HospitalInspections.org

Based on observation, review of records, and interview, the Governing Body failed to:

A. provide complete and correct information to patients or patient representatives of their rights (including State required notices) prior to admission, at time of admission and prior to discharge.

Refer to Tag: A 0117


B. secure 2 of 2 areas where the acid concentrates for dialysis were stored to prevent tampering.

C. ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for Changes to the Legal Health Record.


D. provide clean carts that carry the portable RO (Reverse osmosis for water purification) system to the patients' bedside in different nursing areas of the hospital and provide clean storage areas for the patient dialysis supplies, equipment, and the acid/bicarbonate products.


Refer to Tag: A 0144

E. provide a clear staffing plan or grid to ensure safe nurse to patient ratio was provided in 6 ( Medical/ Surgical, Medical/ Telemetry, Intensive Care Unit, Emergency Department, Nursery, and Obstetrics) of 6 patient units.

Refer to Tag A0392

F. ensure non-employee licensed nurses providing care in the emergency department to sexual assault victims were properly contracted, credentialed and supervised.

Refer to Tag A0398

G. follow policy and procedures to ensure blood and blood products, were administered to the patients in a safe manner, in 3(#55, 22, and 19) out of 3 patient charts and 17 out of 20 transfusion records reviewed.

Refer to Tag A0409

H. ensure that Memorandum of Transfer forms were completed in their entirety on patients transferring from the hospital in 16 (Patient #'s 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) out of 17 (Patient #'s 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) patient transfers.

Refer to Tag A0438

I. ensure outpatient records in 1 outpatient clinic (Sleep Lab) out of 4 (Sleep Lab, Wound Care, Surgery Center, Imaging) were stored in a secure manner that protected the records from fire or water damage and prevented access to records by unauthorized individuals.

Refer to Tag A0441

J. ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for changes to the legal health record.

See Tag A0450

K. ensure the surgeon dated and timed the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies on history and physical updates and the medical record content.

Refer to Tag A0461

L. ensure the surgeon and anesthesia provider signed, dated, and timed the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

Refer to Tag A0466

M. ensure the surgeon dated and timed the Surgical Progress Note form on 2 (#11 and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Content of the Medical Record.

Refer to Tag A0467

N. provide a sanitary environment in the dietary department (food storage and preparation areas). Potential for cross-contamination due to unsanitary food handling, unsanitary cooking implement storage, unsanitary food service items (pots, pans, bowls, and plates) storage, and poor general sanitation practices was found throughout the dietary department.

Failure to provide a sanitary environment may lead to food borne illnesses and possible death. These deficient practices placed all patients at risk for likelihood of harm, injury, or subsequent death.

Refer to Tag A0618

O. ensure that policy and procedures were written and accepted by the Governing Body (GB) for dietary services.

Refer to Tag A0619

P. ensure the off-site vendor had provided the Director of Dietary Services with the necessary education, experience, and training to manage the service, appropriate to the scope and complexity of food service operations.

Refer to Tag A0620

Q. ensure the dietary staff received adequate training and were competent in their respective duties in 8 (#60-67) of 8 files reviewed.

Refer to Tag A0622

R. ensure the facility had a current therapeutic diet manual approved by the dietitian and medical staff.

Refer to Tag A0631

S. provide a sanitary environment in the dietary department (food storage and reparation areas). Potential for cross-contamination due to unsanitary food handling, unsanitary cooking implement storage, unsanitary food service items (pots, pans, bowls, and plates) storage, and poor general sanitation practices was found throughout the dietary department.

These deficient practices were determined to pose an Immediate Jeopardy to the health and safety of patients that had the likelihood to cause harm, serious injury, impairment and/or subsequent death.


T. provide a sanitary environment for the care of patients, including the food preparation areas. The facility failed in its efforts at infection control in 6 of 6 departments and/or services (Nursing, Laundry, Dialysis, Central Supply, Pharmacy, and Maintenance Plant Grounds).

U. ensure the Infection Control Officer had a working system for required logging and reporting communicable diseases, infections, and food borne illnesses.

Refer to Tag A0747

V. ensure the surgical department provided a clean and sanitary environment.

W. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented flash sterilization as an emergency. A review of the flash sterilization logs for the months of June through September 20, 2016 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. The facility failed to document biological indicator time in and time out of the flash sterilizers with the results of the biological indicator on the "3M Steam Flash Sterilization" form. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.

These deficient practices were determined to pose an Immediate Jeopardy to the health and safety of patients that had the likelihood to cause harm, serious injury, impairment and/or subsequent death.



X. provide 2 post anesthesia patient care areas per each operating room. The facility had 10 functional operating rooms that were observed. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas was being used for storage of stretchers, wheelchairs and other equipment.


Y. ensure the surgeon documented the date and time the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies for history and physical updates and the medical record content.


Z. ensure the surgeon and anesthesia provider had signed, dated, and timed the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

Refer to Tag A0940

Based on observation, record review, and interview, the facility failed to:

A. provide complete and correct information to patients or patient representatives of their rights (including State required notices) prior to admission, at time of admission and prior to discharge as follows:

1. An Important Message From Medicare About Your Rights for 3 patients (Patient #s 31, 33, and 34) of 4 patients (Patient #s 31, 32, 33, and 34) was not delivered at admission and/or discharge. The facility failed to follow its own policy.

2. State required posting to notify patients or patient representatives of the statement of duty to report abuse and neglect, or illegal, unethical or unprofessional conduct in English and a second language with their right to contact the appropriate complaint line number was not posted at 3 of 3 entrances/waiting areas (Entrance/Main Lobby Gaslight Boulevard, Entrance/Lobby Loop 287, and Ambulance Entrance/Emergency Room Waiting)

3. Provided the incorrect phone number to all patients for making a Health Facility Complaint at time of admission, creating a barrier to patients from exercising their right to make a complaint.

Refer to Tag: A 0117


B. secure 2 of 2 areas where the acid concentrates for dialysis were stored to prevent tampering.

C. ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for Changes to the Legal Health Record.


D. provide clean carts that carry the portable RO (Reverse osmosis for water purification) system to the patients' bedside in different nursing areas of the hospital and provide clean storage areas for the patient dialysis supplies, equipment, and the acid/bicarbonate products.



Refer to Tag: A 0144

Based on observation, review of records and interview, the hospital failed to provide complete and correct information to patients or patient representatives of their rights (including State required notices) prior to admission, at time of admission and prior to discharge as follows:

A. An Important Message From Medicare About Your Rights for 3 patients (Patient #s 31, 33, and 34) of 4 patients (Patient #s 31, 32, 33, and 34) was not delivered at admission and/or discharge. The facility failed to follow its own policy.

B. State required posting to notify patients or patient representatives of the statement of duty to report abuse and neglect, or illegal, unethical or unprofessional conduct in English and a second language with their right to contact the appropriate complaint line number was not posted at 3 of 3 entrances/waiting areas (Entrance/Main Lobby Gaslight Boulevard, Entrance/Lobby Loop 287, and Ambulance Entrance/Emergency Room Waiting)

C. Provided the incorrect phone number to all patients for making a Health Facility Complaint at time of admission, creating a barrier to patients from exercising their right to make a complaint.

Findings include:

A. Four patient charts (Patient #s 31, 32, 33, and 34) were selected from the Complaints and Grievances Log to be reviewed. Three of the patients (Patient #s 31, 33, and 34) did not receive proper notification.

Patient #31 was admitted on 8-11-2016. The patient was discharged to hospice on 8-12-2016. Review of records showed that the form, An Important Message From Medicare About Your Rights (IM) had notation in the "Signature of Patient or Representative" block "pt cannot sign". This was dated and time 8/11/16 1017 (10:17 A.M.). There was no signature of the person delivering the IM or explanation of why the patient could not sign. The chart did not contain documentation of follow-up action with a patient representative or the patient to provide them with the patient rights information. A second delivery of the IM was not necessary.

Patient #33 was admitted on 8-8-2016. The patient was discharged to home with home health on 8-29-2016. Review of records showed that the IM form had a patient representative's signature in the "Signature of Patient or Representative" block. It was not dated or timed. There was no IM form found in the chart with signature, date, or time of the second delivery of the IM prior to discharge.

Patient #34 was admitted on 6-13-2016. The patient left the hospital against medical advice on 6-19-2016. Review of the records showed that the IM form had a patient representative's signature in the "Signature of Patient or Representative" block. It was dated and timed "6 13 1900" (7:00 P.M.) There was no IM form with a signature, date, or time from the patient to show he had received a second delivery at time of discharge when he signed himself out of the hospital against medical advice.

Review of Community Health Systems Professional Services Corporation Policy Title: Important Message from Medicare Policy was completed. "Section II. Procedure" stated the following:

"Registration personnel are responsible for the following:

A. Delivery of the Important Message from Medicare (IM) at or near admission, but no later than 2 calendar days following the date of admission.

B. If the Medicare patient is admitted and/or transferred to a Distinct Part Unit within the hospital (e.g., Rehab or Psych unit), the IM specific to that Unit, which includes the DPU's Medicare provider number, should be delivered to the patient instead of the acute care IM.

C. When the IM is issued, obtain the signature of the patient or his/her representative on the IM to indicate that he/she received and understood the notice. This includes explaining the notice to the patient if necessary and providing an opportunity to ask questions ...

G. Regardless of the competency of a patient, if it is not possible to personally deliver a notice (initial IM or follow-up IM) to a representative, the attempts should be made to contact the representative by telephone to advise him or her of the patient's rights as a hospital patient, including the right to appeal a discharge decision ...

J. Place a dated copy of the notice in the patient's medical file, and document the telephone contact with the patient's representative (as in #8 above) on either the notice itself, or in a separate entry in the patient's fil or attachment to the notice...

L. If the patient refuses to sign the IM, indicate in writing on the IM the refusal. The date of refusal is considered the date of receipt of notice.

M. It is the ultimate responsibility of Registration personnel to ensure the initial IM is delivered to appropriate patients and/or their representatives, appropriate signature(s) is obtained, the original IM is given to the patient or his/her representative, and a signed and dated copy of the IM is placed in the medical record. A tracking system should be developed whereby there is certainty that the IM is delivered, as per Policy.

III. Delivery of the Follow-up IM Prior to Discharge
The Case Manager is responsible for the delivery and obtaining the patient's or the patient's representative's signature on the follow-up IM prior to discharge. When the CM is not available, the nurse manager, charge nurse or nurse assigned to patient is responsible for this process.

A. Provide the patient or his/her representative a new IM within 2 calendar days of the day of discharge. Obtain the patient's or patient's representative's signature and date on the new IM. Give the patient or the patient's representative the second signed and dated IM and place a copy of the second IM in the medical record."

Interview was conducted with Staff #51 on 9-21-2016. Staff #51 confirmed that it was the Case Management Department's responsibility along with nursing to ensure the second delivery of the IM. Staff #51 was unable to find the second delivery of the IM for Patient #33 and Patient #34.

Interview was conducted with Staff #54 on 9-22-2016. Staff #54 confirmed that registration staff was responsible for the initial delivery of the IM. Staff #54 stated the errors on the initial delivery of the IM on Patient #s 31, 33, and 34 had all been processed by the same person. Staff #54 stated the staff member that had made the mistakes was new and was to be re-educated on the process.

B. Tour of the facility was conducted on 9-19-2016 with Staff #7. State required posting to notify patients or patient representatives of the statement of duty to report abuse and neglect, or illegal, unethical or unprofessional conduct in English and a second language with their right to contact the appropriate complaint line number was not posted at 3 of 3 entrances/waiting areas (Entrance/Main Lobby Gaslight Boulevard, Entrance/Lobby Loop 287, and Ambulance Entrance/Emergency Room Waiting). Staff #7 confirmed that the postings were missing.

C. Review of Patient Admission Forms was conducted. The "Patient Rights and Responsibilities ADM-1901 GHMS-TX" on page 2 of 2 stated:

"You also have the right to:

Lodge a concern with the state, whether you have used the hospital's grievance process or not. If you have concerns regarding the quality of your care, coverage decisions or want to appeal a premature discharge, contact the State Quality Improvement Organization (QIO) ....

If you have a Medicare complaint you may contact

Texas Department of State Health Services

Phone: (512) 834-6700"

Review of the Patient Guide, given to patients upon admission, contained the following information on page 24:
"Regarding Problem Resolution, You Have the Right To:

Express your concerns about patient care and safety to hospital personnel and/or management without being subject to coercion, discrimination, reprisal or unreasonable interruption of care; and to be informed of the resolution process for your concerns. If your concerns and questions cannot be resolved at this level, contact the accrediting agencies indicated below:"

This also lists the phone number for the Texas Department of State Health Services as (512) 834-6700.

An attempt to call the number provided was made with Staff #3 present. The phone number provided was for the Emergency Medical Services (EMS) group. There was an automated response that provided different options to contact various EMS related services. The only option for filing a complaint was for EMS services and not hospital provided care. Staff #3 confirmed this.

Based observation, record review, and interview, the facility failed to:

A. secure 2 of 2 areas where the acid concentrates for dialysis were stored to prevent tampering.

B. ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for Changes to the Legal Health Record.


These deficient practices had the likelihood to cause harm to all patients receiving care at the dialysis unit by exposing them to unsafe dialysate, providing legible documentation in the legal health record, and failure to provide clean dialysis equipment to the patients.


Findings included:


A. During a tour of the dialysis storage areas where acid concentrates are stored noted the door had a key-code lock. The unit manager was asked what personnel have access to the key-code. The unit manager stated, "That managers of different departments, housekeeping, and certain nursing staff have the key-code." Also, observed in one of the storage areas was a rack of six 5 gallon water containers. Staff #8 was asked does this mean the water supply company has access to the storage area too. Staff #8 stated, "I don't know."

