Canadian Valley Family Care

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/12/2023. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant and laboratory manager during an exit conference performed at the conclusion of the survey. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant and laboratory manager, the laboratory failed to ensure a proficiency testing attestation statement had been signed by the laboratory director or designee for one of five events reviewed during 2021, 2022, and to date in 2023. Findings include: (1) A review of the third 2021; first, second, and third 2022; and first 2023 Hematology proficiency testing records identified the following for one of five events: (a) Third 2021 Event - The attestation statement had not been signed by the laboratory director or designee. (2) The findings were reviewed with the laboratory manager and technical consultant. Both stated on 06/12/2023 at 12:10 pm, the attestation statement had not been signed by the laboratory director or designee. 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 -- D2128 HEMATOLOGY CFR(s): 493.851(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the technical consultant, the laboratory failed to take

Summary Statement of Deficiencies D0000 The recertification survey was performed on 08/31/2021. NOTE: Hematology testing was not performed from 02/15/2021 through 08/26/2021 due to a flood in the laboratory. The laboratory continued to perform waived testing during this time. The laboratory was found out of compliance with the following CLIA regulation: 493.1409; D6033: Technical Consultant The findings were reviewed with the laboratory director and laboratory manager at the conclusion of the survey. D1001 CERTIFICATE OF WAIVER TESTS CFR(s): 493.15(e) Laboratories eligible for a certificate of waiver must-- (1) Follow manufacturers' instructions for performing the test; and (2) Meet the requirements in subpart B, Certificate of Waiver, of this part. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to follow the manufacturer's instructions for specimen transport and storage for 3 of 4 patient reports. Findings include: (1) On 08/31/2021 at 09:40 am, the laboratory manager stated to the surveyor the laboratory performed COVID-19 testing using the Abbott COVID-19 ID NOW test system using direct nasal swabs; (2) The surveyor reviewed the manufacturer's product insert under the section titled, "SPECIMEN TRANSPORT and STORAGE" the manufacturer stated, "For best performance, direct nasal, throat or nasopharyngeal swabs should be tested as soon as possible after collection. If immediate testing is not possible, and to maintain best performance, it is highly recommended the nasal, throat or nasopharyngeal swab is placed in a clean, unused tube labeled with patient information, and capped tightly at room temperature (15-30C) for up to one (1) hour prior to testing. Ensure the swab fits securely within the tube and the cap is tightly closed. If greater than one (1) hour delay occurs, dispose of sample. A new sample must be collected for testing." (3) The surveyor reviewed 4 test reports for patients tested on 08/31/2021 and identified 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 4 -- following: (a) Patient Report #1 - The specimen collection time and reported time were identical (09:08 am); (b) Patient Report #2 - The specimen collection time and reported time were identical (09:57 am); (c) Patient Report #3 - The specimen collection time and reported time were identical (10:05 am); (4) The surveyor was not able to determine if the results had been performed within (1) hour since the specimen collection time and reported times were identical; (5) The surveyor reviewed the records with the laboratory manager who stated on 08/31/2021 at 11:00 am, the laboratory could not prove the results had been performed within (1) hour since the reported time had not been recorded. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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: Based on a review of records, and interview with the laboratory manager, the laboratory failed to ensure the demonstrated reportable range was utilized for a new analyzer. Findings include: (1) On 08/31/2021 at 09:30 am, the laboratory manager stated to the surveyor the laboratory began using the Sysmex POCH-100i analyzer to perform CBC (Complete Blood Count) testing on 08/27/2021; (2) The surveyor reviewed the performance specification records and identified the laboratory had demonstrated reportable ranges as follows: (a) Hemoglobin - 0-21.1 g/dl (b) Hematocrit - 0-58% (3) The surveyor requested the reportable range that was being utilized by the laboratory. The laboratory manager provided the surveyor with the manufacturer's reportable ranges contained in the installation manual which were: (a) Hemoglobin - 0.1-25.0 g/dl (b) Hematocrit - 10.0-60.0% (4) The surveyor reviewed the findings with the laboratory manager who stated on 08/31/2021 at 12:50 pm, the laboratory was not using the reportable ranges that had been demonstrated by the laboratory. D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the technical consultant failed to provide technical oversight in accordance with 493.1413 of this subpart. Findings include: (1) The technical consultant failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications. Refer to D6035. -- 2 of 4 -- D6035 TECHNICAL CONSULTANT QUALIFICATIONS CFR(s): 493.1411 (a) The technical consultant must be qualified and must possess a current license issued by the State in which the laboratory is located, if such licensing is required. (b) The technical consultant