Delta Health System - The Medical Center

Summary Statement of Deficiencies 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 surveyor observation of an unlabeled ABG (arterial blood gas) sample, interview with testing personnel (TP) #5 and Respiratory Dept Supervisor as listed on the Centers for Medicaid and Medicare Services (CMS) 209 form and review of the Respiratory Arterial labeling policy, the laboratory failed to follow their policy to ensure positive identification for one of one patient specimen from the time of collection through testing and reporting for ABG results. Findings include: 1. On 12/4 /2025 the surveyor observed TP #5 entering the ER respiratory lab with an unlabeled syringe (one of one) in a plastic bag and no blood gas patient orders or documentation. When asked to explain the process of testing the blood gas sample as she was entering information in the Gem Premier 4000, she exited the ER Respiratory lab to retrieve the patient's label leaving the unlabeled syringe on the counter. She returned moments later with a label and affixed it to the syringe. She entered the patient demographics in the Gem Premier and tested the blood gas patient sample. 2. Interview with TP #5 on 12/4/2025 at 10:30 a.m., revealed that orders are received for the providers through their LIS/computer system and labels are received from the nurses' station prior to entering the patient's room to draw the blood gas sample. After testing they revealed the blood results are manually entered into the LIS system if they don't interface over automatically. A copy of results is given to the provider, and a copy is retained in the Respiratory Department and used to enter into the LIS. 2. Interview with the Respiratory Department Supervisor 12/4/2025 at 11:30 a.m., revealed that the policy is supposed to be followed where after the orders are received, labels retrieved from 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 -- the nurses' station, the sample is labeled at bedside after the blood gas is collected and brought to the lab to be tested. The supervisor also added that the staff were trained to scan the barcode on the patient's label before testing on the Gem Premier. Manually demographic information is only entered in the Gem Premier in certain situations. 3. The Respiratory Department has 2 blood gas collection policies which include the labeling policy: a. In the Arterial Line Blood Sampling, RT. 1108 procedure it states on #23 "Place label (patient identifier) on syringe and place syringe in the biohazard bag." b. In the Capillary Blood Gas Sampling, RT. 1109 procedure it states on #14 "Label the sample and place in biohazard bag." In both procedures "Syringe label (patient identification)" is listed as "necessary equipment" to be obtained and is a part of the blood gas kit to have when entering the patient's room to collect blood gases. -- 2 of 2 --

Summary Statement of Deficiencies 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 the Sysmex CS-2500 coagulation system manufacturer's instructions, observation of coagulation reagents and controls in use on 3/21/2024 at 9: 30 a.m., interview with Technical Consultant #3 on 3/21/2024 at 1:45 p.m., and patient test counts, the laboratory failed to follow manufacturer's instructions for lot changes of reagents, put in use in October and November 2023. Findings include: 1. Sysmex CS-2500 coagulation system manufacturer's instructions stated when new lots of prothrombin time (PT) and activated partial thromboplastin time (APTT) reagents are put in use the patient reference intervals should be established or verified, a normal patient mean should be established for the new PT reagent, quality control ranges should be established with the new reagent lots, a lot-to-lot method correlation should be performed with the current reagent lots and the new reagent lots, and the heparin therapeutic range for APTT should be verified if monitoring unfractionated heparin therapy. 2. Manufacturer's instructions for Dade Ci-Trol Coagulation Control Level 1 and Level 3 stated each laboratory should establish its own level of performance. 3. Observation of PT and APTT reagents and coagulation controls in the laboratory refrigerator on 3/21/2024 at 9:30 a.m. and interview with Technical Consultant #3, listed on the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, on 3/21/2024 at 1:45 p.m. revealed the following lots of reagents and controls were in use: Dade Innovin PT reagent, Lot #564604, expiration date 9/9 /2024, was put in use on 11/13/2023 and used for patient PT testing for 4 of 21 months reviewed. Dade Actin FSL APTT reagent, Lot #562733, expiration date 11/22 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 -- /2024, was put in use on 10/13/2023 and used for patient APTT testing for 5 of 21 months reviewed. Dade Ci-Trol Level 1 Control, Lot #564879, expiration date 3/5 /2026, was put in use on 9/28/2023. Dade Ci-Trol Level 3 Control, Lot #556579, expiration date 3/7/2026, was put in use on 8/27/2023. 4. On 3/21/2024 there was no documentation available of lot conversion studies performed, per manufacturer's instructions, on Dade Innovin PT reagent, Lot #564604, or Dade Actin FSL APTT reagent, Lot #562733, including establishment of acceptable ranges for Dade Ci-Trol Level 1 Control, Lot #564879, or Dade Ci-Trol Level 3 Control, Lot #556579. 