Summary:
Summary Statement of Deficiencies D0000 The laboratory was surveyed and failed to meet the following conditions of the CLIA regulations found at CFR 42 493.1 through 493.1780: 493.1250 Condition: Analytic Systems 493.1403 Condition: Laboratories Performing Moderate Complexity Testing; laboratory director 493.1409 Condition: Laboratories Performing Moderate Complexity Testing; technical consultant 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: Review of package inserts, policies and procedures, observations, quality control records and interview of facility personnel found that the laboratory failed to test external quality control materials as defined by the manufacturer when using the Siemens 10 SG Urinalysis Reagent strips lot 804050 expiration 2019-10-31. THIS IS A REPEAT DEFICIENCY CITED IN THE AUGUST 2011 and the JANUARY 26, 2017 INSPECTION. Findings included: 1. Review of the package insert for the Siemens 10 SG urinalysis reagent strips found under the heading QUALITY CONTROL - "Test known negative and positive specimens or controls whenever a new bottle is first opened." 2. Review of the laboratory's own written policy titled Urinalysis found under the heading Quality Control: "run a control and a microscopic first working day of the week before running a urinalysis. When the control does not meet the standards, check for any deterioration. If the problem is uncorrected send urine to the reference lab (refrigerated)." 3. Observations made during the tour the laboratory found that the laboratory was currently using Siemens 10 SG Urinalysis Reagent Strips lot 804050 expiration 2019-10-31. There was no documentation of the date opened on the bottle. 4. Review of quality control records for 2018 found no Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- documentation of quality control procedures for the Siemens 10 SG urinalysis reagent strips lot 804050 expiration 2019-10-31. 5. Interview of the laboratory quality manager conducted on February 19, 2019 at 10:08 AM confirmed that the laboratory did not document the date of opening of the Siemens 10 SG urinalysis reagent strips and there was no documentation of quality control for this lot number. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Review of proficiency testing records and interview of facility personnel found that the laboratory testing personnel failed to attest to the integration of proficiency testing specimens into the routine, patient workflow for urinalysis in five of six testing events in 2017 in 2018. THIS IS A REPEAT DEFICIENCY CITED IN THE JANUARY 26, 2017 INSPECTION. The findings included: 1. Review of the American Association of Family Practitioners (AAF P) proficiency testing records for urinalysis found that the testing personnel failed to sign three of three testing events in 2017 for urinalysis and two of three testing events in 2018. 2. Interview of the laboratory quality manager conducted on February 19, 2019 at 12:00 PM confirmed that attestation statements had not been signed by testing personnel and that testing personnel were no longer employed. She confirmed that the previous nurse manager left in October 2018 and failed to ensure that proficiency testing records were complete. D5018 URINALYSIS CFR(s): 493.1211 If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy and procedures, procedure manuals, maintenance records, surveyor observations, and staff interview, the laboratory failed to follow written policies and procedures to monitor, assess and correct problems in the analytic laboratory systems specified at 493.1251 through 493.1283. The findings included: 1. The laboratory failed to follow their own procedure for centrifuge speed and time when preparing urine specimen sediment for microscopic analysis, and failed to include pertinent literature references in the procedure. Refer to D5403. 2 .The laboratory failed to define a maintenance protocol to ensure centrifuge performance that is necessary to prepare urine specimen sediment for microscopic analysis. Refer to D5433. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, -- 2 of 8 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)