HospitalInspections.org

Based on record review and interview, it was determined that the St. David's Medical Center facility failed to follow state and local laws that mandate dog bites be reported to the local rabies authority.

Findings:

The Texas Administration Code states in part, " ... Sec. 826.041. REPORTS OF RABIES.

(a) A person who knows of an animal bite or scratch to an individual that the person could reasonably foresee as capable of transmitting rabies, or who knows of an animal that the person suspects is rabid, shall report the incident or animal to the local rabies control authority of the county or municipality in which the person lives, in which the animal is located, or in which the exposure occurs.

(b) The report must include:

(1) the name and address of the victim and of the animal's owner, if known; and

(2) any other information that may help in locating the victim or animal.

(c) The local rabies control authority shall investigate a report filed under this section ..."

The Austin Animal Center for Animal Protection on the state and local website states in part, "All animal bites must be reported to Animal Protection. If medical attention has been received after a bite ..."

A review of patient records revealed 2 out of 2 patients who had been treated for dog bites at St. David's Medical Center failed to report these incidents to the local rabies authority.

The above findings were confined in an interview with the Emergency Department Nurse Manager, Staff #E6.

Based on the review of documents provided by the medical record staff, the Governing Body failed to ensure that Medical Staff enforce its Medical Staff Bylaws that medical records are completed within 30 days following discharge of patients.


Review of the "Medical Staff Bylaws, Approved 4/19/2018" revealed under Section 8.D, "(1)Membership and/or Clinical Privileges may be automatically relinquished if a practitioner: (a) fails to do any of the following: (i) timely complete medical records as required by the Credentials Policy, Rules and Regulation or applicable policies... (2) Automatic relinquishment will take effect immediately and will continue until the matter is resolved and the individual is reinstated, if applicable, as detailed in the Credentials Policy."


Review of the hospital's "Credential Policy, Approved 04/19/2018" revealed under "Section 6.G.1 Failure to Complete Medical Records: A medical record is considered to be delinquent when it has not been completed for any reason within thirty (30) calendar days following a patient's discharge or if a Practitioner fails to respond to coding queries within fifteen (15) calendar days." Further it says, " When a Medical Staff Member or individual with clinical privileges has failed to complete a medical record and the record becomes delinquent, his/her elective admitting privileges maybe automatically suspended after the individual has been notified of the delinquency. The suspension may continue until all of the individual's delinquent records are completed. After thirty (30) more days on the delinquent list,all remaining Medical Center Clinical Privileges maybe suspended."


At the time of the survey, there were 135 medical records not completed within 30 days following discharge of patients. Examples:

MD1 has 3 delinquent medical records that were 55 - 180 days post discharge.

MD2 has a delinquent record that was 111 days post discharge

MD3 has a delinquent record that was 109 days post discharge

MD4 has 4 delinquent record that were 57 - 58 days post discharge

MD5 has 22 delinquent records that were 30 -44 days post discharge

MD6 has 19 delinquent redords that were 30 - 41 days post discharge

NP1 has 3 delinquent record that were 55 - 108 post discharge.

MS1 has 7 delinquent records that were 54 - 61 days post discharge.

PA1 has 9 delinquent records that were 60 - 89 days post discharge.

The Governing Body failed to ensure that medical staff providing services to patients in the hospital was appointed and granted privileges by the Governing Body.

Review of the Medical Staff Bylaws that was approved on 04/19/2018 revealed under Section 4.B Temporary Privileges the following:

"4.B.1 Temporary Clinical Privileges constitute temporary permission to attend to patients at the Medical Center. Temporary Clinical Privileges are distinguished from other Clinical Privileges of the Medical Center in that they are not based upon complete review of credentials and are granted or revoked by the Campus Chief Executive Officer after consultation of the President of the Medical Staff or his or her designee..."

"4.B.3 Temporary Clinical Privileges maybe granted by the Campus Chief Executive Officer or designee upon receiving a favorable recommendation from the appropriate Department Chairperson or President of the Medical Staff..."

Interview with the Chief Medical Officer confirmed the process of granting temporary privileges to practitioners to provide medical services to hospital patients.

Based on record review, documentation, and interviews, the facility did not meet the Condition of Participation 482.13 Patient's Rights as evidenced by:

1. Failing to ensure care is provided in a safe setting, as laboratory procedures were not followed. Cross refer to A0144.

2. Failing to ensure patient's right to adequate care when the unit's tele-tracker erroneously showed that patients were on Contact
Precautions. Cross refer to A0144.

3. Failing to ensure patient medical records were safeguarded from the potential unauthorized access. Cross refer to A0147.

4. Failing to ensure restraints were implemented in accordance with safe and appropriate techniques in accordance with State
Law. Cross refer to A0154.

5. Failing to ensure appropriate less restrictive interventions were employed before applying restraints on aggressive patients.
Cross refer to A0164.

6. Failing to ensure restraints were implemented in accordance with safe and appropriate techniques. Cross refer A0167.

7. Failing to ensure adequate training was provided to all staff on the proper use of restraints. Cross refer A0194.

8. Failing to ensure initial and annual training was provided to all staff on the proper and safe implementation of all types of
restraint. Cross refer to A0196.

9. Failing to ensure training to staff on the safe application of all types of restraints used at the facility. Cross refer A0202.

The effect of these deficient practices resulted in noncompliance with the Condition of Participation 482.13 Patient's Rights.

Based on the review of hospital procedures, observations, and interview, it was found that St. David's Main Hospital did not follow its laboratory procedures.

Findings:

A. Point of Care i-Stat

1. St. David's Medical Center Point of Care - i-STAT System (used to provide quick laboratory chemistry values) Procedure states:

"b. ...cTnl cartridges may be stored at room temperature 18 to 30 degrees centigrade for 14 days. CG4+ cartridges can be stored at room temperature for 2 months ...

d. Write the new expiration date on individual cartridges or the cartridge box that are stored at room temperature."

2. Observations on the afternoon of 7/29/19, in the facility's emergency room revealed Intravenous carts with 2 unopened cTnl and 1 unopened CG4+ i-stat cartridges, the cartridges were available for patient use. The cartridges were not labeled with the expiration dates and had been removed from the original dated box, possibly affecting the efficacy of the test and a delay in treatment.

3. During an interview on the afternoon of 7/29/19, in the facility's emergency room, ED Director confirmed there was no way to tell when the cartridges had been removed and if they were expired.


B. Transfusion Reaction Investigations

1. St. David's Medical Center Procedure Transfusion Reaction Investigation, Number 9.00, Revision date 8/22/18 states

" ...A. First Tier Investigation ...When all clerical checks have passed, the post-DAT (direct antibody test) is negative and the post-urinalysis is negative for hemoglobin, the first tier is negative, and the investigation is complete. Proceed to the second tier of investigation if:

1. Any clerical discrepancies are found

2. DAT is positive

3. Post-transfusion specimen appears hemolyzed

4. Post-urinalysis shows the presence or increase in RBC/hemoglobin

5. The patient experiences a 3-degree Fahrenheit rise in temperature."

2. Review of Transfusion Reaction Investigation records for 2017 and 2018 found when qualifying criteria was present, proceeding the investigation to Tier 2 was not done.

a. 2017 found 4 out of 20 reports had the presence or increase in RBCs/hemoglobin and the Tier 2 workup was not performed.

Patients:

VBW 4/9/17 had 1+ blood in post-urinalysis

MHA 5/26/17 had 3+ blood in post-urinalysis

JJ 10/25/17 had 0-2 RBC in post-urinalysis

MG 10/11/17 had 1+ blood in post-urinalysis

b. 2018 found 3 out of 14 reports had the presence or increase in RBCs/hemoglobin and the Tier 2 workup was not performed.

Patients:

IG 6/26/18 had 1+ blood in post-urinalysis

RD 2/18/18 had 50 RBCs in post-urinalysis

KO 11/16/18 had 2+ blood in post-urinalysis

3. Interview with the laboratory director and blood bank supervisor on August 1, 2019 at 11:15 AM confirmed that criteria was present indicating a Tier 2 investigation should have been performed..


33326


Based on observation, interview, and record review, the St. David's Medical Center facility failed to protect Patient's #D12, D13, and D14's rights to adequate care when the unit's tele-tracker erroneously showed the patients were on Contact Precautions. The tele-tracker was in the public access hallway. This incongruity could place the patients, visitors, and staff at risk of receiving the incorrect care or exposure to infectious diseases.

Findings:

An observation on the morning of 7/31/19, of the facility's 5th floor medical surgical unit's tele-tracker, revealed Patient's #D12, D13, and D14 were on Contact Isolation. Further observations revealed the patients #D12, D13, and D14 did not have signage on their doors indicating they were on Contact Isolation or personal protective supplies readily available.

Review of Patient's #D12, D13, and D14 medical records reflected the patients were no longer on the Contact Isolation.

During an interview on the morning of 7/31/19 on the facility's 5th floor medical surgical unit Staff #D10 stated, "If the sign is not on the door then they are not on isolation ... " and confirmed the practice is not included in the facility's Isolation policy and could lead to confusion for family, visitors and other health professionals visiting the patients.

St. David's Georgetown Hospital (SDGH) location:

Based on observation, review of documentation, and interview, it was determined that the hospital failed to ensure that patient medical records were safeguarded from the potential of unauthorized access.

Findings:

Patient medical records were not safeguarded from the potential of unauthorized access.

During a tour of the 2 North Medical Surgical unit on the morning of 7/30/2019, it was observed that outside of each patient room there was a wall mounted metal lockable storage container with a fold down writing surface (note: these containers were found to unlocked and contained hardcopy portions of the patient medical record). These included:

Room 231 SDGH Patient #6
Medical record contained ER clinical report (triage summary, assessment, vital signs, medications given, lab results, and radiology result).

Room 233 SDGH Patient #7
Medical record contained consent for administration of blood and blood components, Admitting Form (patient name, date of birth, address, and insurance information), transfusion record, and patient labels.

Room 234 SDGH Patient #10
Medical record contained Medical Power of Attorney form and Admitting Form (patient name, date of birth, address, and insurance information).

Room 235 SDGH Patient #11
Medical record contained History & Physical form (patient name, date of birth, physical exam, review of systems, lab results, radiology results, diagnosis/assessment/plan), Intra/Post-Anesthesia notes, Operative/Invasive Procedure notes, Consent to Treat form, and Anesthesia consent form.

Room 236 SDGH Patient #8
Medical record contained Medical Power of Attorney form and Admitting Form (patient name, date of birth, address, and insurance information), lab results, patient labels, consent forms, advance directives, EKG strips, operative note, and Intra Operative Orders.

Room 237 SDGH Patient #9
Medical record contained ER Clinical Report, Sign in sheet for ER services, and patient labels.


Review of hospital policy EC.014, entitled: "Records Management" stated under the policy section: "1 ...Records are to be retained in accordance with all applicable laws and regulations and this policy." "6. Records containing confidential and proprietary information will be securely maintained, controlled and protected to prevent unauthorized access."


Page two of the policy under the Definition section stated: "Medical Records: Medical records include, but are not limited to, patient histories, physicals, diagnostic and therapeutic records, consultation and operative reports, discharge and transfer summaries, diagnoses, prognoses, records of treatments and medication ordered and given, progress and therapy notes, orders other recorded entries, x-rays, and other written or graphic data prepared, kept, made, or maintained in facilities that pertain to facility confinements or services for which a physician order is written for admission to a health care facility or unit."


In an interview with staff member #3 on the morning of 7/30/2019, it was confirmed that the portions of the patient medical records found in the unlocked storage containers were potentially accessible by unauthorized individuals.


At approximately 1905 on 7/30/19, the surveyor entered the facility through the front entrance of St David's Georgetown Hospital and took the North elevator to the 3rd floor. The surveyor entered the back hallway of the 3rd medical/surgical unit. The surveyor reviewed and took pictures of 4 patient records without interruption. The following was observed in each respective patient charts:

SDGH Patient #15
Medical record contained Total Knee or Hip Recovery Flowsheet, active scheduled and PRN medication list, Patient Handoff Report (patient name, date of birth, allergies, and brief medical history and assessment).

SDGH Patient #16
Medical record contained ER Clinical Report (allergies and triage assessment), and active scheduled and PRN medication list.

SDGH Patient #17
Medical record contained Anesthesia notes, Patient Handoff Report (patient name, date of birth, allergies, and brief medical history and assessment), and 12-Lead EKG results.

SDGH Patient #18
Medical record contained Total Knee or Hip Recovery Flowsheet, Intra/Post-Anesthesia notes, Admitting Form (patient name, date of birth, address, and insurance information), and Anesthesia consent form.


While the surveyor was reviewing the 2nd patient chart, a person wearing scrubs came out of a patient room carrying a meal tray and set it down on wall shelf. This person wearing scrubs did not interact with the surveyor or asked the surveyor why they were reviewing a patient's unsecured chart. The hallways is not within line of sight of the Nurse's Station due to design of hallway. After reviewing the 4 patient records, the surveyor walked up to the Nurse's Station and asked the clinical staff for the Night Supervisor or any leadership staff that was still available.

In an interview with the Director of Nursing (SDGH Staff #13) and the Director of Med/Surg (SDGH Staff #56) on the evening of 7/30/19, both staff members acknowledged the findings above.



St. David's Cardiovascular Imaging Center San Marcos location:

Findings:

Portions of outpatient medical records were found unsecured and potentially accessible by unauthorized individuals.

During a tour of the imaging center on the morning of 8/05/2019, it was noted that the door to the physician reading room was not locked. (Note: this unlocked reading room was located on a hallway near restrooms which are used by both patients and staff). Inside the room there were portions of unsecured medical records to include: 7 each ECHS CVI ECHO Worksheets. Each of these worksheets had hand written information on them as well as a patient label, these included: patients #1, #2, #3, #4, #5, #6, and #7.

In an interview on the morning of 8/5/2019 with San Marcos staff #4 the above findings were confirmed.


