Penn Highlands - Brookville

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) proficiency testing (PT) records, patient test reports and interview with the Technical Supervisor #2 (CMS 209 TS #2) the laboratory failed to examine 5 of 5 API PT hematology testing events in the same manner as patient specimens from 02/06/2023 to the date of survey. Findings include: 1. On the day of survey, 10/07/2024, review of the patient test reports and API PT records revealed that the laboratory failed to examine 5 of 5 API PT hematology testing events for semen analysis in the same manner as patient specimens from 02/06/2023 to 10/07/2024. 2. The laboratory's procedural manual titled "Post-Vasectomy Sperm Screen" stated the following: "7. Examine 100 field on the slide under high power, noting the presence and motility of any sperm present." "12. Report out results as: No sperm present per 100 HPF examined or XX-XX motile or nonmotile sperm present per 100 HPF examined." 3. Review of patient test reports revealed the laboratory reported the following quantitative semen analysis results: 02- 23-080-0214 (03/21/1023): Sperm 0-2/HPF Sperm motility: Non Motile 02-23-219- 0189 (08/07/2023): Sperm 2-4/HPF Sperm motility: Approximately 25% of sperm present had moderate motility. Remaining 75% were nonmotile. 4. API PT records showed the laboratory reported the following for semen analysis: - presence/absence Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- (qualitative) of sperm. 5. TS #2 confirmed the finding above on 10/08/2024 at 01:00 pm. 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 lack of documentation and interview with Technical Supervisor #2 (CMS 209 TS #2) the laboratory failed to provide BD BACTEC blood culture temperature records in Microbiology from 02/06/2024 to the day of survey. Findings include: 1. On the days of survey, 10/07/2024 and 10/08/2024, the laboratory could not provide temperature records for 2 of 2 BD BACTEC blood culture drawers from 02/06/2024 to 10/08/2024. 2. TS#2 confirmed the findings above on 10/08/2024 around 01:00 pm D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory and interview with technical supervisor #2 (CMS 209 TS #2), the laboratory failed to label aliquoted reagents with the pertinent information required for proper use in Microbiology from 02/06/2023 to 10/08/2024. Findings include: 1. On day of the survey 10/08/2024 at 12:30 pm, during the laboratory tour, observation of the Gram Stain reagents revealed 1 of 1 container used to aliquot BD Decolorizer was not properly labeled with the following: - identity of reagent - storage requirements - preparation and expiration dates 2. TS #2 confirmed the findings above on 10/08/2024 around 12:30 pm. -- 2 of 2 --

Summary Statement of Deficiencies 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 the urine culture test records and interview with technical supervisor #2 (TS), the laboratory failed to enroll in an HHS approved proficiency testing (PT) program for bacteriology from 11/03/2020 to 02/07/2023. Refer to Dtag: 6015 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: A. Based on review of the laboratory's procedures, competency assessment records and interview with technical supervisor (TS) #2, the laboratory failed to establish a competency assessment procedure to assess the competency of 1 of 2 technical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 12 -- consultants (TC), 1 of 2 technical supervisors (TS), and 3 of 3 general supervisors (GS) for their supervisory responsibilities from 11/20/2020 to the date of survey. Findings include: 1. On the day of survey, 02/06/2022 at 01:30 pm, the laboratory could not provide a competency assessment policy to assess the competency of the following personnel for their supervisory responsibilities from 11/20/2020 to 02/07 /2023: - 1 of 2 TC (on CMS 209, personnel #2) - 1 of 2 TS (on CMS 209, personnel #2) - 3 of 3 GS (on CMS 209, personnel #2, #3, and #4) 2. TS #2 confirmed the findings above on 02/07/2022 around 04:45 pm. B. Based on lack of documention and interview with technical supervisor #2 (TS), the laboratory failed to establish a procedure for competency assessments for 7 of 7 testing personnel (TP) who performed testing in the areas of microbiology, immunology, chemistry, immunohematology and hematology and 8 of 8 TP that performed blood gas examinations from 11/20/2020 to the date of the survey. Findings include: 1. On the day of the survey, 02/06/2023 at 01:30 pm. the laboratory could not provide competency assessment for 7 of 7 TP for each individual test performed in the microbiology, immunology, chemistry, hematology, and immunohematology departments from 11/20/2020 to 02/06/2023. 