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Based on interview and record review, the hospital failed to ensure patient rights had been provided to eight of 55 patients (Patient 5, Patient 6, Patient 9, Patient 10, Patient 49, Patient 50, Patient 51 and Patient 52). This had the potential for patients to be unaware of their rights.

Findings:

During an interview with Registered Nurse 9 (RN 9) and review of the clinical records for Patient 5 and Patient 6, on 7/10/19, at 11 AM, she was unable to provide documented evidence either Patient 5 or Patient 6 had been notified of their patient rights. RN 9 stated both Patient 5 and Patient 6 had been admitted to the hospital from the emergency department.

During an interview with RN Manager 1 (RN MGR 1) and review of the clinical records for Patient 9 and Patient 10, on 7/10/19, at 3 PM, he was unable to provide documented evidence either Patient 9 or Patient 10 had been notified of their patient rights. RN MGR 1 confirmed both Patient 9 and Patient 10 had been admitted to the hospital from the emergency department.

During an interview with the Patient Access Supervisor (PAS), on 7/11/19, at 8:15 AM, she stated the Patient Guide contained the patient rights and responsibilities. The PAS stated the blue Patient Guide was offered to every patient. She confirmed the admission staff did not document the patient rights and responsibilities had been provided to patients upon admission.

During an interview with Patient 49, on 7/12/19, at 8:59 AM, she stated she did not receive a blue booklet regarding patient rights.

During an interview with Patient 50, on 7/12/19, at 9:04 AM she stated she had been at the hospital recently. She stated her first stay was about three weeks ago, and she had been at the hospital for the past two days. Patient 50 stated she did not recall receiving a patient rights booklet at either admission.

During an interview with Patient 51, on 7/12/19, at 9:11 AM, he stated he did not receive a blue booklet regarding patient rights when admitted.

During an interview with Patient 52, on 7/12/19, at 9:15 AM, she stated she did not receive a booklet on patient rights on admission.

The hospital policy titled "Patient Rights/Responsibilities and Resolution of Conflict" dated 4/18, indicated "At the time of inpatient admission to [facility name], Patient Access personnel will be responsible for providing a copy of the Patient's Rights and Responsibilities to each patient, parent and/or guardian."

Based on observation, interview, and record review, the hospital failed to ensure five of 55 patient rooms' (Rooms 108, 109, 114, 115, and 118) personal privacy was maintained. This failure resulted in the exposure of personal patient information to staff and visitors.

Findings:

During a concurrent observation and interview with the Director of Medical/Surgical Services (DMSS), on 7/9/19, at 8:45 AM, in Unit 1, she confirmed the following signage was posted outside patients' rooms:

Room 108, signage indicated stool (human feces) and sputum (saliva and mucous from the respiratory system) samples needed;
Room 109, signage indicated stool and sputum samples needed and 1:1 feeder (patient needed one staff to physically feed one patient all food);
Room 114, signage indicated stool and sputum samples needed;
Room 115, signage indicated stool and sputum samples needed;
Room 118, signage indicated stool and sputum samples needed.

The DMSS stated the signage should be inside the patients' room (not outside) to protect their privacy.

During a review of the hospital policy and procedure titled "Patient Rights/Responsibilities and Resolution of Conflict" dated 4/18, it indicated "The patients always have the right to have their personal privacy respected. Any case discussion, consultation, examination and treatment are confidential and should be conducted discreetly. . .Patients have the right to have their treatment, of all communications and records pertaining to their care remain confidential. . ."

During a review of the hospital policy and procedure titled "Confidentiality of Protected Health information" dated 4/18, it indicated Breach or Violation of patient confidentiality can occur in a variety of ways as follows: 'Carelessness' is defined as a Breach or Violation that occurs when patient information is unintentionally carelessly access, reviewed, or revealed to oneself or others without a legitimate need to know the patient information Examples include. . .Leaving a copy of patient information in a public area. . ."

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

1. Provide nursing supervision for one of 55 sampled patients (Patient 32). This had the potential for lack of oversight of care provided for a critical patient.

2. Indicate where a patient would stand or sit for a vision test. This had the potential for incorrect vision tests.

3. Follow their policy and procedure for preoperative (before surgery) and post operative (after surgery) nursing care for one of 55 sampled patients (Patient 30). This failure had the potential to cause harm and affect patient outcome.

Findings:

1. During an observation and interview with the Director of Critical Care (DCC), on 7/9/19, at 2:10 PM, in the ER (Emergency Room), Patient 32 was on a gurney in the hall. Patient 32 appeared to be sleepy and had an IV (fluid running into a vein) with one IV fluid bottle wrapped in dark plastic. The label on Patient 32's IV bottle indicated the medication added was NTG (nitroglycerin, a blood vessel dilator, medication given for chest pain, high blood pressure or congestive heart failure). A portable heart monitor was attached to the patient and on the gurney, displaying a pulse rate ranging from 51-57 (normal pulse rate is 60-80/minute). The DCC verified the low pulse rate, the IV NTG medication running and that there was no patient call system available for this patient to request help or assistance while in the ER hallway.

During a review of the clinical record for Patient 32, the "ER nurse note" dated 7/9/19, at 8:42 AM, indicated ". . .Patient presented to the ED [ER] with chest discomfort since last night. Patient complains of some nausea, vomiting and shortness of breath. . . The admission pulse rate at 8:39 AM was 62 and Patient 32's blood pressure was 187/110 (normal blood pressure is approximately 13/70)." The electrocardiogram (ECG) taken on 7/9/19, at 9:07 AM indicated the pulse rate was 62. The ECG interpreted Patient 32's heart rhythm as abnormal. At 1:40 PM, Patient 32's pulse rate was documented as 51, blood pressure 149/109. Nurses' notes indicated "Condition: Improved, critical Requires hospital admission. . ."

During an observation in the ER hall and interview with Charge Registered Nurse 3 (CRN 3), on 7/9/19, at 2:14 PM, she stated she was going to move Patient 32 to HAMS (High Acuity Med-Surg), "a step down unit from being in Intensive Care Unit [ICU]." CRN 3 was asked if she was able to print Patient 32's heart rhythm and pattern from the portable cardiac monitor (important to evaluate and document basic heart rhythm or changes). CRN 3 stated she had no ability to print the heart rhythm from the portable monitor. At 2:25 PM, Patient 32 was moved by CRN 3 and another staff member to the HAMS unit.

During an interview with Registered Nurse 5 (RN 5) on 7/9/19, at 2:33 PM, she stated Patient 32 had been her patient until she was moved into the hall at 1:40 PM, when RN 5 returned from lunch. RN 5 stated, "At that point, she [Patient 32] became [CRN 3's] patient." RN 5 was asked what Patient 32's basic cardiac rhythm had been during the time she cared for her. RN 5 looked at the ECG and stated, "There's a lot of interference [electrical static]."

During interviews with the DCC and Registered Nurse Manager 2 (RN MGR 2) of the ER on 7/9/19, at 3 PM, RN MGR 2 stated her expectation of registered nurse staff was to be aware of each patient's basic heart rhythm at any time during care. RN MGR 2 was aware Patient 32 had been waiting admission/transfer in the ER hall. The DCC verified Patient 32 had spent a total of 45 minutes in the hall, awaiting transfer, in critical condition, IV NTG running, on a monitor whose nurse was not able to obtain a printed monitor rhythm, with no call light available. The Intra-facility Patient Transfer Report (SBAR Report) was requested from the RN MGR 2, who stated there was none made out for Patient 32 in the electronic record.

During a review of the hospital policy and procedure titled "In-House Patient Transfers," revised 3/18, it indicated: "Procedure to be followed by: All personnel. Purpose: To insure the patient a smooth transition from one area to another. To assure continuity of care of the patient. . .4. The nurse will complete the Intra-facility Patient Transfer Report (SBAR Report) in the patient's electronic record. If the patient is transferred to ICU or HAMS, the primary RN will accompany the patient to the receiving unit and give report."

During an interview with the Chief Nursing Officer (CNO), on 7/9/19, at 3:35 PM, she stated "[Patient 32] may not have an SBAR. It might have been verbal. The SBAR does not apply to the ER. The person receiving [Patient 32] can look up on the electronic record if there is any question regarding her physical care and condition."

During an interview with the DCC and record review on 7/9/19, at 4:30 PM, the DCC stated the medical record for Patient 32's time in the ER would only be available if RN 5 had completed charting. At this time, the medical information regarding Patient 32 (symptoms on arrival, care provided, patient response, medications given, etc) was not available.

During a review of Lexicomp Online (an electronic drug reference), dated 5/22/19, it indicated patients receiving NTG should receive "Continuous monitoring of blood pressure and heart rate, as well as other appropriate parameters (e.g., pulmonary capillary wedge pressure), must be performed in all patients. Adequate systemic blood pressure and coronary perfusion pressure must be maintained."

2. During an observation in the ER with the DCC and the RN MGR 2, on 7/10/19 at 8:50 AM, an eye chart (letters of the alphabet on a rectangular sign, size of letters diminish downward) was noted. The instructions for this visual acuity (clarity of vision) testing was the patient was to stand 20 feet from the wall where the sign was posted and read the letters. There was no mark on the ER floor to indicate 20 feet in order to ensure standardization of the test. RN MGR 2 stated, "They repaired the floor and took it [the indicator mark] away. I have not even noticed it." RN MGR 2 indicated on the floor where she thought 20 feet was from the eye chart. The Assistant Director of Plant Operations measured 20 feet from the eye chart. RN MGR 2 estimated her mark was "short by about four feet."



