Glen Rose Medical Center

Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey completed on November 11, 2025. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor direct observation and confirmed in interview, the laboratory failed to remove 20 of 31 expired sodium (Na) citrate (blue top) vacutainer tubes used in patient blood draws for patient testing from use. The findings included: 1.During a tour of the laboratory, on 11/10/2025 at 13:50 hours, the surveyor found 20 following expired tubes in draw station 3: BD Vacutainer Lot 4344934, exp 2025-09-30, Na Citrate 2. In an interview on 11/10/2025 at 13:55 hours, in draw station 3, the general supervisor (GS) 2 confirmed the tubes were expired and were available for patient use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) 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 Aerospray Hematology Pro Model 7152 Applications Manual, laboratory maintenance logs, and interview with laboratory personnel, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- failed to perform and document 20 of 20 weekly maintenance procedures and 5 of 5 monthly maintenance procedures from March 1, 2025, through July 31, 2025. The findings included: 1. Based on review of the Aerospray Hematology Pro Model 7152 Applications Manual, under Section 5 - PREVENTIVE MAINTENANCE AND SAFETY, page 60, the manual stated the following: Weekly Maintenance 1. Wipe the carousel tray and lid using 70-100 percent alcohol. 2. Perform a Volume Test (Section 6.4) 3. Perform a Hub Pattern Testing (Section 4.1). NOTE: If staining will not be performed immediately run a clean cycle after Volume and Hub Pattern tests. 4. Manually clean the nozzles if necessary. 5. Wipe the carousel tray and lid using 70 to 100 percent alcohol 6. Slowly pour 200-300 mL of water into instrument drain to prevent buildup of paper fibers, precipitates, etc. Verify drain is flowing properly and not allowing fluid to back up in bowl or flow out of air vent on case back. 7. Ensure the maintenance procedures listed on the Maintenance Log have been performed and entered into the chart or log." Under Monthly Maintenance, the manual stated the following on page 61: "1. Disassemble and manually clean all nozzles. Refer to Nozzle Disassembly and Cleaning (Section 6.1). 2. Perform a Volume Test (Section 6.4) and Hub Pattern Test (Section 4.1) Section 4.1). NOTE: If staining will not be performed immediately run a clean cycle after Volume and Hub Pattern tests. 3. Disinfect any reagent bottle that is being reused (Section 5.5) 4. Ensure the maintenance procedures in the Preventative Maintenance (PM) log have been performed and entered into the PM chart of log." 2. Based on review of Aerospray Hematology Pro stainer maintenance logs from March 1, 2025, through July 31, 2025, 20 of 20 weekly maintenance procedures were not performed and documented and 5 of 5 monthly maintenance procedures were not performed and documented. 3. In an interview at 11:55 hours on 11/11/2025, the laboratory manager confirmed the missing maintenance had not been documented elsewhere and stated there had been a transition between hematology department leads that may account for the missing maintenance on the hematology slide stainer. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) (d)(3)(ii) Each qualitative procedure, include a negative and positive control material; This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, MEDTOX Scan Reader user manual, laboratory quality control records, laboratory patient testing records, and interview with laboratory personnel, the laboratory failed to perform both positive and negative qualitative control each day of patient testing for 29 of 34 days of testing between May 1, 2025, and July 31, 2025. The findings included: 1. Based on review of the laboratory's policy, "1967 MEDTOX Drugs of Abuse Test System", under section V. Quality Control, the policy stated the following: "External controls are urine-based control materials that contain the drugs to be tested at concentrations above the cutoff (positive control) or contain no drug (negative control). Run external controls as they were patient samples. External controls should be ran routinely or as needed for any of the following reasons: To practice the test with a known control. When you open a new lot of devices. Once per week. This is recorded int he LIS. If you suspect that the reader or test device is not working properly. If you have had a repeated unexpected test result. If you suspect that the test devices have been stored improperly. If external controls do not perform as expected, no patient testing is to be performed until the source of the failed QC is identified." 2. Based on review of the MedTox Scan Reader User manual, on page 26, under Quality Control, the manual stated the following: -- 2 of 5 -- "External controls are urine-based control materials that contain the drugs to be tested at concentrations above the cutoff (positive control) or contain no drug (negative control). Run external controls as they were patient samples. Refer to the instructions that accompany the external controls. You should run external controls routinely or as needed for any of the following reasons: (1) to practice the test with a known control, (2) when you open a new lot of devices, (3) once a week, (4) if you suspect that the Reader or test device is not working properly, (5) if you have had a repeated unexpected test result, or (6) if you suspect that the test devices have been stored improperly. External quality control materials are available from MEDTOX and other commercial sources." 