Pontiac General Hospital

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: . Based on observation and interview with the owner, the laboratory failed to establish safety procedures to ensure protections against chemical and biohazardous materials for one observation of staff with a beverage in the laboratory. Findings include: 1. The surveyor observed a staff member walking through the laboratory between the urinalysis, chemistry, and hematology testing areas with an open beverage on 1/21/25 at 8:54 am. 2. A review of the laboratory's safety policies revealed a lack of policy about eating or drinking in laboratory spaces. 3. An interview with the owner of the laboratory at 8:54 am confirmed that the beverage was present, and beverages were not permitted in testing spaces. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) (d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the technical consultant, the laboratory failed to use approved test procedures for two (Vitros XT 7600 and Tosoh G8 chemistry analyzers) of three chemistry instruments used in the laboratory. Findings include: 1. The surveyor observed the Vitros XT 7600 and Tosoh G8 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- chemistry analyzers in the laboratory on 1/21/25 at 8:58 am. 2. A review of the laboratory's procedure manuals revealed a lack of laboratory director approval for the use of the Vitros XT 7600 and Tosoh G8 chemistry analyzers. 3. An interview on 1/21 /25 with the technical consultant confirmed the laboratory director had not approved the test procedures for the Vitros XT 7600 and Tosoh G8 chemistry analyzers prior to use. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the technical consultant, the laboratory failed to label its control materials with the expiration dates for seven control materials observed. Findings include: 1. The surveyor observed three XN Check control vials used for the Sysmex XN-1000 hematology analyzer with the open date of "12/23" written on the vials on 1/21/25 at 8:58 am. 2. A review of the "XN CHECK" manufacturer's instructions revealed a section stating, "Open vials and vials which have been samples by cap piercing will retain stability for 7 days if stored at 2- 8 degrees C after being recapped." 3. An interview on 1/21/25 at 9:41 am with the technical consultant confirmed the controls did not include the expiration date to reflect the open stability. 4. The surveyor observed four opened MAS DOA TOTAL urine toxicology controls in the refrigerator with no expiration date to reflect its stability once opened. 5. A review of the MAS DOA TOTAL manufacturer's instructions revealed a section stating, "24 month shelf life from date of manufacture at 2 to 8C; 30 day open vial stability for all analytes at 2 to 8C." 6. An interview on 1 /21/25 at 10:38 am with the technical consultant confirmed the MAS DOA TOTAL controls had been opened and did not include an expiration date. B. Based on observation and interview with the technical consultant, the laboratory failed to label two of four reagents observed onboard the Sysmex XN-1000 hematology analyzer. Findings include: 1. The surveyor observed four total reagents attached to the Sysmex XN-1000 hematology analyzer with two of them that had been removed from the original packaging, which would have included the name of the reagent, contents, lot numbers, and expiration dates on 1/21/25 at 8:58 am. 2. An interview on 1/21/25 at 10: 01 am with the technical consultant confirmed the two reagents lacked the name of the reagent, contents, lot numbers, and expiration dates. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the technical consultant, -- 2 of 4 -- the laboratory failed to ensure control materials for its Sysmex XN-1000 did not exceed expiration dates for three controls in use. Findings include: 1. The surveyor observed three XN Check control vials used for the Sysmex XN-1000 hematology analyzer with the open date of "12/23" written on the vials on 1/21/25 at 8:58 am. 2. A review of the "XN CHECK" manufacturer's instructions revealed a section stating, "Open vials and vials which have been samples by cap piercing will retain stability for 7 days if stored at 2-8 degrees C after being recapped." 3. A review of the control records on the Sysmex XN-1000 revealed the previous four runs with this set of controls were performed on 1/7/25, 1/8/25, 1/10/25, and 1/17/25, after the controls had exceeded the seven day stability. 4. An interview on 1/21/25 at 9:41 am with the technical consultant confirmed the controls were no longer stable. B. Based on observation and interview with the technical consultant, the laboratory failed to ensure reagents used in performing partial thromboplastin time (PTT) testing did not exceed expiration dates for one box of reagent observed. Findings include: 1. The surveyor observed one box of PTT reagent with five bottles inside on 1/21/25 at 11:18 am with the lot number 263077 and the expiration date of 11/30/24. 