not maintain a list of patients that it had dispensed CT prep kits. These failures resulted in the potential for patients to be exposed to drugs that have been recalled.

Findings:

1. During a concurrent tour, interview, and record review, on 8/7/17 at 3:45 pm, in the post anesthesia recovery unit, Pharmacist in Charge (PIC) identified the pediatric emergency cart. Inspection of the cart showed a Broselow tape. Review of the Broselow tape showed "Version 2011A." PIC reviewed the Broselow tape and acknowledged it was version 2011A.

During a concurrent tour, interview, and record review, on 8/8/17 at 2 pm, in the operating room, PIC identified the pediatric emergency cart. Inspection of the cart showed a Broselow tape. Review of the Broselow tape showed "Version 2011A." PIC reviewed the Broselow tape and acknowledged it was version 2011A.

An administrative record review, of the American Academy of Pediatrics (professional association of pediatricians to promote health of infants, children, and adolescents) website at https://shop.aap.org/broselow-pediatric-emergency-tape/ showed the current Broselow reference tape was the 2017 version. The 2017 version of the tape will be compliant with the 2015 PALS (pediatric advanced life support) Standards.

No policy and procedure was provided that indicated the pediatric emergency cart required an updated and current Broselow Tape.

2. During a concurrent tour, interview, and record review, on 8/9/17 at 2 pm, in the Clinic 1(ambulatory service area) CT room, Director of Imaging Services (DIS) identified a cabinet containing several CT colonography prep kits. Inspection of one of the kits showed it consisted of 4 items wrapped in cellophane. The items included one bottle of magnesium citrate (medication) oral solution 296 ml (milliliter), 3 bottles of Tagitol V (medication) (barium sulfate [improves of CT image] suspension 40% W [weight]/V [volume]) 20 ml, one bisacodyl (laxative medication) suppository 10 mg, and four unidentified orange pills. DIS inspected the kits and acknowledged they contained unidentified pills. DIS was asked to describe the dispensing process for the kits. Her description did not include that a dispensing log was used to document medications provided to the clinic's patients for home use.

During an interview and record review, on 8/9/17 at 3:35 pm, Pharmacist in Charge (PIC) acknowledged she knew about the practice of Clinic 1 dispensing CT colonography prep kits. PIC acknowledged that unidentified tablets in the kits did not meet her expectation. PIC was requested to describe the drug recall process for items in the CT colonography kit. Her description included that the hospital did not have a log to identify patients that had received the CT colonography kit.

During an interview, on 8/10/17 at 12:35 pm, PIC stated that approximately 20 patients were dispensed the colonography kit over the past year. PIC provided a list of the patients who may have received the CT colonography prep kits.

An administrative record review, on the Clinic 1 schedule (list of patients who may have received the CT colonography prep kits), for the past year, showed 20 patients were scheduled for CT Colonography w/o contrast or CT Colonography screening.

A review of the American Society of Health-System Pharmacists (professional association of pharmacists to improve medication use and enhance patient safety) website at https://www.ashp.org/-/media/assets/policy-guidelines/docs/guidelines-minimum-standard-pharmacies-hospitals.ashx?la=en&hash=FD4232E7C18BF868E25C88E804A4A3737D56E54D showed, American Society of Health-System Pharmacists (2013), ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals, Standard IV. Drug Product Procurement and Inventory Management, "The pharmacy shall be responsible for the procurement, distribution, and control of all drug products used in the hospital for inpatient and ambulatory patients..." Continued review showed, D. Returning Recalled, Expired, and Other Unusable Items, "There shall be a written procedure for the timely handling and documentation of a drug product recall. These procedures should include an established process for removing from use and drugs or devices subjected to a recall, notifying appropriate health care professionals, identifying patients who may have been exposed to the recalled medication..."

No policy and procedure was provided that discussed the method for patient notification in the event of a recall of the prep kits used for CT colonography in the ambulatory clinic.

