Hanover Hospital

Summary Statement of Deficiencies 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: Based on the review of the procedure "Proficiency Testing Policy and Procedure", proficiency testing (PT) "Checklist for

Summary Statement of Deficiencies D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records from American Proficiency Institute (API) and interview, the laboratory failed to evaluate its unacceptable proficiency testing results. Findings: The following samples were scored unacceptable by API. No documentation of the laboratory's evaluation was provided at the time of survey. 1. 2021 Microbiology 1st Event-Gram Stain, samples GS01, GS02, and GS03. 2. 2021 Microbiology 2nd Event- Gram Stain, sample GS07. 3. 2021 Microbiology 3rd Event- Gram Stain, sample GS14. 4. 2021 Hematology/Coagulation 1st Event- Vaginal Wet Prep, sample VA01. 5. 2021 Hematology/Coagulation 2nd Event-ESR, sample ESR-03. 6.2021 Chemistry-Core 3rd Event a. BNP sample CM-13 b. LDL Chol samples CH11, CH12, CH13, CH14, & CH15 c. pCO2 i-STAT samples IB13, IB14 7. 2022 Chemistry-Core 1st Event-BUN sample CH02 8. Interview with the General Supervisor on 4/14/22 at 11:10 a.m. confirmed, the laboratory failed to evaluate 16 unacceptable proficiency testing results in 7 of 13 events in 2021 and to date of survey 2022. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- This STANDARD is not met as evidenced by: Based on a review of proficiency test (PT) performance evaluation records from American Proficiency Institute (API) and interview, the laboratory failed to self- evaluate its not graded results. Findings: The following samples were not graded by API. No documentation of the laboratory's self evaluation was provided at the time of survey. 1. 2021 Hematology/Coagulation 1st Event. Blood Cell Identification samples DIF01, ECI01, ECI02, ECI03, ECI04, ECI05 2. 2021 Hematology/Coagulation 2nd Event. a. Blood Cell Identification samples BCI07, DIF02, ECI06, ECI07, ECI08, ECI09, ECI10 b. Basophil % samples DXH08, DXH10 c. Lymph % samples DXH07, DXH09 3. 2021 Hematology/Coagulation 3rd Event a. Blood Cell Identification samples DIF03, ECI1, ECI12, ECI13, ECI14, ECI15 b. Vaginal Wet Prep sample VKP03 3. 2021 Chemistry-Core 3rd Event Vancomycin samples CH11, CH12 4. 2022 Chemistry-Core 1st Event Vancomycin samples CH01, CH02, CH03, CH04, CH05 5. Interview with the General Supervisor on 4/14/22 at 11:10 a.m. confirmed, the laboratory failed to self evaluate 31 non graded results from 7 of 13 events in 2021 and to date of survey 2022. 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 the lack of procedures, failure to determine normal patient geometric mean for prothrombin time reporting, failure to verify normal ranges for the hematology analyzer, failed to perform QC as required for immunohematology testing and interview the laboratory failed to meet the condition: Analytic systems. The laboratory failed to have procedures for the hematology analyzer, chemistry analyzer and immunohematology crossmatch (refer to D5401); failed to follow manufacturer's instructions to determine the normal patient geometric mean (refer to D5411); failed to verify reference ranges for the hematology analyzer prior to patient testing (refer to D5421) and failed to test negative controls for immunohematology testing (D5451). 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: Based on the lack of procedures for review and interview, the laboratory failed to have written procedures available to and followed by, laboratory personnel. Findings: -- 2 of 5 -- 1. No procedures for the following were made available for review at the time of survey. a. Beckman Coulter DXH 520 hematology analyzer b. Cepheid Gene Expert SARS-COV-2, Flu A/B, RSV c. Horiba ABX Pentra C400 chemistry analyzer maintenance, operation, calibration d. Immunohematology Crossmatch of RBC blood product 2. Interview with the GS on 4/14/22 at 9:20 a.m. confirmed, the laboratory failed to have written procedures available to and followed by, laboratory personnel. 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 review of instrument type, manufacturer instructions, analyzer test settings, lack of reagent lot normal range evaluation data, patient test volume and interview, the laboratory failed to follow manufacturer's instruction to establish the patient mean with each new lot of reagent for prothrombin time testing. Findings: 1. Prothrombin time testing is performed on the IL ACL Elite analyzer using RecombiPlasTin reagent. 2. Review of the package insert for ReombiPlaTin reagent under "Instrument /test procedure" states "Enter the ISI value from the insert and establish the Mean of the PT Normal Range with each lew lot." 3. Review of the ACL Elite settings on the day of survey for prothombin time testing showed RecombiPlasTin reagent lot #N0512868, normal patient geometric mean set at 12.18 seconds and ISI value of 1.04. 