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Based on the review of documents, observations, tests and interviews from 6/28/11 through 7/1/11 from 9:00 am till 4:00 pm, it was determined that the Governing Body failed to carry out its responsibility for the operation and management of the hospital. It did not provide the necessary oversight and leadership as evidenced by the lack of compliance with: (42 CFR 482.41) Physical Environment and (42 CFR 482.56) Rehabilitation Services.

Based on records reviewed (R.R) and Do Not Resuscitate (DNR) Policies and Procedures and interview, it was determined that the facility failed to ensure that patients or their representatives formulate advance directive and comply with these directives related to written DNR or "Do Not Intubate" (DNI) orders in accordance with the patient's signed consent for DNR or DNI for seven out of nine records reviewed (R.R #5, #19, #20, #32, #55, #56 and #65).

Findings include:

1. The facility failed to inform patients or their representatives that they have the right to formulate advance directives and comply with these directives related to DNR and DNI order requests as reviewed on 6/28/11 at 11:30 am, on 6/30/11 at 10:00 am and on 7/1/11 from 11:00 am till 2:30 pm:
a. R.R #5 is an 80 years old female who was admitted on 6/9/11 with a diagnosis of Right Leg infected Ulcer. On 6/30/11 at 10:10 am the record was reviewed with the medicine I supervisor (employee #9). It was found that the patient signed a DNR consent on 6/26/11 at 9:29 pm. The nurse's progress notes performed on 6/26/11 at 9:29 pm stated that the physician oriented the patient about the DNR, patient was oriented, alert and signed by using her fingerprint. On 6/26/11 at 11:00 pm, on 6/27/11 at 7:00 am, on 6/29/11 at 3:00 pm, the nurse's progress notes states that the patient was with the existing DNR. However, no evidence was found of the physician's written DNR order. No evidence was found that the physician oriented the patient and justification the DNR order in the physician's progress notes. In the event that an emergency arises it is not clear what will happen with the patient since the patient signed the DNR but there is no physician order for the DNR.

b. R.R #32 is a 74 years old male who was admitted on 6/6/11 with a diagnosis of Acute Coronary Syndrome (ACS) and Congestive Heart Failure (CHF). On 6/30/11 at 10:30 am the record was reviewed with the medicine I supervisor (employee #9). It was found that the patient's representative signed a DNI consent on 6/6/11 at 3:36 pm, on 6/13/11 at 1:17 pm and on 6/28/11 at 12:50 pm. The nurse's progress notes performed on 6/6/11 at 6:00 pm, at 11:00 pm, on 6/7/11 at 7:00 am, at 5:00 pm, at 11:00 pm, on 6/8/11 at 4:00 pm, at 11:00 pm, on 6/9/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 6/10/11 at 11:00 pm, on 6/11/11 at 7:00 am, at 3:00 pm, 6/12/11 at 11:00 pm, on 6/13/11 at 7:00 am, at 11:00 pm, on 6/14/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 6/15/11 at 3:00 pm, at 11:00 pm, 6/16/11 at 3:00 pm, at 11:00 pm, on 6/17/11 at 7:00 am, on 6/18/11 at 7:00 am, at 3:00 pm, on 6/19/11 at 7:00 am, at 11:00 pm, on 6/21/11 at 1:10 pm, at 3:00 pm, on 6/22/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 6/23/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 6/24/11 at 11:00 pm, on 6/25/11 at 4:00 pm, on 6/26/11 at 3:00 pm, on 6/27/11 at 11:00 pm, on 6/28/11 at 11:00 pm and on 6/29/11 at 3:00 pm provided evidence that the patient had a DNR and Not to Intubate actualized. On 6/8/11 at 7:00 am, on 6/18/11 at 11:00 pm, the nurse's progress notes states that the patient was with an existing DNI. On 6/11/11 at 11:00 pm, on 6/12/11 at 3:00 pm, on 6/13/11 at 3:00 pm, on 6/20/11 at 7:00 am, on 6/24/11 at 7:00 am, at 3:00 pm, on 6/25/11 at 11:00 pm, on 6/27/11 at 7:00 am, on 6/28/11 at 7:00 am, at 3:00 pm and on 6/29/11 at 7:00 am the nurse's progress notes stated that the patient was with an existing DNR. On 6/10/11 for the 7-3 shift and 3-11 shift, on 6/12/11 for the 7-3 shift, on 6/15/11 for the 7-3 shift, on 6/17/11 for the 3-11 shift and 11-7 shift on 6/19/11 for the 3-11 shift on 6/20/11 for the 3-11 shift and 11-7 shift, on 6/21/11 for the 11-7 shift, on 6/25/11 for the 7-3 shift, on 6/26/11 for the 11-7 shift, on 6/27/11 for the 3-11 shift and on 6/29/11 for the 11-7 shift the nurse's progress notes did not provide evidence that the patient had a signed DNI consent or DNR order. On 6/13/11 at 5:15 pm the nurse's signed a physician's order to continue with the DNR. No evidence was found related to the physician's orientation to the patients relative related to the DNR order, No evidence was found related to the physician's justification related to the DNR order. During interview with the patient's sister on 6/30/11 at 11:30 am and she stated that her niece signed a DNI consent if an emergency and consented to not intubated only. However if the patient presented a cardiorespiratory arrest the nurse did not know what to do to the patient due to the patient's relative signing the DNI and the physician ordered for a DNR. In the event that an emergency arises it was not clear if they would proceed with a DNI or DNR.

c. R.R #55 is an 84 years old male who was admitted on 5/25/11 with a diagnosis of Congestive Heart Failure (CHF) and Diabetes Mellitus type II. On 6/30/11 at 1:30 pm the closed record was reviewed. It was found that on the nurse's progress notes performed on 6/2/11 at 12:45 am that the nurse's progress note stated that patient's relative signed the DNR consent, at 7:00 am the nurse documents that the DNR was signed. On 6/2/11 at 3:00 pm, on 6/3/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 6/4/11 at 7:00 am, at 3:00 pm, on 6/5/11 at 7:00 am, at 3:00 pm, on 6/6/11 at 7:00 am, at 3:00 pm, on 6/7/11 at 7:00 am, at 3:00 pm, on 6/8/11 at 7:00 am, at 3:00 pm, on 6/9/11 at 7:00 am, at 3:00 pm, on 6/10/11 at 7:00 am, at 3:00 pm the nurse's progress notes stated that the patient was with an existing DNR. However, no evidence was found that the DNR consent was signed by the patient or a relative. No evidence was found related to the physician's order, patient's orientation by the physician and DNR justification by the physician in the progress notes. Evidence was found that the patient died on 6/11/11, the nurse's progress notes stated that the patient's relative notified that the patient was not breathing, the physician was notified and declared him dead.

d. R.R #56 is a 71 years old female who was admitted on 6/10/11 with a diagnosis of Acute Myocardial Infarct. On 6/30/11 at 2:30 pm the closed record was reviewed. It was found on the nurse's progress notes performed on 6/11/11 at 3:00 pm that the patient had an existing DNR without intubation. However, no evidence was found that the DNR consent was signed by the patient or a relative. No evidence was found related to the physician's order, patient orientation by the physician and DNR justification by the physician in the progress note.

e. R.R #65 is a 60 years old male who was admitted on 5/25/11 with a diagnosis of Chronic Liver Disease. On 7/1/11 at 11:30 am the closed record was reviewed. It was found on the nurse's progress notes performed on 5/25/11 at 7:00 am stated that the patient's care included a signed existing DNR since 5/25/11 at 3:00 pm and the patient's relative referred not to intubate in case of an emergency. On 5/26/11 at 7:00 am, at 3:00 pm, on 5/27/11 at 7:00 am, at 3:00 pm, at 11:00 pm, on 5/29/11 on 5/30/11 at 11:00 pm, on 5/31/11 at 7:00 am, on 6/1/11 at 7:00 am and at 11:00 pm the nurse's progress notes stated that the patient was on a DNR. However, no evidence was found related to the Physician's DNR order and no evidence was found related to the physician's progress notes justifying the DNR.

2. During the review of policies and procedure related to DNR and advance directives documentation on 6/30/11 at 10:00 am the admission department provides the patient or their relative a document named advance directives documentation with two parts, the first part is performed by admission personnel during the admission and the second part is performed by the nurse of the different clinical area where the patient is located. Evidence was found that the facility failed to document the complete advance directives and was left in blank only with the personnel's signature and patient or relative's signature on two out of seven record reviewed R.R #19, #20 and #65.

3. During the review of the facility's "Do Not Resuscitate Policies" on 6/30/11 at 10:00 am, it was determined that the facility failed to have policies and procedures in place related to:

a. Do Not Intubate (DNI).

Based on the review of twenty-five medical staff credential files, it was determined that the facility failed to examine credential files (C.F) to ensure that medical staff have updated Health Certificates and Cardio-pulmonary Resuscitation Certificates (CPR) for eleven out of twenty-five credential files reviewed (C.Fs #3, #9, #12, #13, #14, #16, #18, #19, #20, #22 and #24).

