Northshore Clinical Laboratories,

Summary Statement of Deficiencies D0000 A complaint survey was completed on December 29, 2021. It was determined that Immediate Jeopardy (IJ) existed for the following condition level deficiencies: 42 C.F. R. 493.1230 Condition: General laboratory systems 42 C.F.R. 493.1250 Condition: Analytic systems 42 C.F.R. 493.1441 Condition: Laboratories performing high complexity testing; laboratory director D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on direct observations and an interview with the Testing Personnel (TP), the laboratory failed to follow the manufacturer's instructions for the Quidel QuickVue SARS antigen kits utilized for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal (AN) swab specimens. This deficient practice had the potential to affect all patient SARS-CoV-2 tested at this location. Findings Include:- Item 1- Northshore Clinical Laboratory offsite laboratory location located at 5519 Bigger Road, Dayton, Ohio. 1. On 10/26/2021 at 9:45 AM a review of the manufacturer's instructions for the Quidel QuickVue SARS Antigen rapid test kit found the following statements: "Conditions of Authorization for the Laboratory and Patient Care Setting...must be appropriately trained in performing and interpreting the results..." "Store the kit at room temperature, 59F to 86F (15C to 30C), out of direct sunlight." "Prior to collecting the anterior nares swab, the patient should be instructed to blow their nose." "Anterior nares test procedure...Keep swab in the tube for one (1) minute...at ten (10) minutes, remove the Test Strip, and read result within five (5) minutes..." "Dispose of containers and unused contents in accordance with Federal, State and Local regulatory requirements" 2. Documentation of training was requested Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 11 -- from the TP on 10/26/2021 at 9:45 AM. The TP stated only two to three hours of peer testing observation was conducted prior to independent testing of patients. No documentation of training was performed and the TP was unable to provide the requested information. 3. Storage of Quidel QuickVue SARS Antigen rapid test kits was discovered on 10/26/2021 at 9:46 AM in a large back area conference room in the original shipping boxes. On 10/26/2021 at 9:47 AM TP confirmed no temperature monitoring of the storage area was performed. 4. Observation of specimen processing on 10/26/2021 from 10:15 to 10:35 AM revealed no instructions given to the patient to blow their nose prior to AN swabbing. 5. Observation also revealed after specimen collection the swab was placed into the reagent tube for incubation and swirled for an indeterminate amount of time. The swab was then removed, disposed of in a general waste bin, and a test strip was placed into the reagent tube. The TP periodically checked the test strip for any reaction. After an indeterminate amount of time the test strip was removed and resulted. No timer was used for specimen processing. 6. On 10 /26/2021 at 10:40 AM the TP verified a timer was not used for the testing procedure and the facility did not have any any segregated hazardous waste containers. 7. The surveyor requested a listing of all of the offsite laboratory locations for Northshore Clinical Laboratory The list was provided on December 8, 2021 at 1:10 PM. Including on the list is the following: a) MLC Dayton- A1 b) 5519 Bigger Road, Dayton, Ohio Item 2 - Northshore Clinical Laboratories offsite testing location in the Butera Market store at 815 Center St., Grayslake, Illinois 60030. 1. The surveyor showed Staff OX a photo of COVID-19 testing and PCR collection table directly in the path of the exit door of the grocery store facility. The table area did not have any barrier or screen to provide confidentiality for those who wish to be tested and provide protection for those departing from the grocery store, and a thermometer to monitor room temperatures to ensure optimal test performing conditions. 2. Staff OX confirmed the Butera Market facility is one of their offsite testing locations on December 08, 2021 at 10:08 AM. Item 3. Northshore Clinical Laboratories located at 4751 N. Kedzie Ave., Chicago, Illinois 60625. 1. On December 8, 2021 at 10:05 AM, the surveyor requested the training documents used for employees performing COVID-19 testing and PCR collection at the collection site locations. Staff OX provided the following documents. Northshore Clinical Shift Check List Opening Duties On-site Protocol CDC Anterior Nasal Swab Specimen Collection Instructions GenBoy COVID-19 Ag CareStart COVID-19 Antigen test Quidel QuickVue SARS Antigen test BinaxNOW COVID-19 Ag Card test Closing Duties 2. Review of the four Emergency Use Authorization (EUA) test instructions revealed that each test system required the documented training of all testing personnel and the distribution of an informational "FACT SHEET" to each patient receiving testing. 3. On December 8, 2021 at 10:30 AM, Staff OX and HP confirmed the laboratory did not provide training to those testing at the collection sites and did not provide each site with the information FACT SHEETS associated with the EUA COVID-19 test the collection site was using. 