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510 W TIDWELL

HOUSTON, TX 77091

GOVERNING BODY

Tag No.: A0043

Based on observation, document review, and interviews, it was determined the Governing Body failed to effectively provide oversight in the total operation of the hospital.

Findings include:
1. Emergency Services: Based on observation, interviews and records review the facility failed to provide entrance into the Emergency Room department in a timely manner (North location). This failed practice could likely result in serious harm or death to a patient needing access to emergency services.
See findings in Tag A1101

2. Quality Assessment and Performance Improvement Program (QAPI): Based on document review, policy review, and staff interview, it was determined that the hospital's QAPI program failed to meet the Condition of Participation of QAPI due to not implementing a system-wide performance improvement across all hospital departments and services. The QAPI program at the hospital did not apply performance improvement in that the program:
A) Failed to ensure that policies and a plan of correction that were put into place based on previous survey findings at the Tidwell location and related to Emergency Department (ED) access were also followed system-wide (see A1100).
B) Did not ensure that Pharmaceutical services were reviewed for quality of services and actions were taken to implement corrective actions for the pharmacy quality improvement indicators system-wide; (see A0489, A0502).
C) Did not ensure that performance improvement plans implemented for one location in the hospital were also implemented system-wide.
D) Did not ensure that competency and clinical performance of all clinical staff were evaluated consistently.
E) Did not ensure that the hospital's review of patient's clinical records were maintained in a manner that provided accuracy of information and patient informed consent for care.
F) Failed to implement system-wide pharmacy policies and failed to implement performance improvements for deficient practices found in pharmacy services.
G) Failed to implement performance improvement for infection control deficiencies cited on previous surveys (see A749).

3. Pharmaceutical Services: Based on observations, record reviews, and interviews, the hospital failed to meet Pharmaceutical Services Condition of Participation. The facility's pharmaceutical services failed to:
A) Ensure expired medications were stored separately from non-expired medications (see findings in tag A0491).
B) Ensure non-narcotic drugs were properly disposed of to prevent drug diversion (see findings in tag A0491).
C) Ensure drugs listed in schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act were destroyed and appropriately discarded to prevent diversion (see findings in tag A0491).
D) Ensure integration of pharmaceutical services system-wide for oversight (see findings in tag A0491).
E) Ensure the hospital followed its policy /procedures for wasting and disposing its controlled substance (see findings in tag A0491).
F) The facility failed to ensure the Director of Pharmacy maintained oversight of training and competency evaluation of staff mixing intravenous medications (See findings at A0501).
G) The facility failed to ensure medications were secured in a location accessible only to authorized personnel. (See findings at A0502).
These failures placed the facility at an increased risk of drug diversion and adverse patient outcome.

4. Infection Prevention and Control and Antibiotic Stewardship Programs- Based on policy review, document review, observation, and interview, the facility failed to meet Infection Control and Prevention and Antibiotic Stewardship Program Condition of Participation. The facilities failed to:
A) Implement their COVID-19 (Coronavirus Disease 2019) Pandemic Plan related to screening visitors for signs/symptoms of COVID-19 upon entry to the facility.
B) Implement their policy related to cohorting (rooming together) and separation of patients who present with symptoms of COVID-19 from patients who are asymptomatic for symptoms of COVID-19.
C) Implement their policy and ensure regular screening of hospital staff before reporting to work and entering the hospital.
D) Implement their infection control policy related to hospital construction to prevent and/or decrease the risk of hospital acquired infections in patients, visitors, and healthcare workers. (Refer to A0749).
E) Provide a sanitary environment to avoid sources and transmission of infections.
These failures placed staff, visitors, patients, and future patients at risk for exposure and/or acquisition of hospital acquired infections.

5. Surgical Services- Based on observation, policy review, medical record review, document review, and interview the hospital failed to meet the requirements of the Condition of Participation of Surgical Services.
A) The hospital failed to ensure six (Staff (S)114, S115, S116, S117, S118, S119) of six practitioners' credentialing files reviewed for privileges were granted specific clinical privileges and procedures authorized by the governing board and signed by the department chairman based on the practitioner's license, education, training, experience, current competence, health status, and judgement prior to performing surgery. This deficient practice had the potential to affect all patients receiving surgical services at any of the three hospital campuses (see findings in tag A0945).
B) The hospital failed to ensure an updated examination of the patient, including any changes in the patient's condition, was documented and in the medical record prior to the surgery when the medical history and physical examination (H&P) was completed within 30 days before admission or registration for six (P29, P32, P33, P35, P37, P38) of eleven patient records reviewed for a documented updated H&P prior to surgery from a sample of 58 patients. This deficient practice had the potential to miss current diagnoses/conditions for patients receiving surgical services (see findings in tag A0953).
C) The hospital failed to ensure there was a properly executed informed consent that contained the date, time, and signature of the person witnessing the patient or the patient's legal representative signing the consent form and/or the provider for eight patients (P32, P33, P34, P35, P36, P38, P40, and P41) of twelve patient records reviewed for a properly executed informed consent from a total sample of 58 patients. This deficient practice had the potential to affect all patients receiving services at any of the three hospital campuses (See findings in tag A0955).
D) The hospital failed to ensure an operative report was written or dictated immediately following surgery and signed by the surgeon that described techniques, findings, and tissues removed or altered for two (P40, P41) of two patients observed in Pre-op prior to surgery. There was no operative note documented/dictated/completed in two (P03, P32) of 12 (P03, P22, P29, P31, P32, P33, P34, P35, P36, P37, P38, P39) patient records reviewed for a completed operative note from a sample of 58 patients. This deficient practice had the potential to affect all patients having a surgical procedure at the three hospital campuses (see findings in tag A0959).
E) The hospital failed to: a) ensure a competency evaluation on performing sterile processing duties was completed for one (S113) of one sterile processing technician's personnel file reviewed and b) ensure one of one sterile processing technician (S53) performed manual washing of surgical instruments in accordance with the manufacturer's instructions for use. These deficient practices had the potential to affect all patients receiving surgical services at any of the three hospital campuses (see findings in tag A0951).

QAPI

Tag No.: A0263

Based on document review, policy review, and staff interview, the hospital failed to implement a system-wide performance improvement across all hospital departments and services. The QAPI program at the hospital did not apply performance improvement in that the program:

1. Failed to ensure that policies and a plan of correction related to Emergency Department access based on previous survey findings at the Tidwell location were put into place and followed system-wide; (see A1100)

2. Did not ensure that pharmaceutical services were reviewed for quality of services and actions were taken to implement corrective actions for the pharmacy quality improvement indicators system-wide; (see A0489, A0502)

3. Did not ensure that performance improvement plans implemented for one location in the hospital were also implemented system-wide;

4. Did not ensure that competency and clinical performance of all clinical staff were evaluated consistently;

5. Did not ensure that the hospital's review of patient's clinical records ensured records maintained in a manner that provided accuracy of information and patient informed consent for care;

6. Failed to implement system-wide pharmacy policies and failed to implement performance improvements for deficient practices found in pharmacy services;

7. Failed to implement performance improvement for infection control deficiencies cited on previous surveys (see A749).

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on document review, policy review, and staff interview, the hospital failed to use data collected for QAPI review to ensure performance improvement across the hospital system. The failed practice had the potential to affect all patients receiving care in the hospital and clinics.
Findings:
1. A review of the 2021 Quality Assessment and Performance Improvement (QAPI) Plan Policy # ADM.01.1 44 .0 for UMMC revealed the scope of the QAPI program for the Emergency Department (ED) would include: "an organization-wide program that reflects the full scope and complexity of services provided by the organization, identifies opportunities for improvement, and works to address those opportunities."

2. A federal survey conducted by the state survey agency completed on 01/08/2021 cited findings for a patient unable to access the Emergency Department (ED) at the Tidwell location of the hospital on 01/05/2021. The facility plan of correction for this deficient practice included a plan to redirect incoming calls placed from outside the hospital into the ED to other staff if the ED desk phone was not answered. The hospital's plan to correct the deficient practice also included a plan to provide a door bell in addition to the phone service redirects.

3. The hospital failed to ensure this plan was implemented system-wide which resulted in findings of immediate threat of harm for patients who might present at the North location when the survey team at the North location could not access the ED for a period of 42 minutes upon entrance on 12/17/2021. Surveyors attempted to call ED staff via phone number posted on the ED door and left messages on the ED phone number but were not able to gain immediate access. The phones at the North location did not redirect calls to other staff when the ED desk phone was not answered. The corrective action plan for responding to ED access was not carried out across the hospital system.

4. Interview with S103 and S102 on 12/19/2021 at 3:00 PM confirmed the QAPI program minutes did not address carrying out program improvements to other hospitals in the system for the plan of correction dated 1/8/2021. S103 stated the QAPI action plan did not include the clinics and a system-wide plan to implement corrections, "but that is planned for the future".

5. The hospital QAPI priority grid included a performance improvement project for Medical Staff Credentialing. A review of the QAPI policy revealed the scope of the QAPI program would include monitoring/tracking of all physician privileges.

6. The hospital failed to ensure six of six (S114, S115, S116, S117, S118, S119) practitioners' credentialing files reviewed for privileges were granted specific clinical privileges and procedures authorized by the governing board and signed by the department chairman based on the practitioner's license, education, training, experience, current competence, health status, and judgement prior to performing surgery. This deficient practice had the potential to affect all patients receiving surgical services at any of the three hospital campuses.

QAPI PERFORMANCE IMPROVEMENT PROJECTS

Tag No.: A0297

Based on record review, policy review and interview the hospital failed to ensure that there was measurable progress achieved for quality improvement projects. Medical Staff Credentialing was listed as a QAPI project for the hospital system and QAPI meetings failed to address Medical Staff in six of six QAPI meeting minutes. This failure to document measurable progress to monitor and track credentialing has the potential for adverse patient outcomes when surgical staff credentials are not verified.

Findings:
1. The hospital QAPI priority grid included a performance improvement project for Medical Staff Credentialing. A review of the QAPI policy revealed the scope of the QAPI would include monitoring/tracking of all physician privileges.

2. The hospital failed to ensure six of six (S114, S115, S116, S117, S118, S119) practitioners' credentialing files reviewed for privileges were granted specific clinical privileges and procedures authorized by the governing board and signed by the department chairman based on the practitioner's license, education, training, experience, current competence, health status, and judgement prior to performing surgery. This deficient practice had the potential to affect all patients receiving surgical services at any of the three hospital campuses.

3. Review of Practitioner S114's delineation of privileges application for spine surgery dated
08/26/2021 showed a list of privileges requested but failed to show if the privileges were approved or denied. The application was signed by S120 on 09/18/2021.

Review of Practitioner S115's delineation of privileges application for orthopedic surgery dated 03/10/21 showed a list of privileges requested with a Governing Board member's signature but failed to show the date the privileges were granted.

Review of Practitioner S116's delineation of privileges application for orthopedic surgery dated 03/10/21 showed a list of privileges requested with a Governing Board member's signature but failed to show the date the privileges were granted.

Review of Practitioner S117's delineation of privileges application for orthopedic surgery dated 02/26/2020 showed a list of privileges requested including total shoulder replacement but failed to show if the procedure was granted or denied. The application also failed to show what facility the privileges requested were for. Review of a second application for Practitioner S117's delineation of privileges for general surgery dated 03/28/21 showed a list of privileges requested but failed to show which privileges were granted and also failed to show the required signature of S120. Review of a third application for Practitioner S117's delineation of privileges for plastic surgery dated 03/28/2021 showed a list of privileges requested and signed by S120 on 06/29/21 but failed to show which privileges were granted.

Review of Practitioner S118's delineation of privileges application for podiatry surgery dated
10/29/20 showed a list of privileges requested and signed by S120 on 03/01/2021 but failed to
show what facility the requested privileges were granted for.

Review of Practitioner S119's delineation of privileges application for spine surgery dated
04/13/21 showed a list of privileges but failed to show what privileges were requested. The
application was signed by S120 on 10/30/2021. During an interview on 12/21/21 at 4:30 PM, S93 confirmed the above Practitioner credential file findings and that the applications were not in compliance with the facility Medical Staff Bylaws.

4. Review of Quality/Patient Safety Committee Meeting Minutes dated 2/23/2021, 4/13/2021, 6/16/2021, 8/18/2021, 10/19/2021, and 12/13/2021 revealed:
(A) no mention of medical staff/credentialing reported for 10/19/21, and 12/13/2021, and
(B) medical staff report deferred for 8/18/21, 6/16/2021, 4/13/2021, and 2/23/21.

Failure to ensure credentialing files and practitioner applications were in compliance demonstrated that the facility failed to monitor and track all physician credentials as recommended in the hospital's performance improvement project. There was no documentation the hospital QAPI program addressed this in QAPI meeting minutes. Interview with S103 on 12/20/21 at 4:30 PM confirmed that the QAPI minutes did not include discussion of the credentialing files and any performance improvement for monitoring the files.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on medical record review and interview, the hospital failed to ensure that the registered nurse (RN) clarified a physician's order for cardiovascular medication for 2 patients (P31, P37) of 11 patient records reviewed for physician orders from a total sample of 58 patients. This deficient practice had the potential to affect any patient with physician orders for cardiovascular medication at any of the three hospital campuses.