Finding include:

1. During the review of twenty-five medical staff credential files on 7/1/11 from 10:00 am till 10:30 am the following was found:

a. Ten out of twenty-five medical staff credential files provided evidence of expired Health Certificates for C.Fs #3, #9, #12, #13, #16, #18, #19, #20, #22 and #24.

b. Five out of twenty-five medical staff credential files provided evidence of expired cardio- respiratory certificates for C.Fs #9, #12, #14, #18 and #19.

Based on observations of the medication drug cart with the nursing director (employee #11) and interview, it was determined that the facility failed to ensure that drugs and biologicals are stored and protected in a proper manner related to medications not secured in the medication cart.

Findings include:

1. During the observational tour of medicine I and II ward on 6/28/11 at 9:40 am with the nursing director (employee #11), the medication cart was observed unattended while the nurse was in patient's rooms.

a. The following drugs were found in the hallway of medicine I ward on the top of the medication cart: Guaifenesin DM, Carafate 1gm/10ml, 3 bottles Pre-protein and ASod Citrate/Cit Acid. The Medication Administration Record (MAR) was also observed open.
b. Medication drug carts were observed unlocked and unattended while a nurse administered medications to the patient at the medicine II ward room #222, #221A, #228B at 9:40 am and patient's medications were observed pre-served in patient's drawers (oral medication and piggy bags).
c. The medication cart was observed unlocked and unattended while a nurse administered medications to the patient in room #443 at 9:40 am and the patient's medications were observed pre-served in the patient's drawers (oral medication and piggy bags).

2. The following was observed during the medication administration on 6/28/11 from 8:40 am through 10:00 am related to medication administration:

a. During observations of the medication administration (intravenous antibiotics) performed on 6/28/11 at 9:54 am accompanied by a Registered Nurse (RN) (employee #10), it was identified that he washed his hands with soap and water between rooms #115, #117 and #120, however he only washed his hands for approximately 10-15 seconds instead of the required 20-30 seconds according with the "Guidelines for the Hand Hygiene in Health-Care Settings".

b. During the medication administration (intravenous antibiotics) intravenous piggy bags lines (IVPB) were observed in rooms #117, #120 and #106 on an I.V stand to be used for the next dose. The Registered Nurse (RN) (employee #14) stated during interview on 6/29/11 at 9:37 am that when the IVPB finishes running, nursing personnel connect this line to the next line of the port and leave it there until the next administration. The Registered Nurse (RN) (employee #14) was observed when it was time for the next administration on 6/29/11 at 9:45 am, disconnecting the line from the previous piggy bag and connecting it directly to the next piggy bag and patient without disinfecting the line port of the piggy bag.

c. During the medication administration (via nasogastric tube) on 6/28/11 at 10:00 am with a RN (employee #10), the nurse was observed administering medications by nasogastric tube. The nurse did not verify the position of the nasogastric tube and if patented.

Based on six active patient's records reviewed (R.R) and review of policies/procedures with the nursing director (employee #11), it was determined that the facility failed to ensure that all drugs and biological are administered by or under supervision of nursing personnel in accordance with Federal and State laws and regulations for one out of six active records reviewed (R.R #20).

Findings include:

1. One out of six active records reviewed on 6/28/11 from 10:00 am till 4:00 pm and on 6/29/11 from 9:45 am till 2:40 pm provided evidence that the registered nurse (RN) did not sign the order prescribed by the physician:

a. R.R #20 provided evidence that a physician placed an order on 6/22/11 at 8:20 pm for Lotrisone cream apply to affected area three times a day. The Medication Administration Record (MAR) provided evidence that the nurse did not transcribed the order to MAR however, it was found on the treatment kardex.

Based on records reviewed (R.R) and policies and procedures with the director of nursing (employee #11), it was determined that the facility failed to ensure that telephone orders are signed as soon as possible for two out of six records reviewed (R.R #5 and #17).

Findings include:

1. Evidence was found on 6/28/11 from 10:00 am till 4:00 pm and on 6/29/11 from 9:45 am till 2:40 pm of policies and procedures related to the timeliness of countersignatures when telephone orders are used and it states that the physician has 24 hours to countersign the telephone order.

a. R.R #5 provided evidence of a telephone order placed on 6/26/11 at 9:00 pm for Lasix 40 mg intra muscular intravenous every 6 hours, however no evidence was found that the physician countersigned the order.
b. R.R #17 provided evidence of a telephone order placed on 6/26/11 at 2:50 pm to discontinue Hematron A and start Albafort 1 ml intra muscular daily, however no evidence was found that the physician countersigned the order.

Based on four records reviewed (R.R) with the nursing supervisor (employee #2), it was determined that the facility failed mantain a complete documentation in the medical record related to patient's name, date and hour when the restraints were started in the standarized physician order for restraint for one out of four records reviewed for restraint (R.R #1)..

Findings include:

R.R #1 is an 88 years old male who was admitted on 6/24/11 with a diagnosis of Partial Intestinal Obstruction. The record review was performed on 6/28/11 at 11:30 am with the nursing supervisor (employee #2) and provided evidence that the nurse documented on 6/24/11 at 11:00 pm that the patient was observed with restraints of both upper extremities. However, the standardized physician order for restraints was not provided with the patient's name, date and hour when the restraints were started.

Based on twenty records reviewed (R.R), it was determined that the facility failed to ensure that three out twenty records contain appropriate documentation related to consult evaluations and appropriate findings by clinical and others staff involved in the care of the patients (R.R #41, #50 and #52).

Findings include:

R.R #41, #50 and #52 were reviewed on 6/30/11 at 2:51 pm and failed to provide evidence of the date and hour that the consultation was requested for the patients.

Based on the review of twenty closed records reviewed (R.R) with the Management Information Director (employee #19), it was determined that the facility failed to ensure that clinical records have pertinent information related to license numbers of the physicians who intervene during patient care, for four out of twenty records reviewed (R.R #43, #48, #49 and #53).

Findings include:

1. During the review of twenty clinical records reviewed (R.R) with the Management Information Director (employee #19) on 6/30/11 from 1:15 pm till 3:30 pm the following was determined:

a. R.R #43, #48, #49 and #53 did not have the license numbers of the physicians after they signed their progress notes or orders.

Based on the review of documents and observational tour with the Pharmacist (employee #7), it was determined that the facility failed to ensure that accepted professional principles are followed during the preparation and management of drugs and biologicals.

Findings include:

1. During the initial observational tour with the pharmacist (employee #7) on 6/28/11 from 9:18 am though 11:56 am the following was found:

a. A bunch of intravenous piggy bags were observed located in the medication room of Medicine Ward 2. Piggy bags had attached vial-mate adaptor (used to dilute antibiotic) and a vial of antibiotics on each bag. These piggy bags were prepared in advance for the 3-11 shift.

b. Two vials of Primaxin 500 mgs were observed stored in the medication refrigerator. Each vial was diluted previously to placing in the refrigerator. However, information related with the percent of dilution, name of the person who prepared the antibiotic, date and hour of the preparation were not included nor labeled on the vial.

Based on observations of the medication storage room with the Pharmacist (employee #7), it was determined that the facility failed to ensure that all drugs and biologicals are stored in a proper and safe manner accessible only to authorized personnel.

Findings include:

1. During the initial observational tour with the pharmacist (employee #7) on 6/28/11 from 9:18 am though 11:56 am the following was found:

a. The emergency room medication stock was observed with the lock broken. Medications are available to non authorized personnel.

b. At the Intensive Care unit medication area (stock) did not have a door or lock to protect medications from unauthorized persons.

c. Eight plastic drawers located at the Intensive Care Unit, used to store patient's unit dose medications was found open. Drugs in these drawers are readily accessible to unauthorized persons.

Based on observations, review of policies and procedures and routine equipment testing with the supervisor of the X-ray department (employee #3) and interview, it was determined that the facility failed to ensure that the physicist periodically verifies the badge exposure for radiation exposure.

Findings include:

On 6/29/11 at 11:15 am the supervisor of the X-ray department (employee #3) provided evidence of the monthly radiation dosimetry report revision of badges used by X-ray department personnel. However, no written evidence was found of routine inspections of the dosimeters for radiation by the physicist. The X-Ray supervisor (employee #3) stated during an interview on 6/29/11 at 11:20 am that the badge reports are reviewed for her.

