Ships Medical, Llc

Summary Statement of Deficiencies D0000 A Recertification survey was performed at Ships Medical, LLC, CLIA ID 19D208332 on November 28, 2023. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and proficiency testing records as well as interview with personnel, the laboratory failed to retain proficiency testing records for at least two (2) years for one (1) of four (4) events reviewed. Findings: 1. Review of the laboratory's "Laboratory Record Retention" policy revealed "Ships Medical Laboratory, records will be kept for: Proficiency testing 2 years." 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing records for 2022 and 2023 revealed the laboratory did not retain the raw data to support proficiency testing results for the following event: - 2022 Chemistry - Miscellaneous-1st Event 3. In interview November 28, 2023 at 11:38 a. m., Testing Personnel 1 confirmed the laboratory did not retain the raw data for the proficiency testing event identified above. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedure manual and interview with personnel, the laboratory failed to establish detailed written instructions for providers to maintain the integrity of samples and ensure accurate and reliable testing. Findings: 1. In interview on November 28, 2023 at 11:30 a.m., Testing Personnel 1 stated the laboratory receives samples from outside clinics. 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have detailed instructions for providers that included the following: (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. 3. In interview on November 28, 2023 at 11:30 am, Office Personnel 1 confirmed the laboratory did not provide written instructions to outside providers who submit samples. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's temperature records and policy and procedure manual, as well as interview with personnel, the laboratory failed to define acceptable room temperature limits within the manufacturer's required range for supplies stored in the laboratory. Findings: 1. Observation by surveyor during the laboratory tour on November 28, 2023 at 10:20 a.m. revealed the laboratory stored Medlab Wash Solution (manufacturer's storage requirements 2 - 25 degrees Celsius) in the laboratory. 2. Review of the laboratory's temperature logs revealed the laboratory defined the acceptable room temperature limits as 18 - 30 degrees Celsius. 3. In interview on November 28, 2023 at 12:30 p.m., Testing Personnel 1 confirmed the laboratory's acceptable room temperature range exceeded the manufacturer's temperature limits. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. -- 2 of 5 -- This STANDARD is not met as evidenced by: Based on observation, review of the laboratory's policy and procedure manual, and interview with laboratory personnel, the laboratory failed to establish function check protocols for the Drucker Centrifuge to ensure equipment performance. Findings: 1. Observation by surveyor during laboratory tour on November 28, 2023 at 10:20 a.m. revealed the laboratory utilized one Drucker Diagnostics centrifuge for centrifugation of turbid urine specimens. 2. Review of the laboratory's policy "Centrifuge Maintenance" revealed the laboratory did not include function checks for the centrifuge. 3. In interview on November 28, 2023 at 1:45 p.m., Testing Personnel stated the laboratory did not have the operator's manual for the Drucker centrifuge. He confirmed the laboratory did not perform function checks for the centrifuge. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 A Recertification survey was performed on March 24, 2022 at Ships Medical L.L.C., CLIA ID # 19D2028332. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on observation by surveyor, review of manufacturer's package inserts, review of patient test reports and interview with personnel, the laboratory failed to report Urine Drug Screen (UDS) results as required by the manufacturer. Findings: 1. Observation, by surveyor during the laboratory tour on March 24, 2022 at 11:12 am revealed the laboratory utilizes the Olympus AU400e Chemistry analyzer for Urine Drug Screen (UDS) testing to include the following tests: 6-acetylmorphine (6-AM), Amphetamine (AMP), Barbituate (BAR), Benzodiazapine (BENZ), Buprenorphine (BUP), Cocaine (COC), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Opiates (OPI), Oxycodone (OXY), Phencyclidine (PCP), Tetrahydrocannabinol (THC), 3,4-Methylenedioxymethamphetamine (MDMA/XTC) 2. Review of the Olympus AU400e Chemistry analyzer package inserts for the above identified tests revealed "The Immunalysis Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- used in order to obtain a confirmed analytical result. GC-MS or Liquid Chromatography-tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.". 3. Review of the laboratory's patient test reports revealed the laboratory did not include the disclaimer for intended use on patient reports to state the entire confirmatory process. 4. In interview on March 24, 2022 at 11:47 am, Personnel 2 stated she was unaware the disclaimer for intended use was not included on patient reports. 5. Review of the Task 1&3 form provided to surveyor revealed the laboratory performs 74,880 UDS tests annually. D6026 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(8) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(8) Ensure that reports of test results include pertinent information required for interpretation. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with personnel, the Laboratory Director failed to ensure patient final reports included required pertinent information. Refer to D5805. -- 2 of 2 --

