Revived Soul Medical Pc

Summary Statement of Deficiencies D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on surveyor's review of the laboratory's current standard operating procedure (SOP) and an interview with the current technical supervisor, the laboratory failed to retain a copy for each test procedure on the Agilent 6460 LC/MS/MS analyzer, Carolina CLC 800 chemistry analyzer and the discontinued laboratory SOP manual to include all phases of laboratory testing, for at least 2 years. FINDINGS: The current technical supervisor confirmed on March 5, 2021, at approximately 11:00 AM, the surveyor's finding that the laboratory failed to retain a copy for each test procedure on the Agilent 6460 LC/MS/MS analyzer, Carolina CLC 800 chemistry analyzer and the discontinued laboratory SOP manual for the time period from 7/1/2018 though 8/20 /19. a. the laboratory relocated to this current location 1329 East 17th Brooklyn, NY 11229 from 1901 Avenue P Suite 1A Brooklyn NY 11229 on August 20, 2019. However, the laboratory did not move all the laboratory records, documents and procedure manuals to this location on August 20, 2019. b. the current technical supervisor searched the basement for these records, documents and procedures but could not locate them, therefore, they were not available for review at this survey. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. 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 -- This STANDARD is not met as evidenced by: Based on the lack of 2018 and 2019 Quality (QC) records, calibration records, assay sheets for the stock reagents and control/calibrators for the LC/MS/MS Agilent 6460 Mass spectrum analyzer used for confirmatory testing and the discontinued Carolina CLC 800 chemistry analyzer used for urine drug screening and an interview with the current technical supervisor, the laboratory failed to retain QC records, calibration records, assay sheets for the stock reagents and control/calibrators for at least 2 years. FINDINGS: 1. The current technical supervisor confirmed on March 5, 2021, at approximately 11:30 AM, the surveyor's finding that the laboratory failed to retain QC records, calibration records, assay sheets for the stock reagents and control/calibrators for at least 2 years for the LC/MS/MS Agilent 6460 Mass spectrum analyzer from 7/1 /2018 through 11/30/2019. 2. The following Records and Documents were not available for review at this survey: Agilent 6460 LC/MS/MS- confirmatory testing a. Inventory of stock reagents, reagent log sheets used to record the reagents, QC & calibration material b. Log sheet for reagents, to include strength,concentration, date of preparation,expiration dates and storage requirements c. Maintenance for the Agilent 6460 (e.g. tuning, column changes) and auxiliary equipment and instruments d. Preventative maintenance and service records e. Acceptable criteria for limit of detection,limit of quantitation, upper limit detection for all analytes f. Low and high control acceptable ranges g. List of positive cutoffs for all analytes h.

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on surveyor's observation, review of the RSM Agilent 6460 reagent log sheets and confirmed in an interview with the technical supervisor and consultant, the laboratory failed to ensure that the information on the RSM Agilent 6460 reagent log sheets used to record the reagent, control & calibration materials were properly recorded. FINDINGS: The technical supervisor and consultant confirmed on June 4, 2018 at approximately 4:00 PM, that the current RSM LC/MS/MS worksheet in use did not include the following information: strength and concentration, storage requirements, preparation and expiration dates. 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 the surveyor's review of the laboratory's Quality Assessment (QA) polices Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- /procedures and confirmed in an interview with the technical supervisor and technical consultant, the laboratory failed to follow it's QA policy and perform the monthly QA review for the urine drug testing for the calendar year 2017 through survey date. 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 surveyor's review of test requisitions and confirmed in an interview with the technical supervisor and consultant, the laboratory failed to include the following information: The test(s) to be performed (screening or confirmatory); the source of the specimen and the date and time of specimen collection. D5309 TEST REQUEST CFR(s): 493.1241(e) If the laboratory transcribes or enters test requisition or authorization information into a record system or a laboratory information system, the laboratory must ensure the information is transcribed or entered accurately. This STANDARD is not met as evidenced by: Based on surveyor's review of test requisitions, test reports and confirmed in an interview with the laboratory technical supervisor and consultant, the laboratory failed to have a system in place to ensure that the individual(s) entering the patient data into the laboratory's information system (LIS) and/or Electronic Medical Record (EMR) is transcribing it correctly. 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. -- 2 of 6 -- This STANDARD is not met as evidenced by: Based on a surveyor's review of the laboratory's procedure manual and confirmed in an interview with technical supervisor and consultant, the laboratory failed to establish written procedures to include: patient preparation, specimen collection, specimen labeling, including patient name or unique patient identifier, specimen storage and preservation and specimen acceptability and rejection. FINDINGS: The technical supervisor and consultant confirmed on June 4, 2018 at approximately 2:30 PM, that the laboratory failed to have written preanalytic procedures for patient preparation, specimen collection, specimen labeling, including patient name or unique patient identifier, specimen storage and preservation and specimen acceptability and rejection. 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 surveyor's review test requisition and confirmed in an interview with the technical supervisor and consultant, the laboratory failed to document the date and time of receipt of the urine specimens, used for drug testing, from all four locations. FINDINGS: The technical supervisor and consultant confirmed on June 4, 2018 at approximately 3:30 PM, the laboratory failed to document the date and time of receipt for the urine specimens, used for drug testing, from all four locations. 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)