Urology Center Of Southern Oklahoma, Pc

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/18.19/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director, office manager, and testing person #2 at the conclusion of the survey. 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: Based on observation, manufacturer's package insert and interview with testing person #2 and the laboratory director, the laboratory failed to ensure one of one bottle of Multistix Pro 10 LS urine test strips were stored as required by the manufacturer. Findings include: (1) Observation of the laboratory and interview with testing person #2 on 06/18/2025 at 11:00 am, identified the following: (a) One bottle of Multistick Pro 10 LS urine test strips, with the lid removed and no testing person(s) in the immediatie vicinity of the strips. (b) Observation of the laboratory on 06/18/2025 at 11:05 am (five minutes later), identified the same bottle of test strips remained open on the countertop. (2) A review of the manufacturer's package insert stated, "Replace the cap immediately and tightly after removing the reagent strip". (3) Interview with testing person #2 on 06/18/2025 at 11:05 am confirmed the laboratory was not replacing the cap on the test strips between patient use. 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 D0000 The recertification survey was performed on 10/09/2023 through 10/10/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the office manager, general supervisor, and testing person #2 during an exit conference performed at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the technical consultant, the laboratory director failed to assess the competency of the technical consultant based on the position responsibilities as listed in subpart M. Findings include: (1) A review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of August 2021 through the current date identified competencies, based on job responsibilities, had not been performed for the technical consultant listed on the CMS-209; (3) The findings were reviewed with the technical consultant who stated on 10/09/2023 at 12:23 am there was no policy and competencies were not performed for the technical consultant during the review period of October 2021 to the current date. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the general supervisor and testing person #2, the laboratory failed to ensure the humidity was monitored as required in the Urinalysis Testing Room for nine of nine months reviewed and the Molecular UTI (Urinary Tract Infection) Testing Room for five of five months reviewed. Findings include: URINALYSIS TESTING ROOM (1) On 10 /09/2023 at 10:15 am, testing person #2 stated the laboratory performed urinalysis testing on Siemens Clinitek Advantus analyzer using the Multistix PRO 10LS reagent strips; (2) A review of the Operator's Guide for the test system identified the manufacturer required the analyzer be operated at a relative humidity of 20-80%, non- condensing; and actively controlled; (3) A review of temperature records identified no documentation that humidity had been monitored for the above test system between 01 /01/2023 to 09/30/2023; (4) The records were reviewed with testing person #2 who stated on 10/03/2023 at 02:33 pm, the laboratory humidity had not been monitored as required by the manufacturer. MOLECULAR UTI TESTING ROOM (1) On 10/09 /2023 at 10:35 am, the general supervisor stated the laboratory performed UTI pathogen identification and antibiotic resistance marker testing using the Kingfisher Duo Prime and Applied Biosystems QuantStudio 7 Pro Real-Time PCR Systems; (2) A review of the manufacturer's instructions identified the following: (a) KingFisher Duo Prime Technical Manual Rev. 1.0, Cat. No. N16621 under the section "Operating Conditions" stated "To make sure that condensation does not occurs, the humidity is low (relative humidity is between 10% and 80%); (b) QuantStudio 7 Pro Real-Time PCR System User Guide - Appendix A Instrument Specifications and Layout under the section "Environmental Requirements" identified the manufacturer required the test system be operated at a humidity of 15%-80% (noncondensing). (3) A review of Room Climate Log from the Molecular UTI testing room between 05/01/2023 through 09/30/2023 identified no documentation that humidity had been monitored; (4) The records were reviewed with the general supervisor who stated on 10/03/2023 at 2:33 pm, the laboratory humidity had not been monitored as required by the manufacturer. 48517 Based on a review of records, observation, and interview with the general supervisor, the laboratory failed to ensure materials were stored as required for three of three months reviewed in 2023. Findings include: (1) On 10/09 /2023 at 02:00 pm, observation of the contents of the laboratory freezer identified the following materials: (a) One box of Applied Biosystems MagMax viral/pathogen ultra mag mix, lot #2301032 - the storage requirement as stated on the box was -15 to -25 degrees C (Centigrade). (2) A review of temperature records for three months (May 2023 through July 2023) identified the laboratory documented temperatures using a min (minimum) and max (maximum) thermometer. Three temperatures were documented each day which included the current temperature reading, the coldest reading, and the warmest reading. Documented temperatures were beyond the storage requirement for the materials three of three months as follows: (a) May 2023 - For 24 days, 20 of 72 temperatures were documented as warmer than -15 degrees C and 13 of 72 temperatures were documented as colder than -25 degrees C; (b) June 2023 - For 14 days, 14 of 42 temperatures were documented as warmer than -15 degrees C and 8 -- 2 of 4 -- of 42 temperatures were documented as colder than -25 degrees C; (c) July 2023 - For 22 days, 22 of 66 temperatures were documented as warmer than -15 degrees C and 6 of 66 temperatures were documented as colder than -25 degrees C. (3) The records were reviewed with the general supervisor, who stated on 10/09/2023 at 02:00 pm, the materials were not being stored as required by the manufacturer. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on observation and interview with testing person #2, the laboratory failed to ensure expired supplies were not available for use. Findings include: (1) Observation of the urinalysis laboratory on 10/09/2023 at 11:00 am, identified the following expired collection tubes that appeared to be available for use: (a) 400 Vacuette K2EDTA tubes - lot # B220533T with an expiration date of 08/31/2023. (2) Interview with testing person #2 10/09/2023 at 11:00 am confirmed the Vacuette K2EDTA tubes were available for use. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, and interview with the general supervisor, the laboratory failed to have a function check protocol that ensured the Globe centrifuge was functioning properly for one of one function check performed during the review period of April 2023 through the current date. Findings include: (1) On 10/09/2023 at 10:35 am, the general supervisor stated the following: (a) The laboratory began performing UTI pathogen identification and antibiotic resistance marker testing using the Applied Biosystems QuantStudio 7 Pro Real-Time PCR Systems in April 2023; (b) Sample preparation included centrifuging specimens in the Globe Centrifuge at a speed of 140 rpm (revolutions per minute) for four minutes; (2) A review of the policy titled, "Equipment Description and Maintenance" did not specify the laboratory's method for ensuring the speed and timer will be checked for accuracy and stated the centrifuge "will be maintained every six months"; (3) A review of the centrifuge function check records from April 2023 through the current date identified the following for one of one check performed: (a) 10/02/2023 - The speed had been checked at 139 and 141 rpm. There was no documentation the timer had been checked. (4) The records were reviewed with the general supervisor who -- 3 of 4 -- stated on 10/10/2023 at 10:55 am, the centrifuge timer had not been checked for accuracy. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on a review of record and interview with testing person #2 and office manager, the laboratory failed to ensure a patient test report included the name and address of the laboratory location where the testing was performed for one of one report reviewed. Findings include: (1) On 10/09/2023 at 10:15 am, testing person #2 stated the laboratory performed urinalysis testing on Siemens Clinitek Advantus analyzer using the Multistix PRO 10LS reagent strips; (2) A review of one patient report for the above testing identified the report did not include the name and address of the laboratory location; (3) The report was reviewed with testing person #2 and office manager who stated on 10/09/2023 at 02:10 pm, the laboratory name and address had not been included in the patient test reports. D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of a patient report and interview with testing person #2 and office manager, the laboratory failed to provide normal reference intervals for one of one Urinalysis report reviewed. Findings include: (1) On 10/09/2023 at 10:15 am, testing person #2 stated the laboratory performed urinalysis testing on Siemen Clinitek Advantus analyzer using the Multistix PRO 10LS reagent strips; (2) A review of one patient report for the above testing identified the report did not include normal reference ranges; (3) The report was reviewed with testing person #2 and office manager who stated on 10/09/2023 at 02:15 pm, the patient report did not include normal reference ranges. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/03/2021. The findings were reviewed with the office manager and nurse supervisor at the conclusion of the survey. The laboratory was found in compliance with standard-level deficiencies cited. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager and nurse supervisor, the laboratory failed to verify the accuracy of urinalysis testing, urine sediment examinations, and post vasectomy analysis at least twice annually. Findings include: (1) On 08/03/2021 at 10:10 am, the nurse supervisor stated the following to the surveyor: (a) The laboratory performed routine urinalysis testing using the Clinitek Advantus analyzer; (b) The laboratory performed urine sediment examinations performed as a PPM (Provider Performed Microscopy) procedure; (c) The laboratory performed post vasectomy analysis (present or absent) performed as a PPM procedure. (2) The surveyor reviewed 2019, 2020, and 2021 records and identified the testing had not been verified for accuracy twice annually during the review period; (3) The records were reviewed with the office manager and nurse supervisor who both stated at 01:40 pm, the laboratory had not verified the accuracy twice annually as indicated above. