HospitalInspections.org

Based on observation, interview and record review, the governing body failed to ensure:

A. a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations when:

A. At the Parnassus Campus:


1. There was no evidence of daily cleaning/maintenance for three of three sterilizer machines (machines used to sterilize reusable surgical instruments), and two of two instrument and cart washers, per manufacture instructions;

2. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, staining, and torn color coded tape, on multiple instruments in two of two processed surgical trays (a biopsy tray and a basic instrument set) which had contained previously cleaned, disinfected and sterilized surgical instruments;

3. There was no evidence of terminal cleaning (a cleaning method performed on a daily basis, in healthcare environments to control the spread of infections) of the hospitals sterile processing department, and the decontamination room at the Parnassus Campus, the operating rooms and high level disinfecting rooms at the Mount Zion Campus;

4. There was no evidence to indicate blood pressure cuffs used for multiple patients, in the endoscopy department (an area where medical procedures are performed specific to the digestive tract and genitourinary system) were intended to be used as multi-patient use;

5. Four (4) operating room (OR) staff (OR RN 1, 2, Perfusionist 1 & OR MD 1) did not wear proper OR attire and had exposed arms during a surgical procedure;

6. One (1) anesthesiologist (a doctor who specializes in administering medications that provide total or partial loss of sensation during surgical procedures) prepared a lactated ringer intravenous (IV) solution and an IV start kit, during a surgical procedure, for a following case;

7. Five (5) of 5 surgical instrument washer trolleys ' contained tubing and plastic bottles which were covered in black substance that was easily removed when wiped off;

8. The Trophon (a machine used for the high level disinfection of ultrasound probes) in Radiology Room 3, of the Parnassus Campus,which was also used as a patient exam room, was not located in an area as stipulated in the manufacture user manual.

B. At the Mt. Zion Campus

1. The hospital failed to ensure the sterile processing department and the perioperative department followed the manufacturer's IFUs for daily and weekly cleaning of nine of nine autoclaves (machines used to sterilize surgical instruments), and two of two instrument washers;

2. Surgical instruments, ready for use in surgery, did not meet manufacturer's instructions for use or national infection control standards.

3. The hospital failed to provide evidence to show their Sterile Processing Departments, Decontamination Room, Perioperative Department, and all high level disinfectant areas were terminally cleaned on a daily basis;

4. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards;

5. The hospital failed to ensure the hospitality department followed the manufacturer 's instructions for use (IFUs) for the product's contact time;

6. The hospital failed to ensure the eye wash stations in the outpatient areas were in compliance with infection control standards and in a manner to prevent cross contamination.

C. At the Mission Bay

1. Surgical instruments, ready for use in surgery, did not meet manufacturer's instructions for use or national infection control standards;

2. Terminal cleaning was not performed daily in the sterile processing areas of the facility;

3. The surfaces of surgical table mattresses contained sticky tape residue that prohibited the disinfection during turnover or terminal cleaning;

4. Employees (Employee 2, 3, and 4), in semi-restricted and restricted areas of the facility did not follow facility policy or nationally recognized infection control standards for surgical attire.


B. the provision of pharmaceutical services and care met the needs of the patients as evidenced by (Refer to A 489):

1) 20 out of 27 IV (intravenous, injected through the vein) compounded (mixed) sterile (germfree) preparations (CSP) were assigned extended BUD's (beyond use dates after which a preparation should not be used) without conducting appropriate stability studies. These CSP's were compounded at Mission Bay Campus Owens pharmacy and distributed to Mission Bay Campus, Parnassus Campus and Mt. Zion campus. This failure had the potential of exposing patients to ineffective treatments;

2) Hospital failed to consistently implement the policy and procedure on the safe distribution of high risk/high alert medications. Bags of sodium chloride 3% injection solution, a hypertonic (higher osmotic pressure than a body fluid or intracellular fluid) saline for fluid and electrolyte replenishment, were not packaged and labeled in accordance with the hospital medication management policy and procedure on high-risk medications. This could lead to preventable errors (such as unintentional use due to selection error);

3) Undated opened single dose vials and containers were observed in two of three hospital campuses in the compounding isolators (equipment used for compounding);

4) Two of two pharmacy staff working in the hazardous (for example chemotherapy drugs used to treat cancer) drug compounding room at Mission Bay Campus and one staff at Parnassus Campus were observed not donning (putting on) and doffing (removing) personal protective equipment (PPE) per policy;
5) Pressure readings in the 3rd floor hazardous drug compounding room were not documented per policy at the Mission Bay Campus;

6) Single dose IV (intravenous, injected through the vein) bags of saline solution were pre-spiked (when IV bag is punctured and tubing is attached for administration) and given a BUD (beyond use date after which a product should not be used) of 24 hours in the adult infusion center at Mission Bay Campus;

7) Expired medications were available for patient use and opened undated multi dose vials were observed in the pharmacy and patient care areas. The failure had the potential for patients to be given expired, contaminated or ineffective medications;


8) Drugs were not stored in accordance with manufacturers' direction. Injectable vials of Tysabri (medication used in the treatment of multiple sclerosis and Crohn's disease) were not protected from light as indicated by the manufacturer's storage condition;


The cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality health care in a safe environment.

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

1) 20 out of 27 IV (intravenous, injected through the vein) compounded (mixed) sterile (germfree) preparations (CSP) were assigned extended BUD's (beyond use dates after which a preparation should not be used) without conducting appropriate stability studies. These CSP's were compounded at Mission Bay Campus Owens pharmacy and distributed to Mission Bay Campus, Parnassus Campus and Mt. Zion campus. This failure had the potential of exposing patients to ineffective treatments (refer to-A500).

2) Hospital failed to consistently implement the policy and procedure on the safe distribution of high risk/high alert medications. Bags of sodium chloride 3% injection solution, a hypertonic (higher osmotic pressure than a body fluid or intracellular fluid) saline for fluid and electrolyte replenishment, were not packaged and labeled in accordance with the hospital medication management policy and procedure on high-risk medications. This could lead to preventable errors (such as unintentional use due to selection error) (refer to-A500).

3) Undated opened single dose vials and containers were observed in two of three hospital campuses in the compounding isolators (equipment used for compounding) (refer to-A501).

4) Two of two pharmacy staff working in the hazardous (for example chemotherapy drugs used to treat cancer) drug compounding room at Mission Bay Campus and one staff at Parnassus Campus were observed not donning (putting on) and doffing (removing) personal protective equipment (PPE) per policy (refer to-A501).
5) Pressure readings in the 3rd floor hazardous drug compounding room were not documented per policy at the Mission Bay Campus (refer to-A501).

6) Single dose IV (intravenous, injected through the vein) bags of saline solution were pre-spiked (when IV bag is punctured and tubing is attached for administration) and given a BUD (beyond use date after which a product should not be used) of 24 hours in the adult infusion center at Mission Bay Campus (refer to-A505).

7) Expired medications were available for patient use and opened undated multi dose vials were observed in the pharmacy and patient care areas. The failure had the potential for patients to be given expired, contaminated or ineffective medications (refer to-A505).


