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Based on record reviews and interview, the governing body failed to ensure all services furnished in the hospital, including contracted services, were performed in a safe and effective manner. This deficient practice was evidenced by failing to ensure all services, including contracted services, were included in the hospital wide QAPI program.
Findings:

Review of the hospital's QAPI plan revealed there were no performance improvement indicators identified for the following contracted services: Linen Services, Biohazardous Waste Removal Services, Rehabilitation Services, and Ambulance Services.

In an interview on 10/02/18 at 10:28 a.m. with S23PT (Manager), he confirmed the hospital's Rehabilitation Services were provided through contractual agreement. S23PT confirmed he had no indicators for Rehabilitation Services and had not participated in the hospital wide QAPI program.

In an interview on 10/03/18 at 10:33 a.m. with S21CO and S2CNO present, S21CO indicated she is responsible for QAPI. S21CO confirmed they don't include Linen Services, Biohazardous Waste Removal Services, Rehabilitation Services, and Ambulance Services in the QAPI program.

Based on record reviews and interviews, the hospital failed to ensure it used the data collected to identify opportunities for improvement and changes that will lead to improvement and to take action aimed at performance improvement. The hospital failed to take action for improvement when it had identified a problem with the physicians' completion of H&P updates in 06/19/18. Observations during the survey on 10/02/18 at 9:19 a.m. and 11:05 a.m. revealed H&P updates were not performed in accordance with the hospital's Medical Staff "Rules and Regulations" for Patients #26 and #29.
Findings:

Review of the QAPI meeting agenda and minutes dated 06/19/18 revealed medical records reported H&Ps were 88% compliant. Further review revealed recommendations for action included the OR staff were to be informed that the patient was not to roll into OR unless the H&P was updated and signed as per policy and that a letter would be drafted and sent to all surgeons alerting them to this change in policy.

Observation on 10/02/18 at 9:19 a.m. in Pre-op revealed S12MD came to Patient #26's bedside and asked if she was "ready to go?" Further observation revealed S12MD explained the surgical procedure to Patient #26. Continuous observation revealed at no time did S12MD examine Patient #26 and ask her about any changes in her condition since the original H&P was done on 09/12/18.

Observation on 10/02/18 at 11:05 a.m. in PACU revealed S16MD presented to Patient #29's bedside and confirmed which leg was being operated. S16MD marked Patient #29's right leg, and had him sign the surgical consent. Further observation revealed S16MD asked Patient #29 if he had "any questions for me? Just want it fixed? We've been dealing with this a long time." S16MD then left the room briefly and then returned and asked Patient #29 if "nothing changed, no new health problems?" Continuous observation revealed no examination was conducted by S16MD of Patient #29.

Review of the documentation of the June 2018 staff meeting, presented by S20ORC as evidence of the staff education related to H&P updates, revealed "History and Physicals must be updated prior to surgery." There was no documented evidence that the education included that patients were not to roll into OR unless the H&P was updated and signed as per policy.

In an interview on 10/03/18 at 3:22 p.m. with S20ORC and S2CNO present, S20ORC indicated she addressed the H&P's with staff during the staff meeting in June 2018. S2CNO indicated the Medical Director hasn't sent any documentation to the medical staff related to the identified problem with H&Ps in June 2018.

Based on observations, record reviews, and interviews, the hospital failed to ensure the RN supervised and evaluated the nursing care of each patient as evidenced by:

1) Failing to ensure the RN monitored and documented the cardiac rhythm every 15 minutes after a procedure was completed when the patient received IV conscious sedation for 1 (#29) of 1 patient observed who had IV conscious sedation for a peripheral nerve block and for 2 (#1, #4) of 2 patient records reviewed of patients who had IV conscious sedation for peripheral nerve blocks from a sample of 29 patients. The hospital policy did not include what had to be monitored and documented every 15 minutes after a procedure for which IV conscious sedation was administered in accordance with the LSBN's "Declaratory Statement On The Role And Scope Of Practice Of The Registered Nurse In The Administration Of Medication And Monitoring Of Patients During The Levels of Intravenous Procedures/Conscious Sedation (Minimal, Moderate, Deep, And Anesthesia) As Defined Herein."

2) Failing to ensure the RN documented the administration of the peripheral nerve block medication when she assisted the anesthesiologist by pushing the medication and aspirating the syringe at the direction of the anesthesiologist. The RN documented the nerve block administration was administered by the anesthesiologist rather than documenting that she pushed the medication for 2 (#1, #4) of 2 patient records reviewed that the RN assisted with the peripheral nerve block from a sample of 29 patients.

Findings:

1) Failing to ensure the RN monitored and documented the cardiac rhythm every 15 minutes after a procedure was completed when the patient received IV conscious sedation:
Review of the policy titled "Administration & Monitoring of Moderate Sedation for Medical & Therapeutic Procedures", presented as a current policy by S2CNO, revealed continuous observation and monitoring of the patient during the administration of the medication must be done by an RN and/or physician. The following will be documented: pre-sedation vital signs and mental status; heart rate, respiratory rate, blood pressure, pulse oximetry, continuous cardiac monitoring, and LOC will be monitored every 5 minutes throughout the procedure. Post-procedure the patient will be monitored for a minimum of every 15 minutes for 30 minutes. There was no documented evidence the policy addressed what the RN or physician had to monitor every 15 minutes after the procedure.

Review of the LSBN's "Declaratory Statement On The Role And Scope Of Practice Of The Registered Nurse In The Administration Of Medication And Monitoring Of Patients During The Levels of Intravenous Procedures/Conscious Sedation (Minimal, Moderate, Deep, And Anesthesia) As Defined Herein" revealed the RN (non-CRNA) monitoring the patient will have no additional responsibility that would require leaving the patient unattended or would compromise continuous monitoring during the procedure. Further review revealed documentation and monitoring of physiologic measurements, including but not limited to blood pressure, respiratory rate, oxygen saturation, cardiac rate and rhythm, and level of consciousness shall be recorded pre-procedure and at least every 5 minutes during the therapeutic, diagnostic, or surgical procedure and at a minimum every 15 minutes during the recovery period or as deemed appropriate by the authorized prescriber.