Based on observation, interview, and record review, the hospital failed to ensure it could account for all scheduled (controlled substances, medications with a potential for abuse and dependence) medications. The hospital did not have a process to ensure all medications removed from the scheduled medication lockers were administered to the corresponding patients. These failures resulted in the potential for undetected diversion (theft) of scheduled medications.

Findings:

During a concurrent interview, on 8/7/17 at 1:45 pm, Pharmacist in Charge (PIC) was requested to describe how scheduled medications were tracked in the hospital. Her description included that in preoperative (before surgery) and postanesthesia (after surgery) care units narcotics were kept in a locked cabinet. The medications in the cabinet were counted on an inventory sheet. A medication would be removed from the cabinet and the number of doses would be subtracted from the count on the Controlled Substances Administration Record (inventory sheet). The PIC description included that the nurse would document the medication administration in the patient's electronic (computer) health record (EHR). PIC's description did not include a procedure to ensure the medication removed from the cabinet was documented as administered to the patient.

An administrative record review, of the hospital's Controlled Substances Administration Record, PostAnesthesia Care Unit, Schedule III, IV, V, Date 8/10/17 showed 5 vials of midazolam (controlled medication) 2mg (milligram)/ml (milliliter) vials were removed for five patients (starting count was 12 and ending count was 7).

An administrative record review, of the hospital's Controlled Substances Administration Record,
PostAnesthesia Care Unit, Schedule II, Date 8/10/17, showed 7 vials of fentanyl 100mcg (microgram) /2ml (milliliter) were removed for 7 patients (starting count was 17 and ending count was 10).

An administrative record review, of the hospital's policy and procedure for Controlled Substances Records and Procedures (PH.013, Approved by Board: 19-Jul-16) showed, Policy:, "The Pharmacists and Pharmacy Nurse are responsible for security and proper record keeping pertaining to distribution, control, inventory, wastage, and disposal of specified controlled substances."

Based on observation, staff interview, and administrative document review, the facility failed to ensure three syringes containing different medications were labeled in accordance with hospital policy at Clinic 2 for one of three tracer patients (PT 2). PT 2 was given three different medications from the unlabeled syringes by the Medical Doctor (MD) 2.

This failure placed the patient at risk for receiving the wrong medication at the wrong time.

Findings:

On 8/8/17 at 10:30 a.m., during an observation at the offsite pain surgical center, observed MD 2 drawing up three different medications in three different sized syringes. MD 2 had a three cc (unit of measure) syringe, 5 cc syringe, and a 10 cc syringe. MD 2 placed all three medications down on the surgical tray and did not give to the patient right away. MD did not place a label describing the medication or how much was in each syringe.

On 8/8/17 at 11:06 a.m., during an interview, the Charge Nurse (CN) stated, "(MD 2) uses different syringes for different medication and some of the medications are cloudy so he can tell the difference that way." CN stated, "Yes, it is not safe or best practice and (MD 2) runs the risk of causing a medication error."

On 8/8/17 at 4:26 p.m., during an interview, MD 2 stated, "I do not see the point of wasting my time labeling syringes when I use (different sized syringes) that can show the difference between medications....there is no possible way for me to mix them up." MD 2 stated there was no possibility of any risk or medication error occurring to a patient.

On 8/10/17 at 7:59 a.m., during an interview, Registered Nurse (RN) 4 stated, "None of the doctors have been labeling the medications. They have been using the same technique, three different sized syringes...no one has ever brought this up as a problem."

The facility policy and procedure titled, "Labeling of medications by Anesthesiologists" dated 7/19/2016, indicated, "....1. Medications shall be labeled in a standardized manner consistent with applicable law and regulation. Anytime one or more medication(s) are prepared but not immediately used, the medication container must be labeled...4. At a minimum, all medications must be labeled with: a. Drug name b. Strength c. Amount (if not apparent from the container) d. Expiration date when not used within 24 hours e. Expiration time when expiration occurs in less than 24 hours f. An indication if the medication was diluted."

