Stone Clinical Laboratories Of Fl Llc

Summary Statement of Deficiencies D0000 An unannounced complaint survey #2020016404 was conducted on 11/17/20-11/19 /20 at Stone Clinical Laboratories of Florida LLC. The laboratory was not in compliance with 42 CFR Part 493, requirements for Clinical Laboratories. Based on the survey findings an Immediate Jeopardy situation was identified and the laboratory was notified at 3:51 pm on 11/19/20. 1. The laboratory failed to follow their own written policy for specimen receipt and handling for 3 of 3 days specimens were received from outside clients for COVID-19 testing (10/02/2020, 10/04/2020, 10/06 /2020). Refer to D5311, I. 2. The laboratory failed to ensure specimens for COVID-19 testing had not exceeded their stability for 9 of 10 Runmei swabs and 1 of 10 Beaver swabs (sampling from 10/09/2020 and 10/10/2020). Refer to D5311, II. 3. The laboratory failed to verify shipping/transport conditions for specimens (from outside clients) maintained temperature according to manufacturer's instructions for 1,254 of 1,254 specimens observed on 11/17/2020 and 9 of 9 specimens from a sampling received 10/09/2020. Refer to D5311, III. 4. The laboratory's preanalytical policies and procedures were inconsistent with manufacturer's instructions for Beaver swabs. Refer to D5311, IV. The following Conditions were not met: D5300 - 493.1240 - Preanalytic Systems D5400 - 493.1250 - Analytic Systems D6076 - 493.1441 - Laboratory Director D6168 - 493.1487 - Testing Personnel D6108 - 493.1447 - Laboratory Technical Supervisor D3027 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(1) Test requisitions and authorizations. Retain records of test requisitions and test authorizations, including the patient's chart or medical record if used as the test requisition or authorization, for at least 2 years. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, final test reports, and in interview with staff, the laboratory failed to retain 2 of 13 test requisitions for COVID-19 testing Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 30 -- (specimens received 10/05/2020 and 10/07/2020). Findings included: 1. Review of the laboratory's policy "Specimen Acceptance and Rejections" (SOP #: GENFL-7) stated, "III. Policy A. Requisition Acceptance 1. All specimens must be accompanied by a requisition form." 2. In a sampling of final test reports of COVID-19, the laboratory did not have the test requisitions for the following: Patient #20134491 - collected 9/29 /2020 at 10:53 am, received 10/05/2020, result reported 10/06/2020 at 10:36 am. Patient #11018216 - collected 9/29/2020 at 8:00 am, received 10/07/2020, result reported 10/06/2020 at 10:36 am. 3. During an interview on 11/18/2020 at 12:19 pm, the Team Lead of Accessioning was unable to provide the requisitions; he stated they might be in New Orleans, LA. He stated they may have been reviewed there because of how busy they were during that time. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on direct observation, review of laboratory's policy, patient test requisitions, instrument data, patient final test reports, and in interview with staff, the laboratory failed to ensure positive identification of a mislabeled patient specimen for COVID- 19 testing (11/16/2020). Findings included: 1. During the tour of the accessioning area on 11/17/2020 at 11:12 am, patient swabs that had been analyzed for COVID-19 testing on 11/16/2020, were observed on a counter in blue racks. One of the swabs was observed to have two different requisition labels, Patient #11778097 requisition label was underneath Patient #11782778 requisition label, and Patient #11782778's accession label was on the swab (Accession #1103298501). During a tour of the receiving area on 11/17/2020 at 4:22 pm, a swab for Patient #11778097 was observed in the freezer. The swab was labeled with the patient requisition label (#11778097) and their corresponding accession label (Accession #1103316031). The swab with the two different requisition labels was not rejected (requisition label #11778097 and #11782778). 2. Review of the laboratory's "Specimen Acceptance and Rejections" (SOP #: GENFL-7; effective date: 09/08/2020) policy did not include procedures for specimen swabs labeled with two different patient names. Note: this policy stated, "Copy of version 2.0 (ready for lab director approval)." The policy had been modified and the laboratory director had not reviewed and approved. 3. Review of the above mentioned patient test requisitions, instrument data and final test reports for COVID- 19 included the following: Patient #11782778 (requisition number) requisition included a collection date/time of 11/13/2020 at 9:03 am and an accession label of #1103298501 (Container: Beaver swab); according to the QuantStudio 5 System data, the specimen was analyzed on 11/16/2020 at 16:40 hours; the final test report included COVID-19 result reported date/time of 11/16/2020 18:30 hours. Patient #11778097 (requisition number) requisition included a collection date/time of 11/13 /2020 at 8:01 am and an accession label of #1103316301 (Container: Beaver swab); according to the QuantStudio 5 System data, the specimen was analyzed on 11/16 /2020 at 16:40 hours; the final test report included COVID-19 result reported date /time of 11/16/2020 18:30 hours. The laboratory failed to establish written policies that ensure positive identification for specimens with two different patient requisition labels. 