28043


During a tour of the 4th Floor Women Services unit at the St. David's Georgetown Hospital on the morning of 7/30/19, a wall mounted metal lockable storage container with a fold down writing surface was observed outside of the patient rooms in the Post-Partum area. The containers were found to be unlocked and contained hardcopy portions of the patient medical record. The container outside of room 421 contained the hardcopy medical records of Georgetown patients #12 and #13. The records included face sheets with demographic and insurance information, consent forms, newborn assessment, prenatal records, and the OB episode summary. In an interview with the charge nurse, Georgetown staff #53, during the tour on the morning of 7/30/19, staff #53 acknowledged that the container was unlocked and contained the hardcopy medical records of patients #12 and #13. St. David's Georgetown Hospital Staff #53 was asked if a hospital visitor could open the storage container and look at the medical records and staff #53 stated that yes, that was possible.


A tour of the St. David ' s Cardiovascular Imaging Center - 4316 James Casey St #A Austin was conducted the morning of 8/6/19.
During a tour of the "injection room" at approximately 11 am, the survey team observed unsecured medical records containing protected health information in an unlocked cabinet. The records were in a room which was possibly accessible by unauthorized individuals. In the cabinet, there were 13 accordion/expandable file folders which contained hundreds of pages of Dose Logs for patients at the facility with 4 entries per page. Each log entry contained a patient name, date of birth, gender, address, physician name, and drug dose ordered. The findings were confirmed in an interview with St. David's Cardiovascular Imaging Center - James Casey Staff #4 and Staff #1 the morning of 8/6/19 during the tour.


In the "tech office," there were three patient nuclear stress worksheets for patients which had been seen that day at the facility. The worksheets were in an unlocked drawer just inside the office. The tech office was unlocked, and was across the hall from a bathroom used by patients and potentially accessible by unauthorized individuals. The records contained patient identifying information and protected health information, including name, date of birth, type of exam, and medications from the procedures performed on 8/6/19. The findings were confirmed in an interview with St. David's Cardiovascular Imaging Center - James Casey Staff #4 and Staff #1 the morning of 8/6/19 during the tour.


In the registration area, in an unlocked cabinet, the morning of 8/6/19, there was a blue expanding accordion file folder, labeled "Texas Heart and Vascular ... Echo/Stress Echo Accreditation SET 3". The file folder was in a room which was possibly accessible by unauthorized individuals. The folder contained documents which appeared to be used in a Quality study, however, there were medical records, procedure results, insurance information, identifying information such as name, date of birth, height, weight, and protected health information on at least 28 patients in the file folder. The records were dated 2009. The above findings were confirmed in an interview with St. David's Cardiovascular Imaging Center - James Casey Staff #4 during the tour the morning of 8/6/19.

Based on review of facility policy, review of medical records, and interview, the facility failed to ensure restraints were implemented in accordance with safe and appropriate techniques as determined by hospital policy.

Findings:

St David's Medical Center location:

Facility policy entitled "Restraints and Patient Safety Guidelines" stated in part, "Central West Texas is dedicated to fostering a culture that supports a patient's rights to be free from restraint or seclusion. Restraint or seclusion will be limited to clinically justified situations, and the least restrictive restraint will be used with the goal of reducing, and ultimately eliminating, the use of restraints or seclusion."

Patient # 17 was put into 4-point, "nonviolent" restraint on 6/12/19 at 0918 for "unsafe mobile attempt" and "attempting to remove device." Restraints were removed 6/12/19 at 2330. There was documentation that the patient was assaultive to the nurse prior to application of ankle restraints.

4-point restraint was inappropriate as a means to prevent "unsafe mobile attempt." The "attempt to remove device" reasoning for restraint would have been appropriate only in 2-point restraint. If the patient was assaultive (and there was documentation that the patient was) then the restraint should have been a four-hour behavioral restraint. This was confirmed by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 18 was put into 4-point "non-violent" restraint on 6/18/19 at 0227 for "attempting to remove device." A new order was written on the same date at 1514 for bilateral restraints. Patient was in 4-point restraints for over 12 hours. The 4-point restraint was inappropriate for the documented behavior. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 19 was put into 4-point "nonviolent" restraint on 6/21/19 at 0832 for "unsafe mobile attempt." Nursing documentation stated that patient was attempting to remove IVs and a condom catheter. Patient's restraints were removed at 1704 when he was discharged to North Austin Medical Center. The 4-point restraint was inappropriate for the documented behavior. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 20 was put into 4-point restraint on 5/5/19 at 1445 for "attempt to remove device." The order was changed on 5/5/19 at 1617 to bilateral soft restraints for upper extremities. The initial 4-point restraint was inappropriate for the documented behaviors. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 22 was put into 4-point restraint on 6/10/19 at 0410 for "unsafe mobile attempt." On 6/10/19 at 0939, an order for 4-point restraint was rewritten for "attempt to remove device." On 6/11/19 at 0918, an order was written for 4-point "nonviolent" restraint for "unsafe mobile attempt." On 6/11/19 at 2210, an order was written for 4-point restraint for "attempt to remove device." On 6/12/19 at 0832 an order was written for a "nonviolent" restraint for "unsafe mobile attempts." The 4-point restraints were inappropriate for the documented behavior. The inappropriate restraints were confirmed by the Assistant Vice President of Nursing and the RN Regulatory Coordinator on 7/31/19 during chart review.


Patient # 24 was put into 4-point restraint on 5/6/19 at 1820 for "attempt to remove device" and "unsafe mobile attempt." The order was discontinued on 5/7/19 at 0557. This order was inappropriate for the patient's documented behavior. The inappropriate restraint was confirmed by the Assistant Vice President of Nursing and the RN Regulatory Coordinator on 7/31/19 during chart review.


Heart Hospital - Patient # 39 was seen in the ED of The Heart Hospital on 7/11/19. The MD verbally ordered 4-point restraint for a medical procedure. The Nurse entered the verbal order as "bedrails." Patient was put into bilateral soft restraints and released after the procedure was completed. There was nothing documented related to the restraints actually used nor concerning the documentation errors.


Heart Hospital - Patient # 35 had a verbal order for "nonviolent" soft BLE restraints on 4/30/19 at 2200 for "unsafe mobile attempt." Order was entered as BLE (bilateral lower extremities) which would be unsafe if actually applied. This documentation error was verified by the RN Quality Director on 8/6/19.

Based on review of facility policy, review of medical records, and interview, the facility failed to ensure that appropriate less restrictive interventions were employed before putting aggressive patients into restraint.

Findings:

St David's Medical Center location:

Facility policy entitled "Appendix B: Alternatives to Restraint (s) or Seclusion" stated:

A. Psychosocial Alternatives

1. Diversion/distraction

2. Orientation

3. Reassurance

4. Relaxation techniques

5. Personal possessions available

6. One on one discussion

7. Change in Environment

8. Setting limits

9. Family interaction/sitter

10. Quiet area

11. Decreased stimulation

12. Pastoral Visit

13. Reading

14. Interpreter services

15. Reestablishing communication


B. Environmental Alternative

1. Commode at bedside

2. Music/TV

3. Room close to nursing station

4. Bed/Chair alarms in use

5. Bracelet alarm *where available

6. Sensory aids (hearing aid/glasses etc.)

7. Providing quiet area

8. Orientation

9. Decreased noise

10. Night light

11. Call light within reach

12. Specialty low bed

13. Decreased stimulation

14. Physical activity/PT/OT


C. Physiological Alternatives

1. Toileting

2. Positional devices

3. Rest/sleep

4. Assessing abnormal lab values/effects of medications

5. Fluids/nutrition/snack

6. Re-positioning

7. Providing assistance

8. Assessing and modifying comfort measures (pain, temperature, N/V, etc)

9. Pharmacy consult

10. Assisting with ambulation

11. Modifying room temperature (increase or decrease)


D. Alternative Products/Safety Devices

1. Non-slip mats

2. Activity apron/table top activity overlay

3. Safety belt holder with/without torso support

4. Freedom splints

5. Self releasing wheelchair/chair belt

6. Wedge cushion

7. Skin sleeves/abdominal binder

8. Floor cushions

9. Pillows/seizure pads

10. Low Boy Bed

11. Self-releasing wrap-around


E. Types of Restraint (from least restrictive to most restrictive)

1. Wheel Chair Lap belt

2. Roll belt

3. Freedom Arm Splints (one or both arms)

4. Safety Belt Holder with/without torso support

5. Finger/Hand control mittens untied

6. Finger/Hand Control mittens tied

7. Enclosed Bed

8. Limb restraints

9. ER Security Gurney Cuffs"


Patient # 17 was put into 4-point, "nonviolent" restraint on 6/12/19 at 0918 for "unsafe mobile attempt" and "attempting to remove device." Restraints were removed 6/12/19 at 2330. There was documentation that the patient was assaultive to the nurse prior to application of ankle restraints.

4-point restraint was inappropriate as a means to prevent "unsafe mobile attempt." The "attempt to remove device" reasoning for restraint would have been appropriate only in 2-point restraint. If the patient was assaultive (and there was documentation that the patient was) then the restraint should have been a four-hour behavioral restraint. This was confirmed by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.

There was documented evidence that the above patient was aggressive towards staff but was put into a nonviolent (medical ) 4-point restraint rather than a behavioral restraint. It is questionable whether the above psychosocial interventions were offered to this aggressive patient.

Based on review of facility policy, review of medical records and interview, the facility failed to ensure restraints were implemented in accordance with safe and appropriate techniques as determined by hospital policy.

Findings:

St David's Medical Center location:

Facility policy entitled "Restraints and Patient Safety Guidelines" stated in part "Central West Texas is dedicated to fostering a culture that supports a patient's rights to be free from restraint or seclusion. Restraint or seclusion will be limited to clinically justified situations, and the least restrictive restraint will be used with the goal of reducing, and ultimately eliminating, the use of restraints or seclusion."


Patient # 17 was put into 4-point, "nonviolent" restraint on 6/12/19 at 0918 for "unsafe mobile attempt" and "attempting to remove device." Restraints were removed 6/12/19 at 2330. There was documentation that the patient was assaultive to the nurse prior to application of ankle restraints.

4-point restraint was inappropriate as a means to prevent "unsafe mobile attempt." The "attempt to remove device" reasoning for restraint would have been appropriate only in 2-point restraint. If the patient was assaultive (and there was documentation that the patient was) then the restraint should have been a four-hour behavioral restraint. This was confirmed by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 18 was put into 4-point "non-violent" restraint on 6/18/19 at 0227 for "attempting to remove device." A new order was written on the same date at 1514 for bilateral restraints. Patient was in 4-point restraints for over 12 hours. The 4-point restraint was inappropriate for the documented behavior. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 19 was out into 4-point "nonviolent" restraint on 6/21/19 at 0832 for "unsafe mobile attempt." Nursing documentation stated that patient was attempting to remove IVs and a condom catheter. Patient's restraints were removed at 1704 when he was discharged to North Austin Medical Center. The 4-point restraint was inappropriate for the documented behavior. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 20 was put into 4-point restraint on 5/5/19 at 1445 for "attempt to remove device." The order was changed on 5/5/19 at 1617 to bilateral soft restraints for upper extremities. The initial 4-point restraint was inappropriate for the documented behaviors. This was agreed to by the RN Regulatory Coordinator and the House Supervisor during chart review on 7/30/19.


Patient # 22 was put into 4-point restraint on 6/10/19 at 0410 for "unsafe mobile attempt." On 6/10/19 at 0939 an order for 4-point restraint was rewritten for "attempt to remove device." On 6/11/19 at 0918 an order was written for 4-point "nonviolent" restraint for "unsafe mobile attempt." On 6/11/19 at 2210 an order was written for 4-point restraint for "attempt to remove device." On 6/12/19 at 0832 an order was written for a "nonviolent" restraint for "unsafe mobile attempts." The 4-point restraints were inappropriate for the documented behavior. The inappropriate restraints were confirmed by the Assistant Vice President of Nursing and the RN Regulatory Coordinator on 7/31/19 during chart review.


Patient # 24 was put into 4-point restraint on 5/6/19 at 1820 for "attempt to remove device" and "unsafe mobile attempt." The order was discontinued on 5/7/19 at 0557. This order was inappropriate for the patient's documented behavior. The inappropriate restraint was confirmed by the Assistant Vice President of Nursing and the RN Regulatory Coordinator on 7/31/19 during chart review.

Based on review of documentation and interview, it was determined that the facility failed to provide adequate training to all of its staff on the proper use of restraint and seclusion.

Findings:

Facility policy entitled "Staff Education/Training" stated in part, "All staff who have direct patient contact and any others who may become involved in the application of restraint (s)/seclusion will have ongoing education and training in the proper and safe use of restraints and seclusion, if seclusion is used. All training that is provided is documented and evidence available in staff competency files."

St. David's Healthcare Competency entitled "Restraint Application Check Off" was reviewed. The check-off included the following types of restraint: wrist, mitten, roll belt, velcro, and wheelchair lap belt." No training was provided to include 4-point restraint.

According to the RN Regulatory Coordinator on 7/31/19, staff were not trained on the application of 4-point restraint.

Based on review of documentation and interview, it was determined that the facility failed to provide initial and annual training to all of its staff on the proper use of all types of restraint and seclusion.

Findings:

Facility policy entitled "Staff Education/Training" stated in part: "All staff who have direct patient contact and any others who may become involved in the application of restraint (s)/seclusion will have ongoing education and training in the proper and safe use of restraints and seclusion, if seclusion is used. All training that is provided is documented and evidence available in staff competency files."

St. David's Healthcare Competency entitled "Restraint Application Check Off" was reviewed. The check-off included the following types of restraint: wrist, mitten, roll belt, velcro and wheelchair lap belt." No training was provided to include 4-point restraint.

According to the RN Regulatory Coordinator on 7/31/19, staff were not trained initially or annually on the application of 4-point restraint.

Based on staff interview, record review, and policy and procedure, the facility failed to provide staff training on the use of patient restraints used at the St. David's Medical Center facility .

Findings:

Facility document entitled "Appendix A: Training Requirements" states in part: II. "Training Content: D. Safe Application: 1. Staff will be trained on the safe application of all types of restraints and seclusion used in this facility including training to recognize and respond to signs of physical and psychological distress (EG: Positional asphyxia.)".