5. In an interview on 3/21/2024 at 1:45 p.m., Technical Consultant #3 confirmed there was no documentation of lot conversion studies performed on Dade Innovin PT reagent, Lot #564604, or Dade Actin FSL APTT reagent, Lot #562733, or establishment of acceptable ranges for Dade Ci-Trol Level 1 Control, Lot #564879, or Dade Ci-Trol Level 3 Control, Lot #556579 with the new lots of reagent. 6. According to patient test counts provided by Technical Consultant #3, the following patient test results were reported during the tme frames listed below: Patient PT results reported from 11 /13/2023, when Innovin PT reagent Lot #564604 was put in use, through the day of the survey on 3/21/2024 were 1,970. Patient PTT results reported from 10/13/2023, when Actin FSL APTT reagent Lot #562733 was put in use, through 3/21/2024 were 3,226. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the Gem Premier 4000 and 3500 blood gas analyzer records including quality control, maintenance, calibration verification (PVP-performance verification product) records from last survey on 6/23/2022 through 3/21/2024 and interview with the respiratory testing personnel (TP) #7 and technical consultant (TC) #2 as listed on the CMS (Centers for Medicare and Medicaid Services) 209 personnel form at 12:00 p.m. on 3/21/2024, the laboratory failed to document as performed, the PVP on the Gem Premier 4000 and 3500 blood gas analyzers every six months for pCO2, pH, pO2. Four of four calibration verifications (PVP) were not performed -- 2 of 3 -- during the timeframe reviewed. Findings include: 1. Calibration verification (PVP) is required every six months on any assay which is calibrated with less than 3 levels of calibration material. This PVP material is provided by the manufacturer. The Gem Premier 4000 and 3500 blood gas analyzers use a single calibrator level to perform calibrations. 2. The Respiratory Department testing personnel utilize three Gem Premier blood gas analyzers. The Gem Premier 4000 is located in the ER (emergency room), one Gem Premier 3500 is located in the ICU (intensive care unit) and the second Gem Premier 3500 analyzer is in the Respiratory Department. Gem Premier blood gas analyzer records for all three revealed calibration verification (PVP) was not performed since the last survey on 6/23/2022. 3. Respiratory TP #7 and TC #2 confirmed in an interview at 12:00 p.m. on 3/21/2024 that a PVP on pH, pCO2 and pO2 was not performed at the appropriate timeframe or frequency during the period of 6/23/2022 through 3/21/2024. Four of four PVP verifications required were not performed and exceeded the six-month timeframe required by the manufacturer. -- 3 of 3 --

Summary Statement of Deficiencies D3007 FACILITIES CFR(s): 493.1101(b) The laboratory must have appropriate and sufficient equipment, instruments, reagents, materials, and supplies for the type and volume of testing it performs. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, observation and interviews with the Histology Supervisor and the Laboratory Director/Technical Supervisor, the laboratory failed to have appropriate equipment to process non-gynecologic cytology specimens for microscopic evaluation. Findings include: 1. The procedure COLLECTION AND SUBMISSION OF GYN AND NON-GYN SPECIMENS stated under Specimen Processing: - Centrifuge specimen for 10 minutes or until a well packed cellular sediment appears at the bottom of the tube. - Sediment is smeared uniformly onto glass slides. 2. The Survey Team observed the laboratory utilized a small LABRET Clinical table-top centrifuge, Model Z100-A to concentrate the non- gynecologic cytology specimens. a. The Survey Team requested the revolutions per minute (RPM) of the centrifuge. The Histology Supervisor replied, "There was no tachometer. The centrifuge is set at setting one, two or three depending on what works best." b. The Survey Team observed on November 14, 2023 at 10:30 AM, the lack of well packed cell sediment following centrifugation of non-gynecologic specimens, which was a result of unknown and insufficient RPM to concentrate the non- gynecologic cytology specimens. 3. During an interview on November 14, 2023 at 10: 30 AM these findings were confirmed by the Histology Supervisor. 4. During an interview on November 15, 2023 at 8:30 AM these findings were confirmed by the Laboratory Director/Technical Supervisor. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D0000 The following condition level deficiencies were cited: D2016 - 42 C.F.R. 493.803 Condition: Successful participation, proficiency testing D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and the CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 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 -- /2022, the laboratory has not successfully performed proficiency testing for Prothrombin Time on three of three events (3rd event of 2021, 1st and 2nd events of 2022). Refer to D2130. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory has not successfully performed proficiency testing for Prothrombin Time in three of three events. Findings include: A review of the laboratory records from the American Proficiency Institute (API) and the CMS CASPER reports 0153D/0155D revealed the laboratory scored the following for Prothrombin Time: Year 2021-3rd Event: 0% Year 2022-1st Event: 20% Year 2022- 2nd Event: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER reports 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 /2022, the laboratory director failed to provide overall management and direction for ensuring Hematology proficiency testing was tested for three out of three events as required under Subpart H. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the American Proficiency Institute and CASPER report 0153D /0155D from the Centers for Medicare and Medicaid Services data system) on 9/23 -- 2 of 3 -- /2022, the laboratory director failed to ensure Hematology proficiency testing was tested as required under Subpart H. The laboratory failed to maintain satisfactory performance in three consecutive events (3rd event of 2021, 1st and 2nd events of 2022) resulting in the subsequent unsuccessful performance for Prothrombin Time. Refer to D2130. -- 3 of 3 --

