Commonwealth Health Ctr - Laboratory

Summary Statement of Deficiencies D0000 Federal surveyors from the Centers for Medicare & Medicaid Services (CMS) Survey Branch conducted an announced CLIA recertification survey from July 23, 2025 to July 25, 2025. The laboratory was surveyed under 42 CFR part 493 CLIA regulations, and the following condition level and standard level deficiencies were cited. 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 the Centers for Medicare and Medicaid Services (CMS) Form 209, laboratory policies, competency assessments, and confirmed in interview, the laboratory failed to have documentation of a policy to address competency assessments for two of two technical supervisors (TS) also serving as General Supervisors (GS) in 2023 and 2024. Findings Included: 1. Review of the CMS-209 form submitted by the laboratory at the time of survey, revealed two technical supervisors (TS-1 and TS-2) also serving as General Supervisors (GS-1 and GS-2). 2. Review of the laboratory's policies revealed no documentation of a policy to address competency assessment performance of individuals in the TS and GS roles in 2023 and 2024. 3. Review of the laboratory's competency assessments revealed no competency documentation for TSs and GSs. 4. In an interview on 7/23/2025 at 2:07 PM, the Laboratory Director (LD) confirmed the laboratory did not have an established policy for TS and GS competency assessment and did not assess competency for these positions. D5300 PREANALYTIC SYSTEMS Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 14 -- CFR(s): 493.1240 Each laboratory that performs nonwaived testing must meet the applicable preanalytic system(s) requirements in 493.1241 and 493.1242, 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 preanalytic systems and correct identified problems as specified in 493. 1249 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the review of laboratory records, observations of the laboratory, lack of records, and interviews with laboratory staff, the laboratory failed to meet preanalytic system(s) requirements in 493.1241 and 493.1242 for two of two years (July 2023 to July 2025). Findings Included: Refer to D5311 - Failure to establish specimen transportation procedures and specimen transportation criteria. Refer to D5317 - Failure to establish a client service manual. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) (a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (a)(1) Patient preparation. (a)(2) Specimen collection. (a)(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (a)(4) Specimen storage and preservation. (a)(5) Conditions for specimen transportation. (a)(6) Specimen processing. (a)(7) Specimen acceptability and rejection. (a)(8) Specimen referral. This STANDARD is not met as evidenced by: I. Based on observation of received specimen, lack of laboratory procedures, and interview with the laboratory director (LD), the laboratory failed to establish a procedure for specimen storage and transport criteria for five of five specimen received on July 23, 2025. Findings Included: 1. On July 23, 2025 at 5:30 pm, the laboratory received patient specimens fromfrom Tinian, Northern Mariana Islands in a cooler that stated "frozen" that included the following specimens: a. Order#493104 - Collection date 07/23/2025 - Collection Time: 0705 - Tests Requested: Kidney panel. b. Order#495079 - Collection date 07/23/2025 - Collection Time: 0710 - Tests Requested: Vitima B12, Folate and T4Free. c. Order#475960 - Collection date 07/23 /2025 - Collection Time: 0800 - Tests Requested: TSH and T4Free. d. Order#495016 - Collection date 07/22/2025 - Collection Time: 1645 - Tests Requested: Wound Culture and Senetivity. e. Order#495321 - Collection date 07/23/2025 - Collection Time: 1423 - Tests Requested: Amylase. 2. The laboratory received the specimens with an ice pack, documented the receipt as "frozen", and failed to document the receipt temperature and disposition. 3. The LD on July 25, 2025 at 3:00 pm confirmed the laboratory did not have procedure for the conditions for specimen transportation and did not define specific temperature ranges for room temperature, refrigerated and frozen dispositions. Key: TSH = Thyroid Stimulating Hormone. T4Free = Thyroxine. 47107 II. Based on observation of received specimen, review of laboratory procedures, testing records, and interview with the laboratory director (LD), the laboratory failed to establish a procedure for the conditions for specimen transportation for six of six patient samples received (random sampling) for the Chemistry section on July 23, 2025. Findings Included: 1. On July 23, 2025 at 5:30 -- 2 of 14 -- pm, the laboratory received patient specimens from Tinian, Northern Mariana Islands in a cooler that stated "frozen" that included the following specimens: a. Hospital Patient Number #706082, 7/23/25, Iron Profile. b. Hospital Patient Number #701822, 7/23/25, TSH. c. Hospital Patient Number #708194, 7/23/25, TSH. d. Hospital Patient Number #307539, 7/23/25, Iron Profile. e. Hospital Patient Number #303658, 7/23/25, Lipid Panel. f. Hospital Patient Number #158139, 7/23/25, TSH. 2. The laboratory recieved the patient specimens on ice pack and documented as refrigerated, and did not document the disposition of the sample when it was received. 