In a review of the "Restraints and Patient Safety Guidelines" policy and procedures, Appendix A: Training Requirements: Appendix B: Alternatives to Restraint(s) or Seclusion: Appendix C: Hospital CMS Reporting Requirements: Appendix D: Definitions, and Competency: Restraint Application Check-Off, there is no documented evidence of training provided to staff at any time on the use of lower extremities restraints.

The above finding was acknowledged by Staff #12 Regulatory Coordinator. On the morning of 08/02/19.

St. David's Georgetown Hospital (SDGH) location:

Based on observation, review of documentation, and interview it was determined that the hospital failed to ensure that patient medical records were safeguarded from potential of unauthorized access.

Findings:

Patient medical records were not safeguarded from the potential of unauthorized access.

During a tour of the 2 North Medical Surgical unit on the morning of 7/30/2019 it was observed that outside of each patient room there was a wall mounted metal lockable storage container with a fold down writing surface (note: these containers were found to unlocked and contained hardcopy portions of the patient medical record).

Room 231 SDGH Patient #6
Medical record contained ER clinical report (triage summary, assessment, vital signs, medications given, lab results, and radiology result).

Room 233 SDGH Patient #7
Medical record contained consent for administration of blood and blood components, Admitting Form (patient name, date of birth, address, and insurance information), transfusion record, and patient labels.

Room 234 SDGH Patient #10
Medical record contained Medical Power of Attorney form and Admitting Form (patient name, date of birth, address, and insurance information).

Room 235 SDGH Patient #11
Medical record contained History & Physical form (patient name, date of birth, physical exam, review of systems, lab results, radiology results, and diagnosis/assessment/plan), Intra/Post-Anesthesia notes, Operative/Invasive Procedure notes, Consent to Treat form, and Anesthesia consent form.

Room 236 SDGH Patient #8
Medical record contained Medical Power of Attorney form and Admitting Form (patient name, date of birth, address, and insurance information), lab results, patient labels, consent forms, advance directives, EKG strips, operative note, and Intra Operative Orders.

Room 237 SDGH Patient #9
Medical record contained ER Clinical Report, Sign in sheet for ER services, and patient labels.


Review of hospital policy EC.014, entitled: "Records Management" stated under the policy section: "1 ...Records are to be retained in accordance with all applicable laws and regulations and this policy." "6. Records containing confidential and proprietary information will be securely maintained, controlled and protected to prevent unauthorized access."

Page two of the policy under the Definition section stated: "Medical Records: Medical records include, but are not limited to, patient histories, physicals, diagnostic and therapeutic records, consultation and operative reports, discharge and transfer summaries, diagnoses, prognoses, records of treatments and medication ordered and given, progress and therapy notes, orders other recorded entries, x-rays, and other written or graphic data prepared, kept, made, or maintained in facilities that pertain to facility confinements or services for which a physician order is written for admission to a health care facility or unit."


In an interview with staff member #3 on the morning of 7/30/2019 it was confirmed that the portions of the patient medical records found in the unlocked storage containers were potentially accessible by unauthorized individuals.


At approximately 1905 on 7/30/19, the surveyor entered the facility through the front entrance of St David's Georgetown Hospital and took the North elevator to the 3rd floor. The surveyor entered the back hallway of the 3rd medical/surgical unit. The surveyor reviewed and took pictures of 4 patient records without interruption. The following was observed in each respective patient charts:

SDGH Patient #15
Medical record contained Total Knee or Hip Recovery Flowsheet, active scheduled and PRN medication list, Patient Handoff Report (patient name, date of birth, allergies, and brief medical history and assessment).

SDGH Patient #16
Medical record contained ER Clinical Report (allergies and triage assessment), and active scheduled and PRN medication list.

SDGH Patient #17
Medical record contained Anesthesia notes, Patient Handoff Report (patient name, date of birth, allergies, and brief medical history and assessment), and 12-Lead EKG results.

SDGH Patient #18
Medical record contained Total Knee or Hip Recovery Flowsheet, Intra/Post-Anesthesia notes, Admitting Form (patient name, date of birth, address, and insurance information), and Anesthesia consent form.


While the surveyor was reviewing the 2nd patient chart, a person wearing scrubs came out of a patient room carrying a meal tray and set it down it down on wall shelf. This person wearing scrubs did not interact with the surveyor or asked the surveyor why they were reviewing a patient's unsecured chart. The hallways is not within line of sight of the Nurse's Station due to design of hallway. After reviewing the 4 patient records, the surveyor walked up to the Nurse's Station and asked the clinical staff for the Night Supervisor or any leadership staff that was still available.


In an interview with the Director of Nursing (SDGH Staff #13) and the Director of Med/Surg (SDGH Staff #56) on the evening of 7/30/19, both staff members acknowledged the findings above.


St. David's Cardiovascular Imaging Center San Marcos location:

Findings:

Portions of outpatient medical records were found unsecured and thus potentially accessible by unauthorized individuals.

During a tour of the imaging center on the morning of 8/05/2019, it was noted that the door to the physician reading room was not locked. (Note: this unlocked reading room was located on a hallway near restrooms which are used by both patients and staff). Inside the room there were portions of unsecured medical records to include: 7 ECHS CVI ECHO Worksheets. Each of these worksheets had hand written information on them as well as a patient label, these included: patients #1, #2, #3, #4, #5, #6, and #7.

In an interview on the morning of 8/5/2019 with San Marcos staff #4 the above findings were confirmed.


28043


During a tour of the 4th Floor Women Services unit at the St. David's Georgetown Hospital on the morning of 7/30/19, a wall mounted metal lockable storage container with a fold down writing surface was observed outside of the patient rooms in the Post-Partum area. The containers were found to be unlocked and contained hardcopy portions of the patient medical record. The container outside of room 421 contained the hardcopy medical records of Georgetown patients #12 and #13. The records included face sheets with demographic and insurance information, consent forms, newborn assessment, prenatal records, and the OB episode summary. In an interview with the charge nurse, Georgetown staff #53 during the tour on the morning of 7/30/19, staff #53 acknowledged that the container was unlocked and contained the hardcopy medical records of patients #12 and #13. St. David's Georgetown Hospital Staff #53 was asked if a hospital visitor could open the storage container and look at the medical records and staff #53 stated that yes, that was possible.


A tour of the St. David ' s Cardiovascular Imaging Center - 4316 James Casey St #A Austin was conducted the morning of 8/6/19.
During a tour of the "injection room" at approximately 11 am, the survey team observed unsecured medical records containing protected health information in an unlocked cabinet. The records were in a room which was possibly accessible by unauthorized individuals. In the cabinet, there were 13 accordion/expandable file folders which contained hundreds of pages of Dose Logs for patients at the facility with 4 entries per page. Each log entry contained a patient name, date of birth, gender, address, physician name and dose ordered. The findings were confirmed in an interview with St. David ' s Cardiovascular Imaging Center - James Casey Staff #4 and Staff #1 the morning of 8/6/19 during the tour.


In the "tech office", there were three patient nuclear stress worksheets for patients which had been seen that day at the facility. The worksheets were in an unlocked drawer just inside the office. The tech office was unlocked, and was across the hall from a bathroom used by patients and potentially accessible by unauthorized individuals. The records contained patient identifying information and protected health information, including name, date of birth, type of exam, and medications from the procedures performed on 8/6/19. The findings were confirmed in an interview with St. David's Cardiovascular Imaging Center - James Casey Staff #4 and Staff #1 the morning of 8/6/19 during the tour.


In the registration area, in an unlocked cabinet, the morning of 8/6/19, there was a blue expanding accordion file folder, labeled "Texas Heart and Vascular ... Echo/Stress Echo Accreditation SET 3". The file folder was in a room which was possibly accessible by unauthorized individuals. The folder contained documents which appeared to be used in a Quality study, however there were medical records, procedure results, insurance information, identifying information such as name, date of birth, height, weight, and protected health information on at least 28 patients in the file folder. The records were dated 2009. The above findings were confirmed in an interview with St. David's Cardiovascular Imaging Center - James Casey Staff #4 during the tour the morning of 8/6/19.

Based on the review of documents provided by the medical record staff, the hospital failed to ensure that medical records are completed within 30 days following discharge of patients.

Review of the "Medical Staff Bylaws, Approved 4/19/2018" revealed under Section 8.D, "(1)Membership and/or Clinical Privileges may be automatically relinquished if a practitioner: (a) fails to do any of the following: (i) timely complete medical records as required by the Credentials Policy, Rules and Regulation or applicable policies... (2) Automatic relinquishment will take effect immediately and will continue until the matter is resolved and the individual is reinstated, if applicable, as detailed in the Credentials Policy."

Review of the hospital's "Credential Policy, Approved 04/19/2018" revealed under "Section 6.G.1 Failure to Complete Medical Records: A medical record is considered to be delinquent when it has not been completed for any reason within thirty (30) calendar days following a patient's discharge or if a Practitioner fails to respond to coding queries within fifteen (15) calendar days." Further it says, " When a Medical Staff Member or individual with clinical privileges has failed to complete a medical record and the record becomes delinquent, his/her elective admitting privileges maybe automatically suspended after the individual has been notified of the delinquency. The suspension may continue until all of the individual's delinquent records are completed. After thirty (30) more days on the delinquent list,all remaining Medical Center Clinical Privileges maybe suspended."


At the time of the survey, there were 135 medical records not completed within 30 days following discharge of patients.

MD1 has 3 delinquent medical records that were 55 - 180 days post discharge.

MD2 has a delinquent record that was 111 days post discharge

MD3 has a delinquent record that was 109 days post discharge

MD4 has 4 delinquent record that were 57 - 58 days post discharge

MD5 has 22 delinquent records that were 30 -44 days post discharge

MD6 has 19 delinquent records that were 30 - 41 days post discharge

NP1 has 3 delinquent record that were 55 - 108 post discharge.

MS1 has 7 delinquent records that were 54 - 61 days post discharge.

PA1 has 9 delinquent records that were 60 - 89 days post discharge.

Based on observation, review of documentation, and interviews with facility staff, the facility failed to properly store multi-dose vials as an opened, partially used multi-dose vial was found in a patient care area which was not consistent with CDC Safe Injection Practices. The facility policy regarding multi-dose vials did not specify where opened multi-dose vials could be stored.

Findings:

During a tour of the Georgetown Hospital surgery department on the afternoon of 7/29/19, an opened, partially used multiple dose vial of Labetalol 5 mg/ml, 20 ml labeled with an open date of 7/9/19 was found in the top drawer of the anesthesia cart in OR #4. In an interview with Georgetown staff #19 during the tour on the afternoon of 7/29/19, staff #19 stated that the multi-dose vial shouldn't have been kept in the anesthesia cart.

From CDC 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings. "IV.H. Safe Injection Practices ...IV.H.7. Do not keep multidose vials in the immediate patient treatment area and store in accordance with the manufacturer's recommendations; discard if sterility is compromised or questionable."

The facility policy entitled "Storage of Medications" dated 6/16/16 reflected in part "4. Multi-dose vials may be utilized for 28 days after opening under the following guidelines: a. Unless the manufacturer notes a shorter expiration date. b. Dated with the expiration date when the vial is opened. c. Periodically checked to insure the rubber closure is intact and serving as an appropriate barrier to vial contents. d. Stored according to label instructions. e. The vial must be disposed of if any of the above indicators indicate that the medication is not acceptable for use. All multi-dose vials that have not been dated will be disposed of when discovered."

St. David's San Marcos Cardiovascular Imaging location:

Based on review of documentation and interview, it was determined that the center failed to ensure that monthly and quarterly RSO (radiation safety officer) checklists were completed.

Findings:

Monthly and quarterly RSO (radiation safety officer) checklists were not completed.

On the morning of 8/05/2019, a review of the "St. David's CVIC Nuclear RSO/Authorized User Check List Monthly" form revealed that there were 4 areas that were to be checked monthly. These included: General Lab Procedures Tech Supervision, QC, Daily Records & Equip. Check, and Film Badges. The next column contained an area for the "Tech Initials" and the last column contained an area for the RSO/AU signature. The last date and signature found on the form was from 5/15/19. Additionally, the column where the "Tech Initials were to be documented was blank for all months on the form.

Review of "St. David's CVIC RSO Quarterly Sign Off" sheet revealed that there were 12 separate areas to be signed off quarterly by the RSO. These areas included: surveys, RAM receipt, quality control tests on imaging and analytic detection equipment, waste disposal, dose calibrator test results, employee training records, survey meter calibration, leak test results, inventory of licensed sealed sources, posting requirements, all records of safety tasks and monthly audits of verifying regular supervision by the RSO and/or delegating physician. The most current date on the form was from 3/16/19. The area for the 2nd quarter was blank with no date or signature from the RSO. No other documentation was found by or provided to the surveyor indicating that the above forms had been completed and were current.

In an interview on the morning of 8/05/2019 with San Marcos staff #4 the above findings were confirmed.

Based on observation, interview, and record review, the St. David's Medical Center failed to provide Dietary Services in a safe and sanitary manner.

Findings:

Observations on the morning of 7/29/19 in the St. David's Medical Center's Dietary department revealed the following:

- The ceiling in the dishwashing room had an approximately 20-inch x 20-inch area with an accumulation of a black substance surrounding the air vent. An adjacent light fixture had dust and stains present. The ceiling had loose, chipped paint, and dust throughout the dish room.

- Cooked beef tips were being stored at a temperature range of 130 to 135 degrees Fahrenheit.

- A large plastic container in the meat refrigerator contained approximately 50 pounds of meat that did not have a date of when the items had been placed in the refrigerator; one of the packages of meat was discoloring and the blood had darkened.

- The floor drains were difficult to remove and there was dark material noted in the drains.

- The food holding cabinets had food debris on the rails and on the bottom of the cabinets.

- The patient's individual butters, which required refrigeration, were being stored at room temperature.

- The floor throughout the kitchen had dried, caked on food debris and trash behind and under the equipment.

- The kitchen's stainless-steel drawers had food spills and dried food debris in contact with clean utensils and supplies. The staff were placing personal items in the drawers.

- The shelving for the soda dispensing were noted to have oil and dried food debris on the shelves.