8) Drugs were not stored in accordance with manufacturers' direction. Injectable vials of Tysabri (medication used in the treatment of multiple sclerosis and Crohn's disease) were not protected from light as indicated by the manufacturer's storage condition (refer to-A505).


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

Based on observation, interview and document review facility failed to:

1) Develop and implement policy and procedures for safe compounding when 20 out of 27 IV (intravenous, injected through the vein) compounded (mixed) sterile (germfree) preparations (CSP) were assigned extended BUD's (beyond use dates after which a preparation should not be used) without conducting appropriate stability studies. This failure had the potential for exposing patients to ineffective IV medications compounded without meeting all the requirements/standards of USP 797 (United States Pharmacopoeia chapter sets standards for compounding sterile medications).

2) Consistently implement the policy and procedure on the safe distribution of high risk/high alert medications. Bags of sodium chloride 3% injection solution, a hypertonic (higher osmotic pressure than a body fluid or intracellular fluid) saline for fluid and electrolyte replenishment, were not packaged and labeled in accordance with the hospital medication management policy and procedure on high-risk medications. This could lead to preventable errors (such as unintentional use due to selection error).


Findings:

1) The hospital inpatient pharmacy at the Mt. Zion campus was visited on 4/30/18 with the pharmacy supervisor (Pharm 3) starting at 10:40 a.m. During the visit at approximately 11:00 a.m., medications on various pharmacy shelves were randomly selected to check for expiration. A number of IV bags of CSPs containing the following medications were found on the IV injectable section of the pharmacy shelves. These medications included:
-Epinephrine (hormone that functions primarily to increase cardiac output and to raise glucose levels in the blood) 4 mg (milligram) in 250 ml (milliliter) of Dextrose (sugar) 5% (2 bags). The label on a bag indicated "Store at Room temperature ...Made on 1/13/18 ... Expires: 7/12/18" (6 months BUD).

-Heparin (anticoagulant used to decrease the clotting ability of the blood and help prevent harmful clots from forming in blood vessels) 2000 units in 500 ml of Sodium Chloride (saline solution) 0.9% (10 bags). The label on a bag indicated "Store at Room Temperature ...Made on 3/14/18 ...Expires: 9/10/18" (6 months BUD).

-Ropivacaine (local anesthetic agent) 250 mg in 250 ml of Sodium Chloride 0.9% (3 bags). The label on a bag indicated "Store at Room temperature ...Made on 3/17/18 ... Expires: 9/13/18" (6 months).

In a concurrent interview Pharm 3 stated all of these CSPs were compounded by the sterile compounding pharmacy at the Mission Bay Campus Owens compounding pharmacy and were delivered to the Mt Zion campus for patient use.

During a tour of the Mission Bay Campus inpatient pharmacy on 4/30/18 at 11:25 a.m. the following IV CSP's were observed:
-1 liter IV bag of Heparin 5000 units in Normal Saline (saline solution) was observed. The label on the IV bag indicated "Store at Room temperature ...Made on 11/19/17 ... Expires: 5/18/18" (6 months).
-50 ml syringe of milrinone (used in heart failure) 200 mcg/ml. "The label on the syringe indicated "Store at Room temperature ...packaged on 3/18/18 ... Exp (expiration): 9/14/18" (6 months).

In a concurrent interview the PIC (pharmacist in charge) stated that the IV Heparin and milrinone were compounded at the Mission Bay Campus Owens compounding pharmacy.

On 4/30/18 at 2:05 p.m., an inspection of medications in the Pyxis (automated drug dispensing system) in Operating Room Suite #7 at Parnassus Campus with multiple staff members identified multiple 10-ml syringes of ephedrine (to treat allergic disorders and low blood pressure) 5 mg/ml, stored at room temperature. The label on the ephedrine syringes indicated they were compounded on 3/10/18 and would expire on 9/6/18 (6-month BUD). Also stored within the Pyxis were three 10-ml syringes of phenylephrine (to treat severe low blood pressure and shock) 0.1 mg/ml. The label on the syringe indicated they were prepared on 4/14/18 and had an expiration date of 7/13/18 (3-month BUD). The Director of Pharmacy (DOP), who was present, said the Mission Bay Campus Owens compounding pharmacy compounded these medications.

On 5/2/18 at 9:15 a.m., an inspection of medications in the Pyxis in the 11th floor Neurology Intensive Care Unit (11 Neuro ICU) at Parnassus Campus with Pharmacist 2 (Pharm 2) identified six 250-ml bags of norepinephrine (to treat very low blood pressure and heart problem) 4 mg/250 ml. The label on each bag indicated they had 3-month BUD. Also, there were three 10-ml syringes of phenylephrine 0.1 mg/ml; their labels indicated they had 6-month BUD.

Review of facility policies on compounding sterile products indicated reference to USP 797 (United States Pharmacopeia chapter sets standards for compounding sterile medications). Review of USP 797 indicated that the maximum room temperature storage BUD for low risk CSP's was 48 hours. The chapter indicated in order to extend BUD's of CSP's the stability of the CSP should be considered. "When assigning a beyond-use date, compounding personnel should ... consider the nature of the drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy."

On 5/1/18 at 12:54 p.m. tour of the Mission Bay Campus Owens compounding pharmacy was conducted with the DOP. The DOP explained the compounding processes including use of a compounding robot. DOP stated that sterility was done for every batch of CSP's but potency (strength) and stability ("Stability" is defined as the extent to which a preparation retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding) was not done on a regular basis. DOP stated that stability tests were done for CSP's but not repeated if any manufacturer changes occurred. DOP stated that they used Lab A to do stability studies on the CSP's.


Review of the stability studies provided by the DOP for the CSP's observed at the 3 campuses (see above) indicated the following dates for the stability studies:

- Heparin 2000 units in 500 ml of Sodium Chloride 0.9%: Stability study done on 10/15/2013.

- Ropivacaine 250 mg in 250 ml of Sodium Chloride 0.9%; Stability study done on 2/24/14.

- Epinephrine 4 mg in 250 ml of Dextrose 5%: Stability study done on 11/6/2012.


-1 liter IV bag of Heparin 5000 units in Normal Saline: Stability study done on 11/13/2012.

-10-ml syringes of ephedrine 5 mg/ml: Stability study done on 11/12/2012.

-10-ml syringes of phenylephrine 0.1 mg/ml: Stability study done on 4/22/2013.

-250-ml bags of norepinephrine 4 mg/250 ml. Stability study done on 4/21/2015.

-50 ml syringe of milrinone (used in heart failure) 200 mcg/ml. Stability study done on 5/28/2014.


Review of a stability study performed by Lab A on 10/17/17 indicated "We recommend at least one lot per year be tested to ensure ongoing compliance. Any changes to critical components, raw materials, manufacturers, including container and closures, may require additional stability study work."


During an interview on 5/2/18 at 1:45 p.m. DOP confirmed that stability studies were not repeated after manufacturer changes occurred and acknowledged that some stability studies dated back to 2012 (6 years ago). DOP acknowledged that if the manufacturer of a product changes the active ingredient could be the same but the inactive ingredients might be different.