An interview with the Unit Manager and Staff #8 confirmed that multiple hospital staff have access to the dialysis storage areas.

B. A review of water treatment log for the months of April through August of 2016 revealed numerous mark overs of dates, times, results of total chlorine test performed, drain lines secured, and time RO system was turned off.


A review of Machine/Infection log for the months of April through August of 2016 revealed numerous mark overs of dates, Hepatitis antigen results, and results of residual peracetic acid, residual bleach check, and time machine disinfected.


A review of Patient #1's record revealed 9 write overs and one of the sentences documented in the legal record was completely obliterated by a solid black line. There was no way to know what was to be documented in the legal record. The write overs consisted of vital signs, lot numbers of dialyzes and tubing, dialysis machine rates, and condition of the patient during intradialytic monitoring of the patient.

A review of Patient #2's record revealed 3 write overs and one the times was highlighted in yellow. Staff #8 was asked why the time was highlighted in yellow. Staff #8 stated, "I have no idea, unless it was to remind him to document his time."

A review of the policy titled, "Changes to the Legal Health Record" revealed the following:

"PURPOSE: The purpose of the health record is to provide a basis for planning patient care and for the continuity of such care. Each record should provide documentary evidence of the patient's medical evaluation, treatment, and change in condition as appropriate. The purpose of this policy is to provide guidance on the instances in which a correction, amendment, addendum, deletion or retraction of information is necessary to support the integrity of the health record.

II. DEFINITIONS:
A. Correction - a change to the information meant to clarify inaccuracies after the original document has been signed or rendered complete.
B. Amendment - a document or entry meant to clarify health information within the legal health record. An amendment is made after the original documentation has been completed and signed by the provider.
C. Addendum - a new document or entry used to add information to an original entry.
An addendum is made after the original documentation has been completed and signed by the provider.
D. Deletion - eliminating information from previously signed and closed documentation without substituting new information.
E. Retraction - correcting information that was incorrect, invalid or made in error by preventing display or hiding the entry or documentation from future general view.
F. Late Entry - documentation that is entered after the point of care.

III. POLICY: Providers documenting on paper and within the EHR must avoid indiscriminate use of correction, amendment, addendum, deletion, and retraction functionality as a means of documentation. All attempts to correctly identify patients and their medical conditions should be made prior to documenting within the record.

IV PROCEDURE: Note - please consult applicable state law for further guidance
A. Correction -
a. Electronic records- depending on the system certain administrative members may have access to "unlock" the signed document for the provider to make the correction. If this functionality is not available, an amendment or addendum will need to be utilized.
b. Paper records- draw a single line through the error, initial date and time the entry..."

An interview with Staff #8 on 09/19/2016 at 3:00 PM confirmed the above findings of changes to the legal record and not following the facility policy.

Based on record review and interview, 2 (Wound Care, Sleep Lab) out of 4 outpatient departments and 2(Linen and Laundry, Dietary) out of 3 contracted services were not involved in the Quality Assurance and Performance Improvement process.

Review of the Quality Assurance and Process Improvement documentation for the previous 9 months revealed Wound Care, Sleep Lab, contracted Linen and Laundry and contracted Dietary had not participated in the program.

Staff #3 was interviewed in the conference room on 9-22-2016. Staff #3 reviewed the Quality Improvement reports for the 2016 year and confirmed that Wound Center and Sleep Lab were not included in the Quality Assurance and Process Improvement (QAPI). Staff #3 stated, "I just never thought about them being departments of the hospital."

When asked to review the QAPI reports for contracted Linen and Laundry and Dietary, Staff #3 stated that those contracted services had not been included in QAPI. Dietary and Linen and Laundry only had two quality indicators each that were used to evaluate the contract. They did not have PI plans that went through the Quality Committee.

Based on review and interviews nursing failed to;


A.) to provide a clear staffing plan or grid to ensure safe nurse to patient ration was provided in 6 ( Medical/ Surgical, Medical/ Telemetry, Intensive Care Unit, Emergency Department, Nursery, and Obstetrics) out of 6 patient units.

Refer to Tag A0392

B.) ensure non-employee licensed nurses providing care in the emergency department to sexual assault victims were properly contracted, credentialed and supervised.

Refer to Tag A0398

C.) follow policy and procedures to ensure blood and blood products, were administered to the patients in a safe manner, in 3(#55, 22, and 19) out of 3 patient charts and 17 out of 20 transfusion records reviewed.

Refer to Tag A0409

Based on record review and interviews nursing failed to provide a clear staffing plan or grid to ensure safe nurse to patient ratio in 6 ( Medical/ Surgical, Medical/ Telemetry, Intensive Care Unit, Emergency Department, Nursery, and Obstetrics) out of 6 patient units.
Review of the nurse staffing revealed the facility uses a staffing grid with budgeted full-time equivalents (FTE) and Manhours/Stat. The grid only refers to FTE's and does not distinguish between licensed and unlicensed staff. There is no clarification of RN's and LVN's. Due to the staffing based on FTE's and not nurse/patient ratio it was unclear if staffing was adequate to meet patient care needs.
An interview was conducted with staff #37 and staff #3 on 9/22/16. Staff #37 reported that the staffing is done to the budget grid of FTE's. Review of the staffing grid revealed there was three shifts 7:00AM-3:00PM, 3:00PM-11:00PM, and 11:00PM-7:00AM. Staff #3 reported that they don't have three shifts. Staff #3 stated they have 2- 12 hour shifts 7:00AM-7:00PM and 7:00PM-7:00AM. The grid had not been updated to the 2-12 hour shifts. Staff #3 stated that have been on 2-12 hour shifts for several years now. Staff #37 was asked how she knows the staffing is at a safe level for nurse/pt. ratio, patient acuity, anticipated discharges, and admissions. Staff #37 stated, "I just know." Staff #37 was asked again where she got that information or was it just a guess. Staff #37 stated,"Well, I'm not sure, I just know. I guess you could say it looks like a guess but we just know."

Review of the policy and procedure "Plan for Patient Care: Telemetry Unit Staffing Plan" stated, "Budgeted Man Hours/Stat 10.23
2. Staffing is accomplished through coordinated scheduling by Nurse Manager with input from staff and charge nurses. Staffing may be adjusted by the house supervisor form staff input based on the patient care requirements and census."

Review of the policy and procedure "Plan for Patient Care: Women's Services" stated, "Staffing Plan: 1.) Standard 6.95 man hours/stat
2.) Shift Distribution: 7 a.m-7p.m 50%, 7p.m-7a.m 50% "

Review of the policy and procedure "Plan for Patient Care: Emergency Department" stated, "Staffing is planned to provide for an average daily census of 64 patients per day with 19.97 FTE's."

An interview with staff #34 on 9/21/16 revealed the ICU patient nurse ratio was usually 1 RN to two patients and on occasion 1 RN for three patients. Staff #34 stated, "If it looks like the acuity is changing on my patients or I'm getting a fresh heart patient, and I need more help, I just get on the phone and start calling people in." Staff #34 reported that he has been given the ability to adjust his schedule. Staff #34 stated they schedule to the FTE's but he just "knows" how many he will need.

Based on review of documents and interview, the director of nursing service failed to ensure non-employee licensed nurses providing care in the emergency department to sexual assault victims were properly contracted, credentialed and supervised.

Review of the Sexual Assault Nurse Examination (SANE) program revealed that no hospital nursing staff were certified as SANE nurses.

Interview conducted with Staff #44 revealed that SANE examinations were provided by nurses employed with an outside provider. Sometimes the nurses came to the emergency department to complete the examination. Sometimes the nurses requested the patient be sent to outside provider location.

Interview with Staff # 7 was conducted. Staff #7 stated there was not a contract with the outside provider for these services. Staff #7 stated that there were no policies concerning SANE exams since the hospital did not conduct the exam. Staff #7 stated there were no credentialing files on the nurses who came in to the hospital to examine the sexual assault patients.

Based on chart review and interview nursing failed to follow policy and procedures to ensure blood and blood products were administered to the patients in a safe manner, in 3(#55, 22, and 19) out of 3 patient charts and 17 out of 20 transfusion records reviewed.

1.) Review of patient #55's chart revealed the following;
A.) blood was ordered on 9/19/16 at 2255 (10:55PM). Review of the transfusion record revealed the "Order Verified" box had not been checked. There was no evidence found on the transfusion form that the physician order was checked by the nurse.
B.) The transfusion form stated, "Transfusion MUST begin within 30 minutes of removal from Blood Bank"
The policy and procedure "Blood Component Transfusions" stated, "#6 Administration of blood or blood components should be initiated within 15 minutes after obtaining blood from the laboratory." The blood was picked up from the lab on 9/19/16 at 2255 (10:55PM), however, the blood was not started until 2315 (11:15PM) 20 minutes after received from the lab. According to the policy and procedure the blood administration was started 5 minutes late.

An interview with staff #7 on 9/22/16 revealed that all nursing procedures should follow the policy and procedures.

2.) Review of patient #22's chart revealed the patient had an order for a blood transfusion on 9/19/16. On the transfusion record in the vital signs section, the nurse marked over a previous time that was put down on the "one hour after start" time. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.

3.) Review of patient #19 revealed the following issues on the blood transfusion records:
C.) 9/8/16 at 1243 (12:43PM) and 9/18/16 at 1418 (2:18PM) the signatures of the person accepting the blood from the lab and both verifier signatures and disciplines (Registered Nurse RN or Licensed Vocational Nurse LVN) were illegible.
D.) 9/8/16 at 2224 (10:24PM) the nurse failed to initial, date, and time the "Transfusion Stopped:" section.
E.) 9/9/16 at 0616 (6:16AM) the 2nd verifiers signature and discipline was illegible.
F.) 9/10/16 at 0215 (2:15AM) the 2nd verifiers discipline was illegible. The nurse failed to date and time the "Transfusion Stopped:" section.
G.) 9/10/16 at 0100 (1:00AM) the initial pre-transfusion pulse was written over another number leaving the pulse number illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
H.) 9/10/16 at 1420 (2:20PM) On the transfusion record in the vital signs section, the nurse marked over a previous time that was put down on the "one hour after start" time.
I.) 9/10/16 at 1843 (6:43PM) the signatures of the person accepting the blood from the lab and both verifiers signatures and disciplines (RN or LVN) were illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
J.) 9/10/16 at 2301 (11:01PM) the blood was picked up from the lab on 9/10/16 at 2301 (11:01PM); the blood was not started until 2330 (11:30PM) 29 minutes after received from the lab. According to the policy and procedure the blood administration was started 14 minutes late. The 1st verifier signature and discipline was illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
K.) 9/11/16 at 2152 (9:52PM): the signatures of the person accepting the blood from the lab and 2nd verifier signature and discipline (RN or LVN) was illegible. The pre-transfusion vital sign time, 15 min after start and 1 hour after start times were marked over, leaving the times illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
L.) 9/11/16 at 2017 (8:17PM) the blood was picked up from the lab on 9/11/16 at 2017 (8:17PM). The blood was not started until 2040 (8:40PM), 19 minutes after it was received from the lab. According to the policy and procedure the blood administration was started 8 minutes late. The 1st verifier discipline was illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
M.) 9/12/16 at 2324 (11:24PM): discipline of the person accepting the blood from the lab and 2nd verifier discipline (RN or LVN) was illegible. The pre-transfusion vital sign time was marked over leaving the time illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
N.) 9/12/16 0842 (8:42AM): the nurse failed to have two signatures for verification of blood before transfusion. Only the second verifier was on the form. Administering blood products and failing to have two nurses verify the patient's name, medical record number, arm band, DOB, blood type, donor's number, and expiration dates and times could cause serious injury and possible death. The blood was received from the lab at 8:42 AM and not started till 9:00AM. The blood administration was 3 minutes late.
O.) 9/12/16 at 0316 (3:16AM): the 2nd verifier signature and discipline was illegible. There was no blood pressure documented on the pre transfusion section. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
P.) 9/13/16 at 0043 (12:43AM): The date the blood was picked up from the lab was marked over another date. The nurse failed to strike through the error, initial, and write the correct date. The 2nd verifier's signature and discipline was illegible. The nurse failed to initial, date, and time the "Transfusion Stopped:" section.
Review of the policy and procedure " Changes to the Legal Health Record" stated, "Paper records- draw a single line through the error, initial date and time the entry."
Q). 9/19/16 at 1325 (1:25PM): the nurse failed to have two signatures for verification of blood before transfusion. Only the second verifier was on the form. Administering blood products and failing to have two nurses verify the patient's name, medical record number, arm band, DOB, blood type, donor's number, and expiration dates and times could cause serious injury and possible death. The blood was received from the lab at 8:42 AM and not started till 9:00AM. The blood administration was 3 minutes late.