4. On 11/16/2020, the laboratory had received 157 specimens for COVID-19 -- 2 of 30 -- testing. From 10/03/2020 through 11/17/2020, the laboratory had analyzed 17,233 specimens. 5. During an interview on 11/17/2020 at 1:50 pm, the Team Lead of Accessioning provided the requisitions for the above-mentioned patients and stated the collection facility had labeled the specimen that way (the swab with two different requisition labels). D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to follow their procedures for monitoring, assessing and correcting identified problems. Findings included: 1. Review of the laboratory's procedure titled "Quality Management Plan" showed that under the section titled "Monthly Reviews" the laboratory has a "Form GENFL-32 Quality Assurance Plan Checklist" to document "laboratory performance in general and contains reviews and evaluations of pre-analytic, analytic and post-analytic metrics". The laboratory started testing on 10/02/2020 and no checklist for the month of October 2020 was available for review. 2. During an interview on 11/18/19 at 3:20 PM, the Technical Supervisor - A stated that the Quality Assurance Plan Checklist had not been filled out and that she was unable to locate the form. D5300 PREANALYTIC SYSTEMS CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's policy, test requisitions, patient test reports, instrument data, specimen receipt log sheets, and in interview with staff, the laboratory failed to meet the requirements of prenalytical systems, as follows: 1. The laboratory failed to ensure the test requisitions included the type of swabs (container) used for collection in order to ensure accurate and timely COVID- 19 testing on the Panther Hologic analyzer for 25 of 25 patients from 10/2020. Refer to D5305. 2. The laboratory failed to follow their own written policy for specimen receipt and handling for 3 of 3 days specimens were received from outside clients for COVID-19 testing (10/02/2020, 10/04/2020, 10/06/2020). Refer to D5311, I. 3. The laboratory failed to ensure specimens for COVID-19 testing had not exceeded their stability for 9 of 10 Runmei swabs and 1 of 10 Beaver swabs (sampling from 10/09 /2020 and 10/10/2020). Refer to D5311, II. 4. The laboratory failed to verify shipping /transport conditions for specimens (from outside clients) maintained temperature according to manufacturer's instructions for 1,254 of 1,254 specimens observed on 11 -- 3 of 30 -- /17/2020 and 9 of 9 specimens from a sampling received 10/09/2020. Refer to D5311, III. 5. The laboratory's preanalytical policies and procedures were inconsistent with manufacturer's instructions for Beaver swabs. Refer to D5311, IV. 6. The laboratory failed to document the time patient COVID-19 specimens were received from outside clients for 31 of 31 specimens from 10/2020. Refer to D5313. D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's policy, test requisitions, patient test reports, instrument data, and in interview with staff, the laboratory failed to ensure the test requisitions included the type of swabs (container) used for collection in order to ensure accurate and timely COVID-19 testing on the Panther Hologic analyzer for 25 of 25 patients from 10/2020. Findings included: 1. Review of manufacturer's instructions for collection devices accepted by the laboratory revealed the following stability timeframes: Single-use Samplers Runmei AMIES - "The collected samples can be stored at regular storage temperature (between 20-37C) for at least 96 hours, long-term storage should be placed in low-temperature conditions below -20C, -70C or store at freezing level -196C" (C = degrees Celsius). Aptima Mutlitest - "After collection, specimens in the Aptima Multitest Transport Tube may be stored at 2C to 30C up to 6 days." Copan ESwab - " ...If immediate delivery or processing is delayed, then specimens should be refrigerated at 4 - 8C or stored at room temperature (20 - 25C) and processed within 48 hours except for Neisseria gonorrhoeae [sic] cultures, which should be processed within 24 hours." Beaver - "RNA Viral Preservative performance was tested by detecting different RNA virus concentration diluted in the target reagent and placed at room temperature (20 to 25C) and -20C for 1 to 7 days ...The experimental data provide the evidence that viral RNA samples stored in the Preservative were highly stable at RT for at least 7 days comparing with stored at -20C." Review of patient requisitions did not solicit the swab type to ensure specimens were analyzed within the above timeframes. 