HospitalInspections.org

Based on observation, document review, clinical record review, and staff interview the hospital failed to ensure that Pharmaceutical Services were furnished in accordance with accepted professional principles and in accordance with hospital policies as evidenced by:

1. The hospital failed to ensure that one out of two patients (Patient 1) who had a fentanyl transdermal system (fentanyl patch: contains a potent synthetic pain relieving opioid that is delivered at a constant rate through the skin over a 72 hour period) placed on him was opioid tolerant as documented under the Usage and Indications section of the Food and Drug Administration (FDA: the institution chartered by Congress with the responsibility for regulating and ensuring the safety, quality, and efficacy of medications sold in the United States) approved labeling (package insert). As a result, such use was contraindicated as documented in the boxed warning (most serious warning in product labeling that documents issues that could lead to severe harm or death) section of the product labeling. As a result, Patient 1 was exposed to an increased risk of significant respiratory depression (suppression of the automatic ability to breath) (See C 1016, #1).

2. The hospital failed to ensure a pharmacist was required to review orders for fentanyl patches prior to placement on a patient as required by standards of practice and hospital policy when fentanyl patches were available in computer controlled automated drug dispensing cabinets located on the Medical/Surgical unit which nursing staff could remove without pharmacist review by using an override function. Nursing staff were not aware of fentanyl patch guidelines that hospital policy documented was available for nurse review on the unit. As a result, patients who did not meet safety guidelines for placement of the fentanyl patch potentially could receive such a patch without pharmacist review which could expose them to the risk of respiratory depression (See C 1016, #2).

3. The hospital failed to ensure hospital policies regarding conflicts in orders were implemented when one out of one patient (Patient 2) placed on a Patient Controlled Analgesia (PCA: allows patients to self-medicate to control pain within physician defined parameters) received lorazepam and oxycodone/acetaminophen in conflict with another order that Patient 2 was not to receive such drugs when receiving hydromorphone ordered on the hospital approved PCA order set. As a result, Patient 2 was potentially placed at an increased risk of respiratory depression (See C 1016, #3).

4. The hospital failed to ensure that staff had placed a hospital approved dosing guideline, the Broselow Tape (a color coded tape used to estimate the weight of a child and which provides dosing guidelines for emergency medications based on the child's weight), as required by hospital policy, on one out of one Broselow Cart (an emergency supply cart that contains equipment and drugs used to manage pediatric emergencies) located in the Emergency Department (ED) when staff placed a non-approved dosing guideline on the cart instead of the Broselow Tape, failed to ensure all medications listed in the Pediatric Advanced Life Support (PALS: nationally approved guidelines for the management of pediatric emergencies) and Broselow guidelines, which hospital policies documented staff would use to manage pediatric emergencies, were available on the cart so that they would be immediately available to manage a pediatric emergency, failed to ensure the concentrations of those medications that were available in the cart matched the concentrations listed on the hospital approved PALS and Broselow guidelines on which the dosing guidelines were based, and failed to ensure there was enough medication to manage all weight classes of children for whom the Broselow emergency supply was intended to treat. This had the potential to delay therapy and potentially result in medication errors during a pediatric medical emergency involving the heart and lungs (also called a code or a code blue) (See C 1016, #4).

5. The hospital failed to ensure one out of one Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain medications used in the practice of anesthesiology) Cart (contains medications and supplies used to manage an MH crisis) located in the Surgery Department contained the full amount of amiodarone (used to treat dangerous abnormal heart rhythms known as arrhythmias) recommended by the Malignant Hyperthermia Association of the United States (MHAUS: a nationally recognized organization that has published recommendations regarding the medical management of MH) was contained in the MH cart. This had the potential to delay treatment of arrhythmias that may occur during an MH crisis (See C 1016, #5).

The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision for safe and appropriate use of medications to meet the needs of the patients and to minimize adverse medication outcomes.




34269




38335

Based on review of closed records of two patients who had received fentanyl patches while in the hospital, review of one closed record of a patient who had received an infusion of hydromorphone per the hospital approved patient controlled analgesia order set (PCA: allows patients to self-medicate to control pain within physician defined parameters), inspection of emergency medication supplies, document review and staff interview, the hospital failed to ensure medication policies were implemented when:

1. The hospital failed to ensure the policy regarding use of fentanyl patches was implemented when one of the two patients who had received fentanyl patches (Patient 1) had a 50 mcg fentanyl patch placed on him when he did not meet the minimum requirements in the Food and Drug Administration (FDA: oversees medications in the United States) approved product labeling for opioid tolerance. Therefore, Patient 1 was placed at increased risk of serious respiratory depression (suppression of the automatic ability to breath).

2. The hospital failed to ensure a pharmacist was required to review orders for fentanyl patches prior to placement on a patient as required by standards of practice and hospital policy when fentanyl patches were available in computer controlled automated drug dispensing cabinets located on the Medical/Surgical Unit which nursing staff could remove without pharmacist review by using an override function. Nursing staff were not aware of fentanyl patch guidelines that hospital policy documented was available for nurse review on the unit. As a result, patients who did not meet safety guidelines for placement of the fentanyl patch may have received such a patch without pharmacist review which could expose them to the risk of respiratory depression.

3. For one out of one patient (Patient 2) who received hydromorphone per the hospital approved patient controlled analgesia order set (PCA: allows patients to self-medicate to control pain within physician defined parameters), the hospital failed to ensure pharmacy and nursing staff clarified, as stipulated in hospital policies and procedures, a pre-existing order for an opioid containing medication, oxycodone and acetaminophen, and a new order for lorazepam (a sedative medication) that conflicted with a standing order on the PCA order set that specifically stipulated patients were not to get other opioids (the oxycodone containing medication) or sedative medications (lorazepam) while the PCA order set was in effect. Patient 2 received both the oxycodone/acetaminophen combination and lorazepam while on the protocol without any evidence of staff having contacting the ordering physician regarding the conflict with the standing order in the PCA order set with the potential that Patient 2 was exposed to a greater risk of the adverse additive effects of two opioid medications and the documented potential interaction of opioids with lorazepam which could have resulted in respiratory depression in Patient 2.

4. The hospital failed to ensure that one out of one Broselow Cart (an emergency supply cart that contains equipment and drugs used to manage pediatric emergencies) had a hospital approved dosing guideline, the Broselow Tape (a color coded tape used to estimate the weight of a child and which provides dosing guidelines for emergency medications based on the child's weight) on the cart as required by hospital policy when staff placed a non-approved dosing guideline on the cart, failed to ensure all medications listed in the Pediatric Advanced Life Support (PALS: nationally approved guidelines for the management of pediatric emergencies) and Broselow guidelines, which hospital policies documented staff would use to manage pediatric emergencies, were available on the cart so that they would be immediately available to manage a pediatric emergency, failed to ensure the concentrations of those medications that were available in the cart matched the concentrations listed on the hospital approved PALS and Broselow guidelines on which the dosing guidelines were based, and failed to ensure there was enough medication to manage all weight classes of children for whom the Broselow emergency supply was intended to treat. This had the potential to delay therapy and potentially result in mediation errors during a pediatric medical emergency involving the heart and lungs (also called a code or a code blue).

5. The hospital failed to ensure one out of one Malignant Hyperthermia (MH: a rare but potentially lethal side effect of certain medications used in the practice of anesthesiology) Cart (contains medications and supplies used to manage an MH crisis) located in the Surgery Department contained the full amount of amiodarone (used to treat dangerous abnormal heart rhythms known as arrhythmias) recommended by the Malignant Hyperthermia Association of the United States (MHAUS: a nationally recognized organization that has published recommendations regarding the medical management of MH) was contained in the MH cart. This had the potential to delay treatment of arrhythmias that may occur during an MH crisis.

Findings:

1. The fentanyl transdermal system also called a fentanyl patch contains fentanyl, a potent synthetic opiate medication used to treat pain. This medication has a boxed warning (also called a "black box" warning) which is the most serious warning required by the Food and Drug Administration (FDA: the Federal Agency responsible for protecting the public health by assuring the safety, effectiveness, and security of drugs, vaccines, and other biological products) to be placed in the product labeling (also called the package insert) for a medication. Boxed warnings document potential problems that can lead to serious injury or death. The boxed warning for the fentanyl patch documents that "Serious, life-threatening, or fatal respiratory depression may occur with use of fentanyl transdermal system." It documents: "Because of the risk of respiratory depression, fentanyl transdermal system is contraindicated for use ... in non-opioid tolerant patients ..." Under "Indications and Usage" the product labeling documents opioid-tolerant patients as "... those who are taking, for one week or longer, at least 60 mg [milligrams] of morphine per day, 25 mcg [micrograms] transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid." The product labeling documents that if a patient has taken 60 mg of hydrocodone for 7 days prior to the placement of the patch, the patient would be considered opioid tolerant enough to be able to use a 25 mcg patch. The product labeling documents that a patient would have to receive at least 135 mg of oral morphine (an opioid pain reliever documented to be equivalent to oral hydrocodone on a mg to mg basis) per day for seven days before being considered opioid tolerant enough to receive a 50 mcg patch.

On 1/16/20 at 2:55 p.m. a review, with the Director of Pharmacy, of the product labeling, provided by the Director of Pharmacy, for the fentanyl patch, indicated this information was available in the pharmacy at that time.

On 1/16/20 at 2:09 p.m. a review of Patient 1's clinical record indicated this patient was admitted for observation on 12/26/19 and subsequently was admitted to the hospital on 12/28/19.