Review of the policy and procedure "Blood Component Transfusions" stated, "Policy #5 All blood and blood products must be checked at patient's bedside by two nurses (one of which is an RN), CPP, or physician, also known as the transfusionist) before transfusing. Together they must check the patient's name, date of birth, hospital account number and/or medical record number, blood unit number, blood type, blood expiration date, individual key transfusion/BBID number, physician's original order, and patients arm band.
#6 Administration of blood or blood components should be initiated within 15 minutes after obtaining blood from the laboratory.
#8 Blood transfusions must be completed within 4 hours after it has been issued from the Blood Bank.
Procedure:
C. Check blood/blood component with a registered nurse at the bedside immediately prior to initiating the transfusion. Together they must check the patient's name, date of birth, medical record number, blood unit number, blood type, blood expiration date, key transfusion/BBID number on blood arm band, blood bad tag, and physician's original order. The blood bag tag attached to the unit with the patient's information, patient's blood type, compatibility results, and key transfusion/BBID number must remain attached to the unit and never removed outside of the blood bank. Both nurses must sign the transfusion form.
D. record vital signs and document on these on the transfusion requisition.
K. Stay with patient and monitor for signs of reaction for the first 15-30 minutes.
L. Monitor vital signs once the transfusing has begun, vital signs must be taken 15 minutes from the start time and recorded on the transfusion form in appropriate area.
P. Vital signs must be recorded in the post vital signs area of the transfusion requisition form taken 30 minutes to 1 hour post transfusion of the blood product.
T. Complete the data requested on the transfusion record and lab requisition."

Based on observation, review of records and interview, the facility failed to:

A. ensure that Memorandum of Transfer forms were completed in their entirety on patients transferring from the hospital in 16 (Patient #'s 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) out of 17 (Patient #'s 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) patient transfers.

See Tag A0438

B. ensure outpatient records in 1 outpatient clinic (Sleep Lab) out of 4 (Sleep Lab, Wound Care, Surgery Center, Imaging) were stored in a secure manner that protected the records from fire or water damage and prevented access to records by unauthorized individuals.

See Tag A0441

C. ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for changes to the legal health record.

See Tag A0450

D. ensure the surgeon dated and timed the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies on history and physical updates and the medical record content.

See Tag A0461

E. ensure the surgeon and anesthesia provider signed, dated, and timed the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

See Tag A0466

F. ensure the surgeon dated and timed the Surgical Progress Note form on 2 (#11 and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Content of the Medical Record.

See Tag A0467

Based on review of record and interview, the hospital failed to ensure that Memorandum of Transfer forms were completed in their entirety on patients transferring from the hospital in 16 (Patient #'s 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) out of 17 (Patient #'s 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, and 54) patient transfers.

Review of the Memorandum of Transfer showed that multiple entries were left blank by staff in all but one form.

Review of policy titled Patient Transfer from Woodland Height Medical Center to Another Facility was completed. The policy stated,

"11. Transfer forms

a. A Woodland Height Medical Center memorandum of transfer must be completed for each patient transfer.

b. Section A of the memorandum of transfer are completed at Woodland Heights Medical Center. All blanks should be completed in Section A prior to transfer.

c. The house supervisor will sign, as the administration representative of Woodland Heights Medical Center if administrator or his designated call person is unavailable."

Staff #7 was interviewed in the conference room on 9-20-2016. Staff #7 confirmed that the House Supervisor does sign for the administrator, but is not responsible for ensuring the form is completed in its entirety. Staff #7 stated it had been a house supervisor responsibility at one time, but no longer was. Staff #7 stated it was the individual filling out the form to ensure it was completed.

Staff # 3 was interviewed in the conference room on 9-21-2016. Staff #3 confirmed that there were two sections to the Memorandum of Transfer. The first section was the responsibility of the transferring hospital to complete. The second section, "Acknowledgement of Memorandum of Transfer To be Completed by Receiving Hospital" (sic) was to be completed by the receiving hospital upon arrival of the patient to their facility. Staff #3 stated the forms were not reviewed through the quality program for completion.

Based on observation and interview, the hospital failed to ensure outpatient records in 1 outpatient clinic (Sleep Lab) out of 4 (Sleep Lab, Wound Care, Surgery Center, Imaging) were stored in a secure manner that protected the records from fire or water damage and prevented access to records by unauthorized individuals.

On 9-21-2016 a tour of the outpatient Wound Clinic and Sleep Lab was conducted with Staff #56 and Staff #57. During a tour of the Sleep Lab attic it was found that the door to the second floor of the building was locked. The second floor contained office space that had been converted to storage. Plant operations/maintenance personnel had access and stored items on the second floor. Also found on the second floor were approximately 20 to 30 cardboard boxes. The cardboard boxes were stacked in two rooms, under fire sprinklers.

Staff #57 stated the cardboard boxes contained sleep study records on patients since 1994. Staff #57 stated that the hospital had a policy of only keeping records for five years and that sometimes patients needed older records.

Interview with Staff #53 was conducted on the morning of 9-22-2016 in the conference room. Staff #53 confirmed the records were not being stored in accordance with hospital policy. Staff #53 advised that the boxes had been removed from the Sleep Lab and the records were being properly disposed of since they were copies of records that had already been filed.

Review of Woodland Heights Medical Center Policy Title: Location and Security of Medical Records Policy revealed the following on page 2, Practice or Other Setting:

"Areas housing health information shall be restricted to authorized personnel only and these areas will be secured at all times."

On page 3 of the policy after the first bullet:

"Record storage -- regardless of whether in the practice, other setting or leased space, or through a record storage company -- will be in accordance with state fire safety standards. Smoke and fire alarm systems should be in place to limit smoke and fire damage to records. The environment should ensure climate control such that the paper records are not damaged by high humidity or water."

Based on record review and interview, the facility failed to ensure that medical record entries that were documented by the nursing staff were legible and if changes were made to the legal health record, the changes were made according to the facility policy. A review of legal records revealed 8 of 8 records were illegible or corrections were not made to the record per the facility policy. Also, the facility's policy was not followed for changes to the legal health record.


A review of water treatment log for the months of April through August of 2016 revealed numerous mark overs of dates, times, results of total chlorine test performed, drain lines secured, and time RO system was turned off.


A review of Machine/Infection log for the months of April through August of 2016 revealed numerous mark overs of dates, Hepatitis antigen results, and results of residual peracetic acid, residual bleach check, and time machine disinfected.


A review of Patient #1's record revealed 9 write overs and one of the sentences documented in the legal record was completely obliterated by a solid black line. There was no way to know what was to be documented in the legal record. The write overs consisted of vital signs, lot numbers of dialyzers and tubing, dialysis machine rates, and condition of the patient during intradialytic monitoring of the patient.

A review of Patient #2's record revealed 3 write overs and one the time was highlighted in yellow. Staff #8 was asked why the time was highlighted in yellow. Staff #8 stated, "I have no idea, unless it was to remind him to document his time."

A review of the policy titled, "Changes to the Legal Health Record" revealed the following:

"PURPOSE: The purpose of the health record is to provide a basis for planning patient care and for the continuity of such care. Each record should provide documentary evidence of the patient's medical evaluation, treatment, and change in condition as appropriate. The purpose of this policy is to provide guidance on the instances in which a correction, amendment, addendum, deletion or retraction of information is necessary to support the integrity of the health record.

II. DEFINITIONS:
A. Correction - a change to the information meant to clarify inaccuracies after the original document has been signed or rendered complete.
B. Amendment - a document or entry meant to clarify health information within the legal health record. An amendment is made after the original documentation has been completed and signed by the provider.
C. Addendum - a new document or entry used to add information to an original entry.
An addendum is made after the original documentation has been completed and signed by the provider.
D. Deletion - eliminating information from previously signed and closed documentation without substituting new information.
E. Retraction - correcting information that was incorrect, invalid or made in error by preventing display or hiding the entry or documentation from future general view.
F. Late Entry - documentation that is entered after the point of care.

III. POLICY: Providers documenting on paper and within the EHR must avoid indiscriminate use of correction, amendment, addendum, deletion, and retraction functionality as a means of documentation. All attempts to correctly identify patients and their medical conditions should be made prior to documenting within the record.

IV PROCEDURE: Note - please consult applicable state law for further guidance
A. Correction -
a. Electronic records- depending on the system certain administrative members may have access to "unlock" the signed document for the provider to make the correction. If this functionality is not available, an amendment or addendum will need to be utilized.
b. Paper records- draw a single line through the error, initial date and time the entry..."

An interview with Staff #8 on 09/19/2016 at 3:00 PM confirmed the above findings of changes to the legal record and not following the facility policy.

Based on record review and interview, the surgeon failed to date and time the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies on history and physical updates and the medical record content.

A review of Patient #11's record revealed the History and Physical Update form was not dated or timed by the surgeon.

A review of Patient #12's record revealed the History and Physical Update form was not dated or timed by the surgeon.

A review of Patient #13's record revealed the History and Physical Update form was not dated or timed by the surgeon.

There was no way to determine if the history and physical update form was completed prior to surgery without a date and time.


A review of the facility's policy titled, "History and Physical Content Management" revealed the following:

"PURPOSE: To outline the required content and process for completing the history and physical for patients treated at the .

II. POLICY:
1. A medical history and physical examination (H&P) must be completed and documented within 24 hours following admission to prior to surgery, whichever comes first.
2. An H&P performed prior to admission (within 30 days of admission) may be accepted, but must be accompanied by durable, legible practitioner documentation indicating the H&P was reviewed, the patient examined and noting changes or the lack of changes in the patient's condition. An update to the H&P must be completed and documented within 24 hours after admission or prior to surgery/procedure when utilizing such an H&P.
3. The H&P must be performed and authenticated by a practitioner who is authorized to do so by the Medical Staff.
4. The medical history and physical examination must be completed and documented by a physician, surgeon, or other qualified licensed individual in accordance with state law and facility policy.
More than one qualified practitioner can participate in performing, documenting and authenticating an H&P for a single patient.
When performance, documentation and authentication are split among qualified practitioners, the practitioner who authenticates the H&P is responsible for the content."

A review of the facility's policy titled, "Content of the Medical Record" revealed the following:


"PURPOSE:
To define the contents of patient medical record, whether in paper or electronic format, in such a way that it facilitates communication, coordination and continuity of care and promotes efficiency and effectiveness of treatment.

DEFINITIONS:
A. Medical Record- The collection of information concerning a patient and his or her health care that is created and maintained in the regular course of business made by a person who has knowledge of the acts, events or diagnoses relating to the patient.
The medical record may include records maintained in an electronic health record system, e.g. an electronic system framework that integrates data from multiple sources, captures data at the point of care.
B. EMR/EHR- Electronic Medical/Health Record
C. Authentication- To establish authorship by written or electronic signature
D. Physician/Practitioner- For the purpose of the policy, physician/practitioner includes physicians, dentists, podiatrists, advanced practice nurses, physician assistants, and other credentialed practitioners who give orders.

III. PROCEDURE:
A. All medical record entries, including handwritten and electronic, must be legible, complete, true and accurate, dated, timed and authenticated by the person responsible for providing or evaluating the services provided, consistent with hospital policies."

An interview with Staff #22 on 09/20/2016 at 2:00 PM confirmed the above findings.

Based on record review and interview, the surgeon and anesthesia provider failed to sign, date, and time the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

A review of Patient #11's record revealed the Disclosure and Consent form was not dated or timed by the surgeon.

A review of Patient #12's record revealed the Disclosure and Consent form was not dated or timed by the surgeon.

A review of Patient #13's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #14's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #15's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #16's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #31's record revealed the Disclosure and Consent form was not signed, dated, or timed by the anesthesia provider.

A review of the facility's policy titled, "Informed Consent" revealed the following:

"To insure that proper consent is obtained prior to the designated procedure. To insure that permits are accurately completed.

POLICY AND GENERAL INFORMATION:
1. All patients admitted to our hospital must have an authorization for treatment sheet on their chart signed by the proper person, dated and witnessed prior to a designated procedure.

2. Informed written consent for all procedures must be obtained prior to any invasive procedure. Physician will inform patient of risks, benefits, hazards, and alternatives, and sign consent form or document in progress notes and on history and physical. The purpose of a written consent form is to provide proof that there was a valid consent. The consent itself is not a substitute for the role of the physician in the informed consent process. A signed entry in the physician's progress notes should be made documenting that informed consent was obtained and that the patient was made aware of and understands the risks and possible complications and agrees to the planned procedure, if the informed consent is not signed by the physician."

INFORMED CONSENT FOR PATIENTS RECEIVING ANESTHESIA:

It is the policy of the facility that the patient must be given the opportunity to give an "informed consent" prior to the administration of anesthesia by an anesthesiologist and prior to the performance of operative and/or invasive procedures, diagnostic or therapeutic procedures, or situations when it is deemed advisable to have formal documentation of the patient's consent for treatment. Written verification of the informed consent must be on the patient's chart prior to initiation of anesthesia or any of the above stated procedures.

Informed written consent for all procedures must be obtained prior to any invasive procedure. Physician/staff will inform patient of risks, benefits, hazards, and alternatives, and sign consent form or document in progress notes and on history and physical. The purpose of a written consent form is to provide proof that there was a valid consent. The consent itself is not a substitute for the role of the physician in the informed consent process. A signed entry in the physician's progress notes should be made documenting that informed consent was obtained and that the patient was made aware of and understands the risks and possible complications and agrees to the planned procedure, if the informed consent is not signed by the physician.

Concept of Informed Consent must consist of:

*The risks, drawbacks, complications and expected benefits or effects of anesthesia
*Alternate choices of and to anesthesia
*The nature of the treatment
*The risks, drawbacks, complications and expected benefits or effects of such treatment
*Potential problems related to recuperation
*Any alternatives to the procedure and their risks and benefits
*The likelihood of success
*Possible result of non-treatment
*Verification that the patient understands the information
*Confirmation that the patient has been verbally informed about the anesthesia or procedure
*An opportunity for the patient to ask questions
*If any limitations in the confidentiality of patient information is discovered from or about the patient, the information will be documented in the progress notes
*Is needed for complex procedures, not for simple and common procedures (i.e., blood counts) and is needed for any procedure where anesthesia is planned.