Findings include:

Review of the policy titled, "Medication Use Process: Administration Transcription, Administration, Discharge/Transfer," reviewed April 2019, indicated ". . . Medications which have more than one indication for use will be clarified before that medication will be dispensed by Pharmacy unless patient safety may be compromised as determined in collaboration with Nursing, Pharmacy, and other health care providers. . ."

1. Review of P31's "Anesthesia Orders" signed by the anesthesiologist on 11/30/21 at 9:15AM indicated the "Medication Orders for PACU" [Post Anesthesia Care Unit] included "Cardiovascular (Choose 1 med [medication] only) 1. Labetolol [sic] [used to treat high blood pressure] 10mg IVP [milligrams intravenous push] q [every] 5 min [minutes] PRN [as needed] up to max [maximum] 20mg for SBP > 180mmHg [systolic blood pressure greater than 180 millimeters mercury] (Hold if HR < 60 bpm [heart rate is less than 60 beats per minute] and Notify Anesthesiologist) 2. Hydralazine [used to treat high blood pressure] 10mg IVP q 10 min PRN up to max 20mg for SBP > 180mmHg."

Review indicated two cardiovascular medications were checked rather than only one as the direction was written. There was no documentation that the RN clarified the order with the anesthesiologist. No cardiovascular medication was administered in PACU.


2. Review of P37's "Anesthesia Orders" signed by the anesthesiologist on 11/05/21 with no time documented indicated the "Medication Orders for PACU" included "Cardiovascular (Choose 1 med [medication] only) 1. Labetolol [sic] 10mg IVP q 5 min PRN up to max 20mg for SBP > 180mmHg (Hold if HR < 60 bpm and Notify Anesthesiologist) 2. Hydralazine 10mg IVP q 10 min PRN up to max 20mg for SBP > 180mmHg."

Review indicated two cardiovascular medications were checked rather than only one as the direction was written. There was no documentation that the RN clarified the order with the anesthesiologist. No cardiovascular medication was administered in PACU.


In an interview on 12/19/21 at 12:45 PM, S40 at Sugar Land stated the anesthesiologist's order for cardiovascular medication should have been clarified by the RN.

SUPERVISION OF CONTRACT STAFF

Tag No.: A0398

Based on observation, document review, staff interview, and policy review, the facility failed to maintain responsibility for the competency and clinical activities of all nursing personnel for seven of seven nursing personnel files reviewed, (S41, S42, S43, S44A, S44B, S46, and S47). This failure had the potential to allow unqualified staff members to provide direct patient care, with possible negative outcomes for all patients receiving services from this facility.

Findings include:

Review of the facility policy titled, "Staff Competency," last revised 12/16, revealed, "It is the responsibility of the Department Director to identify and maintain competencies based on the specific needs of the patient population served ...Competence assessment for staff and contracted staff who work in the same capacity as staff providing care, treatment and services is based on the following: Direct observation by qualified supervisor or preceptor. Successful completion of general and unit specific checklist. Successful performance of identified procedure ...Annual Competencies (performance evaluations): Performance evaluation of identified annual competencies will be documented on Skills/Competency checklists.

During a tour of the facility with S40 on 12/18/21 at 10:00 AM, S40 stated that there is no pharmacy in the facility other than the automated dispensing system. S40 stated, nursing staff is responsible for compounding (mixing) some antibiotic powders with normal saline solution to reconstitute the medication prior to intravenous (IV) administration. When asked who provides the training and checks the competency of the the nurses to complete this task, S40 stated, "The pharmacist and myself." S40 stated, he/she "signs off" the compounding of medications and ensures the nurses use aseptic (free from contamination from disease-causing microorganisms) technique.

During an interview with S46, Registered Nurse (RN) on 12/18/21 at 2:20 PM, S46 was unable to recall any annual skills check related to mixing IV medications. S46 stated that he/she trained for clinical skills required by learning from other nurses. Review of the personnel file of S46 revealed no documented orientation or competency evaluation of skill for mixing IV medications.

During an interview with S47, RN, on 12/18/21 at 2:51 PM, S47 stated, he/she was oriented to clinical skills by a "preceptor," an experienced RN. S47 was unable to recall any annual skills check related to mixing IV medications. Review of the personnel file of S47 revealed no documented orientation or competency evaluation of skill for mixing IV medications.

Review of the personnel file of S41, RN, revealed no training or competency check specific to mixing IV medications. The document titled, "(Facility Name) Competency Checklist," dated 08/10/21, showed multiple skills checked and the document signed only by S41 him/herself.

Review of the personnel file of S43, RN, revealed a document titled, "IV Admixture (adding a substance to another substance) Competency Checklist," dated 08/05/21 with the competencies checked and signed only by S43, him/herself.

Review of the personnel file of S42, RN, revealed a document titled, "IV Admixture Competency Checklist," dated 08/06/21, with the competencies checked and signed only by S43, the RN who completed a self-assessment on the competencies the previous day.

Review of the personnel file of S44A, RN, revealed a document titled, "IV Admixture Competency Checklist," was dated 08/21/21, initialed by S40, but had no competency skills checked off.

Review of the personnel file of S44B revealed a document titled, "NurseDash Candidate Profile," dated 12/07/20 and consisting of a skills checklist. No training or competency check by the facility was found in the file.


During a follow-up interview with S40, on 12/19/21 at 1:15 PM, the staff reviewed the personnel file of S44B. S40, stated that the facility does not have any documentation of S44B's training and/or competency check conducted by the facility itself, only those checks provided by the agency providing this staff for employment. During the interview, S40, also confirmed that the facility would not consider it appropriate for a nurse to self-assess for skills competency evaluations and stated it was inappropriate for one nurse to sign off another nurse's competency evaluation. S40, stated that the Director of Nurses (DON) was responsible for the training and skills of all nursing staff, whether employed directly by the facility or employed through a contract.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on policy review, medical record review, and interview, the hospital failed to ensure medications were administered as ordered by the physician for one patient (P36) of eleven patient records reviewed for medication administration from a sample of 58 patients. This deficient practice had the potential to affect any patient receiving pain medication at the three hospital campuses.

Findings include:

Review of the policy titled "Medication Use Process: Administration Transcription, Administration, Discharge/Transfer," reviewed April 2019, indicated ". . . 4) Medications are checked from the medication record against the label on the bottle or unit dose package. The following shall be confirmed prior to each administration: . . . e) The appropriate time, to ensure adherence to the prescribed frequency and time of administration. . ."

Review of P36's "Cervical Post-Operative Order Set" indicated a verbal order from Staff (S58) on 11/01/21 at 11:30 AM, to give "Norco (hydrocodone/APAP) [hydrocodone with acetaminophen, an analgesic preparation used to treat moderate to severe pain] 10/325mg [milligrams] . . . two tablets every 4 hours po PRN [orally as needed] for severe pain (pain rating 7-10)" and "Norco (hydrocodone/APAP) 10/325mg . . . one tablet every 4 hours po PRN for moderate pain (pain rating 4-6)."

Review of P36's "Nurses Notes" indicated on 11/01/21 at 6:40 PM, the nurse documented P36 "complaining of 8 of 10 pain - incision, provided pain medication." Review of the "Medication Administration Record (MAR)" indicated P36 received Norco 10/325 mg, two tablets, on 11/01/21 at 6:40 PM.

Review of P36's "Nurses Notes" indicated on 11/01/21 at 9:20 PM, the nurse documented P36 ". . . complaint of pain post op site cervical area . . . pain 6/10 [six on a pain scale of 10], pain medicine given." Review of the MAR indicated P36 received Norco 10/325 mg, two tablets, on 11/01/21 at 9:20 PM.

Review of P36's medical record indicated P36 received Norco 10/325 mg, two tablets, on 11/01/21 at 9:20 PM for pain at a level of six of 10, when the physician order was to give one tablet for moderate pain at a rate of four to six on a scale of 10. The nurse also administered the second dose of Norco two hours and 40 minutes after the first dose was given rather than four hours between doses as ordered.

In an interview on 12/19/21 at 12:45 PM, S40 confirmed P36 should have received one tablet of Norco for the second administration, and the time between the two administrations was not four hours. S40 stated the physician's order was not followed by the nurse.

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on medical record review, staff interview, and policy review, the facility failed to ensure staff appropriately monitored patients for blood transfusion reactions for one of one transfusion record reviewed (Patient (P)43). Failure to monitor patient reactions to transfusions could lead to undetected adverse reactions and negative outcomes for all patients receiving blood products at this facility.

Findings include:

Review of the facility's policy titled, "Blood Administration Guidelines," last revised 10/2020, revealed, "Monitoring: The following vital signs are the minimum required and should be performed with the administration of each new unit of blood: A. Monitor and record vital signs (temperature, pulse, respiration, and blood pressure): Pre vital signs 15 minutes prior to transfusion initiation, 15 minutes from initiation X1 (one time), 30 minutes from initiation X1 and then every 1 hours from the initiation with the post vital signs and 1 hour from the completion of transfusion. B. Assess signs and symptoms every 15 minutes twice, then every hour until transfusion is completed. 6. Observe for signs of reaction at the end of 15 minutes, 30 minutes, and then every hour until the transfusion is complete. Observe for: Urticaria (rash), chills ...fever ...facial flushing, edema (swelling), bronchial spasm (narrowing of airway, causing shortness of breath), elevated pulse, decreased blood pressure, abdominal cramping, throbbing headache, backache, hemoglobinuria (blood in urine), feeling of anxiety or 'impending doom', untoward oozing of a wound in anesthetized patient."

Review of P43's medical record, "Physician Orders," revealed orders for transfusion of two units of packed red blood cells (PRBCs), the first unit on 05/28/21 and the second unit on 05/29/21.

Review of the "Blood Administration Record" dated 05/28/21 revealed that the first unit of PRBCs was initiated at 1:00 PM. No documentation was found of vital signs 15 minutes prior to initiation of the transfusion.

The set of vital signs timed for "30 minutes post initiation" were documented at 1:45 PM or 45 minutes after initiation.

The set of vital signs timed for "1 hour post initiation" were documented at 2:45 PM or one hour and 45 minutes after initiation.

The set of vital signs timed for "2 hours post initiation" were documented at 4:00 PM, or three hours after initiation.

The transfusion ended at 5:00 PM. The only documentation found of assessments of signs of reaction were on the "Nurses Notes" on 05/28/21 at 3:00 PM, during the transfusion, in which the nurse documented, "First unit of blood transfusion in progress. No adverse reaction noted," and on 05/28/21 at 9:45 PM, in which the nursed documented, "Blood transfusion complete. Patient denies chest pain, SOB (shortness of breath), nausea/vomiting or dizziness." The only assessment of P43 noted one hour post transfusion was a documented set of vital signs, with no assessment of other signs of reaction.


Review of P43's "Blood Administration Record" dated 05/29/21 revealed the second unit of PRBCs was initiated at 1:20 PM. No documentation was found of vital signs 15 minutes prior to initiation of the transfusion.

The set of vital signs timed for "30 minutes post initiation" were documented at 1:55 PM, or 35 minutes after initiation.

The set of vital signs timed for "2 hours post initiation" were documented at 3:25 PM or two hours and five minutes after initiation.

The transfusion ended at 5:00 PM. The only assessment of P43 noted one hour post transfusion was a documented set of vital signs, with no assessment of other signs of reaction.

The only documentation found of assessments of signs of reaction during and after the transfusion were noted on the "Nurses Notes" on 05/29/21 at 3:40 PM, immediately after the transfusion ended, in which the nurse documented, "Patient tolerated blood transfusion very well, no reaction or adverse reaction observed."


During an interview with S40 on 12/20/21 at 12:40 PM, S40 reviewed the above medical record and agreed the nursing staff had not followed facility policy and expectation for monitoring patients during a blood transfusion for timing of vital signs and assessments of sign and symptoms of transfusion reaction. S40 agreed the facility policy for monitoring a patient before, during, and after a blood transfusion included not only vital signs but the other signs of reaction as delineated in the policy.

ORGANIZATION AND STAFFING

Tag No.: A0432

Based on medical record review, document review, staff interview, and policy review, the facility failed to ensure qualified and trained staff were in a position to oversee the quality of medical records. Failure to maintain accurate and complete medical records could interfere with the care and follow-up care of all patients receiving services at this facility.

Findings include:

Review of a sample of the facility's all-paper medical records during the survey revealed multiple variances for completion and accuracy (See specific findings Tag A0450).

During an interview with S40 on 12/17/21 at 11:20, the all-paper medical records were reviewed. S40 agreed the records were incomplete and/or inaccurate. S40 stated, he/she was responsible for auditing all Emergency Department (ED) records. The S40 stated, his/her training for medical record audits was from S39.

