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Based on observations, interviews, and record review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The hospital did not ensure the achievement and maintenance of high standards of medical practice and patient care in accordance with the hospital's policies and procedures and acceptable standards of practice when previously cleaned and sterilized surgical instrument tray sets and surgical instruments were not cleaned per manufacturer's instructions for use (IFU). The hospital could not provide evidence to indicate sterile processing technicians received specific job competencies to ensure they were competent to perform their duties. The hospital could not provide evidence to indicate active surveillance was performed in the hospital's sterile processing department (SPD-performs sterilization and other actions on medical devices, equipment) to ensure the department and staff performed inpatient services in accordance with acceptable standards. (Refer to A-0951, Findings 1 through 4).

An Immediate Jeopardy (IJ) situation was identified on 6/5/19, at 2:21 p.m. related to findings in Surgical Services tag A-951 [42 CFR 482.51], in the presence of the hospital Chief Operating Officer, Vice President of Quality and Infection Control, Quality Director, Sterile Processing Department Manager, Corporate Chief Medical Officer, Director of Patient Safety, and Sterile Processing Department Director. Serious issues were identified with the processing and sterilization of all surgical instruments not following nationally recognized standards and manufacture's instruction for use placing potential serious risks to all patients having surgery. The hospital developed and submitted an acceptable Action Plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included: removing all surgical instruments from service so those instruments could be cleaned, disinfected and sterilized again, new competencies were created in disinfecting and sterilization technique, and all staff involved with the sterilization of surgical instruments were re-trained in proper cleaning. The survey team conducted observations, interviews, and record reviews to ensure staff demonstrated competencies and in-services were performed before the IJ was removed on 6/7/19 at 8:59 a.m. in the presence of the Risk Coordinator.

2. The hospital did not ensure surgical staff implemented the hospital's policy and procedure titled, "Operating Room (OR) - Counts in the OR" for one of 36 sampled patients (Pt 1), which resulted in a retained foreign item. (Refer to A-951 Finding 6).

3. The hospital did not identify opportunities aimed at performance improvement in high-risk and high-volume surgical areas that affected health outcomes, patient safety, and quality of care. The hospital had no documented evidence that indicated active surveillance was performed in the hospital's Sterile Processing Department through observations and validation of staff competencies to ensure SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs). The hospital's quality assessment and performance improvement program did not identify opportunities for improvement in infection control in SPD. (Refer to A-283).

4. The hospital did not implement the infection prevention and control guidelines when the sterile processing department staff did not clean surgical instruments according to acceptable standards of practice. The hospital could not provide evidence to indicate active surveillance was performed in the hospital's sterile processing department (SPD) to ensure the department and staff performed inpatient services in accordance with acceptable standards. The hospital could not provide evidence to indicate sterile processing technicians received specific job competencies to ensure they were competent to perform their duties. (Refer to A-749, Finding 4).

5. The hospital was unable to provide evidence the Director of Infection Control (ICD) was qualified to be designated as the Director of their Infection Control Program. (Refer to A-748).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and sanitary environment.

Based on observation, interview, and record review, the facility failed to provide adequate and appropriate clinical justification for restraining one of 36 sampled patients (Pt 36). This failure placed the patient at risk of developing a negative physiological outcome after the application of the restraints.

Findings:

During a concurrent interview and record review with Informatice Registered Nurse (IRN) 4, on 6/6/19, at 3:10 p.m., IRN 4 stated the physician admitted Pt 27 with diagnoses that included acute (new) right cerebral (brain) infarction (stroke), acute left side hemiparesis (weakness to half the body) and tracheostomy (procedure to create opening in the neck to breath). The progress notes by the consulting physician, dated 5/31/19, indicated Pt 27 had a Glasgow Coma Scale (GCS- scoring system used to describe consciousness; score of eight or less is severe brain impairment; score of nine to 12 is moderate impairment; score of 13 to 15 is mild impairment) of 12 out of 15 which indicated moderate brain impairment and was able to follow simple commands. The receiving nurse's assessment, dated 5/31/19 at 5 p.m., indicated Pt 27's neurological assessment was within defined limits (WDL); Pt 27 was awake, responsive, and followed commands. IRN 4 stated the nurses progress notes, dated 5/31/19 at 5:35 p.m., indicated Pt 27 had a restraint on her right wrist. IRN 4 stated the progress note did not indicate why the restraint was initiated.

During a review of the clinical record for Pt 27, the physician order (238921803), dated 5/31/19 at 5:11 p.m., indicated, " ... Restraint type: soft restraint: location of soft restraints: right wrist ... Restraint reason: Attempting to remove invasive lines/ or tubes ... Process instructions ... Restraints must be removed when an alternative is available and effective and/ or patient no longer meets criteria ..."

During a concurrent observation on the fifth floor and interview with Registered Nurse (RN) 4, on 6/6/19, at 4:05 p.m., Pt 27 sat up at the side of her bed and participated in physical therapy exercises, and followed the instructions provided to her by the physical therapist. RN 4 stated Pt 27 was alert and oriented and performed exercises with the physical therapist routinely. RN 4 stated the right wrist soft restraint prevented Pt 27 from accidentally pulling out her trach (tracheostomy tube). RN 4 stated the restraint was in place "...Just in case..."

During a concurrent interview and record review for Pt 27 with Clinical Supervisor (CS) 4, on 6/7/19, at 1:20 p.m., CS 4 stated Pt 27's record did not clearly indicate why an order for a soft wrist restraint was obtained on 5/31/19. CS 4 stated she expected nurses to document in the clinical record alternative measures used before restraints were initiated and a reassessment of the need for a soft restraint each shift. CS 4 stated there was no clinical justification for soft wrist restraints documented in Pt 27's clinical record.

A review of the hospital policy and procedure titled, "Restraint and Seclusion" dated 2/5/18, indicated, " ... C. Patient rights ...1. All patients have the right to be free from restraint or seclusion, of any form ... 1. The use of restraint or seclusion is limited to those situations for which there is adequate and appropriate clinical justification ..."

Based on observations, interviews and record review, the hospital failed to implement and maintain an ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program to improve both quality and safety when the hospital failed to identify opportunities aimed at performance improvement in high-risk and high-volume areas that affected health outcomes, patient safety, and quality of care when there was no documented evidence that indicated active surveillance was performed in the hospital's Sterile Processing Department (SPD-a department that performs sterilization and other actions on surgical instruments) through observational audits and validation of staff competencies to ensure SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs). (Refer to A-283, A-749 (finding 4) and A-951 (findings 1 through 6).

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

Based on interview and record review, the hospital failed to identify opportunities aimed at performance improvement in high-risk and high-volume areas that affected health outcomes, patient safety, and quality of care when there was no documented evidence that indicated active surveillance was performed in the hospital's Sterile Processing Department (SPD-a department that performs sterilization and other actions on surgical instruments) through observational audits and validation of staff competencies to ensure SPD staff performed duties in accordance with acceptable standards and in a manner to minimize the risks of hospital acquired infections (HAIs). (Cross reference A-951 findings 1 through 6).

These failures resulted in the potential for all patients undergoing surgical intervention to have surgical site and/or HAIs by cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) by not ensuring the sterility (free from bacteria) of surgical instruments used for patient services and the hospital to not recognize the severity of the problem.

Findings:

During an interview with the Infection Control Director (ICD) and Infection Control Preventionist (ICP) 3, on 6/6/19, at 10:30 a.m., both individuals stated they did not know SPD technicians did not have job specific competencies, SPD technicians were not performing job specific tasks related to cleaning instruments per manufacturer's instructions for use, and SPD technicians did not know how to use cleaning enzymatic (cleaner used in healthcare facilities to aid in the cleaning and decontamination of medical devices and other medical equipment and utensils) solution used to clean patient surgical instruments. ICD and ICP 3 stated they did not have documented evidence to demonstrate they provided regular oversight/surveillance of SPD and their staff. ICD stated she "rounded" in SPD once in the last year.

During an interview with the Risk Coordinator (RC), on 6/10/19, at 2:25 p.m., she stated the hospital did not have evidence of surveillance of the SPD's practices in cleaning and disinfection of surgical instruments.

During an interview with the Director of Quality (DQ), on 6/10/19, at 2:32 p.m., he stated the quality department did not recognize performance improvement activities in SPD because there was no data collected from SPD or the Infection Control Program that identified opportunities for performance improvement. The DQ stated his expectation was for the SPD subject matter expert to have identified the severity of the problems that were identified. (Cross reference A-951 Findings 1 through 4). The DQ stated, "...I was a little surprised..."

A review of the hospital document titled, "Financial Statistics" dated 4/18 through 4/19 indicated an average of 1,100 surgeries performed each month.

A review of the hospital document titled, "Performance Excellence Plan" dated 2019, indicated, "...(name of hospital) aims to deliver exceptional healthcare to our patients through a commitment to continuous improvement and performance excellence...Continuous improvement relies on...B. Establishing organizational quality and patient safety goals that are consistent with the needs of internal and external customers. C. Identification, development and adherence to best practices associated with clinical, managerial and leadership practices to minimize variation in patient service processes. D. Education and acceptance of performance improvement tools. E. Reliance on validated analytical metrics to monitor and direct quality and patient safety performance improvement endeavors...Each year (name of hospitals) will conduct a formal review of its quality performance improvement programs. Focuses of this review will include...C. (name of hospital) will be formed, as appropriate, to maintain the integrity of patient care among facilities. Each service line will use criteria (high volume, high costs and/or problem prone) to determine performance improvement projects to focus..."