- The walk-in cooler drink cooler had a black substance on the walls, dried food debris on the floors, and a black growth on the RFI code clip.

- The following spices were not dated when opened: Cinnamon, Chocolate flavoring, Paprika, Italian Seasoning, Ground Ginger, Garlic, Pepper, Cajun Seasoning, and BBQ sauce.

- The multiple plate warmers had copious amounts of dried food debris and clean plates available for use were stored in them.

- The rack holding the clean tray warming lids had dried and fresh food debris on the rails possibly causing recontaminations of the lids.

- The 2 facility can openers had blackened food debris on the cutting gears and the cutting tooth.

- A mop was being stored in a mop bucket with dirty water creating an optimal environment for bacteria growth.

- The vegetable refrigerator had molded lemons available for use.

- The floor drains and walls behind the cooking equipment had old food debris and wet trash sitting on the floor.

- A patient refrigerator on the 4th floor was not cooling appropriately, registering at 45°F, and the food product's internal temperature was at 43°F.


During an interview on the morning of 7/29/19, in the facility's kitchen, Staff #D2 confirmed the findings.


Observation on the morning of 7/31/19 revealed a refrigerator on the 4th floor with patient's meat sandwiches, meal trays, drinks, and puddings was not cooling appropriately; a check of the internal thermometer showed it was registering at 45°F. Staff #D3 placed a digital thermometer into a container of orange juice, the internal temperature was at 43°F. Staff #D3 confirmed the food was out of the safe range and proceeded to throw all the food items away.


Review of the St. David's Medical Center facility provided Kitchen Walkthroughs dated 7/26/18, 3/21/19, and 5/22/19 reflected past ongoing concerns with food items not being labeled and cleanliness issues.


Review of the St. David's Medical Center provided Austin Environmental Health Services inspection dated 10/8/18, reflected past concerns with the food hot holding and the can opener having food debris present.


Review of the St. David's Medical Center provided policies reflected the following:

TITLE: Food Handling Guidelines (Revision date: 1/30/2018)

"PURPOSE: Food handling guidelines are followed to assure food safety and quality maintained .... Cross Contamination Precautions: Food shall be protected against cross-contamination by: ... Cutting boards and other food contact surfaces are sanitized and cleaned between different food preparation steps .... Holding Temperatures [sic] (during preparation, service, and chilling) 1. Holding potentially hazardous foods at temperatures of 135°F or greater or 41°F or less .... These guidelines do not address food quality but food safety ...."


TITLE: Storage of Food and Supplies (Revision date: 1/30/2018)

"PURPOSE: All ... When food is not stored in its original container, the container that it is stored in must be identified with the common name of the food. Label both bin and lid .... food and non-food supplies are stored in such a manner to ensure that foods maintain product quality and safety.

Policy: 1. For all types of storage (dry, refrigerated, or frozen)
... b) Stored food that is past its expiration date is discarded.


Texas Food Establishment Rules 25 TAC §§228 (Effective Date: October 11, 2015) reflected,

Texas §228.63 (a)(6) §228.63 (e) ...

(6) Time/temperature controlled for safety (TCS) food that is cooked to a temperature and for a time specified under section §228.71 of this subchapter and received hot shall be at a temperature of 57 degrees Celsius (135 degrees Fahrenheit) or above ...
.
(8) Upon receipt, time/temperature controlled for safety food shall be free of evidence of previous temperature abuse, such as but not limited to odors, ice crystals, frost or discoloration .... Preventing Contamination from the Premises.

(a) Food storage.

(1) Except as specified in paragraphs (2) and (3) of this subsection, food shall be protected from contamination by storing the food:

(A) in a clean, dry location;

(B) where it is not exposed to splash, dust, or other contamination; ... (d) Food preparation. During preparation, unpackaged food shall be protected from environmental sources of contamination .... §228.106. Functionality of Equipment.

(a) Ventilation hood systems, drip prevention. Exhaust ventilation hood systems in food preparation and warewashing areas including components such as hoods, fans, guards, and ducting shall be designed to prevent grease or condensation from draining or dripping onto food, equipment, utensils ..."


Observations on the morning of 8/5/19 in the St. David's Heart Hospital's Dietary department revealed the following:

- (2) Large dietary trash receptacles were uncovered and being stored outside the facility next to the kitchen; flies were noted to be flying around the containers.

- (4) Metal scoops, in the utensil drawers, had dried food debris present and available for use.

- The manual can opener had dried food debris on the cutting tooth and gears.

- The clean area of the dish washing room had a dusty metal rack that was being used to store clean items.

During an interview on the morning of 8/5/19, in the facility's kitchen, Staff #D15 confirmed the findings.


28043


A tour of the St. David's Georgetown Hospital kitchen/dietary area was conducted the morning of 7/29/19, accompanied by Staff #6, Staff #10, and Staff #15. The kitchen/serving area was not maintained in a clean or sanitary manner and was in need of cleaning. The following was observed at the St. David's Georgetown Hospital:

Dry Food Storage Area:

-The floors in the Dry Food Storage area were in need of cleaning, especially underneath the shelving units, as there was dried food particles, dirt, dust, debris, hair, food items in containers that had fallen onto the floor.

-The baseboards had a layer of dirt and dust.

-In the Dry Food Storage, there was a dead moth in the bag containing plastic cups.

-In the dry storage room were three cardboard boxes of plastic utensils including forks, spoons, and knives open to the air allowing airborne dust and microbes to contaminate the utensils.


Walk In Cooler/Refrigerator

-In the walk-in cooler/refrigerator, there were 2 trays on which were 11 uncooked pizzas which were available for patients and which were uncovered.

-There was a 640 fluid ounce bucket of pickles, the top of which was opened. The top of the container was in need of cleaning as it was dirty and had liquid on the top. The container was not dated to indicate when it was opened or when the contents expired.

-There were three plastic tub containers of food with labels which did not provide the contents. The labels merely stated, "Prepared Food." In an interview with Staff #15, she stated that one tub contained "Ranch Dressing" another contained "Salsa" and the third tub contained "a salad, lettuce and green beans."

-There was a multi-compartment tray, which contained items such as melon chunks, shredded cheese, a red sauce, a white sauce, and other items. The tray was not labeled with the contents and was not labeled with a date which indicated the preparation date or the expiration date of the food products.

-There was a rolling cart which contained at least 6 large trays of a food item, which were uncovered, exposing the food, and were not labeled with the contents, the date prepared or the expiration date of the food product. Staff #15 stated that the food was meat loaf and was thawing to be used that day.

-There was bacon spread individually on 6 large trays with only paper partially covering the trays, leaving the bacon exposed. The trays were not labeled with the contents and were not labeled with a date which indicated the preparation date or the expiration date of the food products. Staff #15 confirmed the above and stated, "We usually have them on a cart with the date."

-There was a 1 gallon container of "Cocktail Sauce" which was labeled "Condiment, Opened. Use By 07-28-19" in the refrigerator, available for use in food prep.

-There was a bowl covered with clear plastic wrap containing what appeared to be lettuce, cucumbers, grape tomatoes, carrots and possibly cheese (a salad). There was no label to indicate the contents, the date prepared or the expiration date of the prepared food. Staff #15 stated, "It was today; it's for the doctors."

-On a cart in the walk-in cooler was an uncovered stainless steel pan containing cooked meatloaf that was open to the air allowing airborne dust and microbes to contaminate the food and was not dated. The walk-in cooler had two fans in the ceiling area blowing cooled air inside the cooler.

-In the walk-in cooler was a plastic bag containing white dried beans which was in an open plastic bin that had dirt and debris on the bottom of the bin. The label on the bag of beans simply stated, "Dry Goods" and did not provide a date.


Walk-in Freezer

-There was condensation and ice on the ceiling of the walk-in deep freezer.

-There was opened and exposed food in the walk-in deep freezer, including food that was unlabeled with contents, date opened, or expiration date. -There was a tray covered with aluminum foil with a label stating "Taco Meat" and a Prep Date of "7-1-19". The space for a "Use By" date was left blank. Staff #15 stated, "that should have been thrown out."

-There were open cardboard boxes with opened plastic bags containing frozen hamburger patties, chicken breasts, biscuits, breaded shrimp, cookie dough, and breaded okra that were all exposed and open to the air allowing airborne dust and microbes to contaminate the food. The walk-in freezer had two fans in the ceiling area blowing cooled air inside the freezer.


Refrigerator in the kitchen:

-There was a thick layer of greasy dust on top of the refrigerator.

-Inside the refrigerator, there were 2 small bowls of sliced lemons - one bowl was covered, one bowl was not covered. Neither of the bowls containing sliced lemons were labeled with the contents, the date prepared, or the expiration date of the food.

-There was a half-filled and a full gallon on milk available in the refrigerator which expired on 7/28/19.


General kitchen:

-The tops of containers, shelving units, food containers and utensil storage boxes had a greasy substance throughout the kitchen; there was a greasy substance on horizontal surfaces in the kitchen, indicating a need for cleaning.

-The food prep tables and other tables on which equipment was placed or mounted were in need of cleaning as there was a layer of grease with dust, dried food, and other debris.

-The floors around and underneath food prep tables and carts and free-standing equipment were dirty with a brown and black greasy appearance. Some of what appeared to be old food particles were up to 1/2 inch in size throughout the kitchen.

-The floor and area behind the stove, grill, and ovens were in need of cleaning as there was what appeared to a significant accumulation and layer of grease and a thick layer of dirt, dried food-like substances, particles, raised debris.

-The floor was very dirty, and the tubes, pipes, and metal brackets and a black, dirty substance adhered to them.

-There were two mops standing on the floor in the corner next to the handwashing sink which were dirty and very wet. The surveyor verified the wetness of the mops by touch, resulting in dripping dirty water on the surveyor's hand after touching. Staff #15 confirmed that the mops were wet by observing the surveyor's hand.

-There was another dirty, wet mop observed on the floor in the kitchen housekeeping closet confirmed by Staff #6.

-There were 7 large muffin tins with a thick carbon build-up, rust, and what appeared to be dried food. The carbon build-up does not allow the pans to be cleaned properly causing a potential for food-borne illness.

-Cookware and utensils were available which had pooled water or condensation on cookware and utensils used in food preparation, which provides a medium for bacterial growth.

-A shelving rack was observed filled with pots, pans, metal bowls and baking sheets and trays near the dishwashing area of the kitchen. Staff #15 identified this cooking equipment as being clean.

-Pots, pans, and metal bowls were stored upside down with like items stacked or nested on top of each other; some were stored bowl up, which allows for the collection of dust or grease inside the clean equipment. An inspection of the stacked pans revealed water condensation on the inside of the pans; some of the pans had water pooled on the bottom of the pan. Approximately 10 pans, stored in the stack had water pooling on the bottom of the pan and water condensation on the inside of the pan.

-An inspection of the stacked metal bowls revealed water condensation and drips of water on the inside of the bowls. Approximately 4 bowls had water pooling on the outside of the bowl and water condensation on the inside of the bowl.

-There was a large plastic drying tray containing utensils that had been cleaned. There were large spoons, ladles and ice cream scoops which were stored bowl up and had water pooled in the bowl.

-On another metal shelving unit where dishware and cookware were stored there was an accumulation of dirt, dried food-like substances, particles, and raised debris on the plastic bottom shelf.

-On the top of the shelving unit was a refrigerator thermometer which was greasy to appearance and touch and had crumbs and other debris adhered to it.

-There was a large plastic bin containing cake decorating and other plastic utensils and supplies for use in food prep, of which the plastic bin and all the contents had a greasy film, including a large plastic zippered bag on top of the utensils.


The surveyor observed staff plating food for patients onto plates with plastic lids from a cart. There was a thick layer of grease, raised dust, debris, and what appeared to be old, dried food covering the cart containing the plates and plate lids. This presents a risk for cross contamination and potential food borne illness for patients at the hospital.

The grill located in a line of cooking appliances had a steel grate that had a buildup of black crusted burnt on food between the bars of the grate. A flat stainless steel area in front of the grate had a thick layer of burnt on grease adhering to the steel surface.


The wire shelving unit next to the cooking area, on which the cooking utensils were stored was very dirty and greasy and in need of cleaning.

-The wire shelves were greasy to the touch, with dried food, a dirty black substance, and raised dust over the surface of the shelving unit.

-There were plastic lidded boxes (the size of shoe boxes and larger) which contained cooking utensils.

-The interior of the boxes were dirty, with drips, dried food, and other unidentifiable debris amongst the utensils.

-A storage box containing tongs had a granular substance which appeared to be salt spilled among the utensils.

-One box had a piece of dirty tape adhered to the inside of the box.

-Spoons, ladles, and ice cream scoops were stored bowl up, and several of the spoons and ladles had water spots inside the bowl indicating they were put up while still wet. There was what appeared to be dried food on some of the spoons and utensils and 3 ice cream scoops had dried food on the interior of the bowl and the handle.

-There was a piece of rusty wire attached to a 1/3 cup metal measuring cup in one of the plastic boxes with other utensils.

-There was dried food on a 4-sided grater indicating improper cleaning.

-A pizza wheel/cutter was greasy with a greasy brownish substance smeared on it.

The above items were confirmed by Staff #15 as available for use in patient food preparation.


On a wall outside the walk-in cooler was a shelving unit which held cardboard boxes which contained plastic bags of soft drink syrups each connected with tubing to gas tanks and a soft drink machine. A box which labeled "Diet Coke" had an "enjoy by" date of 7/21/19.


The surveyor observed water leaking onto the floor from a proofer (food warmer, a standing cabinet approximately 5 foot tall). Staff #15 stated that it was condensation and needed to be drained. Staff #70 was asked to drain the tub in the bottom of the proofer. Staff #70 obtained a kitchen towel, removed the tub and emptied it, then placed the dirty kitchen towel on the food prep table next to a pan of chicken and food on a cutting board. Staff #70 did not wash hands or change gloves. This presents a risk for cross contamination and was observed and confirmed by Staff #6 and Staff #15.


There was a mechanical dial scale observed which was in need of cleaning as there was grease, dust, and a white sticky substance on the flat weighing surface.

A cardboard box of aluminum foil sheets had grease spots all over the cardboard and the top sheet of aluminum foil was greasy to the touch.

