Summary:
Summary Statement of Deficiencies D0000 AN INITIAL CERTIFICATION SURVEY was performed at Xpressmed Urgent Care of Crowley, LLC - CLIA # 19D2134272 on January 25, 2018. Xpressmed Urgent Care of Crowley was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1215 CONDITION: Hematology. 42 CFR 493.1403 CONDITION: Laboratory Director performing moderate complexity testing. 42 CFR 493.1409 CONDITION: Technical Consultant. 42 CFR 493.1421 CONDITION: Testing Personnel. 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 observation, record review and interview with personnel, the laboratory failed to follow the manufacturer's storage requirements for calibration, quality control and verification samples for waived chemistry testing. Findings: 1. Observation by the surveyor on January 25, 2018 found calibration, and quality control samples for waived chemistry testing being stored in the freezer compartment of a Table Top Galanz Refrigerator/Freezer. Further observation found the laboratory failed to monitor the temperature of the Freezer portion of the Galanz Refrigerator /Freezer. The following items were noted as being stored in the Freezer of the Galanz Refrigerator/Freezer without monitoring the temperature of the freezer: a) Biosource Technology BRT Liquid Assayed Chemistry and Lipid Controls: six (6) Vials of Level 1 and six Vials of Level 2; lot number 1703007 with an expiration date of 2018 /06. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 15 degrees Celsius or colder. b) Alere Triage Total 5 Controls: three (3) Vials of Level 1 - lot number C3350A with an Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 13 -- expiration date of 2018/07/11 and, four (4) Vials of Level 2 - lot number C3365A with an expiration date of 2018/07/11. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 20 degrees Celsius or colder. c) Alere Triage Total 5 Calibration Verification Material: nine (9) Vials - lot number 407521 with an expiration date of 2018/05/17. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 20 degrees Celsius or colder. 2. Observation by the surveyor on January 25, 2018 found the following quality control and verification samples for waived testing being stored in the Refrigerator portion of the table top Galanz Refrigerator/Freezer. The following items were being stored between 2 - 8 degrees Celsius which was outside the manufacturers requirements. a) Alere Triage BNP Controls: five (5) Vials of Level 1 - lot number C3340A with an expiration date of 2018/08/14 and, five (5) Vials of Level 2 - lot number C3337A with an expiration date of 2018/07/17. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 20 degrees Celsius or colder. b) Biosource Technology BRT Controls: six (6) Vials of level 1 and six (6) Vials of Level 2 - lot number 1705005 with an expiration date of 2018/09. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 15 degrees Celsius or colder. c) Biosource Technology BRT Verification Samples: three (3) Vials of each level 1, 2 and 3 - lot number 1708005 with an expiration date of 2018/12. NOTE: The manufacturers required storage temperature located on the outside of the box stated the items are to be stores at - 15 degrees Celsius or colder 2. Interview with the Technical Consultant on January 25, 2017 confirmed the laboratory failed to store calibration, quality control and verification samples according to the manufacturer. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on a record review, and interview with personnel, the laboratory failed to ensure the quality of testing in the specialty of Hematology. Findings: 1. The laboratory failed to maintain a complete policy and procedure manual. Refer to D5403. 2. The laboratory failed to verify performance specifications for the Sysmex XP-300 Hematology Analyzer for Complete Blood Cell (CBC) testing. Refer to D5421. 3. The laboratory failed to document the weekly maintenance on the Sysmex XP-300 Hematology Analyzer for two (2) of eight (8) weeks reviewed. Refer to D5429. 4. The laboratory failed to establish means and ranges for Quality Control (QC) material used for the Sysmex XP-300 Hematology Analyzer as required by the manufacturer for six (6) of six (6) lots of quality control material. Refer to D5469. 5. The laboratory failed to establish written policies and procedures in place to monitor, assess, and correct problems identified with the Hematology Systems. Please refer to D5791. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints -- 2 of 13 -- and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure for addressing complaints and problems reported to the laboratory. The policy should include a detailed procedure on how to address, document and handle complaints or problems reported to the laboratory. 2. Interview with the Technical Consultant on January 25, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. D5207 COMMUNICATIONS CFR(s): 493.1234 The laboratory must have a system in place to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory personnel the laboratory failed to have a system in place to ensure that it identifies and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. Findings: 1. Review of the Laboratory's Policy and Procedure Manual revealed the laboratory failed to have written policies and procedure to identify and document problems that occur as a result of a breakdown in communication between the laboratory and an authorized person who orders or receives test results. 2. Interview with the Technical Consultant on January 25, 2018 confirmed the laboratory failed to have a complete policy and procedure manual. 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 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)