1. Based on review of records and interview with the laboratory director, it was determined that the Transfusion Committee had not met during 2011.
The finding includes:
a. The laboratory director stated that the Transfusion Committee must meet every three months. However, no meetings have been held in 2011
2. Based on review of records, observation and interview with the director, it was determined that the transfusion services failed to document the cleaning, disinfection and water changes of the water bath used to thawing fresh frozen plasma units.
The findings include:
a. The laboratory director stated during an interview at 10:05 A. M. that the cleaning, disinfection of the water bath reservoir must be performed and documented monthly in the water bath temperature log.
b. There was no documentation of cleaning, disinfection or changes of water since 12/31/2010.
3. Based on review of records and interview with the transfusion services testing personnel, it was determined that the laboratory used expired reagent red blood cells (Selectogen I &II) to perform patients ' antibody screenings.
The findings include:
a. At 9:35 A.M. the daily reagents quality control record log book was review. The log book showed four red marks for the following dates: 06/08/2011, 06/09/2011, 06/10/2011 and 06/11/2011.
b. The record showed that the Reagent Red Blood Cells (Selectogen I & II), lot # S512 with an expiration date of 06/07/2011 was used from 06/09/2011 to 06/11/2011.
c. The following patients antibodies screening tests were performed with the expired cells:
Date Patient ID Test Result
06/09/2011 31926 Negative
06/09/2011 31984 Negative
06/10/2011 23036 Negative
06/11/2011 5468 Negative

d. The testing personnel acknowledged the used of an expired reagent for patient testing purposes.
4. Based on review of transfusion records and interview with testing personnel and the director, it was determined that the transfusion services failed to evaluate all the possible transfusion reactions.

The findings include:

a. The trans fusion services procedure manual stated that temperature changes over 1° C of the initial patient temperature must be considered a possible transfusion reaction and must be reported to the transfusion services to further evaluation.

b. Review of the " Blood Transfusion Requisition " records showed the following:

i. On 06/15/2011 one (1) unit of fresh frozen plasma (04FT27871- O positive) was transfused to patient #9625. The initial recorded temperature at 10:00 P.M. was 36.1°C. The final temperature at 12:00A.M. was 38.2°C. The transfusion services did not evaluate the case as a possible transfusion reaction.

ii. On 06/14/2011 one (1) unit of fresh frozen plasma (42FX01818- O positive) was transfused to patient #32020. The initial recorded temperature at 11:00 P.M. was 35.4°C. The final temperature at 1:00A.M. was 36.4°C. The transfusion services did not evaluate the case as a possible transfusion reaction.

iii. On 06/24/2011 one (1) unit of pack cells (54Y95490- O positive) was transfused to patient #32104. The initial recorded temperature at 7:45 P.M. was 35.0°C. The final temperature at 11:45 P.M. was 36.3°C. The patient also presented a change in blood pressure from 111/81 mm Hg to 175/92 mm Hg. The transfusion services did not evaluate the case as a possible transfusion reaction.

5. Based on review of records and interview with the testing personnel, it was determined that the laboratory failed to check each lot number of the Vitek gram positive identification system.
The findings include:
a. The laboratory used the Vitek identification system to perform patients ' isolates identification.
b. The Vitek quality Control Card Lot Report showed that the following gram positive identification cards were used and no quality control had been performed: P35M, L144A, M53A, M77A, M54A, C412B and M106A.
c. The laboratory processed 228 patient samples for gram identification isolates from January to June 2011.
6. Based on review of records and interview with the laboratory director it was determined that the laboratory failed to evaluated the quality control statistical parameters of the test performed by the Advia Centaur, the DimensionRXL , Cobas b 221 and Sysmex CA 500 Systems.
The finding includes:
a. The laboratory did not evaluate, since April 2011 the statistical parameters (mean, SD) of the control material processed by the Advia Centaur System for the following analytes: Ferritin, Folate, FSH, LH, Prolactin and B-12.
b. The laboratory did not evaluate, since January 2011 the statistical parameters (mean, SD) of the control material processed by the Dimension RXL System for routine chemistry tests.
c. The laboratory did not evaluate, since March 2011 the statistical parameters (mean, SD) of the control material processed by the Cobas 221 System for blood gases tests.
d. The laboratory did not evaluate, since January 2011 the statistical parameters (mean, SD) of the control material processed by the Sysmex CA 500 System for PT, PTT and fibrinogen tests
7. Based on review of new instrument validation procedures and interview with the laboratory director, it was determined that the laboratory director did not evaluated nor signed the validation procedures studies results of the Advia Centaur system prior to instrument routine use with patient samples.
The findings include:
a. The laboratory processed their validation procedures material during December 2009.
b. The following analytes showed a linear slope (method correlation procedure) out of the acceptable range of (0.95 - 1.05):
Analyte Linear slope
CEA 0.908
CA 125 0.913

c. The laboratory did not document any corrective actions.

8. Based on review of records and interview with the testing personnel, it was determined that the laboratory failed to follow manufacturer ' s instruction for the preventive maintenance of the Cobas B221 system.
The findings include:
1. The laboratory did not perform nor document the daily preventive maintenance of the Cobas B221 system since 4/27/11.
2. The laboratory did not perform nor document the weekly preventive maintenance of the Cobas B221 system since 3/10/11.
9. Based on records review and testing personnel interview, it was determined that the laboratory failed to follow written protocol to calculate and report the INR test.
The findings include:
a. The laboratory did not calculate the geometric mean of the laboratory PT population prior to place in routine the following new lots of trombloplastine Dade Innovin: lot #539122 on 1/31/11, lot #539108 on 3/9/11, lot # 549122 on 3/30/11 and lot #539191 on 5/14/11.
b. The laboratory calculated the INR with the former geometric mean of the laboratory PT population (10.3 sec.) established in December 2010.
10. Based on records review and testing personnel interview, it was determined that the laboratory failed to perform at least every 6 months the calibration verification of the electrolytes tests by the Dimension RXL Max and Dimension Xpand plus systems.
The finding includes:
a. The laboratory did not perform the calibration verification of the electrolytes tests since January 2011.
11. Based on records review and testing personnel interview, it was determined that the laboratory failed to evaluate and define twice a year, the relationships between test results using the different methodologies or instruments.
The findings include:
a. The laboratory did not evaluate the relationships between the routine chemistry test results processed by the Dimension RXL Max and Dimension Xpand plus systems since June 2010.
b. The laboratory did not evaluate the relationships between the WBC deferential examination results processed by the manual method and by the Coulter MAXM and HMX systems since June 2010.
12. Based on records review and testing personnel interview, it was determined that the laboratory failed to verify the manufacturer ' s control limits for every new lot of control material, prior to placed in routine use.
The findings include:
a. The laboratory did not verify the manufacturer ' s control limits for the new lot of PT and PTT control material (Level 1, # 548158), placed in routine use on 3/28/11.
b. The laboratory did not verify the manufacturer ' s control limits for the new lot of routine chemistry control material (Level II, # LMA13112), placed in routine use in June 2011.
13. Based on records review and laboratory director interview, it was determined that the laboratory failed to evaluate at least twice a year the unregulated tests for proficiency testing performance.
The finding includes:
a. The laboratory did not verify at least twice a year, the accuracy and reliability of the serum acetone tests since 2/10 nor the influenza A&B since 12/16/10.
14. Based in personnel records review and laboratory director interview, it was determined that the laboratory director failed to ensure that the testing personnel have the appropriate training to perform blood gases tests .
The finding includes:
1. The personnel records showed that the ten out of the fourteen medical technologies did not have the documentation of the Cobas b 221 system training. This new system where placed in routine use in March 2011 and all the medical technologies performed blood gases tests by this system.
15. Based on quality assessment (QA) record and interview with the laboratory director, it was determined that the laboratory failed to follow QA procedures.
The finding includes:
a. The laboratory did not perform the QA evaluation since January 2011, as the laboratory QA program it required.

16. Based on records review and lab director interview, it was determined that the laboratory failed to follow quality control procedures for the glucose tests processed by the glucometer.
The finding includes:
a. The laboratory did not have available the glucose ' s quality control graphs since 2/28/11.

17. Based on records review and lab director interview, it was determined that the laboratory failed to evaluate periodically the test results reported from calculated data.
The findings include:
a. The laboratory did not evaluate the routine chemistry and CBC results reported from calculated data since June 2010.
b. The laboratory did not evaluate the blood gases results reported from calculated data since January 2010.
18. Based on records review and lab director interview, it was determined that the laboratory failed to evaluate blood gases results that was manually transcribed from the Coba b 221 system to the Sail laboratory information system.
The findings include:
a. T he laboratory manually transcribed the patient ' s blood gases results from the Coba b 221 system to the Sail laboratory information system since April 2011.
b. The 100% of the blood gases patients results did not specify which tests are calculated by the Cobas b 221 system, did not include the method and have incorrect unit for the CHCO2Be tests.

Based on the kitchen observational tour with the administrative dietitian (employee #5), review of policies/procedures and food code guidelines, it was determined that the facility failed to operationalize procedures to ensure that relative humidity and temperatures
of dry food storage area are recorded and registered.

Findings include:

1. The kitchen was visited with the administrative dietitian (employee #5) on 6/29/11 from 10:15 am through 11:58 am and the following was determined:

a. In the dry food storage area the relative humidity was not measured, nor registered by kitchen personnel. A mechanism to ensure that this procedure is performed on an ongoing basis was not developed to verify that they are within established parameters.

Based on ten medical records reviewed (R.R) and policies/procedures and interview, it was determined that the facility failed to ensure that patient's nutritional needs are addressed according with professional standards of practice for two out of ten records reviewed (R.R #23 and #24).