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 laboratory test records, direct observation and interview, the laboratory failed to retain records of test requisitions and test authorizations for at -- 2 of 11 -- least 2 years for one of one patient test report reviewed. Findings include: 1) Review of patient test report NSCL-MLCD1XXXX collected on September 23, 2021 at 4:24 PM shows the following patient test result: a) Test Name- SARS-C0V-2 b) Result- NEGATIVE c) Units- Index d) Flag- (No information noted on report) e) Reference Range/Cutoff- Normal=Negative 2) 1) Review of patient test report NSCL- MLCD1XXXX collected on September 23, 2021 at 4:24 PM shows the following patient identification and demographic information: a) Patient: AXXXXXXX, XXXXX b) Birth: X/XX/20XX c) Age: 1X XXXXXX f) Gender: XXXXX 3) The surveyor requested the test requisition and test authorization for patient test report NSCL-MLCD1XXXX on December 8, 2021 at 10:55 AM. Staff OX stated, "we shred original order," The conversation occured on December 8, 2021 at 10:55 AM. 4) On a laboratory tour on December 8, 2021 at 1:26 PM, the surveyor directly observed, in the lower level of the laboratory accessed through an open unsecured passageway from the laboratory testing area located on the first floor, 14 uncovered containers in various sizes containing numerous patient test requistions which contained patient demographic information. 5) The laboratory was not able to provide the surveyor with the orginal or copy of test requistion for patient sample NSCL-MLCDXXXX. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, 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 general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observation and interview, the laboratory failed to meet the general laboratory system requirments in 42 CFR 493.1231 through 42 CFR 493.1236. Findings include: 1) Failure to ensure confidentiality of patient information: See D5201 2) Failure to ensure positive patient identification. See D5203 3) Failure to have a policy in place to document complaints or problems communicated to the laboratory. See D5205 D5201 CONFIDENTIALITY OF PATIENT INFORMATION CFR(s): 493.1231 The laboratory must ensure confidentiality of patient information throughout all phases of the total testing process that are under the laboratory's control. This STANDARD is not met as evidenced by: Based on direct observation and interview, the laboratory failed to ensure confidentiality of patient information for 14 of 14 patient test requisitions of patient samples submitted for testing that were reviewed. Findings include: 1) On a laboratory tour on December 8, 2021 at 1:31 PM, the surveyor directly observed, in the lower level of the laboratory, which was accessed through an open unsecured passageway from the laboratory testing area located on the first floor, 14 uncovered containers in various sizes containing numerous patient test requisitions which contained patient demographic information. The surveyor retrieved the following 14 -- 3 of 11 -- test test requisitions from a sampling of the 14 uncovered containers: a) Collection Date: 11/7/2021 Patient Name: NXXXXXX, SXXXXXXXX Identification number: No information b) Collection Date: 11/7/2021 Patent Name: ZXXXXX, EXXXXXXXX Identification number: No information c) Collection Date: 11/7/2021 Patient Name: GXXXX, GXXXXX Identification number: No information d) Collection Date: No date Patient Name: DXXXXX, GXXXXXXXX Identification number: No information e) Collection Date: No date Patient Name: AXXX, KXXXXXXXXXX Identification number: No Information f) Collection Date: No date Patient Name: PXXXX, DXXXX Identification number: No Information g) Collection Date: No date Patient Name: RXXXXXXXX, BXXXX Identification number: No Information h) Collection Date: No date Patient Name: PXX, CXXXXXXXX Identification number: ncsltsfb10XXX i) Collection Date: 12/5/21 Patient Name: FXXXXX, BXXXX Identification number: ncslcvs12XXX j) Collection Date: 12/3/21 Patient Name: WXXXXXX, FXXX Identification number: ncslcvs12XXX k) Collection Date: 12/5/21 Patient Name: FXXXXX, BXXXX Identification number: ncslcvs12XXX l) Collection Date: 12/5/21 Patient Name: GXXXXXX, AXXX Identification number: ncslcvs12XXX m) Collection Date: 12/5 /21 Patient Name: GXXXXXXX,GXXXXXXX Identification number: AIO67XXX i) Collection Date: 12/5/21 Patient Name: DXXXXX, LXXX Identification number: AIO67XXX 2) The laboratory failed to ensure confidentiality of patient demographic information by storing patient test requistions in an unsecured area in uncovered storage containers in various sizes. 3) Staff HP confirmed the above findings in a conversation on December 8, 2021 at 1:31 PM. 