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Based on document review, interview and observation, it was determined that the Governing Body failed to demonstrate it is effective in carrying out the responsibilities for the operation and management of the facility. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

482.25 Pharmaceutical Services

Based on review of the Medical Staff Bylaws, review of the medical staff credential file of Staff #16, and staff interview, it was determined that the facility failed to ensure that clinical privileges are granted to members of the medical staff by the Governing Body.

Findings include:

Reference #1: "CareOne LTACH Medical Staff Bylaws" adopted by the Governing Body on December 26, 2012, states under Article VII, Determination of Clinical Privileges; Section 1. Exercise of Privileges.
"Every Medical Staff member or other professional providing direct clinical services at CareOne LTACH by virtue of Medical Staff membership or otherwise shall, in connection with such practice, be entitled to exercise only those clinical privileges or services specifically granted to him/her by the Board."

Reference #2: "CareOne LTACH Medical Staff Bylaws" adopted by the Governing Body on December 26, 2012, states under Article VII, Determination of Clinical Privileges; Section 4. Temporary Privileges. "4.2 Temporary Privileges are not to be routinely used in the following situations: ... An applicant fails to return all required information necessary to process their reappointment before the expiration date ... Under no circumstances will temporary privileges be granted at the time of reappointment."

1. Review of the credential file of Staff #16 revealed that he/she was due for medical staff reappointment on 12/31/2012.

2. The credential file of Staff #16 contained a "Delineation of Medical Privileges" form that was signed and dated on 1/1/13 by Staff #16. There was a handwritten check mark under the column "Requested" in the section labeled as "Category I Internal Medicine."

a. The "Approved" box and the signature line of the "Medical Chairman" were both blank, therefore, it could not be determined if the requested "Internal Medicine" privileges were approved by the Medical Chairman.

3. A copy of a letter addressed to Staff #16, dated January 1, 2013, signed by the Chief Executive Officer was in the credential file of Staff #16. The letter stated, "I am pleased to inform you that your completed application package has qualified you for the granting of temporary privileges at CareOne LTAC Hospital. Temporary Privileges have been granted for 60 days, while we continue processing your application for membership and clinical privileges ... "

a. Upon interview at 10:35 AM on 2/15/13, Staff #2 stated that Staff #16 has been credentialed at the facility for years. He/She was on vacation and did not submit the reapplication package in time. He/She was granted Temporary Privileges effective January 1, 2013, until his/her Peer Reference Evaluations could be returned.

b. Staff #16 was granted Temporary Privileges by the Chief Executive Officer although there was no evidence that his/her clinical privileges were granted by the Governing Body of the facility, as indicated in the Medical Staff Bylaws (Reference #1).

4. A policy titled "Temporary Medical Staff Privileges" was provided by Staff #2. The policy states, "It is the policy of the CareOne LTACH, that temporary clinical privileges may be granted to an applicant by the Medical Director and/or Chief Executive Officer to care for a specific patient(s) or for a new applicant while the credentialing process is pending after receipt of a completed Medical Staff application. Temporary privileges are granted only on a case by case basis or when specific and urgent patient care need arises."

a. The above noted policy does not adhere to the CareOne LTACH Medical Staff Bylaws which state, "Every Medical Staff member or other professional providing direct clinical services at CareOne LTACH by virtue of Medical Staff membership or otherwise shall, in connection with such practice, be entitled to exercise only those clinical privileges or services specifically granted to him/her by the Board."

Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that their restraint policy and procedure defined restraint use.

Findings include:

Reference: Facility policy and procedure titled 'RESTRAINTS' states "... POLICY: ... [3rd bullet] Restraints will be used as a last resort after alternative measures have been utilized and found ineffective. Alternatives to be considered: ... [nine alternatives listed] ... . DEFINITION: A restraint is defined as any manual method, physical or mechanical device, material or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely. ... APPLICATION: POLICY: 1) All restraint devices will be applied in a safe and effective manner. ... HAND MITT: 1) Place the entire hand inside the mitt. 2) Secure the ties of the mitt around the patient's wrist."

1. On 2/14/13 at 10:30 AM, the LTAC Unit was toured in the presence of Staff #10. Patient #5, in Room #231, bed 2, by the window was observed with hand mitts applied to his/her hands and fastened around his/her wrists. According to Staff #10, the hand mitts are restraint alternatives, not restraints.

2. During an interview on 2/14/12 at 12:00 PM, Staff #2 stated that if the hand mitts are not tied, then they are not a restraint.