must-- (b)(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and (b)(1)(ii) Be certified in anatomic or clinical pathology, or both, by the American Board of Pathology or the American Osteopathic Board of Pathology or possess qualifications that are equivalent to those required for such certification; or (b)(2)(i) 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; and (b)(2)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible (for example, physicians certified either in hematology or hematology and medical oncology by the American Board of Internal Medicine are qualified to serve as the technical consultant in hematology); or (b)(3)(i) Hold an earned doctoral or master's degree in a chemical, physical, biological or clinical laboratory science or medical technology from an accredited institution; and (b)(3)(ii) Have at least one year of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible; or (b)(4)(i) Have earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution; and (b)(4)(ii) Have at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service for which the technical consultant is responsible. Note: The technical consultant requirements for "laboratory training or experience, or both" in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service, excluding waived tests. For example, an individual who has a bachelor's degree in biology and additionally has documentation of 2 years of work experience performing tests of moderate complexity in all specialties and subspecialties of service, would be qualified as a technical consultant in a laboratory performing moderate complexity testing in all specialties and subspecialties of service. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director and laboratory manager, the laboratory failed to ensure the individual who performed the duties and responsibilities of the technical consultant, met the qualifications for 2 of 3 competency evaluations performed. Findings include: (1) The surveyor reviewed records for 3 persons performing moderate complexity testing in 2019, 2020 and to date in 2021 (laboratory manager, who is also listed as testing person #1, testing person #2, and testing person #3). The records showed the evaluation for 2 of 3 persons had been performed by an individual who did not meet the regulatory qualification requirements of the technical consultant: (a) Testing Person #2 - The 03 /01/2021 evaluation had been performed by the laboratory manager/testing person #1 (this person had earned a high school diploma); (b) Testing Person #3 - The 06/01 /2021 evaluation had been performed by the laboratory manager/testing person #1. (2) The surveyor reviewed the records with the laboratory director and laboratory manager and explained that all components of the competency evaluations must be performed by a person who qualifies as a technical consultant (an individual with a minimum of a bachelor's degree in a chemical, physical or biological science or -- 3 of 4 -- medical technology from an accredited institution, and at least 2 years of laboratory training or experience, or both in non-waived testing, in the designated specialty or subspecialty areas of service). The laboratory director and laboratory manager stated to the surveyor on 08/31/2021 10:30 am, the above evaluations had been performed by an individual who did not meet the educational qualifications of a technical consultant. -- 4 of 4 --

Summary Statement of Deficiencies D0000 The recertification survey was performed on 05/23/19. The laboratory was found out of compliance with the following CLIA regulations: 493.1250; D5400: ANALYTIC SYSTEMS 493.1403; D6000: LABORATORY DIRECTOR The findings were reviewed with the laboratory manager at the conclusion of the survey. 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 a review of records and interview with the laboratory manager, the laboratory failed to ensure that proficiency testing samples were tested by personnel who routinely performed patient testing. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor the laboratory performed the following: (a) CBC (Complete Blood Count) testing using the Sysmex pocH-100i analyzer; (b) PSA (Prostate Specific Antigen), Testosterone, Vitamin D, TSH (Thyroid Stimulating Hormone), and Free T4 testing using the Beckman Coulter Access 2 analyzer. (2) The surveyor reviewed the Laboratory Personnel Report (Form CMS-209), that had been completed by the laboratory prior to the survey, with the laboratory manager. The laboratory manager stated that 2 persons performed the above patient testing in the laboratory (laboratory manager/testing person #1 and testing person #2); (3) The surveyor then reviewed proficiency testing records and identified that 7 of 9 events performed in 2017, 2018, and 2019 had been tested by the same person (laboratory manager/testing person #1) as follows: (a) Third 2017 Hematology Event - 5 of 5 samples (HSY-12, HSY-13, HSY-14, HSY-15, HSY-16) (b) First 2018 Hematology Event - 5 of 5 samples (HSY-01, HSY-02, HSY-03, HSY- 04, HSY-05) (c) Second 2018 Hematology Event - 5 of 5 samples (HSY-06, HSY-07, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 15 -- HSY-08, HSY-09, HSY-10) (d) Third 2018 Hematology Event - 5 of 5 samples (HSY- 11, HSY-12, HSY-13, HSY-14, HSY-15) (e) First 2018 Chemistry Miscellaneous Event - 3 of 3 samples (IA-01, IA-02, IA-03) (f) Second 2018 Chemistry Core Event - 5 of 5 samples (CH-06, CH-07, CH-08, CH-09, CH-10) (g) Third 2018 Chemistry Core Event - 5 of 5 samples (CH-11, CH-12, CH-13, CH-14, CH-15) (4) The findings were reviewed with the laboratory manager who stated the proficiency testing samples had been tested by the laboratory manager, as indicated above. D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to test proficiency testing samples the same number of times that patient samples were tested. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor the laboratory performed the following: (a) CBC (Complete Blood Count) testing using the Sysmex pocH-100i analyzer; (b) PSA (Prostate Specific Antigen), Testosterone, Vitamin D, TSH (Thyroid Stimulating Hormone), and Free T4 testing using the Beckman Coulter Access 2 analyzer. (2) Later during the survey, the surveyor reviewed proficiency testing records for 9 events (Third 2017, First 2018, Second 2018, Third 2018, and First 2019 Hematology Events; First 2018 and Second 2018 Chemistry Miscellaneous Events; Second 2018 and Third 2018 Chemistry Core Events) and identified the specimens had been tested multiple times for 8 of 9 events as follows: (a) Third 2017 Hematology Event (i) Sample HSY-11 was tested three times (03:01 pm on 11/27/17, 03:04 pm on 11/27 /17, and 09:17 am on 11/28/17) with the results reported to the proficiency testing program as follows: (aa) The WBC (White Blood Cell), RBC (Red Blood Cell), Hemoglobin, Hematocrit, MCH (Mean Corpuscular Hemoglobin), MCHC (Mean Corpuscular Hemoglobin Concentration), LYM%, MXD%, and NEUT% results obtained from the 03:01 pm testing on 11/27/17 had been reported; (bb) The MCV (Mean Corpuscular Volume) result obtained from the 03:04 pm testing on 11/27/17 had been reported; (cc) The Platelet result obtained from the 09:17 am testing on 11/28 /17 had been reported. (ii) Sample HSY-12 was tested three times (03:08 pm on 11/27 /17, 03:12 on 11/27/17, and 09:23 am on 11/28/17) with the results reported to the proficiency testing program as follows: (aa) The WBC, Hemoglobin, Hematocrit, MCV, Platelet, MXD%, and NEUT% results obtained from the 03:08 pm testing on 11 /27/17 had been reported; (bb) The RBC, MCH, MCHC, and LYM% results obtained from the 09:23 am testing on 11/28/17 had been reported. (iii) Sample HSY-13 was tested three times (03:26 pm on 11/27/17, 03:29 pm on 11/27/17, and 09:29 am on 11 /28/17) with the results reported to the proficiency testing program as follows: (aa) The WBC, Hematocrit, MCV, MCH, MCHC, LYM%, MXD%, and NEUT% results obtained from the 03:26 pm testing on 11/27/17 had been reported; (bb) The RBC and Platelet results obtained from the 03:31 pm testing on 11/27/17 had been reported; (cc) The Hemoglobin result obtained from the 09:29 am testing on 11/28/17 had been reported. (iv) Sample HSY-14 was tested three times (03:42 pm on 11/27/17, 03:47 pm on 11/27/17, and 09:38 am on 11/28/17) with the results reported to the proficiency testing program as follows: (aa) The MCH and MCHC results obtained from the 03:42 testing on 11/27/17 had been reported; (bb) The WBC, RBC, Hemoglobin, Hematocrit, MCV, Platelet, LYM%, MXD% and NEUT% results -- 2 of 15 -- obtained from the 03:47 pm testing on 11/27/17 had been reported. (v) Sample HSY- 15 was tested three times (03:50 pm on 11/27/17, 03:53 pm on 11/27/17, and 09:46 am on 11/28/17) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, Hematocrit, MCV, MCH, MCHC, LYM%, and MXD% results obtained from the 03:50 pm testing on 11/27/17 had been reported; (bb) The Platelet result obtained from the 03:53 pm testing on 11/27/17 had been reported; (cc) The NEUT% result obtained form the 09:46 am testing on 11/28 /17 had been reported. (b) First 2018 Hematology Event (i) Sample HSY-01 was tested three times (08:37 am, 08:45 am, and 08:48 am on 03/22/18) with the results reported to the proficiency testing program as follows: (aa) The WBC and Hematocrit results obtained from the 08:37 testing had been reported; (bb) The RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 08:48 testing had been reported. (ii) Sample HSY-02 was tested two times (09:01 am and 09:03 on 03/22/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:03 am testing had been reported. (iii) Sample HSY-03 was tested two times (09:09 am and 09:14 am on 03/22/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:14 am testing had been reported. (iv) Sample HSY-04 was tested two times (09:17 am and 09:21 am on 03/22/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:21 am testing had been reported. (v) Sample HSY-05 was tested two times (09:25 am and 09:28 am on 03/22/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09: 25 am testing had been reported. (c) Second 2018 Hematology Event (i) Sample HSY- 06 was tested two times (09:11 am and 09:15 am on 07/24/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:15 am testing had been reported. (ii) Sample HSY-07 was tested two times (09:21 am and 09:25 am on 07/24/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09: 25 am testing had been reported. (iii) Sample HSY-08 was tested two times (09:32 am and 09:38 am on 07/24/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:38 am testing had been reported. (iv) Sample HSY-09 was tested two times (09:41 am and 09:45 am on 07/24 /18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:45 am testing had been reported. (v) Sample HSY-10 was tested two times (09:48 am and 09:57 am on 07/24/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:48 am testing had been reported. (d) Third 2018 Hematology Event (i) Sample HSY-11 was tested three times (02:42 pm, 02:45 pm, and 02:49 pm on 11/21/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 02:49 pm testing had been reported. (ii) Sample HSY-12 was tested three times (02:53 pm, 02:59 pm, and 03:02 pm on 11/21 /18) with the results reported to the proficiency testing