Findings include:

1. A mechanism to ensure that patients identified at nutritional risk receive dietitian evaluations as early as possible so interventions can be initiated to prevent complications and adverse outcomes was not performed, nor followed for two out of ten records reviewed (R.R #23 and #24) on 6/29/11 at 11:20 am:

a. R.R #23 is a 73 years old female patient admitted to the facility on 6/27/11 with a diagnosis of Sepsis and Urinary Tract Infection. This patient had a PEG tube for enteral nutrition and was ordered Ensure 1 can three times a day. The case was reviewed with the dietitian (employee #5) on 6/29/11 at 1:55 pm and it was identified that the patient was admitted with the PEG tube for feeding from her home. This case was not evaluated by the dietitian after her admission. The dietitian (employee #5) stated during an interview on 6/29/11 at 2:00 pm that patients that are admitted from home with feeding tubes need to be evaluated by the dietitian within 24-72 hours from admission to the facility, in order to determine if enteral products ordered supply nutritional needs of the patient while receiving care at the facility.

b. R.R #24 is a 69 years old female admitted to the facility on 6/26/11 with a diagnosis of Sepsis. The patient was ordered to remain NPO (nothing by mouth) since admission. On 6/29/11 at 1:30 pm the case was reviewed with the dietitian (employee #5). No evaluation for nutritional risk was performed on the patient. The dietitian (employee #5) stated during an interview on 6/29/11 at 1:45 pm that patients with NPO orders for more than 48 hours are considered according at nutritional risk and need an evaluation to address nutritional needs between 24-72 hours from admission to the facility. However the case was not referred to the dietitian and not consulted since the patient was admitted and left NPO as ordered by physician.

c. Facility policies and procedures reviewed with the dietitian (employee #5) on 6/29/11 at 1:23 pm establishes that patients identified at nutritional risk must be evaluated by the dietitian between 24-72 hours after the identification of the risk. On weekends due to non availability of dietitian services, if personnel identify patients at nutritional risk who need emergency intervention of a dietitian they must call her. However policies and procedures do not include on what emergencies the dietitian must intervene on call on weekends.

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the physical structure and care areas failed to allow staff to provide care in a safe manner ensuring the well being of patients receiving services related to all maintenance closets found unlocked, operating suite
#2 walls are not monolithic, fire hose cabinets doors are made of glass, medication storage rooms were found unlocked, exit doors connected to alarms are not tested periodically, some patient's night light pull cords were not accessible to patients lying in bed and exposed light fixtures were found in maintenance closets, the facility failed to follow established procedures for the storage of biohazardous trash related to the outside biohazardous storage room that was found with its door unlocked, the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to the use of multi-plugs and extension cords, electrical circuit breaker panels have open breaker slots, the general storage area and the medical record department with materials and medical records stacked up to within 12 inches of the ceiling, the isolation room of the emergency room was not properly maintained related with the negative pressure machine, a pull down station was found loose, no evidence was found of periodic smoke barrier doors tests to verify function, the crash cart of the recovery area found with a type E oxygen cylinder that was not attached to the cart, maintenance carts found with accessible cleaning chemicals to non authorized persons and no evidence was found of preventive maintenance and calibrations of the facility's scales, this facility's physical structure is not designed in accordance with Federal and State laws to provide protection of patients and staff related to handicapped bathrooms, handicapped parking, water fountain, the operating room department is not appropriately designed, Cidex OPA is not used in an appropriate area, the emergency room does not have a decontamination room, the acute dialysis unit requires cleaning and maintenance, housekeeping closets and the interior biohazardous closet do not have extractors, door closers, a ramp needs a handrail, the kitchen needs an outside grease trap access site, two outside metal garbage containers did not have lids, fluoroscope bathroom did not have an emergency call system, morgue did not have housekeeping facilities or hand sink, six wall oxygen outlets valves in the emergency room were placed side by side with little space between them and no curtains and the facility has not maintained the cistern properly, the physical structure and care areas failed to provide proper ventilation in the emergency rooms' waiting area, triage area and observation areas are not equipped with an air disinfection system (such as ultraviolet lights); also it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101, cited tags are K0018, K0025, K0027, K0033, K0046, K0048, K0050, K0051, K0052, K0062, K0064, K0067, K0130, K0144 and K0147. All of the above findings makes this condition "Not Met".

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the physical structure and care areas failed to allow staff to provide care in a safe manner ensuring the well being of patients receiving services related to all maintenance closets found unlocked, operating suite
#2 walls are not monolithic, fire hose cabinets doors are made of glass, medication storage rooms were found unlocked, exit doors connected to alarms are not tested periodically, some patient's night light pull cords were not accessible to patients lying in bed and exposed light fixtures were found in maintenance closets.

Findings include:

1. All janitor's closets (emergency room and hospital) were visited from 6/28/11 through 7/1/11 from 9:00 am till 3:00 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12). These closets were found with chemicals to clean the facility and equipment and were found unlocked and accessible to non-authorized persons.

2. The operating suites were visited on 6/29/11 from 1:15 pm through 3:00 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence of the following:
a. The walls of operating suite #2 was not monolithic, holes were found in the tiles and a tile was missing above the door which can allow dirt to enter and does not allow for proper cleaning.
b. The observation window in operating suite #2 was found with peeling paint.

3. During the observational tour of the entire facility with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) from 6/28/11 through 7/1/11 from 9:00 am till 3:00 pm, it was determined that fire hose cabinets have glass doors. These fire hose cabinets are located on both floors and these doors do not require a key to open or to break the glass to gain access to the hoses. The glass doors are approximately two feet by three feet in size and pose a potential hazard if broken by accident. The glass is not tempered, laminated or wire mess to prevent shattering.

4. The medication storage rooms located at nursing stations were found with their doors unlocked, medications along the counter, in drawers and medication carts were accessible to non-authorized persons as observed from 6/28/11 through 6/30/11 from 8:45 am till 3:15 pm.

5. No evidence was provided on 7/1/11 at 10:00 am that the facility is periodically verifying the operation of exit doors that are controlled by alarms (such as the door at the back of the emergency room and found at other areas of the facility). These exit doors are connected to an alarm and maintained closed and if opened will emit an alarm, but in the event of an emergency the doors are automatically released by the fire alarm. These doors must be tested periodically to ensure that they are working properly and the facility must document these tests and results.

6. Some patient's night lights above their beds from Medicine Wards I and II were observed on 6/29/11 from 10:45 am till 12:15 pm with pull cords that were too short to be reached by patients when lying in bed. Minimum requirements of "Guidelines for Design and Construction of Health Care Facilities" (GDCHCF) section 10.3.5.2(1)(i) states that reading light controls shall be accessible to the patient without having to get out of bed.

7. Exposed light fixtures were observed from 6/28/11 through 6/30/11 from 9:00 am through 3:00 pm in housekeeping closets throughout the facility. These closets have long fluorescent light bulbs that did not have protective plastic covers over the fixtures or on the light bulbs; as personnel work in these closets with mops and brooms the handle can break these light bulbs and the small pieces of glass can fall on personnel or in their eyes.

Based on tests to equipment and observations made during the survey for Life Safety from fire with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the facility does not meet some applicable provision of the 2000 edition of Life Safety Code of the NFPA 101.

Findings include:

The Life Safety from Fire survey was performed with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) from 6/28/11 through 7/1/11 from 9:00 am till 3:00 pm; for deficiencies related to Life Safety from fire (form 2786R) please see tags with letter K on the 2567 form (K0018, K0025, K0027, K0033, K0046, K0048, K0050, K0051, K0052, K0062, K0064, K0067, K0130, K0144 and K0147).

Based on the review of policies/procedures (P&P) and observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the facility failed to follow established procedures for the storage of biohazardous trash related to the outside biohazardous storage room that was found with its door unlocked.

Findings include:

The outside biohazardous storage room located at the side of the hospital was visited on 6/28/11 at 11:45 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that the door was not locked to prevent unauthorized access. Facility policies and procedures reviewed on 6/30/11 at 2:00 pm provided evidence that this door where biohazardous trash is placed is to be kept in a locked and secure area, away from unauthorized persons.

Based on observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the structure of this facility is not maintained to protect and safe guard supplies and equipment to ensure safety and quality related to the use of multi-plugs and extension cords, electrical circuit breaker panels have open breaker slots, the general storage area and the medical record department with materials and medical records stacked up to within 12 inches of the ceiling, the isolation room of the emergency room was not properly maintained related with the negative pressure machine, a pull down station was found loose, no evidence was found of periodic smoke barrier doors tests to verify function,
the crash cart of the recovery area found with a type E oxygen cylinder that was not attached to the cart, maintenance carts found with accessible cleaning chemicals to non authorized persons and no evidence was found of preventive maintenance and calibrations of the facility's scales.

Findings include:

1. During the observational tour of the entire facility with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) from 6/28/11 through 7/1/11 from 9:00 am through 3:00 pm the following was found related with multi-plug devices used at the facility:
a. Operating suites #2 had cables and two multi-plugs directly on the floor.
b. In the Information System room a multi-plug was directly on the floor.
c. The minor surgery room of the emergency room had one multi-plug directly on the floor.

