Utica Park Clinic-Dermatology

Summary Statement of Deficiencies D0000 The initial survey was performed on 02/09/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory coordinator during an exit conference performed at the conclusion of the survey. 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 coordinator and histotechnician, the laboratory failed to verify the accuracy of Mohs and biopsy testing at least twice annually during the review period of October 2022 through the current date. Findings include: (1) On 02/09/2024 at 10:45 am, the histotechnician stated the laboratory performed microscopic interpretations of H&E (Hematoxylin and Eosin) stained slides from frozen section skin biopsies and tissues removed during Mohs surgery. The tissue would then be observed microscopically; (2) A review of records from October 2022 through the current date identified no evidence the testing had been verified for accuracy twice annually as follows: (a) Mohs - not performed between 10/11/2022 and 12/06/2023; (b) Skin Biopsies - not performed during the review period. (3) The records were reviewed with the laboratory coordinator and histotechnician who stated on 02/09/2024 at 11:45 am, the testing had not been verified for accuracy at least twice annually as stated above. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- 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 records and interview with the laboratory coordinator, the laboratory failed to ensure patient test reports included the address of the laboratory location where the testing was performed for six of six reports reviewed. Findings include: (1) A review of the following six patient reports identified the laboratory address was not included: (a) Patient AM23-152 resulted on 03/22/2023; (b) Patient AM23-186 resulted on 04/04/2023; (c) Patient AM23-821 resulted on 12/12/2023; (d) Patient AM24-004 resulted on 01/02/2024; (e) Patient AM24-017 resulted on 01/08 /2024; (f) Patient AM24-085 resulted on 01/31/2024. (2) The findings were reviewed with the laboratory coordinator who stated on 02/09/2024 at 12:15 pm, the laboratory address had not been included on the patient test reports. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator and histotechnologist, the technical supervisor failed to ensure competency evaluations for high complexity testing had been performed semiannually during the first year of testing for one of one testing person. Findings include: (1) On 02/09/2024 a review of personnel records for one person performing high complexity testing identified the initial training was completed on 10/21/2022. There was no evidence a competency evaluation had been performed to date; (2) The records were reviewed with the laboratory coordinator and testing person #1 who stated on 02/09/2024 at 11:20 am, a semiannual competency evaluation had not been performed. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory coordinator and histotechnologist, the technical supervisor failed to ensure competency evaluations for -- 2 of 3 -- high complexity testing had been performed annually for one of one testing person. Findings include: (1) On 02/09/2024 a review of personnel records for one person performing high complexity testing identified the initial training was completed on 10 /21/2022. There was no evidence a competency evaluation had been performed to date; (2) The records were reviewed with the laboratory coordinator and testing person #1 who stated on 02/09/2024 at 11:25 am, an annual competency evaluation had not been performed. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The recertification survey was performed 10/30/19. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director, the laboratory failed to maintain quality control records for at least 2 years. Findings include: (1) At the beginning of the survey, the laboratory director verified the laboratory performed CBC (Complete Blood Count) (i.e., WBC-White Blood Count, RBC-Red Blood Count, Hemoglobin, Hematocrit, Platelet, etc.) testing on the Medonic M Series analyzer. In addition, it was verified the laboratory tested 3 levels (Low, Normal, High) of CDS Boule Con-Diff QC (Quality Control) materials each day of patient testing; (2) The surveyor reviewed QC records from 03/01/18 through the date of the survey and identified 24 lot numbers of QC materials had been utilized during the review period. The surveyor could not locate the manufacturer's assay value sheets for 3 of the 24 lot numbers. The lot numbers were: (a) Lot #2180521, Low Level-used from 06/24/18 through 09/21/18 (b) Lot #2180522, Normal Level-used from 06/24/18 through 09/21/18 (c) Lot #2180523, High Level-used from 06/24/18 through 09/21/18 (3) The surveyor asked the laboratory director if the manufacturer's assay value sheets for the QC lot numbers listed above were available for review. The laboratory director stated to the surveyor if the assay value sheets were not found in the QC records, 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 2 -- sheets had not been maintained; (4) The surveyor reviewed the findings with the laboratory director and explained that all QC records must be maintained for at least 2 years. -- 2 of 2 --

