Summit Clinical Laboratory, Llc

Summary Statement of Deficiencies D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER reports 155 & 153 (CMS 153&155) and the PT agency, College of American Pathologist (CAP) evaluation report determined the laboratory failed to maintain satisfactory performance for the 2nd and 3rd event 2019 in Cholesterol-HDL (HDL) (Refer to D2096), in the subspecialty of Endocrinology for Cortisol and HCG (Refer to D2107) and in the subspecialty of Toxicolgy (Refer to D2118) for the following analytes: Carbamazepine (CARB), Digoxin (DIG), 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 -- Ethosuximide, Gentamicin (GENT), Lithium, Phenobarbital (PHEN), Phenytoin, Primidone, Quinidine, Theophylline (THEO), Tobramycin, Valproic Acid (VALP) resulting in the first unsuccessful PT occurrence for 2020. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER reports 155 & 153 (CMS 153&155) and the PT agency, College of American Pathologist (CAP) evaluation report determined the laboratory failed to maintain satisfactory performance for the 2nd and 3rd event 2019 in the analyte Cholesterol-HDL (HDL) resulting in the first unsuccessful PT occurrence for 2020. The findings include: 1. Review of the CMS Casper 153 & 155D reports revealed a score of 0% for the 2nd and 3rd event 2019 for the analyte HDL. 2. Review of the CAP evaluation report revealed the laboratory failed to achieve successful performance for the 2nd and 3rd event 2019 with a score of 0% for the analyte HDL resulting in the first unsuccessful PT occurrence for 2020. D2107 ENDOCRINOLOGY CFR(s): 493.843(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER reports 155 & 153 (CMS 153&155) and the PT agency, College of American Pathologist (CAP) evaluation report determined the laboratory failed to maintain satisfactory performance in the subspecialty of Enocrinology for the 2nd and 3rd event 2019 for the analytes Cortisol and HCG resulting in the first unsuccessful occurrence for 2020. The findings include: 1. Review of the CMS Casper 153 & 155D reports revealed a score of 0% for the 2nd and 3rd event 2019 for the analytes Cortisol and HCG. 2. Review of CAP evaluation report revealed the laboratory failed to achieve successful performance for the 2nd and 3rd event 2019 with a score of 0% in the subspecialty of Endocrinology for the analytes Cortisol and HCG resulting in a first unsuccessful PT occurrence for 2020. D2118 TOXICOLOGY CFR(s): 493.845(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on a proficiency testing (PT) desk review of the Centers for Medicare and Medicaid Services CASPER reports 155 & 153 (CMS 153&155) and the PT agency, College of American Pathologist (CAP) evaluation report determined the laboratory failed to maintain satisfactory performance in the subspecialty Toxocology for the 2nd and 3rd event 2019 in the following analytes: Carbamazepine (CARB), Digoxin (DIG), Ethosuximide, Gentamicin (GENT), Lithium, Phenobarbital (PHEN), Phenytoin, Primidone, Quinidine, Theophylline (THEO), Tobramycin, Valproic Acid (VALP) resulting in the first unsuccessful occurrence for 2020. The findings include: 1. Review of the CMS Casper 153 & 155D reports revealed a score of 0% for the 2nd and 3rd event 2019 in the following analytes: CARB, DIG, Ethosuximide, GENT, Lithium, PHEN, Phenytoin, Primidone, Quinidine, THEO, Tobramycin, VALP. 2. Review of CAP evaluation report revealed the laboratory failed to achieve successful performance for the 2nd and 3rd event 2019 with a score of 0% in the subspecialty Toxocology in the following analytes: CARB, DIG, Ethosuximide, GENT, Lithium, PHEN, Phenytoin, Primidone, Quinidine, THEO, Tobramycin, VALP resulting in a first unsuccessful PT occurrence for 2020. -- 3 of 3 --

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 lack of Proficiency Testing (PT) records for 2018 and interview with the facility personnel, the laboratory failed to enroll in an HHS approved PT program for regulated analyte panels including a Complete Metabolic Panel (CMP), Lipid Panel, Thyroid Panel, tested under the specialty of Chemistry; a Complete Blood Count Panel (CBC) and Prothrombin Time (PT) tested under the specialty of Hematology, which is included in subpart I. Findings include: 1. According to the laboratory's daily activity log, the laboratory tested approximately 280 patients during January, February and March of 2018 for the regulated analyte panels listed above . 2. No documentation was presented for review during the survey conducted on December 19, 2018 and December 20, 2018 to indicate that the laboratory was enrolled in a CMS-approved PT program for the regulated analytes for the panels listed above and listed in subpart I, for which the laboratory performs patient testing. 3. The facility personnel confirmed that the laboratory was not enrolled in a CMS-approved PT program for 2018 for the analyte panels indicated above. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) 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 -- The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records for testing performed in the specialty of Hematology and interview with the facility personnel, the laboratory director failed to sign the PT attestation statement. Findings include: 1. The PT attestation statement presented for review for the second event of 2017 for Hematology lacked the director's signature. 2. The facility personnel confirmed that the PT attestation statement indicated above was not signed by the laboratory director. 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 lack of Proficiency Testing (PT) records for review from 2017 and interview with the facility personnel, (A) the laboratory failed to maintain a copy of all PT records for a minimum of 2 years and (B) failed to maintain copies of the instrument printouts documenting that the PT samples were tested by the laboratory. Findings include: 1. The laboratory performs patient testing in the specialties of Chemistry and Hematology. A1. No PT documentation was presented for review for the 1st, 2nd and 3rd event of 2017 for Coagulation testing, to indicate the laboratory maintained copies of all the PT records, including a copy of the PT program report form used by the laboratory to record results, instrument printouts showing the samples were tested by the laboratory, and the attestation statement signed by the analyst and laboratory director. A2. The facility personnel confirmed that the PT records indicated above could not be located during the survey. B1. No instrument records showing the PT samples were tested by the laboratory were presented for review during the survey for all PT testing performed by the laboratory in 2017 in the specialties of Chemistry and Hematology. B2. The facility personnel confirmed that the laboratory failed to retain the instrument printouts from PT samples tested by the laboratory during 2017. 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 -- 2 of 5 -- 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 review of the proficiency testing (PT) evaluation for the first and second events of 2017 received by the laboratory from the PT agency and interview with the facility personnel, the laboratory failed to document a self evaluation for the PT test results that received an exception code [26]=Educational Challenge. Findings include: 1. The laboratory did not present any written documentation of a PT self review for the exception code indicated above for analytes tested under the specialty of Hematology for the first and second events of 2017. 2. The PT booklet provided by the PT agency that lists exception codes and code descriptions indicated that the lab should document its review for exception code [26]. 3. The facility personnel acknowledged that there was no documented self evaluation for the PT results that received exception codes. 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 Quality Assessment (QA) records, Proficiency Testing (PT) records and interview with the facility personnel, the laboratory failed to document