2. The laboratory could not provide documentation of competency assessments performed for 8 of 8 TP that performed blood gas examinations on the RAPIDpoint 500 in 2021. 3. TS #2 confirmed the findings above on 02/07/2023 around 04:45 p.m. *This is a repeat deficiency. 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 of the laboratory and interview with technical supervisor (TS) #2, the laboratory failed to ensure that reagents and supplies used for examinations in microbiology and immunohematology were not used beyond the expiration dates from 07/31/2022 to the date of the survey. Findings Include: 1. On the date of the survey, 02 /07/2023 at 02:15 pm, the laboratory tour revealed that the following reagents and supplies used for immunohematology and microbiology examinations were expired: - 3 packs of BD Macconkey agar plates lot#2305702 expired: 01/31/2023 - 1 box of Hemotemp Blood temperature indicators expired : 07/31/2022 2. The laboratory performed 38 urine microbiology examinations from 02/01/2023 to 02/07/2023. 3. TS #2 confirmed the findings above on 02/07/2023 around 04:45 pm. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with technical supervisor #2 (TS) , the -- 2 of 12 -- laboratory failed to evaluate twice a year the relationship between test results using different methodologies and instrumentation in hematology, urinalysis, chemistry, immunohematology and coagulation from 11/20/2020 to the date of the survey. Findings include: 1. On the date of the survey, 02/07/2023 at 10:10 am, the laboratory failed to provide documentation of the biannual comparison studies for the following tests from 11/20/2020 to 02/07/2023: - 2 of 2 Sysmex XN-10 (hematology) - 2 of 2 Siemens Vista (endocrinology/immunology/chemistry) - 2 of 2 ACL TOPS 350 (coagulation) - manual differentials vs. automated differentials (Sysmex XN-10) - manual microscopic urinalysis vs. automated microscopic urinalysis (Arkray Aution) - blood type tube testing vs manual gel blood typing (Ortho) 2. The laboratory performed the following examinations in 2022 (CMS 116 annual volume): - 260, 438 chemistry examinations - 97,125 hematology examinations - 701 immunohematology examinations 3. TS# 2 confirmed the findings above on 02/07/2023 around 04:45 pm. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on review of the urine culture test records and interview with technical supervisor #2 (TS), the laboratory director (LD) failed to ensure that the laboratory was enrolled in an approved proficiency testing (PT) program by HHS for bacteriology testing performed from 11/03/2020 to 02/07/2023. Findings include: 1. On the date of the survey, 02/06/2023 at 01:51 pm, review of the laboratory records revealed that the laboratory was not enrolled in an approved PT program for urine cultures positive and negative identification from 11/03/2023 to 02/07/2023. 2. The laboratory could not provide evidence of enrollment in an approved proficiency testing program for urine culture examinations at the time of inspection. 3. TS #2 confirmed the finding above on 02/07/2023 around 04:45 pm. D6086 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(3)(ii) The laboratory director must ensure that verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method. This STANDARD is not met as evidenced by: Based on review of the Sysmex XN-10 analyzer validation records and interview with technical supervisor (TS) #2, the Laboratory Director (LD) failed to ensure that the performance specification procedures used to determine the accuracy and precision for the complete blood count (CBC) testing performed on the Sysmex XN-10 were adequate before reporting patient test results from 02/28/2022 to the date of survey. Findings Include: 1. On the day of survey, 02/07/2023 at 08:59 am, review of the Sysmex XN-10 validation records revealed that the validation performed on 02/28 -- 3 of 12 -- /2022 did not include the laboratory's acceptable criteria for performance specifications for precision, accuracy, reportable ranges, and reference intervals/range (normal values) for the following 14 of 14 analytes: - White Blood Count (WBC) - Red Blood Count (RBC) - Hemoglobin (HGB) - Hematocrit (HCT) - Mean Corpuscular Volume (MCV) - Mean Corpuscular Hemoglobin (MCH) - Mean Corpuscular Hemoglobin Concentration (MCHC) - Platelet (PLT) - Nucleated Red Blood Cells (NRBC) - Neutrophils (NEU) - Lymphocytes (LYM) - Monocytes (MON) - Eosinophils (EOS) - Basophils (BAS) 2. The laboratory could not provide documentation of the method comparison performed on the Sysmex XN-10 for NRBC testing. 