Obtaining Informed Consent:

*It is the anesthesiologist and/or treating physician's responsibility to obtain the informed consent.
*Facility personnel cannot be involved in providing information that is necessary for informed consent-only the physician and/or anesthesiologist can provide the information.

The informed consent form is prepared by the attending physician or operating physician and is discussed with the patient by the physician:

*Supplemented with verbal discussion, and/or Supplemented through written additions that give further information relevant to the patient's condition.
*Medical information set forth needs to be written in clear, simple and easily understood terms.
*Documentation must clearly indicate that the patient has had the opportunity to ask any and all questions he/she may have about the proposed anesthesia and/or procedure."

An interview with Staff #22 on 09/20/2016 at 2:00 PM confirmed the above findings.

Based on record review and interview, the surgeon failed to date and time the Surgical Progress Note form on 2 (#11 and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Content of the Medical Record.

A review of Patient #11's record revealed the Progress Note form was not dated or timed by the surgeon.


A review of Patient #13's record revealed the Progress Note form was not dated or timed by the surgeon.

A review of the facility's policy titled, "Content of the Medical Record" revealed the following:


"PURPOSE:
To define the contents of patient medical record, whether in paper or electronic format, in such a way that it facilitates communication, coordination and continuity of care and promotes efficiency and effectiveness of treatment.

DEFINITIONS:
A. Medical Record- The collection of information concerning a patient and his or her health care that is created and maintained in the regular course of business made by a person who has knowledge of the acts, events or diagnoses relating to the patient.
The medical record may include records maintained in an electronic health record system, e.g. an electronic system framework that integrates data from multiple sources, captures data at the point of care.
B. EMR/EHR- Electronic Medical/Health Record
C. Authentication- To establish authorship by written or electronic signature
D. Physician/Practitioner- For the purpose of the policy, physician/practitioner includes physicians, dentists, podiatrists, advanced practice nurses, physician assistants, and other credentialed practitioners who give orders.

III. PROCEDURE:
A. All medical record entries, including handwritten and electronic, must be legible, complete, true and accurate, dated, timed and authenticated by the person responsible for providing or evaluating the services provided, consistent with hospital policies."

An interview with Staff #22 on 09/20/2016 at 2:00 PM confirmed the above findings.

Based on review the facility failed to;

A.) provide a sanitary environment in the dietary department (food storage and reparation areas). Potential for cross-contamination due to unsanitary food handling, unsanitary cooking implement storage, unsanitary food service items (pots, pans, bowls, and plates) storage, and poor general sanitation practices was found throughout the dietary department.

Failure to provide a sanitary environment may lead to food borne illnesses and possible death. These deficient practices placed all patients at risk for likelihood of harm, injury, or subsequent death.


A tour of the hospital was conducted with staff #26 and #45 on 9/19/16. The following infection control findings were found;

A. Dietary Department:

1.) Dining Room
The cabinet under the vending machine had shipping boxes mixed in with food supplies.

The shelves were soiled with dust.

The sheet rock walls, around the exit door, had holes and deep scratches that exposed the sheet rock. The wall is unable to be cleaned properly with sheet rock exposed.

2 large wooden trash can holders were found heavily soiled with veneer missing from the bottom exposing particle board.

The cloth seats on the dining room chairs were visibly soiled.

A stainless serving cart, with doors underneath for storage, was found to be soiled with food particles, dust, a greasy build up on the top, sides, and within the tracks of the sliding doors.

A stainless serving cart had a canister of pine nuts sitting on top of the cart. The canister had a very small amount of nuts in it and was soiled on the inside and greasy. The lid of the canister was rusted and greasy.

A stainless serving cart had a canister labeled "croutons" sitting on top of the cart. The canister had crouton residue in it and was soiled on the inside and greasy. The outside of the canister of the canister was rusted and greasy.

A floor mat was found under the cash register. The floor mat was heavily soiled with a combination of dirt, dust, grease, and hair. Next to the mat, under the register, was an open red bucket of liquid cleaning fluid. The cash register and surrounding area was soiled with dust. The cash register drawer was broken.

The large double coffee maker and surrounding area was found to be soiled with caked on food particles, grease, spilled liquids, and dust. Roach traps were found on the drink serving line next to the double coffee maker.

The ice tea containers were soiled on top with a light greasy substance and dust.
A small table top refrigerator was sitting on the dining room serving line. The refrigerator was mildewed around the top and had a heavily soiled filter. The filter was covered in a heavy dust and hair.

The serving line by the drinks was heavily soiled with a greasy substance.

2.) The Serving Line

The outside of the food service line was heavily soiled in grease and spilled liquids. Dirt and hair was found along the base of the line and floor.
The protective glass and counter of the serving line was heavily soiled with grease, dust, and hair.

A soiled cart was holding paper plates and take out boxes. The paper plates were sitting face up and were not covered. The top plate had food particles on it and felt greasy. The cart was soiled with dried food and liquids.

A warming lamp was found on the serving line with paint missing and heavily soiled with a greasy substance and dust.

The service line grill was soiled with grease and dried food particles. The grill had not been used yet for the day.

In the refrigerator 4 packages of meat and 3 packages of cheese were found open with no date, or expired dates.

On the floor of the service line a heavy duty fan was found blowing on the service line where food was served. The fan was dusty with hair on the blades and casing.

On the backside of the grill two loaves of bread were found tied with holes on the top. Both loaves were found turned upside down on the table. The bread was exposed to the surface of the table that was soiled with greasy substances and dust.

A warming oven was found behind the serving line. The oven had a tray of rolls and biscuits, mashed potatoes, mixed vegetables, and cooked meat in the warmer at 10:30AM. The food was not labeled with a date or time. The cook was asked when the temperatures were taken on the food after cooking. Staff # 55 stated she forgot to take the temps. The inside of the warmer was heavily coated in old grease, spilled on liquids, food particles, and a heavy carbon build up.

The service line refrigerator had a tray of opened chicken sitting in a pan uncovered, in liquid, with no date of when it was put in the refrigerator.

Under the service line was 2 buckets of liquid cleaning solution around open food.

Underneath the serving line and grill floor was heavily soiled with dirt, dust, hair, and food particles.

The door and door frame, entering the main kitchen, was heavily soiled with dust, dirt and grease.

3.) Main Kitchen
Next to the warming oven in the kitchen was a short rolling cart with a rotten piece of plywood on top. The wood was soiled with heavy dust. CO2 canisters for the soda machine were sitting on top of the wood. The canisters were not properly secured. The canisters, cart, and untreated plywood were heavily soiled with grease, dirt and hair.

A large open vat of food was found cooking uncovered and unattended. The spoon used to stir the vat of food was sitting on the side on a greasy and dirty surface.

The floors in the kitchen had cracked tiles, missing grout, mildew, greasy, broken concrete, and was heavily soiled with old food particles and dried liquids. The large drains in the floor were mildewed and growing long strands of mold hanging from the drain plate. A black substance was found all around the floor drain under the open vat of food.

The soda connections are located in the kitchen area. The lines and mechanical valves to the dispenser were coated in a heavy greasy substance and dust. The lines were approximately 3 ft across from the fryer.

The food preparation area and sink were found covered in dried foods and liquids. The back splash was dirty with grease and caked on food. Food was found sitting in colanders uncovered next to a running sink.

The food preparation area was found to be dusty on the sides and up on the back splash. A shelf over the food service area had plastic containers holding spices. The containers were heavily soiled with dust, dried food and liquids.

A food scale was found sitting on a metal table. The top of the scale was dusty and the front of the scale had dried food smeared on it..

A metal table with a shelf, was found to have 43 pans, cleaned and ready for use. The pans were found sitting on a heavily soiled shelf. The pans were soiled with food particles, carbon build up, dust, and 15 pans were found to be wet. Next to the table of pans was a heavily soiled trash can that was touching the table and cooking pans. A used tooth pick was found on the lower shelf holding the pans.

The oven was found to be heavily soiled with dried on food particles and liquids. The inside of the oven and racks had a heavy caked on carbon. Empty cookie sheets were found on the inside heavily covered in carbon.

An uncovered pan of baked chicken was found sitting on the sink prep area. Cleaning liquids were sitting in open buckets under the uncovered food. The preparation area was heavily soiled with a buildup of old food spillage.

A small metal rolling cart was found holding open buckets of cleaning solutions while food was out. The cart was rusted and heavily soiled in dust and calcium build up.

A metal preparation table had food sitting on it getting ready for lunch service. On top of the table was paper plates and food containers sitting next to a newspaper on top of the work area. On the shelf below was a toaster that was soiled in crumbs and greasy substance on all sides. Next to the toaster was two open buckets with cleaning liquids inside. Behind the buckets were employee car keys, sunglasses and magazines.

The food preparation table had pans of food covered sitting on the table.A trash can was located beside the table and the trash can was soiled with dried on food, liquids, and other stains. The Dietary Supervisor confirmed the trash cans are taken from the kitchen, down the hall, to the loading dock, rolled outside, and brought back into the clean area of the kitchen without cleaning.

Under a preparation table a metal cheese grater was found. The Dietary Director confirmed it was clean and ready for use. The legs of the grater were soiled with dried on yellow food substance. The grates were soiled with dried cheese.

The scoop to the ice machine and scoop holder were soiled with a slimy mildew substance. Mildew was found on the inside of the ice machine. There was no schedule for cleaning the ice machine. The ice machine was visibly soiled on the sides with dried spillage. The wall and floor beside the ice machine was visibly soiled.

A large purple spot was found on the floor by the ice machine. The kitchen manager claimed purple mark on the floor was a stain. Purple matter lifted easily with white cloth.

The ice tea makers in the kitchen had two pictures sitting under the dispenser. The cups were heavily stained and the drain had mold, mildew, and rust in it.
A metal cart was found holding drinking glasses. The cart was soiled with dirt, dust and hair.

The industrial can opener was found on the end of a food preparation table. The can opener was heavily soiled in dried on liquids, food, and grease.

The kitchen food supply room was stacked from the floor to the ceiling with shipping boxes. The floors were soiled with dirt and dust. The shelves and boxes were dusty. The walls had spilled dried liquids and food on them. The corners of the floor and walls had spilled food that had molded. The containers holding the food was dirty with food particles and dust. There was roach dropping in one of the containers. The air conditioner vents were molded and mildewed. The metal storage shelves were rusted and heavily soiled with dried liquids, dust and dirt. The supplies not in shipping boxes had no dates. Cereal packages stored in clear plastic bins on top shelf had spilled in bottom of plastic bins. Food products were stored without received date.

The metal cart that holds the large food cans was heavily soiled with grease, dust, hair, and food particles. The cans were labeled without expiration dates.

The walk -in refrigerator door was broken and the gasket on the door was missing in places and torn. Three pans of meat were found with no dates. The red meat was dripping into the chicken pan.

Over ripe cantaloupe and limes were found. A clear container hanging half off the shelf was full of red apples. The apples were rotten on the bottom. The apples had been sitting in water. The apples were under the leaking condenser of the refrigerator that was dripping on the apples.

The inside of the walk-in refrigerator had shipping boxes sitting next to open food. The ceiling of the unit was rusted and mildewed.

70 parfait cups of desserts were sitting on trays in the refrigerator with no dates. The service director was unable to say when the desserts were made. Hot dog buns were found opened up on cookie sheets covered in plastic with no dates. The buns were hard.

In the walk-in freezer ice buildup was found on the floor. The overhead sprinkler had icicles overhead. The floor was covered in dirt and debris. The freezer wall and shelf casters were rusted. The shelf wheels were dirty. Cardboard shipping boxes were stored in the freezer. Freezer fans had dust and frost buildup. Ice buildup was found on ceiling of freezer. The Freezer fan had frost and dust buildup. There was frozen dust collection on ceiling of freezer. The threshold between freezer and refrigerator was visibly soiled. There was icicles hanging from the freezer sprinkler. Shelving was visibly soiled and the bottom shelf was open, without splash guard. Unknown food was found prepared and frozen without label or dates. Boxes stacked to ceiling next to sprinkler head.

A plate warmer was found to have plastic wrap hanging from inside of warmer, over outside edge, and visibly soiled on outside. Plate warmer visibly soiled around lid hinges.

A metal rack was found sitting in the kitchen next to the three sink dish washing area. The metal shelf had plastic pans and lids stacked on the lower shelf with no barrier between the pans and the floor.

An older white upright freezer was found full of shipping boxes, frozen plates, and expired food. A roll of banana bread dough had expired in April of 2016 and 4 packages of unidentifiable meat was found wrapped in cellophane with no date. The outside of the freezer was rusted and soiled with dried spilled liquid. The inside of the freezer was soiled with dust and hair.

The dishwasher was broken and spraying rusted water onto floor and surrounding area. Clean dish storage was found across walkway from dishwashing machine. Clean dishes were found coated with dried rusted water spray.

A hand washing station was next to clean dish storage. Water splashed from the sink onto the clean dishes.

The kitchen dietary manager, chef, and worker were unable to show where the dirty area of the kitchen begins and ends. Carts and trash cans were taken through hospital and then into clean kitchen.

Revisit to the kitchen on 9/22/16 revealed:

12 pans were put on the clean shelf wet. The pans still had food debris, carbon build up, and greasy feeling on them.

Open buckets of cleaning solution were still sitting under the food preparation area. There was food on the preparation table.

4 baking sheets of frozen biscuits were found stacked on top of each other in the small freezer, uncovered.

A white stand up refrigerator was found holding dairy products. The inside of the refrigerator door was rusted missing paint and soiled on the door with spilled dried liquids. Expired milk cartons were found in the refrigerator.