Patient #29
Observation in PACU on 10/02/18 at 10:45 a.m. revealed S7MD and S8MD arrived to perform a right mid-thigh saphenous nerve block using ultrasound for Patient #29. Continuous observation revealed S32RN monitored Patient #29 while he was receiving IV conscious sedation administered by S7MD and every 15 minutes for 30 minutes after the procedure.

Review of Patient #29's "Peripheral Nerve Block Form" documented by S32RN on 10/02/18 from 10:48 a.m. through 11:21 a.m. revealed no documented evidence of Patient #29's cardiac rhythm every 15 minutes for 30 minutes after the procedure. Further review of the form revealed no documented evidenced of a column/row for documentation of the cardiac rhythm.

Patient #1
Review of Patient #1's "Peripheral Nerve Block Form" documented 04/23/18 by S6PACUC revealed the block procedure ended at 6:45 a.m. Further review revealed the vital signs documented every 15 minutes for 30 minutes after the procedure by S6PACUC did not include documentation of Patient #1's cardiac rhythm as required by the LSBN's "Declaratory Statement On The Role And Scope Of Practice Of The Registered Nurse In The Administration Of Medication And Monitoring Of Patients During The Levels of Intravenous Procedures/Conscious Sedation (Minimal, Moderate, Deep, And Anesthesia) As Defined Herein."

Patient #4
Review of Patient #4's Peripheral Nerve Block nursing note revealed no documented assessment of the patient's cardiac rhythm on the post procedure assessments which were documented immediately after completion of the procedure (beginning at 07:20 a.m.), every 15 minutes times 4 (07: 35 a.m., 07:50 a.m., 08:05 a.m., and 08:20 a.m.) then every 30 minutes times 2 (08:35 a.m. and 08:50 a.m.). The patient was transferred to the operating room at 08:53 a.m.

In an interview on 10/02/18 at 4:00 p.m., S6PACUC she documented the nerve block form and monitored Patient #1 after he received IV conscious sedation. She confirmed heart rhythm isn't documented as part of the every 15 minute assessment after the procedure. She confirmed their policy doesn't state what has to be monitored every 15 minutes post procedure.


2) Failing to ensure the RN documented the administration of the peripheral nerve block medication when she assisted the anesthesiologist by pushing the medication and aspirating the syringe at the direction of the anesthesiologist:

Patient #1
Review of Patient #1's "Peripheral Nerve Block Form" documented 04/23/18 by S6PACUC revealed the block procedure ended at 6:45 a.m. Further review revealed S7MD performed a right mid-thigh saphenous nerve block using ultrasound on 04/23/18 and administered Ropivacaine 0.5 mg around the nerves at 6:44 a.m. Further review revealed S4RN and S6PACUC were the RNs who assisted S7MD with the nerve block.

Patient #4
Review of Patient #4's Peripheral Nerve Block nursing note revealed S30RN documented that S31MD was at the bedside on 04/09/18 at 7:00 a.m. to perform a peripheral nerve block. Further review revealed documentation included time out was called, the block began at 7:00 a.m., and the procedure ended at 07:19 a.m. S4RN was also documented as being present for the procedure on the nursing note. There was no documented evidence who assisted S31MD with pushing and aspirating the plunger of the syringe containing anesthetic agents. The administration of the anesthetic agents was documented as per S31MD.

Review of S31MD's documentation on the anesthesia record revealed the procedure ended at 07:19 a.m. There was no documented evidence of the staff member who assisted with the procedure.

Review of the LSBN's "Declaratory Statement On The Registered Nurse Assisting With Peripheral Nerve Blocks" revealed it is within the role and scope of RNs to assist anesthesia providers in the administration of anesthetic agents during the performance of a peripheral nerve block provided the RN is under the direct supervision of the anesthesia provider and the RN has the requisite knowledge, skills, and abilities to do so.

In an interview on 10/02/18 at 4:00 p.m., S6PACUC indicated S4RN pushed the block medication, but she (S6PACUC) documented it was given by S7MD, meaning that S4RN did it as a third hand. She confirmed there was no documented evidence in Patient #1's medical record that S4RN aspirated the syringe and pushed Ropivicaine 0.5 mg to assist S7MD with the nerve block.


30984

Based on record review and interview, the hospital failed to ensure the nursing staff developed and kept current individualized and comprehensive nursing care plans. This deficient practice was evidenced by failure of the nursing staff to address active patient infections as identified problems in the patients' care plans for 2 ( #4, #7) of 2 patient records reviewed with diagnosed active infections from a total of 9 (#1 - #9) patient records reviewed for care plans from a sample of 29 patients.
Findings:

Review of the hospital policy titled," Plan of Care", Policy Number: DOC-010, revealed in part: Purpose: To develop an individualized plan of care which will ensure the continuity of care by other registered nurses and health care professionals. Policy: The admitting RN will review patient information, to include, but not limited to, the Admitting Diagnosis, Procedure, Physican's Orders, History and Physical, and Nursing Assessment Tools for example Admit History, Patient Medication Reconciliation, etcetera. The RN will then conduct a head to toe assessment utilizing the nursing process to determine identifiable actual/potential nursing diagnoses. The nursing plan will be kept current by ongoing assessments of the patient's needs and response to interventions every shift. If the patient's condition changes the appropriate plan of care will be assigned.

Patient #4
Review of Patient #4's medical record revealed an admission date of 04/09/18 for a Right Total Knee Replacement. Further review revealed the patient had the following co-morbid diagnoses: Acute Sinusitis, Herpes Simplex Infection, and Influenza.

Review of Patient #4's care plan revealed no documented evidence that Acute Sinusitis, Herpes Simplex Infection, and Influenza had been included in the patient's plan of care.

Patient #7
Review of patient #7's operative note documented on 04/03/18 revealed she presented with infected hardware of the left mandible. Within the revious 6 weeks she had undergone bilateral sagittal split osteotomies and a genioplasty for degenerative joint disease of th tympanic membrane jpints and a skeletal malocclusion. Further review revealed there was some loosening of the hardware which subsequently became infected.

Review of Patient #7's Interdisciplinary Plan of care dated 04/03/18 revealed a care plan was developed for high risk for infectuion related to the invasive procedure rather than a plan for an active infection.