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3. During an interview and record review with the Chief Nursing Officer (CNO), on 7/10/19, at 3:18 PM, she reviewed Patient 30's clinical record and was unable to provide physician's orders, documentation of a pre-operative nursing assessment, or vital signs prior to the out-patient circumcision (surgical removal of penis foreskin) performed in the nursery by Medical Doctor 1 (MD 1) on 7/9/19. The CNO was unable to provide post operative physician's orders, post-operative nursing assessment or vital signs for Patient 30. The CNO stated circumcision was not considered a surgical procedure at this hospital. The CNO stated the Circumcision Check List was considered the physician's order.

During an interview with the CNO, on 7/11/19, at 11:41 AM, she stated in-patient and out-patient surgical patients all follow the same facility guidelines and policies.

During a review of the American College of Surgeons Definition of Surgery Legislative Toolkit, undated, it indicated "To ensure that these high standards of patient safety and quality are clearly understood in the rapidly changing medical profession, the American College of Surgeons adopted the following definition for surgery: "Surgery is performed for the purpose of structurally altering the human body by incision or destruction of tissues and is part of the practice of medicine. Surgery also is the diagnostic or therapeutic treatment of conditions or disease processes by any instruments causing localized alteration or transportation of live human tissue, which include lasers, ultrasound, ionizing radiation, scalpels, probes, and needles."

The hospital policy and procedure titled "GENERAL ADMISSION, POST-OP CARE, AND DISCHARGE" dated 3/18, indicated "DEFINITION Patients will come in for a surgery or special procedure. . . Close observation will be provided post-op or post procedure and patient will be discharged on physician's orders the same day . . . PURPOSE To provide a safe and quiet environment for infants and children who are admitted for a procedure or surgery and require a short stay PROCEDURE 1. Admit to patient care area, perform surgery assessment, i.e. . . . VS (vital signs), general systems assessment, pre-op assessment of affected system. . . 4. After surgery, receive patient . . . and do post op assessment. Vital signs . . . 6. Follow physician's discharge orders and instructions. DOCUMENTATION 1. Chart pre and post assessments. . . 2. Record post-op vital signs on post-op record."

Based on observation, interview, and record review, the hospital failed to ensure safe and effective use of medications when:

1. Policy and procedures for treating malignant hyperthermia (MH, is an inherited muscle disorder triggered by certain drugs including succinylcholine [a paralytic agent], used in anesthesia and volatile anesthetics that may cause a fast-acting life-threatening crisis) outside of surgical department were not developed and implemented. This failure had the potential of not being able to manage an MH crisis timely, likely to cause serious injury or death to a patient.

2. Fentanyl (potent opioid for pain) patch (a small piece of medicated sticky plastic that is placed on the skin) removal and waste was not witnessed in three of three patients (Patient 19, Patient 20 and Patient 21) reviewed for Fentanyl patch use. This failure had the potential of causing medication errors and opioid diversion.

3. Fentanyl patch was not administered timely per physician order in two of three patients (Patient 19 and Patient 21) reviewed for Fentanyl patch use. This failure had the potential of not treating patient pain effectively.

4. Insulin (to regulate blood sugars) infusion was not monitored and adjusted hourly per protocol for one of three patients (Patient 22) reviewed for use of insulin infusion. This failure had the potential of exposing patients to effects of high or low blood sugars including coma.

Findings:

1. During an observation on 7/9/19, at 10:30 AM, in the emergency department (ED), the refrigerator contained vials of succinylcholine.

During an interview with Registered Nurse 1 (RN 1), on 7/9/19, at 10:35 AM, she stated the drugs for treating MH would be in the ED automated drug dispensing cabinet and she would have to refer to the policy for the procedure to treat an MH case.

During a review of the hospital policy "Malignant Hyperthermia Treatment Guidelines" dated 3/18, it indicated "The Malignant Hyperthermia cart is located in the PACU. . ." (the post anesthesia care unit and not in ED as indicated by RN 1).

During an interview with Registered Nurse Manager 2 (RN MGR 2), on 7/9/19, at 10:40 AM, she stated if there was a case of MH in the ED, she would call ICU (intensive care unit) and pull up the policy.

The policy further indicated "Treatment of Acute MH: Anesthesia Provider (Anesthesiologist/CRNA) - Directs over-all management of patient. Notifies the surgeon to halt the procedure. . .Diagnoses MH and calls Code 99, instruct RN to call MHAUS hotline. . ." The policy did not address patient care areas outside the surgery department where succinylcholine could be potentially used including ED.

During a review of the MHAUS (Malignant Hyperthermia Association of the United States, also referred to in the facility policy) website, at www.mhaus.org, it indicated "The general signs of the MH crisis include increased heart rate, greatly increased body metabolism, muscle rigidity and/or fever that may exceed 110 degrees F along with muscle breakdown, derangements of body chemicals and increased acid content in the blood. Severe complications include: cardiac arrest, brain damage, internal bleeding or failure of other body systems. Thus, death, primarily due to a secondary cardiovascular collapse, can result. . . Facilities that stock and have the potential to administer any triggering agent, including succinylcholine without volatile agents, should have dantrolene (drug to treat MH) immediately available (i.e., the ability to administer dantrolene within 10 minutes of the first sign of MH) in the event that a patient in that facility develops MH."

2. During a review of the clinical records for Patient 19, Patient 20, and Patient 21, and interview with Director of Pharmacy (DPH), on 7/10/19, at 1:40 PM, she confirmed Patient 19, Patient 20, and Patient 21's use of a Fentanyl patch.

During a review of the medication administration records (MAR) for Patient 19, Patient 20, and Patient 21 and the nurses notes, on 7/10/19, they indicated Fentanyl patch removal was not witnessed or documented by two nurses.

During an interview with the DPH, on 7/10/19, at 2:15 PM, she confirmed Fentanyl patch removal or waste was not documented by two nurses.

During a review of the hospital policy "Fentanyl Transdermal Patch," dated 6/16, it did not address removal or wasting of Fentanyl patches.

Fentanyl patch is a high potency opioid (narcotic) used for pain and has a black box warning which is the strongest warning the FDA (Food and Drug Administration) can require. The black box warning indicated opioid substances like Fentanyl have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression.

The manufacturer insert for Fentanyl patch indicated "A considerable amount of active Fentanyl remains in Fentanyl transdermal system even after use as directed. Death and other serious medical problems have occurred when children and adults were accidentally exposed to Fentanyl transdermal system." Fentanyl can be abused and is subject to criminal diversion. The high content of Fentanyl in the patches may be a particular target for abuse and diversion.

3a. During a review of Patient 19's clinical record, on 7/10/19, it indicated Patient 19 was admitted to the hospital on 5/29/19 and his physician orders (PO), dated 5/29/19, included: Fentanyl 25 mcg (microgram - a unit of measurement) every 72 hours. Patient 19's clinical record indicated the Fentanyl patch was not applied on 5/29/19 and the nurses note indicated that Patient 19 had a Fentanyl patch on his back from home dated 5/28/19.

Per PO of "every 72 hours" the next dose should have been 72 hours from 5/28/19 to be changed and applied on 5/31/19. Patient 19's record indicated that the Fentanyl patch was not administered on 5/31/19 but on 6/1/19 at 9:23 AM.

During an interview with the DPH, on 7/10/19, at 1:58 PM, she stated the patch should have been administered on 5/31/19 and pharmacy should have been notified on 5/29/19 when the patch was not administered due to the home patch on Patient 19's back.

3b. During a review of Patient 21's clinical record, on 7/10/19, it indicated Patient 21 was admitted to the hospital on 5/9/19 and her PO, dated 5/9/19, at 8:20 PM, included Fentanyl patch 75 mcg, 2 patches every 72 hours.

Patient 21's record indicated the Fentanyl patches were applied on 5/10/19 at 7:42 PM, (nearly 24 hours later).

During an interview with the DPH, on 7/10/19, at 2:20 PM, she confirmed Patient 21's Fentanyl patch was administered nearly 24 hours after the physician order.

During a review of hospital policy "Bar Code Medication Administration" dated 6/19, it indicated "Observe the 8 rights of patient medication administration. . . [including the] right time."

4. During a review of Patient 22's clinical record, on 7/10/19, it indicated she was on an insulin infusion per protocol that was started on 4/30/19, at 12:10 AM, for a blood glucose (sugar) of over 600 milligram (mg)/deciliter (dl). Normal blood sugar levels range from 72 mg/dl to 140 mg/dl.

During a review of the insulin infusion documentation sheet, on 7/10/19, it indicated no blood glucose or rates of insulin infusion were documented on 4/30/19 between 1:15 AM, (fasting state blood glucose [FSBG]=High) and 4:14 AM, (FSBG=283 mg/dl).

During a review of the insulin protocol, on 7/10/19, it indicated "FSBG Monitoring: Every 1 hour. . ."

During an interview with the DPH, on 7/10/19, at 3:45 PM, she confirmed the blood glucose was not monitored hourly per protocol.

During a review of the hospital policy "Diabetes Management of Hospitalized Patients" undated, it indicated "Per the American Diabetes Association, "Both hyperglycemia (high blood sugars) and hypoglycemia (low blood sugars) are associated with adverse outcomes including death. Therefore, hospital goals for the patient with diabetes include preventing both. . ."