A review of the seven 24 hour periods prior to the application of the patch, as ordered by Physician A, indicated staff had administered the following daily quantities of hydrocodone, as hydrocodone/acetaminophen 10 mg/325 mg tablets to patient 1:

9:08 a.m. 12/29 through 11:31 a.m. 12/30/19 40 mg

11:32 a.m. 12/30 through 11:31 a.m. 12/31/19 20 mg

11:32 a.m. 12/31 through 11:31 a.m. 1/1/20 10 mg

11:32 a.m. 1/1/20 through 11:31 a.m. 1/2/20 40 mg

11:32 a.m. 1/2/20 through 11:31 a.m. 1/3/20 50 mg

11:32 a.m. 1/3/30 through 11:31 a.m. 1/4/20 60 mg

11:32 a.m. 1/4/20 through 11:31 a.m. 1/5/20 50 mg

On 1/5/20 Physician A ordered a 50 mcg fentanyl patch for Patient 1 and nursing staff applied the patch to Patient 1 at 11:31 a.m. on 1/5/20. Patient 1 had not received enough hydrocodone to be considered opioid tolerant enough to receive a 25 mcg patch much less the 50 mcg patch that was placed on Patient 1 on 1/5/20 as Patient 1 had not received at least 60 mg of oral hydrocodone for each of the 24 hour (day) periods prior to placement of the patch on Patient 1.

On 1/16/20 at 2:47 p.m. a review of Policy 1691 titled TRANSDERMAL FENTANYL PATCH ORDERING AND USE GUIDELINES (Last revision 2/7/19) indicated the purpose of the policy was "To promote the safe ordering and use of Transdermal Fentanyl Patches." Under "POLICY" it documented: "Due to the Food and Drug Administration (FDA) black box warning, these guidelines are designed to promote safe use of Transdermal Fentanyl Patches ... These guidelines restrict the use of Transdermal Fentanyl Patches to opioid-tolerant patients ... They provide contraindications to use due to risk of serious or life-threatening respiratory depression ...." Under "PROCEDURE A" it documented fentanyl patches "... should only be used on patients who ... have demonstrated opioid tolerance." Under "PROCEDURE B" it documented a patient would have to have taken 60 mg of (oral) morphine "... for at least a week or longer; or an equianalgesic dose of another opioid."

On 1/16/20 at 2:55 p.m. during an interview with the Director of Pharmacy, she stated it would have been better to use a 25 mcg fentanyl patch than a 50 mcg patch. The Director of Pharmacy then stated she would have told the doctor it would be better not to use a fentanyl patch with this patient (Patient 1) because of the hospital policy.

2. The American Society of Health System Pharmacists (ASHP) is a nationally recognized organization that sets standards of practice for hospital pharmacies. This organization has published ASHP GUIDELINES: MINIMUM STANDARD FOR PHARMACIES IN HOSPITALS in which it documents under "Review of Medication Orders" (found under "Standard VI. Medication Dispensing and Delivery") the following: "All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order."

On 1/17/20 at 11:45 a.m. during an interview of the Director of Pharmacy while inspecting the night locker (an after-hours medication supply available to nursing supervisors for medications ordered after the pharmacy closed) she stated fentanyl patches were not stored in the night locker but they were available in automated drug dispensing cabinets (ADCs) in the hospital. The Director of Pharmacy stated that nurses could obtain the medication after hours without pharmacist review by using an override function (built into the computer program used to control access to the cabinets that would allow the nurse to remove a drug prior to review of the order by a pharmacist; such review would normally be required before the drug could be accessed by the nurse). The Director of Pharmacy stated the nurses must provide a reason as to why they obtained the fentanyl patch by using the override function.

On 1/22/20 at 2:37 p.m. a review of Policy 1600 titled DRUG THERAPY MONITORING (Last Revision 2/1/19) indicated, Procedure II stipulated: "The pharmacist shall maintain a computerized patient medication profile so that he/she can monitor and compare all medications provided and thus prevent potential incompatibilities and interactions." Procedure II. D. stipulated:" All potentially severe interactions, interferences or incompatibilities shall be communicated to the prescribing physician promptly ...." Procedure IV of this policy stipulated: "The pharmacist will also maintain written notes and monitoring parameters on patients currently being monitored."

On 1/22/20 at 6:02 p.m. a review of Policy 1691 titled TRANSDERMAL FENTANYL PATCH ORDERING AND USE GUIDELINES (Last revision 2/7/19) indicated it documented: "These guidelines restrict the use of Transdermal Fentanyl Patches to opioid-tolerant patients ... They provide contraindications to use due to risk of serious or life-threatening respiratory depression ...." Under "PROCEDURE A" it documented fentanyl patches "... should only be used on patients who ... have demonstrated opioid tolerance." Under "PROCEDURE B" it documented a patient would have to have taken 60 mg of (oral) morphine "... for at least a week or longer; or an equianalgesic dose of another opioid." Under "Procedure II" Policy 1691 stipulated: "Fentanyl patches removed after pharmacy hours will require a witness for an override to take place. Witness should verify appropriate usage guidelines have been followed." "Procedure 1. D." stipulated: "The Transdermal Fentanyl Patch Usage Guidelines will be kept on all nursing units and on the MCDH Intranet site and within the ordering module in the electronic health record as an 'on-order message'".

On 1/22/20 at 6:21 p.m. during an interview of Nurse K on the Medical/Surgical Unit she stated fentanyl patches were stored in the ADC located on the Medical/Surgical Unit. Nurse K stated one would need a witness to remove a fentanyl patch from the ADC. She stated it would have to be for an appropriate patient and that the night pharmacy service would verify the orders. When asked about guidelines for the appropriate use of the fentanyl patch, Nurse K stated she usually would not do an override and she would check with her supervisor.

On 1/22/20 at 6:37 p.m. during an interview of House Supervisor L, she stated she was not sure if fentanyl patches were stored in the ADC located on the Medical/Surgical Unit and that she would need to check the binder. A concurrent review, with House Supervisor L, of a list provided by House Supervisor L at that time indicated fentanyl patches were listed as part of the medication inventory of the Medical/Surgical Unit ADC. When asked if the fentanyl patch could be obtained by override, House Supervisor L stated if a pharmacist was not in the hospital, she would have the night pharmacy service verify the order. She stated she would do this even if the ordering physician stated he wanted the patch applied immediately. House Supervisor L stated she was not aware of any guidelines on the unit a nurse could use to identify if a patient was an appropriate candidate for the fentanyl patch other than using one's nursing judgement and asking the patient.

On 1/23/20 at 8:14 a.m. during a concurrent review of Policy 1691 titled TRANSDERMAL FENTANYL PATCH ORDERING AND USE GUIDELINES (Last revision 2/7/19) and interview with the Chief Nursing Officer, she stated the use of the override function as documented in Procedure II meant removal without review of the order by a pharmacist. The Chief Nursing Officer stated the hospital did not pay the night pharmacy service for STAT (immediate; right now) review of medication orders. The Chief Nursing Officer stated she could not imagine a fentanyl patch being a STAT medication. She stated the fentanyl patch was a high alert medication (a medication with increased risk for adverse outcomes) and high alert medications required special attention due to their heightened potential for harm.

During a concurrent review of Procedure 1. D. with the Chief Nursing Officer regarding the Transdermal Fentanyl Patch Usage Guidelines, she stated she had not seen these guidelines.

On 1/23/20 at 8:48 a.m. during an interview of the Inpatient Clinical Manager, she stated the Transdermal Fentanyl Patch Usage Guidelines was the fentanyl patch policy (Policy 1691). She stated the policy was available on the hospital intranet. The Chief Nursing Officer offered that they would have to educate the nurses with regard to the availability of these guidelines.

3. Patient controlled analgesia is a patient controlled drug regimen for opioid pain relieving medications such as hydromorphone in which the patient can self-administer programmed doses of the pain medication to themselves via a programed intravenous solution (IV) pump. The pump can be programmed by nursing staff, pursuant to a physician's order, to limit the self-administered dose to that prescribed to the doctor along with a physician prescribed lockout interval, during which the patient cannot self-deliver a dose of opioid pain relieving medication. The order can include an intravenous (IV: in the vein) infusion of the opioid delivered at a constant rate prescribed by the physician in addition to the patient controlled doses.

For the discussion that follows hydromorphone is a potent opioid used to treat moderate to severe pain and benzodiazepines are a sedative class of drugs that include diazepam (Valium) and lorazepam (Ativan). Oxycodone/acetaminophen is a combination of the opioid pain reliever oxycodone with acetaminophen, the active ingredient of Tylenol used to treat moderate to severe pain. Respiratory depression is a significant inhibition of the ability to breath effectively. Hypotension is a significant reduction in blood pressure that can result in dizziness or actual fainting.

The FDA approved product labeling for hydromorphone contains a boxed warning that documented under: "Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants" the following: "Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants ... may result in profound sedation, respiratory depression, coma, and death [see Warnings and Precautions 5.5), Drug Interactions (7)]." Under the Warnings and Precautions Section 5.5 the product labeling documents "Profound sedation, respiratory depression, coma, and death may result from the concomitant used of Hydromorphone Hydrochloride Injection ... with benzodiazepines or other CNS depressants (e.g. ... other opioids ...) ... Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone ...." Under the drug interactions section, the product labeling documented: "Due to additive pharmacologic effect, the concomitant use of benzodiazepines and other CNS depressants ... can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death."

On 1/16/20 at 9:20 a.m. a review of Patient 2's clinical record indicated Patient 2 was admitted to the hospital on 12/18/19. On 12/18/19 at 2:30 p.m. Physician C ordered oxycodone/acetaminophen (APAP) 5 mg/325 mg (orally) every 4 hours as needed for acute pain for Patient 2. On 12/19/19 at 11:55 p.m. Physician C ordered Patient 2 was to receive hydromorphone 1 mg/hr intravenously. He did this using the hospital approved order set titled PATIENT CONTROLLED ANALGESIA ORDER SHEET. Order #1 on the sheet read: "NO OTHER SEDATIVES OR OPIOIDS WHILE ON PCA." Physician C only provided for an infusion and did not provide for the capability of Patient 2 to self-administer doses of hydromorphone via a programmed IV pump. The rate of the hydromorphone infusion was decreased to 0.3 mg/hr on 12/21/19 at 11:30 a.m. and was subsequently discontinued at 4:05 p.m. on 12/21/19.