2. Electrical circuit breaker panels were observed throughout the facility with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) from 6/28/11 through 7/1/11 from 9:00 am till 3:00 pm. The electrical circuit breaker panels were found unlocked and most had missing breaker switches that were not covered to protect persons or personnel from possible electric contact when they access these panels.

3. The general storage area and the medical record department were visited on 6/28/11 from 9:00 am till 10:20 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that materials and medical records were stacked up to within 12 inches of the ceiling reducing air flow for proper smoke detector function. On 6/29/11 at 11:00 am all material and medical records were removed to below 12 inches of the ceiling.

4. The isolation room of the emergency room was visited with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) on 6/29/11 at 9:15 am and provided evidence that it did not have a patient in it and the negative pressure machine (n.p.m) was off. The log book used to verify the n.p.m provided evidence that the machine was turned on during the morning and a reading of 1.5 was documented. The n.p.m was turned on again on 6/29/11 at 9:20 am and a paper test was performed by the Physical Plant Manager (employee #18) and it was found that the n.p.m did not pull in the paper from under the closed door. No evidence was found that a biomedical technician verified the function of this n.p.m, nor was documentation found of the periodic filter changes as suggested by the manufacturer (the n.p.m has three different filters with different preventive maintenance requirements).

5. The pull down station (used to manually activate the fire alarm) in front of the financing department was found loose on 6/28/11 at 9:25 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12).

6. No evidence was found that the facility is testing on a periodic basis the smoke barrier doors of the hospital as determined on 7/1/11 at 10:00 am. The doors shall be released from their hold open devices and verified for how fast they close (doors can not close too fast because they can harm a patient passing through these doors) and shall be verified to ensure that they close flush and latch properly.

7. The crash cart located at the recovery area of the operating department was found with a type E oxygen cylinder that was not attached to the cart on 6/29/11 at 1:30 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12). To ensure that patients receive immediate care in the event of an emergency the oxygen cylinder shall be attached to the crash cart to ensure that it goes where the cart goes.

8. Maintenance carts were observed from 6/28/11 through 7/1/11 from 9:00 am till 3:00 pm with cleaning chemicals on top and in the middle of the carts and did not have a cabinet on these carts where personnel can lock these cleaning solutions to limit its accessibility to non authorized persons.

9. No evidence was found on 7/1/11 at 10:25 am of the preventive maintenance and calibrations of the facility's scales used to weigh patient's throughout the hospital.

Based on tests performed on equipment and observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and interview, it was determined that this facility's physical structure is not designed in accordance with Federal and State laws to provide protection of patients and staff related to handicapped bathrooms, handicapped parking, water fountain, the operating room department is not appropriately designed, Cidex OPA is not used in an appropriate area, the emergency room does not have a decontamination room, the acute dialysis unit requires cleaning and maintenance, housekeeping closets and the interior biohazardous closet do not have extractors, door closers, a ramp needs a handrail, the kitchen needs an outside grease trap access site, two outside metal garbage containers did not have lids, fluoroscope bathroom did not have an emergency call system, morgue did not have housekeeping facilities or hand sink, six wall oxygen outlets valves in the emergency room were placed side by side with little space between them and no curtains and the facility has not maintained the cistern properly.

Findings include:

1. The handicapped toilets (male and female) located within the emergency room (E.R) waiting area were visited on 6/28/11 at 2:45 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and the following was found:
a. The female toilet was measured at 15 inches high, in order for this bathroom to comply with Americans with Disabilities Act (Ley ADA) requirements for toilet heights, the toilet seat must be between 17 and 19 inches in height from the floor.
b. Both male and female handicapped bathrooms do not have enough space for persons in wheelchairs to maneuver to gain access to the toilets, according with the Americans with Disabilities Act (Ley ADA) requirements, at least 64 square inches in needed.
c. Grab bars are needed behind both toilets.

2. The isolation room of the emergency room was visited with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) on 6/29/11 at 9:30 am and provided evidence that it has a stretcher for a patient next to one wall and next to the other wall is a female examination table usually used for vaginal examinations (examination table with stirrups). The Director of Institutional Services (employee #12) stated during an interview on 6/29/11 at 9:40 am that the isolation room is also used to examine suspected victims of violations (S.V.V). She also stated that if the isolation room is being used by a patient with isolation precautions and a S.V.V arrives, the S.V.V would be examined in a large cubicle (surrounded by curtains). The facility failed to ensure that the isolation room is used and available for isolation precaution patients and failed to have an appropriate room to examine S.V.V to provide them with privacy and materials to perform the examination.

3. The isolation room of the emergency room was visited with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) on 6/29/11 at 9:30 am and provided evidence that it does not have an ante-room or an area located near the entrance of the isolation room where personnel have access to appropriate materials and garments to enter this room when isolation precautions are in effect. Also, the isolation room can be locked from the inside which can limit personnel from assisting the patient in an emergency and the door is locked.

4. The water fountain located between the male and female toilets of the waiting area of the emergency room was measured at 43 inches in height on 6/28/11 at 2:45 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12). According with the Americans with Disabilities Act (Ley ADA) requirements the height of the water fountain can not exceed 36 inches in height in order to ensure that persons in wheelchairs can access the fountain.

5. The emergency room was visited on 6/29/11 at 9:00 am and provided evidence that they do not have a decontamination area according with Guidelines for Design and Construction of Health Care facilities (GDCHCF) chapter 2.1, section 5.1.3.7, number 5 and A5.1.3.7(5). This area should measure at least 80 square feet, there needs to be at least two hand held shower heads, the walls floor and ceiling need to be non-porous (for cleaning) there needs to be an outside door to enter this room and there needs to be a water drain trap to collect the used water. If the facility determines to use an external area for this purpose, it needs to be located within 150 feet from the ambulance entrance, there are water and electrical outlets, the area has to be well lighted and the paved ground needs to be marked off in yellow paint with the word "Decon".

6. The handicapped parking spaces in front of the emergency room were visited on 6/28/11 from 2:00 pm till 2:15 pm and the following was found:
a. The handicapped parking spaces in front of the emergency room do not have handicapped signs and one of these signs must indicate "Van Accessible" and have the appropriate space requirements.
b. The handicapped parking spaces are not paved completely, part of the cars are parked on grass or dirt.
c. The handicapped spaces are not divided with the appropriate painted divisions.
d. The route of travel is not smoothly paved to allow persons in wheelchairs to easily transition from the parking to the building.
e. The path of travel from the handicapped parking spaces to the ramp of the building (crosses a road) is not painted with the appropriate lines to advise persons in cars to be aware of persons crossing.

7. The operating room department was visited on 6/29/11 from 1:15 pm till 3:15 pm and provided evidence of the following:
a. The male and female dressing rooms are not constructed to provide one-way traffic. Staff enter through a door located in a non restricted hallway near the entrance, into the dressing room where they change from their street clothes into their scrubs and then access the same non restricted hallway in their scrubs and then pass through a door that opens into the operating room area (semi-restricted) near the recovery room.
b. Observations made during the initial tour provided evidence that the operating room department (dressing room-street clothes to operating room attire, pre-induction room, surgical area and recovery room) are not divided into different designated areas (unrestricted, semi-restricted and restricted) with signs at each area indicating the surgical attire required.
c. The facility operates on ambulatory patients but they do not have a designated phase II area. The lounge chairs for this area must be separated by curtains and there needs to be at least four feet between each chair and the seats should be placed to avoid visual contact from patient to patient, there needs to be a bathroom for patients, area for patient's family members and area for nursing personnel too write and have visual contact with patients.
d. The central supply area was found with trays of Cidex OPA. According with the Manufacturers' recommendations, they suggest that the solution is used in a well-ventilated area and in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media and no evidence was found that the facility has a spill kit to use if Cidex OPA accidentally fall on the floor.
e. A radio was found in operating suites #3.
f. Operating suites #1 through #3 were found with intercoms, however when they were tested they did not work.
g. The recovery room does not have a designated area assigned for pediatric patients which can accommodate the parents of the minor.

8. The acute dialysis room for two stations was visited on 6/29/11 at 10:15 am and provided evidence that the area is in need of cleaning and painting and the bathroom is used to store materials and was also found in need of cleaning and painting. Also, this room is used for two patients brought to this room in their room beds, however this room is not large enough to accommodate personnel, two beds, machines and in the event of an emergency, personnel will not be able to enter with life saving equipment to attend the patients appropriately.

9. The handicapped male and female toilets located on the ground floor were visited on 6/28/11 at 9:45 am. The toilets did not have grab bars on both sides of the toilets or on one side and behind the toilet to comply with Americans with Disabilities Act (Ley ADA) requirements for toilet grab bars.

10. The ramp located near the administration office on the ground was visited on 6/28/11 at 9:00 am and was found with only one hand rail on one side of the ramp. To ensure that persons with impediments on either side of their bodies can safely access this ramp, hand rails are needed on both sides of the ramp according with the "Americans with Disabilities Act" (Ley ADA) requirements.