program as follows: (aa) The -- 3 of 15 -- WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 02:53 pm testing had been reported. (iii) Sample HSY-13 was tested three times (03:14 pm, 03:19 pm, and 03:23 pm on 11/21/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 03:23 pm testing had been reported. (iv) Sample HSY-14 was tested three times (03:27 pm, 03:30 pm, and 03:38 pm on 11/21/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 03:30 pm testing had been reported. (v) Sample HSY-15 was tested three times (03:37 pm, 03:42 pm, and 03:50 pm on 11/21/18) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 03:39 pm testing had been reported. (e) First 2019 Hematology Event (i) Sample HSY-01 was tested three times (08:55 am, 09:23 am, and 09:44 am on 03/26/19) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:23 am testing had been reported. (ii) Sample HSY-02 was tested three times (08:59 am, 09:27 am, and 09:49 am on 03/26/19) with the results reported to the proficiency testing program as follows: (aa) The Platelet result obtained from the 08:59 am testing had been reported; (bb) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, LYM%, MXD%, and NEUT% results obtained from the 09:27 am testing had been reported. (iii) Sample HSY-03 was tested three times (09:03 am, 09:31 am, and 09:53 am on 03/26/19) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09: 31 am testing had been reported. (iv) Sample HSY-04 was tested three times (09:09 am, 09:35 am, and 09:57 am on 03/26/19) with the results reported to the proficiency testing program as follows: (aa) The Platelet result obtained from the 09:35 am testing had been reported; (bb) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, LYM%, MXD%, and NEUT% results obtained from the 09:57 am testing had been reported. (v) Sample HSY-05 was tested three times (09:14 am, 09:39 am, and 10:03 am on 03 /26/19) with the results reported to the proficiency testing program as follows: (aa) The WBC, RBC, Hemoglobin, MCV, MCH, MCHC, Platelet, LYM%, MXD%, and NEUT% results obtained from the 09:39 am testing had been reported. (f) Second 2018 Chemistry Miscellaneous Event (i) Sample IA-04 was tested three times for PSA and Testosterone; and two times for Vitamin D on 10/30/18 (PSA was tested at 10:28 am, 10:30 am, and 11:59 am; Testosterone was tested at 10:20 am, 10:30 am, and 11: 53 am; Vitamin D was tested at 10:49 am, and 10:51 am) with the results reported to the proficiency testing program as follows: (aa) The PSA result obtained from the 11: 59 am testing had been reported; (bb) The Testosterone result obtained from the 10:20 am testing had been reported; (cc) The Vitamin D result obtained from the 10:51 am testing had been reported. (ii) Sample IA-05 was tested three times for PSA and Testosterone; and two times for Vitamin D on 10/30/18 (PSA was tested at 10:29 am, 10:30 am, and 12:00 pm; Testosterone was tested at 10:20 am, 10:22 m, and 11:53 am; Vitamin D was tested at 10:50 am and 10:51 am) with the results reported to the proficiency testing program as follows: (aa) The PSA result obtained from the 10:30 am testing had been reported; (bb) The Testosterone result obtained from the 10:20 am testing had been reported; (cc) The Vitamin D result obtained from the 10:51 am testing had been reported. (iii) Sample IA-06 was tested three times for PSA and Testosterone; and two times for Vitamin D on 10/30/18 (PSA was tested at 10:29 am, 10:31 am, and 12:01 pm; Testosterone was tested at 10:21 am, 10:23 am, and 11:54 am; Vitamin D was tested at 10:50 am and 10:51 am) with the results reported to the -- 4 of 15 -- proficiency testing program as follows: (aa) The PSA result obtained from the 12:01 am testing had been reported; (bb) The Testosterone result obtained from the 10:23 am testing had been reported; (cc) The Vitamin D result obtained from the 10:51 am testing had been reported. (g) Second 2018 Chemistry Core Event (i) Sample CH-06 was tested two times for TSH and Free T4 on 06/04/18 (TSH was tested at 03:42 pm and 03:48 pm; Free T4 was tested at 03:26 pm and 03:32 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 3.86, which was the calculated average of the result obtained from the 03:42 pm testing (3.94) and the result obtained from the 03:48 pm testing (3.78); (bb) The Free T4 result that had been reported was 2.84, which was the calculated average of the result obtained from the 03:26 pm testing (2.71) and the result obtained from the 03:32 pm testing (2.96). (ii) Sample CH-07 was tested two times for TSH and Free T4 on 06/04/18 (TSH was tested at 03:44 pm and 03:50 pm; Free T4 was tested at 03: 27 pm and 03:33 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 1.81, which was the calculated average of the result obtained from the 03:42 pm testing (1.77) and the result obtained from the 03:48 pm testing (1.85); (bb) The Free T4 result that had been reported was 3.20, which was the calculated average of the result obtained from the 03:26 pm testing (3.24) and the result obtained from the 03:32 pm testing (3.10). (iii) Sample CH-08 was tested two times for TSH and Free T4 on 06/04/18 (TSH was tested at 03:45 pm and 03:51 pm; Free T4 was tested at 03:29 pm and 03:35 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 5.44, which was the calculated average of the result obtained from the 03:45 pm testing (5.36) and the result obtained from the 03:51 pm testing (5.52); (bb) The Free T4 result that had been reported was 2.74, which was the calculated average of the result obtained from the 03:29 pm testing (2.75) and the result obtained from the 03:35 pm testing (2.73). (iv) Sample CH-09 was