In an interview on 10/02/18 at 3:00 p.m. with S2CNO, she confirmed the active infections referenced above had not been included in the patient's plan of care.


30984

Based on record reviews and interview, the hospital failed to ensure medications were ordered with the specific dose/strength, route, and time interval for administration with the RN clarifying the order with the physician when all required information wasn't present in the order for 3 (#1, #10, #13) of 11 (#1 - #10, #13) patient records reviewed for medication orders from a sample of 29 patients.
Findings:

Review of the policy titled "Prescribing, Labeling Administration Of Medication", presented as a current policy by S3ACNO, revealed orders for the administration of drugs and biologicals will include the following: date and time of order; drug name; dose; frequency; route; exact strength and/or concentration; quantity; duration, when applicable; specific instructions, when applicable; name of prescriber. At any time during the administration of a medication, the physician and/or pharmacist may be notified for a clarification order which will be documented on the Physicians Order form.

Patient #1
Review of Patient #1's PSU Orders dated 04/23/18 revealed an order for Oxy IR 5 mg PO Q 4 hours as needed for mild breakthrough pain and Oxy IR 10 mg PO Q 4 hours as needed for moderate breakthrough pain. There was no documented evidence of parameters, such as a pain score, to determine when the RN was to administer Oxy IR 5 mg and Oxy IR 10 mg mild breakthrough pain. There was no documented evidence of a clarification order written by the RN.

Patient #10
Review of Patient #10's Abdominoplasty Post-op Orders dated 09/12/18 at 2:45 p.m. revealed an order for Phenergan 25 mg tablet 1 PO or suppository 1 per rectum Q 6 hours PRN nausea. Further review revealed no documented evidence how the RN was to determine whether to give the Phenergan orally or per rectum, and there was no documented evidence of a clarification order written by the RN.

Patient #13
Review of patient #13's Anesthesia - PACU Orders dated 05/03/18 at 2:02 p.m. revealed an order for Demerol 12.5 mg IVP slowly then Q 5 minutes for a total of 50 mg or until pain is relieved and an order for Dilaudid 0.5 mg IVP slowly, if no relief, then 0.5 mg Q 3 minutes for a total of 2 mg or until pain is relieved. There was no documented evidence how the RN was to determine whether to give the Demerol or the Dilaudid for pain. There was no documented evidence of a clarification order written by the RN.

In an interview on 10/02/18 at 2:30 p.m., S19PSUC indicated the choice of pain medication would be the patient's preference, and then the nurse would discontinue the other one. She further indicated a clarification order should be obtained by the RN from the physician.

Based on interview, the hospital failed to ensure the organization of the medical record service was appropriate and complied with the requirements of State regulations as evidenced by failure to have a RHIT or RHIA designated as responsible for the medical record department.
Findings:

In an interview on 10/01/18 at 9:34 a.m., S2CNO indicated they have not had a RHIA or RHIT since August 2018. She further indicated S5IMRC is the interim medical record coordinator.

Based on observation, record review, and interview, the hospital failed to ensure its patient medical records were stored in a manner to protect them from potential water damage in the event the sprinkler system in the Medical Record Department was activated as evidenced by observation on 10/01/18 at 9:34 a.m. of patient medical records stored on rolling shelving with a space between each shelf that allowed records to be exposed to potential water damage if the sprinkler system was activated. Observation revealed an open shelf unit with medical records on it, > 50 medical records waiting to be scanned stacked on the desk in the room, and a rolling cart with medical records awaiting physician signatures exposed to potential water damage. The hospital's medical record retention policy did not address protecting patient records from fire and water damage.
Findings:

Observation on 10/01/18 at 9:34 a.m. in the Medical Record Department revealed patient medical records stored on rolling shelving with a space between each shelf that allowed records to be exposed to potential water damage if the sprinkler system in the room was activated. Further observation revealed an open shelf unit with medical records on it, > 50 medical records waiting to be scanned that were stacked on the desk in the room, and a rolling cart with medical records awaiting physician signatures exposed to potential water damage.

Review of the policy titled "Retention of Medical Records", presented as a current policy by S2CNO, revealed medical records will be housed in the appropriate designated area. There was no documented evidence that policy addressed that patient medical records had to be stored in a manner to protect them from fire and water damage.

In an interview on 10/01/18 at 9:34 a.m., S2CNO confirmed the patient medical records housed in the Medical Record Department were not stored in a manner that protected them from water damage if the sprinkler system was activated.

Based on observation, record review, and interview, the hospital failed to implement its policy for outdated/expired drugs as evidenced by having 13 vials of Mannitol 25% injection that was expiring on the 10/01/18 available for patient use which should have been removed from the malignant hyperthermia cart on 09/28/18.
Findings:

Observation in PACU on 10/01/18 at 9:15 a.m. revealed the Malignant Hyperthermia Cart had 13 vials of 50 ml Mannitol 25% injection with an expiration date of 10/01/18.

Review of the policy titled "Drug Storage General", presented as a current policy by S2CNO, revealed pharmacy technicians will be responsible for pulling expiring drugs prior to their expiration date within the last week of the month. The pharmacy will inspect all medications monthly.

In an interview on 10/01/18 at 9:15 a.m., S2CNO indicated the pharmacist is supposed to check for expiration dates at the end of the month. She further indicated the pharmacist should have checked the cart on Friday 09/28/18 and pulled the vials of Mannitol.

Based on record review and interview, the hospital failed to ensure Radiological Services were under the direction of a doctor of medicine or osteopathy who was qualified by education and experience in radiology. This deficient practice was evidenced by failure of the hospital's Governing Body to appoint a Radiologist to supervise/direct the hospital's contracted Radiological Services.
Findings:

Review of the hospital's organizational chart, presented as current by S2CNO, revealed no documented evidence of a physician director of the hospital's Radiological Services.

Review of S28MD's credentialing file revealed no documented evidence that S28MD had been appointed by the Hospital's Governing Body to serve as the Medical Director of Radiological Services. Further review revealed no documented evidence S28MD had been privileged to serve as Medical Director of Radiological Services.

On 10/01/18 at 9:30 a.m. in an interview with S29RT, he revealed S28MD was the Director of Radiological Services.