11. The kitchen area was observed on 6/28/11 at 11:15 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) with its grease trap located within the kitchen. According the Guidelines for Design and Construction for Health Care Facilities section 2.1-10.1.2.5 paragraph 5 (Drainage systems) (page 116) (2006 edition) states "kitchen grease traps shall be located and arranged to permit easy access without the need to enter food preparation or storage areas. Grease traps shall be accessible from outside the building without need to interrupt any services".

12. The facility has two outside metal garbage containers located in the parking area as observed on 6/28/11 at 1:30 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12). The containers were found without lids and the containers are used to place trash from the hospital and also from the kitchen. Even though the containers are far from the kitchen and hospital, lids are important to reduce areas for rodents and flies to feed.

13. The handicapped toilets (male and female) located at the main entrance of the hospital were visited on 6/28/11 at 1:45 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and the following was found:
a. Both male and female bathrooms did not have mirrors above the sinks, the most lower portion of the mirrors can not be higher than 40 inches from the floor to comply with the "Americans with Disabilities Act" (Ley ADA) requirements.

14. All housekeeping closets (emergency room and hospital) were visited from 6/28/11 through 7/1/11 from 8:45 am till 3:15 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12). These closets did not have functional air extractors, door closers or smoke detectors and the doors have louvres.

15. The dirty utility room and the minor surgery room of the emergency room were visited on 6/29/11 at 9:45 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that the air conditioner ventilation system was not working properly. The minor surgery room was found with medications and the dirty utility room was found with a container with Cidex OPA. On 7/1/11 the air conditioner system was repaired. However, no evidence was found of the registration of the Cidex OPA since the year of 2010 and the dirty utility room did not have an air conditioner supply vent in this room and the return did not work and no protective garments were found. According with the Manufacturers' recommendations, they suggest that the solution is used in a well-ventilated area and in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media and no evidence was found that the facility has a spill kit to use if Cidex OPA accidentally fall on the floor.

16. The biohazardous waste storage room located in the hallway near the nursery was visited on 6/29/11 at 11:00 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that it does not have an air extractor, smoke detector, door closer, the walls do not go up to the ceiling (floor slab above) to seal this storage room and the door was found unlocked and accessible to non-authorized persons.

17. The bathroom of the fluoroscope room was visited on 6/29/11 at 10:55 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that the bathroom does not have an emergency call system.

18. The bathroom located in the recovery room of the operating room department was visited on 6/29/11 at 2:15 pm with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and was found in need of a grab bar behind the toilet.

19. The morgue was visited on 6/30/10 at 9:25 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that it does not have housekeeping facilities to ensure that spills can be cleaned appropriately and that the area is cleaned after use and does not have a hand sink with soap and paper dispensers.

20. The hospital's emergency room was visited on 6/29/11 at 9:30 am with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) and provided evidence that there are six wall oxygen outlets valves that are in an area that are used to provide respiratory therapy to patients. The six oxygen outlets were placed side by side with little space between them and no curtains were found between the lounge chairs. In order to provide emergency treatment to a patient at least four feet between lounge chairs is needed to accommodate emergency staff and equipment and the curtains are needed to provide privacy during treatment.

21. Written evidence about bacteriological tests and cleaning of the water cistern (45,000 gallons) was requested of the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12) on 7/1/11 at 11:05 am. Laboratory test reports from 5/24/10 through 2/18/11 provided evidence that free chlorine was above 2.0 mg/l. Test results were as high 3.5 mg/l but no evidence was found that the facility took corrective measure to rectify the free chlorine levels. Also no evidence was found that the facility performed the annual cistern cleaning, the last cleaning was performed in March of 2010. The facility failed to be in accordance with state law requirements (Chapter XXV, Article #1, from November 7, 1999). No evidence was found that during the cleaning of the cistern that the facility has a valve dedicated to enter water directly from a spare tank if the water supply is cut off during cleaning.

Based on observations made during the survey for the physical environment with the facility's Physical Plant Manager (employee #18) and Director of Institutional Services (employee #12), it was determined that the physical structure and care areas failed to provide proper ventilation in the emergency rooms' waiting area, triage area and observation areas are not equipped with an air disinfection system (such as ultraviolet lights).

Findings include:

The emergency room (adult and pediatric) was visited on 6/28/11 at 3:00 pm and provided evidence that the waiting area, triage area and the observation area of the adult and pediatric emergency room are not equipped with an air disinfection system (for example: Ultraviolet lights). According to the "Guidelines for Design and Construction of Health Care Facilities" (GDCHCF) the triage area is the point of entry of undiagnosed and untreated airborne infections and should be designed and ventilated to reduce exposure of staff, patients and families to airborne infectious diseases. Through the facility's infection control program, determinations must be made related to general ventilation and air disinfection similar to inpatient requirements for airborne infection isolation rooms according to the CDC "Guidelines for Preventing the Transmission of Mycobacterium Tuberculosis in Health Care Facilities". The waiting area and observation area are other areas to provide protection with an air disinfection system.

8. No evidence was found of policies that related to the procedures reviewed on 6/29/11 at 9:00 am to disinfect enteral feeding machines between patients use to prevent cross contamination. The infection control officer (employee #1) stated during an interview on 6/29/11 at 1:39 pm that after they are used, enteral machines are cleaned by nursing personnel. However, the facility does not have policies/procedures in place in order to ensure that this equipment is disinfected in accordance with manufacturer's instructions and infection control guidelines and standards.


20423


Based on the observational tour with the infection control officer (employee #1) and review of policies/procedures (P&P) and interviews, it was determined that the facility failed to promote sanitary and safe care through its infection control program in the Medicine I, X Ray department, dirty linen area, emergency room related to bedpans, urinal, basin directly on the floor, respiratory therapy equipment on the floor and without a label identifying the date, hour and when it was opened, bottles of irrigation water and saline solution opened without labels with the date and hour when opened, lack of policies and procedures related to disinfection of the enteral feeding machines and medical records without physician order for isolation patients for three out of three medical records with patients in the isolation rooms (R.R #2, #3 and #4).

Findings include:

1. During the observational tour with the infection control officer (employee #1) in the medicine I department on 6/28/11 from 9:20 am till 3:00 pm the following was found:

a. It was observed that patient's urinals were used to empty Foley bag directly on the floor in patient's room #215A at 9:45 am.

b. It was observed that an oxygen cannula was on the oxygen meter without a plastic bag labeled with the date and hour that the equipment was opened for the patient in room #215A at 9:45 am.

c. It was observed that a bedpan was directly on the floor in patient's room #205A, #212B, #214A and #215B.

d. It was observed that the patient's Bi-Level Positive Airway Pressure (BiPAP) mask was over the BiPAP machine without a plastic cover in patient's room #213A at 9:55 am.

e. It was observed that the patient's oxygen cannula was directly on the floor in patient's room #204A and #211B.

f. It was observed that bed linen was directly on the floor in patient's room #223A at 11:00 am.

g. It was observed that patient's respiratory therapy equipment were in a plastic bags without the date and hour that the equipment was opened in rooms #202A, #206B, #207A, #209A, #211B, #212B, #214A, #218A, #218B, #223A and #228A.

h. Two irrigation syringes were observed in rooms #212B on 6/28/11 at 11:05 am without the date and hour when the syringes were first used.

2. Three out of three clinical records reviewed on 6/28/11 from 11:15 am till 3:00 pm for infection control services provided evidence of the following:

a. R.R #2 is a 1 year old female admitted on 6/25/11 with a diagnosis of Acute Bronchitis, suspected pneumonia. The clinical medical record was reviewed on 6/28/11 at 1:15 pm and revealed that on 6/25/11 at 11:30 am the physician ordered Influenza A and B rapid test and Respiratory Syncytial Virus (RSV) test. According to the nursing supervisor (employee #2) interview on 6/28/11 at 1:20 pm the laboratory test result were not available because the results take five working days. The patient's room was observed on 6/28/11 at 10:45 am with a label that was "Contact and Droplet Isolation". However, no evidence was found related to physician order for Isolation. No evidence was found in nurse's progress notes related to the family orientation related to the isolation and isolation precaution until the RSV results were available.
b. R.R #3 is a 29 years old female admitted on 6/13/11 with a diagnosis of Acute pneumonia and R/O Influenza A. The clinical medical record was reviewed on 6/28/11 at 1:30 pm and revealed that on 6/13/11 at 11:41 pm the physician ordered Influenza A and B rapid test and the results were negative on 6/14/11 at 2:45 am. The infection Control Coordinator provided orientation related to the isolation and isolation precaution on 6/15/11. On 6/20/11 the physician ordered purified protein derivative (PPD) test. On 6/22/11 the PPD result was 0 millimeter (negative). The patient's room was observed on 6/28/11 at 10:05 am with an label that was "Contact and Droplet Isolation". However, no evidence was found related to the physician order for Isolation. No evidence was found in the nurse's progress notes related to the patient or family's initial orientation related to the isolation and isolation precautions on 6/14/11 when the patient was placed in the isolation room.
c. R.R #4 is a 5 month old male admitted on 6/25/11 with a diagnosis of Acute Bronchitis and suspected pneumonia. The clinical medical record was reviewed on 6/28/11 at 2:00 pm and revealed that on 6/25/11 at 11:30 am the physician ordered Influenza A and B rapid test and Respiratory Syncytial Virus (RSV) test. On 6/25/11 at 2:21 pm the influenza A rapid test was notified as positive. The patient's room was observed on 6/28/11 at 10:45 am with a label that was "Contact and Droplet Isolation". According to the nursing supervisor (employee #2) interview on 6/28/11 at 1:20 pm the laboratory test result were not available because the results take five working days. However, no evidence was found related to the physician's order for Isolation. No evidence was found in the nurse's progress notes related to the initial family orientation related to the isolation and isolation precaution when the Influenza A was positive and until the RSV results were available.