Based on observation, interview, and record review, the hospital failed to secure all medications in the malignant hyperthermia (MH, fast rise in body temperature) emergency (contains medications and supplies for use in a life-threating emergency) cart. The hospital stored a portion of the MH cart emergency medications in a refrigerator. The refrigerator was not secured from unauthorized access. This failure resulted in the potential for patients to experience a delay in receiving medications needed in a MH emergency.

Findings:

During a concurrent tour, interview, and record review, on 8/8/17 at 3:45 pm, in the operating room, Pharmacist in Charge (PIC) identified a MH cart. Inspection of the cart showed a portion of the emergency medications were stored in a medication refrigerator. The medication refrigerator was a few feet from the sealed MH cart. Inspection of the refrigerator showed that it was not sealed by a pharmacist. PIC inspected the refrigerator that contained MH emergency drugs and acknowledged the medication supply was not sealed by a pharmacist.

An administrative record review, of the hospital's policy and procedure for Crash Cart Checks (PN.028, Approved by Board: 19-Jul-16) showed, Procedure: A. Every Shift:, 1. Check that Crash Cart is intact, "For locks not intact: entire contents must be checked by an RN and relocked."

Based on observation, interview, and administrative record review, the hospital failed to ensure unusable (expired, frozen, stored at wrong temperature) drugs were not available for patient use as evidenced by:

1. Frozen normal saline (salt water) 1 liter (L) intravenous (IV, directly into a vein) bag was stored and available for patient use in the malignant hyperthermia (MH, fast rise in body temperature) emergency drug (medications needed in a life-threating emergency) supply. In the operating suite, the MH cart drug supply included a frozen 1 L bag of normal saline. The normal saline should not have been frozen. This failure resulted in the potential for patients to experience a delay in receiving medications needed in an MH emergency.

2. The Clinic (outpatient ambulatory patient care area) 2's fluid warmer's (cabinet to warm intravenous (IV, directly into a vein) and irrigation fluids) temperature was not monitored. The temperature inside the fluid warmer was documented 25 out of 71 days. These failures resulted in the potential for patients to be exposed to medications at other than labeled strength.

3. Expired medications were stored and available for patient use in patient care areas. Expired 5% dextrose (sugar water) 100 milliliter (ml) bags were stored in SNU's medication area. This failure resulted in the potential for patients to be exposed to medications at other than labeled strength.

4. Intravenous (IV, directly into a vein) fluid bags, removed from their outer wrappers (protective cover), were stored and available for patient use without updated expiration dating in patient care areas. IV bags were stored in several medication areas. The outer wrappers of the IV bags were opened. The bags were not labeled with an updated expiration date that was based upon when the outer wrapper was opened. These failures resulted in the potential for patients to be exposed to medications at other than labeled strength.

Findings:

1. During a concurrent tour, interview, and record review, on 8/8/17 at 3:45 pm, in the operating suite, Pharmacist in Charge (PIC) identified a MH cart. Inspection of the cart showed some of the emergency medications were stored in a medication refrigerator. Inspection of the medication refrigerator showed it contained several bags of normal saline. One of the normal saline bags was frozen. PIC inspected the normal saline and acknowledged one of the bags was frozen. PIC stated that the normal saline should not have been frozen.

An administrative record review, of the hospital's policy and procedure for Storing Drugs (PH.036, Approved by Board: 19-Jul-16) showed, "Store drugs and biologicals in a safe, secure, and orderly manner, at proper temperatures..."


2. During a concurrent tour, interview, and record review, on 8/10/17 at 10 am, in the Clinic 2, Charge Nurse (CN) identified the fluid warming cabinet. Inspection of the warmer showed that it contained fluids for use during surgical procedures. CN was requested to provide the temperature monitoring log for August. Review of the log showed 6, out of 10 days, did not have the warmer temperature documented. CN reviewed the log and acknowledged the temperature for 6, out of 10 days, were not documented. Inspection of the temperature display, on the outside of the warmer, showed the internal temperature was 105 degrees Fahrenheit (F). CN acknowledged the temperature display showed 105 degrees F. The maximum allowed temperature was 104 degrees F.