On 12/20/19 at 9:50 a.m. Nurse E took a telephone order from Physician C for lorazepam 0.5 mg every six hours intravenously for alcohol withdrawal (a valid use for lorazepam).

On 12/21/19 at 9:42 a.m. Nurse D took a telephone order from Physician C for lorazepam 1 mg orally every 6 hours as needed for alcohol withdrawal.

On 1/16/20 at 12:11 p.m. a review of Patient 2's electronic medication administration record (eMAR: an electronically formatted document used by nurses to accurately medicate their patients and to document the date and time a dose of medication was administered) indicated Patient 2 received lorazepam and oxycodone/acetaminophen while on hydromorphone contrary to the order not to receive such medications while on the hydromorphone infusion. Patient 2 received these medications as follows:

Lorazepam 1 mg by IV injection was administered to Patient 2 on 12/20/19 at 5:26 p.m. and 10:42 p.m.; on 12/21/19 at 4:56 a.m. and 10:12 a.m.

Lorazepam 1 mg tablet was administered to Patient 2 on 12/21/19 at 11:49 a.m.

Oxycodone/acetaminophen 5 mg/325 mg 1 tablet was administered to Patient 2 on 12/20/19 at 8:15 p.m. and 12/21/19 at 3:19 a.m.

These observations were verified with the Inpatient Clinical Manager at that time by concurrent review of Patient 2's electronic health record (EHR) and interview. She acknowledged there was no evidence in Patient 2's EHR that a nurse had contacted the doctor regarding the oxycodone/acetaminophen order or the lorazepam orders with respect to order #1 in the PCA order set that Patient 2 was not to receive any other sedatives or opioids while receiving patient controlled analgesia.

On 1/17/20 at 9:23 a.m. during a concurrent review of Patient 2's pharmacy medication profile with the Director of Pharmacy she stated that when the pharmacy was closed, the night pharmacy service reviewed and approved new orders (the hydromorphone was ordered at 11:55 p.m. on 12/19/19 when the pharmacy was closed). There was a note by the night pharmacy service in the PCA order for hydromorphone contained in the pharmcy computerized medication profile that there was duplication of therapy with the oxycodone/acetaminophen order. There was no indication in the pharmacy system that the night pharmacy service had contacted Physician C about this issue. The Director of Pharmacy stated the next morning the night pharmacy service would provide a shift report (to the day pharmacy staff). A concurrent review of the night pharmacy report with the Director of Pharmacy for the morning of 12/20/19 indicated there was no mention of Patient 2 in the report.

On 1/17/20 at 9:38 a.m. during a concurrent review of Patient 2's pharmacy medication profile and interview with the Director of Pharmacy she said the lorazepam orders were entered by the day shift and, therefore, would not appear on the night pharmacy service end of shift report. A review of the pharmacy profile for Patient 2 indicated that for the scheduled injections of lorazepam, the pharmacy profile contained a warning to the pharmacist that there was a potential interaction with lorazepam. The Director of Pharmacy stated this field would be auto filled by the computer program. The "Action" field was blank. The Director of Pharmacy stated at that time, that the "Action" field was where the pharmacist would document any intervention that was made by the pharmacist regarding this order (such as contacting the physician).

A review of the as needed lorazepam order in the pharmacy profile at that time with the Director of Pharmacy indicated the same warning regarding a potential interaction with hydromorphone appeared in the order field however the "Action" field was blank.

On 1/22/20 at 2:37 p.m. a review of Policy 1600 titled DRUG THERAPY MONITORING (Last Revision 2/1/19) indicated, Procedure II stipulated: "The pharmacist shall maintain a computerized patient medication profile so that he/she can monitor and compare all medications provided and thus prevent potential incompatibilities and interactions." Procedure II. D. stipulated: "All potentially severe interactions, interferences or incompatibilities shall be communicated to the prescribing physician promptly ...." Procedure IV of this policy stipulated: "The pharmacist will also maintain written notes and monitoring parameters on patients currently being monitored.

During an interview of the Director of Pharmacy at that time with respect to the application of this policy to the issues regarding Patient 2's hydromorphone order per the PCA protocol, she stated there should have been a clarification (with the doctor). When asked if Procedure II.D. would apply to this situation, she stated "I would think so." The Director of Pharmacy stated the process of documenting a conversation with a doctor regarding the conflict of lorazepam orders with the PCA order not to give sedatives while on the PCA protocol would have been covered by Procedure IV.

On 1/22/20 at 5:33 p.m. a review of Policy 1633 titled MEDICATION ORDERING AND TRANSCRIBING (Last revision: 2/1/19) indicated, "Procedure VIII" stipulated: "When medication orders are incomplete, illegible, or unclear, the nurse and/or pharmacist will contact the prescriber for clarification prior to administration of the medication."

On 1/23/20 at 9:09 a.m. during a concurrent review of Policy 1633 with the Chief Nursing Officer, she stated that Procedure VIII in the policy would apply to situations where one order was in conflict with another order.

4. On 1/14/20 at 10:42 a.m. an inspection of the Broselow Cart located in the ED indicated that it contained two medication dosing guides located on top of the cart. One dosing guide was a one-page double sided table titled, "PALS MEDICATION DOSING TABLE" that provided dosing guidelines for seven medications (PALS means Pediatric Advanced Life Support). These medications were adenosine, amiodarone, atropine, lidocaine (all used to treat abnormal heart rhythms), epinephrine (used to reestablish spontaneous circulation of the blood), calcium chloride (used when epinephrine fails to improve heart contractions), and sodium bicarbonate (used to decrease high acid levels in the blood). Each medication name included the concentration of the medication. Infant/children weights started at 3 kilograms (kg) and ran up to 20 kg on side 1 of the table in 1 kg increments, and ran from 21 kg to 40 kg, in 1 kg increments on side two of the table. Dosing guidelines were provided for each of the seven emergency medications in milligrams (mg) and in milliliters (ml) that were based on the listed concentrations of the medications on the table.

The other dosing guide was a tape titled "2017 - Pediatric Dosing Tape" and it was copyrighted by Mila Medical, Inc. The tape had color code sections that corresponded to weight ranges printed in those color coded areas. The weight ranges on the tape went from 3 kg to 36kg. It also had a list of emergency medications that was repeated in each color coded section that included recommended doses of each medication in the list that was specific for children who fell into the weight ranges in those color coded sections. It included the seven medications listed in the PALS table and in addition included magnesium sulfate (used to treat a dangerous heart rhythm called torsades de pointes). The concentration of each medication was listed on the tape and the doses for each weight range was provided in mg and ml based on the concentration of the medications printed on the tape. Staff had placed this tape in a clear plastic sleeve attached to the top of the cart on which they had written "Broselow Tape".

The Broselow Tape is a nationally recognized tool that provides a rapid way to estimate the weight of a pediatric patient and contains information regarding the dosing of medications used in urgent and emergent situations based on the child's estimated weight. The tape is divided into color coded sections each of which correspond to specific weight ranges for children. A child's weight is estimated by placing the top of the tape at the top of the child's head and then reading the estimated weight range off the corresponding color coded section that the child's feet reaches while lying down next to the tape. The tape lists the medications with their concentrations and the corresponding dosages both in mass units (milligrams) and volume units (milliliters) that are used to manage a pediatric medical emergency. These medications and the associated dosage guidelines appear in all the color coded sections of the tape. The dosages listed with the medications in each color coded section are specific for the weight class of children the color coded section represents.

The medication tray also contained one vial of calcium gluconate, not calcium chloride as listed on the dosing guides kept on top of the cart. The label indicated it contained 0.465 milliequivalents (mEq)/ml of calcium. Calcium chloride contains 1.4 mEq/ml of calcium (three times the amount relative to calcium gluconate). If staff were to follow the volume listed on the dosing guideline for calcium chloride contained within the dosing guidelines available to staff, they would deliver one-third the dose of calcium called for in the guidelines if they used the calcium gluconate.

During an interview with the Director of Pharmcy at that time, she stated she had not personally checked to see if the "2017 - Pediatric Dosing Tape" matched the Broselow Tape. During a second interview with the Director of Pharmacy on 1/15/20 at 11:18 a.m. she stated she was not aware if the "2017 - Pediatric Dosing Tape" had been formally approved by the hospital as she was not involved in that decision. The Director of Pharmacy stated the Pharmacy and Therapeutics Committee had oversight of the medication contents of the emergency medication supplies.

Inspection of the emergency medication tray in the Broselow Cart indicated the following medications that appeared on the "2017 - Pediatric Dosing Tape" and the PALS medication table were not included in the medication tray: adenosine, amiodarone, calcium chloride, lidocaine, and magnesium sulfate. The Director of Pharmacy volunteered, at that time, that these medications were available in the Adult Crash Cart.

Both the Pediatric dosing tape and the PALS table listed sodium bicarbonate at a concentration of 1 mEq/ ml and the doses on the tape were based on that concentration. The ED Broselow Cart medication tray contained two 10 ml pre-filled syringes of sodium bicarbonate at a concentration of 0.5 mEq/ml, not 1 mEq/ml. If staff were to follow the volume listed on the dosing guideline for the 1 mEq/ml concentration of sodium bicarbonate contained within the dosing guidelines available to staff, they would deliver one-half the dose of sodium bicarbonate called for in the guidelines if they used the sodium bicarbonate at a concentration of 0.5 mEq/ml that was available in the medication tray. In addition, the two syringes combined would provide 10 mEq of sodium bicarbonate which was enough for children up to 10 kg per the PALS table or enough for children up to 11 kg per the 2017 Edition of the Broselow Tape. Therefore, not enough sodium bicarbonate was available in the Broselow medication tray to treat all weight classes of children for whom the supply was intended for use.