3. Request was made to review the new lot normal patient value study used to determine the patient geometric mean. Testing personnel #3 (TP3) stated that no normal patient value study was performed. Package insert had "into use 3/30/22" written on it. 4. Results for 16 patients have been reported using this lot from 3/30/22 to date of survey. 4. Interview with general supervisor on 4/14/22 at 1:40 p.m. confirmed, the laboratory failed to follow manufacturer's instruction to establish the patient mean with each new lot of reagent for prothrombin time testing. **This a repeat finding from survey performed 1/8/2020.** 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 review of performance verification documentation for the Beckman Coulter DXH520 hematology analyzer, non-waived test lists, and interview, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to performing patient testing. Findings: 1. Review -- 3 of 5 -- of the verification documentation of the Beckman Coulter DXH520 hematology analyzer, S/N BC111130, for the analytes: White Blood Cell Differential, Red Blood Cell Count, Hemoglobin, Hematocrit, White Blood Cell Count, and Platelet testing showed no verification of normal values at time of survey. Document listed patient testing began in April 2020. 2. Review of the KS-CLIA-PS02 non-waived test lists showed the DXH520 annual test volume was 8,726 patient test results. 3. Interview with General Supervisor on 4/14/22 at 9:30 a.m. confirmed, the laboratory failed to verify the reference intervals (normal values) were appropriate for the laboratory's patient population prior to performing patient testing. D5451 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(iii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Test procedures producing graded or titered results include a negative control material and a control material with graded or titered reactivity, respectively; 493.1256 (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of immunohematology quality control (QC) records from 1/9/20 to date of survey revealed the laboratory failed to perform QC each day of patient testing for the immunohematology test procedures that produce graded or titered results and includes a negative control. Findings: 1. Review of the immunohematology QC records, revealed the following immunohematology reagent QC testing does not include a negative control: anti-A, anti-B, anti-A,B, A1 cells, B cells, Screening Cell (SC) II, and Combs Check Cells. 2. Interview with the GS#1 on 1 /14/22 at 1:40 p.m. confirmed, the laboratory failed to perform QC each day of patient testing for the immunohematology test procedures that produce graded or titered results and include a negative control. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on the review of instrument verification records and interview with GS, the laboratory director failed to ensure the establishment of acceptable levels of analytical performance of the Beckman Coulter DXH520 hematology analyzer before use in patient testing. 1. Review of instrument verification records for the Beckman Coulter DXH520 hematology analyzer, S/N BC111130 for White Blood Cell Count, Red Blood Cell Count, Hemoglobin, Hematocrit, Platelet Count, and White Blood Cell Differential was performed in March 2020 and placed into use for patient testing in April 2020 (exact date patient testing began was not made available at the time of survey) revealed no approval documentation from the laboratory director or designee. -- 4 of 5 -- 3. Interview with the GS 4/14/22 at 9:20 a.m. confirmed, the laboratory director failed to ensure the establishment of acceptable levels of analytical performance of the Beckman Coulter DXH520 hematology analyzer before use in patient testing. -- 5 of 5 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on interview on January 8, 2020 at 1030 am and the lack of documentation produced, the laboratory failed to perform two competency assessments on personnel listed on the Form 209. Findings: 1. Based on the lack of documentation provided by the laboratory, the laboratory failed to perform competency assessments on Testing Personnel (TP) #3 and #4 as determined by their policies of annual assessments for personnel employed greater than 12 months. 2. Interview with TC#5 on 01/08/2020 @1030 confirmed that the laboratory failed to perform competency assessments on TP#3 and #4. 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 an absence of pipette records, microscope maintenance records and interview with Technical Supervisor (TS) #5, the laboratory failed to define a function check protocol for the pipettes and microscopes. Findings were: 1. No documentation 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 -- was available for function checks of pipette for period between 10/09/2018 to 01/08 /2020. No documentation was available for the certification of accuracy for pipettes. 