Oxford Clinical Laboratory

Summary Statement of Deficiencies D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the Laboratory Director (LD) failed to have the Attestation Statements (AS) signed by the analyst and LD for all PT tests performed with the College of American Pathologists (CAP) for events in the calendar year 2019. The findings include: 1. The laboratory did not document handling, processing and each step in the testing and reporting of PT samples for: a. Urine Chemistry - event A b. Urine Drug Testing (Screen) - event C c. Hematology Auto Differential FH13 - event B d. Erythrocyte Sedimentation Rate (ESR) - event A & B e. Diagnostic Immunology - event B f. Viral Markers - event B 2. The GS confirmed on 1/15/20 at 1:15 pm that the laboratory did not maintain all records for PT. D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons 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 -- other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on surveyor review of the Proficiency Testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to undertake appropriate training and employ technical assistance necessary to correct problems associated with PT failures performed with the College of American Pathologists (CAP). The findings include: 1. There was no remedial action taken or documented for unacceptable International Normalized Ratio (INR) in the CGL-A 2019 Coagulation Limited event for samples CGL-01, CGL-03 and CGL-04. 2. The General Supervisor confirmed on 2 /4/20 at 10:55 am that

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on surveyor review of the Laboratory Procedures and interview with the Laboratory President (LP), the laboratory failed to be in compliance with the State of New Jersey (NJ) requirements to report communicable diseases as required by the NJ Administrative Code Title 8, Chapters 57 and 58 from October 2017 to the date of the survey. The finding includes: 1. On 1/27/18, accession # 1801270011 Rapid Plasma Reagin (RPR) test result was positive but it was not reported to the State of New Jersey. 2. The LP stated on 6/6/18 at 1:00 pm that the laboratory was not in compliance with the State of New Jersey. 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 review of Quality Control (QC) records, and interview with the Testing Personnel (TP), the laboratory failed to retain all QC records for Urinalysis performed on the Clinitek Atlas analyzer from 10/4/17 to 5/12/18. The finding Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- includes; 1) The laboratory did not retain repeat QC printouts. 2) The TP # 2 listed on CMS form 209 confirmed on 6/6/18 at 1:10 pm that all QC printouts were not retained. D5018 URINALYSIS CFR(s): 493.1211 If the laboratory provides services in the subspecialty of Urinalysis, the laboratory must meet the requirements specified in 493.1230 through 493.1256, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on review of the Urinalysis Procedure Manual (UPM) and Work Records, lack of the Quality Control (QC) records and interview with the Technical Supervisor (TS), the laboratory failed to meet the requirements of pre analytic, analytic and post analytic Urinalysis test procedures. The findings include: 1. The laboratory did not retain repeat QC printouts. Refer to D 3031 2. The laboratory did not follow UPM procedures. Refer to D 5401 3. The laboratory did not follow manufacturer's procedure. Refer to D 5411 4. The laboratory did not perform maintenance on the certrifuge. Refer to D 5432 5. The laboratory did not run QC. Refer to D 5449 6. The laboratory did not report results accurately. Refer to D 5801 & D 5805 D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: a) Based on surveyor review of the Procedure Manual and interview with the Laboratory President (LP), the laboratory failed to establish a policy to report communicable diseases test results to The State of New Jersey from October 2107 to the date of survey. The LP confirmed on 6/6/18 at 1:00 pm that the laboratory did not establish a policy. b) Based on surveyor review of the Procedure Manual (PM), observation of centrifuge and interview with the Technical Supervisor (TS), the laboratory failed to follow Microscopic Examination (ME) procedure from October 2017 to the date of survey. The finding includes: 1. The ME procedure stated to "Spin urine specimen approximately 2000 RPM" but the laboratory's centrifuge spun at 3406 RPM and was not adjustable. 2. The TS confirmed on 6/6/18 at 1:30 pm that the laboratory did not follow the PM instructions. c) Based on surveyor review of the PM, review of Hematology test results and interview with the TS, the laboratory failed to follow the flag and repeat procedure for Hematology tests performed on the Coulter LH 750 Analyzer from May 2018 to the date of the survey. The findings include: 1. A review of 5 patient results with flags revealed a manual differential was not performed when results were abnormal. 2. A review of the 2 patient results requiring repeats revealed the samples were not repeated. 