On 10/03/18 at 8:00 a.m. in an interview with S2CNO, she reported S28MD was Medical Director of Radiological Services.

In an interview on 10/03/18 at 8:20 a.m. with S2CNO, she confirmed there was no documentation of appointment of S28MD, by the hospital's Governing Body, to serve as Medical Director of Radiological Services.

Based on observations, record reviews, and interviews, the infection control officer failed to implement the system for for identifying and controlling infections and communicable diseases of patients and personnel as evidenced by:

1) Failing to implement surgery-related infection risk mitigation measures by having cloth skull caps and hair protruding from surgical hats and having surgical masks tied loosely allowing venting on the sides as observed during observations on 10/02/18 from 8:32 a.m. through 11:52 a.m.

2) Failing to implement healthcare-associated infection risk mitigation measures by having observed breaches in hand hygiene by staff on 10/01/18 at 9:20 a.m. and on 10/02/18 from 8:52 a.m. to 9:05 a.m.

3) Failing to ensure safe injection practices were implemented by staff by having medications pre-drawn for later use not labeled with the use by/expiration time.

4) Failing to implement techniques for food sanitation by having cool packs used to transport lab specimens stored in the patient nourishment refrigerator on the PSU.

Findings:

1) Failing to implement surgery-related infection risk mitigation measures:

Observation in Pre-op on 10/02/18 at 8:32 a.m. revealed S10MD entered the sterile hall with hair protruding from her bouffant hat at the nape of the neck and sideburns.

Observation in PACU on 10/02/18 at 10:40 a.m. revealed S7MD and S8MD arrived to perform a peripheral nerve block with IV conscious sedation. Further observation revealed S7MD and S8MD hair protruding at the sideburns and nape of the neck. S8MD had part of her cloth skull cap protruding from the bouffant cap.

Observation on 10/02/18 at 11:23 a.m. in OR 3 (with instruments opened on the sterile field) revealed S14CRNA had hair protruding from her bouffant hat at the side of forehead and nape of the neck. Further observation revealed S17CST and SS25ST each had hair protruding from the bouffant hat at the nape of the neck and sideburns. Continuous observation at 11:30 a.m. revealed S33WT was present with his face mask tied loosely allowing his nose and mouth to be visible from side of mask. At 11:36 a.m. S8MD entered OR 3 with part of her cloth skull cap exposed from the bouffant hat, hair exposed from the bouffant hat, and her face mask not tied at the lower strings allowing her nose and mouth to not be covered. At 11:52 a.m. S18SR entered OR 3 with a beard cover on with his hair exposed from his surgical hat at the nape of the neck and sideburns and his beard exposed at the sideburn area.

Review of the policy titled "Surgical Attire", presented as a current policy by S2CNO, revealed all persons entering the OR will be attired by the guidelines established for the hospital and in accordance with AORN Recommended Standards of Practice. A reusable cloth cap that is contained within a disposable cap may be home laundered. All personnel will wear a surgical head covering in semi-restricted and restricted areas. Masks are to be worn when in the presence of open sterile supplies and changed between patients and discarded.

Review of the AORN's "2018 Edition Guidelines For Perioperative Practice" revealed personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair. The surgical mask should cover the mouth and nose and be secured in a manner that prevents venting at the sides of the mask.

In an interview on 10/02/18 at 3:30 p.m., after the surveyor reviewed the observations made related to surgical attire, S20ORC confirmed they were breaches in the hospital's surgical attire policy.


2) Failing to implement healthcare-associated infection risk mitigation measures by having observed breaches in hand hygiene:

Observation on 10/01/18 at 9:20 a.m. revealed S4RN was in the medication room in PACU (enclosed by glass and able to be observed from outside the room) drawing up medication in 2 separate syringes. She removed her gloves and opened the door to exit the room without performing hand hygiene.

Observation in Pre-op on 10/02/18 at 8:52 a.m. revealed S11RN applied the tourniquet to start the IV on Patient #26, removed her gloves, and re-donned gloves without performing hand hygiene. Continuous observation revealed at 8:54 a.m. S11RN removed her gloves after starting the IV and re-donned gloves without performing hand hygiene. Continuous observation at 9:05 a.m. revealed S11RN removed her gloves after doing an accucheck (finger stick to check the patient's glucose level) and re-donned gloves without performing hand hygiene.

Review of the policy titled "Hand Hygiene", presented as a current policy by S2CNO, revealed handwashing may be used for routinely decontaminating hands after removing sterile or non-sterile gloves.

In an interview on 10/01/18 at 9:20 a.m., S4RN Rachel confirmed she did not perform hand hygiene after removing her gloves after drawing up medications.

In an interview on 10/02/18 at 9:39 a.m., S11RN indicated she was aware she was supposed to perform hand hygiene after removing gloves before re-donning gloves. She confirmed she didn't do hand hygiene and indicated "I was just nervous."


3) Failing to ensure safe injection practices were implemented by staff:

Observation on 10/01/18 at 9:20 a.m. revealed S4RN was in the medication room in PACU (enclosed by glass and able to be observed from outside the room) drawing up medication in 2 separate syringes. Further observation revealed the syringes that S4RN pulled out her pocket were labeled "Versed 2 ml" and "Fentanyl 100 mcg/2 ml."

Observation in Pre-op on 10/02/18 at 9:25 a.m. revealed S13RN drew up 2 separate syringes of Tranexamic Acid 1000 mg/10 ml, added each to 100 ml NS, and labeled the bag of NS with the date, time, medication/concentration, and initials with no documented evidence of a use by/expiration time. She then drew up Vancomycin 1 gm and added it to 250 ml NS with the label containing the same information. Observation revealed she didn't wipe the hub of each bag of fluids with an alcohol wipe before attaching the vials of medication.

Observation on 10/02/18 at 11:23 a.m. in OR 3 revealed S14CRNA took 4 pre-drawn syringes containing Propofol, Lidocaine, and Zemuron to be used for Patient #29 that had no use by/expiration time documented on the label.