3. Review of the laboratory test records showed an annual test volume of 84,944 for the speciality of Chemistry. 4. In an interview on July 25, 2025 at 3:00 pm, the LD confirmed the laboratory did not have procedure or written instructions to their clients for the conditions for specimen transportation, and did not establish acceptable ranges for specimens received as room temperature, refrigerated or frozen for chemistry specimens. Key: TSH = Thyroid Stimulating Hormone. D5317 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(d) (d) If the laboratory accepts a referral specimen, written instructions must be available to the laboratory's clients and must include, as appropriate, the information specified in paragraphs (a)(1) through (a)(7) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, lack of a client service manual, and interviews with laboratory director (LD), the laboratory failed to ensure the laboratory has provided written instructions to each client that sends specimens and test requests for 2 of 2 years ( July 2023 to July 2025). Finding Included: 1. Review of laboratory procedures on July 23, 2025 at 12:00 pm revealed test procedures included specific requirements for specimen storage and transport. 2. The laboratory was asked to provide instructions given to clients that included specimen handing (e.g., collection, preservation, storage, transport, testing schedule times and how to obtain additional assistance for unusual circumstances). No documentation was provided. 3. By interview with LD on July 25, 2025 at 3:00 pm, laboratory staff confirmed the laboratory does not have a client service manual. 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 review of laboratory records, observations of the laboratory, lack of records and interviews with laboratory staff, the laboratory failed to meet the applicable analytic systems requirements in 493.1251 through 493.1283 for two of two years (July 2023 to July 2025). Findings Included: 1. Refer to D5401 - Failure to follow procedure manual. 2. Refer to D5411 - Failure to follow manufacturer's -- 3 of 14 -- instructions. 3. Refer to D5413 - Failure to monitor humidity and temperature per the manufacturer. 4. Refer to D5415 - Failure to document new stability expiration dates. 5. Refer to D5417 - Failure to discard expired reagents, media, laboratory materials, etc. 6. Refer to D5421 - Failure to assess instruments for functionality when moved to a new locations. 7. Refer to D5439 - Failure to perform calibration verification after major preventative maintenance. 8. Refer to D5445 - Failure to perform quality control each day of patient testing. 9. Refer to D5783 - Failure to perform patient evaluation after unacceptable QC, recalibration, etc. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (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 direct observation, review of laboratory policy, quality control (QC) records, test records, and interview with Testing Personnel (TP)-4, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to follow its own policy to perform patient controls (PCs) every two hours for 22 of 23 days reviewed (July 1 - July 23, 2025). Findings Included: 1. In direct observation on 7/25/2025 at 9: 06 AM, within the Hematology section of the laboratory, Two Sysmex XN "A" and Sysmex XN "B" analyzers (Serial Numbers #s 21720, 21721) were observed in use. 2. Review of the laboratory's policy titled 'Commonwealth Health Center Laboratory Standard Operating Procedures, Category: Hematology, Subject: Hematology Quality Control, Code: HE 21' stated the following QC requirements for the Sysmex XN Hematology analyzer on page 1 of 3: "Quality Control: 2. A Within Run (Patient) control is run every 2 hours using a normal patient sample. a. Due to decreased workload from 2300-0700 Within Run QC may not be run if there are no patient samples." 