Davita Greater Waterbury Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 44675 Based on observations, facility documentation, facility policy and interviews the facility failed to ensure patients performed hand hygiene after hemodialysis treatment. The findings include: 1. Patient #23 had diagnoses that included End Stage Renal Disease (ESRD). Review of the physician’s orders directed hemodialysis three (3) times weekly for four (4) hours with a left upper Arteriovenous Fistula (AVF). Observations conducted on 11/24/25 at 10:01 AM identified Patient #23 at Station #2 holding his/her access sites after the needles were removed. Patient #23 taped up his/her access sites, Staff Person #3 came over to conduct a standing blood pressure. Staff Person #3 removed Patient #23’s glove and did not offer hand hygiene. Patient #23 proceeded to the scale and did not perform hand hygiene and/or wash his/her hands at the sink. 2. Patient #26 had diagnoses that included ESRD. Review of physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and fifteen (15) minutes with a left upper AVF. Observations conducted on 11/24/25 at 9:52 AM identified Patient #26 holding his/her access sites with his/her gloved right hand, he/she removed the glove at 9:58 AM and did not perform hand hygiene. Patient #26, accompanied by Staff Person #6, proceeded to the scale, weighed him/herself, then exited the clinic without performing hand hygiene prior. 3. Patient #24 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper arteriovenous fistula (AVF). Observations conducted on 11/24/25 at 10:20 AM identified Patient #24 at Station #1 holding his/her access sites after the needles were removed. Staff Person #3 came over to conduct a standing blood pressure. Patient #24 removed his/her glove and Staff Person #3 did not offer hand hygiene. Patient #24 proceeded to the scale and did not perform hand hygiene and/or wash his/her hands at the sink. Review of the infection control for dialysis facilities policy directed that patients and caregivers will be encouraged to perform hand hygiene after treatment before leaving the treatment area.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 44675 Based on observations, facility documentation and interviews, the facility failed to appropriately clean and disinfect the dialysis station after a hemodialysis treatments. The findings included: a. Observations conducted on 11/21/25 at 2:08 PM identified Staff Person #2 disinfected the hemodialysis chair while Patient #22, the next Patient to treat at Station #2, stood in the station. Patient #22 then set up his/her belongings and sat in the chair while still wet, without allowing the chair the appropriate dry time. b. Observation conducted on 11/24/25 at 8:42 AM identified Patient #27 had concluded his/her treatment at Station #27 and exited the facility following his/her treatment. Staff Person #2 initiated station disinfection and omitted cleaning the outside of the chair arms, back counter, and failed to extend the recliner when disinfecting the treatment chair. The observation further identified Staff Person #2 setting up the dialysis machine for the next patient without observing that the machine had been appropriately disinfected after Patient #27 vacated the hemodialysis station. Interview with Staff Person #2 on 11/24/25 at 10:55 AM identified that although the surveyor did not observe Station #27 machine disinfection, Staff Person #2 identified he/she had disinfected the dialysis machine at Station #27 while Patient #27 was still seated at the station, holding his/her sites. Staff Person #2 had questioned the surveyor if it was okay to clean the machine while the patient was still in his/her station post-treatment. c. Observation conducted on 11/24/25 at 10:05 AM identified Staff Person #6 failed to clean the Hansen tubing, the acid line in front of the dialysis machine, outside of the chair arm, wall box, and failed to extend the recliner when disinfecting the treatment chair at Station #21. d. Observation conducted on 11/24/25 at 10:47 AM identified Staff Person #7 failed to clean the Hansen tubing on the side of the machine, acid line in front of the dialysis machine, outside of chair arm, back counter, lower 1/3 of the intravenous pole, partially cleaned the sides of the dialysis machine, and failed to extend the recliner when disinfecting the treatment chair at Station #26. e. Observations conducted on 11/25/25 at 10:10 AM identified Staff Person #4 disinfected the hemodialysis chair while Patient #25, the next Patient to treat at Station #4, stood in the station. Once Staff Person #4 completed wiping down the chair, Patient #25 then sat in the chair while still