tested two times for TSH and Free T4 on 06/04/18 (TSH was tested at 03:46 pm and 03:52 pm; Free T4 was tested at 03:30 pm and 03:36 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 1.09, which was the calculated average of the result obtained from the 03:46 pm testing (1.07) and the result obtained from the 03:52 pm testing (1.10); (bb) The Free T4 result that had been reported was 3.32, which was the calculated average of the result obtained from the 03:30 pm testing (3.25) and the result obtained from the 03: 36 pm testing (3.40). (v) Sample CH-10 was tested two times for TSH and Free T4 on 06/04/18 (TSH was tested at 03:47 pm and 03:54 pm; Free T4 was tested at 03:31 pm and 03:38 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 5.08, which was the calculated average of the result obtained from the 03:47 pm testing (5.08) and the result obtained from the 03:54 pm testing (5.09); (bb) The Free T4 result that had been reported was 2.75, which was the calculated average of the result obtained from the 03:31 pm testing (2.70) and the result obtained from the 03:38 pm testing (2.75). (h) Third 2018 Chemistry Core Event (i) Sample CH-11 was tested two times for TSH and Free T4 on 09/11/18 (TSH was tested at 02:26 pm and 02:32 pm; Free T4 was tested at 02:10 pm and 02:16 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result obtained from the 02:32 pm testing had been reported (1.25); (bb) The Free T4 result that had been reported was 3.4, which was the calculated average of the result obtained from the 02:10 pm testing (3.42) and the result obtained from the 02:16 pm testing (3.38). (ii) Sample CH-12 was tested two times for TSH and Free T4 on 09/11/18 (TSH was tested at 02:27 pm and 02:33 pm; Free T4 was tested at 02:11 pm and 02:17 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 4.20, which was the calculated average of the result obtained from the 02:27 pm -- 5 of 15 -- testing (4.09) and the result obtained from the 02:33 pm testing (4.30); (bb) The Free T4 result that had been reported was 2.9, which was the calculated average of the result obtained from the 02:11 pm testing (2.92) and the result obtained from the 02: 17 pm testing (2.95). (iii) Sample CH-13 was tested two times for TSH and Free T4 on 09/11/18 (TSH was tested at 02:28 pm and 02:34 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 5.62, which was the calculated average of the result obtained from the 02:28 pm testing (5.82) and the result obtained from the 02:34 pm testing (5.43); (bb) The Free T4 result that had been reported was 2.8, which was the value obtained from the 02:12 pm testing and the 02:18 pm testing. (iv) Sample CH-14 was tested two times for TSH and Free T4 on 09/11/18 (TSH was tested at 02:29 pm and 02:35 pm; Free T4 was tested at 02:17 pm and 02:20 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 2.82, which was the calculated average of the result obtained from the 02:29 pm testing (2.79) and the result obtained from the 02:35 pm testing (2.85); (bb) The Free T4 result that had been reported was 3.3, which was the calculated average of the result obtained from the 02:17 pm testing (3.25) and the result obtained from the 02:20 pm testing (3.27). (v) Sample CH-15 was tested two times for TSH and Free T4 on 09/11/18 (TSH was tested at 02:31 pm and 02:37 pm; Free T4 was tested at 02:14 pm and 02:21 pm) with the results reported to the proficiency testing program as follows: (aa) The TSH result that had been reported was 4.91, which was the calculated average of the result obtained from the 02:31 pm testing (4.78) and the result obtained from the 02:37 pm testing (5.04); (bb) The Free T4 result that had been reported was 2.9, which was the calculated average of the result obtained from the 02:14 pm testing (2.86) and the result obtained from the 02:21 pm testing (2.98). (3) The surveyor reviewed the records with the laboratory manager and asked for an explanation of the laboratory's method for testing proficiency testing samples, and if patient samples were tested in the same manner. The laboratory manager stated the following to the surveyor: (a) Proficiency testing samples were tested multiple times, with the mid-range result, first or last testing run, or an average of two testing runs used as the result reported to the proficiency testing program; (b) Patient specimens were routinely tested one time and not in the same manner the proficiency testing specimens had been tested. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory director failed to sign proficiency testing attestation statements. Findings include: (1) During the survey, the surveyor reviewed 2017, 2018, and 2019 proficiency testing records and identified attestation statements for 6 of 9 events had -- 6 of 15 -- been signed by the laboratory manager (as designee) as follows: (a) First 2018 Hematology Event (b) Third 2018 Hematology Event (c) First 2019 Hematology Event (d) Second 2018 Chemistry Miscellaneous Event (e) Second 2018 Chemistry Core Event (f) Third 2018 Chemistry Core Event (2) The surveyor reviewed the personnel records for the laboratory manager and identified the laboratory manager earned a Bachelor of Science and met the qualifications of a technical consultant as required at 493.1409; (3) The surveyor asked the laboratory manager if the responsibility for signing the attestation statements had been delegated in writing by the laboratory director. The laboratory manager stated to the surveyor the laboratory director had not delegated in writing the responsibility for signing the attestation statements; (4) The surveyor explained to the laboratory manager since the responsibility for signing the attestation statements had not been delegated in writing, the laboratory director must sign the attestation statements. NOTE: The Interpretive Guidelines under D2015 state "For moderate complexity testing, in accordance with 493.1407(e)(4)(i), the director may delegate the responsibility for signing the attestation statement to a technical consultant meeting the qualifications of 493.1409." 