3. Review of the Sysmex XN-49728-A QC records from 7/1/25 to 7/23/25 revealed the following days patient controls were not run every 2 hours, with some being run every 3, 4 or 5 hours apart: a. 7/1/25 - 09:15, 11:41, 13:31, 14:38, 15:21, 18: 31, 20:42, 22:41, 23:47 b. 7/2/25 - 09:10, 11:11, 13:18, 15:16, 17:47 c. 7/3/25 - 09:10, 11:09, 13:44, 15:20, 17:38, 19:46, 22:08 d. 7/4/25 - 09:22, 11:14, 13:09, 15:15, 17:36, 20:31, 23:35 e. 7/5/25 - 09:23, 10:56, 14:02, 15:47, 18:38, 19:38, 21:43, 23:15 f. 7/6 /25 - 08:13, 08:49, 11:30, 13:10, 16:19, 17:22, 18:43, 20:53, 23:31 g. 7/7/25 - 09:07, 11:05, 13:34, 15:46, 17:29, 19:14, 21:11, 23:27 h. 7/8/25 - 09:20, 11:15, 13:22, 15:15, 17:35, 20:31, 22:36 i. 7/9/25 - 09:10, 11:03, 13:15, 15:05, 17:36 j. 7/10/25 - 09:03, 11: 04, 13:19, 15:27, 17:30, 20:26, 22:44 k. 7/11/25 - 11:03, 13:43, 16:01, 18:23, 21:18, 23:20 l. 7/12/25 - 09:28, 11:18, 13:10, 15:04, 17:40, 20:44, 23:52 m. 7/13/25 - 08:34, 10:14, 12:59, 14:37, 16:33, 18:21, 20:36, 23:09 n. 7/15/25 - 09:03, 09:25, 11:11, 13: 35, 15:13, 17:10 o. 7/16/25 - 09:03, 11:02, 14:35, 16:06, 18:38, 20:31, 23:22 p. 7/17 /25 - 09:05, 11:15, 13:49, 15:24, 18:24, 20:07, 22:41, 23:43 q. 7/18/25 - 9:09, 11:09, 13:15, 15:11, 19:55 r. 7/19/25 - 20:14 s. 7/20/25 - 09:40, 12:48, 13:07, 15:12, 17:15, 19:59, 21:21, 23:13 t. 7/21/25 - 10:00, 11:32, 16:00, 17:16, 19:52, 22:19, 23:55 u. 7/22 /25 - 09:49, 10:39, 12:57, 16:56, 20:51, 22:58 v. 7/23/25 - 00:04, 09:17, 12:21, 13:25, 16:00, 17:44, 21:19, 23:19 4. Review of laboratory test records revealed an annual patient test volume of 30,541 for the specialty of hematology. 5. In an interview on 7 /25/2025 at 9:06 AM, TS-4 confirmed the findings that QC patient controls were not run on the Sysmex XN hematology analyzers within two hours, as per their policy -- 4 of 14 -- requirement, for the aforementioned dates reviewed. 38555 II. Based on review of laboratory procedures and interview with testing personnel (TP) #3, the laboratory failed to establish control procedures in four of eight microscopic examinations procedures from July 25, 2023 to July 25, 2025 (two of two years). Findings Included: 1. Review of laboratory procedures from July 23, 2025 to July 25, 2025 revealed, the laboratory microscopic examinations procedures failed to include control procedures for the following microscopic examinations: a. Microscopic Urinalysis. b. Semen Post Vasectomy c. Stool for white blood cells. d. Urine wet mounts. 2. From July 1, 2023 to July 25, 2025, the following number for examinations were performed: a. Microscopic Urinalysis - 16,217. b. Semen Post Vasectomy - One. c. Stool for white blood cells - 109. d. Urine wet mounts - 377. 3. By interview on July 25, 2025 at 3:00 pm, TP#3 confirmed the above findings. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) (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 manufacturer's instructions, laboratory policy and procedures, calibration records, test records, and interview with the Testing Personnel (TP)-4 the laboratory failed to follow the manufacturer's instruction in establishing a new patient normal mean for two of two new lots used of Dade Innovin reagent for the Sysmex CA-600 analyzers. Findings Included: 1. Review of the manufacturer's package insert titled 'Siemens Healthineers Dade Innovin 11528733_en Rev. 13' stated the following instructions on page 4 of 9: "The mean normal Prothrombin Time (MNPT) is defined as the mean value of the normal range. It must be determined specifically for each thromboplastin lot using the method used to analyze the patient samples and, where appropriate, using the coagulation analyzer used for the analysis. Follow appropriate laboratory guidelines for establishing an MNPT, if applicable. Use of CLSI guideline is recommended." 2. Review of the manufacturer's package insert titled 'Siemens Healthineers PT-Multi Calibrator 11531301_en Rev. 06' stated the following instructions on page 1 of 7: "Principles of procedure: ...The MNPT is in accordance with the ISTH (International Society on Thrombosis and Haemostasis) the geometric mean of the PT of at least 20 healthy adults." Page 6 of 7: "Limitations: The reference curve is valid only for the particular PT. Multi CALIBRATOR lot and lot of Siemens Healthineers thromboplastin reagent. The calibration is instrument and reagent specific. For every new lot of thromboplastin reagent a new calibration is required. A new calibration is further required with change in experimental conditions, software, and after maintenance and repairs of the instrument." 3. Review of the laboratory's policy titled 'CHC Laboratory Document, Establishment of New Patient Normal Mean for PT/INR Testing, Document # CO 110.01 3/2009' stated the following on page 3 of 3: "Procedure: 1. Set up one instrument to run the new low number of reagent. Do not use this instrument to run patients. 2. Following the specimen requirements list above; collect samples from 20 healthy normal people . The samples should be collected from both men and women covering as broad of an adult group as possible. 3. Aliquot and freeze samples when finished testing. 4. Record results on the Coagulation Calibration/Verification Worksheet found elsewhere in this manual. Attach all results to the back of the worksheet. 