Based on observation, interview, and record review, the hospital failed to ensure that a properly executed informed consent was obtained for three of 55 sampled patients (Patient 28, Patient 29, Patient 30). This failure had the potential for a patient to be unable to make an informed decision regarding a procedure.

Findings:

During an interview and record review with the Obstetric (specialized unit in hospital for the birth of a baby) Assistant Manager (OBAM), on 7/9/19, at 3:30 PM, she reviewed Patient 29's Consent for Epidural, Paracervical, and Pudendal analgesia (procedures to provide pain relief), dated 7/8/19, at 11:30 PM, and was unable to find documentation of the practitioner who was performing the procedure. The OBAM verified findings and stated this is our consent.

During an interview and record review with the OBAM, on 7/10/19, at 11:22 AM, she reviewed Patient 28's Consent for Epidural, Paracervical, and Pudendal analgesia, dated 7/8/19, at 1:50 PM and was unable to find documentation of the practitioner who was performing the procedure. The OBAM verified findings.

During an observation and interview with the Charge Registered Nurse 2 (CRN 2), on 7/9/19, at 12:13 PM, Medical Doctor 1 (MD 1) was observed carrying an infant into the nursery. CRN 2 stated the parents brought Patient 30 in for an out patient circumcision to be performed by MD 1.

During an interview and record review with the Chief Nursing Officer (CNO), on 7/10/19, at 3:18 PM, she reviewed Patient 30's Permit for Circumcision, dated 7/9/19, at 11:20 AM. The CNO was unable to find a physician's order for the procedure.

During a review of the hospital policy and procedure titled "Consent/Informed Consent" dated 12/18, it indicated "The following items shall be included during the informed consent process and shall be documented in a progress note by the physician performing the procedure: . . .8. Verification that the patient has been informed of all personnel involved. . .The physician must order the procedure on the order sheet."

During a review of the Medical Staff Rules, undated it indicated "All patients have the right to receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment. . .and to know the name of the person who will carry out the procedure or treatment."

Based on interview and record review, the hospital failed to ensure a medication was dispensed in a safe and effective manner when a non-emergency medication was dispensed for one of 55 sampled patients (Patient 30) from an automated dispensing cabinet (ADC) without a physician's order and pharmacist's review.

These failures had the potential to prevent safe and effective delivery of medication to patient.

Findings:

During a telephone interview with Registered Nurse 2 (RN) 2, on 7/11/19, at 4:23 PM, she stated she removed the Lidocaine 1% (numbing medication) from the ADC for Patient 30 without a physician's order for an out patient circumcision to be performed by Medical Doctor 1 (MD 1). RN 2 stated she entered Patient 30's name into the ADC and used the "override" function to remove the Lidocaine 1%. RN 2 stated it was part of the out patient circumcision (removal of the penis foreskin) procedure in the nursery. RN 2 stated she handed the medication (Lidocaine 1%) to MD 1 who drew up the medication and injected Patient 30's penis with the medication before the circumcision.

During an interview with the Obstetric (specific part of hospital where babies are born) Assistant Manager (OBAM), Nursery Charge Registered Nurse 2 (CRN 2) and RN 2 with record review, on 7/11/19, at 4:40 PM, neither OBAM nor CRN 2 were able to provide physician's orders for Patient 30. RN 2 stated the Circumcision Checklist was used as a physician's order. RN 2 verified the checklist did not have a physician's name or signature nor did the checklist include a Lidocaine order for Patient 30.

During an interview and record review with the Director of Pharmacy (DPH), on 7/12/19, at 2:05 PM, she stated she was aware there was no order for Lidocaine prior to an out-patient circumcision in the nursery. The DPH stated she was aware the nurse could override the ADC security system to obtain the medication. The DPH stated Lidocaine 2 ml (unit of measure) was stocked in the nursery ADC for the circumcision procedures. The DPH stated pharmacy did not review the override medication prior to removal from ADC. The DPH stated she had not discussed the need for a Lidocaine order with the provider. The DPH stated medication overrides were to be the exception and should not be used in this manner. The DPH reviewed the hospital policy and procedure titled "Procedure for ADC Functions" and verified, per policy, overriding of medication was to be used in an urgent situation only.

The hospital policy and procedure titled "MEDICATION ADMINISTRATION" dated 3/18, indicated "11. Medications are to be checked in the following manner: A. Verify the patient's medication orders in the electronic health record . . . with each new admission, and each new order. B. Check the drug against the medication profile when removing the drug from the patient's medication drawer."

The hospital policy and procedure titled "Procedure for ADC Functions" dated 6/19, indicated, "2. Withdrawing Medications a) A pharmacist will review medication orders for appropriateness prior to withdrawing the medication. When a medication is needed in an urgent situation, when delay would harm the patient, a nurse can use the override function to withdrawal the medication prior to pharmacist verification."

Based on observation, interview, and document review, the hospital failed to ensure sterile (germ-free) compounding (mixing) of IV (intravenous, injected through the vein) drugs was done in accordance with hospital policy and standards of USP 797 (United States Pharmacopeia Convention chapter describing conditions and practices for compounding sterile drugs) when:

1. Hand hygiene was not performed per policy by one of one pharmacy staff observed in the sterile compounding room.

2. A crack/tear was observed in the ceiling of the sterile compounding room.

3. Rust-like and brown debris was observed on the anchors of the compounding hood (equipment used for compounding).

4. Staff were not ensuring wet times (the amount of time that a surface must remain wet to allow the chemical to be in contact with an organism in order to kill it) for cleaning agents were met per policy and manufacturer specifications.

5. Viable (living organisms, such as bacteria or fungal spores) sampling was not done in the environment adjacent to the hoods in the compounding area.

These failures had the potential of exposing patients to contaminated IV medications leading to hospital acquired infections.

Findings:

1. During an observation and interview with the Director of Pharmacy (DPH), on 7/9/19 at 10 AM, during a tour of the sterile compounding area, the DPH was observed washing her hands (hand hygiene) before entering the sterile compounding area. After washing her hands, the DPH applied a sanitizing foam before donning gloves. The DPH was not observed applying an alcohol-based surgical hand rub with persistent activity. The DPH acknowledged there was no alcohol-based surgical hand rub with persistent activity for use in the sterile compounding area.

Review of hospital policy "Hand Hygiene and Garbing" dated 6/2017 indicated "Perform a 30 second hand and forearm wash. . . Apply alcohol-based surgical rub with persistent activity to all surfaces of hands and fingers and allow hands to dry. . . Don sterile gloves. . ."

2. During an observation and interview with the DPH on 7/9/19, at 10 AM, during a tour of the sterile compounding area, the negative pressure hazardous drug (HD, i.e., drugs used in treatment of cancer) compounding room was observed. A crack/tear over two inches long was observed in the ceiling of the room. The DPH confirmed the ceiling was not intact.

During a review of the hospital policy titled "Facility Management Overview" dated 6/17, it indicated "Surfaces of ceilings, walls, floors. . . must be. . . free from cracks and crevices. . . "

3. During an observation and interview with the DPH, on 7/9/19, at 10 AM, of the HD compounding room, the compounding hood was noted. The hood was anchored to the floor and the anchors were covered with rust-like brown substance and debris. The DPH confirmed the finding.

During a review of the hospital policy titled "Cleaning and Disinfecting of the Compounding Facility" dated 1/17, it indicated the floors of the compounding area were to be cleaned daily and outer surfaces of the hoods to be cleaned monthly.

4. During the observation and interview with Pharmacist 1 (RPH 1), on 7/9/19, at 10 AM, of the sterile compounding room, RPH 1 described the cleaning and disinfecting processes for the hood. She stated a disinfectant was applied and after several minutes was then followed by sterile alcohol. RPH 1 stated she wiped the surface and allowed it to dry. She stated she did not know how long the surface stayed wet.

During a review of the manufacturer's label on the disinfectant, on 7/9/19, it indicated a wet time of three minutes for bacteria and ten minutes for fungal.

During an interview with the DPH, on 7/9/19, at 10:10 AM, she confirmed the hospital policy did not indicate the wet times of the disinfectant.

5. During a review of the hospital environmental sampling reports for the sterile compounding area, on 7/9/19, the reports indicated no viable sampling was done in the areas outside the hoods.

During an interview with the DPH, on 7/9/19, at 4 PM, she verified viable testing outside the hoods had not been conducted.

During a review of USP 797, dated 2012, it indicated "Selected sampling sites shall include locations. . . in the segregated compounding areas at greatest risk of contamination (e.g., work areas near the ISO Class 5 [in this case the hoods] environment, counters near doors. . . ). The plan shall include sample location, method of collection, frequency of sampling, volume of air sampled, and time of day as related to activity in the compounding area and action levels."

Based on observation, interview, and record review, the hospital failed to ensure expired drugs were not available for use in patient care areas. This failure had the potential of exposing patients to ineffective and contaminated medications.

Findings:

During an observation and interview with the Director of Pharmacy (DPH), on 7/9/19, at 2:05 PM, in the obstetrics (OB, specific part of hospital where babies are born) unit, two IV (intravenous injected through the vein) bags of 1000 milliliter (ml - unit of measurement) 5% dextrose (sugar) and 0.45% sodium chloride (for hydration) bags with an expiration date of 5/19 were noted. The DPH confirmed the IV bags were expired.