3. TS #2 confirmed the findings above on 02/07/2023 around 04:45 pm. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies 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: A. Based on the American Proficiency Institute (API) proficiency testing (PT) records and interview with the General Supervisor (GS) #1, the Laboratory Director (LD) failed to sign the API PT attestation statement from 2018, 2019, and 2020. Findings include: 1. On the day of survey, 11/03/2020, review of API PT records revealed, the following API PT attestation statements were not signed by the LD: - 2018, Event #3, Hematology/Coagulation. - 2019, Event #1, Chemistry Core (Blood Gases). - 2020, Event #1, Immunohematology. 2. The GS confirmed the findings above on 11/04 /2020 at 12:30 p.m. B. Based on American Proficiency Institute (API) proficiency testing (PT) records and interview with the General Supervisor (GS), the laboratory failed to provide attestation statements from 2018, 2019, and 2020. Findings include: 1. On the day of survey, 11/04/2020 review of API PT records revealed the following API PT attestations statements were missing: - 2018 Event #3, Chemistry Core (Blood gases). - 2019 Event #1 Hematology/Coagulation. - 2019 Event #2 and Event#3, Chemistry Core (Blood gases). - 2020 Event #1 and Event #2, Chemistry Core (Blood gases). 2. The GS confirmed the findings above on 11/04/2020 at 12:30 p.m. 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 -- D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on observation of the Blood Bank refrigerator and interview with General Supervisor (GS) #1,the laboratory failed to ensure areas were designated in the blood bank refrigerator for quarantine blood products from 09/19/2018 to the date of survey. findings include: 1. On the day of survey, 11/03/2020, observation of the blood bank refrigerator revealed, there were no designated areas for quarantine blood products in the blood bank refrigerator. 2. The GS#1 confirmed the finding above on 11/03/2020 at 11:35 a.m. 3. The GS#1 corrected the deficiency on-site on 11/04/2020. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's Continue Education and Competency Assessment Policy, and interview with the General Supervisor (GS) #1, the laboratory failed to establish a complete procedure for the assessment of 2 of 2 General Supervisors for their supervisory responsibilities, 7 of 7 Testing Personnel (TP) for each test performed in Microbiology, Immunology, Chemistry, Hematology, and Immunohematology departments, and 9 of 9 of testing personnel who performed blood gases were not assessed for competencies from 09/19/2018 to the day of survey. Findings include: 1. On the day of survey, 11/03/2020, the GS#1 could not provide a General Supervisor policy to assess the competency of 2 of 2 GS for their supervisory responsibilities in 2018,2019, and 2020. 2. Review of the personal records revealed 9 of 9 TP who performed blood gases testing, were not assessed for competency in 2018, 2019, and 2020. 3. Review of the competency assessment record revealed, the laboratory did not assess 7 of 7 TP for each individual tests performed in the in Microbiology, Immunology, Chemistry, Hematology, and Immunohematology departments in 2018, 2019 and 2020. 4. The GS #1 confirmed the finding above on 11 /04/2020 around 12:30 p.m. 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 -- 2 of 5 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on review of temperature records and interview with General Supervisor (GS) #1, the laboratory failed to record daily temperatures on the Medication Refrigerator and room temperature where the blood gases supplies were store from 2018, 2019 and 2020. Findings Include: 1. On the day of survey, 11/04/2020, review of the Medication Refrigerator records revealed, the following number of days temperatures were not documented each month: 2018: - 4 of 30 days in September. - 2 of 31 days in October. - 2 of 31 days in December. 