3. During the observational tour with the infection control officer (employee #1) in the dirty linen area on 6/29/11 at 9:00 am, the following was observed:
a. It was observed that the dirty linen area has a box of scrubs used by personnel of this area to cover their clothes when they are working with the dirty linen directly on the floor.
b. It was observed that used gloves, hair covers and shoe covers were directly on the floor.
c. It was observed that a box of bathroom curtains were directly on the floor.

4. During the observational tour with the infection control officer (employee #1) in the biohazardous trash area on 6/29/11 at 9:00 am, the following was found:
a. The door of this area was found without a security lock and available to unauthorized personnel.
b. The temperature log provide evidence that during the month of June 2011 no registration was found for the humidity and temperature of this area during the following days 6/2/11, 6/3/11, 6/5/11, 6/6/11, 6/7/11, 6/8/11, 6/10/11, 6/13/11, 6/14/11, 6/15/11, 6/16/11, 6/17/11, 6/19/11, 6/20/11, 6/21/11, 6/22/11 and 6/27/11. The facility's policies and procedures reviewed on 6/29/11 at 10:00 am states that the temperature of the area of biomedical waste will be taken and documented on the report sheet temperature Deposit biomedical waste daily by the environmental control personnel. The biomedical waste area shall remain closed and locked to maintain proper temperature in the area.

5. During the observational tour with the infection control officer (employee #1) of the first floor near the pharmacy area on 6/29/11 at 9:10 am, the following was found:
a. A housekeeping cart was observed in the hallway near the door of the pharmacy department unattended with disinfectant products (air freshener, two window glass cleaners, speed all purpose cleaner, Abadisin antibacterial disinfectant cleaner, Di Bowl Germicidal cleaner deodorant SH Cleaner shower cleaner) available to unauthorized personnel.

6. During the observational tour with the infection control officer (employee #1) in the fluoroscopy area on 6/29/11 from 9:15 am it was observed the following:

a. One sharp container was observed without a security base.

7. During the observational tour with the infection control officer (employee #1) in the housekeeping room on 6/29/11 at 9:30 am, the following was found:
a. The housekeeping room door was found opened and did not close completely. It was found that a gallon of Suhodisen Hospital Disinfectant, one gallon of bleach and one gallon of Pro Shine Floor Furnish and sealer available to unauthorized personnel.

8. During the observational tour with the infection control officer (employee #1) in the medicine I department on 6/29/11 from 9:45 am, the following was found:

a. It was observed that nursing personnel were providing patient care during the morning and the supply cart was observed in the hallway near room #118 and four clean linen were observed on a cart exposure to the environment. Also approximately thirty fitted sheets were observed in a broken plastic bag exposed to the environment. Blue pads were observed on the second shelf exposed to the environment and a washcloth was observed exposed to the environment.

b. It was observed that a physician (surgeon) (employee #21) was in patient's room #119 with surgical scrubs, hair cover and shoe covers and without a lab coat. It was also observed that a internist (physician) (employee #23) went into into this room (#119) with operation room shoe covers.


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9. During the observational tour with the nursing director (employee #11) in the wards of Medicine I and Medicine II on 6/28/11 at 9:40 am, the following was found:

a. Two bottles of sterile water were observed in patient's room #115 opened without the date and time that they were started on and they were found on the top of the patient's night table. The patient in room #115 has a nasogastric tube. This procedure is not an acceptable practice related to infection control standards and cross contamination and the manufacturer's recommendations suggests that once opened the solution must be used and the unused portions must be discarded.

b. Two gastrostomy syringes were observed in patient's rooms #115. The syringes did not have a label with the date started. The facility's did not have policies and procedures that gastrostomy syringes are to be changed at what frequency.

c. Registered Nurse (R.N) #14 was observed on 6/29/11 from 8:45 am till 9:45 am during the medication administration pass, entering and leaving patient's rooms #228, #226, #224 and #221 without washing his hands between rooms and patients (these rooms are double occupancy).

Based on observations made of the surgical department, interview and review of policies/procedures with the Operating Room Manager (employee #20), it was determined that the facility failed to ensure that surgical services maintains a high standard of medical practice and patients' care.

Findings include:

1. Observations made of the surgical department on 6/30/11 from 9:30 am till 3:30 pm provided the following evidence:

a. No delineation was observed on 6/30/11 at 9:00 am for employees to access sterile and non-sterile areas. The surgical facility is not divided into three designated areas: unrestricted, semirestricted and restricted. No signs were provided at all entrances to the restricted areas that clearly indicates the surgical attire required.

b. It is required by local law to comply with the guidelines for Design and Construction of Hospital and Health Care Facilities. These guidelines on table 7.2 (ventilation requirements for areas affecting patient care in hospitals and outpatient facilities) requires that the relative humidity must be kept between 30-60 % and temperature of 68-73ºF in the operating suites, the following relative humidity were measured on 6/30/11: in suite #1 the temperature registered 67ºF at 9:40 am, in suite #3 the temperature registered 66.6ºF at 9:55 am, in suite #4 the temperature registered 66.2ºF at 10:40 am.

c. The housekeeping maintenance room was observed on 6/30/11 at 10:00 am with five mops and five pails without identification labels, also a pail and mop dedicated for contaminated cases was not found. The housekeeping closet was found without an air extractor or mop hangers to ensure that mops dry properly.

d. In the central supply area the following was observed on 6/30/11 at 10:10 am:
i. The door was found opened.
ii. No evidence was found of the relative humidity and temperature log.
iii. One tray was found expired since 6/25/11.

e. Cidex OPA trays were found on a portable stand in operating suite #2. Manufacturers' recommendations suggests that the solution is used in a well-ventilated area and in closed containers with tight fitting lids, and the user must use gloves, eye protection and fluid-resistant gowns. The use of Cidex OPA should be in an area that is ventilated with a local exhaust hood which contains a filter media.
f. An operating room technician (employee #22) was interviewed on 6/30/11 at 10:25 am and she stated that she was not trained nor instructed in the procedures to follow if Cidex OPA spills on the floor. No evidence was found that the operating room department has a spill kit to deal with spills and no evidence was found that they are following manufacturer's recommendations related to "Disinfectant /Container Disposal Information" for neutralizing Cidex-OPA before disposal.
g. A physician (employee #21) was observed working in the operating suites during surgical procedures without a mask on.

h. In operating suite #3 the crash cart was found with rust on 6/30/11 at 9:55 am.

i. In operating suite #1 it was found that the metal cabinets used to store materials have chipped paint on 6/30/11 at 10:15 am.

Based on the review of seven closed medical records and policies/procedures of the operating room with the Operating Room Manager (employee #20), it was determined that the facility failed to execute complete surgery informed consents that includes name of physician, if consented to take pictures and consent the presence of students to the Operation Room and if consented to transfusion for three out of seven records reviewed (R.R #67, #69 and #70).

Findings include:

1. During the review of seven records on 6/30/11 from 9:40 am till 12:00 pm, the following was determined:

a. R.R #67 provided evidence that the surgical procedure consent form lacks the name of physician that took the consent.
b. R.R #69 provided evidence that the surgical procedure consent form did not include the name of the physician or staff authorized to administer the treatment.
c. R.R #70 provided evidence that the surgical procedure consent form did not include if the patient consented to having pictures taken during the procedure or if the patient consented to the presence of students in the Operation Room.

Based on documents reviewed with the Operating Room Supervisor (employee #20), it was determined that the facility failed to ensure that the operating room log registry is complete.

Findings include:

A surgery registration log book and recovery room registration log book were observed on 6/29/11 at 2:00 pm with incomplete spaces and left in blank.

Based on the review of seven medical records to evaluate anesthesia services with the Operating Room Manager (employee #20), it was determined that the facility failed to ensure that informed consent forms are properly executed for two out of seven records reviewed (R.R #66 and #70).

Findings include:

1. During the review of seven medical records on 6/30/11 from 9:30 am till 3:30 pm the following was found:

a. Two out of seven medical records were incomplete for the anesthesia concern due to the lack of type of anesthesia given to the patient (R.R #66 and #70).

b. Two out of seven medical records were incomplete for the anesthesia concern due to the lack of the date and hour when the concern was taken (R.R #66 and #70).