wet, without allowing the chair the appropriate dry time. f. Observations conducted on 11/25/25 at 11:00 AM identified during disinfection of the hemodialysis station, Station #17, after a patient treatment, Staff Person #5 failed to clean and disinfect the wallbox and the oxygen concentrator in the station that was used for the previous patient. The oxygen concentrator remained in Station #17 for the next patient treatment. g. Observations conducted on 11/25/25 at 11:10 AM identified during disinfection of the hemodialysis station, Station #15, after a patient treatment, Staff Person #5 failed to clean and disinfect the wallbox. Review of the cleaning and disinfecting of the dialysis station policy directed the dialysis station must be completely vacated by the previous patient before the teammate can begin to bring disinfection supplies to the station, clean or disinfect the station and set up for the next patient. The policy further directed to externally disinfect the dialysis machine with 1:100 bleach solution after each dialysis treatment. It directed to use a 1:100 bleach solution to clean the dialysis station (chair/bed, tables, machine, television, IV pole, BP cuff, hand sanitizer dispenser, chaise wall behind chair). It further directed that surfaces should be allowed to air dry in order to provide sufficient disinfectant contact time.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47491 Based on observation and interview, the facility failed to ensure that the door to the treatment floor were not propped open. The findings included: Observation at 7:23 AM on 11/25/25 identified the outside door leading into the facility lobby was propped open and the lobby door leading into the clinic floor was left open. Interview with Staff person #10 11/25/25 at 7:31 AM identified the outside door leading into the lobby should never be left open but was as a convenience to patients coming into the lobby from the outdoors. Staff person #10, however, was unable to answer why the lobby door leading to the clinic was left open. Staff Person #10 further indicated that the by leaving both doors open imposed a risk to both staff and patient safety as anyone could have entered the clinic. Interview with the Clinic Services Manger on 11/25/25 at 7:40 AM identified the outside door leading to the lobby was okay to be open, however, the door connecting the lobby to the treatment floor should always remain closed, unless being used to enter or exit the clinic floor. Although requested, the facility did not have a written policy regarding the treatment room door.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 47491 Based on review of clinical records, interview, review of facility documents and policy for two (2) of seven (7) patients (Patient #9, and Patient #11) reviewed for prescription, the facility failed to achieve the patient’s blood flow rate and/or dialysate flow rate during treatment in accordance with physician’s orders. The findings included: 1. Patient #7 had diagnoses that included End Stage Renal Disease (ESRD), a physician’s order for hemodialysis treatments three (3) times weekly, for four (4) hours at a Blood Flow Rate (BFR) of 450 and Dialysate Flow Rate (DFR) of 800 while using a central venous catheter. Review of the following treatment sheets identified the following: i. On 11/4/25, Patient #7’s hemodialysis treatment was initiated and at a DFR of 800, however was decreased to 600 the last thirty-one (31) minutes of treatment without documenting why the prescribed DFR of 800 was not maintained. ii. On 11/11/25, Patient #7’s hemodialysis treatment was initiated at a BFR of 450, however was decreased to 400 for thirty (30) minutes, and 350 for three (3) hours and one (1) minute without documenting why the prescribed BFR of 450 was not maintained. iii. On 11/13/25, Patient #7’s hemodialysis treatment was initiated and maintained at a DFR of 600 throughout the entire treatment without documentation as to why the prescribed DFR of 800 was not achieved. 2. Patient #7 had diagnoses that included ESRD. a physician’s order for hemodialysis treatments three times weekly, for three (3) hours and thirty (30) minutes at a blood flow rate (BFR) of 450 and dialysate flow rate (DFR) of 600 while using an arteriovenous fistula (AVF). Review of the following treatment sheets identified the following: i. On 11/22/25, Patient #9’s hemodialysis treatment was initiated and maintained at a BFR of 400 for the entire treatment without documentation of why the prescribed BFR of 450 was not achieved. ii. On 11/13/25, Patient #9’s hemodialysis treatment was initiated at a BFR of 400 and maintained at this rate for the entire treatment without documentation of why the prescribed BFR was not achieved. Interview with the Clinical Coordinator on 11/25/25 at 3:27 PM identified if the physician’s prescribed blood flow rate (BFR) was unattainable, staff were expected to document the reason why and to notify the nurse and/or physician of this concern. Review of the Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment policy identified if the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason would be documented and the licensed nurse informed.