2. No documentation was available for the maintenance of microscopes for period between 10/09/2018 to 01/08/2020. 3. Interview with TS #5 on 01/08/2020 @1:20 pm confirmed the laboratory had no records of function checks or certification of accuracy for the seven pipettes used in the laboratory for the period between 10/09 /2018 to 01/08/2020. 4. Interview with TS#5 on 01/08/2020 @1:20 pm confirmed the laboratory had no records of microscope maintenance for a 15 month period. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: 1. A review of manufacturer's instructions for Thromboplastin , quality control and quality assessment records for coagulation, observation of the laboratory's equipment, and interview with staff on January 08, 2020 revealed that the laboratory did not follow manufacturer's instructions for International Normalized Ratio (INR) . Findings were as follows: a. Quality control and quality assessment records for Elite top coagulation analyzer on 01/08/2020 did not include determination of the Prothrombin Time (PT) for patient normal range for the current lot of Thromboplatin in use. Therefore the accuracy or reliability can not be verified. b. Interview with the TC#3 on 01/08/2020 @130 p.m. confirmed that the determination of the patient normal range for the current lot of Thromboplastin had not been performed. -- 2 of 2 --

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: A review of proficiency testing records from American Proficiency Institute (API) (a year consists of three testing events) and interview with General Supervisor#1 from the CMS form 209 revealed the laboratory failed to verify the accuracy of analyte (MCV) for which the proficiency testing program.. Findings were as follows: a. Proficiency testing records form API for the third event of 2017 second 2018 event, revealed that the proficiency testing program failed to obtain the accuracy of ( MCV) two of three events. 2017 event 3: 60% 2018 event 2: 20% At the time of survey (10 /09/2018), there was no evidence of verification activities of accuracy by of the analytes available for review. An interview with the Technical Consultant #1 from the CMS form 209 on 10/08/2018, at 10:30 hrs confirmed that no verification of accuracy. 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 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 -- 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 upon a review of quality control (QC) data in the chemistry specialty and staff interview, the laboratory failed to verify the criteria of acceptability of controls by evaluating control results for shifts or trends due to potential instrument malfunction or changes in the analytical system. Findings were: a. During a review of quality control data the delegated technical supervisor could not, upon request, produce evidence that quality control data for QC of analytes performed on the Coulter ACT Pentra C 400 were reviewed for shifts and trending of QC results that could signify a potential instrument malfunction. b. The laboratory did utilize an intra-laboratory comparison service for evaluation of QC results in accordance with statistical parameters. The lab was unable to produce a policy/procedure that defined how that data was utilized for shifts/trends to ensure that the test system was stable. The intra- laboratory comparison data reports were not consistently maintained and there was no evidence of review by the technical supervisor c. The above findings were confirmed by interview with the technical supervisor on 10/09/2018 hours in the laboratory. D5783

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: The laboratory failed to achieve successful performance in proficiency testing (PT) for the regulated analyte glucose (non-waived) (see D2096). D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. 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 -- This STANDARD is not met as evidenced by: Based on a review of proficiency testing (PT) records for 2017 and 2018, the laboratory failed to achieve an acceptable score of 80% or higher for two of three consecutive events for the analyte glucose which resulted in unsatisfactory performance for the regulated analyte. This was confirmed by phone interview with the lab manager 9/4/2018 at 1:00 pm. Findings were: 1. A review of the proficiency testing records for 2017 and 2018 revealed the following performance scores for PT for the glucose (non-waived ) analyte as indicated: a. 2017 Testing event 3 60% b. 2018 Testing event 2 40% -- 2 of 2 --