2. A review of patients tested for PTT revealed the last patient performed was on 12/10/24. 3. An interview on 1/21/25 at 11:19 am with the technical consultant confirmed the reagent had exceeded its expiration date. C. Based on observation and interview with the technical consultant, the laboratory failed to ensure reagents used for its Sysmex XN-1000 did not exceed expiration dates for 2 of 5 bottles Hematology Buffer. Findings include: 1. The surveyor observed two bottles of Volu-Sol Hematology Buffer with an expiration date of 10/31/24 on 1/21/2025 at 9:45 am within the Flammable Storage Cabinet. 2. An interview on 1/21/2025 at 10:00 am with the technical consultant confirmed that the reagent had exceeded its expiration date. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(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: . A. Based on record review and interview with the technical consultant, the laboratory failed to verify its reference intervals prior to using the Vitros XT 7600 chemistry analyzer for patient testing for 11 (February 2024 to January 2025) of 11 months since the laboratory started patient testing with the Vitros XT 7600. Findings include: 1. A review of the verification of performance specifications revealed a lack of documentation verifying reference intervals for analytes tested using the Vitros XT 7600 chemistry analyzer. 2. An interview on 1/21/25 at 3:48 pm with the technical consultant confirmed documentation of the verification of reference intervals for the Vitros XT 7600 was not present. B. Based on record review and interview with the technical consultant, the laboratory failed to establish verification of performance for its Sysmex XN 1000 analyzer for 11 (February 2024 to January 2025) of 11 months since the laboratory started patient testing with the Sysmex XN 1000. Findings include: 1. A review verification of performance revealed a lack of documentation for establishing verification of performance for the Sysmex XN 1000. 2. An interview on -- 3 of 4 -- 1/21/2025 at 3:39 pm with the technical consultant confirmed that documentation was not present, and testing started on 2/09/2024. -- 4 of 4 --

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 record review and interview with the General Supervisor, the laboratory failed to follow its policy to perform competency assessments for 4 (Clinical Consultant/Technical Supervisor, General Supervisor/Technical, Testing Personnel #4, and Testing Personnel #6) of 8 personnel listed on Form CMS-209. Findings include: 1. A review of the laboratory's "Employee Training and Competency Evaluation" policy revealed a section stating, "The competency checklist is a detailed explanation of what is on the competency calendar. The competency checklist should be completed initially, 6 months after completed training and annually thereafter. This should be checked off when the employee is proven to be competent in all areas of testing. This and the calendar should be a final step of training or competency." 2. A review of the laboratory's personnel records revealed the following personnel with a lack of competency assessment documentation: a. Clinical Consultant/Technical Supervisor had a lack of documentation of competency assessments. b. General Supervisor/Technical Supervisor had not had a competency assessment performed since 6/17/19. c. Testing Personnel #4 started testing in February 2022 and did not have documentation of initial competency assessments for the Stago Compact coagulation testing, urinalysis testing, and its C. difficile testing. d. Testing Personnel #6 had started testing in November 2021 and had no documented competency assessments available. 3. An interview on 2/1/23 at 11:09 am with the General Supervisor confirmed competency assessment had not been documented according to the laboratory's policy for the personnel listed above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 observation and interview with Testing Personnel (TP) #2 and #7, the laboratory failed to ensure the reagent bottle used for immunohematology testing was labeled to indicate the identity, concentration, pour date, and expiration date of the reagent for 1 (unlabeled bottle) of 1 reagent bottles observed in innumohematology. Findings include: 1. During a tour of the immunohematology department on 2/01 /2023 at 1:21 pm, the surveyor observed a reagent bottle unlabeled in the testing area with no identity, concentration, pour date, and expiration date for the reagent. 2. When queried on 2/01/2023 TP#2 stated the reagent was for the immunohematology testing and TP#7 confirmed. 