5. Calculate the average PT of the 20 patients. This is -- 5 of 14 -- the new patient normal mean. 6. Verify the results with the Section Supervisor or Lab Director before programming into the Siemens Sysmex CA560 Analyzers. Procedure Notes: 1. Use one instrument for the new lot number of reagent to establish the mean. Continue using the other instrument to run patient samples. Conspicuously post a notice on the machine running the new lot so patient tests are not performed on it. 2. The newly established mean normal patient PT must be programmed into both Siemens Sysmex CA560 Analyzers prior to testing patient results. 3. Manually calculate the INR to make sure the calculation in the analyzer is working correctly. Record the results on the Coagulation Calibration/Verification Worksheet." 4. Review of the laboratory's calibration records showed the following lots of Innovin used: a. 8/1 /2024 to 11/9/2024 - Lot #84740 b. 11/9/2024 to 6/24/2025 - Lot #84760 No patient normal mean calculation could be retrieved for the two lots in use. 4. Review of the laboratory's test records revealed a total annual patient test volume of 30,054 for the specialty of hematology. 5. In an interview on 7/24/2025 at 4:14 PM, TP-4 confirmed he completed the normal patient mean calculation using an arithmetic mean, not geometric mean in accordance with the manufacturer, when first validating the test years ago, and did not perform the calculation with each new lot in use. In addition, TP-4 confirmed the laboratory failed to define specific healthy adult criteria within their policy. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(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: I. Based on observation of the laboratory, review of manufacturer instrument / equipment manuals, and interview with technical supervisor (TS) #2 and testing personnel (TP) #3, the laboratory failed to monitor and document humidity for a sampling of testing areas in the laboratory (four of four). Findings Include: 1. Observations of the laboratory from July 23, 2025 at 10:00 am to July 25, 2025 at 3: 00 pm revealed, the laboratory areas were set up into different spaces based on the type of testing performed, the following areas were observed that did not monitor humidity: a. Microbiology. b. Urinalysis. c. Hematology. d. Immunohematology (Blood bank). 2. The following instrument / equipment manufacturer manuals stated the following humidity requirements: a. Microbiology - July 23, 2025 at 10:00 am. - BioMerieux Biofire Torch operator manual, performance specifications stated, "15 C to 30 C at 20 to 80% relative humidity". - Olympus BX46 clinical microscope instructions, 9. Operating Environment, stated "Maximum relative humidity: 80% for temperatures up to 31C (88F), decreasing linearly through 70% at 34C (93F), 60% at 37C (99F), to 50% relative humidity at 40C (104F)". b. Urinalysis - July 24, 2025 at 3: 00 pm. - Olympus BX46 clinical microscope instructions, 9. Operating Environment, stated "Maximum relative humidity: 80% for temperatures up to 31C (88F), decreasing linearly through 70% at 34C (93F), 60% at 37C (99F), to 50% relative humidity at 40C (104F)". c. Hematology - July 24, 2025 at 3:45 pm. - Olympus BX46 -- 6 of 14 -- clinical microscope instructions, 9. Operating Environment, stated "Maximum relative humidity: 80% for temperatures up to 31C (88F), decreasing linearly through 70% at 34C (93F), 60% at 37C (99F), to 50% relative humidity at 40C (104F)". d. Immunohematology (Blood bank) - July 25, 2025 at 11:00 am. - Helmer Scientific Ultra CW II, operator manual stated, "Relative humidity (maximum for ambient temperature): 80% for temperatures up to 31 C, decreasing linearly to 50% at 40 C." 3. The laboratory could not provide documented humidity conditions for the above testing area with instruments / equipment that have humidity requirements. 4. By interviews, TS#1 and TP#3 confirmed the above findings on July 25, 2025 at 3:00 pm. II. Based on observation of the microbiology laboratory, review of manufacture instructions, and interview with technical supervisor (TS) #2, the laboratory failed to monitor room temperature that is consistent with the manufacturer's instructions for one of one box of AFB check control slides. Findings Included: 1. Observation of the microbiology laboratory on July 23, 2025 at 2:30 pm revealed one box of Fisherbrand AFB check control slides kept at room temperature. 2. The box of Fisherbrand AFB check control slides, package insert stated a temperature requirement to be kept at room temperature (20C - 30C). 3. Review of the laboratory temperature records revealed, the laboratory room temperature range was 19 C to 25 C. 4. In 2024, the microbiology room temperature was lower than the manufacturers established temperature range from August to December. 