An administrative record review, of the hospital's Temperature Monitoring Log, from 6/1/17 through 8/10/17, showed the fluid warming cabinet's temperature was documented 25 days, out of a total of 71 days (30%).

An administrative record review, of the hospital's policy and procedure for Medication storage temperature Monitoring (PH.053.1, Approved by Governing Board: 11-Nov-16) showed, Procedure, Temperature monitoring:, 1. "Check the medication refrigerator/freezer temperature, storage room temperature, medication warmer for mannitol temperature, IV fluid/irrigation solution warmer temperature daily in the morning."

3. During a concurrent tour, interview, and record review, on 8/7/17 at 3:30 pm, on SNU, Pharmacist in Charge (PIC) identified the medication storage room. Inspection of the room showed it contained IV fluid bags. Inspection of the 5% dextrose 100 ml bags showed 4 bags were labeled with an expiration date of 7/17. PIC inspected the 4 bags and acknowledged they were expired.

An administrative record review, of the hospital's policy and procedure for Storing Drugs (PH.036, Approved by Board: 19-Jul-16) showed, Procedure:, 11. Immediately withdraw any drug from stock which is, a. Outdated."

4. During a concurrent tour, interview, and record review, on 8/7/17 at 3:30 pm, on SNU, Pharmacist in Charge (PIC) identified the medication storage room. Inspection of the room showed it contained normal saline (salt water) 100 ml (milliliter) Add Vantage plastic bags. The outer wrapper for the package of five bags was open. Inspection of the two remaining bags did not show an expiration date other than the manufacturer's labeled date. PIC inspected the two bags and acknowledged they were not labeled with an expiration date other than the one assigned by the manufacturer.

During a concurrent tour, interview, and record review, on 8/9/17 at 1:50 pm, at Clinic 1, Director of Imaging Services (DIS) identified the computerized tomography room. Inspection of the room showed that it contained IV medication. Inspection of the IV medications showed the outer wrap for a package of normal saline bags was torn open. DIS acknowledged the outer wrap was torn open. Inspection of the two remaining normal saline 100 ml plastic bags did not show an expiration date other than the manufacturers' labeled date.

During an interview, on 8/9/17 at 3:35 pm, PIC stated that IV solutions removed from their outer wrap had a shorter expiration date than what was assigned by the manufacturer. PIC stated that the hospital did not have a policy and procedure for the assignment of expiration dating to IV bags removed from their outer wrap.

An administrative record review, of the hospital's policy and procedure for Storing Drugs (PH.036, Approved by Board: 19-Jul-16) showed, Procedure, 11. "Immediately withdraw any drug from stock which is, a. "Outdated."

Based on observations, interviews and document reviews the hospital failed to ensure:
1) Hand sanitizer used in the kitchen was approved for food service use;
2) Floors and walls in the kitchen were free from debris accumulation;
3) Kitchen staff did not store personal food in the same refrigerator used to store patient food;
4) Kitchen staff did not use kitchen equipment for personal use;
5) Kitchen staff personal belongings were not stored in the kitchen area;
6) Kitchen staff followed manufacturer guidelines for cleaning ice storage bin;
7) Kitchen staff followed manufacturer guidelines for testing and use of sanitizer;
8) Kitchen staff followed acceptable procedure for glove use and hand washing.

These failures had the potential to increase risk of food borne illness and/or cross contamination of germs.

Findings:

1) On 8/7/17, at 10:20 a.m., during kitchen observations, a hand sanitizer was located at the hand wash sink.

On 8/7/17, at 1:45 p.m., during a subsequent interview, the Dietary Supervisor (DS) stated the hand sanitizer dispensers had been placed in the kitchen by the previous infection control officer. She stated she was not aware if the sanitizer was approved for foodservice use.