2019: - 6 of 31 days in January. - 2 of 28 days in February. - 3 of 31 days in March. - 5 of 30 days in April. - 5 of 30 days in June. - 4 of 31 days in July. - 4 of 31 days in August. - 2 of 30 days in September. - 2 of 31 days in October. - 3 of 30 days in November. -7 of 31 days in December. 2020: -7 of 31 days in January. - 6 of 29 days in February. - 4 of 31 days in March. 2. Review of temperature records revealed, room temperatures were not taken where blood gases reagents were store from 2018, 2019, and 2020. 3. The GS #1 confirmed the finding above on 11/04/2020 around 12:30 p.m. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based upon a review of the Chemistry Instrument Calibration-AMR-Precision policy, review of Siemens Dimension Vista 500 calibration verification records, and interview with Testing Personnel (TP) #4 the laboratory failed to follow perform semiannual calibration verification from 01/01/2020 through 10/24/2020 . Findings include: 1. The Chemistry Instrument Calibration-AMR-Precision policy states: "Calibration verification is performed at a minimum of every six months for all Vista methods". 2. On the day of survey, 11/04/2020, review of the Siemens Dimension Vista 500 (SN DV330217 and DV370126) records revealed, one calibration verification was perform during 2020 (October 24) for the following 35 analytes: - -- 3 of 5 -- Blood urea nitrogen - Calcium - Cholesterol - Creatinine 2 - Glucose - Lactate - Magnesium - Uric Acid - Phosphorus - Salicylate - Triglycerides - Ammonia - Carbon Dioxide - Ethyl Alcohol - Albumin - Total Protein - Alkaline Phosphatase - Acetaminophen - Direct Bilirubin - Total Bilirubin - High-density lipoproteins - Low- density lipoproteins - Total Iron Binding Capacity - Iron - Amylase - Gamma Glutamyltransferase - Lipase - Alanine Aminotransferase - Aspartate Aminotransferase - Lactate Dehydrogenase - Creatine Kinase - Sodium - Potassium - Chloride - Urinary/Cerebrospinal Fluid Protein (UCFP). 3. TP #4 confirmed the finding above on 11/04/2020 around 09:30 a.m. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on Quality Control (QC) records and interview with General Supervisor (GS) #1, the laboratory failed to establish and document QC procedures for Post Vasectomy Microscopic Examinations and for immuno group and RH typing by tube method from 2018, 2019, 2020. Finding include: 1. On the day of survey, 11/03/2020, review QC records revealed the laboratory did not document QC for Post Vasectomy Microscopic examinations and immuno group and RH typing by tube method from 09 /19/2018 to the date of survey. 2. The GS #1 confirmed the finding above on 11/04 /2020 around 12:30 p.m. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the Quality Control (QC) records and interview with the General Supervisor (GS) #1, the laboratory failed to check each batch or shipment of blood culture bottles media for its ability to support growth from 2018, 2019 and 2020. Findings include: 1. On the day of survey, 11/03/2020, review of blood culture media QC records revealed, the laboratory did not check each batch or shipment of blood culture media bottles for its ability to support growth from 2018, 2019 and 2020. 2. The GS #1 confirmed the finding above on 11/04/2020 around 12:30 p.m. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) -- 4 of 5 -- The laboratory director must ensure an approved

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of laboratory performance improvement (PI) policy, laboratory competency record, and interview with the laboratory technical consultant (TC) #2, the laboratory PI overlooked documentation errors in 2018. Findings include: 1. The laboratory PI, the laboratory director signed on 01/29/2018, states "Through this ongoing systematic process, areas of improvement are identified, monitored, evaluated and improved." 2. The testing personnel #10 annual competency summary reads as follows: Validation Statement Sign Off Date Met Runs proficiency samples 01/31/2018 Checked 3. The TP #10, in fact, participated none (3 of 3) 2017 proficiency testing events. 4. The laboratory PI left out above documentation discrepancies. 5. The laboratory did not implement any improvement measures. 6. The TC #2 confirmed above findings on 09/19/2018 at 11:00 AM. ====================================== 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 --