Review of the policy titled "Prescribing, Labeling Administration Of Medication", presented as a current policy by S3ACNO, revealed medication preparation must be performed by the clinician administering the medication and will do so in the medicine room, Operating room, or procedure areas utilizing aseptic technique. Further review revealed in perioperative and other procedural settings both on and off the sterile field, medication or solution labels include the following; medication or solution name; strength; amount of medication or solution containing medication; diluent name and volume; expiration date when not used within 24 hours; expiration time when expiration occurs in less than 24 hours.

In an interview on 10/01/18 at 9:20 a.m., S4RN Rachel confirmed the syringes had only the drug name and dose on the label and did not include the expiration time, the time the medications were drawn, and her initials. She confirmed the medications were to be used by the anesthesiologist when she performed the peripheral nerve block for a patient.

In an interview on 10/02/18 at 9:25 a.m., S13RN confirmed she didn't wipe the bags of fluids before attaching the vials of medication but should have done so. She also confirmed the labels on the 2 bags of NS containing Tranexamic Acid 1000 mg/10 ml did not include the use by/expiration time.

In an interview on 10/02/18 at 11:23 a.m., S14CRNA confirmed the use by/expiration time was not documented on the pre-drawn syringes Propofol, Lidocaine, and Zemuron.

4) Failing to implement techniques for food sanitation:
An observation of the Post-Surgical Unit on 10/01/18 at 9:00 a.m. accompanied by S6PACUC and S19PSUC revealed 20 unlabeled cooling packs (two wrapped with brown paper towels) adjacent to ice cream containers in the patient nourishment freezer.

An observation of the Post-Surgical Unit on 10/02/18 at 10:00 a.m. revealed in the patient nourishment freezer there were 22 unlabeled cooling packs adjacent to ice cream containers.

On 10/02/18 at 4:30 p.m., an observation of the PSU freezer was conducted with S2CNO and S19PSUC. The freezer revealed the above findings of the unlabeled cooling packs adjacent to ice cream containers.

Review of the hospital policy DTY-19 dated 07/30/18 revealed in part, the purpose is to assure that the Dietary Department is meeting the current sanitation standards. Further review revealed under the topic food products and storage: all non-food items should be properly labeled and stored away from food products ....

On 10/02/18 at 4:30 p.m. in an interview with S2CNO and S19PSUC, S19PSUC confirmed that the PSU freezer contained patient ice cream containers adjacent to unlabeled non-consumable frozen packs. S19PSUC stated "these packs are not used on the patients. These packs are used if we have, for example, labs that need to be transferred, we will put a pack with the labs". S19PSUC did not answer if these packs were newly purchased items or reused.


39791

30984

Based on record reviews and interview, the hospital failed to ensure patients and their family members or interested persons were counseled to prepare them for post-hospital care. This deficient practice was evidenced by failing to include a list of all medications the patient should be taking after discharge with clear indication of changes from the patient's pre-admission medications for 4 of 4 (#7, #10, #11, #12) patient records reviewed for discharge medication changes from a total sample of 29 patients.
Findings:

Review of the policy titled "Discharge Planning", presented as a current policy by S2CNO, revealed upon discharge to home or another facility, the nurse will provide the patient with the following information to inform the patient's physician of the outcome of hospital treatment or follow-up care needs including the patient medication list and the discharge instruction sheet. There was no documented evidence the policy addressed that a list of all medications the patient should be taking after discharge with clear indication of changes from the patient's pre-admission medications had to be given to the patient at the time of discharge.

Patient #7
Review of Patient #7's "Patient Medication Reconciliation" form documented on 04/03/18 and used as the list of medications to be taken after discharge revealed Bactrim was to be continued with no documented evidence of the dose. Further review revealed Peridex had no documented evidence of the dose and frequency at which it was to be taken.

Patient #10
Review of Patient #10's Patient Medication Reconciliation form initiated 09/12/18 revealed no documented evidence whether Aspirin was to be continued after discharge. Further review revealed no documented evidence of the dose and route of Brio which was ordered to be continued after discharge. Further review revealed no documented evidence of the dose and route of Pepcid and how often (ordered PRN) it could be taken after discharge.

Patient #11
Review of Patient #11's medical record revealed an admission date of 08/10/18 for a bilateral tubal reversal. Further review revealed the patient had been discharged on 08/11/18.

Review of Patient #11's discharge medication reconciliation documentation revealed "pain medication and stool softener" had been prescribed as new medications to be taken by the patient after discharge. Further review revealed "pain medication" and "stool softener" were documented in the column labeled "new prescriptions to be filled by your pharmacist after discharge" on the discharge record. Additional review revealed the discharge nurse had failed to document the medication, dose, route, frequency, and time of day the medications should have been taken for both pain medication and stool softener.

Patient #12
Review of Patient #12's medical record revealed an admission date of 06/26/18 for a cervical disc replacement (Cervical 5/6). Further review revealed the patient had been discharged on 06/27/18.

Review of Patient #12's discharge medication reconciliation documentation revealed Phenergan and Norco had been prescribed as new medications to be taken by the patient after discharge. Further review revealed Phenergan and Norco 10 were documented in the column labeled "new prescriptions to be filled by your pharmacist after discharge" on the discharge record. Additional review revealed the discharge nurse had failed to document the dose, route, frequency, and time of day the medications should have been taken for both Phenergan and Norco 10.

S2CNO confirmed, in interview on 10/02/18 at 3:20 p.m., that the medication reconciliation for Patient #11 had been incomplete.

S2CNO confirmed, in interview on 10/03/18 at 2:00 p.m., that the medication reconciliation for Patient #12 had been incomplete and indicated the nurse that had discharged the patient no longer worked at the hospital.

In an interview on 10/02/18 at 2:30 p.m., S19PSUC indicated the medication reconciliation list should be complete and accurate, because a copy of it is given to the patient at the time of discharge.




39791

Based on observations, record reviews, and interviews, the hospital failed to meet the requirements of the Condition of participation of Surgical Services as evidenced by failure to ensure surgical services policies were designed and/or implemented to assure achievement and maintenance of high standards of medical practice and patient care.