A stainless steel prep table with an elevated shelf held large plastic containers of various sauces and condiments such as soy sauce, barbeque sauce, and gravy base. The shelf was covered with splotches of a sticky brown substance and the plastic containers were sticky with grease and were visibly dirty.

On a shelf under a stainless steel prep table was a large paper sack of bread crumbs that had been ripped open at the top and was open to the air.

The bottom shelf was also used to store pans and trays for use in food prep. There was a black sticky substance on the shelf.

-There were dried food particles, including some as large as a quarter all over the bottom shelf around the cookware, including a dried, sliced mushroom.

-There were multiple drips on the cookware closest to the edge of the shelf.

-There was a bucket of seasoned salt on the bottom shelf which had various different drips and sticky substances on the top and sides of the container.


The fire extinguisher at the kitchen door was visibly greasy, with dust adhered to the extinguisher.


Food line cooking and holding temperature records were reviewed for May, June, and July, 2019. The records were a two sided form, on the front of which were items on the serving line such as soups, gravy, vegetables, and starches. The back of the form was cooked-to-order items such as hamburger, grilled chicken breast, stir fry, and chicken tenders. There were no temperatures recorded for the cooked-to-order items on 7/5/19 and 6/21/19.

In an interview with the food service manager, staff #15 during the tour on the morning of 7/29/19, staff #15 acknowledged the above findings.


The facility policy entitled "Storage of Food & Supplies" dated 2/1/09 reflected in part "Purpose: All food and non-food supplies are stored in such a manner to ensure that foods maintain product quality and safety ...Procedure. I. For all types of storage (dry, refrigerated, or frozen) ...5. When food is not stored in its original container, the container that it is stored in must be identified with the common name of the food. Label both bin and lid."


The facility policy entitled "Food Handling Guidelines" dated 2/1/09 reflected in part "Holding Temperatures (during preparation, service and chilling) ...Food temperatures are recorded prior to service at each meal."


The Sodexho "Technical Skills" dated 12/03 reflected in part "Receiving and Storing - Perishable Storage: All foods kept in the refrigerator should be covered, labeled and dated."

The Sodexho "Technical Skills" dated March 2004 stated, in part, "When to Wash Hands ...Wash hands thoroughly and always: ... after cleaning ... after handling dirty equipment ... after handling trash or other contaminated objects."

The Sodexho "Technical Skills" dated December 2003 stated, in part, "Receiving and Storing-Perishable Storage ... All foods kept in the refrigerator should be covered, labeled and dated ...Day dots or labels help identify food shelf life."

The Sodexho "Technical Skills" dated December 2003 stated, in part, "Receiving and Storage - Dry Storage ...Always keep storage carts clean."

The Sodexho "Technical Skills" dated September 2003 stated, in part, "Service - Handling Utensils ... Utensils stored on a clean, dry surface in the appropriate container."

The Sodexho "Technical Skills" dated September 2003 stated, in part, "Cleaning and Sanitizing - Washing Pots and Pans ... Allow to air dry ..."


Texas Food Establishment Rules. 25 TAC 229.164(e) (f). "Preventing food and ingredient contamination. (1) General. At all times, including while being stored, prepared, displayed, served, or transported, food shall be protected from potential contamination ...(A) Food shall be protected from cross contamination by ...(iv) except as specified in subparagraph (B) of this paragraph, storing the food in packages, covered containers, or wrappings; (v) cleaning hermetically sealed containers of food of visible soil before opening; (vi) protecting food containers that are received packaged together in a case or overwrap from cuts when the case or overwrap is opened;"

.
Based on observation and interview, the facility failed to ensure that bathrooms used by patients have an emergency call light system.

Findings:

An observation made during a tour of the St. David's Medical Center's Emergency department on 7/30/19 revealed a patient use bathroom that was located by Patient Bay M4 did not have an emergency call light. The bathroom did not have signage reflecting the bathroom was limited to staff use.

During an interview on 7/30/19, in the facility's ED, Staff #D8, ED Educator confirmed the finding.


Outpatient Breast Center:
One of the two patient's bathrooms in this area did not have an emergency pull cord.

During an interview on Staff #D11, Facility's Manager stated, " ... it was identified two month ago, it was only a staff restroom for years ... We are in the process of changing out all the call lights. They asked if the restroom could be changed to a patient restroom ... We're still working on it." When asked how the Facility's Department ensures the bathroom is not being used by patients until it is repaired, Staff #D11 stated, "right now, it is, in compliance ... They shouldn't be using it for patients ... The Emergency department director is responsible."



39244


Based on observations, interviews, and record reviews, the facility failed to ensure hospital environment was maintained in such a manner that the safety and well-being of patients are assured in that, oxygen tanks were not stored in a safe manner.

Findings:

In an observation on 7/29/19, at 3:40 p.m., at St. David's Medical Center PACU unit (2nd floor), full and empty oxygen cylinders were stored in C1 area (open area that is also used as back up patient care area). Additionally, 1 empty oxygen cylinder was stored on the floor in upright position next to a cylinder rack labeled "empty cylinder" (the slots were already full of oxygen tanks), and 1 empty oxygen cylinder was stored in cylinder rack labeled "full cylinders." The same cylinder rack labeled "full cylinders" had approximately 2-3 full cylinders.

In an interview on 7/29/19, at 3:45 p.m., Staff #J10, stated new and empty oxygen cylinders were kept and stored in "room" C1. Staff #J10 stated, C1 area is also used as a "back-up" patient care area. Staff #J10 further stated empty oxygen cylinders should only be stored in cylinder racks.

In an interview on 7/29/19, at 3:50 p.m., Staff #J9 stated, "we have plenty of additional cylinder racks." Staff #J9 was asked to provide a copy of a policy related to oxygen cylinder storage.

In an interview on 7/30/19, at 11:30 a.m., Staff #J11 stated, oxygen cylinders should be kept stored in a secured and locked area, not in a patient care area.

In an interview on 7/31/19, at 2:52 p.m., Staff #J9 stated, empty oxygen cylinder that was on the C1 room floor next to the cylinder rack should have been stored on the empty cylinder rack. Staff #J9 stated, another empty oxygen cylinder that was placed on the "full" cylinder rack was wrong and it should have been placed on the empty cylinder rack. However, "it is okay to store oxygen cylinders in C1 area since PACU is a secured area and patients do not get out of the bed. Patients can also be placed in room C1 as long as they are 5 feet away from the cylinders." When asked whether nursing staff were aware of the 5 ft requirement, Staff #J9 stated, "we can store oxygen cylinders in a secured room from now."

In an observation on 8/1/19, at 10:50 a.m., at St. David's Medical Center PACU unit (2nd floor), all of the full and empty oxygen cylinders were moved to one of the empty isolation room for storage.

In an interview on 8/1/19, at 10:50 a.m., Staff #J20 stated all the oxygen cylinders were moved to another room to be stored away from patients. Staff #J20 stated, PACU unit can have visitors on "special occasions." Staff #J20 further stated, staff will be trained to ensure all the oxygen cylinders are moved out of the isolation room if patient was admitted to that room. "We rarely have patients in this isolation room."

Review of undated facility provided policy titled O2 CYLINDER STORAGE GUIDANCE reflected in part, "Empty cylinders: once a cylinder valve is opened, it is considered empty, even if gas remains in the cylinder. For storage purposes, any opened cylinders must be physically separated from full (unopened) cylinders. Opened cylinders need to be placed in the "EMPTY" rack. Cylinders in the "EMPTY" rack can still be used if needed for non-emergency situations." This document did not have any other information related to where these oxygen cylinders should be kept for safety.

Review of facility policy titled Respiratory Care Safety, with revision date of 01/18/2019, reflected the following:

- Purpose: "Guidelines for maintaining a safe working environment."

- Policy: " ... to maintain a safe environment for patients and staff."

- Procedure: "... 13. Make sure all oxygen cylinders are placed securely in the 'full' or 'empty' labeled tank holder carts. 14. Do not leave oxygen cylinders unattended on patient floors or hallways unattended."

St. David's Georgetown location:

Based on observation and interview, it was determined that the hospital failed to ensure that the premises were clean and maintained.

Findings:

The premises were not maintained in a sanitary condition. During a tour of the hospital on the morning of 7/29/2019 the following issues were observed:

Window sill ledges in the Rehab gym had visible dust on them. When the surveyor ran their hand on the window ledges dust was visible and remained on the surveyor's hand.

In the Administration Corridor 9 stained ceiling tiles were observed.

3 stained ceiling tiles were observed in the Rehab clean storage room.

In the Rehab unit dining room (for patients) the patient food refrigerator had visible particulate debris observed on the bottom shelf. The 2-seat coach had broken cracker pieces (3) under the seat cushions and small particulate pieces of what appeared to be broken cracker.

The bathroom in patient room 348 on the Rehab unit had visible amounts of dust on one of the ceiling lights.

The medication room on 3 Central nursing unit had 2 stained ceiling tiles and the ceiling air vent was dirty in appearance.

In the Cardiac Rehab Unit, there was a Nu Step Original Seated Stepper exercise machine, the black vinyl covering on the seating area has 3 visible cracks.

In the Central Linen Storage room there were 6 uncovered linen storage carts, each of these carts contained linen. The ceiling mounted fluorescent light fixture in the hallway outside of the Central Linen Storage room contained what appeared to be numerous small dead insects.

There was visible light underneath the exterior doors (threshold area) located adjacent to the Central linen storage area. This provides the potential for insects or rodents to gain access to the building.


St David's San Marcos Cardiovascular Imaging Center location:

Findings:

During a tour of the imaging center on the morning of 8/05/2019, the following issues were observed: One of the chairs in the patient lobby area had a tear (approximately 1 inch in length) on the lower seating area.

The janitorial closet (containing the water heater) had visible amounts of debris on top of the water heater and there was visible debris (some of which appeared to be remnants of fiberglass style pipe insulation) on the floor next to the water heater as well as in the water heater drain pan.

In an interview on the morning of 8/05/2019 with San Marcos staff #4 the above findings were confirmed.


St. David's Cardiovascular Imaging Center, 4316 James Casey, Suite A, Austin, Texas location:

Findings:

During a tour of the imaging center on the morning of 8/06/2019, the following issues were observed in the patient lobby/waiting room area: visible staining on the wall adjacent to the patient coffee area and visible staining on the front of the wooden counter area where the patient coffee/supplies are located; One each stained ceiling tile located next to one of the ceiling lights; 2 large (approximately 10" in diameter) on the carpet.


In the Injection room, an examination of the under-sink cabinet area revealed an opening of approximately 6 inches in diameter with what appeared to be 4 each white plastic PVC pipes that were routed into the hole. Running water was observed draining out of one of one PVC pipes and a slight detectable odor was present when the cabinet door was opened.


In the patient restroom located across from the Tech office, it was observed that the grout in between the floor tile was dirty in appearance.


The water heater room was observed to have a dead insect as well as small pieces of debris on the floor.


The floor of the IT closet was dusty in appearance with visible amounts of dust observed and there were several old telephones stored in one corner of the closet. These telephones had visible amounts of dust on them as well.

In an interview on the morning of 8/06/2019 with Staff #4 the above findings were confirmed.


Review of page 233 of the Environmental Services - Cleaning Procedures Manual (note: provided by hospital staff to the survey team) entitled: "Chapter 9 - Support and Miscellaneous Areas Damp Dusting of Corridors" stated: "5. High dust everything above shoulder level: ceiling, lights, vents."


Review of page 37 stated: "Inspection Standards" "Ceilings, ledges, countertops, vents, TV's, and other high dust surfaces are clean and free of dust." "First impression cleanliness in consistently maintained."

Review of hospital policy EC.02.06.01. EP1-26, entitled: "Providing a Safe Environment" stated under the policy section: "It is the policy of St. David's Medical Center to develop and implement plans, programs and processes which will promote a safe and functional environment." The procedure section stated: "The following are specific areas reviewed: 1. Interior spaces shall meet the needs of the patient population and are safe and suitable to the care, treatment, and services provided." "6. Areas used by patients are clean and free of offensive odors." "8. Furnishing and equipment are maintained to be safe and in good repair."

In an interview with staff member #3 on the morning/afternoon of 7/29/2019 the above findings were confirmed.



29934


During the tour of the 2nd Floor Transitional Unit with St. David's Georgetown Hospital Staff #8 on 7/29/19, it was observed:

- Sani-cloth bleach wipes expired 3/2019

- Sequential Compression Device machine had no preventive maintenance sticker to indicate when the preventive maintenance was last performed.


In an interview with St. David's Georgetown Hospital Staff #1 on the afternoon of 7/29/19, Staff #1 acknowledged the findings above.


During the tour of the Emergency Department with St. David's Georgetown Hospital Staff #8 on 7/30/19, it was observed:

- Baby scale in triage area had a sticker that stated "PM Due 5/2019"

- Adult scale in triage area had a sticker that stated "PM Due 5/2019"

In an interview with St. David's Georgetown Hospital Staff #1 on the afternoon of 7/30/19, Staff #1 acknowledged the findings above.


During a tour of the Georgetown Hospital on 7/30/19, the following observations were made.

1. In the medium risk nursery in a blue cart: Prefilled Normal Saline syringes, 10 ml, 4 expired 6/19; Umbilical vessel catheter tray, 2 expired 5/19.

2. In the medium risk nursery, the neonatal crash cart checklist reflected the crash cart had not been checked on 7/21/19.

3. In the Women's Center OR hallway on a cart near the malignant hyperthermia cart was a black surgery table arm support that had several tears and holes in the vinyl covering covered with clear tape peeling at the edges making proper disinfection impossible.

4. In Women's Center OR #1, Dermabond, 1 package, expired 5/19.

5. In the Respiratory Therapy supply storage closet: Dispatch Hospital Cleaner Disinfectant Towels, 5 containers of 150, expired 7/13/19.

In an interview with the Georgetown Staff #52, during the tour of the Women's Center on the morning of 7/30/19, staff #52 confirmed that the findings in item #1, 2, 3, and 4. In the interview with the Georgetown Staff #55 during the tour on the afternoon of 7/30/19, staff #55 confirmed that the above listed supplies in item #5 were expired.