5. By interview, TS#2 confirmed the findings above on July 23, 2025 at 2:45 pm. III. Based on observation of the blood bank laboratory, review of manufacture instructions, and interview with testing personnel (TP) #3, the laboratory failed to monitor room temperature that is consistent with the manufacturer's instructions when performing RPR tests during a sample of three of three months in 2025. Findings Included: 1. The BD Macro-vue RPR card test, reagents stated, "Therefore, upon removal from the refrigerator, allow the antigen to warm to room temperature (23C - 29C) before use. 2. Observation of the blood bank on July 25, 2025 at 2:30 pm revealed one box of BD Macro-vue RPR card test, reagents were stored at room temperature in the Blood bank laboratory. 3. Review of the blood bank laboratory temperature records revealed, the laboratory room temperature range was 19 C to 25 C. 4. Further review of blood bank room temperature records showed the following number of days temperature were below the manufacturers established ranges: a. February 2025 - 28 out of 28 days. b. June 2025 - 30 out of 30 days. c. July 2025 - 24 out of 25 days. 5. By interview with TP#3 on July 25, 2025 at 2:45 pm confirmed the laboratory room temperatures established acceptable ranges fell outside of the manufacturers range. Key: RPR = Rapid Plasma Reagin. AFB = Acid-fast bacilli. 47107 IV. Based on direct observation, manufacturer's instructions, humidity records, and interview with the Testing Personnel (TP)-4, according to the Centers for Medicare and Medicaid (CMS) Form 209, the laboratory failed to define, monitor and document the humidity in the laboratory for two of two rooms (hematology and coagulation) where analyzers with humidity requirements were in use. Findings Included: 1. In direct observation on 7/25 /2025 at 9:06 AM the following were seen in the hematology and coagulation sections: a. Hematology section - Two Sysmex XN "A" and Sysmex XN "B" analyzers (S/N #s 21720, 21721) were observed in use. b. Coagulation section - Two Sysmex CA 660 "A" and "B" analyzers (S/N #s 25099, 25090) were observed in use. 2. Review of the manufacturer's instructions for both analyzers stated the following: a. Sysmex XN 1000 manufacturer's instructions titled 'Sysmex XN 1000 product fact sheet': "Operative humidity 30-85%". b. Sysmex CA 660 manufacturer instructions titled 'Sysmex Product Fact Sheet CA-650/CA-660': "Technical Specifications, Humidity, 30% - 85%". 3. Review of the laboratory's humidity records revealed no humidity ranges defined, monitored or documented in the hematology and coagulation sections where the analyzers were in use. 4. In an interview on 7/25/2025 at 9:15 AM -- 7 of 14 -- in the laboratory, TP-4 confirmed the laboratory had not defined, monitored or documented humidity in the hematology and coagulation sections of the laboratory. V. Based on direct observation, manufacturer's instructions, review of the freezer temperature ranges, and interview with TP-6, according to the CMS Form 209, the laboratory failed to define freezer temperature ranges consistent with the manufacturer's instructions, for 4 of 4 Bio-Rad Liquicheck control reagent boxes. Findings Included: 1. In direct observation on 7/24/25 at 9:31 AM, the following reagent boxes were found stored in the freezer (Midea, #03706): a. 1 box Bio-Rad Liquicheck Pediatric Control, Lot #74922, Manufacturer storage temperature requirements: -70 to -20 degrees C. b. 1 box Bio-Rad Liquicheck Elevated CRP Level 1 Control, Lot #90911, Manufacturer storage temperature requirements: -70 to -20 degrees C. c. 1 box Bio-Rad Liquicheck Elevated CRP Level 2 Control, Lot #90912, Manufacturer storage temperature requirements: -70 to -20 degrees C. d. 1 box Bio- Rad Liquicheck Elevated CRP Level 3 Control, Lot #90913, Manufacturer storage temperature requirements: -70 to -20 degrees C. 2. Review of the Midea #03706 freezer settings in the chemistry section stated a range of -18 degrees C or colder. 3. In an interview on 7/24/25 at 9:35 AM, TP-6 confirmed that the freezer temperature ranges were not set and defined to follow manufacturer instructions of reagent controls stored within. Key: CRP = C-reactive protein. 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: Based on direct observation, review of manufacturer's instructions, lack of records, and interview with testing personnel (TP) #3, the laboratory failed to indicate the revised stability expiration date on one of one lot of BioRad Virotrol RPR Panel quality control (QC) when opened. Findings Included: 1. The manufacturer's instructions for the BioRad Virotrol RPR Panel QC stated, "60 day open-vial stability at 2-8C. 2. Direct observation of the laboratory on July 25, 2025 at 1:00 pm revealed one box of BioRad Virotrol RPR Panel QC in use did not include a new expiration date that matched the 60 day stability. 3. Review of RPR QC records revealed the previous lot of BioRad Virotrol RPR Panel QC (lot#127160) was in use from January 5, 2024 to August 30, 2024 (238 days). 4. Approximately 1387 RPR tests were performed from July 25, 2023 to July 25, 2025. 5. On July 25, 2025 at 2:00 pm, by interview TP#3 confirmed the laboratory used the BioRad Virotrol RPR Panel QC was used beyond the 60 day stability. Key: RPR = Rapid Plasma Reagin. 