Based on observations, interviews with nursing staff and Administrator and records reviewed on 6/30/11 from 1:30 pm till 3:00 pm and 7/1/11 from 9:40 am till 11:00 am, it was determined that the facility failed to ensure that Rehabilitation services is organized and staffed to ensure the health and safety of patients, No evidence was found policies and procedures, credential files, the organizational chart to indicate lines of authority and delegation of responsibilities within the department, Physical therapy staffing and schedules, implemented and maintained on an ongoing Quality Assessment and Performance Improvement (QAPI) program, quality indicators related to patient's goals being met during their treatment and when discharge, director of the services, written plan of treatment, individualized assessments, short-term and long-term goals ot the patient's response reviewed related to the therapeutic intervention.

Based on the observational tour, interview and five records reviewed (R.R) with the nursing supervisor (employee #11) and administrator (employee #13), it was determined that the facility failed to ensure that services are provided according to the scope of services offered.

Findings include:

1. No evidence was found on 6/29/11 at 2:00 pm of the policies and procedures to verify that the scope of rehabilitation services offered is defined in writing.

2. No evidence was found on 6/29/11 at 2:10 pm of the personnel files to verify current licensure, certifications and ongoing training, consistent with applicable State laws.

3. No evidence was found on 6/29/11 at 2:20 pm of the organizational chart to indicate lines of authority and delegation of responsibilities within the department or services offered in the rehabilitation services.

4. No evidence was found on 6/29/11 at 2:30 pm of the Physical therapy staffing and schedules to determine adequacy of staff or of a registered nurse to provide supervision of the rehabilitation services.

5. No evidence was found that the physical therapy department implemented and maintained an ongoing Quality Assessment and Performance Improvement (QAPI) program as reviewed on 6/29/11 at 2:30 pm for all procedures and conditions for the complexity of cases they managed. No evidence was found of quality indicators related to patient's goals being met during their treatment and when discharged.

6. During interview with the administrator (employee #13) on 6/29/11 at 1:50 pm, he stated there is a Physical Medicine & Rehabilitation (PM&R) Physician who performs consults. Facility physicians place consultations for the PM&R Physician and he evaluates the patients and coordinates with discharge planning to provide services at their home. Once we had a Physical Therapist from Yauco and he provide services to only one patient. At the present time there are no contracts with physical therapist.
7. During interview with the nursing supervisor (employee #2) in medicine II on 6/29/11 at 2:50 pm and she stated that they offer physical therapy services. The physician places an order for a consultation for the PM&R and staff call the PM&R physician and records it on a blackboard if confirmed or not. The PM&R physician reads the record first and then examines the patient, ordered therapies and communicates with the physical therapist who works for the PM&R Physician.
8. During interview with the nursing supervisor (employee #9) in medicine I on 6/29/11 at 3:15 pm stated that the physician places a consultation order for the PM&R physician or the physical therapist and they called to notify the order.

Based on the observational tour, interview, five records reviewed (R.R) with the administrator (employee #13), it was determined that the facility failed to have a director of the services.

Findings include:

1. No evidence was found on 6/29/11 at 2:40 pm that the facility has a director of the rehabilitation services and must have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

2. During interview with the administrator (employee #13) on 6/29/11 at 1:50 pm, he stated there is a Physical Medicine & Rehabilitation (PM&R) Physician who performs consults. Facility physicians place consultations for the PM&R Physician and he evaluates the patients and coordinates with discharge planning to provide services at their home. Once we had a Physical Therapist from Yauco and he provide services to only one patient. At the present time there are no contracts with physical therapist.

Based on interview with the Administrator (employee #13), it was determined that the facility failed to maintain credential files of the Physical Medicine & Rehabilitation (PM&R) Physician and physical therapist personnel.

Findings include:
1. No evidence was provided on 6/30/11 at 9:30 am that the facility maintains credential files for the Physical Medicine & Rehabilitation (PM&R) Physician and Physical Therapist as required in accordance with state and local laws.
a. During interview with the administrator (employee #13) on 6/29/11 at 1:50 pm, he stated there is a Physical Medicine & Rehabilitation (PM&R) Physician who performs consults. Facility physicians place consultations for the PM&R Physician and he evaluates the patients and coordinates with discharge planning to provide services at their home. Once we had a Physical Therapist from Yauco and he provide services to only one patient. At the present time there are no contracts with physical therapist.

Based on the review of five clinical records and interviews with the nursing supervisor (employee #2 and #9) and Administrator (employee #13), it was determined that the facility failed to ensure that services are furnished in accordance with a written plan of treatment, individualized assessments, short-term and long-term goals and the patient's response is reviewed related to the therapeutic intervention for five out of five records reviewed (R.R)
#5, #13, #60, #61 and #62.

Findings include:

1. Five out of five records reviewed on 7/1/11 from 10:00 am till 11:30 am provided evidence that the physician did not write the treatment for the patient, frequency of treatment, the date of medical order and name of patient: (R.R) #5, #13, #60, #61 and #62.

2. Five out of five clinical records reviewed on 7/1/11 from 10:00 am till 11:30 am lacks documentation of the physical therapist related to plans of treatment, short-term and long-term goals, type and duration of services, patient's initial individualized assessment, pain assessment, response and changes to therapeutic interventions. The incomplete treatment and goals did not reflect changes in the patient's status.

Based on the review of eight medical records, policies/procedures, it was determined that the facility failed to ensure that services are provided in accordance with the physician's orders related to the physician's lack of written respiratory therapy notes in accordance to standards of practice related to the type and amount of diluent and the unit of concentration of the medication provided for four out of eight clinical records reviewed (RR #13, #29, #30 and #31).

Findings include:

1. Eight medical records were reviewed on 6/29/11 from 2:00 pm till 3:00 pm and on 6/30/11 from 9:00 am till 10:15 am of patients who received respiratory therapy and provided evidence that the respiratory therapy order lacked the type and amount of diluent of the therapy and lack of unit dose of the respiratory therapy.

a. R.R #13 is an 81 years old female admitted on 6/4/11 with a diagnosis of Clinical Sepsis. The record review was performed on 6/29/11 at 2:30 pm with the Respiratory Therapist (employee #8) and provided evidence that the physician ordered on 6/23/11 at 5:15 pm Xoponex 0.63 + Atrovent 2.5 every 6 hours. However the physician failed to write a complete physician order related to the unit dose of the xoponex and Atrovent and failed to identify the amount and type of diluent. Facility policies and procedures reviewed on 6/30/11 at 11:00 am stated that the written order for aerosolized drug therapy should contain: Name of medication, administration route, volume or quantity to be administered, duration of medication, special precautions /directions and the number of times a day to be administered.

b. R.R #29 is a 76 years old male admitted on 6/27/11 with a diagnosis of Exacerbated Asthma. The record review was performed on 6/30/11 at 9:15 am with the Respiratory Therapist (employee #17) and provided evidence that the physician ordered on 6/27/11 at 10:15 am Free Flow Therapy (FFT) Albuterol 0.5 every 6 hours. However the physician failed to write a complete physician order related to the unit dose of the Albuterol, failed to identify the amount and type of diluent and failed to identify the duration of treatment. Facility policies and procedures reviewed on 6/30/11 at 11:00 am stated that the written order for aerosolized drug therapy should contain: Name of medication, administration route, volume or quantity to be administered, duration of medication, special precautions /directions and the number of times a day to be administered.

c. R.R #30 is a 43 years old male admitted on 6/24/11 with a diagnosis of Acute Coronary Syndrome (ACS). The record review was performed on 6/30/11 at 9:30 am with the Respiratory Therapist (employee #17) and provided evidence that the physician ordered on 6/24/11 at 10:24 am Free Flow Therapy (FFT) with Xopenex every 6 hours .63. However the physician failed to write a complete physician order related to the unit dose of the Xopenex, failed to identify the amount and type of diluent and failed to identify the duration of treatment. Facility policies and procedures reviewed on 6/30/11 at 11:00 am stated that the written order for aerosolized drug therapy should contain: Name of medication, administration route, volume or quantity to be administered, duration of medication, special precautions /directions and the number of times a day to be administered.

d. R.R #31 is a 70 years old female admitted on 6/28/11 with a diagnosis of Bronchopneumonia (BKP) secondary to aspiration. The record review was performed on 6/30/11 at 9:45 am with the Respiratory Therapist (employee #17) and provided evidence that the physician ordered on 6/28/11 at 10:25 am Free Flow Therapy (FFT) with Albuterol .5 every 6 hours. However the physician failed to write a complete physician order related to the unit dose of the Albuterol, failed to identify the amount and type of diluent and failed to identify the duration of the treatment. Facility policies and procedures reviewed on 6/30/11 at 11:00 am stated that the written order for aerosolized drug therapy should contain: Name of medication, administration route, volume or quantity to be administered, duration of medication, special precautions /directions and the number of times a day to be administered.