The hospital failed to ensure its policy related to flammable skin preparation included that the implementation of procedures to reduce the associated risk of fire was documented in the patient's medical record and the policy was implemented. Observation of 1 (#29) of 1 patient in OR on 10/02/18 from 11:12 a.m. through 12:05 p.m. revealed the prepped area was not visually inspected for dryness before the patient was draped, and the time out performed did not include any information related to the prep agent. Alcohol-based skin preparations were used as the surgical prep with the use of the electrocautery system for surgical procedures performed with no documented evidence that the prep drying time was observed and an inspection was conducted for dryness prior to draping for 4 (#1, #4, #26, #29) of 4 patient records reviewed for surgical skin preps from a sample of 29 patients (See Findings in A0951).

Based on observations, record reviews, and interviews, the hospital failed to ensure surgical services policies were designed and/or implemented to assure achievement and maintenance of high standards of medical practice and patient care as evidenced by:

1) Failing to ensure its policy related to flammable skin preparation included that the implementation of procedures to reduce the associated risk of fire was documented in the patient's medical record and the policy was implemented. Observation of 1 (#29) of 1 patient in OR on 10/02/18 from 11:12 a.m. through 12:05 p.m. revealed the prepped area was not visually inspected for dryness before the patient was draped, and the time out performed did not include any information related to the prep agent. Alcohol-based skin preparations were used as the surgical prep with the use of the electrocautery system for surgical procedures performed with no documented evidence that the prep drying time was observed and an inspection was conducted for dryness prior to draping for 4 (#1, #4, #26, #29) of 4 patient records reviewed for surgical skin preps from a sample of 29 patients.

2) Failing to ensure a procedure was developed that addressed that a patient care assessment would be conducted to assure that the patient's care would not be compromised by having a low OR temperature level when the policy was changed from the AORN's standards for OR temperatures to standards provided by the hospital's accrediting agency. There were multiple days in September 2018 that the temperature in the 5 ORs was below the temperature recommended by the AORN standard.

Findings:

1) Failing to ensure its policy related to flammable skin preparation included that the implementation of procedures to reduce the associated risk of fire was documented in the patient's medical record and the policy was implemented:

Observation on 10/02/18 at 11:12 a.m. revealed Patient #29 was transported to OR 3 for a Right Total Knee Replacement. Continuous observation revealed S15RN prepped Patient #29's right knee and leg with Chloraprep and asked S20ORC to set the timer for 3 minutes. Continuous observation revealed the timer sounded at 11:55 a.m., and S15RN stated "that's 3 minutes." Continuous observation revealed S15RN called a "full stop time out" at 11:59 a.m. At this time the members of the surgical staff present in the room identified themselves, the patient's name and procedure was announced, S15RN asked the surgeon if there was any critical or unexpected steps, operative duration, or anticipated blood loss, S15RN asked S14CRNA if there were any patient-specific concerns, S15RN asked if there were any equipment issues or concerns, and S15RN stated antibiotic prophylaxis was in progress and the imaging was displayed. Continuous observation revealed S15RN did not include in the timeout that a flammable skin prep agent was used, that the site was dry, and that pooling did not occur or had been corrected. There was no observation of any staff member inspecting the prepped area to assure that the Chloraprep had dried prior to Patient #29 being draped for the surgical procedure.

Review of the policy titled "Flammable Skin Preparation Agents", presented as a current policy by S2CNO, revealed it is the hospital policy that if a flammable prep agent is used, additional precautions should be taken to minimize the risk of a surgical fire or patient burn injury. Further review revealed prep should be done in a manner that does not allow the prep agent to contact fabric or be allowed to pool on or under body part. If pooling occurs, excess solution will be wiped away, and any solution-soaked materials are to be removed from the procedure room before draping or using electrosurgery, laser, or other ignition source. Allow the prep agent to dry and vapors to dissipate before application of drapes. Duraprep and Chloraprep will be allowed to dry for 3 minutes. Isopropyl alcohol will be allowed to dry completely and fumes allowed to dissipate. The flammable prep agent should be included during timeout. The surgical team members will communicate that a flammable prep agent was used, the site was dry before draping, and pooling did not occur or has been corrected.

Review of the "Surgical Safety Checklist", presented as the current checklist by S20ORC, revealed pre-procedure verification by the RN and anesthesia provider included the fire risk assessment score precautions were taken. Further review revealed before skin incision time out is initiated and includes introduction of team members with all team members confirming patient identity, site, procedure, and consent, and anticipated critical events as follows: surgeon reviews critical or unexpected steps, operative duration, and anticipated blood loss; anesthesia staff reviews patient-specific concerns; nursing staff reviews that sterility has been confirmed and if there are any equipment issues or any concerns. Time out also includes assuring the antibiotic prophylaxis has been given within the last 60 minutes and that essential imaging is displayed. There was no documented evidence that the time out on the surgery safety checklist included time out requirements on the "Flammable Skin Preparation Agents" policy.

Review of the label on the container of "Chloraprep With Tint", provided by S20ORC, revealed active ingredients included Isopropyl alcohol 70%. Warnings included the following: to reduce the risk of fire, prep carefully; solution contains alcohol and gives off flammable vapors; avoid getting solution into hairy areas; do not drape or use ignition source until solution is completely dry (minimum of 3 minutes on hairless skin); do not allow solution to pool; remove wet materials from prep area.

Review of the label on the container of "3M DuraPrep Surgical Solution 8630", provided by S20ORC, revealed active ingredients included Isopropyl alcohol 74%. Warnings included the following: to reduce the risk of fire, prep carefully; do not drape or use ignition source until solution is completely dry (minimum of 3 minutes on hairless skin); do not allow solution to pool; remove wet materials from prep area.


Patient #1
Review of Patient #1's "OR Nursing Record" on 04/23/18 revealed Patient #1 had a Right Total Knee Arthroplasty. Further review revealed his right thigh to toes was prepped with Chloraprep and Alcohol. There was no documented evidence that the implementation of procedures to reduce the associated risk of fire (assured minimum drying time of prep agent and inspection of site dryness prior to draping) was documented in Patient #1's medical record.


Patient #4
Review of Patient #4's medical record revealed the patient was admitted for a right total knee replacement on 04/09/18.

Review of Patient #4's OR Nursing Record, dated 04/09/18, revealed Duraprep scrub solution was used to prep the patient's right leg. Further review revealed no documentation that the area prepped with Duraprep (a flammable surgical prep) was allowed to dry for 3 minutes and was visualized /confirmed to be completely dry prior to draping the patient and initiating the surgical procedure.