3. An interview on 2/01/2023 at 2:37 pm, TP#7 confirmed the reagent bottle in the immunohematology testing area was unlabeled and did not have all required elements recorded on the reagent label. ***Repeat Deficiency from 12/13 /2016 survey*** D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the General Supervisor, the laboratory failed to ensure its BacT Alert blood culture media bottles had not exceeded their expiration date for 2 of 12 bottles observed. Findings include: 1. The surveyor observed two BacT Alert FN blood culture bottles with the expiration date of 1/27/23. 2. An interview on 2/1/23 at 2:39 pm with the General Supervisor confirmed the above blood culture bottles had been expired. **This is a repeat deficiency from the 7 /27/21 recertification survey** D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: . Based on observation, record review, and interview with the Technical Supervisor (TS), the laboratory failed to perform and document pipette calibration for the Stago multi-channel pipette used for coagulation testing for 18 (August 2021 to January -- 2 of 4 -- 2023) of 18 months in use. Findings include: 1. During a tour of the Hematology department on 2/01/2023 at 9:20 am the surveyor observed the multi-channel Stago pipette used with the STart 4 not have a calibration sticker. 2. A record review of the pipette calibrations revealed a lack of documentation for the Stago multi-channel pipette for 18 (August 2021 to January 2023) of 18 months. 3. An interview on 2/01 /2023 at 2:25 pm, the TS confirmed the laboratory failed to include the Stago multi- channel pipette with the other pipettes when calibrated. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor, the laboratory failed to ensure results of Lithium and Creatine Kinase (CK) control materials met the laboratory's and the manufacturer's test system criteria for acceptability before reporting patient test results for 1 (1/31/23) of 5 testing dates reviewed. Findings include: 1. A review of the laboratory's "Dimension EXL 200" procedure revealed a section titled "Quality Control" stating, The Dimension requires two levels of un- assayed controls from Bio-Rad to monitor the performance for most of the general chemistries on the test menu. In addition, two levels of Ethanol/Ammonia controls, two levels of immunoassay controls, two levels of specialty controls, two levels of cardiac controls and two levels of anemia controls for more specialized tests such as Ammonia, Blood Alcohol, Vitamin B 12, Thyroids, Troponin and Glycohemoglobin. QC is performed once in a 24-hour period at a minimum. The lab may opt to run QC more frequently should they feel it's necessary" and "Review the results, record results on QC sheets repeat failed QC. Troubleshoot and if necessary, recalibrate any test out of range as required." 2. A review of the laboratory's quality control records for its Dimension EXL 200 chemistry testing revealed Lithium and CK analyte quality control testing was out of range on 1/31/23. 3. A review of the laboratory's patient testing records revealed two patients had Lithium and CK testing performed on 1/31 /23. 4. An interview on 2/1/23 at 1:43 pm with the General Supervisor confirmed patients had testing performed and reported on 1/31/23 when Lithium and CK control testing was out of range. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

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 record review of the CMS database and the American Proficiency Institute (API) proficiency testing reports, it was determined the laboratory failed to successfully participate in a CMS-approved proficiency testing program for immunohematology compatibility testing. Findings include: Review of the CMS database and the API proficiency testing reports revealed the laboratory failed to achieve satisfactory performance for compatibility testing. Refer to D2173 and D2181. D2181 COMPATIBILITY 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 2 -- CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive testing 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 CMS database and the American Proficiency Institute (API) proficiency testing reports, the laboratory failed to achieve satisfactory performance for 2 (3rd Event 2021 and 1st Event 2021) of 3 testing events for immunohematology compatibility testing. Findings include: Compatibility Testing PT Event Score 3rd event 2021 80% 1st event 2021 80% -- 2 of 2 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Laboratory Director (LD) and the Technical Consultant (TC), the laboratory failed to report SARS-CoV-2 test results every day of patient testing for 43 (10/29/2020 to 7/27/2021) of 43 days of testing. Findings include: 1. SARS-CoV-2 "Laboratory test turnaround" log was reviewed from 10/29/2020 to 7/27/2021. 