The floors were dirty and soiled with mildewed grout. The oven had been cleaned on the doors but continued to have a heavy carbon build up on the grates and carbon covered pans were still inside.

The rack sitting next to the three sink area had clean dishes on it. The rack was soiled with a greasy substance, dust, hair, and food debris. The lower rack had pans stacked on it with no barrier from the rack to the floor. The floor underneath was soiled with dust and dried food particles.

The floor next to the freezer was soiled with dust and dried unidentifiable substances.
A trash can was found in front of the walk in refrigerator touching a cart holding food prepared for patient consumption.

Under the dishwasher, 5 patient trays were found broken.

A small metal rolling cart was found holding open buckets of cleaning solutions while food was out. The cart was rusted and heavily soiled in dust and calcium build up.
A cart was wheeled into the kitchen area from hallway and was going into the clean kitchen. The cart had been through hospital hallways. There was no identifiable clean and dirty area of the kitchen.

Observation of staff revealed workers were wearing gloves. The staff were handling food, touching doors, going into storage areas, touching door knobs, and lifting trash can lids without washing their hands and changing gloves.

An interview with staff # 45, 55, and 26 was conducted on 9/19/16. Staff #45 confirmed the kitchen did not have clear boundaries for clean and dirty areas. Staff #45 confirmed all of the above findings. Staff #45 reported that all the food temperatures should be performed after the food is prepared to ensure the food is safe to serve. Staff #55 confirmed the food prepared for lunch was not checked. Staff #26 confirmed the above findings and stated she had not been through the kitchen when infection control rounds were done.

These deficient practices were determined to pose an Immediate Jeopardy to the health and safety of patients that had the likelihood to cause harm, serious injury, impairment and/or subsequent death.





B.) Based on review and interview the facility failed to ensure that policy and procedures were written and accepted by the Governing Body (GB) for dietary services.

Refer to Tag A0619

C.) Based on review and interview the facility failed to ensure the off-site vendor had provided the Director of Dietary Services with the necessary education, experience, and training to manage the service, appropriate to the scope and complexity of food service operations.

Refer to Tag A0620

D.) Based on review of employee files the facility failed to ensure the dietary staff received adequate training and were competent in their respective duties in 8 (#60-67) of 8 files reviewed.

Refer to Tag A0622

E.) Based on review and interviews the facility failed to have a current therapeutic diet manual approved by the dietitian and medical staff.

Refer to Tag A0631

Based on review and interview the facility failed to ensure that policy and procedures were written and accepted by the Governing Body (GB) for dietary services.
Review of the "Master Service Agreement for Food and Nutritional Services " contract revealed an off-site vendor would be managing the kitchen within the facility. The contract revealed the vendor would be managing the Dietary Manager and kitchen personnel. The contract was signed on 8/14/15.
An interview with staff #46 and #3 on 9/19/16 at 10:30 revealed the vendor had their own policy and procedures to follow in the kitchen. Review of the Governing Board (GB) minutes did not reveal the vendors policy and procedures were accepted and adopted by the facility. Staff #3 confirmed the policy and procedures had never been adopted through the GB.

Based on record review and interview the facility failed to ensure the off-site vendor had provided the Director of Dietary Services with the necessary education, experience, and training to manage the service appropriate to the scope and complexity of food service operations.
Review of staff # 46's employee file revealed he was a fulltime employee and Director of Dietary Services for the off-site vendor's contracted service. Staff # 46 had a job description in his employee file to "Direct Food and Nutrition Services." Staff #46 signed the job description on 8/5/15 but there was no supervisor signature.
Review of staff #46's employee file revealed he did not have a resume or application to verify education or experience. There was a "ServSafe Certification" certificate for food handling in the employee file but the design of the certificate covers the date issued.

Based on record review and interview, the facility failed to ensure the dietary staff received adequate training and were competent in their respective duties in 8 (#60-67) of 8 files reviewed. The facility also failed to ensure the dietary director was competent and had received adequate training in the assigned duties.

Review of staff #46's (Dietary Directors) file revealed he did not have an application or resume to ensure his training and education in managing a kitchen and dietary needs of the patients. Staff #46's job description was signed by staff #46 on 8/5/15 but was never signed by the supervisor for approval.


Review of the employee files (#60- 67) revealed there was no information in the files that the employees had been educated on the policy and procedures or infection control.


Review of the kitchen staff revealed 3 (#60, 61, and 64) out of the 8(#60- 67) files did not have education on hand hygiene.


Staff #3 confirmed the policy and procedures had not been approved through medical
staff or governing body.

Based on record review and interviews the facility failed to have a current therapeutic diet manual approved by the dietitian and medical staff.

Review of the diet manual revealed no evidence that it was approved by the dietician and medical staff.

An interview with staff #31 on 9/20/16 revealed the the dietician had not signed the therapeutic diet manual. Staff #3 reported that they were very involved in the dietary service before the contracted vendor took over in august of 2015. Staff #31 reported that the dieticians were asked to review the menu's sent from the vendors corporate office but never requested they sign off on them. Staff #31 reported the dieticians have been watching the food as it came off the carts on the floors but have not been asked to help out from the kitchen perspective.

Review of medical staff meeting minutes revealed no evidence the manual had been approved.

Interview with staff #3 on 9/21/16 confirmed the dietary vendor therapeutic diet manual and the policy and procedures had not been approved by t medical staff or governing body.

Based on observation and interview, nitrogen bottles, plant grounds, and air bottles were not maintained in manner that assured patient safety.

During a tour of the maintenance plant grounds with staff #36 on 9/21/16 the following safety issues were found:

1.) 10 large Nitrogen bottles were found unsecured inside the gated area for bottled gas storage.

2.) The plant grounds were littered with plastic tops to canisters, leaves, and debris. Trees and bushes were found growing inside the gated plant next to the Liquid Nitrogen tank.



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3.) During a tour of the Wound Clinic and Hyperbaric Chamber (a high pressure chamber, similar to dive conditions, used to increase the oxygen in the blood stream and promote wound healing) in the Wound Clinic, 3 large cylinders that contained air were observed. Each tank contained 2200 pounds per square inch (PSI) of air in them. These are used with the Hyperbaric Chamber beds for wound care treatment. All three cylinders had rust and corrosion on the bottoms of the tank, compromising the integrity of the tank at high pressures.

Staff #57 stated that this is how the cylinders were received and accepted from the supplier.

Based upon observation, record review, and interview, the facility failed to:

A. provide a sanitary environment in the dietary department (food storage and reparation areas). Potential for cross-contamination due to unsanitary food handling, unsanitary cooking implement storage, unsanitary food service items (pots, pans, bowls, and plates) storage, and poor general sanitation practices was found throughout the dietary department.

Failure to provide a sanitary environment may lead to food borne illnesses and possible death. These deficient practices placed all patients at risk for likelihood of harm, injury, or subsequent death.


B. provide a sanitary environment for the care of patients, including the food preparation areas. The facility failed in its efforts at infection control in 6 of 6 departments and/or services (Nursing, Laundry, Dialysis, Central Supply, Pharmacy, and Maintenance Plant Grounds).


C. ensure the Infection Control Officer had a working system for required logging and reporting communicable diseases, infections, and food borne illnesses.


D. provide a clean and sanitary environment for patients receiving dialysis.


Findings:


A. Dietary Department:

1.) Dining Room
The cabinet under the vending machine had shipping boxes mixed in with food supplies.

The shelves were soiled with dust.

The sheet rock walls, around the exit door, had holes and deep scratches that exposed the sheet rock. The wall is unable to be cleaned properly with sheet rock exposed.

2 large wooden trash can holders were found heavily soiled with veneer missing from the bottom exposing particle board.

The cloth seats on the dining room chairs were visibly soiled.

A stainless serving cart, with doors underneath for storage, was found to be soiled with food particles, dust, a greasy build up on the top, sides, and within the tracks of the sliding doors.

A stainless serving cart had a canister of pine nuts sitting on top of the cart. The canister had a very small amount of nuts in it and was soiled on the inside and greasy. The lid of the canister was rusted and greasy.

A stainless serving cart had a canister labeled "croutons" sitting on top of the cart. The canister had crouton residue in it and was soiled on the inside and greasy. The outside of the canister of the canister was rusted and greasy.

A floor mat was found under the cash register. The floor mat was heavily soiled with a combination of dirt, dust, grease, and hair. Next to the mat, under the register, was an open red bucket of liquid cleaning fluid. The cash register and surrounding area was soiled with dust. The cash register drawer was broken.

The large double coffee maker and surrounding area was found to be soiled with caked on food particles, grease, spilled liquids, and dust. Roach traps were found on the drink serving line next to the double coffee maker.

The ice tea containers were soiled on top with a light greasy substance and dust.
A small table top refrigerator was sitting on the dining room serving line. The refrigerator was mildewed around the top and had a heavily soiled filter. The filter was covered in a heavy dust and hair.

The serving line by the drinks was heavily soiled with a greasy substance.

2.) The Serving Line

The outside of the food service line was heavily soiled in grease and spilled liquids. Dirt and hair was found along the base of the line and floor.
The protective glass and counter of the serving line was heavily soiled with grease, dust, and hair.

A soiled cart was holding paper plates and take out boxes. The paper plates were sitting face up and were not covered. The top plate had food particles on it and felt greasy. The cart was soiled with dried food and liquids.

A warming lamp was found on the serving line with paint missing and heavily soiled with a greasy substance and dust.

The service line grill was soiled with grease and dried food particles. The grill had not been used yet for the day.

In the refrigerator 4 packages of meat and 3 packages of cheese were found open with no date, or expired dates.

On the floor of the service line a heavy duty fan was found blowing on the service line where food was served. The fan was dusty with hair on the blades and casing.

On the backside of the grill two loaves of bread were found tied with holes on the top. Both loaves were found turned upside down on the table. The bread was exposed to the surface of the table that was soiled with greasy substances and dust.

A warming oven was found behind the serving line. The oven had a tray of rolls and biscuits, mashed potatoes, mixed vegetables, and cooked meat in the warmer at 10:30AM. The food was not labeled with a date or time. The cook was asked when the temperatures were taken on the food after cooking. Staff # 55 stated she forgot to take the temps. The inside of the warmer was heavily coated in old grease, spilled on liquids, food particles, and a heavy carbon build up.

The service line refrigerator had a tray of opened chicken sitting in a pan uncovered, in liquid, with no date of when it was put in the refrigerator.

Under the service line was 2 buckets of liquid cleaning solution around open food.

Underneath the serving line and grill floor was heavily soiled with dirt, dust, hair, and food particles.

The door and door frame, entering the main kitchen, was heavily soiled with dust, dirt and grease.

3.) Main Kitchen
Next to the warming oven in the kitchen was a short rolling cart with a rotten piece of plywood on top. The wood was soiled with heavy dust. CO2 canisters for the soda machine were sitting on top of the wood. The canisters were not properly secured. The canisters, cart, and untreated plywood were heavily soiled with grease, dirt and hair.

A large open vat of food was found cooking uncovered and unattended. The spoon used to stir the vat of food was sitting on the side on a greasy and dirty surface.

The floors in the kitchen had cracked tiles, missing grout, mildew, greasy, broken concrete, and was heavily soiled with old food particles and dried liquids. The large drains in the floor were mildewed and growing long strands of mold hanging from the drain plate. A black substance was found all around the floor drain under the open vat of food.

The soda connections are located in the kitchen area. The lines and mechanical valves to the dispenser were coated in a heavy greasy substance and dust. The lines were approximately 3 ft across from the fryer.

The food preparation area and sink were found covered in dried foods and liquids. The back splash was dirty with grease and caked on food. Food was found sitting in colanders uncovered next to a running sink.

The food preparation area was found to be dusty on the sides and up on the back splash. A shelf over the food service area had plastic containers holding spices. The containers were heavily soiled with dust, dried food and liquids.

A food scale was found sitting on a metal table. The top of the scale was dusty and the front of the scale had dried food smeared on it..

A metal table with a shelf, was found to have 43 pans, cleaned and ready for use. The pans were found sitting on a heavily soiled shelf. The pans were soiled with food particles, carbon build up, dust, and 15 pans were found to be wet. Next to the table of pans was a heavily soiled trash can that was touching the table and cooking pans. A used tooth pick was found on the lower shelf holding the pans.

The oven was found to be heavily soiled with dried on food particles and liquids. The inside of the oven and racks had a heavy caked on carbon. Empty cookie sheets were found on the inside heavily covered in carbon.

An uncovered pan of baked chicken was found sitting on the sink prep area. Cleaning liquids were sitting in open buckets under the uncovered food. The preparation area was heavily soiled with a buildup of old food spillage.

A small metal rolling cart was found holding open buckets of cleaning solutions while food was out. The cart was rusted and heavily soiled in dust and calcium build up.

A metal preparation table had food sitting on it getting ready for lunch service. On top of the table was paper plates and food containers sitting next to a newspaper on top of the work area. On the shelf below was a toaster that was soiled in crumbs and greasy substance on all sides. Next to the toaster was two open buckets with cleaning liquids inside. Behind the buckets were employee car keys, sunglasses and magazines.

The food preparation table had pans of food covered sitting on the table.A trash can was located beside the table and the trash can was soiled with dried on food, liquids, and other stains. The Dietary Supervisor confirmed the trash cans are taken from the kitchen, down the hall, to the loading dock, rolled outside, and brought back into the clean area of the kitchen without cleaning.

Under a preparation table a metal cheese grater was found. The Dietary Director confirmed it was clean and ready for use. The legs of the grater were soiled with dried on yellow food substance. The grates were soiled with dried cheese.