Patient #26
Review of Patient #26's "OR Nursing Record" revealed she had an Anterior Cervical Disc Fusion on 10/02/18, and Chloroprep was used as a surgical scrub. There was no documented evidence that the implementation of procedures to reduce the associated risk of fire (assured minimum drying time of prep agent and inspection of site dryness prior to draping) was documented in Patient #26's medical record.


Patient #29
Review of Patient #29's "OR Nursing Record" documented by S15RN on 10/02/18 revealed he had a Right Total Knee Replacement. Further review revealed his surgical scrub included Hibiclens and Chloroprep to the right leg "cuff to ankle." There was no documented evidence that the implementation of procedures to reduce the associated risk of fire (assured minimum drying time of prep agent and inspection of site dryness prior to draping) was documented in Patient #29's medical record.

In an interview on 10/02/18 at 3:30 p.m., S20ORC indicated the scrub technicians are trained not to drape unless the prep is dry, and a timer is set for 3 minutes once the prep is completed. She confirmed the policy didn't address that documentation of prep drying and an inspection prior to draping was required.

In an interview on 10/03/18 at 2:03 p.m., S22RN indicated she worked as a circulator in the OR. She further indicated the fire score is part of the time out taken prior to the start of the procedure. She indicated the circulator states everything that's on the safety checklist posted in the OR during the time out.

In an interview on 10/03/18 at 2:15 p.m., S15RN confirmed she was the circulator for Patient #29's procedure that was performed on 10/02/18. She indicated she has to inform all present in the room of the fire score. She further indicated they have to be sure the dry time for the prep agent is at least 3 minutes, and the scrub technician is supposed to check to be sure it's dry before they apply any drapes. When S15RN was informed by the surveyor that observation during the prep on 10/02/18 for Patient #29 revealed no discussion or statement was included in the time out related to the prep agent used and the fact that the area was dry, and no observation was made of the area being inspected for dryness prior to draping, S15RN indicated "I was nervous."


2) Failing to ensure a procedure was developed that addressed that a patient care assessment would be conducted to assure that the patient's care would not be compromised by having a low OR temperature level when the policy was changed from the AORN's standards for OR temperatures to standards provided by the hospital's accrediting agency:
Observation on 10/02/18 at 11:45 a.m. revealed the temperature in OR 3 was 66.5 degrees F.

Review of the policy titled "Temperature and Humidity", presented as a current policy by S20ORC, revealed it is the policy of the hospital that proper ventilation and temperature controls are in place in areas using ethylene oxide, nitrous oxide, or glutaraldehyde, Each OR shall have a separate temperature control. Utilizing the AORN standards for recommended temperature and humidity levels in the OR, the temperature will remain within a range to accommodate normothermia for the surgical patient and humidity levels between 20% and 60%.

Review of AORN's ventilation parameters in the section titled "Environment Of care, Part 2", presented as the current AORN standards for OR temperature by S20ORC, revealed the OR temperature should be between 68 degrees F. to 75 degrees F.

Review of documentation from the hospital's accrediting agency, presented by S20ORC as the basis for maintaining OR temperatures below the AORN standards, revealed that if the temperature is set below the established range, then there needs to be an assessment that patient care will not be compromised by the low temperature level, specifically that the low temperature will not adversely affect the relative humidity level.

Review of the OR temperature logs for each of the 5 ORs for September 2018 revealed there was 10 days the OR 1 temperature was below 68 degrees F., 14 days for OR 2, 14 days for OR 3, 20 days for OR 4, and 20 days for OR 5.

No documented evidence of a procedure for assessing a patient to assure that the patient's care would not be compromised by having a low OR temperature level was presented to the surveyor as of the end of the survey on 10/03/18 at 4:45 p.m.

In an interview on 10/02/18 at 3:30 p.m., S20ORC indicated they follow AORN standards. She further indicated they changed the OR temperature policy to state the OR temperature should be set to maintain normothermia for the patient. She further indicated their accrediting agency had put out a statement related to OR temperature and normothermia.

In an interview on 10/03/18 at 2:22 p.m., S20ORC indicated when they changed their OR temperature policy, they based it on the fact that the CRNA would be monitoring the patient's temperature throughout the surgical procedure. When informed by the surveyor that the accrediting agency's statement references a patient assessment, S20ORC confirmed they had not developed a procedure for a patient assessment to be conducted to assure that the patient's care would not be compromised by having a low OR temperature level.


30984

Based on observations, record reviews, and interviews, the hospital failed to ensure prior to surgery requiring anesthesia services, there would be an updated examination of the patient, including any changes in the patient's condition, completed and documented when the medical H&P was completed within 30 days before admission as evidenced by failure to have observation of an examination by the physician prior to the surgical procedure for 2 (#26, #29) of 2 patients observed for an updated H&P and 7 (#2, #3, #10, #21, #23, #26, #29) of 14 (#1 - #10, #21, #23, #26, #29) patient records reviewed for an updated H&P from a sample of 29 patients.
Findings:

Observation on 10/02/18 at 9:19 a.m. in Pre-op revealed S12MD came to Patient #26's bedside and asked if she was "ready to go?" Further observation revealed S12MD explained the surgical procedure to Patient #26. Continuous observation revealed at no time did S12MD examine Patient #26 and ask her about any changes in her condition since the original H&P was done on 09/12/18.

Observation on 10/02/18 at 11:05 a.m. in PACU revealed S16MD presented to Patient #29's bedside and confirmed which leg was being operated. S16MD marked Patient #29's right leg, and had him sign the surgical consent. Further observation revealed S16MD asked Patient #29 if he had "any questions for me? Just want it fixed? We've been dealing with this a long time." S16MD then left the room briefly and then returned and asked Patient #29 if "nothing changed, no new health problems?" Continuous observation revealed no examination was conducted by S16MD of Patient #29.

Review of the Medical Staff "Rules and Regulations", presented by S2CNO, revealed a medical H&P examination of the patient must be completed within 30 days before admission or registration and prior to surgery. When the medical H&P examination are completed within 30 days before admission, an updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission, but prior to surgery or procedure requiring anesthesia services.