3. Based on review of MEDTOX quality control records, positive and negative controls were performed on the following dates between May 1, 2025, and July 31, 2025: 05/02/2025 05/07/2025 05/21/2025 05/28/2025 06/04/2025 06/11/2025 06/18/2025 06/25/2025 07/01/2025 07/09/2025 07/16/2025 07/23/2025 07 /30/2025 4. Based on review of patient records, 43 patients were tested between May 1, 2025, and July 31, 2025. The laboratory performed patient testing on 34 days during this time, and quality control was not performed on 29 of the 34 days. The following 34 patients were tested on days when quality control was not performed: Patient Date 59845 5/4/2025 93767 5/6/2025 164942 5/18/2025 147352 5/19/2025 165003 5/22/2025 165055 5/27/2025 155487 5/29/2025 14223 6/3/2025 165161 6/7 /2025 93843 6/8/2025 87137 6/13/2025 131846 6/20/2025 30834 6/22/2025 39206 6 /22/2025 165319 6/24/2025 55059 6/29/2025 165365 6/29/2025 57115 6/30/2025 131519 6/30/2025 62706 7/3/2025 165424 7/5/2025 37446 7/6/2025 116026 7/6/2025 144198 7/8/2025 30822 7/12/2025 67949 7/12/2025 165496 7/14/2025 159003 7/15 /2025 92692 7/17/2025 165579 7/22/2025 163177 7/24/2025 165598 7/25/2025 11452 7/26/2025 165658 7/31/2025 5. In an interview at 11:50 hours on 11/11/2025, the Laboratory Manager confirmed the laboratory had not established an individualized quality control plan to reduce quality control frequency for the MEDTOX Drugs of Abuse System and that quality control was performed weekly, not each day of patient testing. D5465 CONTROL PROCEDURES CFR(s): 493.1256(d)(8)(g) (d)(8) Test control materials in the same manner as patient specimens. This STANDARD is not met as evidenced by: Based on review of laboratory policy, manufacturer instructions for the Germaine Laboratories, Inc. AimTab Ketone Tablets, patient testing records, and interview with laboratory personnel, the laboratory failed to run a serum matrix control when running serum patient samples for 13 of 13 patients tested between May 1, 2025, and July 31, 2025. The findings included: 1. Based on review of the laboratory policy "490 Acetest AimTab Ketone Tablets", under Section VII - Quality Control, the policy stated the following: "BioRad Bilevel Urinalysis 1 (Negative) and 2 (Positive) must perform as expected. A positive result will turn the tablet a dark purple. A negative result will be indicated by the tablet remaining colorless. Controls must be ran alongside each patient sample and results entered into the LIS> QC must be performed on all new lot numbers and shipments before patient samples are run." 2. In contrast, the laboratory's individualized quality control plan (IQCP) titled "Acetone Serum Ketone", under Quality Control, stated the following: "JCO requires policy to be performed to as described in WT.01.01.01 EP1, policy was formed on the basis of the manufacturer's package insert and recommendations. Manufacturer states to use with each new lot and operator. GRMC policy states to run external negative and positive controls (Sure -- 3 of 5 -- Vue Mono HCG controls for serum), with each new lot, each new shipment, with each new operator, and minimally every 30 days. This IQCP to address serum testing only." 4. Based on a review of the manufacturer's instructions-for-use of the "AimTab Ketone Tablets", under QUALITY CONTROL, the instructions stated the following: 'Performance can be confirmed by using commercially available positive and negative control materials. Contact Germine Laboratories at 210-692-4192 for a list of acceptable control materials." The Germaine Laboratories, Inc. document "Approved List of Controls for AimTab Ketone Tablets" listed the following acceptable serum control materials: Reference 13112 Ketone Serum Controls by Germaine Laboratories - Serum 5. Based on a review of patient testing performed between May 1, 2025, and July 31, 2025, the laboratory tested the following 13 patient samples for serum ketones: Sample ID Performed On 1271193 05/28/2025 1272097 06/03/2025 1272309 06/04/2025 1272659 06/05/2025 1273407 06/11/2025 1274476 06/18/2025 1274983 06/22/2025 1276237 06/25/2025 1277547 07/04/2025 1277631 07/05/2025 1278210 07/09/2025 1278380 07/10/2025 1278543 07/12/2025 6. In an interview at 10:52 hours on 11/11/2025, the Laboratory Manager confirmed the laboratory was not using a serum matrix control when performing quality control for the Germaine AimTab Ketone tablets when performing patient testing for serum ketones. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood shall be stored in a clean and orderly environment in a manner to prevent mix-ups. Expired blood must not be in the routine inventory. Unacceptable units must be segregated from routine inventory. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. This STANDARD is not met as evidenced by: I. Based on laboratory policy, manufactures instructions for use, review of blood bank temperature recorder charts, and confirmed in interview, the laboratory failed ensure quarterly alarm verifications were performed appropriately by biomed for the blood banks continuous monitoring system for one of one refrigerator where blood and blood products were stored for records reviewed in 2024. The findings included: 1. Review of the laboratory policy titled "Blood Bank Maintenance Schedule" section "Quarterly" included the following instructions: "1. Blood Bank Refrigerator: Alarm Verification will be performed by Glen Rose Medical Center's Biomedical personnel. Records of this maintenance are kept in the Maintenance Director's office. 2. Blood Bank Freezer: Alarm Verification will be performed by Glen Rose Medical Center's Biomedical personnel. Records of this maintenance are kept in the Maintenance Director's office. The procedure can be found on page 6 of the Jewett Hema Pro Digital Temperature Power Monitor manual. This manual is in the Blood Bank Equipment Manual binder located in the cabinet above the Blood Bank computer." 