Summary Statement of Deficiencies D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of quality control (QC) records for the BD Phoenix M50 antimicrobial susceptibility system since 3-5-21, lack of documentation of an Individualized Quality Control Plan (IQCP), and confirmation by the technical supervisor on 6-21-22, the laboratory failed to either perform quality control testing with appropriate control organisms each day of susceptibility testing or develop an IQCP. The technical supervisor confirmed an IQCP was not developed for susceptibility testing performed on the BD Phoenix M50 antimicrobial susceptibility system. Findings include: Review of QC records for the BD Phoenix M50 antimicrobial susceptibility system since 3-5-21 revealed quality control for susceptibility testing was performed weekly with the appropriate control organisms. There was no documentation of establishment of an IQCP, required after 1-1-16 if quality control is not included each day of patient susceptibility testing. The technical supervisor confirmed an IQCP was not developed for susceptibility testing performed on the BD Phoenix M50 antimicrobial susceptibility system. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of testing personnel records from 2/21/2021 through 6/23/22, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form and interview with the technical consultant (TC), the TC failed to evaluate and document the performance of TP #8 in the Cath Lab department and TP # 4, TP #10 and #12 in the OB department at least semiannually during the first year of employment. Findings include: 1. Review of the Cath Lab personnel records indicated that TP #8 had an initial training performed in December 2020 and began testing on patients. An annual evaluation was performed on 12/22/2021. There was no six month evaluation /competency available for review on the day of survey which is required in the first year of testing. 2. Review of the OB nursing department personnel records revealed: a. TP #4 had initial training on 11/11/2021. There was no documented 6 month competency evaluation available for review on 6/23/2022. b. TP#10 had initial training on 11/10/2021. There was no documented 6 month competency evaluation available for review on 6/23/2022. c. TP#12 had initial training on 11/12/2021. There was no documented 6 month competency evaluation available for review on 6/23 /2022. 3. The technical consultant for the Cath Lab and OB nursing departments confirmed in an interview at 3:00 p.m. on 6/23/22 that there was no 6 month evaluation/competency performed on TP #8 in the Cath lab and TP#4, TP#10 or TP#12 in the OB Nursing department. -- 2 of 2 --

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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/20/22, the laboratory has not successfully performed proficiency testing for PROTHROMBIN TIME. Findings include: Our records indicate the following proficiency testing scores for your laboratory for PROTHROMBIN TIME: PROFICIENCY TESTING PROVIDER: American Proficiency Institute PROTHROMBIN TIME: Year 2021 3rd Event 0% Year 2022 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 -- 1st Event 20% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. 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 surveyor desk review of the laboratory proficiency testing (PT) records (graded copies from the proficiency testing provider and the Centers for Medicare and Medicaid Services data system) on 5/20/22, the laboratory has not successfully performed proficiency testing for PROTHROMBIN TIME. Findings include: Our records indicate the following proficiency testing scores for your laboratory for PROTHROMBIN TIME: PROFICIENCY TESTING PROVIDER: American Proficiency Institute PROTHROMBIN TIME: Year 2021 3rd Event 0% Year 2022 1st Event 20% Scores less than 80% for this analyte or parameter indicate failure for unsatisfactory performance. A failure of the analyte or parameter for two consecutive or two out of three testing events is scored as initial unsuccessful performance. -- 2 of 2 --

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of laboratory temperature records since the last survey 3/22/18 and confirmation with a laboratory technical consultant (TC) at 3:00 PM on 2/20/20, the laboratory failed to monitor and document the temperatures of the Beckman Coulter Power Processor Stockyard Refrigeration Unit where patient samples are stored after testing. Findings include: 1. Observation of the laboratory "Stockyard" refrigerator where samples (serology, immunology, chemistry, endocrinology, toxicology, hematology and immunohematology) are refrigerated and stored for at least 6 days revealed that there was no mechanism to monitor the internal temperature. There was no attached thermometer control panel nor was there a calibrated thermometer inside the refrigerator. 