Review of United States Pharmacopeia 1191 (USP chapter on stability considerations in dispensing practice) indicated "Each ingredient, whether therapeutically active or pharmaceutically necessary, can affect the stability of drug substances and dosage forms."


On 5/3/18 at 9:34 a.m. a facility document listing CSP's with extended BUD's compounded by the robot was reviewed with the DOP. The list indicated that 7 of 27 CSP's with extended BUD's had complete stability studies including container closure studies. DOP confirmed that 20 CSP's did not have the newer stability studies recommended by Lab A including the container closure studies.

DOP stated that the syringes used for CSP's were made by Manufacturer A and DOP was aware that in 2015 the FDA (Food and Drug Administration) issued a recall of Manufacturer A's syringes due to the rubber closure affecting the drug potency (strength).

Review of Manufacturer A's website indicated a customer letter was issued stating that the plastic syringes were recalled due to the rubber closure interacting and thereby reducing the drug potency of the dug stored within.

DOP stated that stability studies were not repeated after new syringes were used and said in retrospect we should have repeated the stability studies.

ISMP (Institute for Safe Medication Practices a resource also used by the facility) issued comments on Manufacturer A's syringe recall on 8/27/2015 indicating Manufacturer A's "syringe issue also brings to light important information to consider when using syringes to store medications ...to validate beyond-use dating for a product drawn up in syringes, testing would be needed to monitor drug potency over the period of time intended to store the product in the syringe, plus additional time for a margin of safety, for assurances about potency ...You should bear in mind that syringe manufacturers can change components of their syringe, potentially rendering the stability information unreliable."


DOP stated that the California State Board of Pharmacy (BOP) had notified the facility in September 2017 that the use of 6 month BUD's was not acceptable.


DOP stated that there were no policies addressing the use of extended BUD's of CSP's.

Review of facility compounding policies and procedures indicated a reference to ASHP (American Society of Health-System Pharmacists). Review of "ASHP Guidelines for Compounding Sterile Preparations" indicated "results must be evaluated along with stability data to establish the extended BUD. The policies and procedures of the individual facility must outline the processes used to determine extended BUDs."

Review of facility provided BOP "inspection report" indicated the facility was compounding 26,000 CSP's per month.


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2) The hospital's high risk medications policy and procedures, approved 9/2016, identified sodium chloride 3% injection solution in 500 milliliters (ml) bags as one of the high-risk medications, those that bear a heightened risk of causing significant patient harm when used in error. The policy outlined risk reduction strategies throughout the medication use process to minimize the potential for patient harm. One of the strategies included the application of auxiliary (extra) labels to the medication prior to dispensing to identify high-risk medications. It indicated bags of sodium chloride 3% "will be labeled with High Risk Sticker." The High Risk Stickers are large, bright warning labels allowing the staff to identify them as high-risk medications, so to take extra precautions with their use.

On 5/1/18 at 1:20 p.m. at the Parnassus Campus' Emergency Department accompanied by Pharm2 and other staff members, inspection of medications identified two 500-ml bags of sodium chloride 3% injection solution in a Pyxis. There were nothing that signified they were a high-risk medication. Pharm2 said the hospital deemed it was not necessary to apply auxiliary labels or other reduction strategies to the bags due to "label fatigue."

On 5/2/18 at 9:05 a.m., Pharm 2 said she misspoke. She said the sodium chloride 3% in 500-ml bags should have been labeled with the high-risk sticker to help staff identify them as such, according to the hospital high-risk policy and procedure.

Based on observation, interview and document review facility failed to implement policies and procedures for safe compounding (mixing) of drugs when:
1) Undated opened single dose vials and containers were observed in two of three hospital campuses in the compounding isolators (equipment used for compounding).

2) Two of two pharmacy staff working in the hazardous (for example chemotherapy drugs used to treat cancer) drug compounding room at Mission Bay Campus and one staff at Parnassus Campus were observed not donning (putting on) and doffing (removing) personal protective equipment (PPE) per policy.

3) Pressure readings in the 3rd floor hazardous drug compounding room were not documented per policy at the Mission Bay Campus.

These findings had the potential of exposing patients to contaminated drugs and spreading traces of hazardous drugs.


Findings:

1a) On 4/30/18 at 12:30 p.m. tour of the inpatient satellite compounding pharmacy at Mission Bay Campus revealed an isolator (equipment for compounding) containing an opened and used IV bag of sterile water. There was no label on the IV bag indicated when it had been opened.

In a concurrent interview registered pharmacist Pharm 1 stated that the bag was used to compound products and should not be used after 12 hours of opening.
Review of a facility used standard, USP 797 (United States Pharmacopeia chapter sets standards for compounding sterile medications), 2012 indicated "SINGLE-DOSE ... CONTAINERS ...Beyond-use time of 6 hours, unless specified otherwise by the manufacturer, for closure sealed single-dose containers in ISO Class 5 or cleaner air after initial opening or entry."
During an interview on 4/30/18 at 12:35 p.m. the PIC (pharmacist in charge) acknowledged that the IV bag of sterile water was undated and should only be stored for up to 6 hours after opening.


1b) On 5/1/18 at 1:40 p.m. tour of the Mission Bay Campus Owens compounding pharmacy revealed a laminar flow hood (equipment for compounding) with an automated compounder. There were several undated, opened and used single dose vials of sodium bicarbonate (to treat metabolic acidosis which can occur in severe kidney disease) and sterile water for injection attached via tubing to the automated compounder.
In a concurrent interview the DOP (Director of Pharmacy) stated that the automated compounder required users to replace the tubing after 24 hours. DOP acknowledged that the single dose vials were undated and that USP 797 indicated single dose vials when opened cannot be stored for more than 6 hours.

2a) On 4/30/18 at 12:15 p.m. two staff members were observed in the hazardous compounding satellite pharmacy at Mission Bay campus. One staff member identified as a pharmacist by the PIC entered the hazardous clean room without putting on an additional pair of boot covers and a gown. The second staff member was identified as a pharmacy technician by the PIC and was observed compounding medications in the hazardous clean room and was not wearing 2 pairs of outer shoe covers.
On leaving the hazardous drug clean room the two staff members did not remove or change their shoe covers.
In a concurrent interview the PIC stated that her expectation was for a gown to be worn when entering the hazardous clean rooms and 2 pairs of shoe covers of which the outer pair should be removed before exiting the hazardous drug clean room to prevent carrying any hazardous drug residue out of the clean room.
Review of facility policy "Hand Hygiene, Gloving and Garbing" dated 9/2017 stated "For Hazardous Drug Sterile Compounding Area ...Place a second layer (outermost) of shoe coverings over each foot ...When exiting the Designated Chemotherapy Compounding Area ...Remove with gloved hands the outermost shoe coverings one foot at a time ..."