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and 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 -- test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the office manager and nurse supervisor, the laboratory failed to ensure quality control materials were stored as required by the manufacturer for 2 of 3 months. Findings include: (1) On 08/03/2021 at 10:10 am, the nurse supervisor stated to the surveyor: (a) The laboratory performed routine urinalysis testing using the Clinitek Advantus analyzer; (b) The laboratory used two levels of Premium Liquid Urine Controls to perform QC (quality control) each day of patient testing. (2) The surveyor reviewed the manufacturer's storage requirements for the QC materials: (a) The package insert for the QC materials required storage at 2-8 degrees C (Celsius) or 36 - 46 degrees F (Fahrenheit). (3) The surveyor reviewed laboratory refrigerator records for 3 months (December 2020 through February 2021) and identified that for 2 of 3 months the refrigerator temperatures were colder than the manufacturer's storage requirements as follows: (a) December 2020 - 3 of 21 days (i) 12/14/2020 - The refrigerator temperature had been documented at 34 degrees F; (ii) 12/17/2020 - The refrigerator temperature had been documented at 34 degrees F; (iii) 12/18/2020 - The refrigerator temperature had been documented at 34 degrees F. (b) January 2021- 2 of 18 days (i) 01/11/2021- The refrigerator temperature had been documented at 34 degrees F; (ii) 01 /21/2021- The refrigerator temperature had been documented at 34 degrees F. (4) The surveyor reviewed the records with the office manager and nurse supervisor who both stated to the surveyor on 01:55 pm, the laboratory did not store the QC material according to the manufacturer's requirements as indicated above. 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 a review of records and interview with the office manager and nurse supervisor, the laboratory failed to use materials that had not expired for 2 of 7 months. Findings include: (1) On 08/03/2021 at 10:10 am, the nurse supervisor stated the following to the surveyor: (a) The laboratory performed routine urinalysis testing using the Clinitek Advantus analyzer; (b) The laboratory used two levels of Premium Liquid Urine Controls to perform QC (quality control) each day of patient testing. (2) The surveyor reviewed 8 months of QC records (December 2020 through July 2021) and identified the following: (a) Lot# 150031 (level 1) and Lot#150032 (level 2) with an expiration date of 03/31/2021 were used to determine acceptability of patient testing from 04/01/2021 through 05/31/2021; (3) The surveyor asked the nurse supervisor if patients were tested between 04/01/2021 through 05/31/2021 using the expired QC material. The nurse supervisor and office manager reviewed the QC -- 2 of 4 -- records and stated at 01:55 pm, the laboratory used the expired QC materials to determine acceptability of patient testing on 04/01,05,08,12,15,19,22,26,29/2021; and 05/03,05,06,10,13,14,17,20,24,27,28/2021. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the office manager and nurse supervisor the laboratory failed to perform function checks on the urine centrifuge, with at least the frequency specified by the manufacturer. Findings include: (1) On 08/03/2021 at 10:10 am, the nurse supervisor stated the following to the surveyor: (a) The laboratory performed urine sediment examinations as a PPM (Provider Performed Microscopy) procedure; (b) The specimens were processed in the Unico PowerSpin LX centrifuge. (2) The surveyor reviewed the centrifuge function check records that had been performed in 2019, 2020, and 2021. The RPM (revolution per minute) calibrations had been performed on 07/17/2019 and 12/07/2020; (3) The surveyor then reviewed the manufacturer's operation manual for the centrifuge. Page 5 of the manual under the heading, "Calibration" stated "It is recommended that your centrifuge's RPM be calibrated at least every 6 months"; (4) The surveyor reviewed the findings with the office manager and nurse manager who both stated at 01:45 pm the laboratory's policy to perform the RPM calibrations was on an annual basis and was not aware the manufacturer required the calibrations every 6 months. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on a review of records and interview with the office manager and nurse supervisor, the laboratory failed to follow their function check protocol for ensuring the urine centrifuge was functioning properly. Findings include: (1) On 08/03/2021 at 10:10 am, the nurse supervisor stated the following to the surveyor: (a) The laboratory performed urine sediment examinations as a PPM (Provider Performed Microscopy) procedure; (b) The specimens were processed in the Unico PowerSpin LX centrifuge at a speed of 2000 rpm (Revolutions Per Minute) and a time of 3 to 5 minutes. (2) The surveyor asked the nurse supervisor to explain how often function checks (speed and -- 3 of 4 -- timer checks) were performed on the centrifuge. The nurse supervisor stated at 10:15 am it was the laboratory's policy to check the speed and timer of the centrifuges annually; (3) The surveyor reviewed the centrifuge function check records that had been performed in 2019, 2020, and 2021. The centrifuge time had been checked as follows: (a) 07/17/2019 for 10 minutes; (b) 12/07/2020 for 10 minutes. (4) The surveyor reviewed the records with the office manger and nurse supervisor and asked if the timer had been checked at a time of 3 minutes and 5 five minutes according to the laboratory's policy for performing urine sediment examinations. Both stated at 01: 42 pm, the checks had not be checked at 3 minutes and 5 minutes. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 07/24/19. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the practice manager and testing person #1 at the conclusion of the survey. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, and interview with the office manager and testing person #1, the laboratory failed to have a written policy for verification of the accuracy of automated urinalysis testing. Findings include: (1) At the beginning of the survey, the office manager stated to the surveyor, the laboratory performed automated urinalysis testing using the Multistix PRO 10LS reagent dipsticks. In addition, the office manager stated the Clinitek Advantus dipstick reader (moderate complexity) was the primary instrument and the Clinitek Status dipstick reader (waived complexity) was the backup. Because dipstick urinalysis analytes (i.e., pH, glucose, ketones, specific gravity, blood, protein, nitrates, leukocyte esterase, and creatinine) are not regulated tests, twice per year accuracy verification is required; (2) The surveyor reviewed records from 09/01/17 through the day of the survey for accuracy verification of urinalysis testing performed on the Clinitek Advantus. The surveyor identified the laboratory performed twice per year accuracy of urinalysis testing by analyzing a "positive" and a "negative" patient sample on both the Clinitek Advantus and the Clinitek Status dipstick readers. The laboratory director then reviewed the results and determined if the comparison was acceptable; (3) The surveyor asked the office manager and testing person #1 how the results of the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- accuracy testing had been evaluated. Testing person #1 stated to the surveyor the laboratory director reviewed and compared the results and determined if the accuracy was acceptable; (4) The surveyor then reviewed the laboratory policy and procedure manual but could not locate a written policy and procedure for performing and evaluating the results of the twice per year accuracy verification of the urinalysis testing; (5) The surveyor then asked the office manager if the laboratory had a written policy and procedure for performing the twice per year accuracy verification of urinalysis testing, which would include guidance on the evaluation of results and determination of the acceptability of the results. The office manager and testing person #1 stated to the surveyor, the laboratory did not have a written policy and procedure which included criteria for determining acceptability of the accuracy verification. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the office manager and testing person #1, the laboratory failed to ensure the manufacturer's environmental requirements were met. Findings include: (1) At the beginning of the survey, the office manager stated to the surveyor the laboratory performed urinalysis testing using the Clinitek Advantus dipstick reader and the Multistix PRO 10LS reagent dipsticks. In addition, testing person stated to the surveyor two levels of urinalysis QC (Quality Control) materials were tested each day of patient testing; (2) The surveyor reviewed the QC records for 2018 and 2019 and identified the laboratory used the following QC materials: (a) From 01/01/18 through 05/31/19, Level 1 and Level 2 of Avantametrix Dipper Urinalysis Dipper Controls were used. The manufacturer required a storage temperature of 35.6-46.4 degrees F (Fahrenheit) (2-8 degrees Centigrade) (b) From 05/31/19 through the day of the survey, Level 1 and Level 2 of Consult Diagnostic Premium Liquid Urine Controls were used. (Level 1, Lot #150021 and Level 2, Lot #150022 were in use on the day of the survey). The manufacturer required a storage temperature of 35.6-46.4 degrees F (2-8 degrees Centigrade). (3) Testing person #1 stated to the surveyor the urinalysis QC materials were stored in the GE refrigerator located in the laboratory. The surveyor then reviewed the refrigerator temperature logs from 7 months (January, September, and December 2018; February, May, June, and through the day of the survey in July 2019) and identified on 12 of the 205 days reviewed, the refrigerator temperature was colder than the manufacturer's storage temperature. The findings follow: (a) May 2019: 4 of 19 days the temperature was too cold: (i) The temperature was 34.0 degrees F: Days 6,13,28,19 (b) June 2019: 4 of 18 days the temperature was too cold: (i) The temperature was 34.0 degrees F: Days 19,20,24,27 (c) July 2019: 4 of 14 days the temperature was too cold: (i) The temperature was 34.0 degrees F: Days 1,19,23,24 (4) The surveyor reviewed the findings with the office manager and testing person #1. The office manager and testing person #1 stated to the surveyor the -- 2 of 3 -- laboratory failed to ensure the urinalysis QC materials had been stored as required by the manufacturer, as listed above. -- 3 of 3 --