3. The facility's policy and procedure for Restraints was reviewed and does not identify untied hand mitts as a restraint alternative. It does list Hand Mitts as a restraint.

4. Patient #5 was observed a second time in the presence of Staff #10 on 2/14/13 at 12:15 PM. The hand mitts were applied to the patient's hands and secured around her wrist with a buckle type fasten. The mitts could not be removed by the patient easily and would require the buckle fastening to be loosened so as to remove the hand mitts.

5. The hand mitts are not listed as a restraint alternative in the facility's policy and procedure when applied and not tied as per staff interviews.

6. The hand mitts do fit the facility's definition of a restraint in that they are a device or material that immobilizes or reduces the ability of the patient to move his or her body/ hands.

Based on observation and staff interview, it was determined that the facility failed to ensure implementation of its policy and procedure for checking the crash cart contents.

Findings include:

Reference: Facility policy and procedure titled 'CRASH CART CHECKLIST PROCEDURE' states, "POLICY: The emergency cart is expected to be ready for patient use at any time. The emergency cart integrity is maintained with a secured lock. A daily check of the emergency equipment outside the cart, a daily defibrillator discharge test and monthly open cart inventory is performed by the professional staff ... It is the RN's responsibility to assure readiness of emergency equipment. PROCEDURE: 1. Crash cart contents will be checked by the following circumstances: a. Any unlocked crash cart requires an immediate recheck of all contents. b. Following a Code Blue, the crash cart will be restocked, rechecked and relocked. ... c. An open crash cart review will be completed monthly provided the cart remains locked at all times. This review is to include a check of intubation equipment. ... 5. The security system utilized the [sic] --[facility name]-- relies on break-away locks. The professional staff member restocks the emergency cart, checks all contents as outlined in Item I, and relocks the cart. A replacement lock is issued only when exchanged for broken lock. ..."

1. On 2/14/13 at 10:55 AM the LTAC Unit was toured in the presence of Staff #10. The 'Code Cart Checklist' for the month of February, completed on 2/1/13, was reviewed. The new code cart lock number, placed at the completion of the code cart check and to replace one that was broken at the beginning of the code cart check per Staff #10, was documented as lock #4875378.

a. According to Staff #10, the 'Code Cart Checklist' is completed at the first of every month, or if the code cart is opened, for example in a Code Blue procedure.

b. The 'Code Cart Checklist' has a checklist area, 'Reason cart opened', and "routine monthly check" was checked off. The other options to check are, "Patient cardiac arrest" and "Emergency item needed."

2. The code cart lock number was observed to be 4875241 at this time, 10:55 AM on 2/14/13. This number, 4875241, did not match the number documented on the 'Code Cart Checklist' dated 2/1/13, which was 4875378.

a. There was no evidence of another 'Code Cart Checklist' after 2/1/13 to indicate when the initial lock was broken and the second lock applied. This was confirmed by Staff #10.

3. The 'Daily defibrillator Check' sheets were reviewed and on 2/4/13 for the 7 AM- 7 PM shift, it was documented that the lock number was 4875378. The 7 PM-7 AM shift of 2/4/13 documented the lock number as 4875241. There was no evidence of a 'Code Cart Checklist' on 2/4/13 to indicate why the code cart was opened, and that the supplies were restocked and ready for patient use as per facility policy.

Based on observation, medical record review, policy review, and staff interview on 2/15/13, it was determined that the facility failed to implement policies and procedures to ensure that medications administered by nursing personnel are administered in accordance with prescriber orders and medical staff policy.

Findings include:

Reference #1: Facility policy titled "Medication Administration Record (MAR)" states, "...4. Routine medication: a. The RN [Registered Nurse] transcribing the medication order, will enter the order date and his/her initials in the column labeled "Initials" to the left of the medication name. The registered nurse, who checks the order, should also initial the order date. Two initials are necessary to confirm physician order. ...b. Fill in the medication, dose [sic] frequency, and route. ...5. PRN [as needed] Medication orders: ...All PRN orders must have an indication for use."

Reference #2: Facility policy titled "Medication Administration: General Guidelines for the Administration of Medications" states, "...Procedure: ...1. Nurse prepares the medication cart prior to beginning medication pass. Nurse ensures that all needed equipment and items are available including but not limited to: ...b) Medication Reference Book...c) Pill Crusher...d) Fluids/Applesauce...e) Measuring Cups...f) Medicine Cups...g) Tongue Blades/Spoons...2. While administering medications, the nurse ensures that the medication cart is locked anytime it is out of his/her direct line of vision."