The facility policy entitled "Crash Cart Defibrillator Checks" dated 12/6/16 reflected in part "Crash carts/bags and defibrillators will be checked every 24 hours (that a department or activity is open) by a designated employee."


During a tour of the Georgetown Hospital Radiology Department on the morning of 7/31/19, the following observations were made.

1. The blanket warmer in the CT control room had a biomedical sticker affixed which reflected "PM due 4/19."

2. The linen cart cover in the RF room had several tears in the vinyl covering exposing fabric below which made proper disinfection impossible.

3. In the Ultrasound room, Skin Affix topical skin adhesive, 3 expired 6/19 were found in a drawer.

4. In the Mammography room a Kopans Breast Lesion Localization Needle, expired 8/16 was found in a cart drawer.


In an interview with the Georgetown Staff #65 during the tour on the morning of 7/30/19, staff #65 acknowledged the above findings.


The facility policy entitled "Maintaining, Testing and Inspecting Med Equipment" dated 7/3/19 reflected in part "The Biomedical Department identifies in writing the frequencies for inspecting, testing and maintaining all operating components of medical equipment on the inventory. The frequency of planned maintenance is determined based on criteria, including manufacturer's recommendations, risk levels, current hospital experience or strategies of alternate equipment maintenance (AEM) program."


During a tour of the Cardiovascular Imaging Center located at 1015 E 32nd St. #513 on the morning of 8/5/19, BD Angiocath, 24 gauge x 0.75", 5 expired 11/17 and 1 expired 7/19 were found in a cabinet in the Hot Lab available for use. In an interview with the 32nd St. MRT, staff #4 during the tour on the morning of 8/5/19, staff #4 confirmed that the angiocaths were expired.


In the supply room of the 32nd St. Cardiovascular Imaging Center, an open metal shelving unit was observed with two packages of clean linens, sheets, and bath blankets that had been opened and were exposed to the air making them exposed to airborne dust and microbes. In an interview with the 32nd St. Staff #2 during the tour on the morning of 8/5/19, staff #2 acknowledged that the linens were uncovered.


The Centers for Disease Control "Guidelines for Environmental Infection Control in Health-Care Facilities" dated 2003 reflected in part "After washing, cleaned and dried textiles, fabrics, and clothing are pressed, folded, and packaged for transport, distribution, and storage by methods that ensure their cleanliness until use."


Review of hospital policy FAC-1744, entitled: "Obsolete, Expired, or Non-Moving Inventory Removal (Floor Stock)" stated: "F. If the item is expired, see FAC -1568: Managing Products with Expiration Dates."


Review of hospital policy FAC-1658, entitled: "Managing Products with Expiration Dates" stated under the Rationale section: "Supplies should be evaluated against expiration dates to ensure proper use of dated product is occurring so potential risk to the patients is lessened and product isn't being wasted." The policy section stated: "All expired merchandise (including intravenous solutions, kits with pharmaceuticals, other various medical devices, etc.) that is no longer saleable must be identified and expeditiously removed physically (to quarantine) and systemically from the warehouse/storeroom/pharmacy/POU area (including Pharmacy Pyxis/Omnicell)." Page two stated: "D. If an expired product is identified, the following process should be followed. 1. Upon discovery of expired product the person who found the expired item must escalate to the SCD, DOP or designee. 2. The SCD, DOP, or designee must expeditiously remove product physically (to quarantine) and systemically from stock."


St. David's Cardiovascular Imaging Center San Marcos location:

Finding:

During a tour of the imaging center on the morning of 8/05/2019 the following issues were observed: One of the chairs in the patient lobby area had a tear (approximately 1 inch in length) on the lower seating area.

The janitorial closet (containing the water heater) had visible amounts of debris on top of the water heater and there was visible debris (some of which appeared to be remnants of fiberglass style pipe insulation) on the floor next to the water heater as well as in the water heater drain pan.

In an interview on the morning of 8/05/2019 with San Marcos staff #4 the above findings were confirmed.


28043


A tour of the 4th floor of St. David's Georgetown Hospital was conducted the morning of 7/31/19 accompanied by St. David's Georgetown Hospital Staff #52 and #54. In the Labor and Delivery OR suite, the neo crash cart contained expired items, including the following:

- 10 inch blade - expired 2/2019

- 3-way stopcock - expired 8/2018

- Exuderm odorshield - expired 1/2019

- Isolation Bag - expired 7/2018

- Pre-filled NS syringes 10 ml - expired 7/2019

The above findings were confirmed during the tour on 7/30/19 with St. David ' s Georgetown Hospital Staff #54.


Facility policy, "Crash Cart Defibrillator Checks" last reviewed 12/6/2016, stated, in part,

"I. Defibrillator/crash carts located in patient care areas will maintain medications and equipment in the quantities designated on the expiration date/checklist.

II. Crash carts/bags and defibrillators will be checked every 24 hours (that a department or activity is open) by a designated employee ...

V. Ccentral Supply/Materials Management will be responsible for the replacement and maintenance of all crash cart supply items and irrigation solutions."


Review of hospital policy FAC-1658, entitled: "Managing Products with Expiration Dates" stated under the Rationale section: "Supplies should be evaluated against expiration dates to ensure proper use of dated product is occurring so potential risk to the patients is lessened and product isn ' t being wasted."

Review of hospital policy FAC-1744, entitled: "Obsolete, Expired, or Non-Moving Inventory Removal (Floor Stock) stated: "F. If the item is expired, see FAC -1568: Managing Products with Expiration Dates."


39244


Based on observation, interviews, and record reviews, the facility failed to maintain medical equipment to ensure an acceptable level of safety and quality in that:

(1) Annual maintenance was not performed on medical equipment used in ICU unit

(2) Annual/initial maintenance were not performed on medical equipment used in ED unit

Findings:

(1) In an observation on 7/29/19 at 10:50 a.m., at St. David's Medical Center ICU unit (5th floor), in room #502, an Alaris IV Pump was found with labels "GE Healthcare 402303665" and "Inspected: Due Date 12/2018."

In an interview on 7/29/19 at 10:50 a.m., Staff #J5 confirmed the above findings and stated Biomed was responsible for maintenance of medical equipment.

In an interview on 7/30/19 at 12:07 p.m., Staff #J12 and #J13 stated last successful maintenance on Alaris IV Pump (control number 402303665) was done in 11/2017. They stated an attempt was made on 11/2018 to do maintenance work on this same pump but was unable to locate it. They further stated this pump should be maintained annually, and yesterday they were notified of the whereabouts of this equipment via email.

Review of email notes from Staff #J14 to Staff #J12 on 7/29/19 at 11:20 a.m., reflected in part, "CMS ... found this attached pump in use by a patient in ICU. They want all maintenance logs on the attached Alaris pump ..."

Review of Service Request Details with service request #SR5802503 reflected service request details for Alaris IV Pump (control number 402303665) for a scheduled maintenance. Under the notes section indicated "action taken: can not locate" and "closing summary: CNL 29 Apr 2019."

Review of facility policy titled Maintaining, Testing and Inspecting Med Equipment, with revision date of 7/3/19 reflected under criteria: " ... The Biomedical Department also assures that medical equipment is scheduled according to its strategy and completed on schedule."


(2) During a tour of St. David's Medical Center emergency department on the afternoon of 7/29/2019, 2 Transport Pro Monitors behind the nursing station revealed an "Inspected Due Date" of 3/2019 and 4/2019. The "Site Rite" in room #1 used to locate veins for IV insertion did not have an inspection sticker located on it.

While touring the emergency department, Staff #E6 was asked to provide evidence that the oral thermometers had been inspected prior to patient use and he stated in part, "I am not sure about that, but I know those are new ...." The facility was unable to provide evidence or documentation the oral thermometers had been inspected prior to patient use.

During an interview on 7/30/2019, with Staff #E15, from the Biomedical Department, when asked if new oral thermometers are inspection prior to patient use, he stated in part, " ...They should have a green (inspection) sticker on them. Supply chain informs us with an entry form when there is a new order, and they dispense it before it goes to each department. We go to materials, we check it and then it goes to the units." In response to this statement Staff #E16, Chief Nursing Officer, stated in part, "so those thermometers should have been checked before going to the unit?" Staff #E15 responded "yes."

Based on observations, interviews, and record reviews, the facility failed to meet the Condition of Participation for Infection Control as evidenced by:

(1) Failing to ensure physical environment and hospital/patient care equipment were effectively cleaned and/or maintained to allow for effective cleaning at St. David's Medical Center- Medical/Surgical unit, ICU unit, Surgical Services area, Rehabilitation area, Orthopedic unit, Kitchen area, Emergency Department, and laboratory. (refer to A0749)

(2) Failing to ensure staff followed transmission-based precautions and policies during patient care at St. David's Medical Center- Emergency Department and Rehabilitation area. (refer to A0749)

(3) Failing to ensure minimized use of immediate-use steam sterilization (IUSS) and by ensuring IUSS was used only for reasons allowed by current standards of professional practice at St. David's Medical Center- surgical services. (refer to A0749)

(4) Failing to ensure staff used appropriate PPE or perform hand hygiene as needed at St. David's Medical Center- Emergency Department. (refer to A0749)

(5) Failing to ensure physical environment and/or hospital/patient care equipment were effectively cleaned and/or maintained to allow for effective cleaning at St. David's Georgetown Hospital- Emergency Department, OR Suite, Surgery Department, Women's Center OR, Radiology Department, and 4th floor units. (refer to A0749)

(6) Failing to ensure hospital/patient care equipment/supplies were stored in a manner to prevent contamination at St. David's Georgetown Hospital- OR Suite and 4th floor units. (refer to A0749)

(7) Failing to ensure hospital/patient care supplies were stored in a manner to prevent contamination at St. David's Cardiovascular Imaging Center located at 1015 E 32nd St. #513. (refer to A0749)

The cumulative effect of these systemic deficient practices resulted in noncompliance with the Condition of Participation for Infection Control.

Based on observation and interview, it was determined that the facility did not always practice effective infection control.

Findings:

Tour of the fifth floor medical surgical floor at St. David's Medical Center revealed the following:

* The tile floor had evidence of water damage throughout with swollen and chipped tile with discoloration.

* The 5th floor medication room had a dirty vent and a posted placard that was stained with liquid medications. The wall behind the narcotic disposal system (Cactus) had torn sheetrock. The torn sheetrock and the placard which was taped to the wall would not allow for effective cleaning of the area.

These items were confirmed by the Charge Nurse on July 29, 2019.


Tour of the laboratory at St. David's Medical Center revealed the following:

* A dirt stained floor throughout

* The refrigerator that held urine samples was visibly dirty

* Items were stored under a sink near the break room. This area was also dirty.

* There was collected dust on a wifi unit on the ceiling.


The above items were acknowledged by the Laboratory Director on July 31, 2019.



30250


Facility based policy entitled, "Transmission-based Precautions" stated in part,

"2) Transmission Based Precautions: Transmission-based Precautions include Contact Precautions, Droplet Precautions, and Airborne Infection Isolation (All) per the CDC guidelines. In addition, Enteric Contact Precautions are also practiced for patients who are known or suspected to have Clostridioides difficile infection. Precautions may be used in combination since some diseases may have multiple routes of transmission.

Implementation: Transmission based precautions should be implemented as soon as the organism or condition warranting precautions is suspected. A physician's order is not required, and precautions should not be delayed pending confirmatory testing...

a) Contact Precautions- use contact precautions for patients with known or suspected infections, conditions or evidence of syndromes that represent an increased risk for contact transmission as described by the following:...

Personal protective equipment (PPE)

(1) Wear a gown and gloves for all interactions that may involve contact with the patient or the patient's environment. Don PPE upon room entry and properly remove and discard before exiting the patient room to contain pathogens.

(2) To facilitate communication, the area within the "swing of the door" just inside the room is a space where staff and providers may enter without donning PPE, as long as the patient and objects in the patient's environment are not touched."


A tour of the rehabilitation hospital area of St. David's Medical Center on 07/30/19 revealed the following:

* Room #206 was observed by the surveyor and staff member #H11 with a contact isolation instruction sign on the door to this room. A staff member was observed inside the patient room in conversation with the patient with no Personal Protective Equipment (PPE) on. The staff member was observed in scrubs with no gown or gloves on. Staff member #15 verified this patient was on contact isolation precautions. The staff member observed in room 206 with no PPE on came out of the room and stated they were not touching the patient.

* According to the facility policy the staff member observed in room 206 should have had PPE on (gown and glove) after entering the room to maintain effective infection control practices.

* On the fourth floor a NuStep machine was observed with tears in the seat, preventing effective cleaning of this surface.

* In Room 406 a chair was observed with the gel interior exposed. This prevents effective cleaning of this surface also.

The above findings were confirmed on 07/30/19 with staff members #H4, 11, and 15.


32870


Based on a review of facility documentation and staff interviews, the facility failed to ensure a safe and sanitary surgical environment by minimizing the number of loads of surgical instruments that were processed by immediate-use steam sterilization (IUSS) and by ensuring IUSS was used only for reasons allowed by current standards of professional practice. This placed all patients undergoing a surgical procedure at the hospital at greater risk for acquiring a healthcare-associated infection.

Findings:

Facility policy entitled "Immediate Use Steam Sterilization IUSS," last revised 2/26/19, included the following:
"POLICY: Immediate-use steam sterilization will be defined as a sterilization method that involves the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field before a biological result. If the item has implants the item cannot be released until the biological result is negative ..."

The St. David's Enterprise Infection Prevention Program Annual Infection Prevention Plan - 2019 included the following:
" ...The hospital reduces the risk of infections associated with medical equipment, devices and supplies ...
H. Immediate use steam sterilization (IUSS) rates will be monitored and reasons for IUSS will be investigated. Surgical Services and Central Sterile Processing (CSP) will minimize IUSS ...IUSS rates noted to be increasing will be reviewed by IP, Surgical Services Leadership and CSP Leadership for opportunities to reduce ..."