3. The TS confirmed on 6/6/18 at 11:45 am the PM was not followed. d) Based on surveyor review of the PM, review of Hematology test results and interview with the TS, the laboratory failed to have a procedure for Cold Agglutinin tests from October 2017 to the date of the survey. The -- 2 of 8 -- TS confirmed on 6/6/18 at 11:00 am the laboratory did not have a Cold Agglutinin procedure. e) Based on surveyor review of the PM, Quality Control (QC) records and interview with the TS, the laboratory failed to follow the QC verification procedure for QC used on the Coulter LH 750 and Premier Trinity Biotech 9210 from October 2017 to the date of the survey. The finding includes: 1. The PM stated new QC must be run over 3 days before using but the laboratory did not run Hematology or Hemoglobin A1C QC before putting it into use. 2. The TS confirmed on 6/6/18 at 11: 55 am that the laboratory did not follow the PM. f) Based on surveyor review of the PM, calibration records and interview with the TS, the laboratory failed to follow their calibration procedure for Hematology tests performed on the Coulter LH 750 from October 2017 to the date of the survey. The finding includes: 1. The PM stated calibration was to be performed every six months but there was no documented evidence that calibration was performed after 11/19/16. 2. The TS confirmed on 6/6 /18 at 11:30 am that the laboratory did not follow the PM. 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: Based on surveyor review of the Clinitek Atlas Reagent Package Insert (RPI) and interview with the Laboratory President (LP), the laboratory failed to follow RPI instructions for specimen integrity from October 2017 to the date of survey. The finding includes: 1. The RPI stated "If testing cannot be performed within an hour after voiding, refrigerate the specimen immediately" but the laboratory did not ensure that urinalysis specimens were refrigerated immediately. 2. The LP confirmed on 6/6 /18 at 1:30 pm that RPI was not followed. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor observation of the Quality Control (QC) material and interview with the Testing Personnel (TP), the laboratory failed to put open and new expiration dates on Hematology, Routine Chemistry, Special Chemistry and Endocrinology QC material at the time of survey. The findings include. 1) The expiration date of control material shortens once opened. 2) The laboratory did not put new expiration dates on Bio-Rad Liquichek Immunoassay Plus Control Lot# 40360, Bio-Rad Lymphochek Assayed Chemistry Control Lot# 26440, and Bio-Rad Liquicheck Specialty Immunoassay Control Lot# 60200 in use. 3) The laboratory did not put open and new expiration date on Coulter QC in use. 4) The TP #2 listed on CMS form 209 -- 3 of 8 -- confirmed on 6/6/18 at 11:00 am the laboratory failed to put open and new expiration dates on the control material b) Based on surveyor observation of the Manual Differential (MD) reagents and interview with the Technical Supervisor (TS), the laboratory failed to label the reagents used to perform staining with pertinent information required for proper use on the date of the survey. The finding includes: 1. The laboratory had three plastic pour off containers that were not labeled as to their identification,storage requirements, preparation and expiration date. 2. The TS confirmed on 6/6/18 at 1:05 pm reagents did not have all the pertinent information on the label. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of the Performance Specification (PS) records and interview with the Technical Supervisor (TS), the laboratory failed to verify Reference Interval (RI) for Endocrinology, Special Chemistry and Routine Chemistry testing performed on the VITROS 5600 analyzer from October 2017 to the date of survey. The finding includes; 1) The laboratory failed to verify RI for Creatine Kinase, C-Reactive Protein, Chloride, Ferritin, Parathyroid Hormone, Microalbumin, Progesterone, Prolactin, Testosterone, Vitamin D. 2) The TS confirmed on 6/6/18 at 2: 00 pm that the laboratory did not perform RI PS. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on surveyor review of the Maintenance Records (MR), observation of Centrifuge and interview with the Technical Supervisor (TS), the laboratory failed to perform and document maintenance on the Hamilton Bell/Van Guard V6500 centrifuge used for spinning blood and urine samples from October 2017 to the date of the survey. The findings include: 1. The observation of maintenance sticker on centrifuge had due date of April 2018 but there were no records to substantiate that it was performed. 2. The TS confirmed on 6/6/18 at 1:45 pm that the laboratory did not perform maintenance on the centrifuge. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) -- 4 of 8 -- Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on lack of the Quality Control records and interview with the Technical Supervisor (TS), the laboratory failed to perform and document quality control for Urine Microscopic test from October 2017 to the date of the survey. The finding includes: 1. The laboratory did not perform and document QC on each day of patient testing. 2. The laboratory ran and reported around 25 patient results a month. 3. The TS confirmed on 6/6/18 at 1:15 pm that the laboratory did not perform and document quality control on each day of patient testing. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of the Quality Control (QC) records and interview with the Technical Supervisor (TS) the laboratory failed to verify that the assayed QC materials were within the acceptable ranges before they were put into use for analytes performed on the VITROS 5600 analyzer from May 2018 to the date of survey. The TS confirmed on 6/6/18 at 2:30 pm that the laboratory did not verify QC materials for analytes performed on VITROS 5600 analyzer. D5781