2b) During a visit to the pharmacy with Pharmacy Staff 1 (PStaff 1) and the director of pharmacy (DOP) on 4/30/18 at 12:35 p.m., the chemo room was identified. The DOP explained that double shoe covers, double gloves, and double gowns were required to be worn by any personnel entering the chemo room. A disposable chemotherapy (blue) gown was to be worn over the regular (white) compounding jacket.

On 4/30/18 at 12:45 p.m. with PStaff 1 present, Pharmacy Technician 2 (PTech 2) was observed working with the materials inside a chemo compounding hood in the chemo room. He did not have the blue gown on. PStaff 1 grabbed the blue gown and gave it to Ptech2 to wear during this observation. PStaff 1 confirmed that PTech 2 did not have proper garbing while working in the chemo room, as required.


3) On 4/30/18 at 12:15 p.m. during a tour of the Mission Bay Campus a hazardous drug compounding room was observed. In a concurrent interview the PIC indicated the room was a negative pressure (at a lower pressure than surrounding areas to ensure that hazardous drug residue stays contained in the room) and was monitored continuously by the facilities department and an alert was issued if the pressure was out of range. Surveyor requested pressure readings for 2 weeks.

On 5/2/18 at 8:45 a.m. PIC stated that pressure readings were not available for review. PIC stated that the pressure range was programmed incorrectly and was only set to alert if the pressure was out of range of -0.1 and -0.01 inches water column (measurement of pressure). PIC confirmed that there was no documentation of pressure readings recorded by pharmacy staff.

Review of facility policy "Airflow & Pressure Differential Requirements" dated 9/2017 indicated "Controlled environments that are constructed to accommodate ...compounding of hazardous drugs ...maintain a negative pressure differential of not less than -0.01 inches water column [range -0.01 to -0.03] to the adjacent anteroom space."

Review of facility policy "Environmental Monitoring and Quality Control" dated 9/2017 indicated "Documentation of room pressures and isolator pressures of pharmacy compounding areas are maintained in Simplifi 797 (facility used software)."



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Based on observation, interview and document review facility failed to ensure that unusable drugs were not available for patient use when:

1) Single dose IV (intravenous, injected through the vein) bags of saline solution were pre-spiked (when IV bag is punctured and tubing is attached for administration) and given a BUD (beyond use date after which a product should not be used) of 24 hours in the adult infusion center at Mission Bay Campus.

2) Expired medications were available for patient use and opened undated multi dose vials were observed in the pharmacy and patient care areas. The failure had the potential for patients to be given expired, contaminated or ineffective medications.

3) Drugs were not stored in accordance with manufacturers' direction. Injectable vials of Tysabri (medication used in the treatment of multiple sclerosis and Crohn's disease) were not protected from light as indicated by the manufacturer's storage condition.


Findings:


1) On 4/30/18 at 12:25 p.m. in the adult infusion unit of Mission Bay Campus a medication room was observed. In the medication room several IV bags of 0.9% sodium chloride (saline solution for hydration) were observed, the bags were attached to tubing sets and dated with pink stickers indicating "Expires in 24 hours."

In a concurrent interview the PIC (pharmacist in charge) stated that the IV bags were pre-spiked by nurses to prepare for infusions needed during the day.

Review of facility followed standards of USP 797 (United States Pharmacopeia chapter sets standards for compounding sterile medications), indicated "Opened or needle-punctured single-dose containers, such as bags ...of sterile products ...shall be used within 1 hour if opened in worse than ISO Class 5 (measure of air cleanliness achieved in special equipment used for compounding sterile preparations) air quality."

During an interview on 5/3/18 at 10:05 a.m. the DOP (Director of Pharmacy) stated that she was not aware that nurses were pre-spiking IV fluids and assigning a 24 hour date. She stated that the expectation is to spike it for immediate use of no more than 1 hour after opening.

The facility did not provide a policy addressing this practice. The policy provided "Perioperative Services Procedures Manual -Intravenous (IV) Administration Set-Up" did not address pre-spiking of single dose containers in the adult infusion unit.



2a) On 5/1/18 at 1:53 p.m. observation of a refrigerator at the Mission Bay Campus Owens compounding pharmacy revealed an opened used undated 30 ml (milliliter) multi dose vial of tobramycin 40 milligrams/ml.
In a concurrent interview the DOP acknowledged that the multi dose vial of tobramycin should have been dated.
Review of facility policy "Medication Management: Single-Dose and Multi-Dose Vials" dated 1/2018 indicated "MDVs (multi dose vials) should be dated upon first puncture with a 28 day expiration date or the shorter expiration date as recommended by the manufacturer's package insert."


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2b) During a visit to the Parnassus Campus pharmacy on 4/30/18 at 10:52 a.m. accompanied by the director of pharmacy (DOP), inspection of medications identified an opened, partially-used vial of desmopressin (to treat bedwetting problems and certain bleeding disorders) in a medication refrigerator. The DOP said desmopressin (a multi-dose vial or MDV) vial should have been dated with a date of opening because multi-dose vials were only good for 28 days after opened.

The hospital's "Medication Management: Singled-Dose and Multi-Dose Vials" policy and procedures, dated 1/2018, indicated, "All MDVs, excluding allergen extracts, must be discarded within 28 days after the first puncture or use unless the manufacturer' package insert lists a shorter expiration date."


2c) During a visit to the Operating Room (OR) on 4/30/18 at 2 p.m. with multiple hospital staff members including the DOP, inspection of medications in the Pyxis (automated drug dispensing system) in OR Suite #7 identified three bottles of Florane inhalation solution (for induction and maintenance of general anesthesia). One had an expiration date of 3/2018. The DOP acknowledged one Florane bottle had expired and should have been removed from the Pyxis.

On 5/2/18 at 9:15 a.m., an inspection of intravenous solutions in the storage room of the 11th floor Neurology Intensive Care Unit (11 Neuro ICU) at Parnassus Campus with Pharmacist 2 (Pharm 2) and Nursing Director 4 (ND 4) identified two of seven 50-milliliter bags of normal saline (a salt solution) had an expiration date of 4/30/18. ND 4 confirmed they had expired and should have been put away.

The hospital's "Medication Management: Medication Access and Storage" policy and procedure, dated 10/2017, indicated, "Outdated, expiration, discontinued... medications... will be identified and removed from the patient care area as soon as possible."



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3) The hospital inpatient pharmacy at the Mt Zion campus was visited on 4/30/18 with the pharmacy supervisor (Pharm 3) starting at 10:40 a.m. During the visit at approximately 11:50 a.m., medications in the pharmacy refrigerator located in the compounding ante room were randomly selected to check for expiration. While inspecting the injectable medications in the refrigerator, it was noted the opening of a dark amber bag which containing about a dozen injectable vials of Tysabri (medication used in the treatment of multiple sclerosis and Crohn's disease) was wide opened. The bag was opened in such a way that would allow ambient light of the refrigerator to make direct contact with most of the vials inside the dark amber bag.

During the concurrent interview with Pharm 3, she acknowledged the medication stored in the opened bag was light sensitive.

Review of the manufacture package insert of Tysabri provided by Assistant Director of Regulatory Affair (ADORA), under the section "How Supplied/Storage and Handling", it reads "Do not shake or freeze. Protect from light."