The scoop to the ice machine and scoop holder were soiled with a slimy mildew substance. Mildew was found on the inside of the ice machine. There was no schedule for cleaning the ice machine. The ice machine was visibly soiled on the sides with dried spillage. The wall and floor beside the ice machine was visibly soiled.

A large purple spot was found on the floor by the ice machine. The kitchen manager claimed purple mark on the floor was a stain. Purple matter lifted easily with white cloth.

The ice tea makers in the kitchen had two pictures sitting under the dispenser. The cups were heavily stained and the drain had mold, mildew, and rust in it.
A metal cart was found holding drinking glasses. The cart was soiled with dirt, dust and hair.

The industrial can opener was found on the end of a food preparation table. The can opener was heavily soiled in dried on liquids, food, and grease.

The kitchen food supply room was stacked from the floor to the ceiling with shipping boxes. The floors were soiled with dirt and dust. The shelves and boxes were dusty. The walls had spilled dried liquids and food on them. The corners of the floor and walls had spilled food that had molded. The containers holding the food was dirty with food particles and dust. There was roach dropping in one of the containers. The air conditioner vents were molded and mildewed. The metal storage shelves were rusted and heavily soiled with dried liquids, dust and dirt. The supplies not in shipping boxes had no dates. Cereal packages stored in clear plastic bins on top shelf had spilled in bottom of plastic bins. Food products were stored without received date.

The metal cart that holds the large food cans was heavily soiled with grease, dust, hair, and food particles. The cans were labeled without expiration dates.

The walk -in refrigerator door was broken and the gasket on the door was missing in places and torn. Three pans of meat were found with no dates. The red meat was dripping into the chicken pan.

Over ripe cantaloupe and limes were found. A clear container hanging half off the shelf was full of red apples. The apples were rotten on the bottom. The apples had been sitting in water. The apples were under the leaking condenser of the refrigerator that was dripping on the apples.

The inside of the walk-in refrigerator had shipping boxes sitting next to open food. The ceiling of the unit was rusted and mildewed.

70 parfait cups of desserts were sitting on trays in the refrigerator with no dates. The service director was unable to say when the desserts were made. Hot dog buns were found opened up on cookie sheets covered in plastic with no dates. The buns were hard.

In the walk-in freezer ice buildup was found on the floor. The overhead sprinkler had icicles overhead. The floor was covered in dirt and debris. The freezer wall and shelf casters were rusted. The shelf wheels were dirty. Cardboard shipping boxes were stored in the freezer. Freezer fans had dust and frost buildup. Ice buildup was found on ceiling of freezer. The Freezer fan had frost and dust buildup. There was frozen dust collection on ceiling of freezer. The threshold between freezer and refrigerator was visibly soiled. There was icicles hanging from the freezer sprinkler. Shelving was visibly soiled and the bottom shelf was open, without splash guard. Unknown food was found prepared and frozen without label or dates. Boxes stacked to ceiling next to sprinkler head.

A plate warmer was found to have plastic wrap hanging from inside of warmer, over outside edge, and visibly soiled on outside. Plate warmer visibly soiled around lid hinges.

A metal rack was found sitting in the kitchen next to the three sink dish washing area. The metal shelf had plastic pans and lids stacked on the lower shelf with no barrier between the pans and the floor.

An older white upright freezer was found full of shipping boxes, frozen plates, and expired food. A roll of banana bread dough had expired in April of 2016 and 4 packages of unidentifiable meat was found wrapped in cellophane with no date. The outside of the freezer was rusted and soiled with dried spilled liquid. The inside of the freezer was soiled with dust and hair.

The dishwasher was broken and spraying rusted water onto floor and surrounding area. Clean dish storage was found across walkway from dishwashing machine. Clean dishes were found coated with dried rusted water spray.

A hand washing station was next to clean dish storage. Water splashed from the sink onto the clean dishes.

The kitchen dietary manager, chef, and worker were unable to show where the dirty area of the kitchen begins and ends. Carts and trash cans were taken through hospital and then into clean kitchen.

Revisit to the kitchen on 9/22/16 revealed:

12 pans were put on the clean shelf wet. The pans still had food debris, carbon build up, and greasy feeling on them.

Open buckets of cleaning solution were still sitting under the food preparation area. There was food on the preparation table.

4 baking sheets of frozen biscuits were found stacked on top of each other in the small freezer, uncovered.

A white stand up refrigerator was found holding dairy products. The inside of the refrigerator door was rusted missing paint and soiled on the door with spilled dried liquids. Expired milk cartons were found in the refrigerator.

The floors were dirty and soiled with mildewed grout. The oven had been cleaned on the doors but continued to have a heavy carbon build up on the grates and carbon covered pans were still inside.

The rack sitting next to the three sink area had clean dishes on it. The rack was soiled with a greasy substance, dust, hair, and food debris. The lower rack had pans stacked on it with no barrier from the rack to the floor. The floor underneath was soiled with dust and dried food particles.

The floor next to the freezer was soiled with dust and dried unidentifiable substances.
A trash can was found in front of the walk in refrigerator touching a cart holding food prepared for patient consumption.

Under the dishwasher, 5 patient trays were found broken.

A small metal rolling cart was found holding open buckets of cleaning solutions while food was out. The cart was rusted and heavily soiled in dust and calcium build up.
A cart was wheeled into the kitchen area from hallway and was going into the clean kitchen. The cart had been through hospital hallways. There was no identifiable clean and dirty area of the kitchen.

Observation of staff revealed workers were wearing gloves. The staff were handling food, touching doors, going into storage areas, touching door knobs, and lifting trash can lids without washing their hands and changing gloves.

An interview with staff # 45, 55, and 26 was conducted on 9/19/16. Staff #45 confirmed the kitchen did not have clear boundaries for clean and dirty areas. Staff #45 confirmed all of the above findings. Staff #45 reported that all the food temperatures should be performed after the food is prepared to ensure the food is safe to serve. Staff #55 confirmed the food prepared for lunch was not checked. Staff #26 confirmed the above findings and stated she had not been through the kitchen when infection control rounds were done.




B. Six of six departments and/or services (Nursing, Laundry, Dialysis, Central Supply, Pharmacy, and Maintenance Plant Grounds)

1.) Medical Surgical Floor

1a.) The Pyxis MS1 (Pyxis MedStation (Trademark) ES system is an automated medication dispensing system) was opened by the nurse manager. On the inside of the Pyxis the shelves were dusty. On the shelves were clear open containers that hold the different medications. The containers were heavily soiled with dust and hair.

1b.) Entered Isolation room 303. The isolation room was a private room that has monitored negative air pressure in relation to the surrounding area, to prevent the transmission of airborne diseases. It was considered Terminally Clean (Terminal cleaning - thorough, extensive cleaning and disinfection of an isolation room after the patient is discharged from that room.) It is important that these rooms are cleaned properly to protect the patient and staff from transmitting diseases. Upon entering the room a cloth couch was found in the room. The infection control nurse and nurse manager was asked how the cloth couch could be terminally cleaned after the patient was discharged. The infection control nurse and nurse manager reported there was no way to properly clean the couches and were not aware on how or if they would be cleaned. The couches have been in both isolation rooms for over a year. Failure to clean the furniture in an isolation room may cause a spread of infection from patient to patient.

The isolation room also had a lounger with wooden arms. The arms were worn exposing the porous wood making it difficult to keep down infection. The floor in room 303 had splits in sections on the floor.

On the outside of the isolation room door a caddy that holds gloves, gowns, and masks was found sitting on the soiled floor outside of the Isolation Room. The gloves and gowns were touching the soiled floor. There was no trash can outside of the isolation rooms to place isolation personal protective equipment (PPE) in.

1c.) The outside crash cart was soiled with dust and hair. The tray on the bottom and to the side of the crash cart had dried liquid spillage in the bottom.

1d.) The patient supply room was also used as the patient nutritional room. The patient syringes were sitting on top of the refrigerator next to the silverware. Both bins were covered in a fine dust. Food preparation for patient was being done next to clean patient supplies. A drawer of patient syringes were found with food crumbs mixed in.
Supplements and ice cream were found to be out of date in the supply room refrigerator. The food was sitting in a soiled drawer in the freezer. The drawer was soiled with food crumbs and paper.

The door of the refrigerator, in the supply room, was soiled with dried liquids, food particles, dust and hair. Juice containers in the refrigerator drawer, in the supply room, had spilt in the drawer. The juice cups were sticky sitting in spilled juice.

A dirty trash can was found in the patient clean supply room. The can was sitting next to patient supplies cart. The lid to the trash receptacle was soiled with dirt and unidentifiable substances.

1 bag of IV fluids was found expired in August 2016.

1e.) The tube system in the hospital is used to transport paper and laboratory samples in clear plastic tubes to other departments. There was no cleaning schedule for the tubes. The tubes were soiled with dried liquids and dust.

1f.) 2 Medication pill crushers were found soiled with residue and dust. The crushers were missing paint and rusted.

1g.) The clean equipment room had soiled equipment in it. The equipment had rust, dust, and dried unidentifiable liquids spilled on the carts. Shipping boxes were found next to the equipment. The room contained 3 Rusted IV poles, Christmas supplies found lying on the floor, clean bedside commodes were found stacked on top of each other, and the screws on the commode frame were rusted. The oxygen metal frame holder was sitting on a soiled floor. The floor was dusty with trash of plastic, paper, and torn glove material on the floor. A clean commode chair bucket was found sitting on the soiled floor.

2.) Postpartum /Labor &Delivery

2a.) The Pyxis refrigerator was found sitting on the floor. The inside of the refrigerator was heavily coated in dust, hair, and dead bugs. In the medication room the wall behind the copier had paper missing from the sheet rock exposing it along the back wall and side walls.

2b.) An ice machine was found in the patient supply room. The ice machine drain was found dripping into an open PVC pipe drain and had left a rusted area on the floor. The floor was soiled with trash, dust, and hair.

A microwave was found in the patient clean supplies room. The microwave was used for warming patient food. The microwave was heavily soiled and scorched.

Shipping boxes were found in the patient clean supplies room. Patient medical supplies were stored with food and nutritional supplements.

2c.) The baby receiving blankets, hats, diapers, a scale, and formula bottles were found sitting on a cart uncovered in the L&D hallway. The shelves on the cart were dusty.

2d.) Multiple holes were found on three different walls of the L&D room #3. A stool with a tear in the vinyl cushion and a bedside cabinet with a broken door and a missing drawer were found in L&D #3. The patient supplies were exposed to dust, dirt, hair, and bodily fluids.

2e.)The crash cart in L&D was not locked. The cart was soiled with dust. Inside the drawer was a pair of soiled scissors, soiled tape, and an unwrapped oxygen register lying next to clean and wrapped patient supplies.

2f.) In the medication preparation room of L&D the refrigerator was found sitting on the floor. In the corner behind the refrigerator was 2 soiled brooms and 2 dust pans. The soiled brooms were sitting next to the Pyxis. Nursing staff confirmed they sweep the nurses station with the brooms that were sitting in the medication room. A trash can and shipping boxes were sitting on the floor next to the Pyxis medication refrigerator.

2g.) A patient urine sample was found sitting next to the sink in the medication preparation room. Staff # 45 confirmed the urine sample should not have been in the medication room sitting on a work/ medication preparation area.

2h.) The Pyxis refrigerator was sitting on the floor. The inside of the refrigerator was soiled with dust, hair, and dried particles that were unidentifiable.

3.) Emergency Department

3a.) The rubber on the top of the side rail of the trauma stretcher was torn and broken

3b.) The large main Pyxis in the ER was soiled on the inside and outside. The inside of the containers holding medication were soiled in dust and hair. The inside area of the door was soiled in a sticky substance.

4.) ICU

4a.) The large main Pyxis in the ICU was soiled on the inside and outside. The inside of the containers holding medication were soiled in dust. The smaller refrigerated Pyxis was sitting on the floor. The inside of the refrigerator was found soiled on the inside with dust, hair and a dead cream fly. The handle of the Pyxis was heavily soiled with dust and dirt.

5.) Laundry and Linen Department

5a.) In a large open room all of the clean laundry was found sitting on stacked shelves uncovered and exposed to the heavily soiled room. Uncovered laundry was stacked on tables next to shipping boxes.

The top of the shelving holding the uncovered laundry was heavily soiled in dust and dirt. A rusted molded air vent was blowing over the shelves of the uncovered laundry. A shelf in the laundry linen room was soiled with dirt with shipping boxes underneath.

4b.) A door was broken exposing wood next to a dirty cart in the clean laundry holding room. A large air condition return vent was found next to clean laundry heavily soiled with dust.

5c.) The air conditioner was leaking on the floor leaving a large pool of rusted water running under a cart of clean linen. A metal stool sitting in water from the air conditioner had rusted and was sitting next to a full rolling laundry cart with uncovered clean linen.

5d.) The washer in the laundry department had floor mops in the washer. The washer was heavily soiled with dirt, hair, and debris inside and out.

6.) Maintenance Plant Grounds

6a.) Inside the gated area 10 large Nitrogen bottles were found unsecured.

6b.)The plant ground were littered with plastic tops to canisters, leaves, and debris. Trees and bushes were found growing inside the gated plant are next to the Liquid Nitrogen tank.

7.) Central Supply

7a.) Inside the central supply room, 10 large supply shelves were stacked with shipping boxes sitting next to open patient supplies. Employees were bringing the supplies off the shipping dock directly into the clean supply area in shipping boxes and stacking them on the shelves with open patient supplies. There was no defined clean or dirty areas.

7b.) The shelves and floors were dusty and dirty.