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. -- 8 of 14 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, interview with technical supervisor (TS) #1 and testing personnel (TP) #4, the laboratory failed to ensure a sampling of bacteriology media plate (8 of 56) and one of two containers of pH strips were not available for use after they exceed their expiration dates. Findings Included: 1. Observation of the microbiology laboratory on July 23, 2025 at 10:00 am, revealed the following expired media available for use for patient tesing: a. Two of three Remel HE agar plates. b. One of two Remel TM agar plates. c. Five of sixteen Remel CNA agar plates. 2. Observation of the hematology laboratory on July 23, 2025 at 3: 00 pm, revealed one container of LRS Universal Plastic pH strips expired October 15, 2023. 3. Interview with TS#1 and TP#4 , on July 23, 2025 at 3:30 pm confirmed the above media and pH strips were expired. Key: TM - Thayer Martin. HE - Hektoen enteric. pH - potential of hydrogen. CNA - Columbia Nalidixic Acid. 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: I. Based on observation of the laboratory, lack of documentation and interview with technical supervisor (TS) #1, the laboratory he laboratory failed to perform verification studies for six of six microbiology test systems after instrumentation relocation in May 2024. Findings Included: 1. During the introduction of the survey, on July 23, 2025 at 10:30 am, observation of the laboratory revealed the laboratory was under construction. 2. While observing the microbiology laboratory, TC#1 was asked if any test systems have been moved in the past two years, in which they replied "yes". 3. The laboratory was asked to provide documentation of verification studies after the relocation. No documentation was provided. 4. The following microbiology test systems were moved in May of 2024: a. Two Cepheid GeneXpert system with four modules. b. One Cepheid GeneXpert system with sixteen modules. c. Two BioMerieux Vitek2. d. One BioMerieux Biofire Torch. 5. TS#1 on July 23, 2025 at 2: 00 pm confirmed the above findings. 6. Per form CMS 116, signed by the laboratory director on July 23, 2025, there were 9,100 microbiology tests performed annually. 47107 II. Based on observation of the laboratory, lack of documentation and interview with the Laboratory Director (LD), and test records, the laboratory failed to perform performance verification studies for two of two Hematology analyzers and two of two Coagulation analyzers after instrument relocation in April of 2024. Findings Included: 1. During the introduction of the survey, on July 23, 2025 at 10:30 AM, observation of the laboratory revealed the laboratory was under construction; the following analyzers were seen in use: a. Hematology - Two Sysmex XN 'A' & 'B' analyzers (S /Ns # 21720, 21721) b. Coagulation - Two Sysmex CA-600 Series 'A' & 'B' analyzers (S/Ns # 25099, 25090) 2. Review of the laboratory's procedures and documentation of accuracy verification yielded no findings of either documentation of performance verification being performed or a policy/procedure. 3. Review of the laboratory's test records revealed an annual total patient test volume of 30,541 for the specialty of -- 9 of 14 -- hematology. 4. The LD on July 25, 2025 at 12:59 PM confirmed the laboratory did not perform verification of performance specifications (accuracy and precision) after relocation. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (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 instrument preventative maintenance records (random review May-December 2024), calibration records, test records, and confirmed in interview, the laboratory failed to perform calibration verification to ensure the accuracy of the Siemens Dimension EXL analyzer after there was a major preventative maintenance and/or replacement of critical parts that may influence test performance for 3 of 3 Integrated Multi-Sensor (IMT) analytes that used single point calibration. Findings Included: 1. Review of the laboratory instrument preventative maintenance records revealed the following dates when a major preventative maintenance and/or replacement of critical parts occurred by Siemens Healthineers (service technicians): a. 5/6/2024 - Contract #0450096718 - Employee #196995 -