On 1/15/20 at 10:59 a.m. a review of Policy 577 titled PEDIATRIC RESUSCITATON SUPPLIES (Last Revision: 12/18/19) indicated, it documented under "POLICY": "Mendocino Coast District Hospital will maintain pediatric emergency supplies and equipment and utilizes the Broselow system for their organization. Under "Protocol. II." it documented: "Broselow carts ... will be stocked with a Broselow measuring tape and the corresponding supplies for each color-coded weight range."

On 1/15/20 at 11:28 a.m. a concurrent review of the 2017 Edition of the Broselow Tape, which was provided by hospital staff, with the Director of Pharmacy indicated that it listed sodium bicarbonate 0.5 mEq/ml, not 1 mEq/ml as on the "2017 - Pediatric Dosing Tape", for infants who fell in the first weight range on the Broselow tape of 3 kg, 4 kg, and 5 kg. It listed magnesium sulfate in concentrations of 40 mg/ml or 80 mg/ml with concomitant dosing guidelines, rather than at 500 mg/ml as listed on the "2017 - Pediatric Dosing Tape". The Director of Pharmacy verified these observations by interview at that time.

On 1/15/20 at 11:40 a.m. a review of Policy 243 titled CODE BLUE AND CODE APGAR (Last revision: 12/15/19) indicated it provided guidelines for managing an adult and a pediatric code. It documented: "The code team will respond immediately and adhere to the American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) guidelines. There was no indication in the policy as to which emergency cart to bring to a code blue. This observation was verified by the Director of Pharmacy during an interview conducted at that time. The Director of Ph

Based on observation, interview and record review, the facility failed to ensure the Condition of Participation for §485.640 was met when facility staff DID NOT:

1) Demonstrate terminal cleaning in (a) the operating room or (b) its work rooms for the sterile processing department according to industry guidelines adopted by the facility (Cross Reference C-1208);
2) Reprocess medical devices and surgical instruments through sterilization according to industry guidelines adopted by the facility (Cross Reference C-1206);
3) Safely transport biohazardous material using the (a) appropriate processes and (b) equipment (Cross Reference C-1206);
4) Monitor air exchanges in the sterile processing department according to industry guidelines adopted by the facility (Cross Reference C-1208);
5) Monitor the humidity and temperature in decontamination areas for the sterile processing department according to industry guidelines adopted by the facility (Cross Reference C-1208).

An IMMEDIATE JEOPARDY (IJ) was identified on 1/23/20, at 5:00 p.m., under Infection Prevention and Antibiotic Stewardship Programs, at C-1208 and C-1206. Administrator and Chief Nursing Officer (CNO) were notified of the IJ on 1/23/20, at 5:44 p.m. The IMMEDIATE JEOPARDY was abated on 1/31/20, at 12:26 p.m. with the Infection Preventionist and Quality Manager present.

Additionally, facility staff DID NOT:

6) Maximize hair coverage when providing patient care and services in the operating room (Cross Reference C-1208);
7) Dispose of biohazardous human waste in patient care areas using a clean and sanitary process (Cross Reference C-1208);
8) Ensure the facility's surgery department participated in the Integrated Quality Management Committee's program for surveillance of infection control practices (Cross Reference C-1237);
9) Ensure up-to-date policies and procedures for the sterile processing department consistent with industry guidelines adopted by the facility (Cross Reference C-1231);
10) Ensure dietary staff wore protective covering to avoid cross contamination while washing and handling dishes (Cross Reference C-1208);
11) Ensure dietary equipment was maintained to avoid cross contamination in refrigerated food storage area (Cross Reference C-1208);

The cumulative effect of these systemic problems resulted in the inadequate surveillance of infection control practices in the facility, as well as the inability to ensure delivery of quality health care services in a safe environment.


38335

Based on observation, interview, and record review, the facility failed to ensure provision of an effective infection control program, and infection control practices were not implemented in accordance with hospital policy and nationally recognized standards when:

1) Facility staff did not reprocess medical devices and surgical instruments through sterilization according to industry guidelines adopted by the facility.
2) Safely transport biohazard material using the (a) appropriate processes and (B) equipment

An IMMEDIATE JEOPARDY (IJ) was identified on 1/23/20, at 5:00 p.m., under Infection Prevention and Antibiotic Stewardship Program, at C-1208 and C-1206. Administrator and Chief Nursing Officer (CNO) were notified of the I on 1/23/20, at 5:44 p.m. The IMMEDIATE JEOPARDY (IJ) was abated on 1/31/20, at 12:26 p.m. with the Infection Preventionist and Quality Manager present.

The cumulative effect of these systemic problems resulted in the inadequate surveillance of infection control practices in the facility, as well as the inability to ensure delivery of quality health care services in a safe environment.

Findings:

1) During a concurrent observation and interview on 1/14/20, at 10:17 a.m., Sterile Processing Department Tech (SPD Tech) H entered Work Room 2 and brought with her a transport bin containing "clean instruments." SPD Tech H stated the facility used Work Room 2 to decontaminate and disinfect soiled endoscopes (or "scopes," a medical device used to look inside the gastrointestinal tract). Work Room 2 housed both clean and dirty scopes. The facility did not use a sign or indicator to distinguish between clean and dirty areas in Work Room 2. New, clean containers meant to hold cleaned and disinfected scopes were located a few millimeters away from a trash receptacle holding soiled containers the dirty scopes once occupied. The room's environment felt warm and muggy. Work Room 2's temperature was 72.5ºF (Fahrenheit). Work Room 2's relative humidity (relative humidity is the percentage of the moisture against the highest possible level of moisture in the air at a specific temperature) was 55%. An oscillating fan was on the counter across from the sink. The fan was off. SPD Tech H stated the facility used another room located in the facility's obstetrics (OB) department to decontaminate surgical instruments.

During an interview on 1/17/20, at 1:30 p.m., Infection Preventionist stated the facility applied guidelines from "APIC" (Association for Professionals in Infection Control and Epidemiologist) and "AORN" (Association of preoperative Registered Nurses) to direct instrument cleaning and sterilization processes in the SPD.

During an interview on 1/17/20, at 3:15 p.m., inside Work Room 2, SPD Tech I stated the facility had removed from Work Room 2 the new, clean containers used to hold cleaned and disinfected scopes. SPD Tech I stated the containers were moved to a "clean area," because Work Room 2 was a "dirty area."

During an observation on 1/17/20, at 3:15 p.m., Work Room 2 contained an oscillating fan on the counter, across from the sink. The fan was on and blowing over the area where an endoscope was processing through mechanical disinfection.

During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer (CNO) stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

During an observation on 1/22/20, at 3:10 p.m., the new, clean containers and covers used to hold cleaned and disinfected scopes were now located inside the clean area of SPD.

During an observation on 1/23/20, at approximately 10:00 a.m., Patient 3 presented for surgery to have an incision and drainage of a surgical wound on her left leg. Patient 3 had surgery performed in the facility's operating room during the first week of January 2020; this was Patient 3's second procedure in January. The need for Patient 3's current surgical procedure arose from an infection to the surgical site after the patient's first surgery. Following the surgery, in OR 2, Surgical Tech S separated the plastic supplies and metal surgical instruments. Surgical Tech S disposed the plastic supplies into the trash. Surgical Tech S then separated the metal instruments into two groups: Instruments used during Patient 3's surgical case, and instruments opened on the surgical field but not used during the case. Surgical Tech S placed the used instrument into a large metal basin. Surgical Tech S placed a medium metal pitcher containing "0.9% Sodium Chloride," otherwise called normal saline, irrigation fluid into the basin, which spilled-out and pooled. Surgical Tech S sprayed a yellow chemical (Prepzyme, a chemical used to prevent biological matter from drying on the instrument's surface) ten times onto the basin and its contents. Surgical Tech S's technique did not cover all instruments with the chemical. Surgical Tech S did not spray the chemical on the instruments opened on the surgical field but not used during the case.

During a concurrent interview and record review on 1/23/20, at 11:05 a.m., Surgery Charge Nurse (SCN) stated a surgical tech was required to spray surgical instruments with Prepzyme after a surgical procedure while the instruments were still in the OR. SCN stated if the instrument was opened on a sterile field but not used, Prepzyme spray is not required. SCN stated the surgical tech must spray instruments "until all instruments are covered." SCN reviewed a photo of the items Surgical Tech S following Patient 3's surgery. SCN stated the photo did not indicate Prepzyme was sprayed to ensure full coverage of instruments. SCN stated if a surgical tech did not fully cover instruments with Prepzyme, then she would request the surgical tech to "spray more."

During an interview on 1/23/20, at or around 3:15 p.m., CNO stated the facility had not reached a point where it reviewed and applied professional and industry guidelines into its policies and procedures for the sterile processing department.

The facility policy and procedure titled, "Cleaning Surgical Instruments Prior to Sterilization," reviewed 8/15/19, indicated multiple workflow processes for preparing instruments for sterilization on a one-page document, including the separation of reusable and disposable instruments, the cleaning and scrubbing of instruments, and the process for sterilization. The policy and procedure indicated a reference to outdated AAMI guidelines: "ANSI/AAMI ST79:2010 & A1 & A2."

The facility policy and procedure titled, "Instrument Care and Cleaning," reviewed 9/17/18, indicated the facility policy "that all surgical instruments shall be properly decontaminated, cleaned, maintained and stored." The policy and procedure did not reference AAMI guidelines.

AAMI guidelines adopted by the facility indicated, "6.2 ... Used, soiled, contaminated instruments, devices, and supplies are sources of microorganisms that could cause infections in personnel or patients." Page 33. ANSI/AAMI ST79:2017.