These deficient practices were determined to pose an Immediate Jeopardy to the health and safety of patients that had the likelihood to cause harm, serious injury, impairment and/or subsequent death.





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C. An interview with Staff #45 was conducted on 9-21-2016 in the conference room. Staff #45 stated she did not have a certified Infection Preventionist in the facility as a resource. Staff #45 had taken the basic course requirements to serve in the infection control role, but stated she was not ready to obtain her certification. She stated she was new to the role and had been attending training regularly to learn her job. Staff #45 was able to provide evidence of regular participation in infection control activities. When asked who she had as a resource, Staff #45 stated she had Staff #2 for physician related guidance. She stated she also reached out to a former employee who had retired from the hospital and had held the position prior to her.

Upon reviewing of data collected through the infection prevention department, Staff #45 was asked to provide her log of reported communicable diseases, infection, and food borne illnesses. Staff #45 reported that she was not aware that she was required to keep a log and did not have one. She stated she kept a file of information that had been faxed to the required agency, but did not keep a log.



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D. Dialysis Department:

During a tour of the dialysis 2 store rooms on 09/19/2016 at 11:00 AM with Staff #8 and Staff #39 the following infection control issues were observed:

First Dialysis Storage Room:

1. In the first dialysis room observed "Four Monks" cleaning Vinegar x 12 jugs stored on a pallet underneath the dirty medical hopper sink. The hopper sink had dirty ring around the water line. The hopper sink had very unclean appearance. The cleaning vinegar was being used to rinse the dialysis machines after bleaching process.

2. The molding around the floor of the dialysis room was missing and tubing of some sort was lying on the dirty floor.

3. The cabinets in the first dialysis room would not close because the cabinets were full of supplies and plastic containers. There were numerous used blood pressures cuffs lying on the bottom shelf and falling out of the cabinet on to the dirty floor. There was stack of extra plastic lids lying on the counter. The counter had missing strips of molding, which caused exposed porous particle board wood to be showing and unable to clean. The bottom shelf of the cabinet was porous wood and patient supplies were being stored on the exposed wood.

4. The floor had dirty and discolored appearance with dust and trash particles.

Second Dialysis Storage Room:

1. The second storage room had eight 5 gallon water containers being stored with the dialysis supplies and equipment giving access to the acid concentrate and patient dialysis sterile supplies from the water company that delivers water to the facility.

2. The carts that held the portable RO systems #2, #5, and #6 were dirty, rusted, and had trash particles on the bottom shelf beside the tanks. The carts holding the RO system were used to dialyze patients at the bedside in different nursing areas of the hospital.


An interview with the Unit Manager (Staff #39) and Staff #8 confirmed that multiple hospital staff have access to the dialysis storage areas.

Based on observation, record review, and interview, the facility failed to:

A. ensure the surgical department provided a clean and sanitary environment.

B. ensure the surgical department sterilized implant trays and complete sets of instruments per the facility's sterilization policy or documented flash sterilization as an emergency. A review of the flash sterilization logs for the months of June through September 20, 2016 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. The facility failed to document biological indicator time in and time out of the flash sterilizers with the results of the biological indicator on the "3M Steam Flash Sterilization" form. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards and the CDC guidelines.

C. provide 2 post anesthesia patient care areas per each operating room. The facility had 10 functional operating rooms that were observed. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas was being used for storage of stretchers, wheelchairs and other equipment.


D. ensure the surgeon documented the date and time the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies for history and physical updates and the medical record content.


E. ensure the surgeon and anesthesia provider had signed, dated, and timed the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.



Findings:

A. During a tour of the surgical department on 09/20/2016 from 2:00 PM to 4:00 PM with the Surgical Director the following infection control issues and expired supplies were observed:


1. In the sub-sterile utility room #5 observed a water leak under the sink. The bottom shelf had a 4 x 6 rusty, yellowish-brown stain. Also, there was dust and dirt noted on the bottom shelf. The floor in the sub-sterile utility room #5 was dingy and discolored. There was trash, dust, and dirt behind and beside the flash sterilizer.

2. In the same cabinet there was an assortment of patient supplies being stored under the cabinet in the sub-sterile utility room #5. The supplies consisted of a patient's urinal, ice tray, 2 boxes of gloves, tubing, cables to equipment monitoring, and a card board shipping box. The supplies were sitting on top of the card board box. Also, there were supplies touching the side of the card board box.

3. Observed several water spillage stains of rust, dirt, and trash in the sterilization wash room on the bottom shelf under the wash sinks which a (2 x 5) foot stainless steel shelf. Also, observed a hole in the wall plaster under the sink from the plumbing and there was exposed insulation coming through the wall. This had the likelihood for rodents and bugs to enter the sterilization area where instruments were washed.


4. The air conditioning vent in the sterilization wash room was covered in rust spots.

5. There were 2 intravenous poles observed with the word "ANES" sketched in the metal base of the poles. The letters were completely rusted. One of the poles was located in the new heart room of the surgery department. The other pole was located in one of the new operating room suites.

6. The freezer of the refrigerator in the surgical department was a solid piece of ice. There was medication being stored in the bottom part of the refrigerator.

7. The anesthesia carts observed in the surgical suites had pieces of chip metal missing from the drawers and the base of the cart. The chipped metal areas were completely rusted.


8. A board of porous wood was being used in the new heart surgical suite to store a bear hugger on another piece of surgical equipment. Also, the room had been cleaned and prepped for the next patient having a heart procedure. Five empty containers of 1000 cc of sterile water had been left in the room from the previous procedure.

9. Numerous pieces of operating room equipment were observed with rust on the caster wheels in 8 of 10 operating room suites.

10. The crash cart in the pre-op surgical area had the following expired patient supplies.
Atropine Sulfate 0.5 mg 5 ml Abboject Syringe expired 05/2016
Nellcor oximetry sensor expired 07/2016
Arrow Central Venous Catheter Kit expired 08/2016

An interview with Staff #21 on 09/20/2016 at 4:00 PM confirmed the above findings.



B. A review of the flash sterilization logs for the months of June 2016 through September 20, 2016 revealed unwrapped implant trays and full sets of instruments trays were being flashed in the flash sterilizers. The facility failed to document biological indicator time in and time out of the flash sterilizers with the results of the biological indicator on the "3M Steam Flash Sterilization" form. Also, the facility failed to follow their own policy for in hospital sterilization, the AORN (Association of perioperative Registered Nurses) standards, and the ANSI/AAMI (Association for the Advancement of Medical Instrumentation) standards.


A review of the flash sterilization logs for the month of June 2016 for flash sterilizer #8, there were 20 individual instruments and tray sets flashed and not sterilized. One set flashed was a set of implantable screws and plates.


A review of the flash sterilization logs for the month of July 2016, for flash sterilizers #6, #8, #9, #11, #13, and #14, there were 42 instruments and tray sets flashed not sterilized. The following items addressed besides the individual flashing were full instrument tray sets and implant trays.

1. An unwrapped Ross Hip Tray was flashed in flash sterilizer #6 on 07/12/2016.

2. An unwrapped Hip retractor was flashed for 3 minutes (policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/14/2016, in flash sterilizer #8.


3. An unwrapped hardware screw and plates (implant tray) was flashed without the biological indicator and flashed for 3 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/15/2016, in flash sterilizer #8.


4. An unwrapped hardware screw and plates (implant tray) was flashed without the biological indicator and flashed for 3 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/15/2016, in flash sterilizer #8.


5. An unwrapped Synthesis hand system (implant tray) was flashed without the biological indicator and flashed for 3 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/18/2016, in flash sterilizer #8. Also, the biological readout was changed to 30 minutes. The facility uses the 3M Attest (Trademark) Super Rapid Readout Biological Indicator, which is an hour result time.

6. An unwrapped Lipo suction instrument Tray was flashed on 07/1/2016, in flash sterilizer #9.

7. An unwrapped Right Total Knee tray was flashed at 7:17 AM and documented rejected due to no chemical indicator was in the instrument tray. A Right Total Knee arthroplasty set was flashed at 7:47 AM. Also, a DePuy total Knee arthroplasty set with tibial insert trials were flashed for 10 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/5/2016, in flash sterilizer #9.

8. An unwrapped Biomet DVR tray (implant tray) was flashed without a biological indicator. (DVR Plate was for treating distal radius fractures) on 07/12/2016, in flash sterilizer #9.

9. An unwrapped Zimmer Tib/fem resection (sic) instrument tray was flashed on 07/13/2016, in flash sterilizer #9 .

10. An unwrapped CABG II (sic) instrument tray was flashed on 07/11/2016, in flash sterilizer #11. This type of tray was used in a heart procedure and the tray was flashed and not sterilized.

11. An unwrapped Laryngoscopy instrument tray was flashed at exposure time of 10/1 and next entry on the log was a Laryngoscopy instrument tray flashed again on exposure time of 3/1 on 07/19/2016, in flash sterilizer #11. The staff were using different flash times for the same instrument tray, even though the trays should have been sterilized. There were no times or dates documented on the individual entries made per each tray that was flashed.

12. An unwrapped Laryngoscopy instrument tray was flashed and the next entry on the log was for the Laryngoscopy instrument tray flashed again on 07/26/2016, in flash sterilizer #13. There were no times or dates documented on the individual entries made per each tray that was flashed.


13. An unwrapped Hip Tray Pinnacle cup system was flashed on 07/14/2016, in flash sterilizer #14.

14. An unwrapped Podiatry tray was flashed on 07/15/2016, in flash sterilizer #14. The staff member documented on the flash log "only 2 had to be run".

15. An unwrapped reverse total shoulder tray were flashed for 3 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/19/2016, in flash sterilizer #14.

16. An unwrapped Zimmer screw TKA (sic) tray were flashed for 10 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 07/27/2016, in flash sterilizer #14.



A review of the flash sterilization logs for the month of August 2016 for flash sterilizers #8, #11, #13, #14 and #15, there were 41 instruments and tray sets flashed. The following items addressed besides the individual flashing were full instrument tray sets and implant trays.


1. An unwrapped Thyroid tray was flashed on 08/2/2016, in flash sterilizer #8.

2. On 08/11/2016 in flash sterilizer #8, were unwrapped DePuy shoulder trays that were flashed for 10 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time). It was documented on the log by a staff member, "DePuy shoulder trays weren't in facility". A review of the logs revealed the shoulder trays were flashed instead of sterilized.

3. An unwrapped 6.5, 7.3, cannulated screw tray (implant tray) was flashed on 08/18/2016, in flash sterilizer #8. There was no biological readout for the implants to know if the results was positive or negative.

4. An unwrapped arthroscopy multi-curettes was flashed on 08/23/2016, in flash sterilizer #8.

5. An unwrapped vascular tray was flashed on 08/30/2016, in flash sterilizer #11.

6. An unwrapped mini frag set & clavicle set (sic) (implant tray) was flashed on 08/4/2016, in flash sterilizer #13. Also, the biological readout was changed to 30 minutes. The facility uses the 3M Attest (Trademark) Super Rapid Readout Biological Indicator, which is an hour result time.

7. An unwrapped Attune CR trails sz 3-8 (sic) was flashed on 08/23/2016, in flash sterilizer #13. Also, the biological readout was changed to 30 minutes. The facility uses the 3M Attest (Trademark) Super Rapid Readout Biological Indicator, which is an hour result time. A staff member documented on the flash log "1 had blood."

8. An unwrapped Zimmer total knee retractor set tray was flashed on 08/8/2016, in flash sterilizer #15.

9. An unwrapped Tib/fem resection tray (sic) was flashed on 08/9/2016, in flash sterilizer #15.

10. An unwrapped patella trials (sic) were flashed for 3 minutes (the facility's policy was written that all orthopedic instruments will be sterilized at 20 minutes exposure time) on 08/9/2016, in flash sterilizer #15.

11. An unwrapped Ross Hip Tray was flashed on 08/18/2016, in flash sterilizer #15.

12. An unwrapped femoral head trials were flashed on 08/18/2016, in flash sterilizer
#15.

13. An unwrapped Synthesis small frag (sic) (implant tray) was flashed without the biological indicator on 08/18/2016, in flash sterilizer #15. There was no documented biological indicator for the implant tray.

14. An unwrapped Podiatry tray was flashed on 08/19/2016, in flash sterilizer #14.

The flash sterilization logs from September 1 through September 20th were reviewed. There were 14 flashed instruments and tray sets, flashed in flash sterilizers #13, #14, and #15. The following items addressed besides the individual flashing were full instrument tray sets and implant trays.

1. An unwrapped Attune tibia prep tray was flashed on 09/6/2016, in flash sterilizer #13.

2. An unwrapped Synthesis multi loc humeral nail system (2 trays) (sic) (implant trays) were flashed on 09/16/2016, in flash sterilizer #14.

3. An unwrapped Laryngoscopy instrument tray was flashed on 09/8/2016, in flash sterilizer #15.

4. An unwrapped Laparoscopic Cholecystectomy instrument tray was flashed on 09/16/2016, in flash sterilizer #15 and the next entry on the flash log was There were dates or time for the entries made on the flash log. The flash cycle time for the sets was 10/1. That was a 10 minute exposure and 1 minute dry time.

5. An unwrapped Olympus cysto instrument tray and camera was flashed on 09/9/2016, in flash sterilizer #15 and the next entry on the flash log was an Olympus cysto instruments tray again.


A review of the facility's policy titled, "In Hospital Sterilization" revealed the following:

"PURPOSE:

1. To provide an explanation of the parameters and procedures needed to accomplish sterilization in the hospital setting.
2. Sterilization is the mechanism utilized for the destruction of all bacteria, microorganisms, or spores.