2. Lack of documentation of SARS- CoV-2 test result reporting to a "healthcare provider and relevant public health authorities" from 10/29/2020 to 7/27/2021. 3. Lack of documentation of test reporting revealed for 49 SARS-CoV-2 Total Antibody assay (CV2T) patient test results were not reported as required. 4. The LD and TC confirmed the findings on 7/27/2021 at 2: 21 pm that CV2T patient test results are not reported to a relevant public health authority, only being reported to the in-house Infection Control Manager. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the General Supervisor (GS), the laboratory failed to use 3 (hematology, microbiology, and histopathology) of 3 specimen collection supplies before the expiration date. Findings include: 1. During a tour of the laboratory on 7/27/2021 at 9:05 am, the surveyor observed 3 of 3 specimen collection supplies still in circulation in the laboratory past their expiration dates as follows: a. hematology - Beckton Dickinson dipotassium ethylenediaminetetraacetic acid (K2 EDTA) tubes - expiration date of 5/31/2021 (5 tubes) b. microbiology - Cary Blair with indicator - expiration date of 5/17/2021 (1 container) c. histopathology - Histopak 10% Neutral Buffered Formalin - expiration date of 6/2021 (45 containers) 2. Review of the "Laboratory Reagents and Supplies" policy/procedure states under section IX "Reagent and Item Use and Disposal" under step 2 "Expiration Dates" detail ii "If an item is past the expiration date is should be properly disposed of immediately." 3. An interview on 7/27/2021 at 9:13 am, the GS confirmed the above supplies were still in circulation past their expiration dates. ***Repeat Deficiency from 12/13/2016 survey *** D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to comply with 21 CFR 606.100(b)(12) and did not establish criteria for determining whether returned blood is suitable for reissue for 2 (July 2019 to July 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's policy binder "Blood Bank" revealed the absence of criteria for determining whether returned blood is suitable for reissue. 2. An interview on 7/27/21 at 11:31 am with the GS confirmed the laboratory did not have criteria for determining whether returned blood is suitable for reissue. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the General Supervisor (GS), the -- 2 of 3 -- laboratory failed to perform comparison testing between the troponin test using the Quidel Triage analyzer and the troponin test using the Siemens Dimension analyzer at least twice a year to evaluate the relationship between the test results for 2 (July 2019 to July 2021) of 2 years. Findings include: 1. A review of the laboratory's chemistry analytic system records revealed a lack of documentation showing the comparison testing between the two troponin test methods using the Quidel Triage analyzer and the Siemens Dimension analyzer at least twice a year to evaluate the relationship between the test results. 2. An interview on 7/27/21 at 2:15 pm with the GS confirmed the laboratory did not have documentation of comparison testing for the two methods used in troponin testing. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . A. Based on record review and interview with Office Staff, the laboratory failed to ensure ABO typing results were transferred to the final report for 2 (Patient 20059804 and Patient 20063706) of 4 blood bank patient test records reviewed. Findings include: 1. A review of blood bank patient test records revealed the following patients had ABO type and screen testing performed: a. Patient 20059804 performed on 8/5/20 b. Patient 20063706 performed on 1/4/21 2. A review of the test reports for the patients listed above revealed a lack of results of the ABO types on the test reports. 3. An interview on 7/27/21 at 1:27 pm with Office Staff confirmed the patients listed above did not have the ABO type test results on the test reports. B. Based on record review and interview with Office Staff, the laboratory failed to ensure blood unit compatibility test results were transferred to the final report for 3 (Patients 20059804, 20063706, and 20066131) of 4 blood bank patient test records reviewed. Findings include: 1. A review of blood bank patient testing log revealed the following patients had compatibility testing performed: a. Patient 20059804 on 8/5/20, 2 units were crossmatched b. Patient 20063706 on 1/4/21, 3 units were crossmatched c. Patient 20066131 on 4/22/21, 2 units were crossmatched 2. A review of the test reports for the patients listed above revealed a lack of results of the compatibility testing. 3. An interview on 7/27/21 at 1:27 pm with Office Staff confirmed the test reports did not include the results of compatibility testing for the patients listed. -- 3 of 3 --