1. Medication Administration Record for Patient #11 contained the entry "Vancomycin 1gm [gram] Q24hr [every 24 hours]" started on 2/8/13.

a. The entry lacked the route of administration in accordance with facility policy (Reference #1).

b. During a medication pass observation at 10:05AM on 2/15/13, using the Medication Administration Record, Staff #17 could not determine the route of administration for Vancomycin 1gm due to be administered at 10:00AM.

c. Review of the Medication Reconciliation Order Form for Patient #11 revealed the physician's order "Vancomycin 1gm IVPB [intravenous piggy-back] Q24hr" ordered on 2/8/13. The route of administration ordered had not been transcribed onto the Medication Administration Record.

2. Medication Administration Record for Patient #11 contained an entry, "Albuterol 2.5mg [milligram] 3mls [milliliters] + Atrovent 0.5mg Q3 [every 3] (sic) PRN" started on 2/8/13.

a. The Medication Administration Record lacked the indication for use in accordance with facility policy (Reference #1).

3. At 11:00AM, Staff #19 was observed passing medications to Patient #12 using a wheeled chart rack in place of a medication cart.

a. Upon interview, Staff #10 stated that the facility had two medication carts and between four to five nurses passing medications depending on the patient census. He/she stated that it was the practice of the facility for two nurses to pass medications using the two medication carts, while the other nurses used wheeled chart racks with only the patient's medication administration record and medication cassette drawer (containing the patient's medications) obtained from the medication cart.

b. The practice of using wheeled chart racks to pass medications is not in compliance with the facility's policy and procedure (Reference #2).

i. The wheeled chart racks did not have the equipment and items needed by the nurses to pass medications as outlined in the facility policy (Reference #2).

ii. The wheeled chart racks had no mechanism to keep medications locked and secure in accordance with facility policy (Reference #2).

4. These findings were confirmed with Staff #10 and #20.

Based on medical record review, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure implementation of its medical records department policies in 2 of 4 medical records reviewed (Medical Records #4 and #5).

Findings include:

Reference #1: Facility policy and procedure titled 'Medical Transcription' states, "DEFINITION: To provide and ensure accurate and timely transcription of hospital reports dictated on the transcription system. POLICY: Turn-around time on all reports transcribed as follows: ... Consultation Reports: Routinely transcribed within 24 hours."

Reference #2: Facility policy and procedure titled 'TIMELINESS OF MEDICAL RECORD DOCUMENTATION' states, "... PROCEDURE: The following significant clinical information shall be documented within the following required timeframe: ... History and Physical Exam within 24 hours of patient's Admission."

1. On 2/14/13 review of Medical Record #4 indicated that the patient was admitted on 2/11/13. The following was evident in the medical record:

a. A 'Report of Consultation' form dated 2/12 [year not identified], signed by the practitioner that indicated the Infectious Disease consult was dictated.

b. A 'Report of Consultation' form dated 2/11/13, signed by the practitioner that indicated the Pulmonary consult was dictated.

2. Staff #11 stated during interview on 2/14/13 at 11:10 AM that dictated consultations are on the charts after 24 hours of dictation. Staff #11 confirmed that the Infectious Disease and Pulmonary consults were not in Medical Record #4.

3. There was no evidence that the dictated infectious disease and pulmonary consults for Patient #4 were completed and placed in Medical Record #4 within 24 hours as per facility policy.

4. Review of Medical Record #5 on 2/14/13 indicated that the patient was admitted to the facility on 2/12/13. The 'HISTORY & PHYSICAL EXAMINATION' form was blank. There was no evidence of a completed history and physical exam within 24 hours of admission in the medical record as per facility policy and procedure.

Based on document review, observation and staff interview conducted on 2/15/13, it was determined that the facility failed to ensure that pharmaceutical services were directed by a registered pharmacist in accordance with facility policies and acceptable standards of practice.

Findings include:

1. The facility failed to develop and approve policies and procedures addressing the beyond use date of multidose vials that were in accordance with acceptable standards of practice. Refer to Tag A491.

2. The facility failed to ensure that approved policies and procedures addressing pharmacy services were appropriate for a Long Term Acute Care Hospital. Refer to Tag A491.

3. The facility failed to ensure that medications were dispensed by the pharmacy in accordance with physician's orders. Refer to Tag A500.

4. The facility failed to ensure that medications were kept in a secure area, and locked when appropriate. Refer to Tag A502.