During an observation and interview with the DPH, on 7/9/19, at 2:20 PM, in the OB nursery (for newborn babies), a refrigerator was observed. An opened multidose vial of Tubersol (to test for tuberculosis, an infectious lung disease) was observed. A handwritten date of 4/19/19 was indicated on the vial. The DPH stated the date reflected when the vial was opened. The manufacturer label indicated to discard after 30 days of opening.

During a review of the hospital policy titled "Storage of Pharmaceuticals" dated 6/19, it indicated "No open medication will be stored beyond 28 days. . ."

During an observation and interview with the DPH, on 7/11/19, at 9:30 AM, in the anesthesia workroom, a 10 milliliter ampoule of preservative free sodium chloride (salt solution) with an expiration date of 8/18 and a lidocaine (numbing agent) 1% with an expiration date of 2/1/19 were noted. DPH verified the expired drugs.

During a review of the hospital policy titled "Storage of Pharmaceuticals" dated 6/19, it indicated "All medication areas shall be devoid (free of) of outdated, discontinued, or recalled drugs."

Based on observation, interview, and record review, the hospital failed to ensure an effective, active, system-wide infection control program as evidenced by:

1. Failure to follow hospital isolation policies. Refer to A 749, finding 1.

2. Failure to follow hospital hand hygiene policies. Refer to A 749, finding 2.

3. Failure to maintain a clean and safe medical laboratory environment. Refer to A 749, finding 3.

4. Failure to ensure expired quality control products were removed from the laboratory. Refer to A 749, finding 4.

5. Failure to ensure biohazard material, in dirty utility rooms, was not accessible to the general public. Refer to A 749, finding 5.

6. Failure to ensure medical supplies and equipment were stored in a sanitary manner. Refer to A 749, finding 6.

7. Failure to ensure family pet was appropriately evaluated prior to entering Unit 1. Refer to A 749, finding 7.

8. Failure to ensure manufacturer's instructions for use were followed for sanitizing hospital equipment. Refer to A 749, finding 8.

9. Failure to ensure expired supplies and medication were not available for use. Refer to A 749, finding 9.

10. Failure to ensure refrigerator temperatures for stored breast milk were within Centers for Disease Control (CDC) guidelines. Refer to A 749, finding 10.

11. Failure to ensure a clean and safe environment in the nursery outpatient surgical procedure area. Refer to A 749, finding 11.

12. Failure to ensure their policy for labeling intravenous (IV) site was followed. Refer to A 749, finding 12.

13. Failure to ensure multi-dose vials were not used in a patient care area. Refer to A 749, finding 13.

14. Hospital administration failed to identify, report, monitor or control potential transmission sources of infections and communicable diseases in multiple areas of the hospital. Refer to A 756.

The cumulative effects of these systemic problems resulted in the hospital's inability to ensure an effective system-wide infection control program that failed to provide a safe environment, free of transmission sources of infections and communicable disease to be in compliance with the Condition of Participation for Infection Control.

Based on observation, interview, and record review, the hospital failed to ensure adequate methods for preventing the spread of infection when:

1. Nationally accepted practices and hospital isolation policies were not followed.

2. Hospital hand hygiene policies were not followed.

3. A clean and safe medical laboratory (lab) environment was not maintained.

4. Expired quality control products were not removed from lab work area.

5. Dirty utility (Biohazard) room doors were not kept closed.

6. Supplies and equipment were not stored in a sanitary manner.

7. One patient's family pet was not appropriately evaluated prior to entering a patient care area.

8. Manufacturer's instructions for use were not followed for sanitizing hospital equipment.

9. Expired supplies and medication were not removed from the work area.

10. Staff was not knowledgeable in breast milk storage temperatures.

11. A clean and safe environment in the nursery outpatient surgical procedure area was not maintained.

12. The hospital policy for labeling intravenous (IV) site was not followed.

13. Multi-dose vial (MDV) medications were not prepared in the immediate patient care area.

These failures had the potential for patients, staff and visitors to develop healthcare-associated infections and food borne illnesses.

Findings:

1a. During an observation on 7/9/19, at 9:11 AM, on Unit 2, an isolation cart and portable sink were noted outside Patient 5's room. There was no signage indicating Patient 5 was on isolation or the type of isolation measures required.

During an observation on 7/9/19, at 9:11 AM, on Unit 2, an isolation cart was noted outside Patient 6's room. There was no signage indicating Patient 6 was on isolation or the type of isolation measures required.

During an interview with the Director of Critical Care Services (DCC), on 7/9/19, at 9:15 AM, she verified neither Patient 5's room nor Patient 6's room had signage that indicated Patient 5 and Patient 6 were on isolation. The DCC was unable to confirm Patient 5 and Patient 6 were on isolation precautions. The DCC conferred with Charge Registered Nurse 1 (CRN 1) regarding Patient 5 and Patient 6's isolation status. CRN 1 stated Patient 5 was in isolation for meningitis (an infection in the brain) and Patient 6 was in isolation for clostridium difficile (C. Diff, an infectious and potentially deadly form of diarrhea).

1b. During an observation and interview with the DCC, on 7/11/19, at 5 PM, signage on Patient 5's room indicated "Droplet Precautions (In addition to Standard Precautions) [precautions recommended by the Centers for Disease Control and Prevention (CDC) to minimize the transmission of infections] . . . Mask required when working within 3 [three] feet of patient (or when entering room). Environmental Services 1 (EVS 1) rolled a biohazard container down the hallway, with gloves on, to Patient 5's room. With her gloves still on, she removed an isolation gown from the isolation cart. EVS 1 donned the isolation gown, pulling the sleeves up her arms. The gown was not tied at the neck or waist and left her upper chest, shoulders, and back exposed. She exited Patient 5's room with her gloves still on, disposed of the biohazards into the biohazard container. EVS 1 then removed her isolation gown and rolled the biohazard container down the hallway without performing hand hygiene and donning clean gloves. The DCC confirmed the observations.

1c. During an observation with the DCC on 7/10/19, at 4:45 PM, a visitor was noted seated in Room 202. The signage "Droplet Precautions" was posted on the doorway and the visitor had a mask on, no isolation gown nor gloves were on. The DCC asked the visitor to come to the door and she assisted him to put on a gown. No gloves were provided. The visitor stated no one had instructed him in applying the Personal Protective Equipment (PPE).

During an observation with the DCC on the Medical Surgical Unit 1, on 7/11/19, at 5:05 PM, Room 101 (Patient 36) was noted to have "Contact Isolation" posted at the doorway. Voices could be heard from within the room. A paper sign in the shape and color of a "Stop Sign" was noted on the floor outside Room 101. This sign pictured a mask, gown, and gloves with the instructions to wear these when going into room 101. The DCC picked the Stop Sign up and discarded it. At 5:30 PM, a visitor not wearing or discarding PPE left the room. He stated he was unaware his family member was in isolation and stated, "No one has told me to wear gown or mask. I just walked in."

During an observation with the DCC on the Medical Surgical Unit 2, outside Room 202, on 7/22/29, at 5:35 PM, two female visitors were putting on isolation gowns prior to going into the room. They were asked how they knew to put them on. They both pointed to the "Stop Sign" posted on the doorway. They put on gloves and masks and entered the room. The DCC was asked how the purses both women carried on the outside of their gowns were to be addressed. The DCC stated she would get plastic bags for them to place them into.

During a review of the hospital policy and procedure titled "Isolation Guidelines" dated 5/1/18, it indicated "Standard Precautions - Use for the care of all patients Handwashing . . .Wash hands immediately before and after gloves are worn. Wash hands immediately after gloves are removed, between patient contacts, and when otherwise indicated to avoid transfer of microorganisms to other patients or environments. . .Remove gloves promptly after use, before touching non-contaminated items and environmental surface. . .Remove dirty gown as promptly as possible and wash hands to avoid transfer of microorganisms to other patients or environments. . . Any patient with an infection or condition listed in the CDC guidelines will be placed in isolation as needed. . .A "STOP" sign indicating which types of personal protective equipment are required will be placed below the isolation sign. . ."

During a review of the CDC guidelines titled "Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)" dated 10/14, it indicated under Donning PPE: "Gown Fully cover torso from neck to knees, arms to end of wrist, and wrap around the back. Fasten in back at neck and waist." and under Removing PPE: "Gown Gown front and sleeves are contaminated! Unfasten neck, then waist ties."

2a. During an observation on 7/11/19, at 9:50 AM, in the surgical area, a hand sanitizing station was noted outside Operating Room 5 (OR 5).

During an observation on 7/11/19, at 9:53 AM, Registered Nurse 4 (RN 4), exited OR 5 after the completion of an outpatient cataract surgery. She changed her gloves and reentered OR 5. RN 4 wiped down various items in OR 5. She changed her gloves again, opened up the medication cart and drew up a medication in a syringe which she added to the sterile (without microorganisms) field. RN 4 then added a sterile intraocular (in the eye) lens to the sterile field. No hand hygiene was observed between glove changes.

During an observation on 7/11/19, at 10:28 AM, RN 4 exited OR 5 with a bag of trash and a handful of surgical towels. She dropped the bag of trash in the sterile hallway by OR 5's door and discarded the surgical towels. She removed her gloves, picked up the bag of trash, opened the trash bin with her bare hand and discarded the trash. RN 4 put on clean gloves and reentered OR 5 and prepared the room for Patient 35's sterile cataract surgery. She exited OR 5, discarded her dirty gloves, put on a clean mask and clean gloves before she reentered OR 5. RN 4 opened her medication draw and drew up lidocaine 1% (a numbing medication) which she added to the sterile field. No hand hygiene station was noted in OR 5. No hand hygiene was observed between multiple glove changes.