Based on interview and record review, the hospital failed to ensure two licensed personnel were involved in the transfusion of blood in accordance with the hospital's policy and procedure titled, "Blood Products Transfusion" for one of 36 sampled patients (Pt 56) when the "Transfusion Record" was not signed by the transfusionist (medical professional who transfers blood into someone).

This failure resulted in an incomplete medical record and had the potential for Pt 56 to receive the wrong quantity of blood and/or blood product.

Findings:

During a concurrent interview and record review with Informatics Registered Nurse (IRN) 3, on 6/4/19, at 3:25 p.m., a review of Pt 56's clinical record titled, "Transfusion Record" dated 2/22/19 at 7:49 p.m., indicated the transfusionist signature field was blank. IRN 3 validated the findings and stated two individuals were required to verify and sign for Pt 56's blood transfusion.

During a concurrent interview and record review with the Manager of the Emergency Department (EMD), on 6/7/19, at 1:42 p.m., he reviewed Pt 56's clinical record titled, "Transfusion Record" dated 2/22/19 at 7:49 p.m. and validated the transfusionist signature field was blank. The MED stated the, "Transfusion Record" required signatures from the two individuals that verified the blood. The MED stated without the transfusionist's signature, there is no indication who the transfusionist was.

A review of the hospital policy and procedure titled, "Blood Products Transfusion" dated 12/16, indicated, "I. Purpose ...A. To provide guidelines for appropriate handling of blood products during transfusion and to ensure safe transfusion ...V. Procedure ...F. Patient Identification at the Bedside ...3. Two licensed personnel involved in the transfusion ...shall be an RN (registered nurse) and serves as the transfusionist, verify correct blood product and correct patient ...4. If all information is correct, both checking parties sign the Transfusion Record Chart Copy ...VII. Documentation ...C. Document the following on the Transfusion Record Chart Copy, using the spaces provided ...2. Bedside signatures of two licensed personnel ..."

Based on interview and record review, the hospital failed to ensure physician verbal and telephone orders were authenticated (verified and signed) in patients medical records within 48 hours in accordance with approved hospital policy and procedures for three of 36 sampled patients (Pts 27, 42 and 56).

This failure resulted in unverified physician orders and had the potential for inappropriate treatment and/or care of Pts 27, 42, and 56.

Findings:

During a review of the clinical record for Pt 27, the right wrist soft restraint order details indicated, " ...Soft Restraint: right wrist ... Restraint reason: Attempting to remove invasive lines/ tubes ... Frequency continuous ... Order date and time 5/31/19 1711 ... Mode ...Telephone with readback ... Signed on 6/3/19 1140..."

During a concurrent interview and record review with Informatics Registered Nurse (IRN) 4, on 6/6/19, at 3:10 p.m., Pt 27's clinical record indicated Medical Doctor (MD) 6 placed a telephone order for right wrist soft restraints (applied to the body to restrict movement) on 5/31/19 at 5:11 p.m. The telephone order was signed by MD 6 on 6/3/19 at 11:40 a.m. IRN 4 validated the findings and stated the order was signed late by the prescribing physician.

During a concurrent interview and record review with Registered Nurse (RN) 20 and IRN 3, on 6/5/19, at 2:25 p.m., Pt 42's clinical record indicated Pharmacist 1 placed a verbal order for Levofloxacin (a medication used to treat or prevent infections) 500 milligrams (mg-form of measurement) on 6/2/19 at 1:26 p.m. The verbal order was not signed by MD 5. RN 20 stated verbal orders were commonly used and validated the order was not signed by the ordering provider. IRN 3 validated the order was entered by Pharmacist 1 and the order was not signed by MD 5.

During a review of the clinical record for Pt 56, the heparin order details indicated, " ...heparin ...4,000 units ...Ordered Dose: 4,000 Units ...Route: Intravenous (into the vein) ...Frequency: PRN (as needed) for Line Care ...Admin Instructions: High Alert/High Risk ...Anticoagulant (prevent from clotting) medication - ensure appropriate monitoring and precautions ...Verbal Order Info ...Created on ...3/4/19 0706 ...Order Mode ...Telephone with readback ...Signed on 3/15/19 0830 ..."

During a concurrent interview and record review with IRN 3, on 6/4/19, at 3:25 p.m., Pt 56's clinical record indicated MD 4 placed a telephone order for heparin (a medication used to prevent blood clotting) 4,000 units (form of measurement) on 3/4/19 at 7:06 a.m. The telephone order was signed by MD 4 on 3/15/19 at 8:30 a.m. IRN 3 validated the findings and stated telephone orders were supposed to be signed by the ordering physician within 24-48 hours.

During a concurrent interview and record review with the Manager of the Emergency Department (MED), on 6/7/19, at 1:50 p.m., he stated telephone orders were infrequently used. The MED reviewed Pt 56's heparin order and stated the physician was supposed to sign the telephone order within 24 hours. The MED validated Pt 56's heparin order was entered on 3/4/19 via (by the way of) telephone with readback and MD 4 signed the order on 3/15/19. The MED stated, " ...That [physician signature for heparin order] looks a little late ..."

A review of the hospital policy and procedure titled, "Physician Order" dated 6/16, indicated, "I. Purpose ...C. To provide guidelines for the receipt, documentation, authentication and use of verbal or telephone orders ...G. Telephone Orders ...1. Telephone orders are to be used infrequently and limited to those situations in which it is impossible or impractical for the ordering provider to enter the order in the HER (electronic health record) ...I. All verbal and telephone orders must be cosigned by the ordering provider within 48 hours from the date and time the order was entered ..."

Based on observations, interviews, and record reviews, the hospital failed to implement the infection control program and guidelines for infection prevention and control when:

1. The employee file for the Director of Infection Control (ICD) did not have documented evidence to show that she was qualified to oversee the Infection Control Program. (Refer to A-748).

2. Multiple cardboard boxes which contained sterile items were found in an overflow sterile storage room, located adjacent to the sterile (free from bacteria) processing department (SPD-performs sterilization and other actions on medical devices and equipment). (Refer to A-749 finding 1).

3. Five ceiling vents located in the clean instrument assembly area contained thick, grey, fuzzy matter. (Refer to A-749 finding 2).

4. The endoscope reprocessor (a machine used to clean and disinfect flexible scopes), was not cleaned and maintained according to manufacturer's instructions. (Refer to A-749 finding 3).

5. The SPD staff did not clean surgical instruments according to acceptable standards of practice. (Refer to A-749 finding 4).

6. Registered Nurse (RN) 4 did not use personal protective equipment (PPE- gloves, masks, gown, etc.) upon entering a Clostridium Difficile (C. diff. - is an extremely contagious bacterium that causes diarrhea and more serious intestinal conditions) isolation room and did not perform proper hand washing after exiting the room. (Refer to A-749 finding 5).

7. Surgical instruments sterilized and processed at the hospital's remote facility (Facility C), contained cracked and lifting identification tape on multiple instrument handles in two of three extraction (dental instruments) trays. (Refer to A-749 finding 6).

8. Patient clean supplies were kept in Facility C's biohazard (contaminated) room. (Refer to A-749 finding 7).

9. High level disinfection (HLD - the process of complete elimination of all microorganisms in or on a device, with the exception of small numbers of bacterial spores) of endoscopes (ES- flexible tube with a light and camera to examine the digestive tract) was performed in the clean area of Facility B's reprocessing room (RR- designated to clean, disinfect, and test scopes). (Refer to A-749 finding 8).

10. Endoscopy Technician (ET) 2 failed to follow hospital policies for proper use of Personal Protective Equipment (PPE- gown, masks, gloves, etc.). (Refer to A-749 finding 9).

11. Facility B's procedure room (PR) was not fully cleaned and disinfected between patient procedures. (Refer to A-749 finding 10).

12. Facility B staff failed to follow hospital policies for recapping a syringe filled with blood. (Refer to A-749 finding 11).

13. RN 6 failed to wear a gown when he removed dialysis (a medical process of removing waste products and excess fluid from the body when the kidneys are not able to filter the blood) tubing from the machine. (Refer to A-749 finding 12).

14. A red sharps biohazard bin (a container used to safely hold any device or object used to puncture or cut the skin that contain infectious waste) located in the medication room on the second floor, in a unit that was utilized as an extension of the emergency department, was greater than 3/4 full; (Refer to A-749 finding 13).

15. Three blue pharmaceutical waste containers (bins used for safe disposal of used medication bags and tubes) located in the medication room in the Intensive Care Units (ICUs) were greater than 3/4 full. (Refer to A-749 finding 14).

16. Two separate nutrition refrigerators (refrigerators on 8th floor and 10th floor) had expired fat free milk cartons available for use. (Refer to A-749 finding 15).

17. One of ten employee files reviewed did not have evidence of a health screening upon hire and yearly. (Refer to A-749 finding 16).

The cumulative effect of these systemic problems resulted in failure to ensure implementation of a safe and effective infection control program.

Based on interview and record review, the hospital failed to demonstrate the Director of Infection Control (ICD) was qualified to be designated as the Director of their Infection Control Program.

This failure placed all 765 patients at risk for being exposed to infectious diseases by not having a qualified, educated and properly trained Infection Control Director.

Findings:

During an interview with the ICD, on 6/6/19 at 9 a.m., she stated she was the Director for the hospital's Infection Control Program, she had ten infection control preventionists that she supervised and she reported to the hospital Vice President/Chief Risk Management Officer.