2. Beckman Coulter Power Processor Stockyard Refrigeration manufacturer's instructions read that if the laboratory's Stockyard refrigerator does not have a Refrigeration Control Panel Display on the outside of the "Stockyard", the laboratory is to use a calibrated thermometer to check the temperature. The temperature should be read and recorded daily. 3. Beckman Coulter Stockyard manufacturer's instructions require optimal temperature range for sample storage to be between 2 and 8 degrees centigrade. This refrigeration unit houses thousands of post- test samples. These samples have the potential to be used for add-on testing at a later date and must be maintained at the appropriate temperature. 4. Interview with the 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 -- laboratory TC at 3:00 PM on the day of survey confirmed there was no external Refrigeration Control Panel Display on the "Stockyard" nor was there a calibrated thermometer in the refrigerator unit. 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 review of maintenance logs for the two Stago STA Compact MAX coagulation systems (Serial #5031212 and Serial #5031214) from 4-1-18 through 1- 31-20 and confirmation by General Supervisor #2, listed on the Centers for Medicare and Medicaid Services (CMS) 209 Laboratory Personnel Form, the laboratory failed to document daily function checks, as defined by the manufacturer, for the coagulation system in use for eleven days during this time frame. Findings include: Review of maintenance logs for the two Stago STA Compact MAX coagulation systems (Serial #5031212 and Serial #5031214) from 4-1-18 through 1-31-20 revealed the following daily function checks were not documented, as performed, for either of the coagulation systems on 5-2-19, 5-3-19, 5-23-19, 5-24-19, 7-25-19, 9-14- 19, 9-15-19, 10-17-19, 10-18-19, 10-26-19, and 10-27-19: Needle temperature Measuring Block temperature Reagent Drawer temperature Syringe percentage General Supervisor #2 confirmed that one of the two coagulation systems is used every day for patient testing. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the Laboratory Coagulation Procedure Manual, lack of calibration verification records for the two Stago STA-Compact MAX coagulation systems, interview on 2-20-20 at 4:30 p.m. with General Supervisor #2, listed on the CMS Laboratory 209 personnel form, and confirmation by Technical Consultant #2, the laboratory failed to document, as performed, calibration verification for D-dimer and fibrinogen testing at least once every six months since 3-22-18. Findings include: Review of the Laboratory Coagulation Procedure Manual revealed the Calibration Verification policy for the D-dimer and fibrinogen tests state, "Since a pre-calibrated test cannot be calibrated every six months, calibration verification must be performed in lieu of the calibration." On the day of the survey, 2-20-20, there was no documentation of performance of calibration verification for D-dimer and fibrinogen testing on the Stago STA-Compact MAX coagulation systems (Serial #5031212 and Serial #5031214) since the last survey on 3-22-18. In an interview on 2-20-20 at 4:30 p.m., General Supervisor #2 stated calibration verification for D-dimer and fibrinogen testing was not performed since the last survey on 3-22-18. Technical Consultant #2 confirmed calibration verification was not performed for D-dimer and fibrinogen testing since 3-22-18. -- 3 of 3 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records for all events of 2016 and 2017 and the first event of 2018, the (CMS) Centers for Medicare & Medicaid Services 209 personnel form and confirmation by respiratory staff at 11:30am on 3/22 /18, the Respiratory Department failed to rotate the proficiency testing events among all testing personnel responsible for performing patient blood gas testing. 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 review of the Roche Cobas 501 chemistry analyzer (serial number 1394) maintenance form from 4/17/16 to 3/22/18, day of survey and interview with chemistry staff and Roche service representative at 4:00 pm on 3/22/18, the laboratory failed to document as performed the bi-monthly maintenance on the Cobas 501 chemistry analyzer as required by the manufacturer. The following maintenance was not documented as performed according to the required maintenance instructions of the manufacturer: Every 2 Months Maintenance: Replace ISE measuring cartridges 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 -- D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- 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 review of manufacturer's instructions for the Alere Determine Human Immunodeficiency Virus (HIV) 1/2 Combo Test, quality control records, patient test log for HIV testing from 2-11-18 through 3-19-18, lack of documentation of an Individualized Quality Control Plan (IQCP), and confirmation by the technical consultant of serology, the laboratory failed to include a positive and negative control for HIV-1 antibodies, HIV-2 antibodies, and HIV-1 p24 antigen, each day of patient testing during this time frame. A total of sixteen patient HIV 1/2 specimens were tested and results reported on twelve days when controls were not documented as performed on the Alere Determine HIV 1/2 Combo Test. Findings include: Review of manufacturer's instructions for the Alere Determine HIV 1/2 Combo Test revealed the test kit is categorized as moderate complexity for venous whole blood specimens. The technical consultant of serology confirmed the laboratory uses venous whole blood specimens for testing with the Alere Determine HIV 1/2 Combo Test. Review of quality control records for the Alere Determine HIV 1/2 Combo Test and the patient test log from 2-11-18, when the test kit was put in use, through 3-19-18 revealed the laboratory failed to include a positive and negative control for HIV-1 antibodies, HIV- 2 antibodies, and HIV-1 p24 antigen each day of patient testing for twelve days during this time frame when sixteen patient HIV 1/2 results were reported. The technical consultant of serology confirmed an IQCP was not established for the Alere Determine HIV 1/2 Combo Test. -- 2 of 2 --