Summary Statement of Deficiencies 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 direct observation and laboratory testing personnel interview on April 24, 2023 at 10:12 am, it was determined that the laboratory failed to ensure that all reagents were not available for use when they have exceeded their expiration date. Findings include: a. During a tour of the Microbiology section of the laboratory, it was observed that Gram stain reagent, BBL Gram Iodine, Lot #1145691, had an expiration date of December 31, 2022, which was found among other Gram stain reagents used for patient testing that were available for use in patient testing. b. The laboratory personnel and manager confirmed that the Gram Iodine reagent was available for use when it had exceeded its expiration date. c. According to laboratory personnel, the laboratory performs approximately 108 Gram stains on patient specimens annually. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of quality control (QC), one of one patient result, proficiency testing (PT) and interview, the laboratory failed to perform a positive control with graded or titered reactivity for quantitative syphilis testing. Findings: 1. Review of rapid plasma reagin (RPR) quality control revealed the laboratory failed to perform a positive control with a graded or titered result. 2. Review of PT showed results of graded amounts reported to the proficiency provider. 3. Review of one of one patient report showed a result with a titered amount for quantitative RPR. 4. Phone interview with the laboratory director on December 2, 2021 at 4:00 PM confirmed the laboratory failed to perform a graded or titered positive control at least once a day for RPR testing. D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. 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 -- This CONDITION is not met as evidenced by: Review of personnel records and interview with the laboratory director, one of seven testing personnel did not have academic qualifications required to perform high complexity testing (Refer to D6171). D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals -- 2 of 3 -- qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on the lack of academic credentials and interview with the laboratory director (LD), the laboratory failed to provide academic credentials to qualify one of seven testing personnel (TP) for high complexity testing. Findings: 1. The laboratory could not provide foreign equivalency documentation to verify academic credentials for TP #7. 2. Interview with the LD on September 24, 2021 at 3:30 PM confirmed the documentation needed to qualify testing personnel #7 was not available for review. -- 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 proficiency testing record review and laboratory director and testing personnel interviews on March 28, 2019, the laboratory failed to ensure that proficiency testing samples were examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory. Findings include: a. The laboratory's bacteriology section has one fulltime lead microbiologist, one full time technologist and one backup technologist. b. The laboratory's copy of the attestation statements for all bacteriology proficiency testing (CAP D module) events for 2017 and 2018 indicated that the lead microbiologist performed all six proficiency testing events. c. The laboratory's copy of the attestation statements for all GC/Chlamydia proficiency testing ( CAP GC/CHLAM HC7 module) events for 2017 and 2018 indicated that the lead microbiologist performed all six proficiency testing events. d. The laboratory's copy of the attestation statements for all mycobacteriology proficiency testing (API AFB module) events for 2017 and 2018 indicated that the lead microbiologist performed all four proficiency testing events. e. The laboratory director and the microbiology testing personnel confirmed by interview on March 28, 2019 at approximately 12:45 pm that all personnel listed at (a) routinely performed patient testing covered by proficiency testing modules listed at (b), (c) and (d). D5543 HEMATOLOGY CFR(s): 493.1269(a)(d) 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 -- (a) For manual cell counts performed using a hemocytometer-- (a)(1) One control material must be tested each 8 hours of operation; and (a)(2) Patient specimens and control materials must be tested in duplicate. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on the laboratory's cerebral spinal fluid (CSF) hemocytometer patient testing record review and laboratory personnel interviews on March 29, 2019, the laboratory failed to perform quality control procedures as required for manual cell counts performed using a hemocytometer. Findings include: a. The laboratory performed manual CSF cell counts using a hemocytometer. b. For 11 of 11 randomly selected CSF patient records from March 2017 to January 2019, the laboratory maintained no documentation to indicate that quality control materials were tested on the days of patient testing. c. The laboratory staff and laboratory director confirmed by interview on March 29, 2019 at approximately 10:35 am that the laboratory did not maintain and test quality control materials for CSF hemocytometer body fluid testing. d. Based on record review the laboratory tested 4-5 CSF patient specimens monthly . D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 a random review of the laboratory's transfusion records from March 2017 through March 2019 and interview with the transfusion lead technologist