During an interview with S72 on 12/20/21 at 2:15 PM, the variances noted in the record reviews were reviewed. S72 stated, he/she had been employed in the Medical Services department for three months and was responsible for auditing inpatient and surgery medical records. S72 stated, he/she was not certified as a medical services technician and had received training at this facility only from S39. When asked, S72 stated that he/she was unfamiliar with the facility's policy on medical records and required documentation and stated that he/she had received no job-specific training other than practice audits conducted with S39. When asked if he/she had resources for questions and/or concerns about medical record/documentation requirements, S72 stated, "Sometimes I'm not sure who is the author to talk to, I can't read it," and "I'm not sure who to ask questions. Sometimes I 'google' things."

During an interview with S39, on 12/20/21 at 3:15 PM, S39 stated that he/she is the direct supervisor of S72 and stated he/she provided orientation and training for S72, "hands on, we went through the charts and showed (him/her) how we want it done." When asked if S39 provided any oversight or review of S72's work, S39 stated, "I do it about once a month but not at a regular date and not a certain number of charts per month." After reviewing the variances in the medical records, S39 stated, "(S72) does have a certified person to go to with problems at (another facility location). I'll give her the name and contact information."

Review of the personnel file of S72 revealed only basic facility orientation and no documented job-specific training or competency checks pertaining to audits of medical records.

Review of the facility's policy titled, "Documentation of Medical Records," last revised 10/07, revealed, "All documentation is to be completed in ink in clearly legible writing or by mechanical processes that result in clear, durable copies. All documentation entries are to be dated and time [sic] as required by law. All documentation entries are to be initialed or signed with the indication of the individual's credentials where indicated."

Condition of Participation: Pharmaceutical Se

Tag No.: A0489

Based on observation, interview, document review, and policy review, the acute care hospital failed to meet the requirements of the Condition of Participation for Pharmaceutical Services. This failure had the potential to affect all patients receiving services in the hospital.

The facility failed to ensure:

1. The Director of Pharmacy maintained oversight of training and competency evaluation of staff mixing intravenous medications. (See findings at A0501).

2. Medications were secured in a location accessible only to authorized personnel (see findings at A0502);

3. Expired medications were stored separately from non-expired medications (see findings at A0491);

4. Non-narcotic drugs were properly disposed of to prevent drug diversion (see findings at A0491);

5. Drugs listed in schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act were destroyed and appropriately discarded to prevent diversion (see findings at A0491);

6. Integration of pharmaceutical services in all the hospital and satellite clinics for oversight (see findings at A-0491);

7. The hospital followed its policy /procedures for wasting and disposing its controlled substance (see findings at A-0491).

PHARMACY ADMINISTRATION

Tag No.: A0491

Based on observations, record reviews, and interviews, the facility's pharmaceutical services failed to:
1). Ensure expired medications were stored separately from non-expired medications.
2). Ensure non-narcotic drugs were properly disposed of to prevent drug diversion.
3). Ensure drugs listed in schedules II, III, IV, and V of the Comprehensive Drug Abuse Prevention and Control Act were destroyed and appropriately discarded to prevent diversion.
4). Ensure integration of pharmaceutical services in all the hospital and satellite clinics for oversight.
5). Ensure the hospital followed its policy /procedures for wasting and disposing its controlled substance.
These failures placed the facility at an increased risk for drug diversions and adverse patient outcomes.

Findings included:
On 12/17/21, at 9:30AM, while conducting an observation tour at the Specialty Outpatient Clinic at UMMC North, the following medications in the clinic medication cabinet were found expired:
1. Three (3) Humulin N-Kwik-Pen U-100 unit/ml Pre-filled insulin. Expired November 2021;
2. One (1) Libre 2- Flash Glucose Monitor System Sensor. Expired October 31, 2021;
3. One (1) Synjardy XR 12.5 mg/1000mgs. Expired November 2021;
4. One (1) Victoza Injectable 1.2mg/18mg. Expired October 2021.

Further observation, revealed the following medications were found in the clinic room trashed in an open trash container:
1. Three (3) packets of Xigduo XR (dapagliflozin / metformin) 5/500 mg. Expired October 2021;
2. One (1) packet of Synjardy XR (empagliflozin/ metformin) 10mg/1000mg. Expired November 2021.

These findings were confirmed by S28, who was assigned to work in the clinic.

Interview with S28 on 12/17/21 at 9:55AM revealed it was the staff's responsibility to remove expired medications for disposal. S28 reported she disposed of expired medications by throwing medications in the trash, which is to be taken out by housekeeping staff. S28 said that the Pharmacist never came to check on the clinic medications.
On 1217/21 at 10:35AM, the following medications were observed in a patient examination room at the Specialty Outpatient clinic in an open trash container:
1. Three (3) bottles: Xarelto 20 mg tablet. Expired November 2021
2. One (1) 1% Xylocaine 10 ml/injectable

Interview with S20 on 12/17/21 at 2:40 PM, revealed he was not aware of any approved procedures to destroy or dispose of expired medications in the clinic. S20 reported he was not in-serviced or trained on medication disposal.
Interview with S22 on 12/17/21, at 2:50 PM, revealed a lack of hospital pharmacist or pharmacy staff coordination and integration of the Outpatient Clinic pharmacy services with the hospital. S22 further stated there were no licensed clinical staff members other than the specialty doctors at the clinic and not being aware that expired medications were all discarded in open trash by the housekeeping staff and later dumped outside in a non-covered dumpster. S22 reported a lack of hospital policy and procedures in the disposal of medications in the clinic and no pharmacist involvement in the clinic medications oversight.

Observation tour of UMMC North medication room, emergency department (ED) medication room, and the main hospital pharmacy on 1218/21, revealed the hospital had not set up process in place for wasting (disposal) of used (partial) bulky narcotics.

Interview with S15 on 12/18/21, at 9:44 AM revealed all narcotics were disposed of in the sink and flushed down the drain. S15 stated, "I normally pour it in the sink, to tell you the truth." S15 reported she was not aware of the hospital's procedure for disposal of narcotics. She stated in the past she would dispose in sharps containers, but "another older nurse told me I can waste it in the sink." When asked about how she would dispose of used bulky narcotics, S15 reported she would return them to the pharmacy for destruction. S15 reported she had not engaged with the pharmacist on narcotic waste and disposal. S15 further clarified that they were not documenting how and where the controlled drug was wasted, as required per the hospital policy.

Interview with S31 12/18/2121 at 10:08AM revealed all narcotics were disposed in the sharps container. S31 reported she was a new employee and had not wasted any used bulky narcotics. S31 further stated, "I used to waste narcotics in the cactus (a controlled substance waste management system), but here they don't have one."

Interview with S14 on 12/18/21 at 10:30AM, revealed she was not aware nurses were wasting controlled substances in the sink. S14 reported that it was her expectation for the medication to be wasted in the sharp container. When asked how they wasted bulky, unused controlled substances that would not fit in the sharp's container, she reported it was taken back to the pharmacy.

Interview with S27 on 12/18/21, at 11:00AM at revealed he was not aware nurses were wasting and disposing of narcotics in the sink. S27 also reported the nurses did not bring "partial narcotics to the pharmacy for disposal." When asked about the proper wasting and disposal of narcotics, S27 replied, "we're in the process of looking at buying cactus for our pharmacy and med rooms. Narcotics shouldn't be wasted in the sink". When asked about supervision of the medications in the Specialty Outpatient Clinic, S27 replied, "I don't handle medications at the Specialty Outpatient clinic." S27 reported he was not aware medications were disposed of in open trash and expired medications being stored with unexpired medications. S27 confirmed there was a lack of oversight by his department on medications used by the Specialty Outpatient Clinic. S27 further clarified the lack of hospital policies and procedures in regards to how and where the drug was physically wasted.

The hospital policy and procedures Titled" Medication use process: Automated dispensing cabinet system, policy # PHA.TX 097", with an effective date of May 12, 2021, provided by S27 on December 18, 2021, stated, "All controlled Substances require a witness to waste and a waste comment to be entered, which includes how and where the drug was physically wasted."

PHARMACIST SUPERVISION OF SERVICES

Tag No.: A0501

Based on document review, staff interview, and policy review, the facility failed to ensure that nursing staff training and competencies for mixing of intravenous (IV) medication were supervised by a pharmacist for seven of seven nursing personnel files reviewed (S41, S42, S43, S44A, S44B, S46, and S47). Failure to ensure staff is trained to maintain sterility of the IV end product had the potential to cause negative outcomes for patients receiving these medications.

Findings include:

During a tour of the facility with S40 on 12/18/21 at 10:00AM, S40 stated that there is no pharmacy in the facility other than the automated dispensing system. S40 stated that nursing staff is responsible for mixing some antibiotic powders with normal saline (NS) solution to reconstitute the medication prior to IV administration. S40 stated, "it is mostly the preop nurses who prepared the IV meds." When asked who provides the training and checks the competency of the the nurses to complete this task, S40 stated, "the pharmacist and myself." S40 stated that he/she "signs off" the training and competency checks for compounding of medications and aseptic (free from contamination from disease-causing microorganisms) technique. When asked to provide documentation of Pharmacist and DON involvement in the training and competency program, the S40 was unable to provide such evidence.

Review of the list of IV medications routinely prepared and administered in the facility, titled, "IV Infusion Rx (prescription) Reference Chart," listed the following medications and the diluent (solution mixed with the powdered medication):

Ceftriaxone 500 mg (milligrams) - NS 50 ml (milliliters)
Ceftriaxone 1 gram - NS 50 ml
Cefepime 1000 mg - NS 50 ml
Doxycycline 100 mg - NS 100 ml
Vancomycin 500 mg - NS 100 ml
Vancomycin 1000 mg - NS 250 ml
Zosyn 3.75 gram - NS 100 ml


During an interview with S46, Registered Nurse (RN) on 12/18/21 at 2:20 PM, S46 was unable to recall any annual skills check related to mixing IV medications. S46 stated that he/she trained for clinical skills required by learning from other nurses, not from the DON or pharmacist. Review of the personnel file of S46 revealed no documented orientation or competency evaluation of skill for mixing IV medications.


During an interview with S47, RN, on 12/18/21 at 2:51 PM, S47 stated that he/she was oriented to clinical skills by a "preceptor," another experienced RN, and not from the DON or pharmacist. S47 was unable to recall any annual skills check related to mixing IV medications. Review of the personnel file of S47 revealed no documented orientation or competency evaluation of skill for mixing IV medications.


Review of the personnel file of S40 revealed no documented training or competency check specific to mixing IV medications.

Review of the personnel file of S52 revealed no documented training or competency check specific to mixing IV medications.

Review of the personnel file of S41 revealed no documented training or competency check specific to mixing IV medications. The document titled, "(Facility Name) Competency Checklist," dated 08/10/21, showed multiple skills checked and the document signed only by S41 him/herself, and not by the DON or pharmacist.

Review of the personnel file of S43 revealed a document titled, "IV Admixture (adding a substance to another substance) Competency Checklist," dated 08/05/21 with the competencies checked and signed only by S43 him/herself, not by the DON or pharmacist.

Review of the personnel file of S42 revealed a document titled, "IV Admixture Competency Checklist," dated 08/06/21, with the competencies checked and signed only by S43 noted above who completed a self-assessment on the competencies, and not by the DON or pharmacist.

Review of the personnel file of S44A, RN, revealed a document titled, "IV Admixture Competency Checklist," dated 08/21/21, was initialed by S40, DON, but had no competency skills checked off as completed.

Review of the personnel file of S44B revealed a document titled, "NurseDash Candidate Profile," dated 12/07/2020, including a skills checklist. No training or competency check by the facility was found in the file. No training or competency check specific to IV mixing was found in the file.


Review of the facility's policy titled, "Medication Use Process: Dispensing-Obtaining Medication After Hours-Preparation of IV Admixtures," approved by S27, effective date 08/98, revealed, "The Director of Pharmacy, in collaboration with Nursing and Nursing Education, assures that all nurses who may be called upon to make an IV Admixture during non-Pharmacy hours are appropriately and adequately oriented and trained in this Pharmacy function. This will be accomplished by means of orientation and annual inservice updates (Nursing Skills Workshops).

SECURE STORAGE

Tag No.: A0502

Based on observation, staff interview, and policy review, the facility failed to secure medications in the nursing unit and surgical unit on one of two observation days. Failure to maintain the security of medications could lead to access by unauthorized personnel, with possible negative outcomes for all patients receiving care at this facility.

Findings include:

1.During an observation on the inpatient nursing unit on 12/17/21 from 5:30 AM to 5:50 am, a cabinet in the nurses' station was unlocked with the key in the lock. No personnel were visible in the unit at the time of the observation. Upon examination of the contents of the cabinet, two boxes were noted to contain medications.

The first box, labeled, "Med. Counter box," contained vials of the following medications: diazepam (a controlled substance) 10 milligrams (mg) and gabapentin (an anticonvulsant). These medications were labeled with the name of a current inpatient.