2. Review of the laboratory's policy "Specimen Collection and Shipping" (SOP #: GENFL-43; no effective date), stated "D. Specimen Storage: 1. After collection, specimens must be stored in the appropriate storage temperature conditions listed below. Storage temperatures are dependent on specimen type and collection container/kit. 2. Specimens must be received in the laboratory within the specimen's stability. Specimen stability is dependent upon specimen type and collection container/kit. Specimens should be shipped daily to avoid specimen rejection. Collection Container -- 4 of 30 -- /Kit: Copan eSwab, Storage Temperature Range: 20-25C, Specimen Stability 48 hours; Collection Container/Kit: Aptima Multitest ,Storage Temperature Range: 2- 30C, Specimen Stability 6 days; Collection Container/Kit: Remel Microtest M4RT, Specimen Storage Temperature Range: 20-25C, Specimen Stability: 48 hours; Collection Container/Kit: Run Mei Amies, Specimen Storage Temperature Range: 20- 37C, Specimen Stability: 96 hours; Collection Container/Kit: Beaver, Specimen Storage Temperature Range: 15-30C, Specimen Stability: 7 days." The policy was not signed and approved by the laboratory director. 3. Review of patient test requisitions, test reports, and instrument data for COVID-19 specimens received 10/02/2020, 10/06 /2020, and 10/09/2020, revealed the laboratory did not ensure the swab type was solicited in order to meet stability timeframes when analyzed on the Panther Hologic, as follows (sampling of patients): Patient #20132819 - collected 9/29/2020 at 1:04 pm; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 2:35 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132737 - collected 9/30 /2020 at 11:33 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT: SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 1:10 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132713 - collected 9/28/2020 at 12:00 pm; Code: 401310, Tube: SWAB, Description: SARS- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 12:45 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132796 - collected 10/01/2020 at 12:06 pm; Microogranisms: SARS-CoV-2; Order Code: 401310; Site: Oropharyngeal; Sample Type: Swab; the Accession label: CONT: SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 2:10 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132717 - collected 9/28/2020 at 2:23 am; Code: 401310, Tube: SWAB, Description: SARS- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 12:40 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132718 - collected 9/28/2020 at 2:19 am; Code: 401310, Tube: SWAB, Description: SARS- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 12:40 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132720 - collected 9/28/2020 at 2:26 am; Code: 401310, Tube: SWAB, Description: SARS- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 12:40 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132846 - collected 9/30/2020 at 12:00 am; Code: 401310, Tube: SWAB, Description: SARS- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 2:25 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132790 - collected 9/30/2020 at 11:37 am; Code: 401310, Tube: SWAB, Description: SARS- -- 5 of 30 -- CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/02/2020. Panther Hologic results report revealed the specimen was analyzed 10/03/2020 at 2:00 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #2013505601 - collected 10/02/2020 at 2:02 pm; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 12:30 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20134964 - collected 10/02/2020 at 1:34 pm; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 3:15 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135342 - collected 09/29/2020 at 10:16 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 2:45 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135371 - collected 9/29/2020 at 8:18 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 2:30 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135348 - collected 9/29/2020 at 8:02 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 2:25 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135419 - collected 9/29/2020 at 10:24 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 2:15 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135357 - collected 9/28/2020 at 2:21 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 1:50 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20134549 - collected 9/29/2020 at 10:24 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 1:25 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20134464 - collected 9/29/2020 at 10:29 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 1:15 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135069 - collected 10/02/2020 at 2:49 pm; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 12:50 am. -- 6 of 30 -- Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135373 - collected 9/29/2020 at 10:26 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 2:00 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20134602 - collected 9/29/2020 at 7:43 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID 19 QS; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 3:30 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20135490 - collected 9/29/2020 at 10:40 am; Code: 401310, Tube: SWAB, Description: SARS-CoV-2, Additional Info: Coronavirus SARS-CoV-2 Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/06/2020. Panther Hologic results report revealed the specimen was analyzed 10/06/2020 at 1:25 am. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20136956 - collected 10/06/2020 at 10:40 am; Microogranisms: SARS-CoV- 2; Order Code: 401310; Site: Nasal Mid-Turbinate; Sample Type: Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/09/2020. Panther Hologic results report revealed the specimen was analyzed 10/10/2020 at 2:32 pm. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20136924 - collected 10/06/2020 at 9:40 am; Microogranisms: SARS-CoV- 2; Order Code: 401310; Site: Nasal Mid-Turbinate; Sample Type: Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/09/2020. Panther Hologic results report revealed the specimen was analyzed 10/10/2020 at 2:27 pm. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20136958 - collected 10/06/2020 at 9:30 am; Microogranisms: SARS-CoV- 2; Order Code: 401310; Site: Nasal Mid-Turbinate; Sample Type: Swab; the Accession label: CONT:SWAB, WL: COVID PANTHER; received 10/09/2020. Panther Hologic results report revealed the specimen was analyzed 10/10/2020 at 2:32 pm. Final test report included "SPECIMEN TYPE: SW-Swab; SOURCE: VTM." Patient #20132717, Patient #20132718, Patient #20132720, Patient #2013505601, Patient #20134964, Patient #20134549, Patient #20134464, Patient #20135069, and Patient #20134602 worklist was for QuantStudio analyzer but specimens were analyzed on the Panther Hologic. The laboratory did not ensure the swab type was solicited on the test requisitions in order to meet the stability timeframes when tested. 4. From 10/03/2020 through 11/17/2020, the laboratory had analyzed 17,233 specimens. 5. During an interview on 11/17/2020 at 4:02 pm, Technical Supervisor - A was asked what type of swab is "VTM" (as printed on the final reports), she stated it might be Beaver or Runmeis. During an interview on 11/19/2020 at 9:33 am, a staff from accessioning was asked what type of swab was "Code 401310" (as printed on the requisitions), he stated Runmeis or VTM, which were maybe Aptimas. He stated the code meant the swab was meant to be analyzed on the Panther (Hologic). The laboratory was unable to determine the swab types that were analyzed on the Panther Hologic in order to assess stability timeframes as outlined by the manufacturer. Word Key: CONT = container WL = worklist QS = QuantStudio RT = room temperature 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 -- 7 of 30 -- 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: I. Based on review of the laboratory's policy, patient test reports, specimen receipt log sheets, and in interview with staff, the laboratory failed to follow their own written policy for specimen receipt and handling for 3 of 3 days specimens were received from outside clients for COVID-19 testing (10/02/2020, 10/04/2020, 10/06/2020). Findings included: 1. Review of the laboratory's policy "Specimen Receipt and Handling" (SOP #: GENFL-5; effective dates: 9/8/2020 and 11/11/2020) stated, "III. PROCEDURE F. Record the measured temperature, date, time, number of packages, courier service name, and receiving personnel on the SharePoint Molecular Tox Receipt Log along with the package(s) tracking number and client name. G. Receipt log will be monitored for non-compliance. If repeated trends of non-compliance are found with a service, the laboratory will reevaluate shipping and transport procedures." 2. Review of patient test reports with received dates of 10/02/2020, 10/04 /2020, and 10/06/2020 did not include documentation of temperatures, times, number of packages from clients, courier service names, receiving personnel, package tracking numbers and client names in SharePoint Molecular Receipt Log, as required by the laboratory's written policy mentioned above. The following is a sampling of specimens received for COVID-19 testing 10/02/2020, 10/04/2020, and 10/06/2020: Patient #20132866; received date 10/02/2020 Patient #20132819; received date 10/02 /2020 Patient #20132864; received date 10/02/2020 Patient #20132737; received date 10/02/2020 Patient #20132713; received date 10/02/2020 Patient #20132796; received date 10/02/2020 Patient #20132717; received date 10/02/2020 Patient #20132718; received date 10/02/2020 Patient #20132720; received date 10/02/2020 Patient #20132846; received date 10/02/2020 Patient #20134160; received date 10/04/2020 Patient #20134094; received date 10/04/2020 Patient #20134192; received date 10/04 /2020 Patient #20134195; received date 10/04/2020 Patient #20134290; received date 10/04/2020 Patient #20134313; received date 10/04/2020 Patient #20134324; received date 10/04/2020 Patient #20134169; received date 10/04/2020 Patient #20135056; received date 10/06/2020 Patient #20134964; received date 10/06/2020 Patient #20135342; received date 10/06/2020 Patient #20135371; received date 10/06/2020 Patient #20135348; received date 10/06/2020 Patient #20135419; received date 10/06 /2020 Patient #20135357; received date 10/06/2020 Patient #20134549; received date 10/06/2020 Patient #20134464; received date 10/06/2020 Patient #20135069; received date 10/06/2020 Patient #20135373; received date 10/06/2020 Patient #20134602; received date 10/06/2020 Patient #20135490; received date 10/06/2020 From 10/03 /2020 through 11/17/2020, the laboratory had analyzed 17,233 specimens. 