POLICY:

1. All in hospital sterilization shall be performed in a manner which assures the proper handling and processing of items requiring sterility based on the basic principles of steam sterilization as outlined below.
A. Articles requiring sterilization should have properties, which permit them to withstand the temperature, steam penetration and time frames, required for effective steam sterilization.
B. Non-penetrable articles for sterilization must be clean and free from foreign contaminants to allow for surface contact of the sterilizing steam.
C. Penetrable items (i.e. lines) shall be clean, freshly laundered and delineated prior to preparation and processing in the steam autoclave.
D. Articles, which may be disassembled, should be sterilized in the unassembled mode and positioned so that the steam can achieve maximum penetration or surface contact.
E. Hinged instruments should be sterilized in the open position.
F. To be effective, steam sterilization should meet the parameters of time, temperature, and steam pressure as prescribed by the autoclave manufacturer instructions.
G. Expiration dates are guidelines only and are dependent on the storage and handling of the sterilized items.

11. Flash Sterilization/Immediate Use Sterilization

A. This is discouraged and allowed only as emergency.
B. Items for flash sterilization should be washed and cleaned in the same manner as items for regular sterilization.
C. Place the unwrapped item and a sterilization indicator in the wire basket or sterilization container system for the flash sterilizer and place in autoclave.
D. Check the temperature setting. It should be set at 270 degrees, for 3 minutes. If items has a lumen should be 10 minutes, all orthopedic instruments should be ran for 20 minutes, our as manufacture suggestion. Do not put towels, linen or wrappers in the autoclave.
E. Special items such as power equipment should be autoclaved as per the manufacturer's instructions.
F. Close and seal the door. Push the button marked gravity, the flash autoclave will automatically begin the cycle once the door is closed properly.
G. Record the item sterilized, date, time, load number cycle minutes, temperature, results of indicator strip and the nurses initials on the flash sterilization record sheet near the flash autoclave.
H. An indicator buzzer will sound once the time cycle is completed. Open the door, being careful to avoid any excess steam, which could escape when the door is opened.
I. Utilize the unsterile basket handle to transport the gasket to the proper surgical room, both the circulator and scrub nurse should check the sterilization indicator for the proper color change which indicates sterility, and have the scrub nurse remove the item from the basket. Return the basket to the flash autoclave. Do not place the basket on the sterile field large instrument sets may be removed by a gowned and gloved scrub sterile gloves when removing items from the autoclave.
J. Implants should not be flashed sterilized except in EXTREME emergency.
K. The nature of the emergency should then be documented on the operative record.
RESPONSIBILITY:
1. The surgical supervisor should provide each employee with in-service training on the use of autoclaves and sterilization procedures.
2. The circulating RN is responsible to ensure proper procedure is followed for sterilization of items.
3. The OR staff is responsible for checking the package integrity of sterile supplies and communicating any items found to be compromised with the circulating nurse.
4. The Sterile Processing personnel will check the sterile supply area for compromised packaging and resterilize all items that are resterilizable."


A review of the perioperative standards and recommended practices "Association of perioperative Registered Nurses" revealed the following:

"Recommendation VII

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. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately. Flash sterilization cycles have traditionally been either 3 or 10 minutes of exposure, depending on the nature of the device being sterilized or the type of cycle indicated, minimal or no dry time, and no cooldown, thereby making the entire cycle time shorter than the cycle times for wrapped or terminally sterilized items. However, current manufacturers ' instructions for use may require a variety of cycle times and the use of single wrappers or flash containers as opposed to sterilizing unwrapped items. The term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS.

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."


An interview with Staff #22 on 09/20/2016 at 3:00 PM confirmed the facility surgical department follows the AORN standards.


Upon a review of the 2011 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2010, the guidelines revealed the following:

"10.6.3 Release criteria for implants
As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the SI testing are available (CDC, 2008).
Releasing implants before the SI results are known is unacceptable and should be the exception, not the rule.
When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the SI results are known. In this case, the release of the device before the SI results are known should be documented; the SI result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected.
NOTE-See Section 12 (New product evaluation) for general guidelines on how to assess the specific label claims of new products that become commercially available.
Rationale: Patient safety could be adversely affected by the implantation of a nonsterile device. The sterilization of implantables should be closely monitored and each load containing implants should be quarantined until it is verified that SI testing has yielded negative results. In defined emergency situations in which the quarantine of implants cannot be maintained, breaking of the quarantine is allowed for documented medical exceptions in accordance with facility policies and procedures. See also the rationale for 10.6.1."

A review of the CDC guidelines recommends routine BI monitoring and BI monitoring of all implant loads and that the load be quarantined until the results of the BI testing are available.

A review of the surgical clinical indicators that was reported to the quality department from the surgery department revealed no indication that the flash sterilizations was a quality issue that needed to be addressed.


An interview with Staff #21 on 09/20/2016 at 4:00 PM confirmed the surgical department was flashing instruments and instrument trays on a routine basis and not just for emergencies.


These deficient practices were determined to pose an Immediate Jeopardy to the health and safety of patients that had the likelihood to cause harm, serious injury, impairment and/or subsequent death.


C. During a tour of the surgical area on 09/20/2016 at 3:00 PM observed 10 functional operating rooms. In the postoperative care unit there were only 8 post anesthesia patient care areas. One of the patient care areas was being used for storage of stretchers, wheelchairs, and other equipment.

The recommendations and standards of practice by the American Society of Anesthesiologist recommended the following:

"The appropriate number of PACU bed slots will vary with the surgical case mix, the length of the cases (e.g., will first cases likely be discharged from the PACU before second cases are finished?) and the usual turnover time of both the OR and PACU beds. A high turnover of outpatients or a significant number of long-stay ICU patients will create a need for more PACU bed slots. In the past, the suggested guideline was that the number of PACU bed slots should equal the number of rooms in the OR suite. This idea has been replaced by a newer algorithm that recommends there should be one and a half to two PACU slots for each room in the OR suite. The factors described above and any other unusual issues for that particular PACU could impact such calculations. The important point is to involve all relevant personnel and departments (including support services, such as respiratory therapy and housekeeping) very early in the decision-making process. Their input can impact the decision as to how many bed slots to build."
The recommendations and standards of practice by the Facility Guidelines Institute; September 15, 2014 revealed the following:

"Operating Room Requirements for 2014 and Beyond

The number of Phase I (PACU or post-anesthetic care unit) patient care stations required in both inpatient and outpatient settings has been defined as 1.5 per OR. If that calculation yields a fraction, the number of patient care stations provided is to be rounded up to the next whole number. As explained in the definition of patient care areas, a patient care station can be a single-patient room or a bay or cubicle in a room with spaces for multiple patients."

An interview with Staff #21 on 09/20/2016 at 3:00 PM confirmed the above findings.

D. ensure the surgeon documented the date and time the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies on history and physical updates and the medical record content.

Refer to Tag: A 0952


E. ensure the surgeon and anesthesia provider failed to sign, date, and time the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

Refer to Tag: A 0955

Based on record review and interview, the surgeon failed to date and time the History and Physical Update form on 3 (#11, #12, and #13) of 10 surgical records reviewed. Also, the facility failed to follow their own policies on history and physical updates and the medical record content.

A review of Patient #11's record revealed the History and Physical Update form was not dated or timed by the surgeon.

A review of Patient #12's record revealed the History and Physical Update form was not dated or timed by the surgeon.

A review of Patient #13's record revealed the History and Physical Update form was not dated or timed by the surgeon.

There was no way to determine if the history and physical update form was completed prior to surgery without a date and time.


A review of the facility's policy titled, "History and Physical Content Management" revealed the following:

"PURPOSE: To outline the required content and process for completing the history and physical for patients treated at the .

II. POLICY:
1. A medical history and physical examination (H&P) must be completed and documented within 24 hours following admission or prior to surgery, whichever comes first.
2. An H&P performed prior to admission (within 30 days of admission) may be accepted, but must be accompanied by durable, legible practitioner documentation indicating the H&P was reviewed, the patient examined and noting changes or the lack of changes in the patient's condition. An update to the H&P must be completed and documented within 24 hours after admission or prior to surgery/procedure when utilizing such an H&P.
3. The H&P must be performed and authenticated by a practitioner who is authorized to do so by the Medical Staff.
4. The medical history and physical examination must be completed and documented by a physician, surgeon, or other qualified licensed individual in accordance with state law and facility policy.
More than one qualified practitioner can participate in performing, documenting and authenticating an H&P for a single patient.
When performance, documentation and authentication are split among qualified practitioners, the practitioner who authenticates the H&P is responsible for the content."

A review of the facility's policy titled, "Content of the Medical Record" revealed the following:


"PURPOSE:
To define the contents of patient medical record, whether in paper or electronic format, promotes efficiency and effectiveness of treatment.

DEFINITIONS:
A. Medical Record- The collection of information concerning a patient and his or her health care that is created and maintained in the regular course of business made by a person who has knowledge of the acts, events or diagnoses relating to the patient.
The medical record may include records maintained in an electronic health record system, e.g. an electronic system framework that integrates data from multiple sources, captures data at the point of care.
B. EMR/EHR- Electronic Medical/Health Record
C. Authentication- To establish authorship by written or electronic signature
D. Physician/Practitioner- For the purpose of the policy, physician/practitioner includes physicians, dentists, podiatrists, advanced practice nurses, physician assistants, and other credentialed practitioners who give orders.

III. PROCEDURE:
A. All medical record entries, including handwritten and electronic, must be legible, complete, true and accurate, dated, timed and authenticated by the person responsible for providing or evaluating the services provided, consistent with hospital policies."

An interview with Staff #22 on 09/20/2016 at 2:00 PM confirmed the above findings.

Based on record review and interview, the surgeon and anesthesia provider failed to sign, date, and time the Disclosure and Consent form on 7 (#11, #12, #13, #14, #15, #16 and #31) of 10 surgical records reviewed. Also, the facility failed to follow their own policy on Informed Consent.

A review of Patient #11's record revealed the Disclosure and Consent form was not dated or timed by the surgeon.

A review of Patient #12's record revealed the Disclosure and Consent form was not dated or timed by the surgeon.

A review of Patient #13's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #14's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #15's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #16's record revealed the Disclosure and Consent form was not signed, dated, or timed by the surgeon.

A review of Patient #31's record revealed the Disclosure and Consent form was not signed, dated, or timed by the anesthesia provider.

A review of the facility's policy titled, "Informed Consent" revealed the following:

"To insure that proper consent is obtained prior to the designated procedure. To insure that permits are accurately completed.

POLICY AND GENERAL INFORMATION:
1. All patients admitted to our hospital must have an authorization for treatment sheet on their chart signed by the proper person, dated and witnessed prior to a designated procedure.

2. Informed written consent for all procedures must be obtained prior to any invasive procedure. Physician will inform patient of risks, benefits, hazards, and alternatives, and sign consent form or document in progress notes and on history and physical. The purpose of a written consent form is to provide proof that there was a valid consent. The consent itself is not a substitute for the role of the physician in the informed consent process. A signed entry in the physician's progress notes should be made documenting that informed consent was obtained and that the patient was made aware of and understands the risks and possible complications and agrees to the planned procedure, if the informed consent is not signed by the physician."

INFORMED CONSENT FOR PATIENTS RECEIVING ANESTHESIA:

It is the policy of the facility that the patient must be given the opportunity to give an "informed consent" prior to the administration of anesthesia by an anesthesiologist and prior to the performance of operative and/or invasive procedures, diagnostic or therapeutic procedures, or situations when it is deemed advisable to have formal documentation of the patient's consent for treatment. Written verification of the informed consent must be on the patient's chart prior to initiation of anesthesia or any of the above stated procedures.

Informed written consent for all procedures must be obtained prior to any invasive procedure. Physician/staff will inform patient of risks, benefits, hazards, and alternatives, and sign consent form or document in progress notes and on history and physical. The purpose of a written consent form is to provide proof that there was a valid consent. The consent itself is not a substitute for the role of the physician in the informed consent process. A signed entry in the physician's progress notes should be made documenting that informed consent was obtained and that the patient was made aware of and understands the risks and possible complications and agrees to the planned procedure, if the informed consent is not signed by the physician.

Concept of Informed Consent must consist of:

*The risks, drawbacks, complications and expected benefits or effects of anesthesia
*Alternate choices of and to anesthesia
*The nature of the treatment
*The risks, drawbacks, complications and expected benefits or effects of such treatment
*Potential problems related to recuperation
*Any alternatives to the procedure and their risks and benefits
*The likelihood of success
*Possible result of non-treatment
*Verification that the patient understands the information
*Confirmation that the patient has been verbally informed about the anesthesia or procedure
*An opportunity for the patient to ask questions
*If any limitations in the confidentiality of patient information is discovered from or about the patient, the information will be documented in the progress notes
*Is needed for complex procedures, not for simple and common procedures (i.e., blood counts) and is needed for any procedure where anesthesia is planned.

Obtaining Informed Consent:

*It is the anesthesiologist and/or treating physician's responsibility to obtain the informed consent.
*Facility personnel cannot be involved in providing information that is necessary for informed consent-only the physician and/or anesthesiologist can provide the information.

The informed consent form is prepared by the attending physician or operating physician and is discussed with the patient by the physician:

*Supplemented with verbal discussion, and/or Supplemented through written additions that give further information relevant to the patient's condition.
*Medical information set forth needs to be written in clear, simple and easily understood terms.
*Documentation must clearly indicate that the patient has had the opportunity to ask any and all questions he/she may have about the proposed anesthesia and/or procedure."

An interview with Staff #22 on 09/20/2016 at 2:00 PM confirmed the above findings.