A review of the hospital's organizational chart, provided on 6/6/19 by the Risk Coordinator, indicated the ICD as the Infection Control Director who reported to the Vice President (VP)/Chief Risk Management Officer.

A review of the "Executive Job Description," revised 3/2/19, on 6/6/19 at 10 a.m., indicated ICD was the "Director of Clinical Performance Improvement - Infection Prevention." ICD's job description indicated, "Directs, coordinates, and evaluates organization-wide activities, to ensure clinical performance improvement and quality management is consistent ..."

A review of ICD's employee file indicated the following:
ICD was appointed to the position of ICD in May 2018;
ICD took one Infection Prevention course from May 14 - 17, 2018;
ICD was a Certified Professional in Healthcare Quality (demonstrated specialized experience, knowledge, and the highest standard of professionalism {not specific to infection control training});
ICD was Board Pharmacotherapy credentialed (not specific to infection control);
ICD was a regular and advanced practice pharmacist;
ICD's resume (from 1998 to present) indicated she was a staff pharmacist, patient safety pharmacist and director of quality performance improvement. ICD's experience did not indicate she was an Infection Control Preventionist.

A review of the ICD's employee file did not have documented evidence to show she received ongoing infection control training and her performance evaluation was specific to a leadership role, not infection control practice roles.

During a concurrent interview and record review with the Medical Director of Infectious Disease (MDIC), on 6/7/19 at 9 a.m., a review of the hospital's organizational chart and ICD's job description was conducted. The MDIC stated, "Functionally speaking, I am in charge of the infection control program." The MDIC stated he did not perform active surveillance of the SPD and did not provide oversight. A review of the hospital's organizational chart indicated the MDIC was not listed as the director of infection control.

Based on observations, interviews, and record reviews, the hospital failed to implement the infection prevention and control guidelines when:

1. Multiple cardboard boxes which contained sterile ( germ-free) items were found in an overflow sterile storage room, located adjacent to the sterile processing department (SPD-performs sterilization and other actions on medical devices, equipment) against hospital policy and procedure and accepted professional standards. The sterile storage room's humidity was not maintained at 70 percent or less according to professional standards;

2. Five ceiling vents located in the clean instrument assembly area contained thick, gray, fuzzy matter;

3. The endoscope (an illuminated usually fiber-optic flexible or rigid tubular instrument for visualizing the interior of a hollow organ or part such as the bladder or esophagus) reprocessor (a washing machine used to clean and disinfect flexible scopes) was not cleaned and maintained according to manufacturer's instructions;

4. The SPD staff did not clean surgical instruments according to acceptable standards of practice;

5. Registered Nurse (RN) 4 did not use personal protective equipment (PPE- gloves, masks, gown, etc.) upon entering a Clostridium Difficile (C. diff. - is an extremely contagious bacterium that causes diarrhea and more serious intestinal conditions) isolation room and did not perform proper hand washing after exiting the room;

6. Surgical instruments sterilized and processed at the hospital's remote facility (Facility C), contained cracked and lifting identification tape on multiple instrument handles in two of three extraction (dental instruments) trays;

7. Patient clean supplies were kept in Facility C's biohazard (contaminated) room;

8. High level disinfection (HLD - the process of complete elimination of all microorganisms in or on a device, with the exception of small numbers of bacterial spores) of endoscopes (ES- flexible tube with a light and camera to examine the digestive tract) was performed in the clean area of Facility B's reprocessing room (RR- the area designated to clean, disinfect, and test scopes);

9. Endoscopy Technician (ET) 2 did not follow hospital policies for proper use of Personal Protective Equipment (PPE- gown, masks, gloves, etc.);

10. Facility B's procedure room (PR) was not cleaned and disinfected between patient procedures according to nationally recognized standards;

11. Facility B's staff failed to follow hospital policies for recapping a syringe filled with blood;

12. RN 6 failed to wear a gown when he removed dialysis (a medical process of removing waste products and excess fluid from the body when the kidneys are not able to filter the blood) tubing from the machine;

13. A red sharps biohazard bin (a container used to safely hold any device or object used to puncture or cut the skin that contain infectious waste) located in the medication room on the second floor, in a unit that was utilized as an extension of the emergency department, was greater than 3/4 full;

14. Three blue pharmaceutical waste containers (bins used for safe disposal of used medication bags and tubes) located in the medication room in the Intensive Care Units (ICUs) were greater than 3/4 full;

15. Two separate nutrition refrigerators (refrigerators on 8th floor and 10th floor) had expired fat free milk cartons available for use; and

16. One of 10 employee files reviewed did not have evidence of a health screening upon hire and yearly.

These failures placed all 765 patients and the hospital's staff at risk of being exposed to infectious diseases (producing or capable of producing infection) and the growth of microorganisms (germs) which could lead to food borne illnesses.

Findings:

1. On 06/03/19 at 9:50 a.m., an interview was conducted with Infection Control Preventionist (ICP 2) who stated the hospital followed nationally recognized guidelines from the Association for Professionals in Infection Control (APIC), Association of Perioperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and the Centers for Disease Control (CDC).

During a concurrent observation of the hospital SPD and interview with the Case Picking Supervisor, on 6/3/19 at 10:05 a.m., multiple cardboard boxed items were found in a room adjacent to SPD, case picking area (an area used to store sterile items which are used for patient services). The Case Picking Supervisor stated the multiple cardboard boxes were the original corrugated shipping boxes of clean and sterile items such as, sterile water, syringes, drapes, gauze, "raytec" sponges (a surgical sponge folded to 4X4), and most of the items were considered to be sterile (free from bacteria). The humidity in the room was observed to be 74% according to the humidity measuring device.

A record review of the hospital policy titled, "Sterile Storage Protocol" dated 10/11/17, indicated, "3. No exterior shipping cartons, including corrugated cardboard, are to be brought into the sterile storage area. 4. Monitor ...humidity per facility environmental system, including regulation of the following: ...b. Relative humidity shall not exceed 70%."

A review of the Association of Perioperative Registered Nurses (AORN-one of the guidelines the hospital followed) sterilization guidelines, indicated, "Supplies and equipment should be removed from external shipping containers and web-edged or corrugated cardboard boxes before transfer into the sterile storage area...The sterile storage area includes any semirestricted (eg, sterile processing, storage areas within the surgical suite) or restricted area, including the OR... The rationale for this statement is that external shipping containers and web-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite."

2. During a tour of the clean prep and pack area of SPD on 6/3/19 at 10:05 a.m., five ceiling vents contained thick, gray, fuzzy matter.

The Case Picking Supervisor was unsure of the cleaning schedule of environmental services (EVS) (she thought it was midshift) and did not know if they cleaned the ceilings.

During an interview with the Environmental Services (EVS) Manager, on 6/3/19 at 11:45 a.m., the EVS Manager validated there was dust present on the ceilings vents and stated the ceiling vents should not have "dust" if his staff terminally cleaned (thorough environmental cleaning that is performed at the end of each day when the area is being used) the rooms.

A review on 6/3/19 of the hospital policy titled, "Sterile Processing Terminal Cleaning, dated 10/27/10, indicated, " ...Step 3. High dust items above shoulder level, clean the vents ..."

A review of AORN, indicated terminal cleaning is, "...thorough environmental cleaning that is performed at the end of each day when the area is being used."

A review of both AORN and Association for the Advancement of Medical Instrumentation (AAMI-professional organization) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms.

3. During a concurrent interview and tour of SPD, on 6/3/19 at 11:47 a.m., 2 (Brand Name) endoscope reprocessors contained yellow, brown and black matter around the internal lid and edges of the processors (used to clean and disinfect reusable endoscopes). The manufacturer's guidelines were reviewed and discussed with SPD Lead (SPD L) 2. SPD Lead 2 stated that he had not reviewed the guidelines and did not know the details which were described in the manual of the daily cleaning process.

A review of the manufacturer's guidelines indicated, "...Clean processing tray... Clean chamber..." No documented evidence was provided to show the daily manufacturer's guidelines were performed for the two processors.

4. a. On 06/03/19, at 10:35 a.m., during the tour of SPD with Sterile Processing Lead (SPL), three sterilization containers filled with various cleaned and sterilized surgical instruments The following was observed:

Eighteen of 104 instruments had identification tape partially peeled off and post-manufacture etching (marks or carving that had been added by the hospital, not by the manufacturer).

Eight of 85 surgical instruments had chipped tape, post-manufacture etching, and brown staining.

Three of five instruments that had removable parts, were not disassembled prior to sterilization.

During the interview, SPL stated the instruments with the chipped and peeled tape should have been removed and the instruments with the post-manufacture etching should have been removed from use. SPL also stated the instruments with removable parts should have been disassembled (taken apart) before they were sterilized.

A review of AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative [during the course of an operation] practice and healthcare) guidelines, their recommendations, indicated 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 ..." "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization."

During a review of the manufacturer's IFUs for tape, it indicated, "...overlap tape 1.5 times.... Replace when tape starts to discolor, chip, crack or flake."