Review of the hospital policy entitled "Medication Management: Medication Access and Storage" dated 10/2017, on page 3 under "C. Medications Storage", it reads "3. Special Conditions: Medications requiring special conditions for storage ae properly stored (e.g. temperature, light) according to USP guidelines."

Based on observation, interview, and document review, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by:


1. At the Parnassus Campus, there was no evidence of daily cleaning/maintenance for three of three sterilizer machines, and two of two instrument and cart washers, per manufacture instructions (Refer to A-0749).

2. At the Parnassus, Mission Bay, and Mt. Zion Campuses, the processing and sterilization of surgical instruments did not follow nationally recognized infection control standards or manufacture instructions (Refer to A-0749).

3. At Parnassus Campus, there was no evidence of terminal cleaning (a cleaning method performed on a daily basis, in healthcare environments to control the spread of infections) of the hospital sterile processing department, and the decontamination room. There was no evidence of terminal cleaning of the operating rooms and high level disinfecting rooms at Mt. Zion, and at Mission Bay, there was no evidence of terminal cleaning in the sterile processing department (Refer to A-0749).

4. At Parnassus Campus, and Mission Bay Campus, staff in the semi-restricted and restricted areas, did not follow hospital policy or nationally recognized infection control standards for surgical attire did not wear proper OR attire (Refer to A-0749).

5. At the Parnassus Campus, one (1) anesthesiologist prepared an intravenous bag of lactated ringer solution and prepared an intravenous (IV) start kit, during a surgical procedure, for a following case (Refer to A-0749).

6. There was no evidence to indicate blood pressure cuffs used for multiple patients, in the endoscopy department, at the Parnassus Campus, were intended to be used as multi-patient use (Refer to A-0749).

7. At the Parnassus Campus, five (5) of 5 surgical instrument washer trolleys contained tubing and plastic bottles which were covered in black substance that was easily removed when wiped off (Refer to A-0749).

8. The Trophon in Radiology Room 3, at the Parnassus Campus, was not located in an area as stipulated in the manufacture user manual (Refer to A-0749).

9. At the Mission Bay Campus, the surfaces of a surgical table mattress contained sticky table residue that prohibited the disinfection during turnover or terminal cleaning (Refer to A-0749).

10. At the Mt. Zion Campus, surgical instruments were not cleaned and processed according to nationally recognized infection control standards (Refer to A-0749)

11. At the Mt. Zion Campus, the hospital failed to ensure the hospitality department followed the manufacturer ' s instructions for use {IFU} (Refer to A-0749)

12. At the Mt. Zion Campus, the hospital failed to ensure the eye wash stations in the outpatient areas were in compliance with infection control standards and in a manner to prevent cross contamination (Refer to A-0749)

The cumulative effects of these systemic problems resulted in the hospital's inability to provide an effective hospital wide Infection Control Program. Resulting in the hospitals inability to provide patient care in a safe and effective manner and in accordance with §482.42 Condition of Participation for Infection Control Services.

Based on observation, interview, and record review, the facility failed to ensure a system was in place for identifying, investigating, and controlling infections and communicable diseases in accordance with internal policies and procedures, as well as nationally recognized infection control practices, guidelines, and regulations. The facility's infection control program failed to:

A. At the Parnassus Campus:

1. There was no evidence of daily cleaning/maintenance for three of three sterilizer machines (machines used to sterilize reusable surgical instruments), and two of two instrument and cart washers, per manufacture instructions.

2. The processing and sterilization of surgical instruments did not follow nationally accepted standards when the hospital failed to ensure there was no presence of spotting, staining, and torn color coded tape, on multiple instruments in two of two processed surgical trays (a biopsy tray and a basic instrument set) which had contained previously cleaned, disinfected and sterilized surgical instruments.

3. There was no evidence of terminal cleaning (a cleaning method performed on a daily basis, in healthcare environments to control the spread of infections) of the hospitals sterile processing department, and the decontamination room at the Parnassus Campus, the operating rooms and high level disinfecting rooms at the Mount Zion Campus.

4. There was no evidence to indicate blood pressure cuffs used for multiple patients, in the endoscopy department (an area where medical procedures are performed specific to the digestive tract and genitourinary system) were intended to be used as multi-patient use.

5. Four (4) operating room (OR) staff (OR RN 1, 2, Perfusionist 1 & OR MD 1) did not wear proper OR attire and had exposed arms during a surgical procedure.

6. One (1) anesthesiologist (a doctor who specializes in administering medications that provide total or partial loss of sensation during surgical procedures) prepared a lactated ringer intravenous (IV) solution and an IV start kit, during a surgical procedure, for a following case.

7. Five (5) of 5 surgical instrument washer trolleys ' contained tubing and plastic bottles which were covered in black substance that was easily removed when wiped off.

8. The Trophon (a machine used for the high level disinfection of ultrasound probes) in Radiology Room 3, of the Parnassus Campus,which was also used as a patient exam room, was not located in an area as stipulated in the manufacture user manual .

B. Mt. Zion Campus

1. The hospital failed to ensure the sterile processing department and the perioperative department followed the manufacturer's IFUs for daily and weekly cleaning of nine of nine autoclaves (machines used to sterilize surgical instruments), and two of two instrument washers.

2. Surgical instruments, ready for use in surgery, did not meet manufacturer's instructions for use or national infection control standards.

3. The hospital failed to provide evidence to show their Sterile Processing Departments, Decontamination Room, Perioperative Department, and all high level disinfectant areas were terminally cleaned on a daily basis.


4. Surgical instruments were not cleaned and processed according to nationally recognized infection control standards.


5. The hospital failed to ensure the hospitality department followed the manufacturer 's instructions for use (IFUs) for the product's contact time.


6. The hospital failed to ensure the eye wash stations in the outpatient areas were in compliance with infection control standards and in a manner to prevent cross contamination.


C. Mission Bay

1. Surgical instruments, ready for use in surgery, did not meet manufacturer's instructions for use or national infection control standards.

2. Terminal cleaning was not performed daily in the sterile processing areas of the facility.

3. The surfaces of surgical table mattresses contained sticky tape residue that prohibited the disinfection during turnover or terminal cleaning.

4. Employees (Employee 2, 3, and 4), in semi-restricted and restricted areas of the facility did not follow facility policy or nationally recognized infection control standards for surgical attire.


Immediate Jeopardy

On 5/2/18 at 4:38 PM, the survey team identified significant concerns in the hospital Sterile Processing Departments, due to the seriousness of the situation, an Immediate Jeopardy (IJ) was declared for failing to maintain an environment to prevent the risk of cross contamination. The IJ was called in the presence of the Director of Regulatory Affairs, as a result of:

1. The hospital failed to maintain sterilizers, instrument and cart washers at the Parnassus and Mt. Zion Campuses, in a manner as recommended by the manufacture.

2. At Mt. Zion Campus, the hospital did not clean, disinfect and sterilize surgical instruments in accordance with the national infection control standards the hospital follows.

