Summary:
Summary Statement of Deficiencies D5002 BACTERIOLOGY CFR(s): 493.1201 If the laboratory provides services in the subspecialty of Bacteriology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1261, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on Microscan microorganisms identification(ID) and antimicrobial susceptibility tests quality system quality control records (from August 24, 2016 to August, 21 2018), review, bacteriology testing records (from August 24, 2016 to August, 21 2018), direct observation and interview testing personal #2 on August 21, 2018 at 9:25 AM, it was determined that the laboratory failed to ensure compliance with the analytic system requirements for the subspecialty of Bacteriology from January 2, 2017 to August 20, 2018. Refer to D 5471 (The laboratory did not check each batch, lot number and shipment of reagents of Microscan microorganisms identification system for positive and negative reactivity of each substrate included in this identification system from January 2, 2017 to August 20, 2018). Refer to D 5507 (The laboratory failed check with appropriate control organism(s) each batch, lot number, shipment of reagents and each day of testing the Microscan antimicrobial susceptibility tests from July 31, 2017 to August 20, 2018). This deficiency was cited on survey performed on October 09, 2014. As a results an Immediate Jeopardy was called. D5014 GENERAL IMMUNOLOGY CFR(s): 493.1208 If the laboratory provides services in the subspecialty of General immunology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- This CONDITION is not met as evidenced by: Based on manufacturer's instructions, Antinuclear Antibody (ANA) IgG by Immunofluorescence quality control records review in year 2018 and laboratory technical supervisor interview at 1:00 PM on August 21, 2018, it was determined that the laboratory failed to ensure compliance with analytic system requirements for general immunology. Refer to D5403 (The laboratory did not have the procedure manual for Antinuclear Antibody (ANA) IgG test by immunofluorescence kit.), D5405 (The laboratory did not follow the manufacturer's instructions when perform the Antinuclear Antibody (ANA) IgG test by immunofluorescence kit with 1:40 screening dilution) and D5411 (The laboratory did not follow the manufacturer's instructions for temperature incubation when perform the Antinuclear Antibody (ANA) IgG test by immunofluorescence kit with temperature range). This deficiency was cited on survey performed on October 09, 2014. As a results an Immediate Jeopardy was called. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on written policies for sperm cell analysis and count specimens, sperm cell testing records(years 2017 to 2018) and testing personnel # 2 interview on August 21, 2018 at 11:20 AM, it was determined that the laboratory failed to have and follow written procedures for the acceptability and rejection of the sperm cell analysis that was collected out side the laboratory from January 4, 2017 to August 20, 2018. The findings include: 1. The written procedures for the collection of the sperm cell analysis and count specimens did not include specific instructions of rejections for the sperm cell analysis that were not taken in the laboratory. 2. The testing personnel confirmed on August 21, 2018 at 11:20 AM, that the laboratory did not have specific instructions of rejections for the sperm cell analysis that were not taken in the laboratory. She stated that the laboratory did not document the receipt time in to the laboratory. She stated, that she does not know how many sperm cell analysis were taken out side the laboratory from January 4, 2017 to August 20, 2018. 3. On August 21, 2018 at 11:20 AM, the sperm cell testing records showed that the laboratory processed 168 from January 4, 2017 to August 20, 2018. 35 out of 168 sperm cell specimens did not include the time of collection and 168 out of 168 did not include date and receipt time. 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, storage, preservation, transportation, processing, and referral; and criteria for -- 2 of 11 -- 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)