The second box, labeled, "Room 3 Home Meds," contained vials of the following medications: esomeprazole (decreases stomach acid) 40 mg, celecoxib (used for arthritis pain), metaxalone (muscle relaxant) 800mg, gabapentin 300 mg, tizanidine Hcl (hydrochloride/short-acting muscle relaxant) mg., clonidine HCl (treats high blood pressure) 0.1mg, buspirone HCl (treats anxiety) 15 mg, nebivolol HCl (treats elevated blood pressure) 10 mg.


During an interview on 12/17/21 at 5:50 AM, S44B stated that the medication cabinet should be locked, and the key should be kept in the nurse's pocket, not in the cabinet. S44B stated that the medications found unlocked in the cabinet belonged to the two current inpatients.


During an interview with S40 on 12/17/21 at 6:25 AM, the above observations were reviewed. S40 stated, "all medications should be locked."


Review of the facility policy titled, "Medication Use Process: Administration - Management of Bedside Medications," last revised 04/00, revealed, "Medications stored at patient's bedside must be secured and accessible by only authorized personnel and the patient themselves."


2.Observation on 12/17/21 at 7:27 AM, in Operating Room (OR) 2 at the Sugar Land site revealed a full 250 milliliter bottle (not opened) and an opened, half-full bottle of Sevoflurane Inhalation Anesthetic (a volatile anesthetic that provides hypnosis, amnesia, analgesia, akinesia, and autonomic blockade during surgical and procedural interventions) in the unlocked second drawer of the anesthesia cart. Further observation revealed the first, locked drawer of the anesthesia cart was labeled as having medications in the drawer.

In an interview on 12/20/21 at 9:55 AM, S73, when asked by the surveyor if Sevoflurane Inhalation Anesthetic should be locked/secured, S73 stated "it's not a narcotic, but I'm guessing it should be locked."

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on policy review, document review, observation, and interview, the facility failed to (1) implement their COVID-19 (Coronavirus Disease 2019) Pandemic Plan related to screening visitors for signs/symptoms of COVID-19 upon entry to the facility, (2) implement their policy related to cohorting (rooming together) and separation of patients who present with symptoms of COVID-19 from patients who are asymptomatic for symptoms of COVID-19, (3) implement their policy and ensure regular screening of hospital staff before reporting to work and entering the hospital, (4) implement their infection control policy related to hospital construction to prevent and/or decrease the risk of hospital acquired infections in patients, visitors, and healthcare workers. (Refer to A0749).

Findings include:

1. The facility failed to implement their policy and ensure that visitors were screened during working hours at the entrance and at the emergency department (ED) doors after hours. The facility failed to ensure visitors were checked and screened for fever, signs and symptoms of COVID-19, or known or suspected contact with an individual diagnosed with COVID-19.

2. The facility failed to implement their policy related to cohorting patients who present with similar syndromes of COVID-19, grouping affected patients into a designated section of a clinic or emergency department, designated ward or floor of a facility, or a response center in a separate building to minimize the possibility for transmission to other patients at the facility and to staff members.

3. The facility failed to implement their policy related to regular screening of hospital staff before reporting to work using CDC screening instructions to include the presence of fever greater than 100.4 F one hour before reporting to work and associated COVID-19 signs and symptoms. Staff failed to sign daily log whenever reporting to work acknowledging the absence of fever and associated COVID-19 symptoms.

4. The facility failed to implement their infection control policy to prevent and/or decrease the risk of nosocomial (hospital acquired) infections in patients, visitors, and healthcare workers during hospital construction.

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on policy review, document review, observation, and interview, the facility failed to (1) implement their COVID-19 (Coronavirus Disease -2019)Pandemic Plan related to screening visitors for signs/symptoms of COVID-19 upon entry to the facility, (2) implement their policy related to cohorting and separation of patients who present with symptoms of COVID-19 from patients who are asymptomatic for symptoms of COVID-19, (3) implement their policy related to regular screening of hospital staff before reporting to work and entering the hospital, (4) implement their infection control policy related to hospital construction to prevent and/or decrease the risk of hospital acquired infections in patients, visitors, and healthcare workers.
Failure of the facility to ensure infection control policies were followed and implemented placed staff, visitors, patients, and future patients at risk for exposure and acquisition of hospital acquired infections.

Review of the policy entitled, "Visitation - COVID-19," #INF.0.25.0, revised 06/21, showed ... "policy it applies to visitors of ICU (Intensive Care Unit) and all care settings and services where a presumptive (likely but not confirmed) or confirmed case of COVID-19 is being treated, and to screening of the hospital staff ...1) ...visitor access to the facility shall be limited to the following points of entry: during working hours: main entrance of the hospital only. After hours: through ED (Emergency Department) door for visitors who are permitted to visit the vulnerable patients only, of ICU or of the COVID unit ...2) process of screening during visitation: during working hours: when the visitor is entering through the main door/lobby; screening will be performed ...after hours: visitors will enter the hospital through the ED door. The ED personnel at the front desk will be responsible to screen the visitor by checking the temperature and asking for screening questions ...6) Screening of regular staff of the hospital before reporting to work: all staff members should be actively screened using the CDC (Centers for Disease Control and Prevention) screening instructions, for the following signs and symptoms: Presence of fever (i.e., temperature above 100.4 F) which should be checked by the staff themselves an hour before reporting to work and if negative report to work or if positive, inform their manager and stay back. Staff should also check themselves for possible COVID-19 symptoms. Staff is expected to sign the log for screening provided at their workstation and should acknowledge the absence of fever and the associated symptoms of COVID whenever they report to work, and for any history of exposure to a known or suspected contact diagnosed with COVID-19."

Review of the policy entitled, "Hospital Planning and Response To Pandemic COVID-19, #INF.036.0, revised 11/18/21, showed ..."Key Concepts in this Policy/Plan ...1) limit points of entry and manage visitors, screen patient for respiratory symptoms ...2) Isolate symptomatic patients as soon as possible. Set up separate well ventilated triage areas, place patients with suspected or confirmed COVID-19 in private rooms with door closed ...prioritizing AIIR's (Airborne Infection Isolation Rooms) for undergoing aerosol generating procedures ...3) Protected healthcare personnel ...prioritize respirators and AIIRs for aerosol generating procedures ...B. Upon arrival and during the visit ...UMMC ensure rapid safe triage and isolation of patients with symptoms of suspected COVID-19 or other respiratory infection (e.g., fever, cough) ...all patients are asked about the presence of symptoms of respiratory infection and history of travel to areas experiencing transmission of COVID-19 or contact with possible COVID-19 patients. All COVID positive patients are isolated in an examination room with the door closed. If an examination room is not readily available, it is ensured that the patient is not allowed to wait among other patients seeking care ...3. Adhere to Standard and Transmission-Based Precautions ...4. Patient Placement ...cohorting patients who present with similar syndromes, i.e., grouping affected patients into a designated section of a clinic or emergency department, or a designated ward or floor of a facility, or even setting up a response center in a separate building ...designated cohorting sites should be chosen in consultation with infection control, and hospital epidemiologist, and facility engineering staff, based on patterns of airflow and ventilation ...and capacity to safely hold potentially large numbers of patients ...the cohort site has a controlled entry to minimize the possibility for transmission to other patients at the facility and to staff members not directly involved in managing the outbreak ...d) Screening of Visitors ...each visitor should be actively screened for the following: presence of fever ( ...above 100.4F) and/or possible COVID-19 symptoms, known or suspected history of COVID-19, known or suspected contact with an individual diagnosed with COVID individual who do not pass this screening are not permitted to enter the facility ...design and install engineering control to reduce or eliminate exposure by shielding healthcare personnel (HCP) and other patients from infected individual. Example of engineering controls include; physical barriers or partitions to guide patients through triage areas ...air-handling systems (with appropriate directionality, filtration, exchange rate etc.) that are installed and properly maintained."

Review of the policy entitled, "Infection Control Construction/Renovation Policy (Risk Assessment & Permit), #INF.012.2, revised 04/19, showed "Purpose "To prevent and decrease the risk of the acquisition of nosocomial (hospital acquired) infection in patients/visitors/healthcare workers during hospital construction and renovation ...an essential first step in a comprehensive Construction and Renovation Plan is an Infection Control Risk Assessment (ICRA)."

Review of the "Infection Control Construction Permit," dated 12/18/21 for the project posted on the barrier outside the cafeteria/dining room showed a duration of four days for the construction project. The permit was listed as a Class II but failed to show the infection control risk group as required. The permit showed a Class II permit required the following:
- Provide active means to prevent air-borne dust from dispersing into the atmosphere.
- Water mist work surfaces to control dust while cutting.
- Seal unused door with duct tape and black? [sic]
- Block off and seal air vents.
- Wipe surface with cleaner/disinfectant.
- Contain construction waste before transport in tightly covered containers.
- Wet mop and/or vacuum with HEPA filtered vacuum before leaving work area.
- Place dust mat at entrance and exit of work area.
- Isolate HVAC systems in area where work is being performed; restore when work completed.
- Additional requirements to include; use hard barrier / sheet rock and seal door towards hallway.

1. On 12/17/21 at 5:30 AM, four surveyors entered the facility during after-hours visitation through emergency department (ED) entrance doors. The surveyors were greeted by staff at the ED nursing station located at the entrance of the ED. None of the four surveyors were screened for fever, signs and symptoms of COVID-19, or known or suspected contact with an individual diagnosed with COVID-19 prior to touring the ED and facility nursing units.

During an interview with S102 on 12/17/21 at 6:03 AM, S102 confirmed visitors that enter during after-hours visitation from 9:00 PM to 6:00 AM enter through the ED entrance door. A request for the after-hours visitation log was requested and S102 was unable to produce a visitors log for after-hours visitation reflecting visitors were screened for COVID-19 as required per facility policy.

During an interview on 12/17/21 at 2:50 PM, S99 confirmed the facility policy for visitor screening was not being followed.

On 12/18/21 at 8:30 AM, four surveyors entered the facility and none of the surveyors were screened for signs and symptoms of COVID-19 or known or suspected contact with an individual diagnosed with COVID-19. A review of the "Security Visitor/Patient Sign-In Log" and the "COVID-19 Daily Visitors' Screening" main entrance patient screening log dated 12/17/21 and 12/19/21 revealed no evidence of visitor screening for signs and symptoms of COVID-19 or known or suspected contact with an individual diagnosed with COVID. The logs showed the facility had a total of 224 individuals enter the facility without being screened for signs and symptoms of COVID-19 or known or suspected contact with an individual diagnosed with COVID-19.

During an interview on 12/18/21 at 9:00 AM, S99 confirmed the facility failed to appropriately screen visitors entering the main entrance during visitor hours. S99 confirmed visitors entering the ED during after-hours visitation and visitors entering the facility through the main entrance during visiting hours should have been screened for signs and symptoms of COVID-19 or known or suspected contact with an individual diagnosed with COVID-19 per facility policy. S99 confirmed the findings on the main entrance security patient visitor screening log entries for 12/17/21 through 12/19/21.

2. During a tour conducted at the facility main entrance on 12/17/21 at 7:00 AM, two waiting rooms were observed. While facing the main entrance greeting desk where a security guard was sitting, one waiting room was located on the left and a secondary waiting room was located to the right. Observation of the waiting room on the right showed a patient registration window located inside the waiting room with approximately ten seats along the wall and directly in front of the patient registration window.

During an interview on 12/17/21 at 7:00AM, S97 stated that COVID-19 symptomatic patients are placed in waiting room located on the right, which was also where all ED patients and patients being admitted to inpatient register. S97 confirmed patients that are asymptomatic for COVID-19 must enter the waiting room along with symptomatic COVID-19 patients to register.

During an interview on 12/17/21 at 7:05AM, S98 confirmed all patients, including ED patient, as well as patients being admitted to inpatient, register at the window located in the COVID-19 symptomatic waiting room.

During an interview on 12/19/21 at 9:00AM, S99 confirmed the "Hospital Planning and Response To Pandemic COVID-19" policy was not being followed. S99 confirmed COVID positive patients were not being isolated in an examination room with the door closed and COVID-19 symptomatic patients were being allowed to wait among asymptomatic patients seeking care.

3. During a tour of the ED on 12/17/21 at 6:40AM, accompanied by S102, a review of the "Individual Employee Log For COVID-19 Screening," showed the staff currently on duty S104, S105, S106 had no entries for the month of December 2021 and S106 had no entries from August 2021 through December 2021. The employee COVID-19 screening log findings were confirmed with the S102 at the time of the ED tour.

During a tour of the ICU on 12/19/21 at 11:00 AM, accompanied by S91, a random review of 20 "Individual Employee Log For COVID-19 Screening," showed 12 employees with no entries in December 2021 and eight employees with no entries from July 2021 through December 2021. These findings were confirmed with S91 at the time of the tour.