During a record review of the manufacturer's IFUs for a table mounted retractor (a surgical instrument used for holding open the edges of a surgical incision) on 6/5/19 at 1:50 p.m., an instrument which had not been disassembled for sterilization, indicated, "Preparation for Cleaning: Instruments designed to come apart must be disassembled prior to cleaning ..." "Packaging for Sterilization: Arrange all devices to allow access of steam to all surfaces. Open hinged devices and ensure devices are disassembled if it is recommended ..."

b. During a concurrent observation of the hospital SPD and interview with Sterile Processing Technician (SPD) 1, on 6/5/19 at 8:50 a.m., in the presence of ICP 2 and the Sterile Processing Manager (SPM). SPD 1 was observed cleaning reusable surgical instruments.

SPD 1 did not fully submerge or brush all reusable surgical instruments in four of four different cart sets (carts filled with surgical instruments from different patient surgeries);

SPD 1 soaked staplers (robotic surgical systems designed to facilitate complex surgeries using a minimally invasive approach, and controlled by a surgeon from a console) for less than four minutes;

SPD 1 did not use a timer to measure soak time. (Soak time is the time needed for surgical instruments to be soaked in the enzymatic [cleaning] solution). SPD 1 did not use a thermometer to measure the water temperature. The label on the enzymatic solution indicated, "warm water ...clean for a minimum of 1 to 5 minutes. Cleaning times may be longer with dried on proteinaceous [substances from the human body] materials if lower temperatures are used, a longer cleaning time may be necessary. Do not exceed 130 degrees Fahrenheit ...";

SPD 1 did not clean the sink between cleaning each surgical cart set;

SPD 1 did not disassemble instruments with removable parts;

SPD 1 used the same wired toothbrush-style cleaning brush to clean all four cart set instruments. SPD 1 stated they used the brushes for the entire shift and do not clean the brushes between uses;

The "Heart Tray set" contained a retractor (a surgical instrument used for holding open the edges of skin). SPD 1 stated one "Heart Tray set" was placed into the same enzymatic solution filled sink used for cleaning one of the other cart sets (an implantable set) and soaked for two minutes. The removable part of the retractor was not disassembled during the soaking phase;

SPD 1 brushed sixteen needle holders (reusable surgical instruments) using the same brush used for previous instruments. The needle holders were not brushed individually;

SPD 1 submerged hinged instruments into the enzymatic solution without first ensuring the instruments were in the open position;

SPD 1 stated a device used for spinal surgeries was placed into the same enzymatic solution as the "Heart Tray set.";

SPD 1 removed two instruments from the enzymatic filled solution and placed them into the clean water rinse sink. The instruments still contained red matter;

SPD 1 used the same gloves while cleaning the four cart set filled instruments;

During an observation and interview, on 6/5/19 at 10:05 a.m., Sterile Processing Manager (SPM) informed SPD 1 that he was not properly cleaning the instruments and asked him to stop. SPM stated that the robotic stapler system should have been soaked for 30 minutes. SPM stated the process was to change the enzymatic solution between each cart set, to use a different brush for each set, to use a timer to monitor soak times, and to monitor the enzymatic solution temperature. In addition, SPM stated that SPD 1 should have cleaned the sinks between each use, and should have changed his gloves between each cart set.

During a record review, on 6/5/19 at 1:30 p.m., the manufacturer's IFUs for the robotic stapler indicated, "Soak the instrument for 30 minutes ... Brush entire device thoroughly with a nylon brush for at least 60 seconds under running cold water ..."

A review of the manufacturer's instructions for the implantable device. The instructions indicated, "This document is intended to establish safe and effective reprocessing procedures in health care facilities for surgical instruments supplied by [Brandname of implantable device] ...The most important step in decontamination is thorough cleaning and rinsing. Cleaning primarily removes rather than kills microorganisms. The factors that contribute to cleanliness are: quality of water; concentration; type of cleaner; washing method ...Instruments are optimally cleaned in water and detergent solutions at temperatures between 80 to 110 degrees Fahrenheit but not to exceed 140 degrees ..."

During an interview, on 6/5/19 at 1:55 p.m., SPD 1 stated he did not receive specific training on how to clean the robotic stapler or the implantable device. SPD 1 stated he did not know the soak times required to meet the manufacturer's cleaning instructions. SPD 1 stated he was not familiar with enzymatic soak times or temperature requirements and was not aware he had to adhere to those times or temperature requirements. SPD 1 stated the SPD Technicians did not receive specific competencies or training on how to clean instruments. SPD 1 stated he only brushed instruments if they were grossly soiled and did not know he was supposed to brush all instruments individually, and he learned to clean instruments by watching another SPD technician.

A review of AORN, one of the nationally recognized infection control guidelines the hospital followed, indicated, "Manual cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization of contaminants. Aerosolization [the process or act of converting some physical substance into the form of particles small and light enough to be carried on the air] of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water."

A review of AAMI (an organization for advancing the development, safe and effective use of medical technology and one of the guidelines the hospital followed), "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (leaders in advocating for excellence in perioperative practice and healthcare) guidelines, indicated, "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 review of the manufacturer's IFUs for the cleaning brush indicated, "Brushes must be cleaned prior to reuse ..."

c. During a concurrent interview and review of SPD 1's employee file, on 6/5/19 at 4:38 p.m., the SPD Supervisor and the SPD Director confirmed there was no evidence of job specific competencies from 2017 to current and there was no evidence SPD 1 received competencies specific to the robotic staplers, implantable devices, the use of enzymatic solution or general cleaning instructions required to perform his SPD tasks.

d. During an interview with the SPD Director, on 6/5/19 at 5 p.m., he stated there was no documented evidence that staff in SPD were provided oversight to ensure they were competent performing their job specific tasks.

During an interview with the ICD and Infection Control Preventionist (ICP) 3, on 6/6/19 at 10:30 a.m., the ICD and ICP 3 stated they did not know that SPD technicians did not have job specific competencies, they did not know if SPD technicians were not performing their job specific tasks related to cleaning instruments correctly, and they did not know that SPD technician did not know how to use the cleaning enzymatic used to clean reusable patient surgical instruments. ICD and ICP 3 stated they did not have documented evidence to demonstrate they provided regular oversight/surveillance of SPD and the SPD staff. The ICD stated she "rounded" (walked through and made observations of staff performing their job duties) in SPD once in the last year.

5. During a concurrent observation on the fifth floor and interview with RN 4, on 6/6/19, at 4:05 p.m., RN 4 entered Patient (Pt) 27's room, who was on contact (when touching a patient) isolation precautions for Clostridium Difficile (C. diff. - is an extremely contagious bacterium that causes diarrhea and more serious intestinal conditions), without putting on Personal Protective Equipment (PPE- gown, gloves, and mask). RN 4 exited the room and used an alcohol based sanitizer to perform hand hygiene. RN 4 stated she was aware Pt 27 was on contact isolation for C. diff. RN 4 stated she thought Pt 27's airway was compromised, therefore entered the room quickly without putting on PPE. RN 4 stated PPE was not required during an emergent situation.

During an interview, on 6/10/19, at 2:10 p.m., ICP 2 stated PPE should always be applied before entering a contact isolation room. ICP 2 stated hands should be washed to prevent the transmission of germs. ICP 2 stated the expectation was for nurses to wash hands immediately after leaving a contact isolation room, especially when on contact isolation for C. diff.

A review of the hospital policy and procedure titled, "Contact Precautions" dated 1/19/17, indicated, "Purpose ... a. To minimize the spread of diseases transmitted by direct or indirect contact with the causative agent or microorganism [germ] ... E. Hand Hygiene: 1. For caregivers of patients with Clostridium difficile (C. diff.) appropriate hand hygiene is to wash hands with warm, soapy water, NOT alcohol hand gel ... D. Personal protective Equipment for Medical Caregiver ... 1. Staff must always put on gloves before entering the patient's room- NO EXCEPTIONS. 2. Staff must put on a gown if there is a potential for any contact with the patient, patient's secretions, or the room environment ... 5. Employees are ... upon leaving the room ... perform appropriate hand hygiene ..."

6. During a concurrent observation in Facility C's sterile (free of bacteria)/clean room and interview with Registered Dental Assistant (RDA) 1 and Facility C Director (FCD), on 6/4/19, at 1:25 p.m., RDA 1 opened a sterilized extraction tray for examination. Two surgical instruments, RDA 1 called elevators (dental elevator- a surgical instrument used to extract or loosen teeth), had cracked and lifting identification tape on the instrument handles. RDA 1 stated she was unsure if the lifted tape could be sterilized by the autoclave. The FCD stated the cracked and lifted tape had the potential to retain bacteria (germs) underneath the tape therefore could not be sterilized.

During a concurrent observation in the Facility C's sterile/clean room and interview with FCD, on 6/4/19, at 3:30 p.m., RDA 2 opened two newly sterilized extraction trays for examination. One extraction tray had two elevators with cracked and lifted identification tape on the handles. The FCD was asked if instruments could be inspected for cleanliness during tray preparation with tape wrapped around the handles. The FCD stated, "No." FCD stated the tape on the instruments was an infection control issue.

A review of the hospital policy and procedure titled, "Surgical Instrument Handling and Tray Preparation" dated 8/17, indicated, " ... Policy A. After decontamination, instruments are to be checked ... Examine each instrument for cleanliness. Return instruments to Decontamination that are not visibly clean ..."

7. During a concurrent observation in Facility C's biohazard (contaminated) room and interview with RDA 1 and FCD, on 6/4/19, at 1:55 p.m., RDA 1 opened a storage cabinet located above the sink used to manually clean surgical instruments. Clean urinals (plastic bottle to hold urine) for patient use were stored inside the cabinet. RDA 1 stated, "They [staff] store urinals here and give them [urinals] to patients as needed." FCD stated she was not aware of urinals being stored in the biohazard room. FCD stated storage of patient clean supplies in contaminated areas increased the risk of cross contamination.