AAMI guidelines adopted by the facility indicated: "7.2 ... The health care organization should establish policies and procedures for all methods of cleaning and decontamination of reusable items. Process audits to monitor compliance with various policies and procedures should be performed on a scheduled basis, with appropriate follow-up to address problems." Page 39. ANSI/AAMI ST79:2017.

AAMI guidelines adopted by the facility indicated: "3.3.6.4 ... Except for exhaust fans on ventilation systems and properly installed and operated fume control hoods, neither fixed nor portable fans should be permitted in any area of Central Service." Page 28. ANSI/AAMI ST79:2010 & A1 & A2.

AORN guidelines adopted by the facility, published 2018 indicated: "... Instruments should be cleaned and decontaminated in an area separate from locations where clean items are handled. Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items ... . The sterile processing area should have ... separate clean and decontamination spaces ... ." Guidelines for Perioperative Practice. Page 913. AORN, 2018.

Guidelines adopted by the facility indicated: "Instruments that are opened on the sterile field, whether used or not used, during the surgical procedure must be thoroughly decontaminated prior to disinfection and/or sterilization." Standards of Practice for the Decontamination of Surgical Instruments, effective 4/16/09, by the Association of Surgical Technologists.

Guidelines adopted by the facility indicated: "Instruments should never be soaked in saline ... solution. The chloride ions in both solutions are highly corrosive, causing breakdown of the finish on instruments, as well as metal." Standards of Practice for the Decontamination of Surgical Instruments, effective 4/16/09, by the Association of Surgical Technologists.

2a) During a concurrent observation and interview on 1/17/20, at 3:10 p.m., SPD Tech J stated the facility used the same hard, rectangular, plastic bins to transport "dirty and clean" surgical instruments through sterile processing processes. From the OR to Work Room 1, the transport bins contained soiled instruments for decontamination. From Work Room 1 to Work Room 2, the transport bins contained clean instruments intended for further cleaning inside Work Room 2. SPD Tech J stated the facility cleaned the entire transport bin "in between" each sterile processing step, before replacing the instruments inside for relocation and further processing.

During an observation on 1/23/20, between 9:57 a.m. and 10:50 a.m., SPD Tech H entered OR with a plastic container labeled "biohazard." SPD Tech H walked toward two suction canisters connected to a suction machine. SPD Tech H removed each canister and placed them in her biohazard bin. Each canister contained, roughly, a two-liter mixture of "0.9% Sodium Chloride," used for irrigation, and Patient 3's blood. Then, SPD Tech H packaged the metal basin with its soaking instruments, as well as the opened but unsprayed instruments into the biohazard container. SPD Tech H could not close the biohazard container completely after packaging everything. With the container lid ajar, SPD Tech H transported the container on a cart out of OR 2, to Work Room 1. Inside Work Room 1, after rinsing surgical instruments off with tap water, SPD Tech H placed instruments in the sink containing a blue chemical, to soak. SPD Tech H allowed items to soak for 3 minutes. In the meantime, SPD Tech H used a germicidal chemical wipe to clean the interior sides and bottom of the biohazard transport bin. SPD Tech H did not wipe clean the interior top, or the entire exterior of the bin. Eventually, after completing her work in Work Room 1, SPD Tech H repackaged all cleaned items into the biohazard transport container with a dirty interior lid. SPD Tech H left Work Room 1 and continued the sterilization process, delivering the container to Work Room 2.

During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer (CNO) stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

During an interview on 1/23/20, at 3:20 p.m., CNO stated, in regard to the facility's policy development process: "We haven't reached the point where we're incorporating professional standards and guidance into policies for central supply."

The facility policy and procedure titled "Transporting Instruments to be Sterilize," reviewed 1/25/19, did not indicate the process for staff to safely transport soiled instruments through the reprocessing and sterilization process. The policy and procedure indicated no process for cleaning soiled transport bins prior to using the bins to transport clean instruments. The policy and procedure indicated no reference to AAMI guidelines or OSHA.

The facility policy and procedure titled "Medical Waste Management," reviewed 2/6/19, indicated the facility's "Procedures" for "transport" of "biohazardous waste." The policy indicated biohazard waste to include "fluid blood," as well as "equipment containing blood." The policy indicated for staff to use "rigid containers with tight-fitting lids" when transporting biohazard waste.

AAMI adopted by the facility indicated, "6.2 ... Used, soiled, contaminated instruments, devices, and supplies are sources of microorganisms that could cause infections in personnel or patients." Page 33. ANSI/AAMI ST79:2017.

2b) During a concurrent observation and interview on 1/17/20, at 3:10 p.m., SPD Tech J stated the facility used the same hard, rectangular, plastic bins to transport "dirty and clean" surgical instruments through sterile processing processes. From the OR to Work Room 1, the transport bins contained soiled instruments for decontamination. From Work Room 1 to Work Room 2, the transport bins contained clean instruments intended for further cleaning inside Work Room 2's ultrasonic cavitation machine (a machine that uses soundwaves to remove particulate matter from surgical instruments). SPD Tech J stated the facility cleaned its transport bins "in between" each sterile processing step, before replacing the instruments inside for relocation and further processing.

During an interview on 1/17/20, at 3:55 p.m., Facilities Manager stated he did not know whether the facility's transport bins were puncture-proof. Facilities Manager stated the facility had no instructions for use (IFU) for the facility's plastic transport bins. Facilities Manager stated the plastic transport bins were purchased at a "hardware store."

During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

AAMI guidelines adopted by the facility indicated, "6.2 Separation of waste and reusable items at point of use ... At the point of use, ... c) sharps must be placed in puncture-resistant sharps containers that are OSHA compliant." (Association for the Advancement of Medical Instrumentation, 2017. ST79:2017. Page 33.)

OSHA standard indicated, "... [C]ontaminated reusable sharps shall be placed in appropriate containers until property reprocessed. These containers shall be: Puncture resistant ... ." OSHA Standard 1910.1030(d)(2)(viii)(A).

On 1/23/20, the facility provided a product description for its plastic transport container, which indicated no statement regarding the container's relative strength or fitness for puncture.

An IMMEDIATE JEOPARDY (IJ) was identified on 1/23/20, at 5:00 p.m., under Infection Prevention and Antibiotic Stewardship Program, at C-1208 and C-1206. Administrator and Chief Nursing Officer (CNO) were notified of the IJ on 1/23/20, at 5:44 p.m.

The facility's corrective actions (plan of Action or POA) to abate the Immediate Jeopardy included:
A. Two Housekeepers were immediately trained and determined competent to perform terminal cleaning in the surgery and sterile processing areas in accordance with current AAMI and AORN guidelines by 1/30/20.
B. Surgical Services Charge Nurse was assigned the responsibility to ensure Two Central Sterile and Two OR Staff were immediately trained with documented competence to perform surgical instrument cleaning in accordance with current AAMI (2017)/AORN (2018) guidelines by 1/30/20.
C. Lead Central Sterile Technician and Surgical Services Charge Nurse were immediately assigned the responsibility to develop a Central Sterile workflow in accordance with current AAMI (2017)/AORN (2018) guidelines by 1/30/20. Bins used for tranport of surgical instruments to decontamination areas were ordered in accordance with OSHA standards by 1/30/20.
D. Plant Operations Manager was immediately assigned the responsibility to develop and implement a schedule for monitoring air exchange in the OR and sterile processig areas by 1/29/20.
E. Surgery Services Charge Nurse was immediately assigned the responsibility to develop and implement a schedule for monitoring temperature and humidity in the decontamination areas by 1/29/20.

The IMMEDIATE JEOPARDY was abated on 1/31/20, at 12:26 p.m. with the Infection Preventionist and Quality Manager present.

Based on observation, interview, and record review the facility failed to ensure provision of an effective infection control program, and implement infection control practices in accordance with hospital policy and nationally recognized standards when:

1) Facility staff did not demonstrate terminal cleaning in (a) the operating room or (b) its work rooms for the sterile processing department according to industry guidelines adopted by the facility
2) Air-exchanges were not monitored in the sterile processing department according to industry standards adopted by the facility
3) Humidity and temperatures were not monitored in the decontamination areas for the sterile processing department according to industry guidelines adopted by the facility

An IMMEDIATE JEOPARDY (IJ) was identified on 1/23/20, at 5:00 p.m., under Infection Prevention and Antibiotic Stewardship Program, at C-1208 and C-1206. Administrator and Chief Nursing Officer (CNO) were notified of the IJ on 1/23/20, at 5:44 p.m. The IMMEDIATE JEOPARDY (IJ) was abated on 1/31/20, at 12:26 p.m. with the Infection Preventionist and Quality Manager present.

4) Hair coverage was not maximized when providing patient care and services in the operating room
5) Biohazardous human waste was not disposed in patient care areas using a clean and sanitary process
6) Dietary staff did not wear protective covering to avoid cross contamination while washing and handling dishes
7) Dietary equipment was not maintained to avoid contamination of food in refrigerated storage area

The cumulative effect of these systemic problems resulted in the inadequate surveillance of infection control practices in the facility, as well as the inability to ensure delivery of quality health care services in a safe environment.

Findings:

1a) During an interview on 1/13/20, at 8:00 a.m., Interim Surgery Manager stated variable facility staff cleaned its operating room during a day. Interim Surgery Manager stated, "techs and nurses" cleaned the surgical suite and procedure room "during the day," and "housekeeping" performed "terminal cleaning" of surgical suites "in the later evening." Interim Surgery Manager stated staff who terminally cleaned learned from "other staff." Surgery Manager stated, "nurses and techs [taught] nurses and techs." Surgery Manager stated he also provided management over the facility's Sterile Processing Department (SPD). (The department of a hospital responsible for cleaning and sterilizing surgical devices used for surgery).