5. The facility failed to ensure that expired medications were not available for patient use. Refer to Tag A505.

A. Based on observation, review of policies and procedures, and staff interview on 2/15/13, it was determined that the facility failed to develop and approve policies and procedures addressing the use of multidose vials that were in accordance with acceptable standards of practice.

Findings include:

Reference #1: Facility policy titled "Multidose Vials" states, "...2. Vial must be discarded not later than one month (30 days) from date of opening."

Reference #2: Facility policy titled "Medication Administration: Use of Injectable Vials" states, "...3. The nurse will use multidose vials in the following manner: ...f) Discard the vial 30 days after the outer cap has been removed or in accordance with the manufacturer expiration date, whichever is first."

Reference #3: The United States Pharmacopeia, Chapter 797 when addressing the beyond use date (BUD) for multi-dose vials states " The BUD after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days ...unless other wise specified by the manufacturer. "

1. At 2:00PM, an opened Lantus insulin vial was observed labeled with a 28 day beyond-use date.

a. Upon interview, Staff #10 stated that the practice of the facility was to discard multidose vials 28 days from the date of opening.

b. Facility policy and procedure (Reference #1 and #2) states that multidose vials are discarded 30 days from the date of opening.

c. The approved policy and procedure (Reference #1 and #2) do not reflect the current practice of the facility or acceptable standards of practice (Reference #3).

2. These findings were confirmed with Staff #10 and Staff #20.

B. Based on observation, review of policies and procedures, and staff interview on 2/15/13, it was determined that the facility failed to ensure that approved policies and procedures addressing pharmacy services were appropriate for a Long Term Acute Care Hospital (LTACH).

Findings include:

1. Review of facility policies and procedures with Staff #20 revealed that the following policies are not consistent with the practices of the facility:

a. "Medication Dispensing: Pass Medications"

b. "Medication Ordering and Prescribing: Psychoactive Medication Use"

c. "Medication Dispensing: Back Up Medications"

d. "Medication Dispensing: Controlled Dangerous Substance Inventory for Back Up Box and Emergency Kit"

e. "Medication Dispensing: OTC Stock List"

f. "Controlled Substances"

g. "Medication Dispensing: Distribution System"

h. Upon interview, Staff #20 stated that the current pharmacy policies and procedures were adapted from Long Term Care policies and procedures from the provider pharmacy. He/she confirmed that the facility's pharmacy policy and procedure manual needed to be revised to reflect the current practices of the facility.

2. These findings were confirmed with Staff #10 and Staff #20.

Based on observation, medical record review, and staff interview on 2/15/13, it was determined that the facility failed to ensure that drugs were dispensed by the pharmacy in accordance with a physician's order.

Findings include:

Reference: Facility policy titled "Unit Dose Distribution System" states, "...POLICY: Medication will be dispensed via a 24-hour unit dose drug distribution system...2. The pharmacy will dispense a 24-hour supply of medications for each patient within their cassette...6. The pharmacy will deliver a new set of cassettes every 24 hours. The pharmacy courier will exchange the previous day's cassettes for the new cassettes on the nursing unit."

1. At 10:30AM, in the presence of Staff #20, eight (8) Risa-Bid tablets were observed in the cassette drawer assigned to Patient #11.

a. Upon interview, Staff #20 stated that Risa-Bid was dispensed by the pharmacy in substitution of Bacid (lactobacillus) ordered on 2/8/13.

b. Review of the Medication Administration Record revealed that the order for "Lactobacillus 2 caps NGT [nasogastric tube] Q6hr [every 6 hours]" was discontinued on 2/11/13.

i. A corresponding order "D/C [discontinue] Zinc Sulfate/Vit C [vitamin c]/ & Lactobacillus" written on 2/11/13 was noted in the "Physician's Orders" sheet.

c. Upon interview, Staff #10 and Staff #20 could not explain why the pharmacy was dispensing Risa-Bid tablets when the order was discontinued on 2/11/13.

Based on observation, policy review, and staff interview on 2/15/13, it was determined that the facility failed to implement policies and procedures to ensure that drugs are kept in locked storage areas.

Findings include:

Reference: Facility policy titled "Medication, Oral Medication Administration" states, "...6. ...If called away while pouring medicine, always lock the cart. ...8. NEVER leave medication unattended."