During an interview with Infection Preventionist (IP) 5, on 6/10/19, at 2:10 p.m., she stated clean supplies could not be stored in a contaminated room. IP 5 stated the practice of storing clean supplies in a contaminated room increased the risk for cross contamination and could potentially compromise the health and well- being of the patients.

8. During an interview, on 6/4/19 at 9:55 a.m., the Testing Center Manager (TCM) at Facility B stated the center followed nationally recognized infection control guidelines from the Centers for Disease Control (CDC- national health protection agency) and Standard of Gastroenterology Nurses and Associates (SGNA- professional organization of nurses).

During a concurrent observation in the RR and interview with TCM and Endoscopy Technician (ET) 2, on 6/4/19 at 10:30 a.m., the RR was divided by a red line to delineate dirty and clean areas of the room. ET 2 performed manual cleaning of the ES in the dirty sink. ET 2 transferred the ES to the clean area for HLD. Droplets of water from the ES splashed onto the clean area's floor during the transfer. ET 2 walked back and forth between the dirty and clean areas to complete the ES reprocessing procedure. ET 2 stated the dirty area of the room was too small for the automated endoscope reprocessors (AER- device to disinfect endoscopes) and HLD had to be performed in the clean area. TCM stated maintaining a separate dirty work area from the clean work area was difficult. TCM stated the room set up did not promote infection control best practice.

During an interview with IP 2 and IP 5, on 6/10/19 at 2:10 p.m., IP 2 stated she was aware HLD was performed in the clean area of RR at Facility B. IP 5 stated the room set up was not ideal to maintain infection control standards. IP 5 stated HLD of ES in the clean area increased the risk for cross contamination (spreading germs). IP 2 stated ET 2 should have transferred the ES in a plastic container to avoid water from dropping onto the clean area floor. IP 2 stated the current process increased the risk for cross contamination.

A review of the CDC document titled, "Essential Elements of a Reprocessing Program for Flexible Endoscopes- Recommendations of the Healthcare Infection Control Practices Advisory Committee" dated 6/28/17, indicated, " ... Essential Elements of a Reprocessing Program for Flexible Endoscopes ... Physical setting ...2. Review the physical setting to ensure a "one way" work flow that separates contaminated work spaces from clean work spaces ..."

A review of the hospital policy and procedure titled, "Decontamination" dated 11/15/18, indicated, " ... Policy ... 1. All procedures are strictly adhered to ... All instrumentation will be decontaminated in accordance with all pertinent regulations, industry standards, and manufacturer's instructions for use ... B. Contaminated instrumentation and equipment are to enter the Decontamination, which is separated from the clean area ..."

9. During a concurrent observation in the RR at Facility B and interview with TCM, on 6/4/19 at 10:30 a.m., ET 2 wore PPE to clean an ES in the sink located in the designated dirty area of the room. ET 2 entered the clean area wearing the same PPE to transfer the ES into the AER. ET 2 removed the PPE in the clean area, and discarded the PPE into the trash can located in the corner of the clean area. TCM stated the PPE was contaminated and should have been discarded in the dirty area before entering the clean area.

During an interview with IP 5, on 6/10/19, at 2:10 p.m., IP 5 stated the removal of contaminated PPE in the clean area of the RR at Facility B was concerning. IP 5 stated the expectation was to remove the contaminated PPE in the dirty area and to wash hands prior to entering the clean area. IP 5 stated removal of contaminated PPE in the clean area increased the risk for cross contamination for staff and patients.

A review of the hospital policy and procedure titled, "Bloodborne Pathogen Exposure Control Plan- Standard Precautions" dated 11/20/18, indicated, " ... Policy ... It is the responsibility of the healthcare provider to comply with standard precautions [infection control practices to control the spread of disease] ... 4. Wash hands or use an alcohol-based hand sanitizer immediately after removing all PPE ... E. PPE must be removed and discarded in regular waste before leaving the work area ..."

10. During an interview on 6/4/19 at 9:55 a.m., TCM stated Facility B's testing center (TC) followed nationally recognized infection control guidelines from: CDC -Centers for Disease Control and SGNA - Standard of Gastroenterology Nurses and Associates.

During an observation in the PR at Facility B, on 6/5/19 at 10:56 a.m., staff brought Patient 87 into procedure the room. ET 1 was disinfecting the diagnostic equipment and work space counters while Patient 87 laid on a gurney adjacent to the equipment. ET 1 wiped the (diagnostic) equipment and counters with a germicidal (kills germs) disposable wipe.

During an interview, on 6/5/19 at 11:00 a.m., Facility B's Testing Center Director (TCD) stated she was aware that Patient 87 laid in the procedure room while the room was cleaned. The TCD stated it was the common practice for patients to be brought in to PRs while the rooms were cleaned and disinfected. The TCD stated the equipment dried as patients were prepared for procedures in the room.

During an interview, on 6/7/19 at 10:40 a.m., the IP 2 stated PRs and equipment had to be cleaned and disinfected before the next patient was brought into the room. IP 2 stated patients left in an unclean room increased the risk of cross contamination. IP 2 stated germicidal products used to disinfect the equipment had specific dwell times (the amount of time that a sanitizer or disinfectant must be in contact with the surface) that must be followed to be effective. IP 2 stated exposure to germicidal chemicals had the potential to affect the health and well-being of the patients.

A review of the hospital policy and procedure titled, "Surgery Suite Between Case Cleaning" dated 2/18/17, indicated, " ... Procedure ... f. Allow disinfectant to remain wet for at least the dwell time specified by the manufacturer ... g. When cleaning the OR/ Procedure room: ... make sure the room is cleared for cleaning ..."

A review of the germicidal wipes product label indicated, " ... Contact time: ... Allow to remain wet two [2] minutes, let air dry ... Precautionary Statements ... Hazards to Humans ..."

A review of then Society of Gastroenterology Nurses and Associates (SGNA) document titled, "Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes" dated 2012, indicated, " ... To prevent cross- contamination in an endoscopic procedure room ... All contaminated areas must be cleaned and decontaminated between patients ..."

11. During a concurrent observation in Facility B's pre-operative (before procedure) holding area and interview with RN 21, on 6/ 5/19 at 9:20 a.m., RN 21 assisted the admission nurse with the collection of Patient 78's blood sample. RN 21 held the blood filled syringe (hollow plastic tube with a needle to inject or withdraw fluids) in her hands while recapping the syringe's needle. RN 21 confirmed recapping the needle and stated, "I always do it that way."

During an interview with IP 5, on 6/10/19 at 2:10 p.m., she stated, "...No one should ever recap needles, it's a hazard and infection control issue, potential for injury and cross contamination of bloodborne pathogens [germs in blood]."

A review of the hospital policy and procedure titled, "Bloodborne Pathogen Exposure Control Plan- Standard Precautions" dated 11/20/18, indicated, " ... Policy ... It is the responsibility of the healthcare provider to comply with standard precautions [infection control practices to control the spread of disease] ... g. Generally, recapping of needles is not allowed ... under situations in which recapping must take place; (e.g.; titration of medications, specimen [sample] transport, etc.), the one- handed scoop method technique is recommended ..."

12. During a concurrent observation and interview on 6/3/19, at 10:35 a.m., in the inpatient (a patient who stays in a hospital while under treatment) dialysis unit, RN 6 removed dialysis tubing from station 5's machine. The tubing contained fluid that was pink and red. RN 6 did not have a gown on. Clinical Supervisor (CS) 10 validated RN 6 was not wearing a gown and stated, " ...He should have had a gown on ..."

During an interview with RN 6, on 6/3/19, at 10:55 a.m., he stated when cleaning the dialysis machine, the staff are supposed to have a gown, mask, and gloves on. RN 6 stated, " ...I'm supposed to have it [gown] on, I usually have it on ..." RN 6 stated the importance of wearing a gown when cleaning the dialysis machine was to protect himself from blood borne pathogens (germs that spread through contamination with blood) and to prevent cross contamination.

During an interview with IP 5, on 6/3/19, at 4:02 p.m., she stated during the task of cleaning of the dialysis machine, it was important for staff to wear a gown, gloves, and a face shield for the staff's protection.

A review of the facility policy and procedure titled, "Dialysis Station Disinfection" dated 5/19, indicated, "I. Purpose ...To define the appropriate process to perform routine disinfection of the dialysis station ...III. Definitions ...A. PPE-personal protective equipment to include gown, gloves, and face shield ...V. Procedure ...B ...1. Don full PPE ..."

13. During a concurrent observation and interview on the second floor, in a unit that was utilized as an extension of the emergency department, on 6/4/19, at 9:53 a.m., a red sharps biohazard bin was stored in the medication room. The sharps bin was filled above the ¾ full line indicator that was located on the container. The sharps bin contained needles and intravenous (into the vein) supplies. Clinical Supervisor (CS) 9 validated the findings and stated, " ...These are ready to go ...this could have been changed earlier ..." CS

Based on observations, interviews, and record reviews, the hospital failed to ensure the achievement and maintenance of high standards of medical practice and patient care in accordance with the hospital's policies and procedures and acceptable standards of practice when:

1. Three of three previously cleaned and sterilized surgical instrument tray sets, contained multiple instruments with chipped and peeled off identification tape (Refer to A-951 Finding 1).