The 2013 Federal Food Code, Section: 2-301.16, titled "Hand Antiseptics", indicated:
"(A) A hand antiseptic used as a topical application, a hand antiseptic solution used as a hand dip, or a hand antiseptic soap shall: (1) Comply with one of the following: (a) Be an approved drug that is listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations as an approved drug based on safety and effectiveness; or (b) Have active antimicrobial ingredients that are listed in the FDA monograph for OTC Health-Care Antiseptic Drug Products as an antiseptic hand wash, and (2) Consist only of components which the intended use of each complies with one of the following: (a) A threshold of regulation exemption under 21 CFR 170.39 - Threshold of regulation for substances used in food-contact articles; or (b) 21 CFR 178 - Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers as regulated for use as a food additive with conditions of safe use, or (c) A determination of generally recognized as safe (GRAS). Partial listings of substances with food uses that are GRAS may be found in 21 CFR 182 - Substances Generally Recognized as Safe, 21 CFR 184 - Direct Food Substances Affirmed as Generally Recognized as Safe, or 21 CFR 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe for use in contact with Food, and in FDA's Inventory of GRAS Notices,"

2) On 8/7/17, at 10:30 a.m., during an observation in the kitchen, the floor and walls behind the ice machine and the grill/stovetop area had visible debris buildup.

On 8/7/17, at 1:45 p.m., in a subsequent interview, the DS acknowledged the areas needed to be cleaned.

A review of the facility document, dated July 2016, titled "Cleaning Schedules and Procedures", indicated cleaning frequency for walls was weekly, and for floors was 1-3 times daily.

A review of the 2013 Federal Food Code, Section 4-601.11, Titled, "Equipment, Food-Contact Surfaces, Nonfood-Contact Surfaces, and Utensils" indicated:

"(C) Nonfood-contact surfaces of equipment shall be kept free of an accumulation of dust, dirt, food residue, and other debris."

3) On 8/7/17, at 10:35 a.m., during observations and a concurrent interview in the kitchen, Cook 1 had personal food items stored in a reach in refrigerator used to store patient food. Cook 1 acknowledged that his personal food items should be stored in the refrigerator in the employee break room.

On 8/7/17, at 1:45 p.m., in a separate interview, the DS stated Cook 1 should not have stored personal food items in the refrigerator with patient food.

A review of the 2013 Federal Food Code, indicated, "Because employees could introduce pathogens to food by hand-to-mouth and because personal belongings carry contaminants, areas designated to accommodate employees' personal needs must be carefully located. Food must not be in jeopardy of contamination." It also indicated that, "only food from approved sources was to be stored in the dietary kitchen." Food brought from home is not considered an approved source.

4) On 8/7/17, at 10:35 a.m., during observations in the kitchen, Cook 1 stated that he had brought in the turkey stored in the reach in refrigerator (referenced in item #3 above), so that he could slice it using the meat slicer in the kitchen.

On 8/7/17, at 1:45 p.m., in a subsequent interview, the DS stated that employee use of kitchen equipment for personal use was unacceptable.

A review of the 2013 Federal Food Code, indicated, "Because employees could introduce pathogens to food by hand-to-mouth and because personal belongings carry contaminants, areas designated to accommodate employees' personal needs must be carefully located. Food must not be in jeopardy of contamination." It also indicated that "only food from approved sources was to be stored in the dietary kitchen." Food brought from home is not considered an approved source.

5) On 8/7/17, at 10:45 a.m., during an observation in the kitchen, various employee personal items were stored in a room used for patient food storage.

On 8/7/17, at 1:45 p.m., in a subsequent interview, the DS acknowledged that the food storage room should not be used for storage of employee personal items.

A review of the 2013 Federal Food Code, indicated, "Because employees could introduce pathogens to food by hand-to-mouth and because personal belongings carry contaminants, areas designated to accommodate employees' personal needs must be carefully located. Food must not be in jeopardy of contamination." It also indicated that, "Employee lockers shall be located in a designated room or area where contamination of food, utensils, linens, and single-service and single-use articles cannot occur."