Summary Statement of Deficiencies D0000 The findings were reviewed with the laboratory director/technical consultant 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 director/technical consultant, the laboratory failed to follow the manufacturer's instructions for waived testing. Findings include: (1) At the beginning of the survey, the laboratory director /technical consultant stated to the surveyors the laboratory used the CLINITEK Status + Analyzer to perform macroscopic urinalysis testing; (2) Surveyor #2 reviewed the manufacturer's instructions for the analyzer which required storage from 18-30 degrees Centigrade (C) and 18-80% Relative Humidity; (3) Surveyor #2 reviewed temperature and humidity records from January 2016 through December 2017 and identified the following: (a) Temperature - for 14 of 24 months the documented temperature was less than 18 degrees C (i) March 2016 - Days 19,20,21,25 (ii) April 2016 - Day 2 (iii) June 2016 - Day 28 (iv) July 2016 - Days 5,19 (v) August 2016 - Days 3,24 (vi) September 2016 - Day 17 (vii) October 2016 - Day 18 (viii) November 2016 - Days 24,26 (ix) December 2016 - Days 1,18,19,27,30,31 (x) January 2017 - Day 4 (xi) June 2017 - Day 6 (xii) October 2017 - Day 29 (xiii) November 2017 - Days 19,20,22 (xiv) December 2017 - Days 16,18,23,24,25,26,31 (b) Humidity - for 3 of 24 months the documented humidity was less than 18% (i) January 2016 - Days 18,19 (ii) February 2016 - Days 5,10,12 (iii) January 2017 - Days 5,6,7,8,9 (4) 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 5 -- surveyors reviewed the findings with the laboratory director/technical consultant, who stated the laboratory failed to follow manufacturer's storage instructions for CLINITEK Status + Analyzer. 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 director/technical consultant, the laboratory failed to ensure proficiency testing attestation statements had been signed by the laboratory director. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records. The following was identified for 2 of 28 proficiency testing events: (a) 2017 Chemistry Core 3rd Event - The attestation statement had not been signed and dated by the laboratory director; (b) 2017 Hematology 2nd Event - The attestation statement had not been signed and dated by the laboratory director; (2) The surveyors reviewed the records with the laboratory director/technical consultant, who stated the attestation statements, as indicated above, had not been signed and dated by the laboratory director. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of records and interview with the laboratory director/technical consultant, the laboratory failed to verify the accuracy of testing when the proficiency testing program did not evaluate submitted results. Findings include: (1) At the beginning of the survey, surveyor #2 reviewed 2016 and 2017 proficiency testing records and identified the following had not been evaluated by the proficiency testing program (the proficiency report referred the laboratory to the proficiency data summary, non-graded or see commentary in order to obtain the expected result): (a) Hematology (i) 2016 Hematology 2nd Event (aa) 1 of 5 Monocytes/Mids for sample HEM-06 (ii) 2016 Hematology 3rd Event (aa) 1 of 5 Monoctyes/Mids for sample HEM-11 (iii) 2017 Hematology 2nd Event (aa) 2 of 5 Monocytes/Mids for samples -- 2 of 5 -- HEM-07 and HEM-10 (2) Surveyor #2 further reviewed the records and could not locate documentation verifying the laboratory had reviewed the data summary, non- graded or see commentary in order to evaluate their results; (3) The surveyors asked the laboratory director/technical consultant if the results had been documented as evaluated. The laboratory director/technical consultant reviewed the records and stated the data summaries, non-graded or see commentary had not been documented as reviewed and therefore, the results had not been evaluated for accuracy. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on a review of records, manufacturer's instructions, and interview with the laboratory director/technical consultant, the laboratory failed to follow the manufacturer's instructions for verifying automated differential flags. Findings include: (1) At the beginning of the survey, the laboratory director/technical consultant stated to the surveyors CBC (Complete Blood Count) testing was performed, which included a three part automated differential, using the Boule Medonic M-Series analyzer. The laboratory director/technical consultant also stated the laboratory did not perform manual differential testing in house, but sent them to a reference laboratory when needed; (2) Surveyor #1 reviewed the manufacturer's operator's manual for information regarding flagged results. The instructions stated the following: (a) For BD differential flags, the