3. There was no evidence of terminal cleaning (a cleaning method performed on a daily basis, in healthcare environments to control the spread of infections) of the hospitals sterile processing department, and the decontamination room at the Parnassus Campus, in the sterile processing areas of the Mission Bay Campus, and the operating rooms and high level disinfecting rooms at Mt. Zion Campus.

4. At the Parnassus Campus, five (5) of 5 surgical instrument washer trolleys contained tubing and plastic bottles which were covered in black substance that was easily removed when wiped off .

On 5/2/18 at 6:17 PM, the hospital leadership and Director of Regulatory Affairs, provided the team an acceptable corrective action plan to lift the immediacy of the IJ situation. The hospital established a process for daily terminal cleaning of all restricted and semi-restricted reprocessing areas and staff were educated on terminal cleaning requirements. Terminal cleaning was completed the evening of 5/2/18 at all three campuses and staff completed a checklist documenting each step of the terminal cleaning process. The hospital, contracted a Mobile Instrument company to perform repairs and to clean the Parnassus steam sterilizers and washer/disinfectors. Mount Zion steam sterilizers and washer/disinfectors were serviced. The interior of the steam sterilizers were cleaned per manufacturer instructions and staff were trained on the weekly exterior and interior cleaning process. Staff were re-educated and competency verified on the proper instrument cleaning procedures, per nationally recognized infection control standards. The practice of using tubing and bottles to drain the instrument cart trolleys ceased effective 5/2/18. The trolleys were cleaned and disinfected and will continue daily by SPD staff. Staff were trained on 5/2/18 and 5/3/18 on the process for cleaning and disinfecting the trolleys. All drains on the trolleys were plugged by the manufacturer on 5/2/18 and the trolleys were inspected by staff as part of the end of day cleaning checklist. Supervisors conducted a visual inspection of the trolleys and reviewed the checklist for completion on a shift by shift basis and will continue for 30 days. After 30 days, the results of the audits will be reported to the Infection Control Committee where the plan for continued monitoring will be determined.


On 5/3/18 at 12:15 PM, the immediate jeopardy was abated, after the team validated, through observations, interviews, and record reviews, the hospital's corrective action plan. The IJ was abated in the presence of the Director of Regulatory Affairs.


Findings:

A. Parnassus Campus

A1. During an interview with the Infection Preventionist Director (IPD), on 4/30/18 at 9:45 AM, she stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) and manufacture instructions, among others.

On 4/30/18 at 10:25 AM, during a tour of Parnassus Campus Sterile Processing Department (SPD), the following concerns were identified:

* Two sterilizers, contained significant amount of reddish/orange coating within the chamber walls and the exterior surfaces contained visible hand prints and white smudge prints.

* Two cart washers, contained brown staining of the internal chambers.

During an immediate interview with the Sterile Processing Manager (SPM 1), he stated, "we do not clean the internal areas of any of the sterilizers (3 total), or the washers, in about 1.5 years. They took that assignment from us because we are so busy." According to SPM 1, the exterior surfaces of the sterilizers get cleaned by their hospitality department (environmental services).

During the same observation, on 4/30/18, an interview was conducted with SPM, while reviewing the "Operator Manual" for the sterilizers. SPM. He stated the following "Routine Maintenance Schedule" was not performed per the manufacture instructions:

* They did not have evidence of "daily cleaning of the sediment screens".

* They did not perform "weekly cleaning of the exterior surfaces, cleaning the chamber interior, cleaning the accessories" and they did not have the "cleaner/polish" the manufacture recommended when cleaning the interior and exterior surfaces.

According to the sterilizer manufacture "cleaning the accessories" section, "Stainless steel accessories, (including: loading carts, transfer carriages, and trays) must be properly cleaned and maintained to ensure the long life expected of this material. Failure to maintain the stainless steel surfaces properly may result in discoloration and deterioration of those surfaces".

During the same tour of SPD, two cart washers contained reddish/orange staining of the internal chambers. The SPM stated they did not clean any internal surfaces of their sterilizers or any of the cart/instrument washers.

During an interview with a Day Shift Operations Hospitality Manager (DSHM) and a Hospitality Manager (HM 1), they stated their department did not clean any of the machines.

After reviewing the cart washer "User Manual", the hospital did not provide evidence to show the following "Routine Maintenance" was performed per the manufacture "maintenance schedule":

* "Daily cleaning of the coarse debris filters..."

* "Weekly cleaning of the exterior surfaces, chamber interior, accessories and fine debris filter"... and the hospital did not have the "cleaner/polish" the manufacture recommended.


On 4/30/18 at 2:20 PM, during the tour of the decontamination room of Parnassus Campus SPD, four (4) of 4 instrument washers, contained reddish/brown staining of the internal chambers and the exterior surfaces contained white matter.
After reviewing the instrument washer "Operating Instructions", the hospital did not provide evidence to show the following "Maintenance" was performed on the washers:

* "Daily cleaning of the spray arms ..."

* "Daily cleaning of the coarse filters ..."

* "Washing of the chambers and exterior" surfaces.

A2. During a tour of SPD at the Parnassus Campus, on 4/30/18 at 1 PM, two (2) of 2 sterilization containers (a biopsy tray and a basic instrument set) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the Sterile Processing Manager (SPM 1) and an Instrument Technician (IT 2). The following concerns were identified upon observation of the surgical instruments:

The biopsy tray contained 59 instruments and 12 of the instruments, contained the following:

a) One had chipped and peeled color coding identification tape.

b) 12 hinged instruments contained brown staining.

c) One (1) instrument contained a rough non-manufacture engraving.

d) Four hinged instruments were stiff to open.

The "Basic Instrument Set", contained 91 surgical instruments and 14 of the instruments contained the following:

a) 14 had brown staining.

b) Four instruments contained chipped and peeled color coding identification tape.

During a concurrent interview with the IT 2, he stated prior to sterilization, the instruments with non-manufacture engraving should have been replaced, the instruments with brown staining should have been reprocessed, the stiff instruments should have been lubricated and any color coded tape that was chipped off, should have been removed and replaced, before sterilization of instruments occurred.

During an earlier interview, on 4/30/18 at 9:45 AM, with the IPD, she stated the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), among other nationally recognized infection control guidelines.

According to AAMI guidelines, their recommendations, stipulated the following:

"Instruments should undergo an inspection for proper function and cleanliness.

1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects

2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A record review of a document provided by hospital staff, titled, "Key Surgical Identification Tape", from the identification tape manufacturer, stipulated, "Tape should lay flat without gaps..." and to replace as necessary, when tape starts to discolor, chip, crack or flake.

A3. During a tour, on 4/30/18 from 9:55 AM to 11 AM and at 2 PM, of the Parnassus SPD and Decontamination areas, the following concerns were identified:

* The floors contained black and brown substance, throughout both areas.

* Paper sticker/labels were adhered throughout the floor.

* Ceiling air vents/registers contained fuzzy white/gray matter.

* Beneath the instrument sinks in the decontamination room, was significant amount of brown, and black matter. The same findings were identified directly above the instrument sinks.

