A Preferred Women's Health Center

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based upon review of the laboratory's 2021, 2022 and 2023 API proficiency testing records, interview with TP (Testing Personnel) #6 on 8/23/2023 and review of 2022 and 2023 patient test logs, the laboratory failed to handle proficiency testing samples in the same manner as patient samples. Findings: Review of the proficiency testing records from seven events from 2021, 2022 and 2023 revealed that the same testing personnel performed the last 3 proficiency testing events received by the laboratory. TP#6 performed all proficiency testing challenges contained within the First and Second Proficiency Testing Events of 2023 as well as the Third Proficiency Testing Event of 2022. The laboratory has a total of 11 Testing Personnel. Review of these proficiency testing records also revealed the absence of patient logs documenting the integration of proficiency testing samples within the routine patient workload. An interview with TP #6 at approximately 10:55 a.m. confirmed that proficiency testing results are not documented on the routine patient test logs. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based upon review of the laboratory's procedure manual, review of patient test logs, interviews with TP (Testing Personnel) #6 and the Office Manager on 8/23/23 and an email received from the Office Manager on 9/1/23, the Laboratory Director did not review, approve, sign and date a revised Anti-D (Rh Type) Reagent Test procedure when the quality control protocol for this test changed in May 2021. Findings: Review of the laboratory's "Anti-D (Rh Type) Reagent Test" procedure revealed in "Section D: Test Procedure-Slide Method" the steps to perform one negative external control and one positive external control. "Section F. Quality Control" states " #1. Quality Control testing is required to confirm reactivity of the product. Positive and negative external controls must be run daily, before patient testing." A review of the patient test log revealed the documentation of two positive external controls and one negative external control each day of patient testing as well as an additional BGS external quality control that is performed along with each patient sample. An interview with TP #6 at approximately 10:30 a.m. confirmed that the quality control protocol detailed in the laboratory's "Anti-D (Rh Type) Reagent Test" procedure is not the current protocol in use in the laboratory. An interview with the Office Manager at approximately 12:05 p.m. revealed the laboratory changed its quality control protocol due to supply chain issues. Via email on 9/1/23, it was confirmed by the Office Manager that the change occurred in May 2021. D6038 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(a) The technical consultant must be accessible to the laboratory to provide on-site, telephone, or electronic consultation. This STANDARD is not met as evidenced by: Based upon review of the laboratory's procedure manual, interview with TP (Testing Personnel) #6 on 8/23/23 and review of the TC (Technical Consultant)'s Agreement, the TC failed to maintain a procedure that detailed how to perform Anti-D testing on patient samples in the laboratory. Findings: A review of the laboratory's "Anti-D (Rh Type) Reagent Test" procedure revealed that "Section D. Test Procedure-Slide Method" did not contain step by step directions for the performance of Anti-D testing on a patient sample. A review of this section also revealed that the quality control protocol detailed in the procedure is not the current quality control protocol in use in the laboratory. An interview with TP (Testing Personnel) #6 at approximately 10:30 a. m. confirmed that the quality control protocol detailed in the laboratory's "Anti-D (Rh Type) Reagent Test" procedure is not the current protocol in use in the laboratory. A review of the TC's Agreement revealed the following responsibility in the "Duties" section: " #3. Development of all needed procedures/forms for the laboratory department for continuous on-going CLIA compliance." D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based upon review of the laboratory's procedure manual and interview with TP -- 2 of 3 -- (Testing Personnel) #6 on 8/23/23, TP #6 failed to follow the laboratory's policy. Findings: The laboratory's "Anti-D (Rh Type) Reagent Test" procedure states in "Section D. Test Procedure-Slide Method...#3. Add 1 drop of Anti-D to each of the labeled wells, or to each of the labeled glass slides." An interview with TP #6 at 10:30 a.m. revealed that this employee uses 2 drops of Anti-D when performing this test. TP #6 stated she was trained to perform the test using 2 drops of Anti-D. -- 3 of 3 --

Summary Statement of Deficiencies D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on review of the manufacturer's product instructions, review of laboratory procedures and laboratory logs, observation, and testing personnel (TP) interview 11/7 /19, the laboratory failed to follow manufacturer's instructions and the laboratory's procedure for the HemoCue Hemoglobin (Hb) 201 microcuvettes used with the HemoCue Hb 201+ analyzer. Findings: 1. The HemoCue Hb 201 Microcuvettes product insert states "... Storage and Handling Use HemoCue Hb 201 Microcuvettes prior to expiry date on each package. ... Once the seal of the vial is broken the microcuvettes in the vial are stable for three months. ..." Review of laboratory logs revealed Hb microcuvettes were documented as expired and were used for patient testing on the following dates: a. 10/5/17, 10/6/17, 10/7/17 - lot #1703078, expired 1/5 /17; b. 10/28/17 - lot #1706257, expired 1/28/17; c. 10/30/17,10/31/17 - lot #1708320, expired 1/28/17; d. 11/1/17 - lot #1708320, expired 1/30/17; e. 11/24/17, 11/25/17 - lot #1706237, expired 2/22/17; f. 11/28/17,11/29/17, 12/1/17 - lot #1706237, expired 2 /27/17; g. 12/7/17, 12/8/17, 12/9/17 - lot #1706237, expired 3/6/17. During interview at approximately 11am, TP#1 confirmed the Hb microcuvettes were documented as being expired. She stated the TP had trouble documenting the correct 3-month expiration date for the microcuvette vials once opened. 