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 laboratory manager, the laboratory failed to verify the accuracy of urine microscopic testing at least twice annually. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor the laboratory performed microscopic urine sediment examinations; (2) The surveyor reviewed proficiency testing records for 2018 and to date in 2019. The laboratory had not enrolled and participated in a proficiency testing program for urine microscopic testing; (3) Since the laboratory was not enrolled in proficiency testing (participation in a proficiency testing program is not required for microscopic urine sediment examinations; it is not a regulated test), the surveyor asked the laboratory manager to explain how the testing was verified for accuracy during 2018 and to date. The laboratory manager stated microscopic urine sediment examinations had not been verified for accuracy during 2018 and to date in 2019; (4) The following were examples of patient urine sediment examinations performed: (a) Patient #3 - Testing performed on 01/09/18 (b) Patient #4 - Testing performed on 01 /24/18 (c) Patient #5 - Testing performed on 02/16/18 (d) Patient #6 - Testing performed on 03/01/18 (e) Patient #7 - Testing performed on 04/04/18 (f) Patient #8 - Testing performed on 05/24/18 (g) Patient #9 - Testing performed on 06/03/18 (h) Patienet #10 - Testing performed on 07/19/18 (i) Patient #11 - Testing performed on 08/21/18 (j) Patient #12 - Testing performed on 09/26/18 (k) Patient #13 - Testing performed on 10/12/18 (l) Patient #14 - Testing performed on 11/20/18 (m) Patient #15 - Testing performed on 12/17/18 (n) Patient #16 - Testing performed on 01/21/19 (o) Patient #17 - Testing performed on 02/11/19 (p) Patient #18 - Testing performed on 03/12/19 (q) Patient #19 - Testing performed on 04/17/19 (r) Patient #20 - Testing performed on 05/15/19 D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 -- 7 of 15 -- 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 a review of records, manufacturer's instructions, policies and procedures, observation, and interview with the laboratory manager, the laboratory failed to monitor and evaluate the overall quality of analytic systems and correct identified problems for each specialty and subspecialty of testing performed. Findings include: (1) The laboratory failed to ensure materials were stored as required. Refer to D5413; (2) The laboratory failed to have a function check protocol for ensuring the urine centrifuge was functioning properly. Refer to D5435; (3) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process. Refer to D5441; (4) The laboratory failed to follow the manufacturer's quality control specifications. Refer to D5479; (5) The laboratory failed to have an ongoing mechanism for performing quality assessment. Refer to D5791. 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, observation, and interview with the laboratory manager, the laboratory failed to ensure materials were stored as required. Findings include: (1) During the survey, the surveyor observed the contents of the Roper freezer in the laboratory phlebotomy room (designated by the laboratory as Room 2). The freezer was a frost free freezer. The following materials were being stored in the freezer, along with the manufacturer's storage requirements: (a) Access Free T4 Calibrators - 1 box (lot #831941) and 1 box (lot #832347); the storage requirement was -20 degrees Centigrade (C) and colder; (b) Access 25 (OH) Vitamin D Total Calibrator - 1 box (lot #832318); the storage requirement was -15 to -30 degrees C. (2) The laboratory manager explained to the surveyor the materials were used to perform calibration procedures for Free T4 and Vitamin D testing performed on the Beckman Coulter Access 2 analyzer; (3) The surveyor then reviewed laboratory temperature records from 05/01/18 through the day of the survey which verified temperature readings were documented as warmer than -20 degrees C (the warmest temperature to allow for both of the calibrators stored together) 12 of 12 months as follows: (a) May 2018 - 12 of 22 temperature readings were documented as warmer than -20 C (days 01,02,03,04,09,11,14,15,16,18,22,24) (b) June 2018 - 15 of 20 temperature readings were documented as warmer than -20 C (days 01,04,05,06,07,08,11,12,14,15,25,26 ,27,28,29) (c) July 2018 - 18 of 21 temperature -- 8 of 15 -- readings were documented as warmer than -20 C (days 02,03,05,06,09,10,11,12,13,16,17,18,19,20,26,27,30,31) (d) August 2018 - 22 of 23 temperature readings were documented as warmer than -20 C (days 01,02,03,06,07,08,09,10,13,14,15,16,20,21,22,23,24,27,28,29,30,31) (e) September 2018 - 17 of 19 temperature readings were documented as warmer than -20 C (days 04,05,06,07,10,11,12,13,14,19,20,21,24,25,26,27,28) (f) October 2018 - 24 of 24 temperature readings were documented as warmer than -20 C (days 01,02,03,04,05,08,09,10,11,12,15,16,17,18,19,20,22,23,24,25,26,29,30,31) (g) November 2018 - 20 of 20 temperature readings were documented as warmer than -20 C (days 01,02,05,06,07,08,09,12,13,14,15,16,19,20,21,26,27,28,29,30) (h) December 2018 - 18 of 18 temperature readings were documented as warmer than -20 C (days 