During a concurrent interview with an Infection Preventionist Manager (IPM), he stated that he identified the same concerns with the floors during a previous "rounding" of the department but nothing had been done about it yet.
During an interview with the SPM 1, who was present during the tour, he stated that hospitality terminally cleaned the decontamination and sterile processing departments, once a week but did not have any documented evidence.

On 5/1/18 at 9:15 AM, during an interview with the DSHM, and a concurrent record review of hospitality logs, DSHM stated the logs indicated the floors in decontamination and sterile processing departments, get scrubbed once a week but not terminally cleaned. She agreed and stated the departments did not appear as if they received daily terminal cleaning.

During an earlier interview, on 4/30/18 at 9:45 AM, with the IPD, she stated the hospital followed nationally recognized infection control guidelines from AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) and manufacture instructions and AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), among other nationally recognized infection control guidelines.

AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) standard (ST79) recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas.

AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are being used. Terminal cleaning should not be performed when personnel are actively de-contaminating instruments. Cleaning should progress from cleanest to dirtiest areas.

AORN recommends (Recommendation V) a schedule for cleaning the following:
"Clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a routine basis..."

During a record review of a hospital policy titled, "Hospitality Services Cleaning Procedures Sterile Processing Decontamination Area, last approved 6/2014." The policy stipulated, "A. Daily and as needed per AAMI standards, recommended practices and guidelines ..."

According to AAMI ST79, the guidelines stipulate:

"Walls, storage shelves, and air intake and return ducts should be cleaned on a regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should be repaired. Lighting fixtures or covers should be cleaned at least once every 6 months..."

A4. On 5/1/18, at 10:45 AM, a tour was conducted of the Endoscopy Unit of the Parnassus Campus. An observation was made of a porous nylon material blood pressure (BP) cuff.

During a concurrent interview with an Endoscopy Technician (GI Tech 1), she was asked if the BP cuffs were used for multiple patients. GI Tech 1 stated, they were and they cleaned them with the hospital's standard Sani-wipes. A request was made to provide the manufacture instructions for cleaning the blood pressure cuffs.

During a review of the manufacture description and cleaning instructions for use, the document indicated:

* "...may be single-patient use or optional limited reuse..."

* "Note: Limited reuse is a term that applies to a cuff that may be reused but is less durable than a standard reusable cuff..."

* "Low-level disinfection instructions: For limited Reuse and Reusable Cuffs only ...Disinfection Cycles Allowed, 1000..."
There was no indication on the manufacture guidelines to specify the BP cuffs were multi-patient use.

A5. On 5/1/18 during the tour of the hospital OR unit, at 12:50 PM, four (4) hospital staff (OR RN 1, 2, Perfusionist 1 & OR MD 1) were observed having exposed arms, during surgical procedures, in OR 9, 11, and 15.


During a concurrent interview with the Interim Unit Director (ID), she indicated that the staff were not compliant with their hospital practice. ID stated the hospital practice and policy was to have arms covered during the surgical procedures and instructed staff to cover their arms.


A6. On 5/1/18, at 1:15 PM, during the OR tour observations, a staff was observed entering a room that was being cleaned following a surgical procedure. On the floor was paper items used during the surgical case and visible red substance adjacent to the OR bed. The staff entered the uncleaned room, picked up an IV fluid bag with tubing, from the back of the room, and left the room with the items in her hand.


During an immediate concurrent interview with the ID, she stated the staff was an Anesthesiologist but did not know why she entered the room and left after obtaining the items from the room.

During an interview, on 5/1/18, with the Anesthesiologist, at 1:20 PM, she stated she had prepared an IV solution and an IV start kit, while she was in surgery for her following case. The Anesthesiologist also stated, "If I don ' t prepare it while in the previous case, I won't have time otherwise."

During an interview, on 5/1/18, with the ID who was present during the interview with the Anesthesiologist, on 5/1/18 at 1:20 PM, she stated that the Anesthesiologist should not prepare IV solutions for a case during a surgical procedure of another patient.

During an earlier interview with the IPD, on 4/30/18 at 9:45 AM, she stated that the hospital followed nationally recognized infection control guidelines from CDC (Centers for Disease Control), among other nationally recognized infection control guidelines.

According to the CDC, Safe Injection Practices, parenteral medications (situated or occurring outside the intestine by intravenous, intramuscular, or subcutaneous injection), should be accessed in an aseptic manner (the state of being free of pathogenic microorganisms). It included using a sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment (at the time the anesthesiologist entered the room, the room was non-sterile). In addition, medications should be drawn up in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed. These areas would include, used equipment such as syringes, needles, IV tubing ... or other soiled equipment or materials that have been used in a procedure. In general, any item that could have come in contact with blood or body fluids should not be in the medication preparation area.

A7. During a tour of the Parnassus Campus Decontamination Room and the SPD, on 5/2/18 at 9:30 AM, the following concerns were identified:

* Three instrument washer trolleys in the decontamination room, had tubing connected from a drain hole beneath the cart, and into a plastic bottle. The tubing and the plastic bottles, on all 3 carts, contained large amount of black substance.

* Two instrument washer trolleys located in SPD, had tubing connected from a drain hole beneath the cart, and into a plastic bottle. The tubing and the plastic bottles, on the two carts, contained large amount of black substance.

During a concurrent interview, on 5/2/18 at 9:40 AM, with a sterile processing technician (SPD 4), he stated the black substance was, "It's probably mold but the two located in the clean side are not as bad." SPD 4 also stated the hospital did not have a process or policy to address the cleaning or maintenance of the tubing and bottles. SPD 4 stated, "They probably haven't been replaced in a long time" and instructed a sterile processing technician (SPD A) to clean the tubing.


An immediate observation was made, SPD A inserted a wired brush through the end of one tubing and from the other end, the brush was visibly soiled with significant amount of thick black matter. After the brush was exposed, some of the black matter fell to the floor and a large amount remained attached to the brush. SPD 4, who was present during the observation stated, "It's just regular mold."


During an interview, on 5/2/18 at 10:25 AM, with an Infection Control Preventionist, (ICP A), who was present during the tour of SPD, she stated that she made observational rounds in the decontamination and SPD, on March 12, 2018 but had not noticed the tubing or plastic bottles and stated, "I am glad you brought it to my attention."


A8. An observation was made on 5/2/18 at 2 PM, of the Radiology Department at the Parnassus Campus. A Trophon (a machine used to perform high level disinfection of transvaginal probes), was located in a patient procedure room (#3) with a bed and above a cart which contained two trays labeled, "soiled", gloves, "trophon chemical indicators", a fan, and multiple other items. Adjacent to the Trophon was a storage cabinet which contained clean transvaginal probes.

During concurrent interviews with two radiology supervisors (RDS 1 and 2), the following concern and interview was obtained:


* When the trophon room/patient exam room #3, is in use during a patient exam, staff take soiled/used transvaginal probes to be disinfected in Room 3 from other patient exam rooms. In addition, staff take soiled probes from other rooms, after closing the privacy curtain, and while a patient is in the process of being examined in Room 3, and proceed to perform high level disinfection of the probe.