and laboratory director on March 29, 2019, the laboratory failed, according to its established procedures, to promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility, and make recommendations to the medical staff regarding improvements in transfusion procedures. Findings include: a. The laboratory performs compatibility testing for transfusion services. The laboratory and hospital policies define a transfusion reaction as "a change in blood pressure +/- 30 mmHg." Laboratory policy states that when the laboratory receives post-transfusion information indicating that a change of +/- 30 mmHg blood pressure occurred post-transfusion, and hospital staff did not declare a transfusion reaction had not occurred, the laboratory is to notify the nursing staff to initiate a transfusion reaction workup. b. For 1 (XBX9651 transfused on March 07, 2019) of 8 randomly selected patient transfusion records from March 2017 through March 2019, laboratory records indicated that the patient had a pre-transfusion blood pressure of 117/41 mmHg, and a post-transfusion blood pressure of 74/41 mmHg, a drop of 41 mmHg. c. The laboratory maintained no documentation that the laboratory had notified nursing -- 2 of 4 -- staff to initiate a transfusion reaction workup for patient XBX9651. d. The laboratory director and the nursing director confirmed by interview on March 29, 2019 at approximately 12:30 pm, that the laboratory had not initiated a transfusion reaction workup for patient XBX9651. e. The laboratory reports performing approximately 134 transfusion compatibility tests annually. 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 laboratory record review and staff interviews on March 28, 2019, the laboratory failed to have a system in place that twice a year evaluates and defines the relationship between test results using different instruments. Findings include: a. The laboratory performed patient complete blood counts (CBC) on Penta ABX 60 and Penta ABX 80 hematology analyzers. The laboratory had no documentation of performing twice annual evaluations to determine the relationship between the two analyzers. b. The laboratory performed patient coagulation tests on two Siemens Sysmex 600 analyzers. The laboratory had no documentation of performing twice annual evaluations to determine the relationship between the two analyzers. c. By interview on March 28, 2019 at approximately 1:18 pm, the laboratory director and laboratory testing personnel confirmed the lack of such documentation between the analyzers listed in (a) and (b) . d. The laboratory reportedly tested approximately 24,313 patient CBC and coagulation specimens annually. D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on the laboratory's proficiency testing record review for bacteriology and microbiology, and interview with testing personnel on March 28., 2019, the laboratory director failed to ensure that proficiency testing samples are tested by personnel who routinely perform the testing in the laboratory. Findings include: Proficiency record review for bacteriology and mycobacteriology indicates that the same individual performed all the proficiency testing for the bacteriology/mycobacteriology proficiency testing modules for 2017 and 2018. See D2007. D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on laboratory's record review and staff interview on March 28-29, 2019, the laboratory director failed to ensure that the quality control programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. Findings include: The laboratory performs manual cerebral spinal fluid cell counts. The laboratory failed to provide evidence quality control material or documentation of quality control performed. See D5543. D6123 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(iii) The procedures for evaluation of the competency of the staff must include, but are not limited to review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. This STANDARD is not met as evidenced by: Based on review of the laboratory's annual competency records for the years 2017 and 2018, and personnel interviews on March 28, 2019, the technical supervisor failed to ensure the procedures for evaluation of the competency of the staff included, but are not limited to, review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records and direct observation. Findings include: a. Although the laboratory had indicated on their annual competency form that all testing personnel were competent in preanalytical , analytical and postanalytical processes, the laboratory did not have documentation on how this competency was determined. b. The laboratory director and section lead personnel confirmed by interview on March 28, 2019 at approximately 10.35 am the lack of identification and documentation of how personnel competency was assessed. c. The laboratory reports testing approximately 92,391 patient specimens annually. -- 4 of 4 --