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 and interview, the laboratory failed to establish and follow written procedures that ensure positive identification of patients specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results for 1 of 1 patient sample and 1 of 1 Federal Express shipping box reviewed. Findings include: Item 1 1). Direct observation on December 9, 2021 at 11: 10 AM, the surveyor observed a hallway with shelves and carts of patients' specimens from courier drop-offs and Fedex shipment packages. Staff HP opened a randomly selected Fedex package labeled from the following location: BXXXXXXX XXXX Grand Dominion Testing 2305 W Springfield Champaign, IL 61821 The surveyor observed in the box, 14 bagged specimen tubes that were not labeled with any patient name or any other type of identifying information. 2). Staff HP confirmed the above findings on December 9, 2021 at 11:15 AM. Item 2 1). Direct observation on December 9, 2021 at 11:58 AM, the surveyor observed staff X1 register, add collection dates, generate computer labels, and order SARS-CoV-2 PCR tests for six specimen tubes that were submitted without their Northshore Clinical Laboratories requisition cards. The surveyor observed each specimen had a patient's name and no collection date. Staff X1 explained that these specimens did not require requisition cards because they were from a school location with a standing order. The survey asked Staff X1 how often were the specimen pick-ups at this site. Staff X1 stated once -- 4 of 11 -- per week. Staff X1 could not verify the actual collection date of the specimens and further stated the collection date issued was the date before the specimen was received in the laboratory. 2) Staff OX confirmed the above findings on December 9, 2021 at 12:00 PM. Item 3 1) The surveyor directly observed staff BJ register, generate computer label 1957XXX and order a SARS-CoV-2 PCR test for a specimen tube that was not labeled with any patient name or any other type of identifying information. The direct observation occurred on December 9, 2021 at 12:00 PM. 2) Staff HP confirmed the above findings on December 9, 2021 at 12:00 PM. D5205 COMPLAINT INVESTIGATIONS CFR(s): 493.1233 The laboratory must have a system in place to ensure that it documents all complaints and problems reported to the laboratory. The laboratory must conduct investigations of complaints, when appropriate. This STANDARD is not met as evidenced by: Based on review of laboratory documents and interview, the laboratory failed to have a system in place to ensure that it documents all complaints and problems reported to the laboratory for 1 of 1 patient test report reviewed. 1) Review of patient test report 1254XXX shows the telephone number of the laboratory listed as 773-570-6510. 2) The surveyor requested the complaint policy or procedure in use for complaints or problems communicated to the laboratory at the listed laboratory telphone number of 773-570-6510. Staff HP replied, "Do not have policy on that level." The conversation occured on December 9, 2021 at 9:40 AM. Item 2. 1. Surveyor requested on December 8 2021 at 9:55 AM, to Staff X1 for the McHenry health department reporting confirmation of 20 patient results. McHenry health department reported that the laboratory was sending duplicate final patient results which interferred with their contact tracing process. Staff OX stated the laboratory contracted with Lifepoint Informatics to report all COVID-19 results to local health departments. XXXXX0009 XXXXX0063 XXXXX0071 XXXXX0065 XXXXX0080 XXXXX0046 XXXXX0053 XXXXX0066 XXXXX0063 XXXXX0081 XXXXX0010 XXXXX0064 XXXXX0070 XXXXX0066 XXXXX0079 XXXXX0047 XXXXX0054 XXXXX0065 XXXXX0464 XXXXX0082 2. On December 8 2021 at 10:45 AM, Staff X1 stated Lifepoint did have reporting issues with McHenry health department on September 30, 2021. Lifepoint did not document the reporting complaint and the patient results involved and did not notify the laboratory. Staff X1 stated that they did not have a policy or procedure for Lifepoint to document issues that occur with patient reporting results to the health departments. 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 record review, lack of documentation, and interview, the laboratory failed to ensure test requisition or authorized information is transcribed or entered accurately into the laboratory information system (LIS) for four out of four patient results. -- 5 of 11 -- Findings Include: 1. The Specimen receiving, Labeling, and Storage; the COVID-19 Data Entry SOP for LabDaQ, and specimen rejection criteria policy and procedure, patients' electronic record and final reports were reviewed. 2. Review of two patients' electronic printout and test reports showed the following: Electronic Record Patient A4 #XXX25 - date of birth (DOB): XX/X9/2009; Collection date: 11/17/2021 Patient J4 #XXX24 - DOB: XX/X9/2009; Collection date: 11/17/2021 Patient A4 #XXX63 - DOB: XX/X9/2009; Collection date: 11/20/2021 Patient J4 #XXX64 - DOB: XX/X9 /2009; Collection date: 11/20/2021 Final test Reports Patient A4 #XXX25 - DOB: XX /X3/2007; Coll. date: 11/17/2021; Rapid Antigen = Negative; SARS-CoV-2 = Positive. Patient J4 #XXX24 - DOB: XX/X9/2009; Coll. date: 11/17/2021; Rapid Antigen = Negative; SARS-CoV-2 = Negative Patient A4 #XXX63 - DOB: XX/X3 /2007; Coll. date: 11/20/2021; Rapid Antigen = Positive; SARS-CoV-2 = Positive Patient J4 #XXX64 - DOB: XX/X9/2009; Coll. date: 11/20/2021; Rapid Antigen = Positive; SARS-CoV-2 = Positive 3. On December 8, 2021 at 2:00PM, the surveyor requested for the requisitions received from Grapefruit testing for Patients' A4 and J4. Staff OX stated patient specimens submitted by GraXXXX Testing (located in New Jersey) have a standing order and do not require a requisition with their specimen. 