3. The following refrigerator was available for the storage of blood and blood products: Helmer Scientific Refrigerator, ID: DFW100639 2051595 4. Surveyor asked for the documentation biomed quarterly alarm verification for 2024 and 2025 for the Helmer Scientific Blood Bank Refrigerator and was provided with documentation for an annual PM in March 2024 that did not include documentation of an alarm verification. Review of the blood bank continuous temperature wheel charts for the duration of March 2024 did not include documentation of a temperature shift to indicate a temperature challenge for the alarm verification. 5. In an interview on 11/11/2025 at 14:58 hours, in the conference room via phone, the biomed representative confirmed -- 4 of 5 -- that the blood bank refrigerator only received annual preventive maintenance, and that the temperature verifications were not documented appropriately. II. Based on laboratory policy, manufactures instructions for use, review of blood bank temperature recorder charts, and confirmed in interview, the laboratory failed ensure quarterly alarm verifications were performed appropriately by biomed for the blood banks continuous monitoring system for one of one freezer where blood and blood products were stored for records reviewed in 2024. The findings included: 1. Review of the laboratory policy titled "Blood Bank Maintenance Schedule" section "Quarterly" included the following instructions: "1. Blood Bank Refrigerator: Alarm Verification will be performed by Glen Rose Medical Center's Biomedical personnel. Records of this maintenance are kept in the Maintenance Director's office. 2. Blood Bank Freezer: Alarm Verification will be performed by Glen Rose Medical Center's Biomedical personnel. Records of this maintenance are kept in the Maintenance Director's office. The procedure can be found on page 6 of the Jewett Hema Pro Digital Temperature Power Monitor manual. This manual is in the Blood Bank Equipment Manual binder located in the cabinet above the Blood Bank computer." 3. The following refrigerator was available for the storage of blood and blood products: Jewett - Freezer, ID:DFW100638 U23U-143040-UU 4. Review of the "Jewett Hema Pro Digital Temperature Power Monitor", page 6, included the following instructions: "1. Hemapro Low Alarm Activation (Always check the low activation first) a. Fill an 8 ounce glass half full of chilled water (+4(degrees) C.). b. Crush ice 1/8/" particles in a separate container. c. Remove the thermistor sensor from the solution bottle, tape or rubber band the probe to test the thermometer (NBS Certified) then insert into the glass. The thermistor sensor and test the thermometer must be at the same level. d. Slowly add crushed ice at the proper rate to provide a temperature drop of no more than 0.5(degrees)C. per minute (approximately 1 teaspoonful every 15 to 25 seconds). e. Stir the test thermometer and thermistor in a circular motion, keeping the ends in the lower liquid, not in the upper ice slurry. f. Log the low alarm activation. 2. HemaPro High Alarm Activation a. Slowly add warm water to the ice slurry (refrigerators) or a container of pre-cooled (-30(degrees) C.) antifreeze solution (freezers) at the proper rate to provide a temperature rise of no more than 0.5(degrees) C. per minute. b. Stir the test thermometer and thermistor in a circular motion, keeping the ends in the lower liquid not the upper ice slurry. c. Log the high alarm activation. 3. Check and log the reaction of the remote monitor during these test procedures if applicable." 5. Surveyor asked for the documentation biomed quarterly alarm verification for 2024 for the Jewett Blood Bank Freezer and was provided with documentation for an annual PM in March 2024 that did not include documentation of an alarm verification. Review of the blood bank continuous temperature wheel charts for the duration of March 2024 did not include documentation of a temperature shift to indicate a temperature challenge for the alarm verification. 6. In an interview on 11 /11/2025 at 14:58 hours, in the conference room via phone, the biomed representative confirmed that the blood bank freezer only received annual preventive maintenance, and that the temperature verifications were not documented appropriately. -- 5 of 5 --

Summary Statement of Deficiencies D0000 The laboratory was surveyed in response to complaint TX for compliance with CMS 42CFR regulations. Complaint TX00471994 was substantiated. CONDITION LEVEL DEFICIENCIES were found to be out of compliance: 493.801 Enrollment and testing of [proficiency testing] samples 493.1441 Laboratory Director, high complexity 493.1447 Technical Supervisor D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the laboratory failed to meet the requirements of participating in PT for the specialty of Hematology. The laboratory did not ensure proficiency testing samples were tested as required and engaged in any inter-laboratory communications pertaining to the results of proficiency testing samples. Refer to D2011 and D2013. D2011 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- Laboratories that perform tests on proficiency testing samples must not engage in any inter-laboratory communications pertaining to the results of proficiency testing sample (s) until after the date by which the laboratory must report proficiency testing results to the program for the testing event in which the samples were sent. Laboratories with multiple testing sites or separate locations must not participate in any communications or discussions across sites/locations concerning proficiency testing sample results until after the date by which the laboratory must report proficiency testing results to the program. This STANDARD is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the laboratory engaged in inter-laboratory communications with another laboratory Glen Rose Medical Center Pecan Location(CLIA #45D1071102) prior to their submission for 3 of 5 testing events in 2022 and 2023 (2022 Event 3, 2023 Events 1 and 2). The laboratory manager had access to and knowledge of the PT results