6) On 8/7/17, at 10:50 a.m., during an observation in the kitchen, Dietary Aid (DA) 1 did not properly explain the procedure for using and cleaning the ice machine storage bin in accordance with manufacturer instructions. DA 1 stated the process is to wipe down the interior surface of the ice storage bin with sanitizer, then to rinse out the surface of the bin. Additionally there was a sign posted by the ice machine stating employees were to put on gloves or use hand sanitizer before getting ice from ice storage bin.

On 8/7/17, at 1:45 p.m., in a subsequent interview, the DS stated employees should be washing hands before taking ice out of the ice storage bin.

A review of the manufacturer's instruction manual for the ice machine, dated 6/6/1996, indicated on pg. 23: "2) Storage Bin and Scoop: Wash hands before removing ice. Use the plastic scoop provided. Clean the bin liner by using a neutral cleaner. Rinse thoroughly after cleaning. "

The 2013 Federal Food Code, Section 4-904.14 titled, "Rinsing Equipment and Utensils after Cleaning and Sanitizing.", indicated: "After being cleaned and sanitized, equipment and utensils shall not be rinsed before air drying or use unless: (A) The rinse is applied directly from a potable water supply by a ware washing machine that is maintained and operated as specified under Subparts 4-204 and 4-501; and (B) The rinse is applied only after the equipment and utensils have been sanitized by the application of hot water or by the application of a chemical sanitizer solution whose EPA-registered label use instructions call for rinsing off the sanitizer after it is applied in a commercial ware washing machine."

7) On 8/7/17, at 11:10 a.m., during observations and a concurrent interview in the kitchen, Cook 1 did not follow the manufacturer guidelines for (a) mixing and (b) testing of the chemical sanitizers used in the red sanitizer buckets and the 3-compartment sink.

a. Cook 1 tested the chemical concentration of the chlorine sanitizer in one of the red sanitizer buckets in the kitchen, and the white colored test strip turned nearly black, which indicated the concentration was above the manufacturer indicated 200 parts per million (ppm). Cook 1 stated the acceptable chlorine sanitizer concentration should be between 50-100 ppm; when asked about verifying the sanitizer concentration when manually mixing the sanitizer solution, Cook 1 stated he would measure a predetermined amount of sanitizer to mix with a predetermined amount of water, but he did not regularly check the chemical concentration of the mixture.

On 8/7/17, at 1:45 p.m., in a separate interview, the DS stated the chemical concentration of the mixture should be checked and verified when manual mixing of sanitizer solution is performed.

A review of guidance provided in the Code of Federal Regulations Section 180.940, on chemical residue indicated: "When ready for use, the end-use concentration of all hypochlorous acid chemicals in the solution is not to exceed 200 ppm determined as total available chlorine."

b. Cook 1 tested the chemical concentration of the quaternary ammonium sanitizer used in the 3-compartment sink. The temperature of the test solution was measured at 98 degrees Fahrenheit.

A review of the facility document, dated August 2017, titled "3-compartment sink log, indicated test solution temperatures on four separate dates of 84, 84, 92, and 92 degrees Fahrenheit.

A review of Ecolab's (chemical manufacturer) instructions titled, "Test Procedures", indicated: "Solution should be between 65-75 degrees Fahrenheit."

8) On 8/7/17, at 11:20 a.m., during observations and a concurrent interview in the kitchen, Cook 1 did not follow the acceptable procedure for either glove use or hand washing. Cook 1 performed multiple glove changes without performing any handwashing activity. Cook 1 stated that he knew he was to wash his hands whenever he changed his gloves.

On 8/7/17, at 1:45 p.m., in a separate interview, DS stated employees are expected to wash their hands when changing gloves.

A review of the facility document, dated July 19, 2016, titled "Hand Hygiene", indicated " Hand hygiene is indicated by all Medical Staff, Allied Health, and all staff at the following times: 2. Before: ii. Donning gloves ... 3. After: ii. Removing gloves"

Based on observation and interview, the hospital failed to ensure facilities and equipment were maintained as evidenced by:

1. The hospital failed to ensure operating room #7 was free of dust and damaged paint. In the operating room, a low air return (intake) was covered with a thin layer of dust. In the operating room, the paint above a section of steel cabinets was damaged. These failures resulted in the potential for patients to be exposed to preventable infections.