2. Multiple instruments were not processed according to manufacturer's instructions for use (IFU) and infection control standards (Refer to A-951 Finding 2).

3. There was no documented evidence to indicate sterile processing technicians received specific job competencies to ensure they were competent to perform their duties (Refer to A-0951 Finding 3).

4. There was no documented evidence to indicate active surveillance was performed in the hospital's sterile processing department (SPD) to ensure the department and staff performed inpatient services in accordance with acceptable standards (Refer to A-0951 Finding 4).

5. A mouth mirror (dental instrument) was cracked and missing fragments in one of three extraction trays examined. (Refer to A-951 Finding 5).

6. The "Operating Room (OR) - Counts in the OR" policy was not implemented for one of 36 sampled patients (Pt 1) who underwent an abdominal (belly) surgery on 9/1/18. (Refer to A-951 Finding 6).

An Immediate Jeopardy (IJ) situation was identified on 6/5/19, at 2:21 p.m. related to findings in Surgical Services tag A-951 [42 CFR 482.51], in the presence of the hospital Chief Operating Officer, Vice President of Quality and Infection Control, Quality Director, Sterile Processing Department Manager, Corporate Chief Medical Officer, Director of Patient Safety, and Sterile Processing Department Director. Serious issues were identified with the processing and sterilization of all surgical instruments not following nationally recognized standards and manufacture's instruction for use placing potential serious risks to all patients having surgery. The hospital developed and submitted an acceptable Action Plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included: removing all surgical instruments from service so those instruments could be cleaned, disinfected and sterilized again, new competencies were created in disinfecting and sterilization technique, and all staff involved with the sterilization of surgical instruments were re-trained in proper cleaning. The survey team conducted observations, interviews, and record reviews to ensure staff demonstrated competencies and in-services were performed before the IJ was removed on 6/7/19 at 8:59 a.m. in the presence of the Risk Coordinator.

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

Based on observation, interview, and record review, the hospital failed to ensure the achievement and maintenance of high standards of medical practice and patient care in accordance with the hospital's policies and procedures and acceptable standards of practice when:

1. Three of three previously cleaned and sterilized surgical instrument tray sets, contained multiple instruments with chipped and peeled off identification tape;

2. Sterile Processing Technician (SPD) 1 did not process multiple surgical instruments according to manufacturer's instructions for use (IFU), or according to infection control standards;

3. Evidence documenting SPDs received job-specific training and were evaluated as competent to perform their duties, was not provided for review.

4. No documented evidence was provided to indicate the techniques and practices of SPD staff were monitored in their performance of their duties to ensure acceptable standards of practice were followed.

An Immediate Jeopardy (IJ) situation was identified, on 6/5/19, at 2:21 p.m., related to findings in Surgical Services tag A-951 [42 CFR 482.51], in the presence of the hospital Chief Operating Officer, Vice President of Quality and Infection Control, Quality Director, Sterile Processing Department Manager, Corporate Chief Medical Officer, Director of Patient Safety, and Sterile Processing Department Director. The observed failure of SPD technicians to process and sterilize surgical instruments according to nationally recognized standards and manufacturer's instructions, the failure to have a system in place to monitor SPD practices, and the failure to provide documented evidence of the competency of SPD staff, resulted in the serious potential risk of harm to all patients having surgery at the hospital. The hospital developed and submitted an acceptable Plan of Removal that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included: removing all surgical instruments from service so those instruments could be cleaned, disinfected and sterilized again, new competencies were created in disinfecting and sterilization technique, and all staff involved with the sterilization of surgical instruments were re-trained in following nationally accepted standards. The survey team conducted observations, interviews, and record reviews to ensure hospital staff implemented the corrective actions listed on the Plan of Removal and the IJ was removed on 6/7/19 at 8:59 a.m.

5. A mouth mirror (dental instrument) at Facility C, was cracked and missing fragments in one of three extraction trays (surgical instruments used to remove a tooth) inspected.

6. The "Operating Room (OR) - Counts in the OR" policy was not implemented for one of 36 sampled patients (Pt 1) who underwent an abdominal (belly) surgery on 9/1/18.

This failure resulted in a sponge (a cotton pad used to absorb fluids in a surgical procedure) being retained (unintentionally left in the abdomen) in Pt 1 from 9/1/18 through 1/15/19, a total of 135 days. Pt 1 endured preventable pain, a second surgery to remove the retained sponge, and a third surgery to remove additional retained sponge material.

Findings:

1. On 06/03/19 at 9:50 a.m., an interview was conducted with Infection Control Preventionist (ICP 2) who stated the hospital followed nationally recognized guidelines from the Association for Professionals in Infection Control (APIC), Association of Perioperative Registered Nurses (AORN), Association for the Advancement of Medical Instrumentation (AAMI), and the Centers for Disease Control (CDC).

On 06/03/19, at 10:35 a.m., during the tour of SPD with Sterile Processing Lead (SPL), three sterilization containers (wire buckets or baskets that hold surgical instruments) filled with various cleaned and sterilized surgical instruments. The following was observed:

Eighteen of 104 instruments had identification tape partially peeled off and post-manufacture etching (marks or carving that had been added by the hospital, not by the manufacturer).

Eight of 85 surgical instruments had chipped tape, post-manufacture etching, and brown staining.

Three of five instruments that had removable parts, were not disassembled (taken apart) prior to sterilization.

During the interview, SPL stated the instruments with the chipped and peeled tape should have been removed and the instruments with the post-manufacture etching should have been removed from use. SPL also stated the instruments with removable parts should have been disassembled before they were sterilized.

A review of AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) - "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative [during the course of an operation] practice and healthcare) guidelines, their recommendations, indicated 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 ..." "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization."

A review of the manufacturer's IFUs for tape, undated indicated, "...overlap tape 1.5 times.... Replace when tape starts to discolor, chip, crack or flake."

During a record review of the manufacturer's IFUs for a table mounted retractor (a surgical instrument used for holding open the edges of a surgical incision) on 6/5/19 at 1:50 p.m., an instrument which had not been disassembled for sterilization, indicated, "Preparation for Cleaning: Instruments designed to come apart must be disassembled prior to cleaning ..." "Packaging for Sterilization: Arrange all devices to allow access of steam to all surfaces. Open hinged devices and ensure devices are disassembled if it is recommended ..."

2. During a concurrent observation of the hospital SPD and interview with Sterile Processing Technician (SPD) 1, on 6/5/19 at 8:50 a.m., in the presence of ICP 2 and the Sterile Processing Manager (SPM). SPD 1 was observed cleaning reusable surgical instruments.

SPD 1 did not fully submerge or brush all reusable surgical instruments in four of four different cart sets (carts filled with surgical instruments from different patient surgeries);

SPD 1 soaked staplers (robotic surgical systems designed to facilitate complex surgeries using a minimally invasive approach, and controlled by a surgeon) for less than four minutes;

SPD 1 did not use a timer to measure soak time. (Soak time is the time needed for surgical instruments to be soaked in the enzymatic [cleaning] solution). SPD 1 did not use a thermometer to measure the water temperature. The label on the enzymatic solution indicated, "warm water ...clean for a minimum of 1 to 5 minutes. Cleaning times may be longer with dried on proteinaceous [substances from the human body] materials if lower temperatures are used, a longer cleaning time may be necessary. Do not exceed 130 degrees Fahrenheit ...";

SPD 1 did not clean the sink between cleaning each surgical cart set;

SPD 1 did not disassemble instruments with removable parts;

SPD 1 used the same wired toothbrush-style cleaning brush to clean all four cart set instruments. SPD 1 stated they used the brushes for the entire shift and do not clean the brushes between uses;

The "Heart Tray set" contained a retractor (a surgical instrument used for holding open the edges of skin). SPD 1 stated one "Heart Tray set" was placed into the same enzymatic solution filled sink used for cleaning one of the other cart sets (an implantable set) and soaked for two minutes. The removable part of the retractor was not disassembled during the soaking phase;

SPD 1 brushed sixteen needle holders (reusable surgical instruments) using the same brush used for previous instruments. The needle holders were not brushed individually;

SPD 1 submerged hinged instruments into the enzymatic solution without first ensuring the instruments were in the open position;

SPD 1 placed a device used for spinal surgeries into the same enzymatic solution as the "Heart Tray set.";

SPD 1 removed two instruments from the enzymatic filled solution and placed them into the clean water rinse sink. The instruments still contained red matter;

SPD 1 used the same gloves while cleaning the four cart set filled instruments;

During an observation and interview, on 6/5/19 at 10:05 a.m., Sterile Processing Manager (SPM) informed SPD 1 that he was not properly cleaning the instruments and asked him to stop. SPM stated that the robotic stapler system should have been soaked for 30 minutes. SPM stated the process was to change the enzymatic solution between each cart set, to use a different brush for each set, to use a timer to monitor soak times, and to monitor the enzymatic solution temperature. In addition, SPM stated that SPD 1 should have cleaned the sinks between each use, and should have changed his gloves between each cart set.

During a record review, on 6/5/19 at 1:30 p.m., the manufacturer's IFUs for the robotic stapler, undated, indicated, "Soak the instrument for 30 minutes ... Brush entire device thoroughly with a nylon brush for at least 60 seconds under running cold water ..."