2. The HemoCue 201 Microcuvettes product insert states "... Store at room temperature (15-30 degrees C (Celsius), 59-86 degrees F (Fahrenheit) in a dry place. ... Note: Always keep the vial properly closed. ... Limitations a) Fill the microcuvette within 3 minutes after removal from the package. ... Procedure ... Note: The microcuvette should be filled within 3 minutes after the microcuvette has been taken out of its package. ... " The laboratory's Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- HemoCue Hb 201+ procedure states under "Reagents and Storage...Once opened, the microcuvettes are stable for 3 months..." The procedure also states, "...2. Remove a cuvette from the vial with a dry hand and replace the cap tightly to avoid humidity damage to the remaining cuvettes." During tour of laboratory at approximately 12pm, the surveyor observed an open vial of microcuvettes on the laboratory counter. The contents of the vial were emptied into a cardboard box lid on the counter. During interview at approximately 12:15pm, TP #3 confirmed she empties the microcuvettes into the cardboard box lid first thing in the morning and places them back in the vial at the end of the day. She stated she was unaware the microcuvettes needed to be kept in a closed vial until time of patient testing. 3. The laboratory's "Critical Values List" states "The following are the alert values specific for (the laboratory). Repeat any specimen with results occurring within the parameter listed below. ..." A notation dated 11/7/19 stated that Hemoglobin values less than 10.0 g/dl (grams per deciliter) are considered critial/alert values. Random review of 2019 daily logs revealed repeat testing of hemoglobin values below 10.0 was not routinely documented. Examples: a. On 6/29/19, patient #40 had a hemoglobin of 8.0 g/dl with no documentation of repeat testing; b. On 8/2/19, patient #12 had a hemoglobin of 6.6 g/dl with no documentation of repeat testing; c. On 8/5/19, patient #29 had a hemoglobin of 7.4 g/dl with no documentation of repeat testing; d. On 9/17/19, patient #7 had a hemoglobin of 8.7 g /dl with no documentation of repeat testing. During interview at approximately 11:30 a.m., TP # 1 stated that they usually repeat hemoglobins below 10. She stated that if the two readings are comparable, the repeat test is not always documented. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on review of 2017, 2018, and 2019 Quality Control (QC) records, absence of documentation, and interview with the Technical Consultant(TC) 11/7/19, the laboratory failed to retain all required records for at least 2 years. Findings: The laboratory performs Rhesus D (RhD) antigen testing using Anti-D Blend ALBAclone Blood Grouping Reagent. QC is performed each day of patient testing using Quotient ALBAcyte Reagent red blood cells - cell #1 as a positive control and cell #3 as a negative control. Review of QC records revealed the laboratory failed to retain the ALBAcyte Red blood cell assay sheets with appropriate antigen typing for the control lot numbers in use in 2017, 2018, and 2019. During interview at approximately 11: 30am., the TC confirmed the laboratory did not retain the assay sheets. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: -- 2 of 4 -- Based on the review of manufacturer's instructions, review of laboratory procedure, observation, and technical consultant(TC) interview 11/7/19, the laboratory failed to follow manufacturer's instructions for Rhesus D antigen (RhD) testing. Review of manufacturer's instructions for RhD testing, ALBAclone Anti-D blend blood grouping reagent, revealed under "Slide technique... 1. Add 1 drop of blood grouping reagent... 2. Add 1 drop of whole blood...3. Mix well by rocking the slide for approximately 30 seconds and incubate the test at 20-24 degrees Celsius(C) for 5 minutes with occasional mixing. 4. After incubation, immediately observe macroscopically for agglutination." The laboratory performs a BGS control with each patient tested. The manufacturer's instructions for ALBAcheck-BGS Reagent Control for Anti-D states the BGS reagent control "should be substituted for, and used by the recommended techniques for the monoclonal Anti-D reagent being controlled." The laboratory's procedure"Anti D blend ALBAclone Blood Grouping Reagent" states "...Mix well by rocking the slide for approximately 30 seconds and incubate the test for 5 minutes at 18-24C with occasional mixing....After incubation, immediately observe macroscopically for agglutination..." The procedure fails to follow the manufacturer's instruction for incubation temperature...the manufacturer states to incubate at 20-24 degrees C, not 18-24 degrees C. During tour of the laboratory at approximately 12: 15pm., the surveyor observed TP#3 rock the slide for approximately 30 seconds and immediately interpret the test. The TP failed to incubate the slide for 5 minutes as stated in the manufacturer's instructions and the laboratory's procedure. Interview with the TC at approximately 12:30pm. confirmed patient test results that come up positive after rocking for 30 seconds are interpreted and are not incubated for the full 5 minute time-frame. D5783