4. A tour of the cafeteria, kitchen, and dining room on 12/18/21 at 10:08AM, accompanied by S111, revealed contractors actively tearing up vinyl flooring causing large amounts of dirt, dust, and debris to be dispersed into the atmosphere. The area under construction failed to have an Infection Control Construction Permit or any barriers or active means to prevent air-borne dust from dispersing into the atmosphere. Staff member S111 asked the contractor to stop all construction until appropriate barriers could be put into place. The tour findings were confirmed by staff member S111 at the time of the tour.

During an interview on 12/18/21 at 11:45AM with S111, S99, S112, and S103 regarding the Cafeteria Construction Project, all members confirmed the facility was removing vinyl floor using a machine to scrape up the old floor. S111 stated the construction project started on 12/17/21 around 3:00 PM. All staff confirmed the construction did not have a completed Infection Control Construction Permit per facility policy or required barriers to control dirt, dust and debris from being dispersed into the air.

During a tour of the cafeteria/dining room construction area on 12/18/21 at 12:00 PM team members S111, S112, S113, S103, and S99 confirmed the presence of dust, dirt and debris being generated and floating in the air without the presence of required containment barriers. The team members confirmed there should have been a Class II Infection Control Construction Permit barrier and stated they would immediately complete the Infection Control Construction Permit for the project and post it on the construction site, as well as complete the required barriers for a Class II construction project. The team members confirmed the following were required, but not present for a Class II Infection Control Construction Permit:
- Active means to prevent air-borne dust from dispersing into the atmosphere
- Water mist work surfaces to control dust while cutting.
- Sealed unused door with duct tape and black plastic.
- Blocked off and seal air vents.
- Surface being wiped with cleaner/disinfectant.
- Workers perform wet mopping and/or vacuum with HEPA filtered vacuum before leaving
work area.
- The presence of a dust mat at entrance and exit of work area.

SURGICAL SERVICES

Tag No.: A0940

Based on observation, policy review, medical record review, document review, and interview, the hospital failed to meet the requirements of the Condition of Participation of Surgical Services.

1. The hospital failed to ensure six (Staff (S)114, S115, S116, S117, S118, S119) of six practitioners' credentialing files reviewed for privileges were granted specific clinical privileges and procedures authorized by the governing board and signed by the department chairman based on the practitioner's license, education, training, experience, current competence, health status, and judgement prior to performing surgery. This deficient practice had the potential to affect all patients receiving surgical services at any of the three hospital campuses. (see findings in tag A0945)

2. The hospital failed to ensure an updated examination of the patient, including any changes in the patient's condition, was documented and in the medical record prior to the surgery when the medical history and physical examination (H&P) was completed within 30 days before admission or registration for six (Patient (P) 29, P32, P33, P35, P37, P38 of eleven patient records reviewed for a documented updated H&P prior to surgery from a sample of 58 patients. This deficient practice had the potential to miss current diagnoses/conditions for patients receiving surgical services (see findings in tag A0953).

3. The hospital failed to ensure an operative report was written or dictated immediately following surgery and signed by the surgeon that described techniques, findings, and tissues removed or altered. Observation on 12/20/21 at 9:25AM in the pre-operative (Pre-op) area at the Sugar Land site revealed the operative note was written, signed, dated, and timed by S58 for two (P40, P41) of two patients observed in Pre-op prior to surgery. There was no operative note documented/dictated/completed in two (P03, P32) of twelve (P03, P22, P29, P31, P32, P33, P34, P35, P36, P37, P38, P39) patient records reviewed for a completed operative note from a sample of 58 patients. This deficient practice had the potential to affect all patients having a surgical procedure at the three hospital campuses (see findings in tag A0959).

4. The hospital failed to: ensure a competency evaluation on performing sterile processing duties was completed for one of one sterile processing technician's personnel file reviewed and ensure one of one sterile processing technician performed manual washing of surgical instruments in accordance with the manufacturer's instructions for use when observed on 12/20/21 at 11:08 AM. These deficient practices had the potential to affect all patients receiving surgical services at any of the three hospital campuses (see findings in tag A0951).

SURGICAL PRIVILEGES

Tag No.: A0945

Based on medical staff bylaws review, credentialing files review, and interview, the facility failed to ensure six practitioners (S114, S115, S116, S117, S118, S119) were granted specific clinical privileges and procedures authorized by the governing board and signed by the department chairman based on the practitioner's license, education, training, experience, current competence, health status, and judgement prior to performing surgery. The failure to ensure surgeons are qualified prior to performing a surgical procedure places all surgical patients at risk for a negative outcome.

Findings include:

Review of the document titled, "United Memorial Medical Center Medical Staff Bylaws," last reviewed April 19, 2019, showed, " ...3. Applicant: Any Practitioner who is qualified to and does submit a complete application for appointment to the Medical Staff of the Hospital. 4. Bylaws: The Medical Staff Bylaws of United Memorial Medical Center ...7. Clinical Privileges The authorization granted by the Governing Board to a Member of the Medical Staff based on a Practitioner's license, education and training, experience, current competence, health status, and judgment to provide specific care services with well defined limits. The delineation of a Practitioner's clinical privileges included limitations, if any, on the individual's privileges to admit and treat patients or direct the course of treatment for the conditions for which the patients were admitted. 8. Credentialing: The process of granting authorization to members of the Medical Staff by the Governing Board to provide specific patient care and treatment services in the hospital within defined limits based upon a Practitioner's license, education and training, experience, current competence, health status, and judgment. 9. Delineation of Clinical Privileges: The process of listing the specific clinical privileges a Medical Staff Member may be granted ...11. Department Chairman: The Medical Staff Member appointed or elected in accordance with the Bylaws to serve as the head of a Medical Staff department ...A. Credentials Committee 1. The Medical Executive Committee serves as the Medical Staff Credentialing Committee. 2. Duties: ...c. Review the medical staff application forms and the clinical privileges cards ...g. Review all Department Chairman recommendations for medical staff appointment applications, progression from provisional status and reappointment applications and requested clinical privileges ...Section 1 Clinical Privileges, Appointment / Reappointment A. Every Practitioner with Medical Staff membership and clinical privileges shall be entitled to exercise only those clinical privileges specifically granted to him by the Governing Board ...D. The initial application for medical staff appointment must indicate the specific clinical privileges requested by the applicant ...including consideration as to whether the facility is capable of providing the required equipment, personnel and supportive services within a specified time frame."

Review of Practitioner S114's delineation of privileges application for spine surgery dated 08/26/2021 showed a list of privileges requested but failed to show if the privileges were approved or denied. The application was signed by the S120 on 09/18/2021.

Review of Practitioner S115's delineation of privileges application for orthopedic surgery dated 03/10/21 showed a list of privileges requested with a Governing Board member's signature but failed to show the date the privileges were granted.

Review of Practitioner S116's delineation of privileges application for orthopedic surgery dated 03/10/21 showed a list of privileges requested with a Governing Board member's signature but failed to show the date the privileges were granted.

Review of Practitioner S117's delineation of privileges application for orthopedic surgery dated 02/26/2020 showed a list of privileges requested including total shoulder replacement but failed to show if the procedure was granted or denied. The application also failed to show what facility the privileges requested were for. Review of a second application for Practitioner S117's delineation of privileges for general surgery dated 03/28/21 showed a list of privileges requested but failed to show which privileges were granted and also failed to show the required signature the S120. Review of a third application for Practitioner S117's delineation of privileges for plastic surgery dated 03/28/2021 showed a list of privileges requested and signed by the S120 on 06/29/21 but failed to show which privileges were granted.

Review of Practitioner S118's delineation of privileges application for podiatry surgery dated 10/29/20 showed a list of privileges requested and signed by S120 on 03/01/2021 but failed to show what facility the requested privileges were granted for.

Review of Practitioner S119's delineation of privileges application for spine surgery dated 04/13/21 showed a list of privileges but failed to show what privileges were requested. The application was signed by S120 on 10/30/2021.

During an interview on 12/20/21 at 4:30PM, S93 confirmed the above Practitioner credential file findings and that the applications were not in compliance with the facility Medical Staff Bylaws.

OPERATING ROOM POLICIES

Tag No.: A0951

Based on observation, policy review, document reviews, personnel file review, and interviews, the hospital failed to:
1. Ensure a competency evaluation on performing sterile processing duties was completed for one of one sterile processing technician's personnel file reviewed (S113).
2. Ensure one of one sterile processing technicians (S53) performed manual washing of surgical instruments in accordance with the manufacturer's instructions for use.These deficient practices had the potential to affect all patients receiving surgical services at any of the three hospital campuses.

Findings include:

1. Review of the policy titled, "Staff Competency," #HRD.019.042.3, last reviewed 04/19 showed, "Purpose: To describe the hospital's program for ensuring that patient care and services are provided by individuals competent to perform their assigned duties. Scope: This policy applies to all individuals providing patient care and services at United Memorial Medical Center ...It is the policy of the hospital to maintain a comprehensive program for ensuring that employees possess the skills and competencies required to safely and effectively provide patient care and services. It is also the policy of the hospital to demonstrate, assess, maintain and improve staff competence on an on-gong basis ...It is the responsibility of the Department Director to identify and maintain competencies based on the specific needs of the patient population served ...Competence assessment for staff and contracted staff who work in the same capacity as staff providing care, treatment, and services is based on the following: ...Direct observation by qualified supervisor or preceptor. Successful completion of general and unit specific skills checklist. Successful performance of identified procedure ...Competency of skill inventory is updated when any of the following occur: New technology is introduced, performance of skill is limited and competency needs to verified ...2. Orientation Period ...c) Competency assessment: The employee will complete skills/competency self-assessment. The department director or designee will verify verification of the employee's initial competency level through the first 90-120 days of employment."

Review of S113's personnel file showed a consultant agreement dated 11/16/21 for the position of sterilization technician in the sterile processing department. Continued review of S113's personnel file failed to show the presence of a resume, skills/competency self-assessment, or verification by the director or designee of the employee's initial competency level through the first 90-120 days of employment.

In an interview on 12/20/21 at 4:00 PM, the S122 confirmed the above findings in the personnel file of staff member S113.


2. Review of the Center for Disease Control and Prevention's (CDC) "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 Update: May 2019" indicated ". . . Duration of Exposure Items must be exposed to the germicide for the appropriate minimum contact time . . . all applicable label instructions on EPA [environmental protection agency]-registered products must be followed . . . in general, longer contact times are more effective than shorter contact times. . . . Cleaning is the removal of foreign material (e.g, [for example] soil and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process becomes more difficult and the disinfection or sterilization process less effective or ineffective. . . . With manual cleaning, the two essential components are friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is an old and dependable method. Fluidics (i.e., [that is] fluids under pressure) is used to remove soil and debris from internal channels after brushing and when the design does not allow passage of a brush through a channel . . . For instrument cleaning . . . Enzymatic solutions should be used in accordance with manufacturer's instructions, which include proper dilution of the enzymatic detergent and contact with equipment for the amount of time specified on the label. . ."

Review of the "Renuzyme Plus Product Specification," the enzymatic cleanser used by S53 to manually wash surgical instruments, indicated "Renuzyme Plus is a dual-enzyme formula providing extra cleaning at lower temperatures. Application Designed for severe soils, cold-water applications, and when shorter contact/soak times are required. Items placed in soak tanks, ultrasounds, or manually cleaned benefit from the dual-enzyme formula. . . Manual Cleaning Immerse soiled instruments in a basin containing a solution of 1 oz [ounce] to 2 oz per gallon (8-16ml/L) [milliliters per liter] of water. Amount of product used will vary depending on severity of soil conditions. Renuzyme Plus can be used in both cold and warm water. For best results, Renuzyme Plus should be used in warm water 27[degrees symbol]-65[degrees symbol]C [Centigrade] (81[degrees symbol]F[Fahrenheit]-149[degrees symbol]F). Soak for 1-10 minutes. Do not exceed 65[degrees symbol]C (149[degrees symbol]F) temperature. Lower water temperatures will require longer soak times. After soaking, thoroughly rinse and transfer to manual, ultrasonic or washer/disinfector cleaning operation. Discard used solutions daily or when visibly soiled."

Review of CDC's "Guideline for Hand Hygiene in Health-Care Settings," dated 10/25/02, indicated, ". . . Recommendations 1. Indications for handwashing and hand antisepsis A. When hands are visibly dirty or contaminated with proteinaceous material or are visibly soiled with blood or other body fluids, wash hands with either a non-antimicrobial soap and water or an antimicrobial soap and water . . . B. If hands are not visibly soiled, use an alcohol-based hand rub for routinely decontaminating hands in all other clinical situations . . . H. Decontaminate hands if moving from a contaminated-body site to a clean-body site during patient care. . . . J. Decontaminate hands after removing gloves . . ."

Review of the hospital policy titled, "Infection Control Decontamination Flow," last reviewed April 2019, indicated, ". . . There will be established guidelines for the flow of contaminated equipment and supplies in the Operating Room to minimize the potential for cross-contamination. II. Process Standards To facilitate the attainment of Outcome Standards A. Instrument washed between cases for re-sterilization will be cleaned in designated cleaning areas and NOT in scrub sinks or other areas of the Operating Room Suite. B. Instruments being washed between cases must be cleaned in the Decontamination Room with designated disinfectant. C. Instrument are transported on carts and covered while in transport. Carts will be cleaned with disinfectant after use." There was no documentation of the process to be followed for disinfection and sterilization of surgical instruments.