3. During an interview on 11/18/2020 at 11:45 am, a staff from the accessioning team stated they began documenting client names and package tracking numbers on 10/07/2020 in an Excel sheet. He stated the SharePoint was not operational until 10/12/2020 and they transcribed information from Excel sheets to the SharePoint then. He confirmed that documentation of shipments received prior to 10/07/2020 was not available. II. Based on review of the laboratory's policy, manufacturer's instructions, test requisitions, instrument data, patient test reports, and in interview with staff, the laboratory failed to ensure specimens for COVID-19 testing had not exceeded their stability for 9 of 10 Runmei swabs and 1 of 10 Beaver swabs (sampling from 10/09 /2020 and 10/10/2020). Findings included: 1. Review of the laboratory's policy "Specimen Collection and Shipping" (SOP #: GENFL-43; no effective date), stated "2. Specimens must be received in the laboratory within the specimen's stability. -- 8 of 30 -- Specimen stability is dependent upon specimen type and collection container/kit. Specimens should be shipped daily to avoid specimen rejection. Collection Container /Kit: Copan eSwab, Storage Temperature Range: 20-25C, Specimen Stability 48 hours; Collection Container/Kit: Aptima Multitest ,Storage Temperature Range: 2- 30C, Specimen Stability 6 days; Collection Container/Kit: Remel Microtest M4RT, Specimen Storage Temperature Range: 20-25C, Specimen Stability: 48 hours; Collection Container/Kit: Run Mei Amies, Specimen Storage Temperature Range: 20- 37C, Specimen Stability: 96 hours; Collection Container/Kit: Beaver, Specimen Storage Temperature Range: 15-30C, Specimen Stability: 7 days." The laboratory director had not approved and signed the policy. 2. Review of manufacturer's instructions for collection devices accepted by the laboratory revealed the following stability timeframe's: Single-use Samplers Runmei AMIES - "The collected samples can be stored at regular storage temperature (between 20-37C) for at least 96 hours, long-term storage should be placed in low-temperature conditions below -20C, -70C or store at freezing level -196C." Beaver - "RNA Viral Preservative performance was tested by detecting different RNA virus concentration diluted in the target reagent and placed at room temperature (20 to 25C) and -20C for 1 to 7 days ...The experimental data provide the evidence that viral RNA samples stored in the Preservative were highly stable at RT for at least 7 days comparing with stored at -20C." Note: The laboratory's policy was not consistent with the manufacturer's instructions for temperature storage (policy: 15-30C; Beaver: 20-25C). 3. Review of test requisitions, instrument data (Panther Hologic and QuantStudio), and final test reports revealed the laboratory analyzed COVID-19 specimens that had exceeded their stability (Runmei swab: 96 hours; Beaver swab: 7 days) according to the manufacturer's instructions, as follows (sampling): Patient #20137013 - Source: Run Mei swab; collected 10/06/2020 at 11:33 am; received date 10/09/2020; analyzed 10/10/2020 at 2:22 pm; 98 hours and 49 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137019 - Source: Run Mei swab; collected 10/06/2020 at 10:05 am; received date 10/09/2020; analyzed 10/10/2020 at 2:22 pm; 100 hours and 17 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137031 - Source: Run Mei swab; collected 10/06/2020 at 11:15 am; received date 10/09/2020; analyzed 10/10/2020 at 2:17 pm; 99 hours and 2 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137036 - Source: Run Mei swab; collected 10/06/2020 at 11:00 am; received date 10/09/2020; analyzed 10/10/2020 at 2:12 pm; 99 hours and 12 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137074 - Source: Run Mei swab; collected 10/06/2020 at 11:37 am; received date 10/09/2020; analyzed 10/10/2020 at 2:07 pm; 98 hours and 30 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137007 - Source: Run Mei swab; collected 10/06/2020 at 9:50 am; received date 10/09/2020; analyzed 10/10/2020 at 2:22 pm; 100 hours and 17 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137077 - Source: Run Mei swab; collected 10/06/2020 at 10:00 am; received date 10/09/2020; analyzed 10/10/2020 at 2:07 pm; 100 hours and 7 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137086 - Source: Run Mei swab; collected 10/06/2020 at 9:30 am; received date 10/09/2020; analyzed 10/10/2020 at 2:12 pm; 100 hours and 42 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20137055 - Source: Run Mei swab; collected 10/06/2020 at 11:10 am; received date 10/09/2020; analyzed 10/10/2020 at 2:17 pm; 99 hours and 7 minutes of elapsed time between collection and analysis (Panther Hologic). Patient #20136110 - Source: Beaver swab; collected 10/01/2020 at 2:31 pm; received date 10 /07/2020; analyzed 10/09/2020 at 8:51 pm; 8 days, 6 hours and 20 minutes elapsed time between collection and analysis (QuantStudio). From 10/03/2020 through 11/17 /2020, the laboratory had analyzed 17,233 specimens. 