During an interview on 1/14/20, at 10:00 a.m., Interim Surgery Manager provided a tour of one SPD work room (Work Room 2) where SPD staff processed soiled endoscopes (or "scopes," an optical medical device used to look into a patient's digestive tract) to disinfect them for patient care.

During an interview on 1/14/20, at 5:30 p.m., Infection Preventionist stated he supervised the facility's housekeeping services, as well as imaging, lab, respiratory therapy, and ambulance services. Infection Preventionist stated the facility had trained "two of [its] three" housekeeping staff to terminally clean surgery suites.

During an observation on 1/14/20, from 5:40 p.m. until 6:30 p.m., Housekeeper G performed a terminal cleaning (cleaning that occurs at the end of the day to control the spread of infections) of operating room (OR) 2. During the terminal cleaning of OR 2, Housekeeper G did not use a top-to-bottom method (a method for cleaning used to ensure dirt and debris fall to the floor and minimize transfer of dirt and debris from the floor to higher, cleaner areas of the room) to clean the walls. Housekeeper G did not clean the ceiling. Housekeeper G did not clean the light fixtures on the ceiling. Housekeeper G cleaned the "trash" bin prior to cleaning the surgery table. After Housekeeper G cleaned the pads for the surgery table, Housekeeper G placed each pad on a countertop to dry. Each pad did not stay wet for 10 minutes.

During an interview on 1/14/20, at 6:30 p.m., Housekeeper G stated the chemical she used to clean required a "10 minute" dwell time (the amount of time a surface must remain wet with chemical solution) to disinfect the surface; "Leave it wet, so it kills the bacteria."

During a concurrent interview and record review on 1/15/20, at 5:20 p.m., Infection Preventionist stated he supervised housekeeping services at the facility. Infection Preventionist was presented two policies for terminal cleaning of surgical suites; one for housekeeping, the other for nursing services. Infection Preventionist stated the facility's housekeepers applied the housekeeping policy when performing a terminal cleaning of the operating room.

During a concurrent interview and record review on 1/17/20, at 11:30 a.m., Infection Preventionist stated he misspoke during the earlier interview about terminal cleaning policies. Infection Preventionist stated housekeepers utilized the "procedures" within the nursing policy for terminal cleaning the operating room. The Infection Preventionist stated housekeeping's policy was "meant to be part of" nursing's policy. However, Infection Preventionist reviewed both policies and stated neither policy referenced the other.

During an interview on 1/22/20, between 2:15 p.m. and 3:10 p.m., Surgery Charge Nurse (SCN) stated both nurses and housekeepers cleaned the operating room. SCN stated either the facility's surgery charge nurse or surgery manager supervised housekeeping's cleaning of the facility's operating room. SCN stated the facility's surgery department no longer had a manager. SCN stated she validated housekeeping performed daily terminal cleaning of the operating room by making observations each morning, before surgery. SCN stated housekeeping also recorded its daily cleaning on a weekly log form but stated she did not use the log form to verify daily cleaning. SCN stated nursing's responsibilities for cleaning the operating room were different than housekeeping's. SCN stated nursing staff used germicidal "wipes" to disinfect the "table/bed," "computer," "equipment," and mayo "tables" (a surgical table meant to hold instruments and supplies) between surgical cases, and after the final case of the day. SCN also stated the "surgery team" performed a "pre-clean" in the morning to ensure the operating room was ready for the day's first case. SCN stated if she identified an issue with housekeeping's terminal cleaning, then she would notify the facility's Infection Preventionist.

During an interview on 1/22/20, between 4:05 p.m. and 4:30 p.m., Housekeeper M stated she was the "lead" housekeeper at the facility. Housekeeper M stated past nurse managers in the surgery department trained Housekeeper G on how to terminally clean the operating room. Housekeeper M stated Housekeeper G trained her on how to terminally clean the operating room. Housekeeper M was unsure whether the facility maintained a policy to describe how and when housekeepers must clean the operating room. Housekeeper M stated, "there was [a policy] ... three years ago. I think [Infection Preventionist] has the policy because [Infection Preventionist] took over housekeeping." Housekeeper M stated the facility's housekeepers terminally cleaned the SPD areas "the same" way as housekeepers terminally cleaned the operating room. Housekeeper M stated she knew housekeeping staff terminally cleaned consistently with applicable industry guidelines because "[the facility] trained us," and Housekeeper M viewed streaming videos on "YouTube" and "the Internet," not pursuant to supervisor directive.

During an interview on 1/22/20, at 4:30 p.m., in the presence of SCN, Quality Manager stated the facility identified a concern with its OR cleaning processes in "April" of 2019. Quality Manager stated the facility performed a root cause analysis (RCA, an investigation tool used to identify the root cause of an issue) based on the concern. Quality Manager stated the concern was not escalated to the facility's Integrated Quality Management Committee (IQMC), but the facility "closed surgery" for a week to "study the issue."

During an interview on 1/22/20, at 4:46 p.m., Infection Preventionist stated the facility maintained "no document" to indicate the facility deemed Housekeepers G and M competent to terminally clean the surgical suites or SPD prior to tasking them with the responsibility.

During an observation on 1/22/20, from 5:40 p.m. until 6:50 p.m., Housekeeper G (with Housekeeper M present) performed a terminal cleaning of OR 2. During the terminal cleaning of OR 2, Housekeeper G did not use a top-to-bottom for cleaning the walls. At times, Housekeeper G cleaned the walls bottom-to-top, and applied broad, lateral strokes along the walls with her cleaning brush. Housekeeper G cleaned the ceiling air ducts and light fixtures after cleaning the walls. Housekeeper G did not clean the ceiling. Housekeeper G cleaned the surface of each door, but the surface of OR 2's main door dried in less than 10 minutes. Through the period of observation, Housekeeper G used the same chemical disinfectant as she used during the observation of terminal cleaning on 1/14/20.

During an interview on 1/23/20, at 2:05 p.m., CNO stated she had been with the facility for two-and-one-half years as the facility's nursing leader. CNO stated she was responsible for OR and SPD processes in the absence of an OR manager. CNO stated she tasked SCN to provide direction (e.g. "give assignments" to staff and cover "lunch and break") to OR and SPD staff. CNO stated she hoped the arrangement could "provide identified leadership" in both work settings. CNO stated the facility staffed "travelers" in the OR manager role since "Fall 2017."

During an interview on 1/23/20, at 3:12 p.m., Infection Preventionist stated the housekeeping staff applied guidelines from the Association of periOperative Registered Nurses (AORN) for cleaning in the operating room.

During a concurrent interview and record review on 1/24/20, at 11:35 a.m., Quality Manager, Infection Preventionist, CNO and Facilities Manager were present to discuss the facility's (IQMC) and review IQMC records. Quality Manager stated the facility's surgery department was the only work setting to not participate in IQMC's process improvement and infection control monitoring during calendar years 2019. Quality Manager stated, "All other work settings reported." CNO stated, "Not having managers in the department complicated," the surgery department's engagement.

The facility instruction for use (IFU) titled, "How to Use Vesphene IIse," (a germicidal detergent), dated 6/1998, indicated the process housekeepers followed to prepare the facility's chemical used to clean the walls, floor, and equipment in the operating room during a terminal cleaning. The IFU indicated the chemical required staff to ensure surfaces cleaned with the chemical "remain[ed] wet for 10 minutes" to be effective.

The facility policy and procedure titled "Environmental Cleaning: Intraoperative," reviewed 4/18/19, indicated it applied to the, "nursing, surgical services," departments. The policy indicated a comprehensive process for "environmental cleaning in operating and procedure rooms." The policy indicated references to outdated industry guidelines from AORN. The policy indicated the following definition for terminal cleaning: "Thorough environmental cleaning that is performed at the end of each day when the area is being used." The policy indicated the facility would ensure "perioperative personnel performing environmental cleaning of intraoperative areas ... will receive education and complete competency verification activities on the principles and processes of environmental cleaning ...."

The facility policy and procedure titled, "Cleaning of the Operating Room by Housekeeping Department Staff," reviewed 9/6/18, indicated it applied to the "housekeeping" department. The policy indicated a one-page review of "procedures" housekeeping staff must implement when cleaning "the [operating room] suite and the [Sterile Processing Department] after the daily surgery schedule is completed." The policy indicated no reference to industry guidelines adopted by the facility.

The facility policy and procedure titled, "Environmental Cleaning and Disinfection," reviewed 8/15/19, indicated it applied to the "Infection Prevention" department. The policy indicated "Terminal cleaning of each operating and procedure room will be completed daily ...." The policy did not indicate those cleaning the operating room should clean its ceiling or ceiling vents. The policy did not indicate the facility desired method for cleaning its operating room (e.g., cleaning dirty areas last, or using a top-to-bottom process when cleaning the walls). The policy did not indicate any reference from AORN.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Disinfectants should be applied and reapplied as needed, per manufacturers' instructions, for the dwell time required to kill the targeted microorganism." Pg. 11.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used." Pg. 14.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Cleaning an area in a methodical pattern establishes a routine for cleaning so that items are not missed during the cleaning process." ... "Cleaning should progress from clean to dirty areas." ... "Cleaning should progress from top to bottom areas. During cleaning of top areas, dust, debris, and contaminated cleaning solutions may contaminate bottom areas." Pg. 17.

AORN guidelines adopted by the facility titled, Guidelines for Perioperative Practice," published 2018, indicated "Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the health care organization's plan to improve understanding of and compliance with the principles of processes of environmental cleaning." Pg. 22.