Review of the undated printed list titled, "UMMC [United Memorial Medical Center] - Sugarland Endoscopy," contained in a plastic sleeve above the work area in the decontamination room, indicated, "Sterile Processing Detergent - Getinge Clean [name of washer used for washing surgical instruments] - Renuzyme [name of disinfectant] . . . Man [manual] = [equals] 1-2 oz [ounce] per Gal. [gallon] = We use 6 Gal. [referring to amount of water] = 6-12 oz per wash [referring to Enuzyme Plus] = 9 oz [amount of Enuzyme Plus dispensed automatically from wall-mounted dispenser] = 266.14 ML [milliliter]"

Observation in the Decontamination Room at the Sugar Land location on 12/20/21 at 11:08AM revealed S53 donned a plastic apron over S53's scrubs, gloves, mask, and face shield. S53 was observed to not tie the apron which resulted in the apron flapping and exposing the back of S53's scrubs when S53 turned S53's back to the cart with contaminated surgical instruments to place the first washed tray of instruments into the washer. S53 filled the sink that had a marked line for six gallons with water from the tap. S53 then dispensed Renuzyme Plus from the wall-mounted dispenser. S53 stated the dispenser dispensed nine ounces of Renuzyme Plus and the water from the tap was filtered. There was no observation of a thermometer and timing device in the room. Observation revealed S53 did not check the temperature of the water and Enuzyme solution before placing surgical instruments to soak and throughout the cleaning of three separate sets of instruments. Observation revealed once S53 added the last surgical instrument to the solution, S53 began to remove instruments and rinsed the instruments under the running tap water in the next sink compartment from the one used to soak instruments. There was no timing done by S53 to assure that the last instruments placed to soak had soaked for at least one minute before removing the instruments and rinsing them. After each tray of instruments had been manually washed, S53 placed one tray in the washer at 11:35AM and a second tray in the washer at 11:52AM. S53 removed the rubber mat from the tray that contained the contaminated surgical instruments at 11:53AM, rinsed the mat under running filtered tap water, dipped the rinsed mat in the enzymatic solution, immediately removed the mat from the enzymatic solution, and placed the mat in the empty third compartment sink (not used for soaking or rinsing instruments). At 11:58AM S53 removed the rubber mat from the third compartment sink and placed the mat in the wire basket that had contained the contaminated surgical instruments (had not been washed and soaked with enzymatic solution). S53 then placed the instruments that had been soaked and rinsed on the rubber mat. S53 was observed to remove gelpi retractor (a self-retaining surgical instrument used to hold back organs and tissues to increase access in deep incisions) from the enzymatic solution and placed the retractor in the tray to be placed in the washer without first rinsing the retractor. Observation revealed once the washer was filled, S53 started the washer at 12:25PM. At 12:30PM, while wearing the same gloves used to clean contaminated surgical instruments, S53 used CaviWipes (disposable towelettes pre-saturated with CaviCide Surface Disinfectant Cleaner) to wipe the counter and sinks. Observation revealed S53 touched and opened the CaviWipe container with contaminated gloves to place a wipe through the opening used to remove wipes without opening the entire container.

In an interview on 12/20/21 at 1:50PM, S53 confirmed S53 did not check the temperature of the water and enzymatic solution. S53 stated he/she is supposed to check the temperature. S53 confirmed S53 did not tie his/her apron. S53 stated S53 does not have a means of measuring the time that instruments are soaked. S53 stated S53 has no procedure for decontamination and sterilization of instruments other than the one-page policy S53 presented. S53 confirmed the above observations when the observations were reviewed with S53.

UPDATED EXAM

Tag No.: A0953

Based on medical staff rules and regulations review, medical record review, and interview, the hospital failed to ensure an updated examination of the patient, including any changes in the patient's condition, was documented and in the medical record prior to the surgery when the medical history and physical examination (H&P) was completed within 30 days before admission or registration for six of 11 patient surgical records reviewed (P29, P32, P33, P35, P37, P38). This deficient practice had the potential to affect all patients receiving surgical services at any of the three hospital campuses.

Findings include:

Review of the "United Memorial Medical Center Medical Staff Rules & [and] Regulations," last reviewed 04/19/19, indicated ". . . B. History and Physical Examination for Inpatient Admissions, Observation Status and Day Surgery Procedures. 1. Complete History & Physical A complete admission history and comprehensive physical examination, dictated or hand written shall be completed by an admitting physician or the admitting physician's AHP [allied health professional] authorized to perform a history and physical examination and shall be recorded and in the medical record within twenty-four (24) hours after admission including weekends and holidays. The history & physical shall include the following: . . . Signature/date/time . . . 2. If the H&P was performed within thirty (30) days by the MD/DO [medical doctor/doctor of osteopathic medicine] a. An appropriate assessment must be performed by the MD/DO. The assessment must include: A physical assessment of the patient to update any components of the patient's current medical status that may have changed since the H&P or to address any areas where more current data is needed. Confirmation that the necessity for the surgical procedure or care is still present based on the assessment of the patient's condition, and any comorbidities, in relation to the reason the patient was admitted or surgery is to be performed. B. An updated entry must be documented within twenty-four (24) hours after admission but prior to surgery, for any procedure requiring consent or anesthesia services, documenting the patient's current status and/or any changes in the patient's condition when the medical history and physical examination are completed within 30 days prior to admission. The updated note must be attached on the H&P. c. The H&P, including all updates and assessment for the admission must be on the patient's chart within twenty-four (24) hours, but prior to surgery. 3. An H&P that has been documented more than 30 days prior to admission does not meet the requirements for a current H&P and cannot be updated with an interval note. A new H&P is required. 4. When the history and physical examination are not recorded before an operation, or any potentially hazardous diagnostic or invasive procedure, the procedure shall be canceled, unless the Physician states in writing that delay would be detrimental to the patient. . . ."

1. Review of P29's H&P indicated S58 performed the H&P on 12/11/21. Further review indicated there was no documentation of an update documented on 12/14/21 prior to P29's surgical procedure.

2. Review of P32's medical record indicated P32 had a surgical procedure on 11/18/21. Review of P32's "Intraoperative Record" indicated the surgery began at 12:30 PM on 11/18/21. Further review indicated P32's H&P was performed on 10/27/21 and updated on 11/18/21 at 1:00 PM after the surgery had begun and not prior to surgery.

3. Review of P33's medical record indicated P33 had two endoscopy procedures (examination of the gastrointestinal tract using a camera held on to a flexible tube called an endoscope) on 11/01/21 performed by S59. Further review indicated an H&P was documented on 10/27/21. There was no documentation of an updated H&P by S59 prior to P33's surgery.

4. Review of P35's medical record indicated P35 had a surgical procedure on 11/01/21 performed by S58. Further review indicated S35's H&P was performed by S58 on 10/21/21. There was no documentation of an updated H&P by S58 prior to P35's surgery.

5. Review of P37's medical record indicated P37 had a surgical procedure performed on 11/05/21 by S62. Further review indicated S62 performed a H&P on 10/21/21. There was no documentation of an updated H&P by S62 prior to P37's surgery.

6. Review of P38's medical record indicated P38 had an injection procedure in the operating room on 11/11/21 performed by S64. Further review indicated S64 documented a H&P on 10/18/21. S64 documented an update on 11/11/21 at 6:51 AM, and the surgery began at 6:48 AM. The updated H&P was not documented prior to the start of the surgery.

In an interview on 12/19/21 at 11:26 AM, S40 stated an updated H&P should be in the patient's medical record before the procedure if the H&P was performed within 30 days of the procedure. S40 stated a new H&P is needed if the H&P was done more than 30 days before the procedure.

In an interview on 12/20/21 at 9:40 AM, S58 stated if an H&P update is not timed, one cannot assure it was done prior to surgery.

INFORMED CONSENT

Tag No.: A0955

Based on medical staff rules and regulations review, medical record review, and interview, the hospital failed to ensure that there was a properly executed informed consent for eight (P32, P33, P34, P35, P36, P38, P40, and P41) of twelve surgical patient records reviewed . This deficient practice had the potential to affect all patients receiving services at any of the three hospital campuses.

Findings include:

Review of the "United Memorial Medical Center Medical Staff Rules & [and] Regulations," last reviewed 04/19/19, indicated ". . . 7. Informed Consent All inpatient and outpatient medical records must contain a properly executed and completed written informed consent form. . . . 9. Clinical entries 1. The author of each entry shall be identified and shall authenticate his entry. All clinical entries in the patient's medical record shall be accurately dated, timed and authenticated by written signature, identifiable initials or computer key. . . ."


1. Review of P32's "Anesthesia /Perioperative/Pain Management" consent for a procedure performed on 11/18/21 indicated no date and time when the anesthesiologist and the witness signed the consent.

2. Review of P33's "Anesthesia /Perioperative/Pain Management" consent for a procedure performed on 11/01/21 indicated no date and time when the witness signed the consent and no signature, date, and time of the anesthesiologist providing the anesthesia.

3. Review of P34's "Anesthesia /Perioperative/Pain Management" consent for a procedure performed on 12/03/21 indicated no date and time when the anesthesiologist and the witness signed the consent.

4. Review of P35's "Disclosure and Consent" for a surgical procedure performed on 11/01/21 indicated no time when the surgeon signed the consent, and no date and time when the witness signed the form.

5. Review of P36's "Anesthesia /Perioperative/Pain Management" consent for a procedure performed on 11/01/21 indicated no date and time when the anesthesiologist and the witness signed the consent.

6. Review of P38's "Anesthesia /Perioperative/Pain Management" consent for a procedure performed on 11/11/21 indicated no date and time when the anesthesiologist and the witness signed the consent.

7. Review of P40's "Disclosure and Consent" for a surgical procedure performed on 12/20/21 indicated no time when the surgeon signed the consent and no date and time when the witness signed the form.

8. Review of P41's "Disclosure and Consent" for a surgical procedure performed on 12/20/21 indicated no time when the surgeon signed the consent and no date and time when the witness signed the form.

In an interview on 12/19/21 at 12:45 PM, S40 stated, "everything should be dated and timed," when shown patient consents that had no signature, date, and/or time when signed by the physician and witness.

OPERATIVE REPORT

Tag No.: A0959

Based on observation, medical staff rules and regulations review, medical record review, and interview, the hospital failed to ensure an operative report was written or dictated immediately following surgery and appropriately dated, timed, and signed by the surgeon for two of two patients observed (P40, P41) and for two of twelve patient surgical records reviewed (P03, P32) . This deficient practice had the potential to affect all patients having a surgical procedure at the three hospital campuses.

Findings include:

Review of the "United Memorial Medical Center Medical Staff Rules & [and] Regulations," last reviewed 04/19/19, indicated ". . . A medical record must be maintained for each inpatient and outpatient evaluated or treated in any part or location of the hospital. 9. Clinical entries 1. The author of each entry shall be identified and shall authenticate his entry. All clinical entries in the patient's medical record shall be accurately dated, timed and authenticated by written signature, identifiable initials or computer key. . . . 11. Operative Reports . . . b. Operative or other high-risk procedure reports shall include a detailed account of the findings of surgery, details of the surgical technique, specimens removed, post-operative diagnosis, and name of primary surgeon and any assistants. c. Operative or other high-risk procedure reports shall be written or dictated immediately following surgery for inpatients as well as outpatients. d. The completed operative report is authenticated by the surgeon and filed in the medical record as soon as possible after surgery. e. An operative or other high-risk procedure progress note is entered in the medical record immediately after the procedure, if the full operative report cannot be entered into the record upon completion of the operation or procedure before the patient is transferred to the next level of care."

Observation on 12/20/21 at 9:25 AM in the Pre-op area at the Sugar Land site revealed P40's "Immediate Post-Op Note / Orders" was signed by S58 on 12/20/21 at "12P" (12:00 PM) and included the preoperative diagnosis, postoperative diagnosis, procedure performed, no complications, no estimated blood loss, and no specimen. The operative note was observed by the surveyor on 12/20/21 at 9:30 AM while P40 was in Pre-op waiting to be taken to surgery.

Observation on 12/20/21 at 9:25 AM in the Pre-op area at the Sugar Land site revealed P41's "Immediate Post-Op Note / Orders" was signed by S58 on 12/20/21 at "11 A" (11:00 AM) and included the preoperative diagnosis, postoperative diagnosis, procedure performed, no complications, no estimated blood loss, and no specimen. The operative note was observed by the surveyor on 12/20/21 at 9:30 AM while P41 was in Pre-op waiting to be taken to surgery.