Patient #2
Review of Patient #2's medical record revealed an admission date of 04/13/18 with an admission diagnosis of hemorrhoids and abdominal pain. Further review revealed Patient #2 was scheduled for a colonoscopy.

Review of Patient #2's original H&P revealed the examination was dated 03/29/18. Further review revealed no documented evidence that Patient #2 had an H&P examination by S27MD prior to having his colonoscopy on 04/13/18.

Patient #3
Review of Patient #3's medical record revealed an admission date of 09/28/18 with an admission diagnosis of rectal cancer. Further review revealed Patient #3 was scheduled for a colon resection.

Review of Patient #3's original H&P revealed the examination was dated 09/24/18. Further review revealed no documented evidence that Patient #3 had an H&P examination by S26MD prior to having his colon resection on 09/28/18.

Patient #10
Review of Patient #10's medical record revealed her original H&P was conducted by S9MD on 08/20/18. Further review revealed Patient #10 had an Abdominoplasty on 09/12/18. Review of her H&P revealed the box before the statement "H&P exceeds 24 hours prior to admission, the current exam has not changed" was blank and not checked. There was no documented evidence of notes in the section titled "Follow up Notes." S9MD signed the update section on 09/12/18 at 12:15 p.m. There was no documented evidence that an examination was performed and whether there were any changes in Patient #10's medical condition since the original H&P was documented on 08/20/18.

Patient #21
Review of Patient #21's medical record revealed an admission date of 03/22/18 with an admission diagnosis of right eye cataract. Further review revealed Patient #21 was scheduled for a cataract surgery.

Review of Patient #21's original H&P revealed the examination had no documented evidence of the date and time it was performed and no documented evidence of the signature of the physician who performed the H&P. Further review revealed no documented evidence that Patient #3 had an H&P examination prior to having her cataract surgery on 03/22/18.

Patient #23
Review of Patient #23's medical record revealed an admission date of 06/11/18 with an admission diagnosis of abdominal pain with constipation. Further review revealed Patient #23 was scheduled for a laparoscopic epigastric hernia repair.

Review of Patient #23's original H&P revealed the Review of Systems was incomplete as evidenced by no documentation of the following systems: Gastro Uterine, Muscular Skeletal, Skin, Neurological, Psychiatric, Hemodynamic, or Breast. Further review revealed the Physical Exam had no documented evidence of a pulse or respiratory rate. Further review revealed no documented evidence that Patient #23 had an H&P examination prior to having his laparoscopic epigastric hernia repair on 06/11/18.

Patient #26
Review of Patient #26's medical record revealed she had an Anterior Cervical Disc Fusion on 10/02/18. Review of her H&P documented by S12MD on 09/12/18 revealed it was signed by S12MD on 10/02/18 at 9:15 a.m. with no documented evidence that an examination was performed and whether there were any changes in Patient #26's medical condition since the original H&P was documented.

Patient #29
Review of Patient #29's medical record revealed he had a Right Total Knee Replacement on 10/02/18. Review of his H&P documented by S16MD on 09/12/18 revealed a stamped "H&P Update" stating "The H&P was reviewed, the patient was examined, and no change has occurred in the patient's condition" that was signed by S16MD on 10/02/18 at 11:10 a.m. (observation revealed no examination was performed).

On 10/01/18 at 12:50 p.m. in an interview with S19PSUC, she confirmed the medical record for Patient #2 did not contain an updated H&P by S27MD.

On 10/1/18 at 12:50 p.m. in an interview with S19PSUC, she confirmed the medical record for Patient #3 did not contain an updated H&P and the H&P contained an additional date of 09/28/18 at 8:00 a.m. and signature by S26MD, but there was no documentation of a follow-up examination.

In an interview on 10/02/18 at 12:35 p.m., S12MD confirmed he could have asked Patient #26 if she had any changes in her condition, but there "won't be any changes orthopedically." When informed by the surveyor that the federal regulations require an examination be performed as part of the H&P update, S12MD indicated "that's a nursing policy.

In an interview on 10/02/18 at 1:20 p.m., S16MD, when informed by the surveyor that there had been no observation that he performed an examination of Patient #29 as part of his H&P update, he indicated "you want me to treat heart and lungs? That's anesthesia." When the surveyor informed S16MD that the anesthesiologist had not performed a pre-anesthesia evaluation prior to performing his (Patient #29) peripheral nerve block, he indicated "you don't want me to treat their heart and lungs."

In an interview on 10/02/18 at 3:30 p.m., S20ORC indicated both the Pre-op RN and the OR circulator should check the patient's medical record for a completed H&P update prior to the patient being taken to the OR.

On 10/03/18 at 2:00 p.m. in an interview with S2CNO confirmed the medical record for Patient #21's did contain an incomplete H&P and no additional H&P in Patient #21's medical record.

On 10/03/18 at 2:00 p.m. in an interview with S2CNO, she confirmed the medical record for Patient #23 did contain an incomplete H&P. Further review revealed no additional H&P in Patient #23's medical record.



39791

Based on record review and interview, the hospital failed to ensure Respiratory Care Services was under the direction of a doctor of medicine or osteopathy on a full time or part time basis. This deficient practice was evidenced by failure of the hospital's Governing Body to appoint, credential, and privilege a physician to serve as Medical Director of Respiratory Services.
Findings:

Review of the hospital's organizational chart, presented as current by S2CNO, revealed no documented evidence of a physician director of the hospital's Respiratory Services.

Review of S24MD's credentialing file revealed no documented evidence that S24MD had been appointed by the Hospital's Governing Body to serve as the Medical Director of Respiratory Services. Further review revealed no documented evidence S24MD had been credentialed and privileged to serve as Medical Director of Respiratory Services.

In an interview on 10/03/18 at 8:00 a.m. with S2CNO, she confirmed respiratory services were provided directly by the hospital and not via contracted services. S2CNO reported S24MD was Medical Director of Respiratory Services.

In an interview on 10/03/18 at 8:20 a.m. with S2CNO, she confirmed there was no documentation of appointment of S24MD, by the hospital's Governing Body, to serve as Medical Director of Respiratory Services.