4. During an interview on 11/17 -- 9 of 30 -- /2020 at 4:02 pm, Technical Supervisor-A stated the laboratory discontinued accepting Runmei swabs because there were "issues." Technical Supervisor-A was asked what the issues were and she stated she was unsure. During an interview on 11 /19/2020 at 10:16 am, Technical Supervisor-A confirmed specimens had been analyzed beyond their stability. Word Key: C = degrees Celsius III. Based on direct observation, review of laboratory's policy, manufacturer's instructions, client services manual, test requisitions, instrument data, final test reports, and in interview with staff, the laboratory failed to verify shipping/transport conditions for specimens (from outside clients) maintained temperature according to manufacturer's instructions for 1,254 of 1,254 specimens observed on 11/17/2020 and 9 of 9 specimens from a sampling received 10/09/2020. Findings included: 1. Review of the laboratory's policy "Specimen Receipt and Handling" (SOP #: GENFL-5; effective date with modification: 11/11/2020 - no laboratory director approval) stated, "III. PROCEDURE A. Samples are delivered to the accessioning department via courier (i. e., FedEx, UPS, or another courier service). C. Verify shipping containers are approved shipping containers outlined in GEN 8 Specimen Shipping & Transportation Procedure. Reject all specimens not received as required. E. Measure the temperature in the shipping container. 1. Measure the temperature using a IR thermometer by scanning the surface of the samples in each shipping container. 2. Specimen must be received within acceptable temperatures listed below ... Copan eSwab: 20 - 25C, Aptima Multitest 2 - 30C, MTM 2 - 25C, Beaver 15 - 30C." Run Mei was removed (11 /11/2020), per manufacturer the temperature range was "between 20-37C" and Beaver manufacturer's instructions temperature range was "20-25C" not 15-30C. The laboratory had not verified shipping/transport conditions maintained manufacturer's storage temperature for the collection swabs mentioned in SOP #: GENFL-5. 2. Review of manufacturer's instructions for collection devices documented by the laboratory revealed the following stability timeframe's: Single-use Samplers Runmei AMIES - "The collected samples can be stored at regular storage temperature (between 20-37C) for at least 96 hours, long-term storage should be placed in low- temperature conditions below -20C, -70C or store at freezing level -196C." Beaver - "RNA Viral Preservative performance was tested by detecting different RNA virus concentration diluted in the target reagent and placed at room temperature (20 to 25C) and -20C for 1 to 7 days ...The experimental data provide the evidence that viral RNA samples stored in the Preservative were highly stable at RT for at least 7 days comparing with stored at -20C." Note: The laboratory's policy was not consistent with the manufacturer's instructions for temperature storage (policy: 15-30C; Beaver: 20- 25C). The laboratory director had not approved and signed the policy. 3. During a tour of the accessioning area on 11/17/2020 at 10:39 am, patient Beaver swab specimens for COVID-19 testing were observed being received and accessioned by staff. The accessioning staff was observed opening UPS/FedEx bags/boxes of specimens in biohazard bags and obtaining a temperature via "Traceable fisherbrand" infrared thermometer. Temperatures were documented in a paper log (effective date 10/19 /2020) and in SharePoint (effective date 10/12/2020) with client name, total specimen count, date and manifestation availability. Total specimens received 11/17/2020 was 617 (from TX, TN, and NV). On 11/18/2020 at 3:00 pm, patient Beaver swab specimens for COVID-19 testing were observed being received and accessioned by staff. The accessioning staff was observed opening UPS/FedEx bags/boxes of specimens in biohazard bags and obtaining a temperature via "Treaceable fisherbrand" infrared thermometer. Total specimens received 11/18/2020 was 637 specimens (from TX and NV). The laboratory had not verified shipping/transport conditions maintained manufacturer's storage temperature of 20-25C for Beaver collection swabs. According to documentation, the laboratory received Runmei swabs 10/09 /2020 and shipping/transport conditions had not been verified to ensure storage -- 10 of 30 -- temperature of 20-37C was maintained. 4. Upon further review of the laboratory's client services manual (instructions to clients for specimen handling) revealed inconsistencies with the above-observed practice, as follows: "Specimen Transportation: COVID-19 specimens are transported to the laboratory by a local courier or commercial logistics company. That shipping container (Rubbermaid cooler or medium Styrofoam container) must include a temperature tracking device capable of recording the maximum and minimum temperature of the container throughout transportation to the laboratory ...Rejection Scenarios: A patient specimen will be rejected, and specimen collection will be required for the following: Specimen was not transported to the lab according to specimen transportation requirements." 