During an observation and interview with RN 4, on 7/11/19, at 11:13 AM, she exited OR 5, emptied the trash and changed her gloves without performing hand hygiene. RN 4 stated at the beginning of the day, staff does a long scrub then during the rest of the day uses the alcohol-based hand rub (ABHR - alcohol based preparation used to reduce the number of microorganisms on the hands) unless hands are visibly dirty. RN 4 stated she typically performs hand hygiene when she speaks with the patient prior to the procedure. She confirmed she had not spoken to the three patients during this observation on 7/11/19 because there was an RN in the holding area. RN 4 confirmed a hand hygiene station was not available in OR 5.

2b. During an observation on 7/11/19, at 10:25 AM, OR Technician 1 (ORT 1) exited the decontamination area into a sterile hallway with a wheeled cart. He wiped his shoes off with a sanitizing wipe, stepped back into the decontamination room and tossed the sanitizing wipe away. He then wheeled the cart down the sterile hallway, past a hand hygiene station outside OR 5, and into the sterile (germ free) supply area without performing hand hygiene.

During an interview on 7/11/19, at 11:31 AM, with ORT 1, he stated he had taken the covered cart into the decontamination room and unloaded it. He stated he wiped down the cart, except for the wheels, before bringing the cart out into the sterile hallway and sterile supply area. ORT 1 stated the decontamination room did not have a hand hygiene station, but he had performed hand hygiene in the sterile supply area.

During a review of the hospital policy and procedure titled "Hand Hygiene" dated 8/1/18, it indicated "Decontaminate hands before having direct contact with patients . . .Decontaminate hands after contact with inanimate object (including medical equipment) . . .Decontaminate hands after removing gloves. . ."

3a. During an observation and interview with the Administrative Lab Director (ALD) and record review, on 7/11/19, at 12:17 PM, in the medical laboratory, two uncovered and unlabeled test tubes, one clear and one amber) were noted at a lab station. The ALD confirmed the tubes were unlabeled and uncovered. She identified the tubes as quality control (QC) items. She confirmed the test results may be inaccurate due to evaporation of the QC. The ALD reviewed the QC log and confirmed the QC was performed on 7/11/19 at 6:53 AM.

During a review of the Job Description titled "Director Laboratory Services" dated 9/17, it indicated "Recognizes factors that affect measurements and results. . .takes appropriate action to maintain accuracy and precision. . ."

During a review of the hospital policy titled "General Laboratory Supplies; reagents [a substance used in chemical analysis or other reactions], inventory, storage and disposal" dated 7/11/19, it indicated "All prepared reagents should be labeled (sic) so that the content is clear. Information of the stability of the reagent should be noted on the container or in the reagent IFU [Instructions for Use] or SOP [Standard Operating Procedure]. . .Reagent should be stored as indicated. . .Adherence to temperature requirements, and light or evaporation sensitivity is maintained . . .by use of a properly specified container and lid or covering mechanism. . .The term reagent for the purpose of this document will refer to all solid and liquid materials . . .may include; . . .quality control material. . ."

3b. During an observation on 7/11/19, at 12:38 PM, in the medical laboratory, a purse and a padded jacket were stored in a laboratory cupboard next to the Westergren tubes (used for blood test) and below a bottle of immersion oil and cleaning products.

During an observation on 7/11/19, at 12:57 PM, in the medical laboratory, an insulated lunch bag was observed in another laboratory cupboard next to an adhesive removal agent.

During a review of the CDC's Morbidity and Mortality Weekly Report titled "Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories" dated 1/6/12, it indicated "Do not store food or beverages for human consumption in the laboratory. . .Never bring briefcases, purses, backpacks. . .and other personal items into the laboratory. These items are difficult to disinfect."

During a review of the hospital's Chemical Hygiene Plan, dated 3/3/19, it indicated "No food, beverages, cups and other drinking/eating utensils may be stored in the laboratory. . .Personal property (i.e.: purses coats etc.) should be stored in employee lockers."

3c. During an observation and interview with the DCC, on 7/11/19, at 1:20 PM, in the blood bank, a live bug was crawling in a drawer. The DCC confirmed a live bug was in the blood bank.

During a review of the U.S. Department of Health and Human Services document titled "Biosafety in Microbiological and Biomedical Laboratories, 5th Edition" dated 12/09, it indicated "An effective integrated pest management program is required."

3d. During an observation and interview with the ALD, on 7/11/19, at 12:49 PM, in the medical laboratory, the #13 refrigerator was opened and had ice crystals ranging in depth from one-half to two inches and extending up the sides of the freezer compartment. The ice showed evidence of having been thawed and refrozen near the door. Specimens were stored in the refrigerator. The ALD verified the observation and stated maintenance was called to defrost the refrigerators when the temperatures were out of range.

During an observation and interview with the ALD, on 7/11/19, at 12:50 PM, in the medical laboratory, the #10 refrigerator was opened and had ice crystals ranging in depth from one-half to two inches and extending up the sides of the freezer compartment. The ice showed evidence of having been thawed and refrozen near the door. Specimens were stored in the refrigerator. The ALD verified the observation.

During an observation and interview with the ALD, in the medical laboratory, Refrigerator/Freezer #1 was opened and had ice crystals ranging in depth from one-half to two inches and in the freezer compartment. Control and calibration solutions were stored in the refrigerator door. The ALD verified the observation.

During a review of the Association for Professionals in Infection Control (APIC) online text Chapter 112. Maintenance and Engineering, dated 10/3/14, indicated "Inadequate refrigeration of medicines, biologics, vaccines, blood and blood products may alter potency and/or chemical composition or allow proliferation of microbial contaminants. . .Schedule and perform regular preventive maintenance of all freezers and refrigerators; include air vents, gaskets, cooling coils, and fans."

3e. During an observation on 7/11/19, at 12:55 PM, in the medical laboratory, a can of disinfectant spray was noted on top of a face shield (personal protective device) in the open storage cubicle.

3f. During an observation, on 7/11/19, at 12:59 PM, in the medical laboratory, a microwave was noted on the counter, next to a sink. The sink contained a basin half full of liquid and unwashed lab equipment. The sink sides had unknown liquid spillage with debris. The outside of the microwave door was covered with dried cloudy, gray, splash-debris. There were two small stickers on the door indicating "biohazard". One of the stickers was obscured by the gray debris.

During an observation on 7/11/19, at 1:03 PM, in the medical laboratory, in a cabinet, two bottles of bacteriology stains (used in microbiology to identify specific bacterial characteristics) had splashes down each bottle, obscuring the labels and staining the cabinet and floor.

During a review of the hospital's Chemical Hygiene Plan, dated 3/3/19, it indicated "Laboratory employees are responsible for: . . .Developing and practicing good personal chemical hygiene practices. . . General bacteriological stains may constitute both a chemical and biological hazard. . . Labels on original containers shall not be. . .defaced. . . Clean-up: Promptly clean up all spills using appropriate protective equipment. . ."

3g. During an observation, on 7/11/19, at 1:04 PM, in the medical laboratory, an opened corrugated carton, two white graduated cylinders and four white bottles were stored beneath a sink.

During an observation, on 7/11/19, at 1:15 PM, in the medical laboratory, three red bottles labeled DI H2O for cleaning washer bath, a gallon bottle of bleach, a pink basin with 3 white containers and a graduated cylinder, a second graduated cylinder and a wash bottle, a corrugated box containing cleaning products and six smaller boxes were under a second sink.

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Items are stored at least 12"-18" from a sink or there is a protective barrier (splash guard) to prevent splash contamination; storage under sinks is discouraged. To prevent water damage and/or contamination, store only chemicals and reagents that do not react with each other (or with water) under sinks."

During an observation and interview with the DCC, on 7/11/19 at 1:15 PM, in the medical laboratory, she confirmed the observation of an unsanitary environment, expired supplies and control, ice buildup in refrigerator/freezers, storage of items beneath sinks and corrugated cartons stacked on the floor in multiple areas.

3h. During an observation and interview with the DCC, on 7/11/19, at 1:10 PM, live plants were noted on the laboratory workstation divider. The DCC stated the plants should not be in the lab.

During a review of the U.S. Department of Health and Human Services document titled "Biosafety in Microbiological and Biomedical Laboratories, 5th Edition" dated 12/09, it indicated "Animals and plants not associated with the work being performed must not be permitted in the laboratory."

4. During an observation and interview with the ALD, on 7/11/19, at 12:30 PM, in the medical laboratory, the following expired quality controls vials were in the laboratory refrigerator:

Coulter 6C Cell Control:
1 unit, expired 12/16/18,
2 vials, expired 1/19/19,
3 vials, expired 1/21/19,
2 vials, expired 4/27/19,
2 vials, expired 4/28/19,
4 vials, expired 6/15/19,
2 vials, expired 6/16/19,
8 vials, expired 4/29/19; and,
Coulter S-Cal Calibrator:
2 vials, expired 3/23/19.

The ALD confirmed the expired quality controls.

During a review of the hospital policy titled "General Laboratory Supplies; reagents [a substance used in chemical analysis or other reactions], inventory, storage and disposal" dated 7/11/19, it indicated "Reagents and supplies, including instrument parts are not used passed their expiration date or past their open stability."