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44675 Based on facility documentation, facility policy and interviews for two (2) of six (6) patients (Patient #4 and #14), reviewed for blood pressures, the facility failed to ensure ambulatory patients had their post treatment standing blood pressure completed prior to leaving the clinic in accordance with facility policy. The findings include: 1. Patient #4 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and fifteen (15) minutes with a right Central Venous Catheter (CVC). Review of Patient #4’s hemodialysis treatment flowsheets identified the following: i. On 11/8/25 Patient #4 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. ii. On 11/11/25 Patient #4 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. iii. On 11/13/25 Patient #4 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. iv. On 11/18/25 Patient #4 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. v. On 11/20/25 Patient #4 ambulated independently but did not have a pre-treatment or post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. 2. Patient #14 had diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper Arteriovenous Fistula (AVF). Review of Patient #14’s hemodialysis treatment flowsheets identified the following: i.. On 11/1/25 Patient #14 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. ii. On 11/6/25 Patient #14 ambulated independently but did not have a post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. iii. On 11/15/25 Patient #14 ambulated independently but did not have a pre-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. iv. On 11/20/25 Patient #14 ambulated independently but did not have a pre-treatment and post-treatment standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that a sitting and standing blood pressure measurement is required pre and post treatment (if the patient is unable to stand, document the reason in the patient electronic record of flowsheets).”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation, interviews and policy review, for one (1) of three (3) patients reviewed for anemia, (Patient #20), the facility failed to administer an medication in accordance with physicians orders. The finding includes: Patient #20 had diagnoses that included ESRD. Physician’s orders directed daily peritoneal dialysis of four (4) 2300 milliliter exchanges of dialysate solution interperitoneally over the course of an eight (8) hour and thirty (30) minute treatment, utilizing a peritoneal dialysis catheter. Review of Patient #20’s 10/1/25 lab results identified a hemoglobin level of 9.2 (normal level 12-14), ferritin level of 944 (normal level is 30-400), and iron saturation of 35 (normal level 20-50) Review of Patient #20’s medication orders identified Venofer (iron medication), 100 milligrams, to be administered 10/5/25 to 10/23/25 (one time during this time frame). Further review of Patient #20’s medication orders identified a new order for Venofer, 100 milligrams, dated 10/23/25 was entered. Review of clinic visit documentation dated 10/24/25 failed to identify Patient #20 was administered 100 milligrams of Venofer. Further review of Patient #20’s clinic visit documentation identified he/she was not administered 100 grams of milligrams of Venofer until 11/6/25. Interview with Staff Person #9 on 11/24/25 at 2:01 PM identified Patient #20 was not administered the 100 milligram dose during his/her clinic visit on 10/24/25 as he/she thought the order was placed on hold and that he/she had misinterpreted the order. Review of the Medication Policy directed medications were administered as prescribed and then documented in the patient’s medical record.