1b) During a concurrent observation and interview on 1/22/20, between 3:10 p.m. and 4:00 p.m., in and around surgical process department (SPD) areas, SPD Techs H and I, and SCN were present. While inside the Clean Work Room for SPD, SPD Tech I stated SPD staff cleaned SPD areas daily. SPD Tech I stated she wiped everything with a "purple top" disinfectant cloth "when I get here" in the morning. SPD Tech H stated she "wipe[d] everything down" before leaving at night. SPD Tech I arrived to work one hour before, and left work one hour before SPD Tech H. SPD Tech H stated she knew housekeeping was responsible for cleaning SPD areas, too. SPD Tech H stated housekeeping is tasked to "mop" and remove "garbage," but "that's all I know" about housekeeping's responsibilities. Despite daily cleaning, horizontal surfaces in the Clean Work Room remained dirty. Dust was observed on portions of the countertop, on the top surface of the endoscope storage cabinet, and on top of the cover for the steam sterilizer. Also, black particles of unidentified matter accumulated on the top of the cover protecting a cart of sterilized surgical trays under an air duct in the storage area. While inside Work Room 2 for SPD, SPD Tech H stated SPD staff performed a light dust of Work Room 2 daily. Despite this cleaning, heavy dust was visible on the tops of cabinet doors, and light dust was visible on portions of the countertop.

During an interview on 1/22/20, between 4:05 p.m. and 4:30 p.m., Housekeeper M stated she was the "lead" housekeeper at the facility. Housekeeper M stated past managers of the surgery department trained Housekeeper G how to terminally clean surgical suites. Housekeeper M stated Housekeeper G trained her how to terminally clean surgical suites. Housekeeper M was unsure whether the facility maintained a policy that described how and when to clean surgical suites. Housekeeper M stated, "there was [a policy] ... three years ago. I think maybe [Infection Preventionist] has the policy because [Infection Preventionist] took over housekeeping." Housekeeper M stated the facility's housekeepers terminally cleaned SPD areas "the same" way as housekeepers terminally clean the surgical suites. Housekeeper M stated she knew housekeeping staff terminally cleaned in harmony with applicable industry guidelines because "[the facility] trained us," and because she viewed online streaming videos on "YouTube" and "the Internet," but not pursuant to any facility direction. Regarding terminal cleaning in Work Room 2, Housekeeper M stated housekeeper did not disinfect all walls, but "only dust[ed]" far wall (opposite the doorway) because the "wall is hard to clean." Housekeeper M stated housekeepers would also clean the 2"x4" (two inches by four inches) pieces of exposed wood secured to the far wall.

During a interview on 1/22/20, at 4:30 p.m., in the presence of SCN and the Infection Preventionist, Quality Manager stated that in "April" 2019 SCN identified "unclean surfaces" in the OR prior to surgery. Quality Manager stated the facility performed a root cause analysis (RCA) concerning OR cleaning processes and "closed surgery" for a week because of the cleaning concern. Quality Manager stated the facility "stud[ied] the issue" over that week before reopening surgical services. Quality Manger stated the concern was not formally presented to the facility's Integrated Quality Management Committee (IQMC) for continued discussion, management, or monitoring.

During an interview on 1/22/20, at 4:46 p.m., Infection Preventionist stated the facility maintained "no document" to indicate the facility deemed Housekeepers G and M competent to terminally clean the surgical suites or SPD prior to tasking them with the responsibility.

During a concurrent observation and interview on 1/22/20, from 6:50 p.m. until 7:15 p.m., Housekeeper G (with Housekeeper M present) performed a terminal cleaning of the SPD's Work Room 2. Housekeeper G cleaned the exterior glass surface of the cabinets above the countertops. Housekeeper G did not clean the top of each cabinet door. Housekeeper G did not clean the surface of the lower cabinets, below the countertops. Housekeeper G did not clean portions of the countertop covered by cleaning equipment and plastic transport bins. Housekeeper G did not clean the far wall (opposite the doorway), or the 2"x4" pieces of exposed wood secured to the far wall. Housekeeper G did not clean the ceiling. After mopping the floor, Housekeeper G stated she had "nothing else" to clean in Work Room 2 until "the end of the month." Housekeeper G did not clean Work Room 2's door handle. Housekeeper G stated the facility cleaned the walls of the Clean Work Room "every month," and the walls of Work Room 2 "daily." Housekeeper M stated neither she nor Housekeeper G were not responsible for cleaning SPD's Work Room 1, as that responsibility was tasked to a third housekeeper.

During a concurrent observation and interview on 1/22/20, from 7:15 p.m. until 7:40 p.m., Housekeeper G (with Housekeeper M present) performed a terminal cleaning of the SPD's Clean Work Room. Housekeeper G did not clean the walls, ceiling, or vents. Housekeeper G cleaned horizontal surfaces, such as the countertops and work surfaces, using a chemical with a dwell time (wet contact time) of "ten minutes." Housekeeper G was unable to clean all portion of the countertops because cleaned items packaged for sterilization were batched, covering most available counter space and awaiting sterilization the next day. Housekeeper M stated "I think the people who work here wipe the tables and everything," and added housekeeping was responsible to "give [their work] a little touch-up." Housekeeper G concluded terminal cleaning of the Clean Work Room after mopping its floor.

During an interview on 1/23/20, at 10:55 a.m., in the presence of SPD Tech H, SPD Tech I stated SPD techs and housekeepers both cleaned SPD areas, but the facility had not defined how each discipline must share responsibilities. SPD Tech I stated the SPD department did not define the environmental cleaning duties for which SPD techs were responsible, or the duties for which housekeepers were responsible. SPD Tech I stated SPD techs "wiped down" all work surfaces and carts, such as the "[work] table" and the "counter[tops]," daily. Together, neither SPD Tech H nor SPD Tech I could vocalize how they verified housekeeping performed cleaning in all SPD areas as required. SPD Tech H and SPD Tech I vocalized they would "contact housekeeping" if they identified a concern with housekeeping's cleaning in SPD areas. SPD Tech I stated, "no one's ever asked that" of her.

During an interview on 1/23/20, at 2:05 p.m., CNO stated she had been with the facility for two-and-one-half years as the facility's nursing leader. CNO stated she was responsible for OR and SPD processes in the absence of an OR manager. CNO stated she tasked SCN to provide direction (e.g. "give assignments" to staff and cover "lunch and break") to OR and SPD staff. CNO stated she hoped the arrangement could "provide identified leadership" in both work settings. CNO stated the facility staffed "travelers" in the OR manager role since "Fall 2017."

During an interview and record review on 1/24/20, at 11:30 a.m., Quality Manager, Infection Preventionist, CNO, and Facilities Manager were present to discuss the facility's IQMC. Quality Manager stated the surgery department was the only department to not make a single report to the IQMC over 2019. CNO stated "not having manager in the department complicated the [non-reporting] issue."

The facility policy and procedure titled "Environmental Cleaning and Disinfection," reviewed 8/15/19, indicated it applied to the "Infection Prevention" department. The policy indicated "Terminal cleaning of each operating and procedure room will be completed daily ...." The policy indicated facility staff to clean SPD, or "reprocessing and other sterile storage areas," pursuant to a different method and schedule than for OR cleaning. The policy indicated facility staff to clean SPD some parts of SPD daily, other parts weekly, and other parts monthly. The policy did not indicate facility staff to terminally clean SPD. The policy did not indicate a reference to AORN guidelines.

AAMI guidelines adopted by the facility, published 2010, indicated: "3.4 ... Housekeeping procedures in areas used for any aspect of decontamination, preparation, or sterilization should be the same as those used to clean operating and delivery rooms and should ensure a high level of cleanliness at all times." ANSI/AAMI ST79:2010 & A1 & A2.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Sterile processing personnel conduct critical processes ... in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical or other invasive procedures are performed." Pg. 16.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Disinfectants should be applied and reapplied as needed, per manufacturers' instructions, for the dwell time required to kill the targeted microorganism." Pg. 11.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "A protective barrier covering should be used to protect ... surfaces if the surface cannot withstand disinfection. ... [This] provides a mechanism to prevent surfaces from becoming a reservoir for microorganisms." Pgs. 11-12.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Terminal cleaning and disinfection of perioperative areas, including sterile processing areas, should be performed daily when the areas are being used." Pg. 14.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "During cleaning of sterile processing areas, the clean work areas [such as Clean Work Room] should be cleaned before the dirty work areas [such as Work Rooms 1 and 2] to reduce the possibility of contaminating the clean areas." Pg. 16.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Cleaning an area in a methodical pattern establishes a routine for cleaning so that items are not missed during the cleaning process." ... "Cleaning should progress from clean to dirty areas." ... "Cleaning should progress from top to bottom areas. During cleaning of top areas, dust, debris, and contaminated cleaning solutions may contaminate bottom areas." Pg. 17.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Policies and procedures for environmental cleaning processes and practices should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting." Pg. 22.

2) During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer (CNO) stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

During an interview on 1/17/20, at 3:55 p.m., Facilities Manager stated the facility performed an "annual" air exchange test in the OR and SPD areas. Facilities Manager stated an "outside company" performed the test. Facilities Manager stated facility staff were not responsible to perform air exchange tests.

During an interview on 1/24/20, at 8:53 a.m., Chief Nursing Officer (CNO) stated she spoke with Facilities Manager, who informed her the facility did not test air exchanges (the rate of air changes per hour, used to evaluate the air quality provided by a ventilation system) in the SPD.

Review of electronic correspondence dated 1/21/20, at 11:44 a.m., between the California Department of Public Health (CDPH) and CNO, indicated CNO spoke to facilities manager, who "told [CNO] he was in error about having an annual report for an air exchange test, he was thinking of the medical gas annual test."

AAMI guidelines adopted by the facility, published 2010, indicated: "3.3.6.4 ... Ventilation requirements for function areas," which required "soiled/decontamination" areas, such as Work Rooms 1 and 2, to have "negative" airflow. The adopted guideline indicated the facility had to ensure a "minimum number" of "10" air exchange per hour in those areas. The guidelines indicated an "AAMI committee" judged 10 air exchanges per hour to be the minimum necessary to effectively reduce environmental contamination by means of air dilution. Page 28. ANSI/AAMI ST79:2010 & A1 & A2.