1. Review of P03's "Physician History and Physical" (H&P) dated 12/06/21 at 11:10 PM showed P03 was admitted for complaints of shortness of breath (SOB), cough, headache and body aches. P03 was diagnosed with COVID-19 (Coronavirus Disease-2019) and admitted to the hospital COVID-19 nursing unit. Review of P03's "Physician Postoperative Note" dated 12/15/21 at 9:05 AM showed a diagnosis of COVID-19 pneumonia and respiratory failure. The postoperative note showed the surgical procedure was a placement of a tracheostomy (a hole surgically placed in the throat for an airway). The postoperative note failed to show the following:
-Date and times of the surgery.
-Name(s) of the surgeon(s) and assistants or other practitioners who performed surgical tasks (even when performing those tasks under supervision).
-Post-operative diagnosis.
-Complications, if any.
-A description of techniques, findings, and tissues removed or altered.
-Surgeons or practitioners name(s) and a description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon/practitioner (significant surgical procedures include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues).
-Prosthetic (an artificial device that replaces a missing body part) devices, grafts, tissues, transplants, or devices implanted, if any,

During an interview on 12/20/21 at 3:10 PM, the S102 confirmed the postoperative note findings in the medical record of P03.

2. Review of P32's medical record indicated P32 had an excision of a recurrent pilonidal cyst on 11/18/21. Review of the entire medical record indicated there was no operative note documented or dictated by S65.

In an interview on 12/20/21 at 9:37 AM, S43 stated the operative note is supposed to be completed after surgery. S43 stated the operative note is checked by the post-anesthesia nurse after surgery.

In an interview on 12/20/21 at 9:40 AM, S58 stated the operative note shouldn't be documented until after the procedure. S58 gave no explanation for S58 documenting the operative note before the surgical procedure began.

In an interview on 12/19/21 at 12:45 PM, S40 confirmed the finding of no operative note in P32's medical record, but S40 "would not confirm they're [the findings] against the federal regulations, because I'm not familiar with the regulation."

EMERGENCY SERVICES

Tag No.: A1100

Based on observation, interviews and records review the facility failed to provide entrance into the Emergency Department (ED)/Emergency Room (ER) in a timely manner (North location). This failed practice could result in serious harm or death to a patient needing access to emergency services.
Refer to tag 1101.

ORGANIZATION AND DIRECTION

Tag No.: A1101

Based on observation, interviews and records review the facility failed to provide entrance into the Emergency Department (ED)/Emergency Room (ER) in a timely manner (North location). This failed practice could result in serious harm or death to a patient needing access to emergency services.
On 12/17/21 at 5:30AM surveyors attempted to enter the main entrance of the ED at UMMC North. A security services car was parked in the front of the ED, with a security guard inside. The security guard had a direct vision of the ED main entrance. The warning lights in the car were on.
When the survey team attempted to open the ED main door, the door was locked. There was a sign at the door with instructions in english and spanish that stated "Please call ER staff and explain symptoms". There was also a printed phone number to call.
At 5:38 AM a call was placed to the number posted on the ED main entrance door. The call went to voicemail. A voicemail was left requesting entrance. There was no a return call.
At 5:51 AM a second call was placed to the number posted on the ER main entrance door requesting entrance for medical assistance. The call went to voicemail. There was no return call.
At 5:54 AM surveyors observed two hospital staff entering from the right side entrance door of the ED. The surveyors were within visibility of the two staff members.
At 5:59 AM a third call was placed to the number posted on the ED main entrance door. There was no answer.
At 6:12 AM a staff member in the ED was looking out through a small glass window inside the ER when the surveyors waved in an attempt to catch her attention.
At 6:13 AM the staff member came to the ED main entrance and opened the door.
S11 unlocked the ED main entrance door indicating she was the only staff in the ED and was also the House Supervisor. S11 stated she was taking care of one patient and the Doctor and X-Ray Technician were also responsible to answer the telephone however, neither was present. The staff indicated the security guard could unlock the door for patients to enter. According to S11, the ED main entrance door was locked from 7:00 PM to 6:00 AM due to high crime in the area.
When asked what would happen if a patient comes with a serious emergency and the door was locked, S11 stated "The patient will have to wait outside until the ED staff or the security guard can open the door".
On 12/17/21 6:20 AM S25 was interviewed. The staff stated she entered the ED from the side door at 5:54 AM. She indicated the side door is for hospital employees to be screened for COVID symptoms before entering the work area. When asked if she saw two people in front of the ED door waiting to enter earlier in the morning , the staff member stated, "Yes I did, but it is not my job to unlock the door". When asked if she mentioned to anyone there were people at the ER main entrance waiting to come inside, she responded, "No, there was nobody at the ED desk".

On 12/17/21 at 6:24 AM an interview was conducted with S12. During the interview the staff member stated she does not work in the ED, however, she knows the ED main entrance door is locked from 7:00 PM to 6:00 AM because of uncertainty at night.
On 12/17/21 at 6:40 AM an interview with S13 was conducted. The staff member stated the ED main door is locked from 7:00 PM to 6:00 AM.
On 12/17/21 at 6:47 AM S14 was interviewed. The staff member indicated the hospital ED main entrance door is locked from 7: 00 PM to 6:00 AM due to security issues. S14 stated the ED nurse is usually the night shift house supervisor, and the only nurse from 7:00 PM to 7:00 AM. S14 stated the ED Doctor and the X-Ray Technician should be at the ED front desk to open the door or answer the telephone.
On 12/17/21 at 12:15 PM S14 provided the hospital policy and procedure titled "Assessment and Reassessment of the ED Patient." The policy reflects: "To efficiently assess and prioritize patient according to acuity of patient's condition, and to provide timely medical screening examination and treatments to patients who present to the Emergency Department requesting examination or treatment of an emergency medical condition".
On 12/17/21 at 12:20 PM an interview with S14 was conducted. During the interview the staff member stated she did not know the Doctor or X-Ray Technician location from 5:00 AM to 6:00 AM or why they did not respond to the telephone call or voicemail. The staff member also admitted to not having a hospital policy and procedure in writing that addressed the locking of the ER door from 7:00 PM to 6:00 AM. The hospital administration agreed to lock the ER doors from 7:00 PM to 6:00 AM during the COVID-19 pandemic due to security issues at the location. When asked what process the hospital has in place to answer the telephone in the ED during the time the doors are locked, the staff member replied, "I thought we had a process but I see the process failed".
On December 17, 2021 approximately 3:30 PM security guard company owners S18 and S19 were interviewed. During the interview, it was revealed the security guard did not have keys to the ED main door entrance but can call the ED staff and inform them of a patient outside their doors. The security guard company owners did not know why the security guard on post did not call the ED staff.

EMERGENCY ROOM LOG

Tag No.: A2405

Based on interview and record review, the facility failed to maintain an accurate ED Central Log. P15 was transported via ambulance on 8/22/2021 and was not recorded in the ED Central Log.

Findings included:

TX00394743

Record review of a facility policy titled "Emergency Medical Treatment & Labor Act, last reviewed date 04/2019, stated "Record-keeping: The hospital must maintain the following ...-a central log on each individual who comes to the emergency department seeking assistance and whether ...transferred, admitted, stabilized, discharged etc ...for five(5) years.

During a telephone interview on 12/20/2021 at 11:42 AM with Houston Fire Department (HFD) Emergency Medical Services (EMS) Supervisor (FD80), he stated he was called out to United Memorial Medical Center (UMMC) to assist his EMS crew. His crew arrived on scene to United Memorial Medical Center on 8/22/2021 at 12:08PM with a patient to present to UMMC emergency room. The EMS crew on scene was told by UMMC ER staff that the facility was not accepting patients at that time and that the EMS crew and patient should go elsewhere or wait with the patient for unknown amount of hours. Upon arrival to the scene, FD80 stated he observed patient (P15) in a wheelchair along with his crew outside of the emergency room in between the first and second set of double doors, "in a breezeway area." FD80 stated "the patient had not been triaged or registered" and "I asked to speak to the supervisor". The nursing supervisor (S121) at the time, came to speak with FD80 and stated they are not refusing the patient, but the HFD crew will have to wait with the patient for about "7 hours". FD80 stated he then called the HFD medical director and was given the directive to transport the patient to a different hospital.

During a telephone Interview on 12/19/21 at 12:10PM with FD79, Houston Fire Department (HFD), supervisor, FD79 stated his crew arrived at UMMC Tidwell location on 08/16/2021 at approximately 11:00 pm. HFD crews, per their policies, had called ahead to the emergency medical services base station and inquired as to the "status" of UMMC. According to the base station, UMMC was on "Drive By" status, indicating that EMS units "should pass if possible". The patient was then informed of UMMC's status as busy, but the patient insisted on going to UMMC for personal reasons. The HFD crew was not able to enter the emergency room, as the doors would not open. The HFD crew and the patient waited in the parking lot for several minutes attempting to gain access. FD79 stated he eventually was able to speak to the house supervisor (S121). The house supervisor (S121) stated the crew would have to wait two to three hours due to the emergency room being busy. FD79 stated he then called the HFD Medical Director and got approval for transport to a different hospital.

Record review on 12/19/2021 at 11:50AM of the UMMC ED Central log for August 22 & 23, 2021, failed to reveal documentation of registration of P15.

Record review on 12/20/2021 at 09:45AM of the UMMC facility ED Central log for August 15, 16, &17, failed to reveal documentation of registration of P59

Record review of UMMC policy titled "Emergency Medical Treatment & Active Labor Act (EMTALA)", last reviewed 04/19, showed:

-the hospital shall provide a medical screening exam (MSE) by qualified medical personnel for every patient who comes to the emergency department and makes a request for examination or treatment of a medical condition;
-an MSE shall also be conducted when a request is made on behalf of an individual, even if the person requesting the exam is not the individual's legally authorized representative.

Record review of UMMC policy titled "Diversion Policy" last reviewed 04/19 showed:
-All patients presenting to the Emergency Department will be medically screened and evaluated regardless of the hospital's drive-by status.

MEDICAL SCREENING EXAM

Tag No.: A2406

Based on interview and record review, UMMC Tidwell location failed to provide a medical screening exam (MSE) to patients transported to the facility by ambulance on 8/16/2021 & 8/22/2021 (P59 & P15). Both patients were subsequently transported to Hospital A Emergency Department (ED).

Findings include:

During a telephone Interview on 12/19/21 at 12:10PM with the Houston Fire Department (HFD), supervisor (FD79), FD79 stated his crew arrived at UMMC Tidwell location on 08/16/2021 at approximately 11:00PM. HFD crews, per their policies, had called ahead to the emergency medical services base station and inquired as to the "status" of UMMC. According to the base station, UMMC was on "Drive By" status, indicating that EMS units "should pass if possible". The patient was then informed of UMMC's status as busy, but the patient insisted on going to UMMC for personal reasons. The HFD crew was not able to enter the emergency room, as the sliding glass doors were locked. FD79 stated his crew was met by a UMMC staff member. The UMMC staff member told the HFD crew that UMMC was on divert and had no staff and no beds. The UMMC supervisor also came out to the ambulance and told the HFD crew that they would not be allowed in and must wait in the parking lot. The UMMC supervisor then closed the emergency room doors and walked away. The HFD crew and the patient waited in the parking lot for several minutes while they continued their attempts to gain entry to the ED. The sliding glass automatic door remained locked.
FD79 stated his crew called him to the scene for assistance. Upon arrival to UMMC, FD79 attempted to enter the emergency room department doors, which were locked. FD79 stated UMMC staff would not allow him to enter the UMMC ED either. After a period of time, FD79 stated that someone who appeared to be a UMMC staff member entered the facility via a door, and he stated "I was able to sneak in behind that person in order to get into the facility." FD79 said he then walked into the emergency room, to the front desk. There was no one at the front desk. He also observed the waiting room was empty. He proceeded further down the hall and encountered a staff member. FD79 inquired as to who was the charge nurse on duty. FD79 stated the staff member replied "They are working." "I thought we were on saturation." "There are only two nurses." FD79 stated, he eventually was able to speak to the house supervisor S121. The house supervisor S121 stated the crew would have to wait two to three hours due to the emergency room being busy. FD79 stated he then called the HFD medical director and got approval for transport to a different hospital. Over 30 minutes of time had elapsed during the crew's attempts to gain access to UMMC's emergency department.

Record review of the Patient Care Report (PCR) from Houston Fire-EMS (an official report and transcript of a patient encounter) dated August 16, 2021 for P59 showed:
"Telemetry contacted for transport to United Memorial Medical Center with a 3 min eta. Telemetry responded with ER sat [sic] and diversion, as with every other local hospital. Situation was explained to patient and patient stated she still wanted to go because she has no transport, and it is within walking distance." "Patient was assisted to front entrance ....where crew was met by nurse. Nurse stated to crew and patient that UMMC was on divert and also had no beds and no staff. Crew asked nurse if they are denying care to which she replied she is getting her supervisor."

HFD Supervisor was then contacted.

"Dr. approached at ambulance and stated the same as nurse and told crew he can't allow us to come in, but wait outside and cannot guarantee a bed for patient, and would not let anyone in to triage pt. Dr. was asked if he is refusing care, which he closed doors and walked away"

HFD supervisor spoke to UMMC then to HFD medical director.