Summary Statement of Deficiencies D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: . Based on record review, lack of documentation, and interview with the Laboratory Director (LD) and the Technical Consultant (TC), the laboratory failed to report SARS-CoV-2 test results every day of patient testing for 43 (10/29/2020 to 7/27/2021) of 43 days of testing. Findings include: 1. SARS-CoV-2 "Laboratory test turnaround" log was reviewed from 10/29/2020 to 7/27/2021. 2. Lack of documentation of SARS- CoV-2 test result reporting to a "healthcare provider and relevant public health authorities" from 10/29/2020 to 7/27/2021. 3. Lack of documentation of test reporting revealed for 49 SARS-CoV-2 Total Antibody assay (CV2T) patient test results were not reported as required. 4. The LD and TC confirmed the findings on 7/27/2021 at 2: 21 pm that CV2T patient test results are not reported to a relevant public health authority, only being reported to the in-house Infection Control Manager. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other 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 -- supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with the General Supervisor (GS), the laboratory failed to use 3 (hematology, microbiology, and histopathology) of 3 specimen collection supplies before the expiration date. Findings include: 1. During a tour of the laboratory on 7/27/2021 at 9:05 am, the surveyor observed 3 of 3 specimen collection supplies still in circulation in the laboratory past their expiration dates as follows: a. hematology - Beckton Dickinson dipotassium ethylenediaminetetraacetic acid (K2 EDTA) tubes - expiration date of 5/31/2021 (5 tubes) b. microbiology - Cary Blair with indicator - expiration date of 5/17/2021 (1 container) c. histopathology - Histopak 10% Neutral Buffered Formalin - expiration date of 6/2021 (45 containers) 2. Review of the "Laboratory Reagents and Supplies" policy/procedure states under section IX "Reagent and Item Use and Disposal" under step 2 "Expiration Dates" detail ii "If an item is past the expiration date is should be properly disposed of immediately." 3. An interview on 7/27/2021 at 9:13 am, the GS confirmed the above supplies were still in circulation past their expiration dates. ***Repeat Deficiency from 12/13/2016 survey *** D5553 IMMUNOHEMATOLOGY CFR(s): 493.1271(b)(f) (b) Immunohematological testing and distribution of blood and blood products. Blood and blood product testing and distribution must comply with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40; 640.5(a), (b), (c), and (e); and 640.11(b). (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on record review and interview with the General Supervisor (GS), the laboratory failed to comply with 21 CFR 606.100(b)(12) and did not establish criteria for determining whether returned blood is suitable for reissue for 2 (July 2019 to July 2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's policy binder "Blood Bank" revealed the absence of criteria for determining whether returned blood is suitable for reissue. 2. An interview on 7/27/21 at 11:31 am with the GS confirmed the laboratory did not have criteria for determining whether returned blood is suitable for reissue. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on lack of documentation and interview with the General Supervisor (GS), the -- 2 of 3 -- laboratory failed to perform comparison testing between the troponin test using the Quidel Triage analyzer and the troponin test using the Siemens Dimension analyzer at least twice a year to evaluate the relationship between the test results for 2 (July 2019 to July 2021) of 2 years. Findings include: 1. A review of the laboratory's chemistry analytic system records revealed a lack of documentation showing the comparison testing between the two troponin test methods using the Quidel Triage analyzer and the Siemens Dimension analyzer at least twice a year to evaluate the relationship between the test results. 2. An interview on 7/27/21 at 2:15 pm with the GS confirmed the laboratory did not have documentation of comparison testing for the two methods used in troponin testing. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: . A. Based on record review and interview with Office Staff, the laboratory failed to ensure ABO typing results were transferred to the final report for 2 (Patient 20059804 and Patient 20063706) of 4 blood bank patient test records reviewed. Findings include: 1. A review of blood bank patient test records revealed the following patients had ABO type and screen testing performed: a. Patient 20059804 performed on 8/5/20 b. Patient 20063706 performed on 1/4/21 2. A review of the test reports for the patients listed above revealed a lack of results of the ABO types on the test reports. 