5. Review of requisitions, instrument data, and final test reports for COVID-19 testing revealed the following sampling of patients received by the laboratory when shipping /transport conditions had not been verified to ensure storage temperature: Beaver swabs received 11/17/2020 at 10:45 am (observation by surveyor) and analyzed on the QuantStudio 11/18/2020 at 1:42 am - Patient #11035282 - collected 11/16/2020 at 3: 07 pm Patient #11035196 - collected 11/16/2020 at 2:18 pm Patient #11035168 - collected 11/16/2020 at 2:02 pm Patient #11035311 - collected 11/16/2020 at 3:31 pm Patient #11035332 - collected 11/16/2020 at 3:52 pm Patient #11035316 - collected 11 /16/2020 at 3:38 pm Patient #11035199 - collected 11/16/2020 at 2:20 pm Patient #11035208 - collected 11/16/2020 at 2:28 pm Patient #11035344 - collected 11/16 /2020 at 4:03 pm Patient #11035297 - collected 11/16/2020 at 3:20 pm Patient #11035340 - collected 11/16/2020 at 3:59 pm Patient #11035212 - collected 11/16 /2020 at 2:30 pm Patient #11035187 - collected 11/16/2020 at 2:18 pm Patient #11035329 - collected 11/16/2020 at 3:49 pm Patient #11035323 - collected 11/16 /2020 at 3:44 pm Patient #11035242 - collected 11/16/2020 at 2:46 pm Patient #11035321 - collected 11/16/2020 at 2:42 pm Patient #11035263 - collected 11/16 /2020 at 3:04 pm Patient #11035147 - collected 11/16/2020 at 1:52 pm Patient #11035151 - collected 11/16/2020 at 1:57 pm Runmei specimens received 10/09/2020 and analyzed on the Panther Hologic - Patient #20137013 -collected 10/06/2020 at 11: 33 am; analyzed 10/10/2020 at 2:22 pm Patient #20137019 -collected 10/06/2020 at 10:05 am; analyzed 10/10/2020 at 2:22 pm Patient #20137031 - collected 10/06/2020 at 11:15 am; analyzed 10/10/2020 at 2:17 pm Patient #20137036 - collected 10/06 /2020 at 11:00 am; analyzed 10/10/2020 at 2:12 pm Patient #20137074 - collected 10 /06/2020 at 11:37 am; analyzed 10/10/2020 at 2:07 pm Patient #20137007 - collected 10/06/2020 at 9:50 am; analyzed 10/10/2020 at 2:22 pm Patient #20137077 - collected 10/06/2020 at 10:00 am; analyzed 10/10/2020 at 2:07 pm Patient #20137086 - collected 10/06/2020 at 9:30 am; analyzed 10/10/2020 at 2:12 pm Patient #20137055 - collected 10/06/2020 at 11:10 am; analyzed 10/10/2020 at 2:17 pm From 10/03/2020 through 11/17/2020, the laboratory had received and analyzed 17,233 specimens. 6. Review of the laboratory verification studies revealed Beaver and Runmei swabs had not been verified in the systems used for COVID-19 testing. Refer to D5423. 7. During an interview on 11/17/2020 at 11:08 am, Technical Supervisor - A stated when they began testing (10/03/2020) they were receiving Aptima swabs or eSwab's but that stopped. They had not received Runmei swabs recently because there were issues and they had mostly received Beaver swabs. During an interview on 11/17/2020 at 11: 25 am, Technical Supervisor - A stated the shipping and stability studies of the collection devices (Beaver, Aptima, MTM, eSwab, and Run Mei) were ongoing and that she was almost done. She stated the studies had not been performed prior to COVID-19 testing. She stated she attempted conducting the shipping studies but there were issues with the temperature trackers and had restarted those studies. The laboratory had not verified their preanalytical system for shipping and handling all swab types prior to initiating COVID-19 testing to ensure accurate and reliable test results. IV. Based on review of manufacturer's instructions, laboratory's policy, client -- 11 of 30 -- services manual, and in interview with staff, the laboratory's preanalytical policies and procedures were inconsistent with manufacturer's instructions for Beaver swabs. Findings included: 1. Review of manufacturer's instructions for collection devices documented by the laboratory revealed the following stability timeframe's: Beaver - "RNA Viral Preservative performance was tested by detecting different RNA virus concentration diluted in the target reagent and placed at room temperature (20 to 25C) and -20C for 1 to 7 days ...The experimental data provide the evidence that viral RNA samples stored in the Preservative were highly stable at RT for at least 7 days comparing with stored at -20C." 2. Review of the laboratory's policy "Specimen Receipt and Handling" (SOP #: GENFL-5; effective date with modification: 11/11 /2020 - no laboratory director approval) stated, "III. PROCEDURE A. Samples are delivered to the accessioning department via courier (i.e., FedEx, UPS, or another courier service). C. Verify shipping containers are approved shipping containers outlined in GEN 8 Specimen Shipping & Transportation Procedure. Reject all specimens not received as required. E. Measure the temperature in the shipping container. 1. Measure the temperature using and IR thermometer by scanning the surface of the samples in each shipping container. 2. Specimen must be received within acceptable temperatures listed below ... Copan eSwab: 20 - 25C, Aptima Multitest 2 - 30C, MTM 2 - 25C, Beaver 15 - 30C." Beaver swabs temperature of "15- 30C" was not consistent with manufacturer's instructions of 20-25C. Review of the laboratory's policy "Specimen Collection and Shipping" (SOP #: GENFL-43; no effective date), "2. Specimens must be received in the laboratory within the specimen's stability. Specimen stability is dependent upon specimen type and collection container/kit. Specimens should be shipped daily to avoid specimen rejection. Collection Container/Kit: Copan eSwab, Storage Temperature Range: 20- 25C, Specimen Stability 48 hours; Collection Container/Kit: Aptima Multitest , Storage Temperature Range: 2-30C, Specimen Stability 6 days; Collection Container /Kit: Remel Microtest M4RT, Specimen Storage Temperature Range: 20-25C, Specimen Stability: 48 hours; Collection Container/Kit: Run Mei Amies, Specimen Storage Temperature Range: 20-37C, Specimen Stability: 96 hours; Collection Container/Kit: Beaver, Specimen Storage Temperature Range: 15-30C, Specimen Stability: 7 days." Beaver swabs temperature of "15-30C" was not consistent with manufacturer's instructions of 20-25C. 3. Review of client services manual (instructions for clients) stated, "Specimen Stability: Collection Container/Kit: Beaver Swab; Room Temperature Storage: 15-30C ..." and in section "Beaver Swab Collection Instructions: Store Specimen after collection at room temperature (15C to 30C) ...Specimen Transportation: The temperature of the container must maintain 15C to 30 C to be acceptable." The temperature of Beaver swabs in the client services manual was not consistent with the manufacturer's instructions of 20-25C. 4. Further review of client services manual (instructions for clients) stated, "Specimen Transportation: COVID-19 specimens are transported to the laboratory by a local courier or commercial logistics company. That shipping container (Rubbermaid cooler or medium Styrofoam container) must include a temperature tracking device capable of recording the maximum and minimum temperature of the container throughout transportation to the laboratory ...Rejection Scenarios: A patient specimen will be rejected, and specimen collection will be required for the following: Specimen was not transported to the lab according to specimen transportation requirements." The instructions to clients was not consistent with the laboratory's observed practice on 11 /17/2020 and 11/18/2020 (Refer to 5311, II). The laboratory's practice included clients submitting patient specimens in UPS/FedEx bags/boxes and the laboratory staff obtains a temperature via "Traceable fisherbrand" infrared thermometer. The specimens were not observed submitted in "Rubbermaid cooler or medium Styrofoam container" with "a temperature tracking device." 5. During the exit interview on 11/19 -- 12 of 30 -- /2020 at 3:36 pm, the inconsistencies of the laboratory's preanalytical policies and procedures was communicated to the Laboratory Director (via phone), Technical Supervisor-A, and Vice President. D5313 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(b) The laboratory must document the date and time it receives a specimen. This STANDARD is not met as evidenced by: Based on review of final patient test reports and in interview with staff, the laboratory failed to document the time patient COVID-19 specimens were received from outside clients for 31 of 31 specimens from 10/2020. Findings included: 1. Review of a sampling of final patient test reports for COVID-19 testing from 10/2020 revealed no documentation of receipt time, as follows: Patient #20132866; received date 10/02 /2020 Patient #20132819; received date 10/02/2020 Patient #20132864; received date 10/02/2020 Patient #20132737; received date 10/02/2020 Patient #20132713; received date 10/02/2020 Patient #20132796; received date 10/02/2020 Patient #20132717; received date 10/02/2020 Patient #20132718; received date 10/02/2020 Patient #20132720; received date 10/02/2020 Patient #20132846; received date 10/02/2020 Patient #20134160; received date 10/04/2020 Patient #20134094; received date 10/04 /2020 Patient #20134192; received date 10/04/2020 Patient #20134195; received date 10/04/2020 Patient #20134290; received date 10/04/2020 Patient #20134313; received date 10/04/2020 Patient #20134324; received date 10/04/2020 Patient #20134169; received date 10/04/2020 Patient #20135056; received date 10/06/2020 Patient #20134964; received date 10/06/2020 Patient #20135342; received date 10/06/2020 Patient #20135371; received date 10/06/2020 Patient #20135348; received date 10/06 /2020 Patient #20135419; received date 10/06/2020 Patient #20135357; received date 10/06/2020 Patient #20134549; received date 10/06/2020 Patient #20134464; received date 10/06/2020 Patient #20135069; received date 10/06/2020 Patient #20135373; received date 10/06/2020 Patient #20134602; received date 10/06/2020 Patient #20135490; received date 10/06/2020 From 10/03/2020 through 11/17/2020, the laboratory had analyzed 17,233 specimens. 2. During an interview on 11/18/2020 at 11:45 am, a staff from the accessioning team stated they began documenting client names and package tracking numbers on 10/07/2020 in an Excel sheet. He stated the SharePoint was not operational until 10/12/2020 and they transcribed information from Excel sheets to the SharePoint then. He confirmed that documentation (including receipt time) of shipments received prior to 10/07/2020 was not documented. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on review of manufacturer's instructions, laboratory's policy, test requisitions, patient test reports, instrument data, specimen receipt log sheets, and in interview with staff, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicate, correct problems -- 13 of 30 -- identified in the preanalytical systems, as follows: 1. The laboratory failed to ensure the test requisitions included the type of swabs (container) used for collection in order to ensure accur