2. The hospital failed to ensure a medication storage refrigerator, the kitchen walk-in freezer and the small reach-in freezer located in the PostAnesthesia Unit (PACU - after surgery) were free of ice buildup. These failures resulted in the potential for patients to be exposed to medications stored at the wrong temperature (medications at other than labeled strength) and would negatively affect any item stored in the freezers.

Findings:

1. During a concurrent tour and interview, on 8/8/17 at 2:30 pm, in the operating suite, Registered Nurse (RN 3) identified operating room #7. Inspection of the room showed a low air return grill on the far side of the room from the main door. Inspection of the air return grill showed that it was covered by a coat of dust. Further inspection showed a section of damaged paint, at the far end of the room, above a stainless steel cabinet. RN 3 acknowledged the dusty low air return grill and the damaged paint. RN 3 stated that the dusty air grill and the damaged paint were not acceptable in the operating room.

2. During a concurrent tour and interview, on 8/9/17 at 8:50 am, on Surgical Nursing Unit (SNU), Pharmacist in Charge (PIC) identified the unit's medication storage refrigerator. Inspection of the refrigerator showed the freezer compartment contained a thick layer of ice. PIC inspected the freezer compartment and acknowledged it was not free of ice buildup. PIC stated the maintenance of the medication refrigerator did not meet the hospital's expectation.

During a group interview, on 8/9/17 at 10:50 am, Director of Plant Operations (Dir 2) and PIC were requested to describe the process for maintaining the medication refrigerator freezer compartment free of ice buildup. Dir 2's description included that nurses were to communicate to engineering that a medication refrigerator needed to be defrosted. In addition, Dir 2 stated that engineering would have created a work order, with a tracking number, for the defrosting of the refrigerator. Dir 2 was requested to provide the number of work orders, for the past year, for defrosting medication storage refrigerator.

During an interview, on 8/10/17 at 8:30 am, PIC stated that, during the past year, engineering did not have any work orders to defrost medication storage refrigerators.

On 8/7/17, at 10:15 a.m., during observations in the kitchen's walk-in freezer, ice buildup was observed on a pipe coming from the condenser unit in the freezer.

On 8/7/17, at 1:45 p.m., in a subsequent interview, the dietary supervisor (DS) stated the maintenance supervisor (MS) had checked the freezer unit and replaced a door seal to address the ice buildup.

On 8/8/17, at 9:30 a.m., in a separate interview, the MS stated that he did not know what was causing the ice buildup on the condenser pipe in the walk in freezer.

On 8/9/17, at 11:20 a.m., during an interview, the MS stated that the ice buildup issue had been determined to be caused by the heat strip tape installed on the condenser not properly conducting heat to all necessary sections of the unit.

On 8/8/17, at 9:25 a.m., during observations and a concurrent interview of the small Magic Chef brand refrigerator/freezer in the PACU, the freezer section had ice accumulated so that the door to the ice bin could not be opened. The MS acknowledged the ice buildup needed to be cleaned and that he had not noticed the buildup before.

A review of the manufacturer's recommendations, undated, for maintaining the small refrigerator/freezer unit indicated:
"Defrost the freezer compartment when the ice / frost is approximately ¼" thick. Set the thermostat dial to "0" to defrost. Remove all contents from the freezer compartment. Leave the freezer door open to allow accumulated ice / frost to melt. Remove large pieces of ice as needed. Do not use hot water or other electric heating devices to melt the accumulated ice. After defrosting, remove accumulated ice / water and wipe the freezer compartment dry with a soft cloth. Restart the unit per starting instructions."