instructions stated "The calculated populations for LYM, MID, GRAN overlap too much. Often in pathological samples with granulocytosis or lymphocytosis a blood smear is recommended"; (b) For OM differential flags, the instructions stated "There was only one mode in the WBC distribution between the LYM-L and GRAN-H settings. Often in pathological samples with granulocytosis or lymphocytosis a blood smear is recommended". (3) Surveyor #1 then reviewed patient CBC test records and identified 10 records containing differential flags. The manufacturer's instructions had not been followed for 2 of the 10 records as follows: (a) Record #1- OM flags were obtained on 10/23/17 at 12:57 pm. There was no evidence the specimen had been sent to the reference laboratory for a slide review; (b) Record #2 - BD flags were obtained on 11/10/17 at 07:08 pm. There was no evidence the specimen had been sent to the reference laboratory for a slide review. (4) The findings were discussed with the laboratory director/technical consultant who stated the manufacturer's instructions had not been followed. 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 -- 3 of 5 -- 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 laboratory director/technical consultant, the laboratory failed to ensure equipment was stored as required by the manufacturer. Findings include: (1) At the beginning of the survey, the laboratory director/technical consultant stated to the surveyors CBC (Complete Blood Count) was performed on the Boule Medonic M Series analyzer; (2) Later during the survey, surveyor #2 reviewed the manufacturer's environmental requirements for the analyzer. The manufacturer required the operating environment temperature be maintained within the range of 18 - 32 degrees C (Centigrade); (3) Surveyor #2 then reviewed laboratory's temperature records from January 2016 through December 2017 which verified the documented temperature readings were less than 18 degrees C for 14 of 24 months as follows: (a) March 2016 - Days 19,20,21,25 (b) April 2016 - Day 2 (c) June 2016 - Day 28 (d) July 2016 - Days 5,19 (e) August 2016 - Days 3,24 (f) September 2016 - Day 17 (g) October 2016 - Day 18 (h) November 2016 - Days 24,26 (i) December 2016 - Days 1,18,19,27,30,31 (j) January 2017 - Day 4 (k) June 2017 - Day 6 (l) October 2017 - Day 29 (m) November 2017 - Days 19,20,22 (n) December 2017 - Days 16,18,23,24,25,26,31 (4) The surveyors reviewed the records with the laboratory director/technical consultant who stated the documented temperatures of the laboratory had been maintained below 18 degrees C as indicated above. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 director/technical consultant, the laboratory failed to verify the stated value of control materials before they were put into use. Findings include: (1) At the beginning of the survey, the laboratory director/technical consultant stated the following to the surveyors: (a) CBC (Complete Blood Count) testing was performed using the Boule Medonic M-Series analyzer; (b) Three levels of Boule Con-Diff control materials were analyzed each day of patient testing; (c) The manufacturer's provided ranges were used to determine acceptability of quality control results. (2) Later during the survey, surveyor #1 reviewed records for 15 control lot numbers. There was no evidence the provided ranges were verified before the lot numbers were put into use for 3 of 15 lot numbers as follows: (a) Low control lot #21705-21, Normal control lot #21705-22, and High -- 4 of 5 -- control lot #21705-23 put into use on 06/26/17 and used through 09/15/17. (3) The findings were reviewed with the laboratory director/technical consultant, who stated the manufacturer's ranges had not been verified before the above lot numbers had been put into use. 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 director/technical consultant, the laboratory failed to ensure reference intervals were determined as appropriate for the laboratory's patient population. Findings include: (1) At the beginning of the survey, the laboratory director/technical consultant stated to the surveyors CBC (Complete Blood Count) testing was performed using the Boule Medonic M-Series analyzer; (2) Later during the survey, surveyor #1 reviewed two patient CBC reports - the first report was for an adult female patient with the testing performed on 09/15/17 at 10:07 am; the second report was for an adult male patient with the testing performed on 01/07/18 04:39 pm. Both reports included the same reference intervals for the CBC parameters of RBC (Red Blood Cell), Hemoglobin, and Hematocrit, which were: (a) RBC - 3.50 - 5.50 x10(6)/uL (b) Hemoglobin - 11.5 - 16.5 g/dL (c) Hematocrit - 35 - 55% (3) The surveyors reviewed the findings with the laboratory director/technical consultant who agreed the patient reports did not include gender specific reference ranges. NOTE: Routinely, female reference intervals for the analytes RBC, Hemoglobin, and Hematocrit are lower than male reference intervals. -- 5 of 5 --