Summary Statement of Deficiencies D5032 CYTOLOGY CFR(s): 493.1221 If the laboratory provides services in the subspecialty of Cytology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1274, and 493.1281 through 493.1299. This CONDITION is not met as evidenced by: Based on record review, surveyor interview and observation, the laboratory failed to establish written policies and procedures to assess the competency of the cytology staff (refer to D5209); failed to establish written policies and procedures for cytology specimen submission and handling (refer to D5311); failed to establish four written policies and procedures (refer to D5403); failed to perform testing according to the manufacturer's instructions (refer to D5411); failed to ensure all solutions were labeled to identify content (refer to D5415); failed to establish written policies and procedures to determine the causes of discrepancies between the cytology diagnosis and the histopathology diagnosis (refer to D5623); failed to establish written policies and procedures to ensure the search and review of all prior negative gynecologic specimens received within the previous five years was performed (refer to D5625); failed to establish written policies and procedures for the evaluation and comparison of six laboratory statistics (refer to D5629); failed to establish policies and procedures for the evaluation of case reviews of each individual examining slides against the laboratory's overall statistics (refer to D5631); failed to establish written policies and procedures for establishing workload limits, reassessing workload limits, not exceeding workload limits, prorating workload, and documenting workload (refer to D5633, D5637, D5639, D5641, and D5645); failed to establish written policies and procedures to identify and report unsatisfactory specimens or slide preparations (refer to D5655); failed to establish written policies and procedures to ensure nongynecologic test reports contained narrative descriptive nomenclature (refer to D5657); failed to establish written policies and procedures to ensure that corrected Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- reports indicated the basis for correction (refer to D5659); and failed to include the name and address of the laboratory location where the cytology test was performed (refer to D5805). The cumulative effect of these systemic problems resulted in the laboratory's inability to ensure the accuracy and reliability of patient test results in the subspecialty of Cytology. 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 review of laboratory policies and procedures, laboratory records and interview, it was determined that the laboratory failed to establish written policies and procedures to assess Technical Supervisor competency and failed to assess the competency of two of two Technical Supervisors. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the laboratory's process for assessing Technical Supervisor competency. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for two of two Technical Supervisors who performed cytology microscopic evaluations during 2016, 2017 and to the date of the survey in 2018. 3. During an interview on 2/12/18 at 4:30 PM, the Laboratory Director /Technical Supervisor A and Laboratory Manager confirmed these findings. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures and interview, it was determined that the laboratory failed to establish written policies and procedures for the collection and submission of gynecologic and nongynecologic cytology specimens. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures for the following specimen processing requirements for cytology specimens: a. Patient preparation b. Specimen collection c. Specimen storage and preservation d. Conditions for transportation to the laboratory e. Specimen acceptability and rejection 2. During an interview on 2/13/18 at 8:30 AM, the Laboratory Manager stated there were no written procedures for the collection and submission of gynecologic and nongynecologic cytology specimens. 3. During an interview on 2/14/18 at 12:00 PM, the Laboratory Director/Technical Supervisor A and Laboratory Manager confirmed these findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT -- 2 of 15 -- CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Cross Refer to D5311 Based on review of laboratory policies and procedures and interview, it was determined that the laboratory failed to establish written policies and procedures to monitor and assess the preanalytic systems. There were no programs to ensure cytology requirements for specimen submission and handling. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to monitor the quality of the cytology preanalytic laboratory system. 2. The Survey Team requested and the laboratory failed to provide documentation of any cytology preanalytic quality assessment activities or problems. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)