5. During an observation and interview with the Director of Pharmacy (DPH), on 7/9/19, at 2:35 PM, on Unit 1, the dirty utility room door was open. The dirty utility room contained two large clear bags of trash on the floor. The DPH confirmed that the dirty utility room door was open.

During an observation and interview with the DPH, on 7/9/19, at 2:45 PM, on Unit 1, the door to the dirty utility room was open. The DPH confirmed the dirty utility room was left open a second time.

During an observation on 7/9/19, at 3:45 PM, on Unit 1, the dirty utility room door was open. Signage on the door indicated "Biohazard" and "Keep Door Closed." Inside, on the floor, were two clear bags of trash.

During an observation and interview with RN 8, on 7/10/19, at 9:06 AM, in the Intensive Care Unit (ICU), the door to the dirty utility room was open. This dirty utility room was across from the automated drug dispensing cabinets and drug refrigerator. RN 8 confirmed the door was open and stated it should be closed.

6a. During an observation on 7/9/19, at 8:59 AM, in Labor and Delivery, a paper sign taped to the supply room door indicated "NO SUPPLIES ARE ALLOWED ON THE FLOOR!! THEY MUST BE ON WOODEN SUPPORTS!"

During an observation and interview with the Obstetrics (specific part of the hospital where babies are born) Assistant Manager (OBAM), on 7/9/19, at 9:06 AM, in the obstetrics supply room, unfinished two x fours (2 X 4) with rough sawed ends were noted on the floor under sterile supplies. Two additional unfinished rough sawed 2 x 4's were leaning against the wall. Sterile supplies were stored less than six inches from the floor.

6b. During an observation and interview with the Director Medical Surgical Services (DMSS), on 7/9/19, at 9:19 AM, in Unit 2's clean utility room, the room was overfilled with medical and nursing equipment. Equipment filled the shelves, some within an inch of the ceiling, next to an air vent and fire sprinklers. There was also multiple equipment on the floor, making walking in the room difficult. The DMSS specifically confirmed the continuous passive motion machine, additional bed parts, hover mat air blower (used to inflate mattress when a patient fell to the floor), blanket lifters (used to prevent blankets from causing pressure to patients' feet) were on the floor. The DMSS stated patient care equipment should not be on floor; she stated the hover mat blower was a patient shared item, which should be on a cart and not stored in this room.

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Items are stored at least 12"-18" from a sink or there is a protective barrier (splash guard) to prevent splash contamination; storage under sinks is discouraged. To prevent water damage and/or contamination, store only chemicals and reagents that do not react with each other (or with water) under sinks. Supplies are stored on shelves and off floors."

6c. During an observation and interview with the DCC, on 7/9/19, at 9:44 AM, in the intensive care unit's medication room, two bronchoscopes (a thin flexible tube attached to a video screen, passed through a patient's nose or mouth, down the throat and into the lungs to diagnose lung diseases) were in a clear cabinet with the door ajar over a trash can. The DCC confirmed the door should be closed and the scopes should not be stored over a trash can.

During a review of the CDC guidelines titled "Essential Elements of a Reprocessing Program for Flexible Endoscopes - Recommendations of the Healthcare Infection Control Practices Advisory Committee" dated 6/28/17, it indicated "Storage a. After reprocessing [disinfection] is complete, store endoscopes [any device consisting of thin flexible tubes, typically attached to a camera and video screen, inserted into a body opening, to diagnose and/or treat illness] and accessories in a manner that prevents recontamination, protects the equipment from damage, and promotes drying. Store processed flexible endoscopes in a cabinet. . ."

6d. During an observation on 7/11/19, starting at 12:30 PM, in the medical laboratory, many corrugated boxes were observed in several locations in the lab.

One corrugated carton in a cupboard with maintenance supplies;
Six corrugated cartons of Acid Wash Buffered Solution on the floor;
One opened, corrugated carton with several smaller boxes covered with a grayish fluffy debris of Flow Cell Scrub (used in testing blood), expired 9/30/01;
One opened, corrugated carton containing Activated Carbon Filters, (used for tissue processing) in a walkway;
Three corrugated carton containing cassettes, used for tissue processing in a walkway;
One corrugated carton cyrofunnel (used to hold samples) and one corrugated carton of 10% formalin (a tissue preservative), stored next to a biohazard container in a walkway;
Two corrugated cartons of blood grouping reagents (used to determine blood type), dated received 6/26/19 and four cartons of Anti-Human Globulin Anti IgG (Rabbit) (used for blood testing), dated received 6/26/19, stacked against the wall.

During an interview with the DCC, on 7/11/19, at 1:10 PM, she stated supplies should not be stored on the floor.

During a review of the hospital policy titled "X-ray/Lab Work Schedule," dated 4/19, it indicated this policy was for environmental services. The policy listed the following cleaning responsibilities: "Clean all horizontal surfaces. . .(Laboratory employees clean their own work station counter). Dust mop and wet mop all floor areas. . ."

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Supplies are stored on shelves and off floors."

During a review of the CDC's Morbidity and Mortality Weekly Report titled "Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories" dated 1/6/12, it indicated "Common causes of tripping include. . .clutter in the hallway. . .Keep clutter to a minimum. Make sure boxes and other items do not protrude into aisles. . ."

During a review of the hospital Chemical Hygiene Plan, dated 3/3/19, it indicated "No items are to protrude beyond the shelf limit. Aisles, exits and walkways must not be blocked. . .Keep the work area clean and uncluttered, with chemicals properly labeled and stored."

7. During an observation on 7/9/19, at 3:47 PM, on Unit 1, a visitor was in the hallway, outside room 117, holding small gray dog in their arms.

During an interview with RN 6, on 7/9/19, at 4 PM, she stated typically service dogs are allowed; the service dogs wear an identifying vest. RN 6 confirmed this dog did not have a vest on. RN 6 spoke with Room 117's family members, who stated the dog was not a service dog, but it had all its shots and they would not allow the dog on the floor.

During an interview with RN 7, on 7/9/19, at 4:08 PM, she confirmed service dogs were allowed but would check policy regarding this situation.

During an interview with RN 7, on 7/9/19, at 4:22 PM, she stated the hospital did not have a policy and it was taken on a case by case basis with the Infection Control Professional (ICP). RN 7 was unable to find documentation the ICP had been notified or made aware of the situation.

During an interview with the ICP, on 7/10/19, at 1:23 PM, she stated pets should be evaluated by her on an individual basis. She stated she had not evaluated this case.

8. During an observation and interview with Director Outpatient Clinics (DOPC) and Outpatient Physical Therapy Technician 1 (OPTT 1), on 7/12/19, at 9:50 AM, OPTT 1 stated the physical therapy mats are sanitized with a quaternary ammonium acid based sanitizer (quat - reduces microbial population on an inanimate object to a safe or relatively safe level) solution. He stated he mixes 1 capful of the quat solution into a bottle of water. The bottle had graduated marks and indicated 20 ounces. OPTT 1 stated he fills it up more because the instruction for use indicated a dilution ratio of one ounce (of quat) to a quart (32 ounces) of water. He estimated the bottle held about 25 ounces of solution. OPTT 1 poured out a capful of the quat sanitizer and measured it as 1/2 ounce. OPTT 1 read the MIFU and stated the MIFU indicated dilute 1/8 ounce of quat sanitizer to 1 quart of water. OPTT 1 stated he mixed the solution too strong. The DOPC confirmed the quat solution was not diluted according to the MIFU.

During an observation and interview with OPTT 2, on 7/12/19, at 9:56 AM, she was sanitizing a stationary cycle. OPTT 2 stated the stationary cycle was cleaned after each patient use with an alcohol based wipe and then dried with a towel.

During an interview with the DOPC, on 7/12/19, at 10:18 AM, she stated the equipment was cleaned with Sani-wipes (sanitizing), not alcohol. The DOPC confirmed the MIFU indicated a dwell time (the amount of time that a surface must remain wet to allow the chemical to be in contact with the organism in order to kill it) of two minutes and not wiped dry.

During a review of the hospital policy titled "Cleaning, Disinfection, and Sterilization" dated 5/18, it indicated "General principles of cleaning. . . Physical cleaning eliminates large numbers of organisms associated with the soil. Sound cleaning practices in health-care facilities are important. . .Manufacturer's recommendations for. . .use of cleaning supplies must be followed carefully. . .Factors affecting disinfectant activity Concentration of disinfectant In general, the more concentrated the solution, he greater the killing capacity of a chemical. However, he higher the concentration, the more likely a chemical is to damage the surface it is designed to disinfect. A successful product must be effective at a low enough concentration to avoid corrosion, staining, or other damaging effects to inanimate surfaces, hands or mucous membranes of the personnel. If the concentration is too low, the killing capacity of the chemical is decreases. . .Disinfection requires that the object to be disinfected have direct contact with the wet disinfecting agent for a specified time. . .The number of surviving organisms decreases with the time of exposure to the disinfectant.

During a review of the sanitizing wipes MIFU titled "General Guidelines for Use" dated 2016, it indicated "4. Allow surface to remain wet for two (2) minutes. Let air dry."