A review of the hospital immediate-use steam sterilization (IUSS) log revealed a large number of loads sterilized at the facility in 2018 using IUSS. The number of loads had decreased in 2019, but the reasons listed for the sterilizing the instruments by IUSS did not meet current professional guidelines.

For example, in 2019, the following number of loads were sterilized with the associated reason:

#21 times - "All like items in use."

#48 times - "Late arrival by vendor."

#2 times - "Surgeon brought in."


In an interview with Staff #G2 and Staff #G1 on the morning of 7/30/19 during a tour of the OR suite, immediate-use steam sterilization was discussed. Staff #G1 addressed the reason noted as "Late arrival by vendor," stating, "We're finding when some of our surgeons need some type of specialized instrument that they're often not brought in early enough for us to have time to use a regular sterilization process." When asked if she was referring to instruments used as "loaners", she stated she was.


A position statement on Immediate Use Steam Sterilization endorsed by the Association of periOperative Registered Nurses (AORN), Association of Professionals in Infection Control and Epidemiology (APIC), as well as a number of other surgical services professional organizations, and available at http://www.apic.org/Resource_/TinyMceFileManager/

Position_Statements/Immediate_Use_Steam_Sterilization_022011.pdf, includes the following:

" "Immediate Use" is broadly defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field ...A sterilized item intended for immediate use is not stored for future use, nor held from one case to another ...
It should be noted that IUSS is not equivalent to "short cycle" sterilization. Regardless of the cycle duration, correct use of a sterilization cycle for a wrapped/contained load that meets the device manufacturer's instructions for use (IFU) is the equivalent of terminal sterilization and is not IUSS if it includes use of a dry time and is packaged in a wrap or rigid sterilization container intended to be stored for later use ...


Professionally Accepted IUSS Standards of Practice

Consistent with standards of practice previously articulated by national associations with expertise in infection prevention, the availability of IUSS is not considered an appropriate substitute for maintaining a sufficient inventory of instruments ... While IUSS will accomplish sterilization if all of the steps before, during, and after the process are performed correctly, and used in compliance with specific device manufacturer's; sterilization manufacturer's; and, if applicable, container manufacturer's validated written instructions for use (IFU). Practices associated with the outmoded term "flash" sterilization have been implicated in surgical site infections and are considered to pose an increased risk of complications because of potential barriers to thorough completion of all necessary reprocessing steps ... IUSS also entails an increased risk of inadvertent contamination during transfer to the sterile field and damage to the instruments ... as well as risks related to wet instruments and the potential for burns ... Therefore use of IUSS, even when all steps are performed properly, should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization ..."


AORN (Association of periOperative Registered Nurses) 2015 Guidelines for Perioperative Practice includes the following:

"Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner ...Immediate use steam sterilization may be associated with increased risk of infection to patients ...
VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory ..."


The hospital was accredited by the Joint Commission (JC). A statement regarding the use of IUSS by the JC and available at https://www.jointcommission.org/standards_information/jcfaqdetails.aspx?StandardsFAQId=1474 included the following:
" ...Immediate-Use Steam Sterilization (IUSS), formerly termed "flash" sterilization, is described as "the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field". IUSS items are not intended to be stored for future use.

Considerations for IUSS: ...

o IUSS should not be used for mere convenience, or due to limited instruments or equipment for the number of cases/procedures performed.

o Evidence-based guidelines should be adopted to minimize the use of IUSS. Scenarios when IUSS may be appropriate include:

o When a specific instrument is needed for an emergency procedure.

o When a non-replaceable instrument has been contaminated and needs to be replaced to the sterile field immediately.

o When an item has dropped on the floor and is needed to continue a surgical procedure ...


Identifying Gaps and Risk reduction strategies to consider: ...

o When 'loaner' trays or instruments (including those brought in by a provider) are used, establish an agreement with the vendor/provider requiring that delivery occurs sufficiently in advance of scheduled case(s) to allow complete reprocessing of trays by the organization. Such a requirement is an example of a performance expectation to include in a contract ..."


A statement from the Association of Professionals in Infection Control and Epidemiology (APIC), available at http://text.apic.org/toc/infection-prevention-for-support-services-and-the-care-environment/sterile-processing/infection-prevention-rounds-audit-tool-for-sterile-processing, included the following:

" ...Establish a loaner instrument program that requires receipt of loaner instruments in time for appropriate cleaning and sterilization instead of processing by IUSS ..."


Based on observations made during a tour of the surgical and central sterile processing areas and staff interviews, the facility failed to ensure a safe and sanitary environment which minimized the risk of patients acquiring a healthcare-associated infection (HAI).

Findings:

During a tour of St David's Medical Center surgical and central sterile processing areas on the morning of 7/30/19 with Staff #G1-3, the following items were noted:

In the PACU:

o An old, sticky-looking substance covered an area approximately 2" x 2" on top of the cabinets. This made thorough cleaning impossible.

In the surgical center:

o An uncovered drink was found in the linen closet

o A housekeeping closet had an ill-fitting ceiling tile and an approximate one-inch circular opening around a water pipe. The wall had crusty areas of peeling paint. Opening into areas behind walls and crawl spaces can serve as portals for pests, dirt, dust and debris.

o Bed S19 with adhesive substance on mattress, making it impossible to clean.


In the OR Suite:

o The red rubber line delineating the sterile OR suite from the other area was broken and an approximate 18" strip was open to the floor below. It was dirty and there was a large paper clip lying in this space. This made thorough cleaning of the floor impossible.

o OR 16 with cracks in the floor


In a sub-sterile rooms outside ORs #7 and #8:

o There was shelving with uncovered linen ready for patient use. Uncovered linen is exposed to multiple environmental contaminants, especially from sneezing, coughing or spills.


In the anesthesia supply area:
o The floor was overtly dirty.

In interviews with Staff #G1-G3 during the tour, they confirmed each of the above findings.


During a tour of St David's Medical Center orthopedic unit on the afternoon of 7/30/19 with Staff #C31, 32 and 33, the following items were noted:

o Ortho unit nourishment room with black sticky build-up on tiles under and around the ice machine

o Ortho unit nurse's station sink with pain chipping on wall surrounding

o Ortho storage area with two freezers with approximately one inch of ice build-up throughout

In interviews with staff #C31-33 during the tour, they confirmed each of the above findings.


33326


Based on observation, interview, and record review, the St. David's Medical Center facility failed to ensure infection control policies and procedures were developed, implemented, and enforced, and that patient care was being provided in a sanitary environment.

a) The facility's dishwashing room had an approximately 20-inch x 20-inch area with an accumulation of a black substance surrounding the air vent, there was trash and old food debris under the equipment, and the food preparation surfaces had old dried food debris present.

b) A patient, known to have C-diff was not placed on Enteric Precautions as the facility's policy required.

c) The facility did not have a policy detailing the cleaning of a shared glucometer meter used on patients with C-difficle, and the staff did not know which product should be used to disinfect the glucometer.

d) There was blood residue on the Emergency Department's (ED) Intravenous Catheter (IV) carts and supplies, and a used alcohol pad, with a dark brown substance. The staff proceeded to clean the blood off the IV cart, using alcohol wipes, and did not wash their hands.

Findings:

a) Observations on the morning of 7/29/19 in the St. David's Medical Center's Dietary department revealed the following findings;

- The ceiling in the dishwashing room had an approximately 20-inch x 20-inch area with an accumulation of a black substance surrounding the air vent. An adjacent light fixture had dust and stains present. The ceiling had loose, chipped paint, and dust throughout the dish room.

- The floor drains had a dark material in the drains.

- The food holding cabinets had food debris on the rails and on the bottom of the cabinets.

- The floor throughout the kitchen had dried, caked on food debris and trash behind and under the equipment.

- The kitchen's stainless-steel drawers had food spills and dried food debris in contact with clean utensils and supplies; the staff were placing personal items in the drawers.

- The walk-in cooler drink cooler had a black substance on the walls and dried food debris on the floors and a black growth on the RFI code clip.

- The plate warmers had copious amounts of dried food debris where the clean plates were stored.

- The rack holding the clean tray warming lids had dried and fresh food debris on the rails.

- The facility's (2) can openers had blackened food debris on the cutting gears and the cutting tooth.

- A mop was being stored in a mop bucket with dirty water.

- The floor drains and walls behind the cooking equipment had old food debris and wet trash sitting on the floor.


During an interview on the morning of 7/29/19, in the facility's kitchen, Staff #D2 confirmed the findings.


b) Review of Patient #D1's medical record reflected a 53-year-old male admitted to the ED on 3/10/19 at 12:15 am with a "stated complaint: C DIFF ..." Review of Patient #D1's inpatient electronic record dated 3/10/19 at 6:29 pm reflected, "Isolation status: Contact Isolation"

Review of the facility provided policy Transmission-based Precautions (revision date 4/30/18) reflected,

"PURPOSE: To prevent the spread of infections to anyone in our respective practice areas ... Transmission based Precautions: ... Enteric Contact Precautions are also practiced for patients who are known or suspected to have Clostridioides difficile infection... Patient-care equipment and instruments/devices ... If common use of equipment for multiple patients is unavoidable, clean and disinfect such equipment between patients per manufacturer's instructions using approved disinfectant ... In addition to Contact Precautions, handwashing with soap and water is required after contact with the patient or the patient's environment. ii) The room must be cleaned and disinfected with an approved sporicidal ..."


Review of the facility provided policy Clostrium Difficile Policy (dated 5/01/16) reflected "C. Test Result-Initiation of l Precautions. 3. If C. difficile test is Positive, continue with ENTERIC CONTACT PRECAUTIONS ..."


c) During an interview on the afternoon of 7/29/19, in the facility's ED, when asked what the facility's shared glucometers is cleaned with for a patient with C-Diff, Staff #D6, ED RN stated, "I think purple wipes." The staff picked up the Super Sani-cloth wipes, with a purple top, and proceeded to look to see if the wipe was appropriate for Clostrium Difficile. The facility's ED Director stated the glucometer needed to be cleaned with the orange wipes, which contained bleach.

Review of the glucometer's manufacturer's instructions for cleaning reflected, " ... When cleaning the meter, please follow the guidelines listed below:

" Dilute bleach. A 10% solution of household bleach (sodium Hypochlorite) may be used

" 70% Isopropyl (rubbing) Alcohol may be used.

" Commercial surface decontamination preparations that are approved for use by your facility can be used. Apply to a small test area first to ensure surface finish integrity ..."


Review of the facility provided Policy TITLE: Bedside Blood Glucose Testing with Nova Biomedical StatStrip (revision date 12/6/18) reflected,

" ... Meter Cleaning

a. Meters should be cleaned between each patient.

b. The meter should never be immersed in cleaning agent. A damp cloth of the following antiseptic agents may be used for cleaning the meter:

1. Super Sani-Wipes

2. Dilute bleach (10% solution of household bleach)

3. 70% isopropyl (rubbing) alcohol ..."


The facility's policy did not detail which cleaning agent was to be used for a patient with Clostrium Difficile.

During an interview on the afternoon of 7/31/19, in a facility conference room, Staff #D8 confirmed the findings.


d) An observation made during a tour of the St. David's Medical Center's Emergency department on 7/30/19 revealed, there was blood residue on the Emergency Department's (ED) Intravenous Catheter (IV) carts and supplies, and a used alcohol pad, with a dark brown substance. Staff #D7, ED Director wipe dried drops of blood off two IV carts, without gloves, using alcohol pads. Staff #D7 discarded the used alcohol pads but did not wash their hands.


28043



During the tour of the Emergency Department with St. David's Georgetown Hospital Staff #8 on 7/30/19, it was observed:

- Exam Room #11, the surveyor was told that this room was "clean and ready for the next patient." It was observed that there were 3 small (less than 0.5 cm) bright red dried spots on the left side rail of the treatment bed and 1 small (less than 0.5 cm) bright red dried spot on the right side rail of the treatment bed. The surveyor counted 22 small (less than 0.5 cm) dark red dried spots along the floor and wall surface to the right of the treatment bed.

- Exam Room #8, the surveyor was told that this room was "clean and ready for the next patient." The surveyor counted 12 small (less than 0.5 cm) dark red dried spots along the floor to the left of the treatment bed.

- Crash Room #3, the surveyor was told that this room was "clean and ready for the next patient." The floor next to the treatment bed was still slightly wet and appeared to be have been recently mopped. The surveyor counted 12 small (less than 0.5 cm) bright red dried spots along the floor to the right of the treatment bed. The surveyor used the bottom of their shoe to swipe at the spots and left a red-colored streak stain.

In an interview with St. David's Georgetown Hospital Staff #1 on the afternoon of 7/30/19, Staff #1 acknowledged the findings above.


A tour of the St. David's Georgetown Hospital OR Suite was conducted the afternoon of 7/29/19 accompanied by St. David ' s Georgetown Hospital Staff #18; the following was observed:


Pre/Post-Op Area:

- Linen for use in patient care, including two stacks of folded patient gowns were observed by the survey team uncovered and unprotected. This potentially could have caused clean linens to be contaminated from airborne dust or infectious agents.

- Blood pressure cuffs were observed in a cabinet in an external, corrugated shipping box. "External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material, serve as generators of and reservoirs for dust." (AAMI ST46-Section 5.2 Receiving items).


Endoscopy Storage Area:

- An OR table mattress had small tears in the vinyl covering, which exposed the porous material beneath the vinyl covering. This porous material cannot be adequately cleaned between patients, and could harbor pathogens.

- A step stool had tape wrapped around all four legs with a dirty black, sticky tape residue adhered to the legs.

- Three white metal drawer fronts of a rolling cart had areas of rust which resulted in paint chipping off. This presents a risk for cross contamination as the rusted areas cannot be disinfected.

The above findings were confirmed during the tour on 7/29/19 by St. David ' s Georgetown Hospital Staff #18.


A tour of the 4th floor of St. David's Georgetown Hospital was conducted the morning of 7/31/19 accompanied by St. David's Georgetown Hospital Staff #52 and #54; the following was observed:

Newborn Nursery:

- There was a 3-drawer rolling cabinet with blue plastic bins used to store supplies, including pre-filled syringes, 1ml, 5 ml, 10 ml syringes, vacutainers, and other supplies. There was dust in the blue plastic bins and drawers containing supplies available for use in patient care. There was dust and a sticky substance on top of the rolling cabinet.