A review of the manufacturer's instructions for the implantable device indicated, "This document is intended to establish safe and effective reprocessing procedures in health care facilities for surgical instruments supplied by [Brandname of implantable device] ...The most important step in decontamination is thorough cleaning and rinsing. Cleaning primarily removes rather than kills microorganisms. The factors that contribute to cleanliness are: quality of water; concentration; type of cleaner; washing method ...Instruments are optimally cleaned in water and detergent solutions at temperatures between 80 to 110 degrees Fahrenheit but not to exceed 140 degrees ..."

During an interview, on 6/5/19 at 1:55 p.m., SPD 1 stated he did not receive specific training on how to clean the robotic stapler or the implantable device. SPD 1 stated he did not know the soak times required to meet the manufacturer's cleaning instructions. SPD 1 stated he was not familiar with enzymatic soak times or temperature requirements and was not aware he had to adhere to those times or temperature requirements. SPD 1 stated the SPD Technicians did not receive specific competencies or training on how to clean instruments. SPD 1 stated he only brushed instruments if they were grossly soiled and did not know he was supposed to brush all instruments individually, and he learned to clean instruments by watching another SPD technician.

A review of AORN, one of the nationally recognized infection control guidelines the hospital followed, undated, indicated, "Manual cleaning (cleaning by hand) should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization of contaminants. Aerosolization [the process or act of converting some physical substance into the form of particles small and light enough to be carried on the air] of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water."

A review of AAMI (an organization for advancing the development, safe and effective use of medical technology and one of the guidelines the hospital followed), "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (leaders in advocating for excellence in perioperative practice and healthcare) guidelines, undated, indicated, "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..."

3. During a concurrent interview and review of SPD 1's employee file, on 6/5/19 at 4:38 p.m., the SPD Supervisor and the SPD Director confirmed there was no evidence of job specific competencies from 2017 to current and there was no evidence SPD 1 received competencies specific to the robotic staplers, implantable devices, the use of enzymatic solution or general cleaning instructions required to perform his SPD tasks.

4. During an interview with the SPD Director, on 6/5/19 at 5 p.m., he stated there was no documented evidence that staff in SPD are provided oversight to ensure they are competent performing their job specific tasks.

A review of the manufacturer's IFUs for the cleaning brush, undated, indicated, "Brushes must be cleaned prior to reuse ..."

5. During a concurrent observation in the Facility C's sterile/clean room and interview with Registered Dental Assistant (RDA) 1 and Facility C Director (FCD), on 6/4/19, at 1:40 p.m., RDA 1 was observed to open a sterilized extraction tray for examination within which a mouth mirror was noted to be cracked and fragments of the mirror were missing. RDA 1 stated she was responsible for checking surgical instruments and did not notice the cracked mirror when she prepared the extraction tray. RDA 1 stated she was not aware of a policy which provided guidelines for inspecting Facility C's surgical instruments. The FCD stated Facility C relied on RDAs to determine what instruments were safe to use. The FCD stated the cracked mirror had the potential to cause injury to staff and patients and should have been removed.

A review of the hospital policy and procedure titled "Surgical Instrument Handling and Tray Preparation," dated 8/29/17, indicated, "Policy ... A. After decontamination ... B. Instruments are to be checked for function and defects after cleaning ... C. Any instrument found to be defective or missing from a tray is to be replaced ... 6. Remove any defective instrument from service ..."

6. During a review of Pt 1's clinical record titled, "Operative Report" dated, 9/2/18, indicated Pt 1 was admitted to acute care hospital on 9/1/18, for a preoperative (before surgery) diagnosis of right pneumothorax (air between the lungs and the chest wall causing the lung to deflate), thoracoabdominal (involving the chest and abdomen) stab wound, and liver injury. The procedures performed on 9/1/18 were right tube thoracostomy (a cut in the chest wall for drainage), diagnostic laparoscopy (minimally invasive surgical procedure to examine the organs inside the abdomen), exploratory laparotomy (a full size surgical incision to examine the organs inside the abdomen), IVC repair (fix a large vein), and liver laceration cautery (electric current to stop bleeding vessels and or tissue).

During a review of Pt 1's clinical record titled, "Operating Room Nursing Note" dated 9/1/18, indicated the surgical counts (all instruments, and sponges) were counted by the surgical technician (ST-a surgical team professional that assist the surgeon with instruments and supplies) and verified by Circulating Registered Nurse 1 and 2 (CRN-a perioperative nurse who assists in managing the nursing care of a patient during surgery).

During a review of Pt 1's clinical record titled, "Operating Room Nursing Note" dated 9/1/18, indicated The final count was documented as " ...Correct-Yes..."

During a review of Pt 1's clinical record titled, "Discharge Summary" dated 9/5/18, at 11:24 a.m., indicated Pt 1 was discharged to home.

During a review of Pt 1's clinical record titled, "Emergency Department Provider Note" dated 11/13/18, indicated, " ...is a 24 y.o. (year old) male admitted 9/1/18-9/5/18 for hemopneumothorax (condition of having blood and air in the chest cavity), IVC laceration X2 [two locations], and liver laceration s/p [status post] multiple stab wounds ...presents to the ED ...complaining of abdominal pain ...Imaging review ...CT (computer tomography- allows you to see inside the body) Chest Abdomen and Pelvis W (with) Contrast ...ED interpretation ...enhancing fluid collection in the right hemiabdomen (the part of the body between the thorax and the pelvis) measuring up to 8.3 cm (centimeters-a unit of measurement). There is an associated high density serpiginous (having a wavy margin) focus in collection which may represent a retained sponge ...ED Course ...Ct scan concerning for retained foreign body and patient admitted to surgery and taken to the OR for operative management ...Clinical Impression ...Abdominal pain..."

During a review of Pt 1's clinical record titled, "ED Provider Note" dated 11/13/18, at 8:30 a.m., indicated " ...Patient ...counseled regarding treatment plan. Agreeable to plan ...Pt 1 was admitted to surgery and taken to OR ..."

During a review of Pt 1's clinical record titled, "Surgery Progress Note" dated 11/13/18, at 3:03 p.m., indicated " ...Discussed the risk of waiting for surgery and it was safer to do the surgery before Pt 1 developed any further complications from the retained sponge and there was no other way to remove the sponge other than surgery ...I [MD 3] updated Pt 1's father by phone, with the risk of waiting or not doing the surgery ..."

During a review of Pt 1's clinical record titled, "OR Nursing" dated 11/13/18, at 3:28 p.m., indicated " ... I [MD 3] explained all the risk of leaving against medical advice ..."

During a review of Pt 1's clinical record titled, "Release Form" dated 11/13/18, at 4:46 p.m., indicated Pt 1 signed a form and was leaving the hospital against medical advice of the attending physician and did not have the retained sponge removed.

During a review of Pt 1's clinical record titled, "Progress Notes" dated 11/21/18, at 1:33 p.m., indicated " ...Attempted to call patient for follow-up as well as father, voicemail left on father's cell phone. Unable to leave message on voicemail listed for Pt 1 ..."

During a review of Pt 1's clinical record titled, "CT Abdomen and Pelvis W Contrast" dated 1/12/19, at 8:40 p.m., indicated " ...Findings suggestive of a small bowel obstruction ...retained foreign body in the right mid abdomen ...as noted on prior image of November 13, 2018 ...retained surgical sponge ..."

During a review of Pt 1's clinical record titled, "Surgery H&P (history and physical)" dated 1/13/19, at 12:11 a.m., indicated, " ...Acute Care Surgery ...Admit Date: 1/12/2019 ...a 24 y.o. year old male with recent ex-lap (exploratory Laparotomy) after stab wound to abdomen s/p ex-lap, IVC and liver laceration repair 09/01/18 at (name of hospital), discharged home and returned in November with increasing abdominal pain and was found to have a retained RUQ (right upper quadrant - of the abdomen) laparotomy pad, left AMA [when a patient leaves the hospital against medical advice] from preop (before surgery) area and returns today with nausea and occasional vomiting as well as increasing abdominal pain starting in the morning of 1/12/19.

During a review of Pt 1's clinical record titled, "Operative Report" dated 1/15/19, at 6:13 a.m., indicated Pt 1 had diagnoses that included: small bowel obstruction (blockage of the small intestine), removal of a sponge, and temporary abdominal closure (a procedure where the surgeon leaves the stomach open not permanently) on 1/13/19.

During a review of Pt 1's clinical record titled, "Discharge Summary" dated 1/20/19, at 11:34 a.m., indicated " ...Pt 1 had a third surgery on 1/15/19 for permanent closure of the abdomen and was found to have an ischemic (restriction in blood supply) segment of jejunum (the middle section of the small intestine), that required resection (surgical removed). In addition, retained foreign material (part of a sponge) was adherent (attached) to the distal (end) jejunal serosa (outer skin) was removed and the abdomen was closed ..." Pt 1 was discharged to home on 1/20/19.

During a concurrent interview and record review of the of the hospital's document titled, "Root Cause Analysis" (RCA- a process to identify cause to a problem) with the Patient Safety/Risk Manager (PSRM), on 6/4/19, at 2 p.m., she stated an RCA was completed for the retained sponge on 1/18/19. PSRM stated the following concerns were identified: 1) A traveler RN (An RN that fills gaps in staffing for a specific periods of time) did not always use the hanging counter (a device used in the OR to place sponges and other items used during surgery, that separates the items to allow them to be counted before the end of surgery) in surgeries; 2) Identified counts on the white board were not standardized, some staff used hash marks (a line to represent a number) while others used numbers; 3) Identified a standard deviation (number used to tell how measurements for a group are spread out from the average) of unused sponges not being placed in the counter bags per policy; and 4) Red bags were used in the kick buckets (a medical receptacle on wheels used during surgical procedures to hold used surgical sponges) instead of clear bags.