for both locations. Findings included: 1. The laboratory's PT policy "Proficiency Testing" revealed: "III. Proficiency Testing Requirements ... D. GRMC and PFC laboratories are not in any way permitted to send PT samples to another laboratory for analysis. This includes sending samples back and forth to each other. Each lab is enrolled separately in the PT program and must not test samples for or send samples to the other laboratory until after the result submission deadline for that testing event has passed. E. GRMC and PFC laboratories are not in any way permitted to communicate with another laboratory about the PT results. This includes communicating about PT results back and forth with each other. Each lab is enrolled separately in the PT program and must not share results with the other laboratory until after the result submission deadline has passed. F. It is the responsibility of GRMC Lab as well as PFC Lab to notify Centers for Medicare & Medicaid Services (CMS) and the Joint commission of proficiency testing samples received from another laboratory." 2. Review of API's User Guide revealed: "Treatment of Proficiency Testing Samples Proficiency testing samples should be treated in the same manner as patient samples. According to CMS, "this means testing the PT [proficiency testing] samples the same number of times you would patient specimens, by the same personnel that routinely test the patient specimens, and using the same test system, including analyzer and reagents, that is routinely used for the patient specimens. PT samples should be rotated among the testing personnel in your laboratory." Please note: For CMS/CLIA-regulated laboratories, do not refer any of your proficiency testing samples to another laboratory, even in cases where you would normally do so with a patient specimen." 3. According to PT records, the laboratory, Glen Rose Medical Center (GRMC) (CLIA #45D0485200), was enrolled in American Proficiency Testing (API) PT program in 2022 for Hematology/Coagulation event: 3 and in 2023 for Hematology /Coagulation events: 1 and 2. According to PT records, the laboratory, Glen Rose Medical Center Pecan Location (GRMCPL) (45D1071102), was enrolled in American Proficiency Testing (API) PT program in 2022 for Hematology/Coagulation event: 3 and in 2023 for Hematology/Coagulation events: 1 and 2. 4. Further review of PT records obtained from the laboratories revealed: GRMC 2022 Hematology /Coagulation Event 3(Kit 1; Seq # 14826), original evaluation electronically submitted: 11/30/2022 4:57 p.m. included the following analytes and samples: Analyte: Blood Cell ID (CMS Scored) (#224 +Photos) "224+Photos" were photo images included in the API PT testing package Samples: BCI-11 through BCI-15; ECI-11 through ECI-15 GRMCPL 2022 Hematology/Coagulation Event 3(Kit 1; Seq -- 2 of 10 -- # 12977), original evaluation electronically submitted: 11/30/2022 4:54 p.m. included the following analytes and samples: Analyte: Blood Cell ID (CMS Scored) (Virtual Only) "Virtual Only" were digital images accessed through the API portal Samples: BCI-11 through BCI-15; ECI-11 through ECI-15 The following were the results submitted for both locations: Analyte/Method: Blood Cell Identification BCI-11: Nucleated red blood cell BCI-12: Monocyte BCI-13: Basophil, all stages BCI-14: Neutrophil, segmented BCI-15: Neutrophil, band (stab) Analyte/Method: Blood Cell ID (Educational) ECI-11: Neutrophil, hypersegmented ECI-12: Polychromatophilic RBC ECI-13: Red blood cell, normal ECI-14: Lymphocyte, normal ECI-15: Monocyte GRMC 2023 Hematology/Coagulation Event 1 (Kit 1; Seq # 14782), original evaluation electronically submitted: 03/29/2023 3:42 p.m. included the following analytes and samples: Analyte: Microscopy Package (#233 + Photos) Samples: US-01; US-02 Analyte: Blood Cell ID (CMS Scored) (#244 + Photos) "223+Photos" and "224+Photos" were photo images included in the API PT testing package Samples: BCI-01 through BCI-05; DIF-01 (virtual only); ECI-01 through ECI-05 "Virtual Only" were digital images accessed through the API portal GRMCPL 2023 Hematology/Coagulation Event 1 (Kit 1; Seq # 12910), original evaluation electronically submitted: 03/29/2023 2:27 p.m. included the following analytes and samples: Analyte: Microscopy Samples: US-01; US-02 Analyte: Blood Cell ID (CMS Scored) (Virtual Only) "Virtual Only" were digital images accessed through the API portal Samples: BCI-01 through BCI-05; DIF-01 (virtual only); ECI-01 through ECI- 05 The following were identical results submitted for both locations: Analyte/Method: Urine Sediment US-01: Uric acid crystal(s) US-02: Yeast Analyte/Method: Blood Cell Identification BCI-01: Target cell (codocyte) BCI-02: Neutrophil, segmented BCI-03: Monocyte BCI-04: Lymphocyte, normal BCI-05: Polychromatophilic RBC Analyte/Method: Immature Cell (DIF) (%) DIF-01: 57 Analyte/Method: Lymphocyte (DIF) (%) DIF-01: 30 Analyte/Method: Monocyte (DIF) (%) DIF-01: 4 Analyte /Method: Neutrophil, band (DIF) (%) DIF-01: 6 Analyte/Method: Neutrophil, segmented (DIF) (%) DIF-01: 3 Analyte/Method: Blood Cell ID (Educational) ECI- 01: Blast ECI-02: Neutrophil, band (stab) ECI-03: Blast ECI-04: Dacrocyte (tear-drop cell) ECI-05: Neutrophil with toxic gran GRMC 2023 Hematology/Coagulation Event 2 (Kit 1; Seq # 14789), original evaluation electronically submitted: 08/01/2023 4:16 p.m. included the following analytes and samples: Analyte: Microscopy Package (#233 + Photos) Samples: US-03; US-04 Analyte: Blood Cell ID (CMS Scored) (#244 + Photos) "223+Photos" and "224+Photos" were photo images included in the API PT testing package Samples: BCI-06 through BCI-10; DIF-02 (virtual only); ECI-06 through ECI-10 "Virtual Only" were digital images accessed through the API portal GRMCPL 2023 Hematology/Coagulation Event 2 (Kit 1; Seq # 13151), original evaluation electronically submitted: 08/01/2023 4:44 p.m. included