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 44675 Based on facility documentation, facility policy and interviews for five (5) of seventeen (17) patients (Patient #5, #6, #11, #12 and #14), reviewed for treatment compliance, the facility failed to complete Against Medical Advices (AMA) forms and notify the physician per facility policy, for one (1) of seven (7) patients reviewed (Patient #1) for treatment adherence the facility failed to call/follow-up with a patient when a no call/no show treatment occurred, for one (1) of three (3) patients reviewed for medication administration (Patient #19), the facility failed to enter antibiotic orders for a patient diagnosed with peritonitis, and based on observation, interview, and review of facility documents and policy related to glucometer calibration, the facility failed to ensure the glucometer was calibrated to accurately assess blood glucose levels. The findings included: 1. Patient #5 had diagnoses that included ESRD. Review of physician’s orders directed hemodialysis treatments three (3) times weekly, for three (3) hours and fifteen (15) minutes, utilizing an Arteriovenous Fistula (AVF). Review of Patient #5’s hemodialysis flowsheets identified the following: i. On 11/18/25, Patient #5 had two (2) hours and fifty-eight (58) minutes of treatment (17 minutes short) with no documentation as to why Patient #5’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. ii. On 11/13/25, Patient #5 had three (3) hour and four (4) minutes of treatment (11 minutes short), with no documentation as to why Patient #5’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. iii. On 11/6/25, Patient #5 had three (3) hours of treatment (15 minutes short ), with no documentation as to why Patient #5’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. iv. On 11/1/25, Patient #5 had two (2) hours and fifty-eight (58) minutes of treatment (17 minutes short) with no documentation as to why Patient #5’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. 2. Patient #6 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper AVF. Review of Patient #6’s hemodialysis flowsheets identified the following: i. On 11/3/25 Patient #6 had three (3) hours and four (4) minutes of treatment (26 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. ii. On 11/5/25 Patient #6 had three (3) hours and four (4) minutes of treatment (26 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. iii. On 11/7/25 Patient #6 had three (3) hours and fourteen (14) minutes of treatment (16 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an against medical advice AMA form was completed. iv. On 11/10/25 Patient #6 had three (3) hours and one (1) minute of treatment (29 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. v. On 11/12/25 Patient #6 had three (3) hours and three (3) minutes of treatment (27 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. vi. On 11/19/25 Patient #6 had two (2) hours and fifty-seven (57) minutes of treatment (33 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed and/or if the physician was notified. vii.. On 11/21/25 Patient #6 had three (3) hours and seven (7) minutes of treatment (23 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. 3. Patient #11 had diagnoses that included ESRD. Physician’s orders directed hemodialysis treatments three (3) times weekly, for three (3) hours and thirty (30) minutes, utilizing an AVF. Review of Patient #11’s hemodialysis flowsheets identified the following: i. On 11/18/25, Patient #11 had three (3) hours and twelve (12) minutes of treatment (18 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. ii. On 11/20/25, Patient #11 had three (3) hours and seventeen (17) minutes of treatment (13 minutes short), with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. 4. Patient #12 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes with a left upper arteriovenous graft (AVG). Review of Patient #12’s hemodialysis flowsheets identified the following: i. On 10/22/25 Patient #12 had three (3) hours and three (3) minutes of treatment (27 minutes short) with no documentation as to why Patient #12’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed. ii. On 11/7/25 Patient #12 had 2 hours and 57 minutes of treatment (33 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an AMA form was completed and/or if the physician was notified. iii. On 11/19/25 Patient #12 had 2 hours and 55 minutes of treatment (35 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. The medical record failed to identify an against medical advice (AMA) form was completed and/or if the physician was notified. Review of the against medical advice policy directed that the AMA form will be used for patients who refuse to complete the prescribed treatment. It further directed the charge nurse will review and have the patient sign the AMA form. It directed if shortened/early termination of treatment time exceeds 30 minutes or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any). The AMA form will be maintained in the patients medical records. Review of the Prescribed Treatment Time Not Met policy directed the registered nurse to verify that a patient signs the Early