03,04,05,06,07,10,11,12,13,14,17,18,19,20,21,26,27,28) (i) January 2019 - 22 of 22 temperature readings were documented as warmer than -20 C (days 02,03,04,07,08,09,10,11,14,15,16,17,18,21,22,23,24,25,28,29,30,31) (j) February 2019 - 21 of 21 temperature readings were documented as warmer than -20 C (days 01,04,05,06,07,08,11,12,13,14,15,16,18,19,20,21,22,25,26,27,28) (k) March 2019 - 21 of 21 temperature readings were documented as warmer than -20 C (days 01,04,05,06,07,08,11,12,13,14,15,18,19,20,21,22,25,26,27,28,29) (l) April 2019 - 22 of 22 temperature readings were documented as warmer than -20 C (days 01,02,03,04,05,08,09,10,11,12,15,16,17,18,19,22,23,24,25,26,29,30) (m) May 2019 - 17 of 17 temperature readings were documented as warmer than -20 C (days 01,02,03,06,07,08,09,10,13,14,15,16,17,20,21,22,23) (4) The surveyor reviewed the records with the laboratory manager who stated the temperature of the freezer had not been maintained as required by the manufacturer of the calibrators. 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 laboratory manager, the laboratory failed to have a function check protocol for ensuring the urine centrifuge was functioning properly. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor urine sediment examinations were performed in the laboratory. The specimens were processed in the LW Scientific Ultra Select centrifuge at a speed of 1800 rpm (revolutions per minute) for 5 minutes; (2) The surveyor asked the laboratory manager if the laboratory had a written protocol defining the frequency the centrifuge speed and timer were to be checked and the criteria for acceptability. The laboratory manager stated to the surveyor a detailed protocol had not been written and showed the surveyor a statement contained in the "Laboratory Procedure Manual" which stated,"The centrifuge is calibrated annually by an outside service"; (3) The surveyor requested centrifuge records from 2017 through the current date. The laboratory manager stated to the surveyor centrifuge records could not be located and a sticker on the centrifuge was -- 9 of 15 -- the only documented centrifuge check to date. The surveyor observed the sticker which indicated the centrifuge speed had been checked on 04/01/19 at 1800 rpm. There was no documentation the timer had been checked for accuracy; (4) The surveyor reviewed the findings with the laboratory manager who stated: (a) The laboratory did not have a written protocol for ensuring the urine centrifuge was functioning properly (including criteria of acceptability for the speed and timer checks); (b) There was no documentation timer checks had been performed from 2017 through the day of the survey; (c) There was no documentation speed checks had been performed prior to the one performed 04/04/19. (5) Refer to D5217 for examples of patient urine sediment examinations performed. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory manager, the laboratory failed to have control procedures that monitored the accuracy and precision of the testing process. Findings include: (1) At the beginning of the survey, the laboratory manager stated the following to the surveyor: (a) PSA (Prostate Specific Antigen), Testosterone, Vitamin D, TSH (Thyroid Stimulating Hormone), and Free T4 testing were performed using the Beckman Coulter Access 2 analyzer; (b) Three levels of Thermo Scientific MAS Omni-Immune Liquid Assayed Integrated Immunoassay control materials were tested as follows: (i) Level 1 was tested each day of patient testing, with level 2 and level 3 alternated every other day. (2) Later during the survey, the surveyor reviewed quality control records for 3 lot numbers of control materials used from 09/04/18 through the day of the survey. For 3 of 3 lot numbers (level 1 lot #OIM2010-1, level 2 lot #OIM2010-2, and level 3 lot #OIM2010-3), there were no records (i.e., Levey-Jennings data) proving the control results had been monitored for variances; (3) The surveyor asked the laboratory manager if the lot numbers above had been monitored for variances. The laboratory manager stated to the surveyor the controls were not routinely monitored for variances; (4) The following were examples of patient testing performed when the laboratory had not monitored QC results for variances: (a) Patient #21 - PSA and Testosterone testing performed 09/04/18 (b) Patient #22 - Free T4 and TSH testing performed on 09/04/18 (c) Patient #23 - Vitamin D testing performed on 09/10/18 (d) Patient #24 - Free T4, TSH, Testosterone, and Vitamin D testing performed on 09/13/18 (e) Patient #25 - Free T4 and TSH testing performed on 09/18/18 (f) Patient #26 - TSH, PSA, and Testosterone testing performed on 09/20/18 (g) Patient #27 - PSA and Tsetosterone testing performed on 09/24/18 (h) Patient #28 - Free T4, TSH, and PSA testing performed on 09/27/18 (i) Patient #29 - TSH and Vitamin D testing performed on 10 /01/18 (j) Patient #30 - PSA testing performed on 10/10/18 (k) Patient #31 - Free T4 -- 10 of 15 -- and TSH testing performed on 10/15/18 (l) Patient #32 - Free T4, FSH, Testosterone testing performed on 10/23/18 (m) Patient #33 - PSA and Testosterone testing performed on 10/25/18 (n) Patient #34 - Free T4, TSH, and Vitamin D testing performed on 10/29/18 (o) Patient #35 - Vitamin D testing performed on 01/02/19 (p) Patient #36 - Free T4 and TSH testing performed on 01/02/19 (q) Patient #37 - TSH and Vitamin D testing performed on 01/07/19 (r) Patient #38 - Free T4, TSH, and Vitamin D testing performed on 01/11/19 (s) Patient #39 - TSH and PSA testing performed on 01/15/19 (t) Patient #40 - Vitamin D testing performed on 01/17/19 (u) Patient #41 - TSH and