3) During a concurrent observation and interview on 1/14/20, at 10:25 a.m., SPD Tech H provided a tour of Work Room 1. Work Room 1 was in a dirty utility room within the facility's obstetrics department, about a one-to-two-minute walk from the surgery department. SPD Tech H stated the facility had used Work Room 1 since 2017 to decontaminate and process all surgical instruments for sterilization. SPD Tech H stated the facility had chosen that utility room to process instruments for sterilization because associated processes required the room's "double sink," to "clean" and "rinse" instruments. No thermometer or other device to monitor the room's humidity or temperature was visible inside the room.

During a concurrent observation and interview on 1/17/20, at 3:00 p.m., SPD Tech J stated the facility used Work Room 1 to decontaminate surgical instruments, and Work Room 2 to decontaminate endoscopes (or "scopes," an optical medical device used to observe a patient's digestive tract). An electronic device monitoring relative temperature and humidity was inside Work Room 2. The device indicated Work Room 2's temperature was 77.2ºF, and its relative humidity was 46%.

During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer (CNO) stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

Review of electronic correspondence dated 1/21/20, at 11:44 a.m., between the California Department of Public Health (CDPH) and CNO, indicated the facility's CNO provided CDPH with an "updated form" for humidity and temperature monitoring for "the dirty room back in [obstetrics]," or Work Room 1.

During an observation on 1/23/20, at 10:20 a.m., no temperature or humidity monitor was present in Work Room 1.
AAMI guidelines adopted by the facility, published 2010, indicated: "3.3.6.5 ... The decontamination area[s of SPD] should have a temperature controlled between ... (60ºF and 65 ºF)." Page 29. ANSI/AAMI ST79:2010 & A1 & A2.

AAMI guidelines adopted by the facility, published 2010, indicated: "3.3.6.6 ... Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area, where the relative humidity should not exceed 70%. Relative humidity should be recorded daily. Page 29. ANSI/AAMI ST79:2010 & A1 & A2.

An IMMEDIATE JEOPARDY (IJ) was identified on 1/23/20, at 5:00 p.m., under Infection Prevention and Antibiotic Stewardship Program, at C-1208 and C-1206. Administrator and Chief Nursing Officer (CNO) were notified of the IJ on 1/23/20, at 5:44 p.m.

The facility corrective actions (plan of Action or POA) to abate the Immediate Jeopardy included:
A. Two Housekeepers were immediately trained and determined competent to perform terminal cleaning in the surgery and sterile processing areas in accordance with current AAMI and AORN guidelines by 1/30/20.
B. Surgical Services Charge Nurse was assigned the responsibility to ensure Two Central Sterile and Two OR Staff were immediately trained with documented competence to perform surgical instrument cleaning in accordance with current AAMI (2017)/AORN (2018) guidelines by 1/30/20.
C. Lead Central Sterile Technician and Surgical Services Charge Nurse were immediately assigned the responsibility to develop a Central Sterile workflow in accordance with current AAMI (2017)/AORN (2018) guidelines by 1/30/20. Bins used for tranport of surgical instruments to decontamination areas were ordered in accordance with OSHA standards by 1/30/20.
D. Plant Operations Manager was immediately assigned the responsibility to develop and implement a schedule for monitoring air exchange in the OR and sterile processing areas by 1/29/20.
E. Surgery Services Charge Nurse was immediately assigned the responsibility to develop and implement a schedule for monitoring temperature and humidity in the decontamination areas by 1/29/20.

The IMMEDIATE JEOPARDY (IJ) was abated on 1/31/20, at 12:26 p.m. with the Infection Preventionist and Quality Manager present.

4) During an interview on 1/14/20, at 11:05 a.m., Interim Surgery Manager stated the facility used "AORN" (Association of periOperative Registered Nurses) guidelines to develop the facility policies for surgical attire.

During an observation on 1/23/20, at 8:36 a.m., Nurse P was inside the operating room, a restricted area (a designated area contained within a semi-restricted area (e.g., the peripheral support areas for surgery, such as locations of scrub washing sinks and the sterile processing department), such as an operating room), where Patient 3 was being prepped for surgery. Nurse P was wearing scrub bottoms and a scrub top. Nurse P's scrub top was short-sleeved and had a V-neck opening at the chest. Nurse P's arms were exposed. Nurse P's chest hair flowed out from the V-neck opening. Nurse P's clothing did not restrain the chest hair. During the time of observation, the surgeon and his assistant removed butterfly closures along the patient's incision site, and began reopening the incision site for inspection, irrigation, and tissue culture.

During an observation on 1/23/20, at 8:57 a.m., Nurse P was inside the surgical suite where Patient 3 was undergoing her operation. Nurse P wore short sleeves. Nurse P's chest hair flowed out from the V-neck opening. Nurse P'

Based on interview, and record review the facility failed to ensure hospital policies and procedures for the sterile processing department were up-to-date and consistent with professional standards of practice as evidenced by:

1) Facility staff did not follow or practice current professional standards of practice for sterile processing processes. This failure potentially caused an increase in transmission of infection.

Findings:

1) During an interview on 1/17/20, at 1:30 p.m., Infection Preventionist stated the facility applied guidelines from "APIC" (Association for Professionals in Infection Control and Epidemiology) and "AORN" (Association of periOperative Registered Nurses) to direct instrument cleaning and sterilization processes in the SPD.

During an interview on 1/17/20, at 3:30 p.m., Chief Nursing Officer (CNO) stated the facility applied AAMI (The Association for the Advancement of Medical Instrumentation, an organization who provides recommended practices and standards on the use, care, and processing of medical devices) guidelines for the facility's sterile processing processes.

During an interview on 1/23/20, at 2:05 p.m., CNO stated she had been with the facility for two-and-one-half years as the facility's nursing leader. CNO stated she was responsible for OR and SPD processes in the absence of an OR manager. CNO stated she tasked SCN to provide direction (e.g. "give assignments" to staff and cover "lunch and break") to OR and SPD staff. CNO stated she hoped the arrangement could "provide identified leadership" in both work settings. CNO stated the facility staffed "travelers" in the OR manager role since "Fall 2017."

During an interview on 1/23/20, at or around 3:15 p.m., CNO stated the facility had not reached a point where it reviewed and applied professional and industry guidelines into its policies and procedures for the sterile processing department.

During a concurrent interview and record review on 1/24/20, at 11:35 a.m., Quality Manager, Infection Preventionist, CNO and Facilities Manager were present to discuss the facility's (IQMC) and review IQMC records. Quality Manager stated the facility's surgery department was the only work setting to not participate in IQMC's process improvement and infection control monitoring during calendar years 2019. Quality Manager stated, "All other work settings reported." CNO stated, "Not having managers in the department complicated," the surgery department's engagement.

AAMI guidelines adopted by the facility, published 2010, indicated: "3.4 ... Housekeeping procedures in areas used for any aspect of decontamination, preparation, or sterilization should be the same as those used to clean operating and delivery rooms and should ensure a high level of cleanliness at all times." ANSI/AAMI ST79:2010 & A1 & A2.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Sterile processing personnel conduct critical processes ... in support of operating and invasive procedure rooms. As such, the recommendations for terminal cleaning apply in sterile processing areas as in areas where surgical or other invasive procedures are performed." Pg. 16.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Policies and procedures for environmental cleaning processes and practices should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting." Pg. 22.

AORN guidelines adopted by the facility titled, "Guidelines for Perioperative Practice," published 2018, indicated "Policies and procedures for cleaning and care of instruments used in surgery should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting in which they are used."

Based on observation, interview, and record review, the facility failed to maintain an effective QAPI program for infection prevention and control issues in a manner that ensured patient safety when:

1) The surgery department did not participate in Integrated Quality Management Committee's program for surveillance of infection control practices.

Findings:

1) During an interview on 1/22/19, at 4:30 p.m., in the presence of SCN and the Infection Preventionist, Quality Manager stated the in "April" 2019 SCN identified "unclean surfaces" in the OR prior to surgery. Quality Manager stated the facility performed a root cause analysis (RCA) concerning OR cleaning processes and "closed surgery" for a week because of the cleaning concern. Quality Manager stated the facility "stud[ied] the issue" over that week before reopening surgical services. Quality Manger stated the concern was not formally presented to the facility's Integrated Quality Management Committee (IQMC) for continued discussion, management, or monitoring.

During a concurrent interview and record review on 1/24/20, at 11:35 a.m., Quality Manager, Infection Preventionist, CNO and Facilities Manager were present to discuss the facility's (IQMC) and review IQMC records. Quality Manager stated the facility's surgery department was the only work setting to not participate in IQMC's process improvement and infection control monitoring during calendar years 2019. Quality Manager stated, "All other work settings reported." CNO stated, "Not having managers in the department complicated," the surgery department's engagement.

The facility's bylaws titled "Mendocino Coast Health Care District Bylaws," revised 1/2019, indicated the hospital did not have a standing committee for quality. The facility bylaws indicated the health care district board of directors did not have direct oversight over quality and quality matters.

The medical staff's bylaws titled "Mendocino Coast District Hospital Medical Staff Bylaws," revised 2016, indicated the facility's IQMC was a medical staff quality committee. The bylaws indicated the Infection Preventionist was not vested with a right to vote on committee business. The bylaws indicated IQMC had a responsibility to "develop and maintain a protocol that will ensure constant surveillance of all potential sources of hospital infections."

The facility policy and procedure titled "IQMC Infection Control Authority," reviewed 6/19/19, indicated the health care district board of directors delegated "administrative authority, responsibility, and accountability of implementing" the facility's "established policies and procedures governing infection control" to IQMC. The policy did not delegate authority to identify, develop, or establish new policies concerning infection control practices in the facility.