During a record review of the "Trophon EPR User Manual," the manufacture "Introduction and Initial Setup" description of location of the Trophon, did not list patient exam rooms as an appropriate area to set up the Trophon.









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B. At the Mt. Zion Campus

B1. During an interview with the Infection Preventionist (IP), on April 30, at 10 a.m., he stated that the hospital followed nationally recognized infection control guidelines from AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), CDC (Centers for Disease Control), APIC (Association for Professionals in Infection Control and Epidemiology) and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare).

On April 30, 2018, at 10:12 a.m., a tour was conducted, in the presence of the Sterile Processing Manager (SPM), Lead Sterile Processing Technician (LSPT), and the IP of Mt. Zion Campus, "Sterile Processing Prep & Pack Area". The area contained 5 working sterilizers (machines used to sterilize surgical instruments). An observation was made of five of five sterilizers of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had large amount of brown and black staining. Two (2) of five sterilizers had significant amount of exposed fibrous material, torn silver material on the interior of the sterilizers.

The exterior of two desktop sterilizers were covered with large amount of yellowish-orange staining and dirt.

During a concurrent interview with the SPM and LSPT, both acknowledged the large amounts of brown staining on the interior of the chambers, the exposed fibrous material, the torn silver material, and the stains on the exterior of the 2 desktop sterilizers.
LSPT stated the staff does not clean the inside chambers and the staff only wipes down the exterior of the sterilizers.
SPM was asked to provide documentation or logs to show that the manufacturer ' s information for use (IFU) for routine cleaning and maintenance was done. SPM stated they did not have any documentation to show the sterilizers were cleaned by the users of the machine, as required by the manufacturer.

A review of the manufacturer IFUs was conducted with the Sterile Processing Technician (SPT 1) on April 30, 2018, at 10:20 a.m., and each step of the routine maintenance was discussed. The SPT 1 stated they did not perform the following steps described in the manufacturer ' s IFUs for weekly cleaning:

* "...The chamber interior is constructed of stainless steel and should be cleaned with a non-chloric cleaner such as Getinge USA Stainless Steel Chamber Cleaner (preferred) or Getinge USA Schedule 7 Chamber Cleaner.

* Steel wool must Never be used to clean the chamber interior; always use a different soft lint-free cloth to clean, to rinse, and to dry the stainless steel surfaces.
* Rinse or flush with clean water. Be sure to follow safety and cleaning instructions on the container to prevent injury or damage to equipment.

* "...Routinely clean the the exterior stainless steel surfaces with Getinge USA Lustre Stainless Steel Cleaner/Polish or a mild household cleaning agent. Do not use strong or harsh solutions that may damage the painted surfaces, labels, and plastic surfaces.

* "..Quarterly, clean the chamber thoroughly. If necessary, use a mild chemical scrub.

* The door gaskets should be cleaned weekly. Clean the gaskets with a damp cloth."

A review of the preventive maintenance log indicated the sterilizer chambers were last cleaned April 7 and 8, 2017. The SPM acknowledged the sterilizer chambers had been cleaned in April 2017.

A review of the manufacturer IFUs for the desktop sterilizers was conducted with the SPM and each step of the routine maintenance was discussed. The SPM stated the staff did clean the exterior of the desktop sterilizers and could not locate the department ' s log for documentation. It was noted in the manufacturer ' s IFUs: "Do not attempt to clean the chamber, door, interior surfaces, shelves, or electrode. If these items need cleaning, call your local ASP (as soon as possible) representative for assistance."

A review of the facility policy titled, "Sterilizer Cleaning Policy," stipulated, "Purpose: To ensure that each sterilizer in the Sterile Processing Department are cleaned and maintained on a regular scheduled basis. Cleaning removes scale, usually oxides, from the inner surface chamber of the autoclave. Critical Points: A. Steam sterilizers must be cleaned on a monthly basis. B. Steris System I will be cleaned on a weekly basis with biological testing. C. Sterrad cleaning will be done with Preventive Maintenance performed by the company, records kept in Facilities...Procedure:...H. Dilute the chamber cleaner as appropriate to the manufacturer recommendations. I. Thoroughly scrub the entire inside surface (walls, rear panel, the floor and the inside of the door) with the chamber solution. Rinse well with copious amounts of water several times until the entire soapy residue has been removed. Clean all areas thoroughly... Wipe the door gasket and sealing surfaces on the chamber with a mild nonabrasive cloth. N. Remove the drain screen and clean out any debris that may be trapped. O. Run a full cycle while the chamber is empty. This empty cycle run removes all invisible residue inside the chamber and doors...P. Upon completion of the cleaning the sterilizers cleaned will be logged in the log book and stored in a visible area for quality control and auditing purposes...IV. Maintenance of Sterilizers A. All sterilizers are kept in proper working order at all times by performing preventive maintenance quarterly."

Mt. Zion Campus did not have any documentation or logs to show daily or weekly routine cleaning of sterilizers.

On April 30, 2018, at 1:55 p.m., a tour was conducted, in the presence of the Sterile Processing Manager (SPM), Lead Sterile Processing Technician (LSPT), and the IP of Mt. Zion Campus , "Decontamination Area". The area contained 2 working instrument washers (machines used to wash surgical instruments).

An observation was made on April 30, 2018, at 2:45 p.m., of two of two working instrument washers of the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had small amount of brown staining. The exterior of each sterilizer (stainless steel) was covered with significant amount of water staining and large amount of tape residue on each instrument washer.

During a concurrent interview on April 30, 2018, at 2:50 p.m., with SPM, he was asked to provide documentation or logs to show that the manufacturer ' s IFUs for routine cleaning and maintenance was done. SPM stated the following:

* Acknowledged the water stains, and tape residue on the exterior of the instrument washers.

* The instrument washers are wiped down daily by the staff and chamber drains are cleaned.

* Do not have any documentation to show the instrument washers were cleaned by the users of the machine, as required by the manufacturer.

A review of the manufacturer IFUs for the instrument washer was conducted with the SPM, and each step of the routine maintenance was discussed. The SPM stated the staff did not perform the following steps described in the manufacturer ' s IFUs:

* "...Washing chamber: Do not allow deposits to form in the wash chamber. Remove any deposits as follows: Open the door and dispense 200 ml NEODISHER BU into the wash chamber. Close the door and run the descaling program.

* "...The front and side walls can be cleaned and disinfected with an alcohol-based cleaner, medical spirit or ordinary detergent. The control panel can be cleaned in the same way. To remove stains, use ordinary stainless steel cleaner."

Mt. Zion Campus did not have any documentation or logs to show daily or weekly routine cleaning of instrument washers.
1D. On May 1, 2018, at 10:01 a.m., a tour was conducted, in the presence of the Perioperative Manager (ORM) and Infection Preventionist (IP), of Mt. Zion Campus, Perioperative Department. The area contained 2 working sterilizers (machines used to sterilize surgical instruments) and 2 non-working (out of order) sterilizers.

An observation was ma