Summary Statement of Deficiencies 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: A Revisit survey was performed at Ships Medical, LLC, CLIA ID 19D208332 on January 29, 2020. Based on observation, record review, and interview with personnel, the laboratory failed to follow manufacturer sample storage requirements for urine drug screening (UDS). Findings: 1. In interview on January 29, 2020 at 2:35 pm, the Testing Personnel stated the laboratory was awaiting reagents and samples stored in the refrigerator were awaiting testing. 2. Observation by surveyor on January 29, 2020 and review of the laboratory's pending worklist revealed patient urine samples stored in the laboratory's refrigerator with the following collection dates: January 14, 2020 January 15, 2020 January 17, 2020 January 20, 2020 January 21, 2020 3. In interview on January 29, 2020 at 2:54 pm, the Testing Personnel stated samples are stable for thirty days in the refrigerator. 4. In telephone interview on January 29, 2020, the Technical Consultant stated samples are stable for thirty days. 5. Review of the manufacturer package inserts revealed the following specimen storage requirements: a) Thermo Scientific DRI Barbiturate Assay: "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C." b) Thermo Scientific DRI Ecstasy Assay:"Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory 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 -- may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C for 21 weeks." c) Thermo Scientific Amphetamines Assay: Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C." 6. Further review of the laboratory's pending list revealed the following fifty eight (58) patient samples exceeded the manufacture storage requirements: January 14, 2020: Patient 0100002468, Patient 0100002456, Patient 0100002463, and Patient 0100002461 (total 15 patients) January 15, 2020: Patient 0100002488, Patient 0100002498, Patient 0100002561, and Patient 0100002491 (total 13 patients) January 17, 2020: Patient 0100002543 and Patient 0100002490 January 20, 2020: Patient 0100002534, Patient 0100002547, Patient 0100002539, and Patient 0100002543 (total 11 patients) January 21, 2020: Patient 0100002562, Patient 0100002555, Patient 0100002570, and Patient 0100002574 (total 17 patients) 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: A Revisit survey was performed at Ships Medical, LLC, CLIA ID 19D208332 on January 29, 2020. Based on record review and interview with personnel, the laboratory failed to ensure patient samples for urine drug screening (UDS) were analyzed per manufacturer requirements. Findings: 1. In interview on January 29, 2020 at 2:54 pm, the Testing Personnel stated samples are stable for thirty days in the refrigerator. 2. In telephone interview on January 29, 2020, the Technical Consultant stated samples are stable for thirty days. 3. Review of the manufacturer package inserts revealed the following specimen storage requirements: a) Thermo Scientific DRI Barbiturate Assay: "Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C." b) Thermo Scientific DRI Ecstasy Assay:"Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C for 21 weeks." c) Thermo Scientific Amphetamines Assay: Specimens kept at room temperature that do not receive initial test within 7 days of arrival at the laboratory may be placed into a secure refrigeration unit at 2 to 8 degrees C for up to 7 days. For longer storage prior to analysis or for sample retention after analysis, urine specimens may be stored at -20 degrees C." 4. Review of patient final reports from December 2019 and January 2020 revealed the following patients exceeded manufacturer storage requirements for testing: Patient 0100002233: Collection date: December 18, 2019; Test date: December 26, 2019 Patient 0100002232: Collection date: December 18, 2019; Test date: December 26, 2019 Patient 0100002354: Collection date: January 7, 2020; Test date: January 17, 2020 -- 2 of 3 -- Patient 0100002353: Collection date: January 7, 2020; Test date: January 17, 2020 Patient 0100002352: Collection date: January 7, 2020; Test date: January 17, 2020 Patient 0100002514: Collection date: January 7, 2020; Test date: January 17, 2020 Patient 0100002358: Collection date: January 7, 2020; Test date: January 17, 2020 Patient 0100002357: Collection date: January 7, 2020; Test date: January 17, 2020 Patient 0100002356: Collection date: January 7, 2020; Test date: January 17, 2020 5. In interview on January 29, 2020 at 2:54 pm, the Testing Personnel confirmed the identified patient samples were stored in the refrigerator prior to testing. -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Certification Survey was performed at SHIPS Medical, LLC- CLIA # 19D2028332 on August 2, 2019. SHIPS Medical, LLC was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing; Laboratory Director 42 CFR 493.1415 CONDITION: Laboratories Performing Moderate Complexity Testing; Clinical Consultant D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written policies and procedures to assess competency for the Clinical Consultant were complete. Findings: 1. Review of personnel records for the Clinical Consultant revealed a competency assessment was not performed for their duties. 2. In interview on August 1, 2019, the Technical Consultant confirmed the Laboratory Director did not perform a competency assessment for the Clinical Consultant. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to ensure written specimen labeling and transport instructions for providers to maintain the integrity of samples were current. Findings: 1. In interview on August 1, 2019 at 10: 09 am, the Technical Consultant and Testing Personnel stated the laboratory provides outside clinics the "Urine Specimen Collection" procedure. 2. In interview on August 1, 2019, the Technical Consultant stated urine samples from outside clinics in Opelousas and New Iberia are delivered by an employee at room temperature on varying days of the week. 3. Review of the laboratory's "Urine Specimen Collection" procedure under "Specimens Storage and Transport" section revealed the following instructions: a) "Place two ice packs in an insulated shipping container." b) "Each Friday place the specimen bags on top of ice packs and seal the insulated shipping container. Ensure the specimens are transported to the laboratory in a secured insulated shipping container to eliminate the possibility of spillage or damage during shipment and to prevent undetected tampering." c) "Lonestar Courier will collect the specimens every Friday by 4:00 pm" 4. Further review of the laboratory's "Urine Specimen Collection" procedure revealed the laboratory did not include written instructions for specimen labeling. 5. In interview on August 1, 2019 at 10:30 am, the Technical Consultant confirmed the laboratory's written urine transport instructions need to be updated to reflect the laboratory's current practice. 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)