3. An interview on 7/27/21 at 1:27 pm with Office Staff confirmed the patients listed above did not have the ABO type test results on the test reports. B. Based on record review and interview with Office Staff, the laboratory failed to ensure blood unit compatibility test results were transferred to the final report for 3 (Patients 20059804, 20063706, and 20066131) of 4 blood bank patient test records reviewed. Findings include: 1. A review of blood bank patient testing log revealed the following patients had compatibility testing performed: a. Patient 20059804 on 8/5/20, 2 units were crossmatched b. Patient 20063706 on 1/4/21, 3 units were crossmatched c. Patient 20066131 on 4/22/21, 2 units were crossmatched 2. A review of the test reports for the patients listed above revealed a lack of results of the compatibility testing. 3. An interview on 7/27/21 at 1:27 pm with Office Staff confirmed the test reports did not include the results of compatibility testing for the patients listed. -- 3 of 3 --

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: . A. Based on record review and interview with the General Supervisor (GS), the laboratory failed to retain the ABL 800 blood gas analyzer original instrument data for 1 (July 2017 event) of 4 calibration verification testing events. Findings include: 1. A review of calibration verification data from the ABL 800 blood gas analyzer revealed a lack of original instrument data from the July 2017 calibration verification. The documentation was not available when requested by the surveyor on 6/18/19 at 9:30 am. 2. An interview on 6/18/19 at 9:30 am with the GS revealed the calibration verification data from the July 2017 testing event were not available. B. Based on record review and interview with the General Supervisor (GS), the laboratory failed to retain ABL 800 blood gas analyzer, Beckman Coulter AcT 5 Diff hematology analyzer, and "Beckman Coulter Access" chemistry analyzer maintenance logs for 7 (June - December 2017) of 24 months reviewed. Findings include: 1. A review of the ABL 800 blood gas analyzer, Beckman Coulter AcT Diff hematology analyzer, and "Beckman Coulter Access" chemistry analyzer maintenance logs revealed a lack of documentation of instrument maintenance for June-December 2017. The documentation was not available when requested by the surveyor on 6/18/19 at 11:18 am. 2. An interview on 6/18/19 at 11:18 am with the GS confirmed maintenance logs for the ABL 800, Beckman Coulter AcT Diff, and the "Beckman Coulter Access" instruments were not retained. ***Repeat Deficiency from 12/13/16 survey*** D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) 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 -- 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 record review and interview with the General Supervisor (GS), the laboratory failed to perform Beckman Coulter AcT 5 Diff hematology analyzer monthly maintenance as required by the manufacturer for 3 (June, July, and September 2018) of 24 months reviewed. Findings include: 1. A record review of the "Beckman Coulter AcT-5 Diff Series Analyzer" maintenance logs revealed a lack of documentation of monthly maintenance performed in June, July, and September 2018 as required by the manufacturer. Monthly maintenance includes the following: a. "Check lower rinse block and clean if necessary" b. "Check baths, perform extended clean" 2. An interview on 6/18/19 at 11:35 am with the GS confirmed monthly maintenance had not been performed and documented for the Beckman Coulter AcT 5 Diff analyzer for June, July, and September 2018. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: . Based on Triage Cardiac Panel Quick Reference sheet, record review, and interview with the General Supervisor (GS), the laboratory failed to perform quality control as required for the chemistry Troponin testing for 7 (December 2018 to June 2019) of 7 months reviewed. Findings include: 1. The Triage Cardiac Panel Quick Reference sheet under the header "QC Panel" states to "run daily (every 24 hours)" and "External Controls (2) - run on every new lot, every new shipment, and every 30 days thereafter." 2. Quality Control record review revealed for 7 months the laboratory ran external controls monthly which does not meet the CLIA minimum requirement of "at least each day patient specimens are assayed or examined' or perform and develop an Individualized Quality Assurance Plan (IQCP). 3. During the phone interview on June 24, 2019 at approximately 3:15 pm, the GS confirmed controls were not performed and documented each day of patient testing and and IQCP plan had not been established. 4. The laboratory ran approximately 2206 Troponin testing from December 2018 to June 18, 2019. -- 2 of 2 --