4. The Specimen receiving, Labeling, and Storage policy stated "Specimens received in the lab should be matched with the requisition for primary and secondary identifications (First name, Last name, and Date of Birth)." 5. The COVID-19 Data Entry SOP for LaXXXX stated "Verify that the Last and First Name match the patient's requisition form..." 6. Review of the specimen rejection criteria policy revealed the procedure does not list 'specimens received without requisition card' as a criteria for rejection. 7. Staff OX and Staff HF confirmed the above findings on December 8, 2021 at 2:30 PM. D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, 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 analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on direct observations, record review, procedure's manual, and interviews, the laboratory failed to have complete written procedures for the SARS-CoV-2 Pooled Real-Time Reverse Transcriptase (RT)-Integrated DNA Test (IDT) -Polymerase Chain Reaction (PCR) Assay testing performed (D5403); failed to establish and document performance specifications of the laboratory developed test (LDT) SARS- COV-2 Pooled PCR test (D5423); and failed to establish and document control procedures (D5453) to ensure reliable and accurate test results affecting 1,738,443 patients tests. 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 -- 6 of 11 -- 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)

Summary Statement of Deficiencies D6090 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(ii) The laboratory director must ensure the results are returned within the timeframes established by the proficiency testing program. This STANDARD is not met as evidenced by: Based on record review, CASPER Report 0155D, and interview with technical supervisor (TS1); the laboratory director (LD) failed to ensure proficiency testing (PT) results are returned within the timeframes established by the proficiency testing programs. Findings include: 1. The Report 0155D, American Proficiency Institute (API) and WSLH PT reports for the years 2019, 2020, and 2021, and the laboratory's PT policies and procedures were reviewed. 2. The Report 0155D revealed the following scores for Event #3 of 2020: General Immunology: Antinuclear Antibody (ANA) = 0* Hematology: Cell Identification (I.D) or White Blood Cell (WBC) differential (Diff) = 0* Red Blood Cell Count (RBC) = 0* Hemoglobin (HGB) = 0* Hematocrit (HCT) = 0* White Blood Cell Count (WBC) = 0* Platelets = 0* Endocrinology: Human chorionic gonadotropin (HCG) - 0* 3. The API and WSLH PT reports showed the above "0*" scores were due to late or failed submissions of PT results to the proficiency programs. 4. The LD failed to ensure the laboratory followed its PT policies and procedures to submit all PT results before the PT programs' deadlines. 5. On a Recertification survey conducted on 05/24/2021 at 2:45 PM, the TS1 confirmed the above findings. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER Report 155D (Individual Laboratory Proficiency Testing Profile) and phone interview with an American Proficiency Institute (API) program representative; the laboratory failed to successfully participate in the PT program for the Specialty of Hematology during calendar year 2020. Findings include: 1. Review of the CASPER Report 155D on January 05, 2021 and communication with the PT vendor API at 1:40 PM, the initial unsuccessful PT performance was confirmed under the Specialty of Hematology for the analytes red blood cells and prothrombin time. See D2130. 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 -- D2130 HEMATOLOGY CFR(s): 493.851(f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of the CASPER Report 155D (Individual Laboratory Proficiency Testing Profile) and interview with the PT vendor American Proficiency Institute (API) confirmed the laboratory failed to successfully participate in the testing of proficiency testing samples under the Specialty of Hematology for the analytes Prothrombin Time and Red Blood Cells during the calendar year 2020. Findings include: 1. Review of the CASPER Report 155D on January 05, 2021 revealed that the initial unsuccessful PT performance occurred under the Specialty of Hematology for Prothrombin Time and Red Blood Cells during events 2 and 3 of 2020 as listed below: HEMATOLOGY Prothrombin Time EVENT -2, 2020 = 60% Unsuccessful Prothrombin Time EVENT -3, 2020 = 0% Unsuccessful Red Blood Cells EVENT -2, 2020 = 60% Unsuccessful Red Blood Cells EVENT -3, 2020 = 0% Unsuccessful 2. During a phone interview with the PT vendor API on January 05, 2021 at 1:40 PM, they confirmed the above PT scores for Prothrombin Time and Red Blood Cells for events 2 and 3 of 2020. -- 2 of 2 --