- In an under-sink cabinet in the nursery supply room, there were drips and spills and small black specks, indicating a possible previous water leak. The cabinet was in need of cleaning.


Postpartum:

- In the nutrition room, the refrigerator was in need of cleaning as there were spills and what appeared to be food crumbs in the refrigerator.

- In room 401, the under sink cabinet was in need of cleaning as there were stains on the floor of the cabinet.

- In the patient supply room, the wall mounted plastic storage bins were in need of dusting and cleaning, as the inside of the bins were dusty. These bins contained various items available for use in patient care, such as toothbrushes, contact nipple shields, benzocaine spray, and hair combs.

- A lower cabinet was in need of cleaning, as there was a thick layer of dust where the mesh panties were stored.

- In room 426, there was a dead, cricket in the cabinet under the sink.


Labor and Delivery OR #1:

- There was a thick layer of white, raised dust on the top of the light panel.


Labor and Delivery OR suite:

- The Pre-eclamptic Tray #3 contained a suction catheter kit in a paper sterile pack which stated, "Sterility guaranteed unless package is damaged or opened." Approximately 1/3 of the sterile pack was water stained and damaged, consequently the suction catheter kit was no longer sterile.

- The neo crash cart had a layer of dust on horizontal surfaces and was in need of cleaning. The base of the cart had debris between the bumper and the metal surface of the cart.

The above findings were confirmed during the tour on 7/30/19 with St. David ' s Georgetown Hospital Staff #54.


Review of hospital policy FAC-1744, entitled: "Obsolete, Expired, or Non-Moving Inventory Removal (Floor Stock) stated: "F. If the item is expired, see FAC -1568: Managing Products with Expiration Dates."


Review of hospital policy FAC-1658, entitled: "Managing Products with Expiration Dates" stated under the Rationale section: "Supplies should be evaluated against expiration dates to ensure proper use of dated product is occurring so potential risk to the patients is lessened and product isn ' t being wasted."

The policy section stated: "All expired merchandise (including intravenous solutions, kits with pharmaceuticals, other various medical devices, etc.) that is no longer saleable must be identified and expeditiously removed physically (to quarantine) and systemically from the warehouse/storeroom/pharmacy/POU area (including Pharmacy Pyxis/Omnicell)."

Page two stated: "D. If an expired product is identified, the following process should be followed. 1. Upon discovery of expired product the person who found the expired item must escalate to the SCD, DOP or designee. 2. The SCD, DOP, or designee must expeditiously remove product physically (to quarantine) and systemically from stock."

Review of page 233 of the Environmental Services - Cleaning Procedures Manual (note: provided by hospital staff to the survey team) entitled: "Chapter 9 - Support and Miscellaneous Areas Damp Dusting of Corridors" stated: "5. High dust everything above shoulder level: ceiling, lights, vents."

Review of page 37 stated: "Inspection Standards" "Ceilings, ledges, countertops, vents, TV ' s, and other high dust surfaces are clean and free of dust." "First impression cleanliness in consistently maintained ..."


Review of hospital policy EC.02.06.01. EP1-26, entitled: "Providing a Safe Environment" stated under the policy section: "It is the policy of St. David ' s Medical Center to develop and implement plans, programs and processes which will promote a safe and functional environment."

The procedure section stated: "The following are specific areas reviewed: 1. Interior spaces shall meet the needs of the patient population and are safe and suitable to the care, treatment, and services provided." "6. Areas used by patients are clean and free of offensive odors." "8. Furnishing and equipment are maintained to be safe and in good repair." "9. The status of the environment will be reviewed during the Environmental Tours process and reviewed by the Safety Officer. Deficiencies and corrective actions will be reviewed by the Safety Officer and reported to the EOC Committee as appropriate."


29934


During a tour of Georgetown Hospital Surgery Department on the afternoon of 7/29/19, visible dust was seen on the surveyor's finger after running it on the lower frame of the stretcher in Outpatient Surgery room #2. In an interview with Georgetown Staff #18 during the tour on the afternoon of 7/29/19, staff #18 confirmed the presence of the dust on the stretcher.


During a tour of the Georgetown Hospital on 7/30/19, in the Women's Center OR hallway on a cart near the malignant hyperthermia cart was a black surgery table arm support that had several tears and holes in the vinyl covering covered with clear tape peeling at the edges making proper disinfection impossible. In an interview with the Georgetown Staff #52 during the tour of the Women's Center on the morning of 7/30/19, staff #52 confirmed the above findings.


During a tour of the Georgetown Hospital Radiology Department on the morning of 7/31/19, the linen cart cover in the RF room had several tears in the vinyl covering exposing fabric below which made proper disinfection impossible. In an interview with the Georgetown Staff #65 during the tour on the morning of 7/30/19, staff #65 acknowledged the above finding.


During a tour of the Cardiovascular Imaging Center located at 1015 E 32nd St. #513 on the morning of 8/5/19, in the supply room an open metal shelving unit was observed with two packages of clean linens, sheets, and bath blankets, that had been opened and were exposed to airborne contaminants. In an interview with the 32nd St. Staff #2 during the tour on the morning of 8/5/19, staff #2 acknowledged that the linens were uncovered.


The Centers for Disease Control "Guidelines for Environmental Infection Control in Health-Care Facilities" dated 2003 reflected in part "After washing, cleaned and dried textiles, fabrics, and clothing are pressed, folded, and packaged for transport, distribution, and storage by methods that ensure their cleanliness until use."


39244


Based on observations, interview, and record reviews, the facility failed to ensure patient care rooms, equipment, and supplies were cleaned or maintained in sanitary manner.

Findings:

In an observation on 7/29/19, at 10:45 a.m., at St. David's Medical Center ICU unit (5th floor), the following have been observed:

- room 501: lower part of bed frame (base part) with dust accumulation and dried spots of maroon/brownish debris in scattered areas; horizontal ledges behind bed with dust accumulation; 1 x fitted bed sheet inside an unlocked cabinet

- room 502: lower part of bed frame (base part) with dust accumulation; unlocked cabinet above sink with 1 x flat sheet, 2 x towels, and 1 x washcloth


In an interview on 7/29/19, at 10:50 a.m., Staff #J5 confirmed the above findings. Staff #J5 stated horizontal ledges and lower part of the bed frame should be cleaned every day by EVS (environmental services) and was unsure of what the dried spots of maroon/brownish debris were. Staff #J5 further stated bedsheets and other linens should be cleaned out for possible infection control issues.


Review of undated facility provided policy titled Shine- Patient Room Discharge Cleaning, by Sodexo v17.1, reflected under procedure, " ...High dust everything above shoulder level: ... horizontal ledges ... damp wipe the bed frame and the bedrails on each side ... inspect the room."


Review of facility provided policy titled Linens Policy, with revision date of 07/29/19 reflected the purpose was "to prevent the spread of infection while distributing clean linen and collecting soiled linen." Policy section reflected in part, "Linen will be distributed using methods that will provide clean linen to patients and staff ..."

Based on observation, interview, and record review, the St. David's Medical Center facility failed to ensure written policies and procedures were adopted and implemented to provide surgical services in a sanitary environment.

Findings:

Observations on the morning of 8/5/19 of the facility's surgical department revealed the following:

- The facility's surgical instrument washer had debris on the inner rails located on the front and back side of the washer and was not performing the manufacturer's recommended routine maintenance of the surgical instrument washer.

- An Anesthesiologist was removing medication's dust caps and was not sanitizing the septum before accessing the vial.

- (5) drops of blood were noted on a cardiac defibrillator machine in operating room #4 where there was open sterile instruments for a case.

- The surgical scrub sink, outside of OR #4, had scale built up in the sink's basin, making it difficult to clean.

- A blood Perfusionist was observed leaving the OR's sterile core, enter an office, and return to OR #3 wearing the same mask.


During an interview on the morning of 8/5/19, in the facility's conference room, Staff confirmed the findings and confirmed the Sterile Processing technicians had not been trained on the cleaning of the washers and the facility was not following the manufacturer's routine maintenance recommendations.


The Safe Practice Guidelines for Adult IV Push Medications (July 23, 2015) explains the "pop-off" vial caps from manufacturers are considered "dust covers" and are not intended to maintain sterility of the vial diaphragm or access point. Thus, the diaphragm must always be disinfected after removing the cap of a new vial.


Review of The Centers for Disease Control and Prevention, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Division of Healthcare Quality Promotion (DHQP) https://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html revealed,
"Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."


Review of the facility provided Steris Washer's Operator manual (undated) reflected,

6.3 Cleaning Debris Screen- daily

6.4 Cleaning Water Outlet Connection- weekly

6.5 Cleaning Door Gasket- monthly

6.6 Cleaning Washer/Disinfector Exterior- weekly

6.7 Inspecting and Cleaning Rotary Spray Arm Assemblies- Weekly

Based on review of facility documents, review of medical records, and staff interview, the St. David's Medical Center facility failed to ensure a post-anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia.

Findings:

Facility policy titled "Outpatient Discharge AM Admit Day Surgery" stated in part, "If there are signed post anesthesia orders for PACU [post-anesthesia care unit] ... the patient may be discharged without being seen by the anesthesiologist.


Review of medical records at St David's Medical Center on July 31, 2019, revealed the following:

*Patient #5 had a surgery date of 6/12/9 with an anesthesia end time of 1:25 pm and a post-op evaluation signed by the anesthesiologist timed at 1:25 pm.

*Patient #7 had a surgery date of 7/22/19 with an anesthesia end time of 4:15 pm and a post-op evaluation signed by the anesthesiologist timed at 4:00 pm, before anesthesia end time.

*Patient #8 had a surgery date of 7/24/19 with an anesthesia end time of 12:01 pm. The post-op evaluation was signed but was not timed.


In an interview with staff #C30 while reviewing the medical records, staff #C30 stated, "They [the anesthesiologists] should be seeing the patients prior to discharge from the PACU." When discussed if these patients would be recovered from anesthesia at the documented times, staff #C30 verified they would not be. When asked about the policy stating patients could be discharged without seeing the anesthesiologist, staff #C30 stated the practice is not allowed.

The above was confirmed with staff #C33 on the afternoon of 7/31/19.

St. David's Georgetown location:

Based on review of documentation and interviews, it was determined that the hospital failed to ensure that outpatient services were integrated into the hospital wide QAPI program.

Findings:

The hospital failed to ensure that outpatient services were integrated into the hospital wide QAPI program.

On the morning of 8/01/2019, the surveyors asked staff member #9 if the hospital outpatient clinics were integrated into the hospital wide QAPI program, staff member #9 replied "No".

Review of the St. David's Medical Center "Quality & Performance Improvement Plan" for 2019 listed on the front page the facilities that were included in the plan, among the facilities listed were: "St. David's Georgetown Hospital" and "Outpatient Rehabilitation Clinics". Page two of the plan listed the facilities that comprise St. David's Medical Center (SDMC), these included: "St. David's Georgetown Hospital," St. David's Rehabilitation Hospital to include St. David's Georgetown Hospital's Rehab Unit and four (4) outpatient rehabilitation clinics."

Page two also stated: "The St. David's Medical Center Quality and Performance Improvement Plan is a comprehensive approach to improving aspects of performance developed under the auspices of the Quality Committee and approved by the Medical Executive Committee and the Board of Directors. The following are specific objectives of this plan: A. To ensure objective, ongoing, systemic mechanisms for measuring, assessing and improving the quality of departments and services as well as the clinical performance of members of the medical staff."

Staff #9 provided the survey team with a one-page document entitled: "St. David's Georgetown Hospital". This document listed the Sun City Clinic and the Lake Aire Clinic. Each of the clinics had numerical data for 2018 and 2019 (as of 7/13/19) for UOS (units of service) and customer satisfaction. No other documentation was found by or provided to the survey team to indicate that the Outpatient Services were incorporated into the hospital wide QAPI program.

In an additional interview on the morning of 8/01/2019 (held in the Chief Nursing Officer's Office) it was confirmed again by both staff members #2 and #9 that the outpatient services were not integrated into the hospital wide QAPI program.


30250


Based on a review of documentation and interview, the St. David's Medical Center facility failed to ensure that if the hospital provides outpatient services, the services must meet the needs of the patients in accordance with acceptable standards of practice, including being integrated into its hospital-wide QAPI program.

Findings:

Review of the Quality and Performance Meeting minutes for the facility revealed no reporting from outpatient services for 2018 and 2019.

In an interview with staff member #H4, Director of Rehab and Outpatient Services on 07/31/19 at 10:00 AM, they were asked about outpatient services involvement in the Quality Assurance Plan. This staff member replied, "We actually switched to a new documentation system...part of the reason we switched is it has a reporting setting. We're hoping to track and decrease the cancel no show rate, also to better track referral sources. We also get Press Ganey satisfaction results. We'll be planning to report to quality."

Staff member #H4 was asked if up until this point had the outpatient rehabilitation been reporting to quality previously. This staff member replied, "No". They added, "We went live April. I have Q2 data that I will present at my next presentation meeting in August." The staff member added, "I think historically it was something that was not presented. I came from another HCA where we presented those metrics. I've been in contact with Quality this is the system in place to start reporting up".

Based on review of documentation and interview the facility failed to ensure that outpatient services were integrated into its hospital-wide QAPI program.

Based on observation and interview, it was determined that the St. David's Medical Center facility failed to ensure the emergency department posted the required EMTALA signage. Specifically, the facility failed to ensure EMTALA signs were posted in an area where individuals are waiting for examination and treatment and the signage is visible from 20-feet vintage point.

Findings:

The Texas Hospital Association, Guide to Hospital Signage Requirements, states in part, "... Emergency Care - Rights to examination and treatment for emergency medical conditions and women in labor (EMTALA).

a. In the case of a hospital as defined in 42 CFR § 489.24(b) -
i. To post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area), a sign (in a form specified by the Secretary) specifying rights of individuals under Section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor ..."

Observation on 7/29/2019 of the hospital's emergency department, with the Nurse Manager revealed there were no EMTALA signs in the Emergency waiting room where individuals sign in requesting services, and wait for examination.