31580




39650

10. During an observation and interview with Charge Registered Nurse 2 (CRN 2), on 7/9/19, at 2:40 PM, in the nursery, the following expired items were noted:

Protective Moisture Barrier Ointment (diaper cream) - Expiration Date 9/18 (opened and used);
Sanicloth Bleach Germicidal Disposable Wipes (sanitizing wipes with bleach) - Expiration Date 4/19 (open and used).CRN 2 verified the barrier ointment and sanitizing wipes were expired.

During an observation and interview with CRN 2, on 7/9/19, at 2:58 PM, in the Special Nursery (nursery used for babies requiring more care than a healthy, full-term infant i.e., one born prematurely), the following expired items were noted:

Pediatric CO 2 (Carbon Dioxide) detector colorimetric (used to measure the amount of exhaled CO 2, typically used with babies requiring mechanical breathing assistance), Expiration Date 5/18;
CO 2 detector Infant/Pediatric, Expiration Date 4/22/13;
Surgical blade, size #10, Expiration Date 3/09.CRN 2 verified the CO 2 detectors and surgical blade were expired.

b. During an observation and interview with the Director of Surgical Services (DSS), on 7/11/19, at 9:30 AM, in the anesthesia workroom, the following expired supplies were noted:

Nine Universal Block Trays (trays containing supplies and medications used for pain management procedures), Expiration Date of 5/31/2019.
One ampoule (small glass container) of preservative free sodium chloride (saline solution) for injection, Expiration Date of 8/2018.
DSS verified the expired universal block trays and the expired saline ampoule.

11. During a concurrent observation, interview, and record review with CRN 2, on 7/9/19, at 11:37 AM, in the nursery, a refrigerator labeled for breast mil storage was noted. CRN 2 verified the refrigerator temperature was -21 degrees Celsius (equivalent to -5.8 degrees Fahrenheit (F) - units of measure ) and the freezer temperature was 10 degrees F. The CRN 2 confirmed the freezer was warmer than the refrigerator and stated the temperatures were not correct. She stated she did not know at what temperature breast milk should be stored.

During an interview with CRN 2, and a review of the Breast Milk Refrigerator Log 2006 (sic), on 7/9/19, at 12:15 PM, she verified the Breast Milk Refrigerator Logs, dated January 2019 through July 2019, did not indicate the temperature guidelines for breast milk storage in the refrigerator or the freezer. CRN 2 stated she did not know how the staff would know if the refrigerator and freezer temperatures were appropriate for breast milk storage. She verified the temperatures recorded did not distinguish between Celsius or Fahrenheit. CRN 2 verified the following June 2019 findings and the July 2019 findings:

June (No year) Breast Milk Refrigerator Log 2006 (sic)

June 8 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 10
June 9 Breast Milk Present - Yes Refrig Temp -20 Freezer temp 8
June 10 Breast Milk Present - Yes Refrig Temp -20 Freezer temp 10
June 11 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 12
June 12 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 12
June 13 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 20
June 14 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 20
June 15 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 18
June 16 no data recorded
June 17 Breast Milk Present - Yes Refrig Temp -6 F

Based on observation, interviews and record reviews, hospital administration failed to identify, report, monitor or control potential areas of infection when

1. A safe and sanitary medical laboratory environment was not maintained.

2. A safe and sanitary nursery outpatient surgical procedure area was not maintained.

3. Manufacturer's Instructions for Use (MIFU) for sanitizing products were not followed.

4. Staff was not knowledgeable in safe breast milk storage temperatures.

None of these high risk, problem prone practices were identified by staff, the infection control consultant or through the facility's infection control program, and reported to the hospital wide quality assurance program for implementation of corrective actions, placing patients at risk for infection.

Findings:

1a. During an observation and interview with Administrative Laboratory Director (ALD), on 7/11/19, at 12:30 PM, in the medical laboratory, the following expired quality controls vials were in the laboratory refrigerator:
Coulter 6C Cell Control (a brand name of quality control material used to monitor the accuracy and precision of Coulter analyzer that is designed to measure characteristicc of blood cells. This material needs to be stabilized in a vial and kept in cool places):

1 unit, expired 12/16/18,
2 vials, expired 1/19/19,
3 vials, expired 1/21/19,
2 vials, expired 4/27/19,
2 vials, expired 4/28/19,
4 vials, expired 6/15/19,
2 vials, expired 6/16/19,
8 vials, expired 4/29/19 and
Coulter S-Cal Calibrator:
2 vials, expired 3/23/19.
ALD confirmed the expired quality controls.

During a review of the facility policy titled "General Laboratory Supplies; reagents [a substance used in chemical analysis or other reactions], inventory, storage and disposal" dated 7/11/19, it indicated "Reagents and supplies, including instrument parts are not used passed their expiration date or past their open stability."

1b. During an observation on 7/11/19, starting at 12:30 PM, in the medical laboratory, it was observed one corrugated (thick paperboard) carton in a cupboard with maintenance supplies and one opened, corrugated carton with several smaller boxes covered with a grayish fluffy debris of Flow Cell Scrub (used in testing blood), expired 9/30/01 on the floor.

During an interview with the Infectious Control Professional (ICP) on 7/10/19, at 10 AM, she stated the hospital uses APIC (Association for Professionals in Infection Control and Epidemiology, is the leading professional association sets standards for various healthcare settings to to reduce infections and provide better patient outcomes) recommendations as a guidelines for infectious disease prevention throughout the hospital.

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Supplies are stored on shelves and off floors."

1c. During an observation, on 7/11/19, at 1:04 PM, in the medical laboratory, an opened corrugated carton, two white graduated cylinders and four white bottles were stored under a sink.

During an observation, on 7/11/19, at 1:15 PM, in the medical laboratory, three red bottles labeled DI H2O (Deionized water, has some resistance to electric current) for cleaning washer bath, a gallon bottle of bleach, a pink basin with 3 white containers and a graduated cylinder (laboratory equipment used to measure the volume of a liquid), a second graduated cylinder and a wash bottle, a corrugated box containing cleaning products and six smaller boxes were under a second sink.

During an observation and interview with Director of Critical Care Services (DCC), on 7/11/19 at 1:15 PM, in the medical laboratory, she confirmed the above observations.

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Items are stored at least 12"-18" from a sink or there is a protective barrier (splash guard) to prevent splash contamination; storage under sinks is discouraged. To prevent water damage and/or contamination, store only chemicals and reagents that do not react with each other (or with water) under sinks."

1d. During an observation on 7/11/19, starting at 12:30 PM, in the medical laboratory, many corrugated boxes were observed in several locations in the lab on the floor:

One corrugated carton in a cupboard with maintenance supplies;
Six corrugated cartons of Acid Wash Buffered Solution on the floor;
One opened, corrugated carton with several smaller boxes covered with a grayish fluffy debris of Flow Cell Scrub (used in testing blood);
One opened, corrugated carton containing Activated Carbon Filters, (used for tissue processing) in a walkway;
Three corrugated carton containing cassettes, used for tissue processing in a walkway;
One corrugated carton cyrofunnel (used to hold samples) and one corrugated carton of 10% formalin (a tissue preservative), stored next to a biohazard container in a walkway;
Two corrugated cartons of blood grouping reagents (used to determine blood type), dated received 6/26/19 and four cartons of Anti-Human Globulin Anti IgG (Rabbit) (used for blood testing), dated received 6/26/19, stacked against the wall.

During an interview with DCC, on 7/11/19, at 1:10 PM, she stated supplies should not be stored on the floor.

During a review of the APIC publication titled "Prevention Strategist" dated Winter 2011/2012, it indicated "Supplies are stored on shelves and off floors."

1e. During an observation, on 7/11/19, at 12:59 PM, in the medical laboratory, a microwave was noted on the counter, next to a sink. The sink contained a basin half full of liquid and unwashed lab equipment. The sink sides had unknown liquid spillage with debris. The outside of the microwave door was covered with dried cloudy, gray, splash-debris. There were two stickers on the door indicating "biohazard." One of the biohazard stickers was obscured due to the dried gray splash debris.

During an observation on 7/11/19, at 1:03 PM, in the medical laboratory, in a cabinet, two bottles of bacteriology stains (used in microbiology to identify specific bacterial characteristics) had splashes down each bottle, obscuring the labels and staining the cabinet and floor.

During a review of the facility's Chemical Hygiene Plan, dated 3/3/19, it indicated "Laboratory employees are responsible for: . . .Developing and practicing good personal chemical hygiene practices. . .General bacteriological stains may constitute both a chemical and biological hazard. . .Labels on original containers shall not be. . .defaced. . .Clean-up: Promptly clean up all spills using appropriate protective equipment. . ."

1f. During an observation and interview with DCC, on 7/11/19, at 1:10 PM, live plants were noted on the laboratory workstation divider. DCC stated the plants should not be in the lab.

During a review of the U.S. Department of Health and Human Services document titled "Biosafety in Microbiological and Biomedical Laboratories, 5th Edition" dated 12/09, it indicated "Animals and plants not associated with the work being performed must not be permitted in the laboratory."

1g. During an observation and interview with DCC, on 7/11/19, at 1:20 PM, in the blood bank, a live bug was crawling in a drawer. DCC confirmed a live bug was in the blood bank.

During a review of the U.S. Department of Health and Human Services document titled "Biosafety in Microbiological and Biomedical Laboratories, 5th Edition" dated 12/09, it indicated "An effective integrated pest management program is required."