the following analytes and samples: Analyte: Microscopy Samples: US-03; US-04 Analyte: Blood Cell ID (CMS Scored) (Virtual Only) "Virtual Only" were digital images accessed through the API portal Samples: BCI-06 through BCI-10; DIF-02 (virtual only); ECI- 06 through ECI-10 The following were identical results submitted: Analyte/Method: Urine Sediment US-03: Calcium oxalate crystal(s) US-04: WBCs (Leukocytes) Analyte/Method: Blood Cell Identification BCI-06: Neutrophil, band (stab) BCI-07: Monocyte BCI-08: Metamyelocyte (juvenile) BCI-09: Eosinophil, all stages BCI-10: Neutrophil, segmented Analyte/Method: Eosinophil (DIF) (%) DIF-02: 4 Analyte /Method: Lymphocyte (DIF) (%) DIF-02: 11 Analyte/Method: Lymphocyte reactive (DIF) (%) DIF-02: 10 Analyte/Method: Monocyte (DIF) (%) DIF-02: 6 Analyte /Method: Neutrophil, band (DIF) (%) DIF-02: 2 Analyte/Method: Neutrophil, segmented (DIF) (%) DIF-02: 67 Analyte/Method: Platelet estimate (DIF) DIF-02: Adequate, normal Analyte/Method: Blood Cell ID (Educational) ECI-06: Lymph, reactive (atyp, variant) ECI-07: Neutrophil, segmented ECI-08: Red blood cell, -- 3 of 10 -- normal ECI-09: Platelets, normal ECI-10: Neutrophil with toxic gran 5. Review of laboratory records from the laboratory's LIS system revealed an " API Samples Report" that was used to enter raw data for test results of PT samples for Hematology /Coagulation 2022 Event 3, Hematology/Coagulation 2023 Events 1 and 2. The API Samples Report revealed a "Draw Location". The draw location was GRMC. 6. Review of the GRMCPL API attestation forms for Hematology/Coagulation 2022 Event 3 revealed seven testing personnel who attested to performing PT testing. Five of the seven individuals were NOT testing personnel listed on the CMS 209 form as testing personnel for this facility, GRMCPL. Review of the GRMCPL API attestation forms for Hematology/Coagulation 2023 Event 1 revealed eight testing personnel who attested to performing PT testing. Five of the eight individuals were NOT testing personnel listed on the CMS 209 form as testing personnel for this facility, GRMCPL. Review of the GRMCPL API attestation forms for Hematology/Coagulation 2023 Event 2 revealed no attestation form. The laboratory was asked to provide a copy, and none was provided. 7. A review of the CMS 209 form for GRMC revealed the following testing personnel who attested to performing PT for both facilities: 2022 Hematology/Coagulation Event 3 TP-1; samples: ECI-12 TP-11; samples: BCI-11, ECI-14 TP-5; samples: BCI-12, ECI-15 TP-4; samples: BCI-13 TP-3; samples: BCI- 14 TP-2; samples: BCI-15 TP-7; samples: ECI-11, ECI-13 2023 Hematology /Coagulation Event 1 TP-2; samples: ECI-01, US-02 TP-8; samples: US-01 TP-5; samples: ECI-03 TP-4; samples: BCI-05 TP-1; samples: BCI-04, ECI-05 TP-9; samples: BCI-03 TP-6; samples: BCI-02 Samples: ECI-02, DIF-01, BCI-02 were performed by a terminated testing person who was not listed on the CMS 209 2023 Hematology/Coagulation Event 2 (GRMC only) TP-10; samples: BCI-06, ECI-06 TP- 1; samples: DIF-02 TP-6; samples: ECI-07, US-04 TP-7; samples: BCI-07, ECI-10 TP-2; samples: BCI-10 TP-5; samples: BCI-09, ECI-09 TP-3; samples: BCI-08, ECI- 08 7. During an interview in the break room of Glen Rose Medical Center Pecan Location (45D1071102) on 09/06/2023 at 11:00 am, the Technical Consultant-2 (TC- 2) (as delegated on the CMS 209 form) was asked who the personnel were that signed the attestation forms and she stated that they were testing personnel from the laboratory's main facility Glen Rose Medical Center (CLIA #45D0485200). The TC-2 further stated that the testing for Hematology/Coagulation 2022 Event 1 and 2023 Events 1 and 2 were performed at facility Glen Rose Medical Center (CLIA #45D0485200). The TC-2 further stated that the laboratory had discontinued urine microscopic testing and blood smear differentials at the facility and those patient specimens requiring microscopic testing were sent to the hospital for testing. The TC- 2 stated that she reached out to the accrediting agency for proficiency testing guidance for tests that were discontinued at the laboratory and sent to another facility for testing. According to the TC-2 she was told by the accrediting agency to treat her PT like she treated her patients. Therefore, she took the PT package to GRMC for testing. Laboratory testing personnel at GRMC logged into the API portal to complete the virtual image PT for 2022 Event 3 and 2023 Events 1 and 2. All PT results for GRMCPL were submitted at GRMC. During an interview in the board room of GRMC on 10/03/2023 at 11:00 am, Testing Person-4 (TP-4) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No." TP-4 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes ma'am." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:25 am, Testing Person-6 (TP-6) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No, I work at the hospital." TP-6 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:29 am, Testing Person-3 (TP-3) (as designated -- 4 of 10 -- on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "I have never been to the clinic." TP-3 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "PT was performed at Glen Rose Medical Center, absolutely." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:34 am, Testing Person-7 (TP-7) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No." TP-7 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During a telephone interview in the board room of GRMC on 10/03 /2023 at 11:44 am, Testing Person-8 (TP-8) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "Yes." TP-8 stated that she worked at GRMCPL on Friday's or as needed and she believed the urine microscopy PT at this location, GRMCPL. TP-8 was asked if the PT testing for GRMCPL was performed at GRMCPL and she stated, PT for blood cell identification was performed at GRMC. During a telephone interview in the board room of GRMC on 10/03/2023 at 11:51 am, Testing Person-10 (TP-10) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if he had ever been toGRMCPL to perform proficiency testing and he stated, "No." TP-10 was asked if the PT testing for GRMCPL was performed at GRMC and he stated, "Yes." During a telephone interview in the board room of GRMC on 10/03/2023 at 1:02 pm, Testing Person-11 (TP-11) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, that it had been more than two years since she worked at that location. TP-11 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During an interview in the board room of GRMC on 10/03/2023 at 12:01 pm, Testing Person-1/Technical Supervisor-2 (TP-1/TS-2) (as designated on the CMS 209 form for CLIA #45D0485200) stated "I 100% take ownership for the PT." "I was trying to finish up fast and was having issues logging into API to discontinue testing." She further stated that patient testing for urine microscopy and blood cell identification had been discontinued at GRMCPL in early 2023. TP-1/TS-2 stated that there was no attestation form for 2023 Hematology/Coagulation Event 2 because she used the answers from GRMC for GRMCPL. TP-1/TS-2 stated, "It was the exact same picture." TP-1/TS-2 revealed that the PT for GRMCPL was not entered into the laboratory's LIS system since testing was no longer being performed there. She stated that for the above-mentioned Hematology/Coagulation 2022 Event 3, 2023 Events 1 and 2 the responses for GRMCPL and GRMC were identical. TP-1/TS-2 logged into the API portal at GRMC and used the responses from testing personnel at GRMC to enter the PT responses for GRMCPL. Note: TP-1/TS-2 was also the TC-2/TP-1 for GRMCPL. 9. As confirmed above, the laboratory engaged in inter-laboratory communication with both sister laboratories (Glen Rose Medical Center CLIA #45D0485200 and Glen Rose Medical Center Pecan Location 45D1071102) prior to the November 30, 2022 submission cutoff date for Hematology/Coagulation testing events in 2022 (Event 3), March 29, 2023 submission cutoff date for Hematology /Coagulation testing events in 2023 (Event 1) and August 2, 2023 submission cutoff date Hematology/Coagulation testing events in 2023 (Event 2). Word Key: BCI- blood cell identification DIF- differential ECI- educational blood cell identification US: urine sediment LIS: laboratory information system TP- testing person D2013 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(4) The laboratory must not send proficiency testing samples or portions of proficiency -- 5 of 10 -- testing samples to another laboratory for any analysis for which it is certified to perform in its own laboratory. Any laboratory that CMS determines intentionally referred a proficiency testing sample to another laboratory for analysis may have its certification revoked for at least one year. If CMS determines that a proficiency testing sample was referred to another laboratory for analysis, but the requested testing was limited to reflex, distributive, or confirmatory testing that, if the sample were a patient specimen, would have been in full conformance with written, legally accurate and adequate standard operating procedures for the laboratory's testing of patient specimens, and if the proficiency testing referral is not a repeat proficiency testing referral, CMS will consider the referral to be improper and subject to alternative sanctions in accordance with 493.1804(c), but not intentional. Any laboratory that receives a proficiency testing sample from another laboratory for testing must notify CMS of the receipt of that sample regardless of whether the referral was made for reflex or confirmatory testing, or any other reason. This STANDARD is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the laboratory received Hematology PT samples from another laboratory for analysis for 3 of 5 testing events in 2022 and 2023 (2022 Event 3, 2023 Events 1 and 2). Findings included: 1. The laboratory's PT policy "Proficiency Testing" revealed: "III. Proficiency Testing Requirements ... D. GRMC and PFC laboratories are not in any way permitted to send PT samples to another laboratory for analysis. This includes sending samples back and forth to each other. Each lab is enrolled separately in the PT program and must not test samples for or send samples to the other laboratory until after the result submission deadline for that testing event has passed. E. GRMC and PFC laboratories are not in any way permitted to communicate with another laboratory about the PT results. This includes communicating about PT results back and forth with each other. Each lab is enrolled separately in the PT program and must not share results with the other laboratory until after the result submission deadline has passed. F. It is the responsibility of GRMC Lab as well as PFC Lab to notify Centers for Medicare & Medicaid Services (CMS) and the Joint commission of proficiency testing samples received from another laboratory." 2. Review of API's User Guide revealed: "Treatment of Proficiency Testing Samples ... Please note: For CMS/CLIA-regulated laboratories, do not refer any of your proficiency testing samples to another laboratory, even in cases where you would normally do so with a patient specimen." 3. According to PT records, the laboratory was enrolled in American Proficiency Testing (API) PT program in 2022 for Hematology /Coagulation event: 3 and in 2023 for Hematology/Coagulation events: 1 and 2. 