Termination of Treatment Against Medical Advice form anytime the patient requests to terminate their treatment earlier than the prescribed treatment time. 5. Patient #1 had diagnoses that included ESRD. Physician’s orders directed hemodialysis treatments three (3) times weekly, for three (3) hours and thirty-one (31) minutes, utilizing Central Venous Catheter (CVC). i. Review of Patient #1’s December 2024 treatment log identified he/she missed treatments on 12/11/24, 12/16/24, 12/20/24, 12/22/24, 12/24/24, 12/27/24, 12/29/24, and 12/31/24 without documentation noting a reason for the missed tratements or that contact with the patient was attempted/made. ii. Review of Patient #1’s January 2025 treatment log identified he/she missed treatments on 1/3/25, 1/6/25, and 1/10/25 without documentation noting why or that contact with the patient was attempted/made. Review of a nurse’s note dated 1/13/25 identified Patient #1 was discharged from the clinic (loss to follow-up) due to thirty (30) days of inactivity, and returned to the clinic on 1/21/25 to resume treatment following a hospitalization for fluid overload. Interview with the Clinical Coordinator on 11/25/25 at 3:27 PM identified facility protocol was to contact the patient when a treatment was missed (no call/no show). The Clinical Coordinator further indicated he/she was unsure as to why this wasn’t done. Although requested, the facility did not have a policy regarding missed treatments. 6. Patient #19 had diagnoses that included ESRD. Physician’s orders directed daily Peritoneal Dialysis (PD) of four (4) 2000 milliliter exchanges of dialysate solution interperitoneally over the course of eight (8) hour and thirty (30) minutes, utilizing a peritoneal dialysis catheter. Review of nurse’s note dated 9/22/25 identified Patient #19 was seen on 9/22/25 for cloudy effluent (waste fluid from PD). A specimen was collected and the patient was medicated with two (2) grams of Vancomycin and two (2) grams of Cefazolin (both antibiotics to treat a suspected infection). Interview with Staff Person #8 on 11/24/25 at 1:55 PM identified Patient #19 was administered two (2) grams of Vancomycin and two (2) grams of Cefazolin on 9/22/25, had self-administered Cefazolin on 9/23/25 and 9/24/25 (patient’s daughter was trained on self-administration of the antibiotic), and was switched to two (2) grams of Cefepime intraperitoneally on 9/25/25 (per physician’s verbal order) as the patient’s symptoms were not improving. Review of nursing notes dated 9/26/25 at 11:53 AM identified Patient #19 was feeling slightly better, was administered a repeat cell count and the patient continued to self-administer Cefepime interperitoneally at home. Review of Patient #19’s medication orders for September 2025 failed to identify orders for antibiotic treatment were entered into the patient’s medical chart and signed by the physician. Interview with Staff Person #8 on 11/24/25 at 1:55 PM identified Patient #19 was/had administered antibiotics (per facility protocol/physician’s order) as documented in his/her nursing notes, however he/she failed to enter the order into the electronic medical record (EMR) for the physician to sign off on. Review of the Medication Policy directed medications were administered as prescribed and then documented in the patient’s medical record and that no medications were given without an order from the physician or non-physician practitioner. 5.Review of November 2025 Glucometer Calibration Log Sheet identified the following: Missing entries on 9/4/25, 9/9/25, 9/10/25, 9/19/25, 9/30/25, 10/30/25, 10/31/25, 11/7/25, and 11/8/25 for glucometer #1 and #2 failed identify the facility’s glucometers were tested daily to ensure it was appropriately calibrated for use. i. Glucometer #1 entries dated 11/1/25, 11/3/25, 11/4/25, 10/28/25, 10/29/25 identified low control results exceeded the established range of 89-119 and failed to identify the glucometer was re-tested. ii. Glucometer #2 entries dated 9/11/25, 9/25/25, 10/4/25, 10/28/25, 11/1/25, and 11/3/25 identified low control results exceeded the established range of 89-119 and failed to identify the glucometer was retested. Interview with Staff #11 on 11/21/25 at 9:45 AM identified if the glucometer was out of range to re-test it. If the issue was to continue, staff were to change the test strips and retest the glucometer and if still out of range, report the issue and use an alternate glucometer. Review of the Embracepro Blood Glucose Monitor Quality Control policy directed daily quality control procedures or more often as required by state regulations and that if the control results fell outside of the acceptable range, the test must be repeated.”