1. At 11:00AM, in the presence of Staff #20, two medication cassette drawers were observed on top of a wheeled chart rack in the hallway unlocked and unattended by facility staff.

a. On observation, Staff #19 was in the patient room administering medications to Patient #12 with the privacy curtain drawn.

b. The two unsecured medication cassette drawers, assigned to Patient #12, contained the following medications:

i. Three lactulose 20gm (gram)/30ml (milliliter) unit-dose cups.

ii. One docusate 100mg (milligram)/10ml unit-dose cup.

iii. One acetazolamide 250mg tablet.

iv. One Aspirin 81mg chewable tablet.

v. One Trans-Derm Scopolamine 1.5mg patch.

vi. One Bumetanide 1mg tablet.

vii. One acetaminophen 500mg/15ml unit-dose cup.

2. These findings were confirmed with Staff #10 and Staff #20.

Based on observation and staff interview on 2/15/13, it was determined that the facility failed to ensure that outdated medications were not available for patient use.

Findings include:

1. At 2:00PM, a box labeled "Diltiazem Box #3", found in the refrigerator located in the Medication Room, contained the following outdated medications:

a. Two diltiazem hydrochloride 50mg (milligram)/10ml (milliliter) vials, expired 10/12.

b. Two diltiazem hydrochloride 25mg/5ml vials, expired 10/12.

2. These findings were confirmed with Staff #10 and Staff #20.

A. Based on observation on February 14, 2013, it was determined that the facility failed to ensure that a sanitary physical environment was maintained.

Findings include:

1. The floor in the Respiratory Supply storeroom contained dust and spillage beneath the wire storage racks.

2. The red plastic bins in the Respiratory Supply storeroom, storing clean and sterile respiratory supplies, were soiled with debris.

3. Respiratory equipment to include ventilator bacterial filters were stored in a box on the floor.

4. The equipment storeroom for Environmental supplies and patient equipment was cramped, making access to cleaning difficult.

5. The floor in the Environmental and Patient Supply Storeroom was soiled with dust and debris.

6. One patient lift contained plastic wrap around the hand supports, impeding proper cleaning and disinfection.

7. The clean Doppler equipment used for patient vascular procedures, which was stored on the code cart, ready for patient use, contained dried gel residue on patient contact surfaces, providing a potential source of cross contamination.


B. Based on observation, staff interview, and review of documentation on February 14, 2013, it was determined that the infection control and prevention program failed to adequately implement and follow selected national guidelines from the Association for the Advancement of Medical Instrumentation (AAMI).

Findings include:

Reference #1A: The Association for the Advancement of Medical Instrumentation (AAMI) ST 79.
ST 79 replaces and super cedes ST 46 by consolidating with 4 other AAMI standards. [ST 33, ST 37, ST 42, & ST 35] approved 7/10/09.
The AAMI Standard 7.2.2, Manufacturers Instructions indicates that the written instructions of the device manufacturer should always be followed. The manufacturer ' s written instructions should be kept on file and periodically reviewed for updates.

Reference #1B: Manufacturer ' s instructions for reprocessing of the Welch Allyn Laryngoscope blades and handles indicate steam sterilization not to exceed 280F with a pressure of 28 p.s.i.

Reference #1C: Manufacturer ' s instructions for reprocessing the Green Line Laryngoscopes indicate equipment should be cleaned in an enzymatic detergent, rinsed, dried, and either disinfected with 2.4% glutaraldehyde solution for 45 minutes, or steam sterilized in a pre-vacuum steam cycle at 132C for 4 minutes, or gravity cycle at 121C for 30 minutes.

Reference #1D: The facility has a contract with the host hospital Sterile Processing Department for the reprocessing of Laryngoscope equipment. Facility policy titled " Terminal Cleaning & Disinfecting Patient Care Equipment " states that laryngoscope blades will be sterilized.

1. Infection control policies and procedures have not been developed and implemented between the host hospital Sterile Processing Department and the LTAC facility to include appropriate cleaning, disinfection and sterilization procedures for the Laryngoscope equipment.

2. Two peel pouches of laryngoscope blades did not contain a processing sticker to indicate a sterilization date, sterilizer and load processing information. One peel pouch processing indicator and chemical indicator tape had visually changed color to indicate steam sterilization had taken place; however, the second pouch indicator tape had not visually changed color to indicate that appropriate sterilization had occurred.

a. Staff #2 and Staff #12 indicated that these items had been processed by the host hospital Sterile Processing Department.

3. Staff #2 and Staff #12 indicated that Laryngoscope handles are cleaned in the Care One LTAC unit using the PDI sanitizing wipes.

a. The manufacturer ' s instructions are not followed for the cleaning, disinfection and sterilization of Laryngoscope equipment in use.