During a concurrent interview and record review of Pt 1's clinical record titled, "Operating Room Nurses Notes" (OR notes) dated 9/1/18 with CRN 2, on 6/4/19, at 9:24 a.m., she stated Pt 1 came in as a trauma (physical injury) patient, and when she entered the OR, the surgery had already started. CRN 2 stated while the surgery was in process, she and the Surgical Tech (ST) added sponges to the sterile field. CRN 2 stated the ST placed his finger in between the sponges and counted while they were still in a stack. CRN 2 stated the ST did not fully separate the sponges when he counted. CRN 2 stated she did not do the second count at the time of the first close (counting of sponges at closure of first layer of a cavity or innermost layer of the skin) or the final count (counting of sponges after skin closure). Pt 1's medical record indicated CRN 2 and the ST performed a second and final count. CRN 2 acknowledged someone documented her name as performing the second and final count, but stated she did not do the counts.

During an interview with Medical Doctor (MD) 3, on 6/4/19, at 9:43 a.m., she stated the professional standards followed by the surgical department are the Association of Perioperative Registered Nurses (AORN). MD 3 stated it was her expectation that staff followed AORN and the hospital's policies and procedures (P&P). MD 3 stated during the final counts, occasionally there are laps (sponges) in the surgical field. MD 3 stated the MDs grab items from the STs, but they try not to. MD 3 stated the ST and CRN are responsible for doing the counts and the MD was responsible to acknowledge the counts. MD 3 stated the purpose of the hospital's Counts policy was to standardize the way staff counted and the ultimate goal was to prevent incidents like this (retained sponge). MD 3 stated the retained sponge occurred due to human error, due to incorrect counts.

During an interview with Manager Surgical Services (MSS), on 6/5/19, at 10:15 a.m., she stated the lap sponges came in packs of five. The MMS stated during the task of counts, the ST and CRN were to take off the tab on the sponges and count each sponge separately to visually see each item. The MSS stated the importance of this was there could be inconsistencies with the manufacture's packaging. At the end of the surgery, the goal was to ensure there was reconciliation (returning of all sponges) of the counts. The MSS stated if the sponges were not separated, there was a possibility sponges were not accounted for. The MSS stated the final count starts after staples or suture of the patient's skin. The MSS stated counting started at the surgical field, because items such as sponges, are still on the surgical field during the final count. The MSS stated the process of placing the sponges in the counting bags were to spread the sponges apart and put them in the counter bag from the bottom up because it was easier to see if there was a pouch missing. The MSS stated if the process was not completed this way, there are possibilities of missed pouches and counting a sponge that was not there.

During a concurrent interview and record review with the Certified Registered Nurse Anesthetists (CRNA- professionals that ensure the safe administration of anesthesia [medicine given for loss of sensation in a body part or your entire body when they are having surgery]) on 6/5/19, at 3:38 p.m., she stated she was the CRNA assigned to Pt 1's surgery on 9/1/18. The CRNA stated her role did not include involvement of the counting process. The CRNA stated her responsibilities were to stabilize patients. The CRNA stated the purpose of the Counts policy was to ensure nothing was retained and all items used in surgery were accounted for. The CRNA stated she did not know the Final Count process. The CRNA stated she was not involved in Pt 1's Final Count process. The CRNA stated she did not maintain situational awareness during the count process. The CRNA reviewed the hospital's policy and procedure titled, "OR- Counts in the OR" dated 5/17 specific to her role in the counts process. The hospital policy and procedure titled "OR - Counts in the OR" dated 5/2017, indicated, "...Purpose ...To define a standardized process for consistent and accurate counts of surgical items in all operating rooms (OR's) in Surgery ...To protect the patient from injury as a result of a retained surgical item (RSI) ...RSIs may be: 1. Unintentionally retained due to incorrect count ... III. Policy...All perioperative (during surgery) team members are to be held responsible for prevention of RSIs ...The anesthesia care provider is to maintain a situational awareness of the count process... Not pressure or rush the perioperative team... Closure Counts: The RN Circulator should organize used sponges in a manner to allow the anesthesia provider to visualize and estimate blood loss ... All the sponges -- used and unused sponge --must be in the hanging sponge counters at the end of the case to have a correct final count and to be able to perform a team verification ...Circulator, scrub person, anesthesia provider and surgeon should all witness that there are no empty pockets in the hanging counter bags ..." The CRNA stated she had been employed at the hospital since February 2017 and was never instructed that her role was to maintain situational awareness during the counts process.

During an interview with CRN 1 on 6/6/19, at 8:52 a.m., he stated he was one of the CRNs in Pt 1's surgery on 9/1/18. CRN 1 stated he performed the preliminary count with ST. CRN 1 stated CRN 2 assisted him in Pt 1's surgery. CRN 1 stated CRN 2 and the ST were responsible for the first closing and final count. CRN 1 stated he did not witness CRN 2 and the ST conduct the first closing or final count because he was doing other tasks. CRN 1 stated the purpose of the Counts Policy was to standardize the process to ensure patient safety in regards to accounting for all sponges used during surgery. CRN 1 stated if the policy was not followed, the outcome could be a RSI in a patient. CRN 1 stated in Pt 1's case, between the ST and CRN 2, someone did not follow P&P.

During a concurrent interview and record review of the of the hospital's policy and procedure titled, "OR - Counts in the OR" with MD 2, on 6/6/19, at 10:14 a.m., he stated he was the Acute Care Surgery Fellow (physician completing specialty training for more than one year in trauma, critical care (life-threatening condition), on call that took Pt 1 into surgery on 9/1/18. MD 2 stated Pt 1's surgery was trauma and was a high stress case. MD 2 stated the purpose of the Counts policy was to prevent an RSI (surgical item that was not intended to remain in a patient). MD 2 stated ST and the CRN's roles were to perform the counts together, and his role was to acknowledge the counts. MD 2 stated during the final count, sponges can be left on the surgical field and the ST and CRN will acknowledge the items. MD 2 stated the counts in Pt 1's surgery was completed (9/1/2018), and the counts were incorrect. MD 2 reviewed the policy "OR - Counts in the OR" which indicated, " ...Closure Counts ...use hanging sponge counters ...as follows...in order to complete and visualize the final count, all unused sponges are removed from the sterile field and added to the hanging counter. All the sponge --used and unused sponges -- must be in the hanging sponge counter at the end of the case to have a correct final count and be able to perform a team verification ...Circulator, scrub person, anesthesia provider and surgeon should all witness that there are no empty pockets in the hanging counter bags. Verify that the number of sponges documented on the ...board agrees with the final number of sponges in the hanging sponge counters ..." MD 2 stated it was not a routine practice for him to visualize the counting bag during the final count, and he did not do that in this case.

During an interview with MD 1, on 6/6/19, at 10:30 a.m., he stated the purpose of the OR Counts policy was to ensure no sponges were left in patients. MD 1 stated the ST and CRN 2 were responsible for the final count. MD 1 stated it was his expectation that the ST and CRN 2 both participated in the final count. MD1 stated for Pt 1's surgery on 9/1/18 he did not recall any details.

During an interview with Director of Surgery Services (DSS), on 6/6/19, at 10:52 a.m., she stated the purpose of the OR Counts policy and procedure was to prevent a retained sponge. The DSS stated it was her expectation for the staff to follow the hospital's P&P 100 percent of the time, exactly how it was spelled out. The DSS stated the ST and CRN 1 were responsible for the preliminary (first) count. The ST and CRN 2 were responsible for the second (first close) and final count. The DSS stated for the final count, all sponges, used and unused were to be off the field and in the hanging counter. The DSS stated everyone had to agree the count was correct. The DSS stated the retained sponge should have never happened, it was due to human error of incorrect counts. The DSS stated the counts were documented as correct and clearly it (the count) was not correct.

During a concurrent interview and record review with CRN 3, on 6/6/19, at 2:55 p.m., Pt 1's clinical record titled "Operating Room Nurses Notes", dated 1/13/19, at 8:55 p.m. indicated, " ... Pt 1 had an exploratory laparotomy, and removal of retained foreign body ..." CRN 3 stated he collected the removed sponge and sent it to pathology (a lab exam). CRN 3 stated Pt 1's incision site was not closed due to pending further observation of the abdomen.

During a concurrent interview and record review with Informatics Registered Nurse (IRN) 3, on 6/7/19 at 9:24 a.m., Pt 1's clinical record titled, "ORM-Log 635230 - Counts (audit trail of Pt 1's OR counts)" dated 9/1/18, indicated CRN 1 was logged into Pt 1's electronic health record (EHR) and documented the second sponge count was performed by the ST and verified by CRN 2.

During an interview with the ST, on 6/10/19, at 7:21 a.m., he stated he was the ST in Pt 1's surgery on 9/1/18. The ST stated he was aware of the importance to follow the Counts policy. The ST stated his role was to ensure all sponges were accounted for. The ST stated there are times the surgeons needed items during the count process, the counts get interrupted because the ST is to respond to the MDs request. The ST stated it was a common practice for the counting process to be interrupted. The ST stated he and the CRNs were responsible in performing the counts. The ST stated his role did not include documenting the counting process in the medical record. The ST stated the CRNs document the count process. The ST stated the CRN that completed the counts would document their name and the ST's name. The ST stated the second and