4. Further review of PT records obtained from the laboratory revealed: 2022 Hematology /Coagulation Event 3(Kit 1; Seq # 14826), original evaluation electronically submitted: 11/30/2022 4:57 p.m. included the following analytes and samples: Analyte: Blood Cell ID (CMS Scored) (#224 + pictures) "224+Photos" were photo images included in the API PT testing package Samples: BCI-11 through BCI-15; ECI-11 through ECI-15 The following were the results submitted: Analyte/Method: Blood Cell Identification BCI-11: Nucleated red blood cell BCI-12: Monocyte BCI- 13: Basophil, all stages BCI-14: Neutrophil, segmented BCI-15: Neutrophil, band (stab) Analyte/Method: Blood Cell ID (Educational) ECI-11: Neutrophil, hypersegmented ECI-12: Polychromatophilic RBC ECI-13: Red blood cell, normal ECI-14: Lymphocyte, normal ECI-15: Monocyte 2023 Hematology/Coagulation Event 1 (Kit 1; Seq # 14782), original evaluation electronically submitted: 03/29/2023 -- 6 of 10 -- 3:42 p.m. included the following analytes and samples: Analyte: Microscopy Package (#233 + Photos) Samples: US-01; US-02 Analyte: Blood Cell ID (CMS Scored) (#244 + Photos) "223+Photos" and "224+Photos" were photo images included in the API PT testing package Samples: BCI-01 through BCI-05; DIF-01 (virtual only); ECI-01 through ECI-05 "Virtual Only" were digital images accessed through the API portal The following were the results submitted: Analyte/Method: Urine Sediment US-01: Uric acid crystal(s) US-02: Yeast Analyte/Method: Blood Cell Identification BCI-01: Target cell (codocyte) BCI-02: Neutrophil, segmented BCI-03: Monocyte BCI-04: Lymphocyte, normal BCI-05: Polychromatophilic RBC Analyte/Method: Immature Cell (DIF) (%) DIF-01: 57 Analyte/Method: Lymphocyte (DIF) (%) DIF-01: 30 Analyte/Method: Monocyte (DIF) (%) DIF-01: 4 Analyte/Method: Neutrophil, band (DIF) (%) DIF-01: 6 Analyte/Method: Neutrophil, segmented (DIF) (%) DIF-01: 3 Analyte/Method: Platelet estimate (DIF) DIF-03: Decreased Analyte/Method: Blood Cell ID (Educational) ECI-01: Blast ECI-02: Neutrophil, band (stab) ECI-03: Blast ECI-04: Dacrocyte (tear-drop cell) ECI-05: Neutrophil with toxic gran 2023 Hematology/Coagulation Event 2 (Kit 1; Seq # 14789), original evaluation electronically submitted: 08/01/2023 4:16 p.m. included the following analytes and samples: Analyte: Microscopy Package (#233 + Photos) Samples: US-03; US-04 Analyte: Blood Cell ID (CMS Scored) (#244 + Photos) "223+Photos" and "224+Photos" were photo images included in the API PT testing package Samples: BCI-06 through BCI-10; DIF-02 (virtual only); ECI-06 through ECI-10 "Virtual Only" were digital images accessed through the API portal The following were the results submitted: Analyte/Method: Urine Sediment US-03: Calcium oxalate crystal(s) US-04: WBCs (Leukocytes) Analyte/Method: Blood Cell Identification BCI-06: Neutrophil, band (stab) BCI-07: Monocyte BCI-08: Metamyelocyte (juvenile) BCI- 09: Eosinophil, all stages BCI-10: Neutrophil, segmented Analyte/Method: Eosinophil (DIF) (%) DIF-02:4 Analyte/Method: Lymphocyte (DIF) (%) DIF-02: 11 Analyte /Method: Lymphocyte reactive (DIF) (%) DIF-02: 10 Analyte/Method: Monocyte (DIF) (%) DIF-02: 6 Analyte/Method: Neutrophil, band (DIF) (%) DIF-02: 2 Analyte /Method: Neutrophil, segmented (DIF) (%) DIF-02: 67 Analyte/Method: Platelet estimate (DIF) DIF-02: Adequate, normal Analyte/Method: Blood Cell ID (Educational) ECI-06: Lymph, reactive (atyp, variant) ECI-07: Neutrophil, segmented ECI-08: Red blood cell, normal ECI-09: Platelets, normal ECI-10: Neutrophil with toxic gran 5. Review of laboratory records from the laboratory's LIS system revealed an " API Samples Report" that was used to enter raw data for test results of PT samples for Hematology/Coagulation 2022 Event 3, Hematology/Coagulation 2023 Events 1 and 2. The API Samples Report revealed a "Draw Location". The draw location was Glen Rose Medical Center (GRMC) (CLIA #45D0485200). 6. Review of the Glen Rose Medical Center Pecan Location (GRMCPL) (45D1071102) API attestation forms for Hematology/Coagulation 2022 Event 3 revealed seven testing personnel who attested to performing PT testing. Five of the seven individuals were NOT testing personnel listed on the CMS 209 form as testing personnel for this facility, GRMCPL Review of the GRMCPL API attestation forms for Hematology /Coagulation 2023 Event 1 revealed eight testing personnel who attested to performing PT testing. Five of the eight individuals were NOT testing personnel listed on the CMS 209 form as testing personnel for this facility, GRMCPL. Review of the GRMCPL API attestation forms for Hematology/Coagulation 2023 Event 2 revealed no attestation form. The laboratory was asked to provide a copy, and none was provided. 7. A review of the CMS 209 form for GRMC revealed the following testing personnel who attested to performing PT for both facilities: 2022 Hematology /Coagulation Event 3 TP-1; samples: ECI-12 TP-11; samples: BCI-11, ECI-14 TP-5; samples: BCI-12, ECI-15 TP-4; samples: BCI-13 TP-3; samples: BCI-14 TP-2; samples: BCI-15 TP-7; samples: ECI-11, ECI-13 2023 Hematology/Coagulation -- 7 of 10 -- Event 1 TP-2; samples: ECI-01, US-02 TP-8; samples: US-01 TP-5; samples: ECI-03 TP-4; samples: BCI-05 TP-1; samples: BCI-04, ECI-05 TP-9; samples: BCI-03 TP-6; samples: BCI-02 Samples: ECI-02, DIFF-01, BCI-02 were performed by a terminated testing person who was not listed on the CMS 209 2023 Hematology/Coagulation Event 2 (attestation for GRMC only) TP-10; samples: BCI-06, ECI-06 TP-1; samples: DIFF-02 TP-6; samples: ECI-07, US-04 TP-7; samples: BCI-07, ECI-10 TP-2; samples: BCI-10 TP-5; samples: BCI-09, ECI-09 TP-3; samples: BCI-08, ECI-08 8. During an interview in the break room of GRMCPL on 09/06/2023 at 11:00 am, the Technical Consultant-2 (TC-2) (as delegated on the CMS 209 form) was asked who the personnel were that signed the attestation forms and she stated that they were testing personnel from the laboratory's main facility GRMC. The TC-2 further stated that the testing for Hematology/Coagulation 2022 Event 1 and 2023 Events 1 and 2 were performed at facility GRMC. The TC-2 further stated that the laboratory had discontinued urine microscopic testing and blood smear differentials at the facility and those patient specimens requiring microscopic testing were sent to the hospital for testing. The TC-2 stated that she reached out to the accrediting agency for proficiency testing guidance for tests that were discontinued at the laboratory and sent to another facility for testing. According to the TC-2 she was told by the accrediting agency to treat her PT like she treated her patients. Therefore, she took the PT package to GRMC for testing. Laboratory testing personnel at GRMC logged into the API portal to complete the virtual image PT for 2022 Event 3 and 2023 Events 1 and 2. All PT results for GRMCPL were submitted at GRMC. During an interview in the board room of GRMC on 10/03/2023 at 11:00 am, Testing Person-4 (TP-4) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No." TP-4 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes ma'am." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:25 am, Testing Person-6 (TP-6) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No, I work at the hospital." TP-6 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:29 am, Testing Person-3 (TP-3) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "I have never been to the clinic." TP-3 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "PT was performed at Glen Rose Medical Center, absolutely." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:34 am, Testing Person-7 (TP-7) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "No." TP-7 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During a telephone interview in the board room of GRMC on 10/03/2023 at 11:44 am, Testing Person-8 (TP-8) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, "Yes." TP-8 stated that she worked at GRMCPL on Friday's or as needed and she believed the urine microscopy PT at this location, GRMCPL. TP-8 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, PT for blood cell identification was performed at GRMC. During a telephone interview in the board room of GRMC on 10/03/2023 at 11:51 am, Testing Person-10 (TP-10) (as designated on the CMS 209 form for CLIA #45D0485200) was asked if he had ever been to GRMCPL to perform proficiency testing and he stated, "No." TP-10 was asked if the PT testing for GRMCPL was performed at GRMC and he stated, "Yes." During a telephone interview in the board room of GRMC on 10/03/2023 at 1:02 pm, Testing Person-11 (TP-11) (as designated -- 8 of 10 -- on the CMS 209 form for CLIA #45D0485200) was asked if she had ever been to GRMCPL to perform proficiency testing and she stated, that it had been more than two years since she worked at that location. TP-11 was asked if the PT testing for GRMCPL was performed at GRMC and she stated, "Yes." During an interview in the board room of GRMC on 10/03/2023 at 12:01 pm, Testing Person-1/Technical Supervisor-2 (TP-1/TS-2) (as designated on the CMS 209 form for CLIA #45D0485200) stated "I 100% take ownership for the PT." "I was trying to finish up fast and was having issues logging into API to discontinue testing." She further stated that patient testing for urine microscopy and blood cell identification had been discontinued at GRMCPL in early 2023. TP-1/TS-2 stated that there was no attestation form for 2023 Hematology/Coagulation Event 2 because she used the answers from GRMC for GRMCPL. TP-1/TS-2 stated, "It was the exact same picture." TP-1/TS-2 revealed that the PT for GRMCPL was not entered into the laboratory's LIS system since testing was no longer being performed there. She stated that for the above-mentioned Hematology/Coagulation 2022 Event 3, 2023 Events 1 and 2 the responses for GRMCPL and GRMC were identical. TP-1/TS-2 logged into the API portal at GRMC and used the responses from testing personnel at GRMC to enter the PT responses for GRMCPL. This confirmed the above findings. Note: TP-1 /TS-2 was also the TC-2/TP-1 for GRMCPL. Word Key: BCI- blood cell identification DIF- differential ECI- educational blood cell identification US: urine sediment LIS: laboratory information system TP- testing person D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the laboratory director failed to provide overall management and direction of the laboratory. Refer to D6089. 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 review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the Laboratory Director did not ensure proficiency testing samples were tested as required and did not engage in any inter-laboratory communications pertaining to the results of proficiency testing samples. Refer to D2011 and D2013. D6108 LABORATORY TECHNICAL SUPERVISOR -- 9 of 10 -- CFR(s): 493.1447 The laboratory must have a technical supervisor who meets the qualification requirements of 493.1449 of this subpart and provides technical supervision in accordance with 493.1451 of this subpart. This CONDITION is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, it was revealed that the Technical Supervisor failed to provide technical and scientific oversight. Refer to D6112. D6112 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451 The technical supervisor is responsible for the technical and scientific oversight of the laboratory. The technical supervisor is not required to be on site at all times testing is performed; however, he or she must be available to the laboratory on an as needed basis to provide supervision as specified in (a) of this section. This STANDARD is not met as evidenced by: Based on review of laboratory ' s proficiency testing (PT) policy, American Proficiency Testing (API) User Guide, PT records, laboratory records, Centers for Medicare and Medicaid Services (CMS) 209 form, and confirmed in interview, the Technical Supervisor failed to provide technical oversight, did not ensure proficiency testing samples were tested as required, and ensure the laboratory did not engage in any inter-laboratory communications pertaining to the results of proficiency testing samples. Refer to D2011 and D2013. -- 10 of 10 --