"Crew was advised to transport patient to Hospital A being next closest ER. Patient was secured again on bench and transported to Hospital A. Patient was triaged in ER and taken to waiting room."

FD79 provided an audio recording of the emergency room encounter on 8/16/2021. Recording summary:

FD79 heard saying "Hey! You work here? They wouldn't let them in. So I was in the area and they called me." "Hi sir are you the charge nurse?"
An unknown male voice responded with "No". FD79 then asks "Where is the charge nurse?"
The unknown male voice responded with "They are all working."
FD79 responds with, "We have an ambulance outside and they just called me to see if ...they are outside and they weren't being let in. They just told me to see if I can find out what was.."
The unknown male voice responds, "We are short of staff. We have only two nurses and then we are swamped with patients from the day shift and then at this time also. I thought we are on saturation .....we are two nurses so I don't know who see the patient."
FD79 is heard saying, "We just need to know if you are going to accept the patient or not accept the patient."
The unknown male voice responds, "We are not refusing ...."
FD79 asks "Who is in charge then? You are."
Male voice: [inaudible words] " We or us"
FD79: "So whoever the charge nurse is, we need to know if you are accepting the patient or not accepting the patient."
Male voice: "We need time!" [inaudible words]
FD79: "No sir, but we can't sit in your parking lot."
Male voice: "I know, so who is going to take care of that there?" ..... "You can talk to the supervisor."
FD79: "That's who I want to speak to. The supervisor. Who is that?"
Male voice: "I don't know. He's now in Covid. But I cannot make the decision."
FD79: "You don't know who the supervisor is?"
Male voice: "No, I know who the supervisor is."
FD79: "I'm just trying to find out if we need to go to a different hospital. Is someone getting the supervisor?"
[inaudible words]
Different Male voice responds: "I already talked to them."
FD79: "But that was them. They called me, which I'm their supervisor because they didn't get an answer apparently. So now they called me out and I want to talk to the supervisor, if that is possible."
FD79: "Ok but who is the supervisor? Can you get them, please?"
[several inaudible words]
FD79: "You have a waiting room for patients?"
[several inaudible words]
FD79: "Hi How are you doing? I'm the supervisor for the area and they tell me you are the supervisor."
Different male voice: "Yes"
FD79: "I'm just a messenger, I know you guys are super busy. My ambulance called me out. I was in the area because they said they weren't allowed to come inside and they have a patient in the parking lot. So we just want to know if you are gonna accept the patient or not accept the patient."
UMMC supervisor male voice: "We are saturate. We not saying yes or no. If the ambulance can wait two or three hours until we get chance. They are all busy. Saturated by now. If the ambulance gonna wait ....if they gonna wait 2 or 3 hours ....."
Unknown female voice: "They have to wait! We're not denying nobody.."
UMMC male supervisor: "We are super busy!"
FD79: "At hospitals we don't sit in the parking lot. They let us come inside."
Unknown female voice: "Then they start to be our responsibility!"
FD79: "Are you the supervisor?"
Unknown female voice: "No!" [inaudible words]
FD79: "Well thank you. I tried to talk to you earlier." [inaudible words]
Unknown female voice: "Cause what I said is true?"
FD79: "Cause you didn't want to talk to me earlier!"
Unknown female voice: "I'm not the supervisor! Like you're just mad."
UMMC male supervisor: "If they gonna wait ...in the next 2, 3 hours, nobody. They're super busy."
FD79: "I understand sir, but we deal with 15 different hospitals and no hospital makes our units wait outside. They have waiting rooms. And I saw your waiting room had one person in it! So either you accept or you don't accept and we leave and go to a different hospital and I'll have my medical director call you guys again."
UMMC male supervisor: "We not say we don't wanna accept now, except the ambulance is gonna wait at least 2 hours."
FD79: "If they are gonna get a bed, I'll have them wait a little bit."
UMMC male supervisor: "I can't guarantee you that now. This is a Covid hospital. We are super busy. You see us on tv all the time."
FD79: "I just want to know what y'alls policy is on waiting because is there a way they could wait inside? Do y'all have a lobby for someone like that?"
UMMC male supervisor: "If they are gonna stay here for 2-3 hours. [inaudible words] No one will see this patient."
FD79: "The problems we keep having I'll be honest with you, is my guys call me, like cause they felt they are locked out cause they are out in the parking lot .... So they feel like they are locking the doors and not letting us in, so that's the cause of the conflict."
UMMC male supervisor: "If they wanna come in stay here ...in the next 3 hours the way it look like, nobody gonna take report ...."

During an interview on 12/20/2021 at 10:00AM with S71, Patient Care Technician, who was on staff during the patient encounter, S71 was asked if he had any knowledge of an issue where a patient presented to the ER on 8/16/2021 via HFD and they were asked to wait, the HFD supervisor came on scene, and the patient was transported elsewhere due to not being seen by UMMC staff. S71 said, "I don't remember that situation at all." When asked if he or someone on staff spoke to a HFD supervisor, he stated "I don't remember anyone speaking to a supervisor." "We see everyone that comes here."

During a telephone interview on 12/20/2021 at 11:42AM with the Houston Fire Department (HFD) Emergency Medical Services (EMS) Supervisor (FD80), he stated he was called out to UMMC to assist his EMS crew. His crew arrived on scene to United Memorial Medical Center on 8/22/2021 at 12:08pm with a patient to present to UMMC emergency room. The EMS crew on scene was told by UMMC ER staff that the facility was not accepting patients at that time and that the EMS crew and patient should elsewhere or wait with the patient for unknown amount of hours. Upon arrival to the scene, FD80 stated he observed patient P15 in a wheelchair along with his crew outside of the emergency room in between the first and second set of double doors, "in a breezeway area." FD80 stated "the patient had not been triaged or registered" and "I asked to speak to the supervisor." The nursing supervisor (S121) at the time, came to speak with FD80 and stated they are not refusing the patient, but the HFD crew will have to wait with the patient for about "7 hours". FD80 stated he then called the HFD medical director and was given the directive to transport the patient to a different hospital.

Record review of the Patient Care Report (PCR) from Houston Fire-EMS (an official report and transcript of a patient encounter) dated 08/22/2021 for P15 showed:
"In efforts for continuity of care, M031 (EMS unit) asked for hospital status and was told "saturation" by telemetry. M031 transported pt (patient) non-emergent to UMMC. UMMC refused to register pt, refused to triage pt, and MD (medical doctor) states the only option due to ''no beds'', was for M031 to wait with pt until one became available. Wait time quoted by MD is 7 hours approx. M031 called for AS030 (HFD supervisor) to make location. AS030 made location and was told the same verbiage [sic] from MD as M031 was. AS030 then called for MD (HFD medical officer) on call through telemetry for recorded line purposes. MD at UMMC refused to speak with any HFD personel [sic] after that and was not present for remainder of time throughout UMMC. AS030 was then told by HFD MD on call that it was in the pts best interest to be transported to a different hospital."

Record review of PCR from Houston Fire-EMS Supervisor encounter, dated 8/22/2021 for P15 showed:

"AS030 asked about moving patient the waiting room. S121 again stated he cannot wait inside and needs to wait with HFD crew. When M31 first arrived, M31 stated they were not allowed to enter the second entry way door. AS030 advised S121 that M31 will not be waiting for hours with the patient. S121 turned and walked away. AS030 asked the staff in the ER if S121 was a doctor or the charge nurse. Staff stated S121 is the nurse supervisor and is in charge. There was absolutely no persons waiting in either waiting rooms. AS030 took pictures of the empty waiting rooms. There were also three rooms with beds available behind the nurses area down the hall.
AS030 contacted telemetry to be patched through to online doctor, who was an HFD physician, who stated he will reach out to the HFD Medical Director about the incident. The HFD Medical Director advised AS030 to have another conversation with the Nurse Supervisor S121. AS030 talked with the nurse at the nurse's station and requested to speak with S121. The nurse called S121 on the phone but stated he was not answering at the moment and must be on the other phone line. AS030 waited approximately another 10 minutes and asked if S121 was available again. Nurse called a second time and stated he did not answered (sic), he must be on the other phone line. AS030 waited another 10 minutes and asked again, if S121 was available. The nurse called and somebody answered the phone, however the person on the other line stated S121was unavailable at the moment. AS030 asked if there was anybody else in charge or above S121, ER staff stated he is the only one.
AS030 has been on location for over one hour dealing with the ER staff while the patient is sitting in a wheelchair in the entry way. AS030 contacted the HFD physician about waiting 25 minutes with no contact with S121. AS030, M31, and the patient discussed options about alternate destinations and/or staying at UMMC."

During an interview on 12/19/2021 at 02:00PM, with S36, the charge nurse that was on duty on day shift 08/22/2021, she was asked if she recalled the situation involving HFD attempting to present a patient to UMMC emergency room that day. She stated she did not recall the situation, and stated "we will never turn anyone away here. That is a violation on EMTALA." When asked if every patient that comes to the ER is medically screened for an emergency medical condition, S36 responded, "Yes".
When asked, when a patient arrives to the ED at a time when the ER is "saturated" meaning it is extremely busy or if all of the beds are full, what is done with the patient, S36 explained, "The staff will ask EMS to stay with the patient, but UMMC ED staff will immediately start the triage and registration process at the ambulance. The patient will go on the ED log and process of starting a medical screening exam begins. Even sometimes the physician will go out to the ambulance to see the patient."
When asked if during a time when the ED is on divert, and a patient still arrives at the emergency room for screening, S36 stated they will see the patient anyway and evaluate for an emergency medical condition.


During an interview on 12/19/2021 at 02:10PM, with S70, a staff nurse that was on duty on day shift 08/22/2021, S70 was asked if she recalled the situation involving HFD attempting to present a patient to UMMC emergency room that day. She stated she did not recall the situation, and stated "we welcome everyone at any time to our emergency room."

During an interview on 12/19/2021 at 02:05 pm, with S78, emergency room physician, he was asked if at any time would he turn away a patient presenting to the emergency room to receive a medical screening exam. He stated at no time would he turn away a patient. They would all be seen. When asked what he would do if a patient presented to the emergency room at a time the facility was on saturation or divert or drive by status, S78 stated "If the emergency room is full we would try to discharge a patient in order to make bed space." We will not turn anyone away."


Record review of UMMC policy titled "Emergency Medical Treatment & Active Labor Act (EMTALA)", last reviewed 04/19, showed:

-the hospital shall provide a medical screening exam (MSE) by qualified medical personnel for every patient who comes to the emergency department and makes a request for examination or treatment of a medical condition;
-an MSE shall also be conducted when a request is made on behalf of an individual, even if the person requesting the exam is not the individual's legally authorized representative.

Record review of UMMC policy titled "Diversion Policy" last reviewed 04/19 showed:
-All patients presenting to the Emergency Department will be medically screened and evaluated regardless of the hospital's drive-by status.

APPROPRIATE TRANSFER

Tag No.: A2409

Based on medical record review, interview, and review of the facility's policy, the facility failed to ensure the Emergency Department (ED) provided an appropriate transfer to two of two ED patients requiring transfer to a higher level of care (P23 and P24), by providing written risks and benefits and patient signature related to the transfer. Failure to provide an appropriate transfer to a higher level of care as needed could lead to negative patient outcomes for all patients presenting to the ED.

Findings include:

Review of the facility's policy titled, "Emergency Medical Treatment & Active Labor Act (EMTALA)," last revised 06/17, revealed, "The individual may be transferred ...with physician certification if a physician ...has documented in the 'Physician Certification' section of the Memorandum of Transfer, Part 2 for that based upon the information available at the time of the transfer, the expected medical benefits from transfer outweigh the risks and include a summary of the risks and benefits on which it is based ...The hospital shall notify the individual ...both orally and in writing, of the transfer and the reasons therefore. An acknowledgement of such notification shall be obtained by asking the individual ...to sign the appropriate section of the 'Addendum to Memorandum of Transfer" form."

Review of P23's medical record "Emergency Physician Record," revealed P23 presented to the facility ED on 11/01/21 with "Difficulty Breathing." Following a medical screening exam (MSE), the physician made the decision for transfer of P23 to a higher level of care. Review of the "Physician Certification" revealed, "The following risks and benefits of being transferred have been explained to the individual:" was blank. No document titled, "Addendum to Memorandum of Transfer" containing P23's signature was found in the record.

Review of P24's medical record "Emergency Physician Record," revealed Patient 24 presented to the facility ED on 09/08/21 with "Shortness of Breath." Following a medical screening exam (MSE), the physician made the decision for transfer of P24 to a higher level of care. Review of the "Physician Certification" revealed, "The following risks and benefits of being transferred have been explained to the individual:" was blank. No document titled, "Addendum to Memorandum of Transfer" containing P24's signature was found in the record.

During an interview with S40 on 12/17/21 at 11:20 AM, the above medical records were reviewed. S40 confirmed the physician failed to document the risks and benefits of the transfer and failed to obtain signatures of P23 and P24 acknowledging understanding of those risks and benefits on the Physician Certification.