During an observation and interview with DCC, on 7/11/19 at 1:15 PM, she confirmed the observation of an unsanitary environment, expired supplies and control, ice buildup in refrigerator/freezers, storage of items beneath sinks and corrugated cartons stacked on the floor in multiple areas. DCC stated supplies should not be stored on the floor.

During a review of the facility Chemical Hygiene Plan, dated 3/3/19, it indicated "No items are to protrude beyond the shelf limit. Aisles, exits and walkways must not be blocked. . .Keep the work area clean and uncluttered, with chemicals properly labeled and stored."

1h. During an observation in the medical laboratory, on 7/11/19, at 12:38 PM, a purse and a padded jacket were stored in a laboratory cupboard next to the Westergren tubes (used for blood test) and below it was a bottle of immersion oil and cleaning products.

During an observation in the medical laboratory, on 7/11/19, at 12:57 PM, an insulated lunch bag was observed in another laboratory cupboard.

During a review of the CDC's Morbidity and Mortality Weekly Report titled "Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories" dated 1/6/12, it indicated "Do not store food or beverages for human consumption in the laboratory. . .Never bring briefcases, purses, backpacks. . .and other personal items into the laboratory. These items are difficult to disinfect."

During a review of the facility's Chemical Hygiene Plan, dated 3/3/19, it indicated "No food, beverages, cups and other drinking/eating utensils may be stored in the laboratory. . .Personal property (i.e.: purses coats etc.) should be stored in employee lockers."

2. During an observation and interview, with a charge registered nurse (CRN) 2, on 7/9/19, at 12:13 PM, in the nursery, on the counter to the right of the sink, an outpatient circumcision was performed on Patient 30 by a medical doctor (MD 1).

During an observation and interview, with CRN 2, on 7/9/19, at 2:30 PM, in the nursery, the cupboard below the sink was not locked. CRN 2 opened cupboard and black debris, dirt, two blue medicine caps, a piece of paper towel and a wood piece with black debris were noted on the cabinet floor. CRN 2 verified the findings and stated the area should be clean.

During an observation and interview, with CRN 2, on 7/9/19, at 2:35 PM, in the nursery, a wood foot stool was noted to have dirt, chipped and cracked paint on the surface. CRN 2 verified the findings and stated the footstool should be discarded.

During an observation and interview, with CRN 2, on 7/9/19, at 3:27 PM, in the nursery nurses station, it ws noted the cupboard below the sink was unlocked. CRN 2 opened cupboard and found debris, dirt, and brown liquid stains on the cabinet floor. CRN 2 verified the findings and stated the area should be clean.

During a review of the facility policy and procedure titled "Cleaning, Disinfection, and Sterilization" dated 11/15, it indicated: "Principles and Methods of Cleaning Equipment and Supplies, General principles of cleaning . . . Physical cleaning eliminates large numbers of organisms associated with the soil. Sound cleaning practices in health-care facilities are important for aesthetic effects for reducing the microbial load on environmental surfaces."

3. During an observation and interview with Director Outpatient Clinics (DOPC) and Outpatient Physical Therapy Technician 1 (OPTT 1), on 7/12/19, at 9:50 AM, OPTT 1 stated the physical therapy mats are sanitized with a quaternary ammonium acid based sanitizer (quat - reduces microbial population on an inanimate object to a safe or relatively safe level) solution. He stated he mixes 1 capful of the quat solution into a bottle of water. The bottle had graduated marks and indicated 20 ounces. OPTT 1 stated he fills it up more because the instruction for use indicated a dilution ratio of one ounce (of quat) to a quart (32 ounces) of water. He estimated the bottle held about 25 ounces of solution. OPTT 1 poured out a capful of the quat sanitizer and measured it as 1/2 ounce. OPTT 1 read the manufacturer's instructions for use (MIFU) and stated the MIFU indicated dilute 1/8 ounce of quat sanitizer to 1 quart of water. OPTT 1 stated he mixed the solution too strong. DOPC confirmed the quat solution was not diluted according to the MIFU.

During an observation and interview with OPTT 2, on 7/12/19, at 9:56 AM, she was sanitizing a stationary cycle. OPTT 2 stated the stationary cycle was cleaned after each patient use with an alcohol based wipe and then dried with a towel.

During an interview with DOPC, on 7/12/19, at 10:18 AM, she stated the equipment was cleaned with Sani-wipes (sanitizing wipes) not alcohol. DOPC confirmed the MIFU indicated a dwell time (the amount of time that a surface must remain wet to allow the chemical to be in contact with the organism in order to kill it) of two minutes and not wiped dry.

During a review of the sanitizing wipes MIFU titled "General Guidelines for Use" dated 2016, it indicated "4. Allow surface to remain wet for two (2) minutes. Let air dry."

4. During a concurrent observation, interview, and record review with CRN 2, on 7/9/19, at 11:37 AM, in the nursery, a refrigerator labeled for breast mil storage was noted. CRN 2 verified the refrigerator temperature was -21 degrees Celsius (equivalent to -5.8 degrees Fahrenheit (F) - units of measure ) and the freezer temperature was 10 degrees F. The CRN 2 confirmed the freezer was warmer than the refrigerator and stated the temperatures were not correct. She stated she did not know at what temperature breast milk should be stored.

During an interview with CRN 2, and a review of the Breast Milk Refrigerator Log 2006 (sic), on 7/9/19, at 12:15 PM, she verified the Breast Milk Refrigerator Logs, dated January 2019 through July 2019, did not indicate the temperature guidelines for breast milk storage in the refrigerator or the freezer. CRN 2 stated she did not know how the staff would know if the refrigerator and freezer temperatures were appropriate for breast milk storage. She verified the temperatures recorded did not distinguish between Celsius or Fahrenheit. CRN 2 verified the following June 2019 findings and the July 2019 findings with breast milk present.

June (No year) Breast Milk Refrigerator Log 2006 (sic)

June 8 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 10
June 9 Breast Milk Present - Yes Refrig Temp -20 Freezer temp 8
June 10 Breast Milk Present - Yes Refrig Temp -20 Freezer temp 10
June 11 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 12
June 12 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 12
June 13 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 20
June 14 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 20
June 15 Breast Milk Present - Yes Refrig Temp -4 Freezer temp 18
June 16 no data recorded
June 17 Breast Milk Present - Yes Refrig Temp -6 Freezer temp 18
June 18 Breast Milk Present - Yes Refrig Temp -8 Freezer temp 16
June 19 Breast Milk Present - Yes Refrig Temp -6 Freezer temp 20
June 20 Breast Milk Present - Yes Refrig Temp -6 Freezer temp 8
June 21 Breast Milk Present - Yes Refrig Temp -6 Freezer temp 10
June 26 Breast Milk Present - Yes Refrig Temp -14 Freezer temp (blank)
June 27 Breast Milk Present - Yes Refrig Temp -2 Freezer temp 12

July (No year) Breast Milk Refrigerator Log 2006 (sic)

July 1 Breast Milk Present - No Refrig (refrigerator) Temp (temperature) -4 Freezer temp 20
July 2 Breast Milk Present - No Refrig Temp -4 Freezer temp 20
July 3 Breast Milk Present - No Refrig Temp -6 Freezer temp 16
July 4 Breast Milk Present - No Refrig Temp -6 Freezer temp 18
July 5 Breast Milk Present - No Refrig Temp -6 Freezer temp 18
July 6 Breast Milk Present - No Refrig Temp -6 Freezer temp 20
July 7 Breast Milk Present - No Refrig Temp -8 Freezer temp 20
July 8 Breast Milk Present - No Refrig Temp -8 Freezer temp 8
July 9 Breast Milk Present - No Refrig Temp -10 Freezer temp 18

CRN 2 was unable to provide a facility policy and procedure for breast milk temperature storage.

During a review of the ICP's Quality Improvement Report titled "Infection Control - Surgery" dated 10/3/18, it indicated "Dates of Review July through September, 2018 3rd Quarter Scope of Care being Reviewed: Environmental Points of Concern." The report indicated the following findings:
Storage on floor
Repair to OR walls in each surgery room
Repair to wall trim in main entrance hallway
Cleaning containers found without labels.

During a review of the ICP's "Environmental Points of Concern" quarterly reports for the year of 2018, there was no reports of the above findings.

Based on observation, interview, and record review, the hospital failed to ensure an operative report was written for one of 55 sampled patients (Patient 30). This failure resulted in an incomplete medical record and had the potential to affect Patient 30's future medical care.

Findings:

During an observation and interview with the Charge Registered Nurse 2 (CRN 2), on 7/9/19, at 12:13 PM, Medical Doctor 1 (MD 1) was observed carrying an infant into the nursery. CRN 2 stated the parents brought Patient 30 in for an out patient circumcision to be performed by MD 1.

During an interview and record review with the Chief Nursing Officer (CNO), on 7/10/19, at 3:18 PM, she reviewed Patient 30's medical record and was unable to find an operative report for the circumcision (procedure where tissue is removed from a penis) performed by MD 1 on 7/9/19. The CNO stated circumcision was not considered a surgical procedure at this hospital.

The "[Facility] Hospital Medical Staff Rules" undated, indicated, "IX. General Rules Regarding Surgical Care. . . B. Surgery: All operative reports shall be dictated or entered into the hospital's electronic health record within twenty-four (24) hours by the operating surgeon following surgery for outpatients as well as inpatients, including preoperative and postoperative diagnosis, description of findings, techniques used, and tissue removed or altered. The responsible operating surgeon performing that operation must be shown as such on record."