A review of the 2013 Federal Food Code, Section 4-501.11, titled "Equipment: Good Repair and Proper Adjustment." indicated:
"Proper maintenance of equipment to manufacturer specifications helps ensure that it
will continue to operate as designed. Failure to properly maintain equipment could lead
to violations of the associated requirements of the Code that place the health of the
consumer at risk. For example, refrigeration units in disrepair may no longer be
capable of properly cooling or holding time/temperature control for safety foods at safe
temperatures."

Based on observation, interview, and record review, the hospital failed to ensure a physician wore a surgical mask (to catch bacteria from mouth and nose) while performing a procedure in the operating room. Medical Doctor (MD 6) performed a procedure in the operating room of the Clinic 2. MD 6 did not wear a surgical mask while performing the procedure on Patient 31.

This failure resulted in the potential for Patient 31 to be exposed to an avoidable infection.

Findings:

During a concurrent observation and interview, on 8/10/17 at 10:05 am, at Clinic 2, Charge Nurse (CN) identified the operating room. Observation of the procedure showed Patient 31 was on the operating table. Further observation showed two hospital employees and one surgeon in the room. Hospital employees Registered Nurse (RN 4) and Radiologic Technician were wearing surgical masks. MD 6 was not wearing a surgical mask. RN 4 acknowledged MD 6 was not wearing a surgical mask. RN 4 stated it was the hospital's expectation that MD 6 wear a surgical mask.

During an interview, on 8/10/17 at 10:15 am, at Clinic 2, MD 6 was requested to discuss his decision to not wear a surgical mask. MD 6 stated that the type of procedure he performed on Patient 31 did not require a surgical mask. He was requested to describe the hospital policy and procedure, which provided guidance on when not to wear a surgical mask while performing a procedure in the operating room. MD 6 stated there was not a policy and procedure that provided guidance on when not to wear a surgical mask.

A medical record review, of the Hospital's Schedule for 8/10/17, showed Patient 31 was admitted to Clinic CTR 1 for the procedure "Lt confirmatory cervical (neck) medial branch (nerve) blks (block) @C3-4, 4-5 (nerve locations)."

An administrative record review, of the hospital's policy and procedure for Operating Room and Sterile Processing Dress Code (SS.007.8, Approved by Board: 28-Apr-17) showed, Procedure:, A. Appropriate attire for all staff in the operating room suite will be worn as follows: ...6. "Masks should cover the mouth and nose and be secured at the back of the head and behind the neck."

An administrative record review, of the American College of Surgeons website at https://www.facs.org/about-acs/statements/87-surgical-attire, showed Statement on Operating Room Attire (August 4, 2016), "...In addition, in so far as clean and properly worn attire may decrease the incidence of health care-associated infections, it also speaks to a desire and drive for excellence in clinical outcomes and a commitment to patient safety." Further review showed, "During invasive procedures (cutting or puncturing the skin), the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination ..."

Based on observation, interview, record and document review, the hospital failed to ensure that all practitioners performing surgery have been granted the specific privilege for the surgical procedure that was performed in 1 of 12 (MD 1) credentials examined. The manager for the Department was not aware of MD 1's lack of surgical privilege.

This failure has the potential to adversely impact the quality of healthcare and patient safety.

Findings:

On 8/7/17, while touring the Radiology Department of the hospital with the Director of Imaging Services (DIS), the ultrasound suite was found to be in use by MD 1 who was performing an ultrasound guided biopsy of a breast mass. On review of the Medical Staff credential file on 8/8/17, MD 1's privileges were requested/approved on 3/15/17 for "general radiology" only; no other privileges were requested or approved. The prior list of privileges, dated 1/13/15, contained requested/approved privileges for surgical procedures, such as needle biopsy and epidural injections.

On 8/8/17 at 3 p.m., during an interview, the DIS was asked if they were aware of the new privilege list for MD 1, DIS responded, "I was not informed of the change". The Chief Nursing Officer (CNO) was able to demonstrate that there is an up to date list of all practitioner's privileges located on the hospital's computer G: Drive and accessible to staff in order to verify privileges, including the current list for MD 1.