Testosterone testing performed on 01/21/19 (v) Patient #42 - Free T4 and TSH testing performed on 01/23/19 (w) Patient #43 - PSA and Testosterone testing performed on 01/28/19 (x) Patient #44 - Vitamin D testing performed on 04/01/19 (y) Patient #45 - TSH and PSA testing performed on 04/01/19 (z) Patient #46 - Testosterone testing perforned on 04/01/19 (aa) Patient #47 - Free T4 and TSH testing perforned on 04/01/19 (bb) Patient #48 - Free T4, TSH, and Vitamin D testing perforned on 04/02/19 (cc) Patient #49 - Free T4 and TSH testing perforned on 04/03/19 (dd) Patient #50 - Testosterone and Vitamin D testing performed on 04/11 /19 (ee) Patient #51 - Free T4, TSH, and PSA testing perforned on 04/11/19 (ff) Patient #52 - Free T4, TSH, PSA, and Vitamin testing perforned on 04/12/19 (gg) Patient #53 - PSA and Testosterone testing perforned on 05/01/19 (hh) Patient #54 - TSH and Vitamin D testing performed on 05/01/19 (ii) Patient #55 - PSA, Testosterone, and Vitamin D testing perforned on 05/07/19 (jj) Patient #56 - TSH and Vitamin D testing perforned on 05/13/19 (kk) Patient #57 - Free T4, TSH, PSA, and Testosterone testing perforned on 05/22/19 D5479 CONTROL PROCEDURES CFR(s): 493.1256(e)(5)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (5) Follow the manufacturer's specifications for using reagents, media, and supplies and be responsible for results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory manager, the laboratory failed to follow the manufacturer's quality control specifications. Findings include: (1) At the beginning of the survey, the laboratory manager stated the following to the surveyor: (a) PSA (Prostate Specific Antigen), Testosterone, Vitamin D, TSH (Thyroid Stimulating Hormone), and Free T4 testing were performed using the Beckman Coulter Access 2 analyzer; (b) Three levels of Thermo Scientific MAS Omni-Immune Liquid Assayed Integrated Immunoassay control materials were tested as follows: (i) Level 1 was tested each day of patient testing, with level 2 and level 3 alternated every other day. (2) Later during the survey, the surveyor reviewed the manufacturer's instructions for the control materials which stated, "Instrument values provided are specific to this lot of control only and are intended to assist the laboratory in establishing its own means and ranges."; (3) The surveyor then reviewed quality control records for the current lot numbers of control materials (level 1 lot #OIM2010-1, level 2 lot #OIM2010-2, and level 3 lot #OIM2010-3) used for patient testing from 09/04/18 through the day of the survey, with the laboratory manager. The laboratory manager stated the laboratory had used the package insert means and limits for each level of control instead of establishing -- 11 of 15 -- their own means and limits as stated in the manufacturer's package insert; (4) Refer to D5441 for examples of patient testing performed when the laboratory failed to establish quality control means and limits. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of records, policies and procedures, manufacturer's instructions, observation, and interview with the laboratory manager, the laboratory failed to have an ongoing mechanism for performing effective analytic quality assessment. Findings include: (1) It was determined the laboratory did not have an effective mechanism for performing analytic quality assessment because of the following issues identified during the survey: (a) The laboratory failed to ensure materials were stored as required. Refer to D5413; (b) The laboratory failed to have a function check protocol for ensuring the urine centrifuge was functioning properly. Refer to D5435; (c) The laboratory failed to have control procedures that monitored the accuracy and precision of the testing process. Refer to D5441; (d) The laboratory failed to follow the manufacturer's quality control specifications. Refer to D5479. 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 records and interview with the laboratory manager, the laboratory failed to make appropriate reference ranges available. Findings include: (1) At the beginning of the survey, the laboratory manager stated to the surveyor CBC (Complete Blood Count) testing was performed using the Sysmex pocH-100i analyzer; (2) Later during the survey, the surveyor reviewed two patient CBC reports - the first report was for an adult male (patient #1) with the testing performed on 05/22 /19 at 03:02 pm; the second report was for an adult female (patient #2) with the testing performed on 05/23/19 at 12:51 pm. Both reports included the same reference intervals for the CBC parameter of RBC (Red Blood Cell) which was: (a) RBC - 4.04 - 6.13 (1000000/ul) (3) The surveyor reviewed the findings with the laboratory manager, who stated the patient reports did not include gender specific reference ranges for RBC. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. -- 12 of 15 -- 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a review of records, policies and procedures, manufacturer's instructions, observation, and interview with the laboratory manager, the laboratory director failed to provide overall management and direction. Findings include: (1) The laboratory director failed to ensure test methods were performed as required by the manufacturer to ensure accurate and reliable results were reported. Refer to D6014; (2) The laboratory director failed to ensure proficiency testing samples were tested as required under Subpart H. Refer to D6016; (3) The laboratory director failed to ensure proficiency testing reports were reviewed to evaluate the laboratory's performance and to identify problems requiring