Lindsay York, Md, Llc

Summary Statement of Deficiencies D6040 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(2) The technical consultant is responsible for-- (b)(2) Verification of the test procedures performed and the establishment of the laboratory's test performance characteristics, including the precision and accuracy of each test and test system. This STANDARD is not met as evidenced by: A Follow-up survey was performed at Lindsay York, MD, LLC-CLIA# 19D2113375 on December 29, 2021. Based on review of the laboratory's

Summary Statement of Deficiencies D0000 A Recertification Survey was performed at Lindsay York, MD Pediatrics-CLIA # 19D2113375 on July 26, 2021. Lindsay York, MD was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.1215 CONDITION: Hematology 42 CFR 493.1403 CONDITION: Laboratories performing moderate complexity testing; Laboratory Director 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 observation by surveyor, review of the U.S. Food and Drug Administration recall memo, patient test logs, and interview with personnel, the laboratory failed to discontinue use of recalled LeadCare II kits as required for one (1) of (1) patient reviewed. Findings: 1. Observation by surveyor during laboratory tour on July 26, 2021 at 9:40 am revealed the laboratory had one (1) LeadCare II kit, lot # 2013M in use, opened on July 6, 2021. 2. Review of the FDA "Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results" memo revealed the following recalled kits and customer directives: " LeadCare II: 2013M, 2014M, 2015M, 2016M, 2017M, 2102M, 2103M, 2105M, 2016M, and 2017M. LeadCare Plus and LeadCare Ultra: 2011 MU, 2104MU, and 2108M. Customers: Discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory. Laboratories should evaluate patient test results that were generated with the impacted lots. Confirm suspect results with an alternative lead testing options, such as those using inductively coupled plasma mass spectrometry or graphite furnace atomic absorption spectroscopy at a high complexity, CLIA-certified, reference laboratory. Promptly complete and return 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 14 -- Customer Notification Form in the Urgent Medical Device Recall letter. After the form has been submitted, contact Magellan Technical Support. Be aware, product will be replaced based on availability; replacement product is NOT currently available." 3. In interview on July 26, 2021 at 9:41 pm, the Lead Medical Assistant stated the laboratory received the identified LeadCare II lot on January 28, 2021. The Lead Medical Assistant further stated the laboratory was unaware of the recall of the identified LeadCare II kits. 4. Review of patient logs revealed the laboratory reported one (1) patient utilizing the recalled lot number on July 7, 2021. 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 review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to ensure attestation statements were signed by the appropriate personnel as required for three (3) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Proficiency Testing" policy revealed " The laboratory director will sign the attestation statement confirming that the PT samples were tested in the same manner as the patient specimens. The laboratory director will attest to the individual performing the test. This should be kept in a binder labeled 'proficiency testing.' " 2. Review of the laboratory's "Attachment 6031 Proficiency Testing" policy revealed "Keep a copy of all records associated with PT testing, including the signed attestation sheet, instrument printouts, the results form submitted to the PT agency, and the graded results report. Retain these records for two years from the PT even date." 3. Review of the laboratory's American Proficiency Institute's (API) PT results for 2019, 2020, and 2021 revealed the laboratory did not ensure attestation statements were signed by personnel as follows: a) 2019 Hematology/Coagulation 2nd Event: Laboratory Director and Testing Personnel b) 2020 Hematology/Coagulation 3rd Event: Laboratory Director and Testing Personnel c) 2021 Hematology/Coagulation 1st Event: Laboratory Director and Testing Personnel 4. In interview on July 26, 2021 at 3:35 pm, the Lead Medical Assistant confirmed the appropriate personnel did not sign the PT attestation statements as required. 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. -- 2 of 14 -- This STANDARD is not met as evidenced by: Based on review of laboratory policies and procedures, quality control (QC) records, and interview with personnel, the laboratory failed to retain QC records for at least two (2) years as required for the Sysmex XN-330 analyzer for one (1) of three (3) months reviewed. Findings: 1. Review of the laboratory's "Analytic Phase" policies and procedures revealed " Keep all QC records for at least 2 years" 2. Review of the laboratory's Sysmex XN-330 analyzer's QC records for December 2019, September 2020, and June 2021 revealed the laboratory did not retain records for December 2019. 3. In interview on July 26, 2021 at 11:56 am, the Lead Medical Assistant confirmed the laboratory did maintain the identified QC records. D5024 HEMATOLOGY CFR(s): 493.1215 If the laboratory provides services in the specialty of Hematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493.1269, and 493. 1281 through 493.1299. This CONDITION is not met as evidenced by: Based on observation by surveyor, record review, and interview with personnel, the laboratory failed to ensure the quality of testing for the specialty of Hematology. Findings: 1. The laboratory failed to document the review of the performance evaluation for four (4) of seven (7) proficiency testing (PT) events reviewed. Refer to D5211. 2. The laboratory failed to perform an assessment for three (3) of seven (7) proficiency testing (PT) events reviewed. Refer to D5221. 3. The laboratory failed to follow established laboratory policies for Complete Blood Count (CBC) flags. Refer to D5401. 4. The laboratory failed to ensure policies and procedures were updated to current practices. Refer D5407. 5. The laboratory failed to ensure reagents did not exceed their expiration date. Refer to D5417. 6. The laboratory failed to have complete performance verification studies for the Sysmex XN-330 analyzer. Refer to D5421. 7. The laboratory failed to ensure maintenance for the Sysmex XN-330 was performed as required for twenty (20) of twenty two (22) months reviewed. Refer to D5429. 8. The laboratory failed to establish the quality control performance prior to use per manufacturer requirements for the Sysmex XN-330. Refer to D5469. 9. The laboratory's quality assessment monitors failed to correct issues identified with the analytic system. Refer to D5793. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to document the review of the performance evaluation for four (4) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Evaluation Proficiency Testing Performance" policy revealed "Employees and the laboratory director review and evaluate the results from the proficiency testing. If all results are acceptable, the laboratory director -- 3 of 14 -- will then sign off on the results." 2. Review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) results for 2019, 2020, and 2021 revealed the Laboratory Director did not evaluate the results for the following four (4) PT events: a) 2019 Hematology/Coagulation 2nd Event b) 2019 Hematology/Coagulation 3rd Event c) 2020 Hematology/Coagulation 2nd Event d) 2021 Hematology/Coagulation 1st Event 3. In interview on July 26, 2021 at 3:35 pm, the Lead Medical Assistant confirmed the Laboratory Director did not review/sign the identified results of the identified PT events. . D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to perform an assessment for three (3) of seven (7) proficiency testing (PT) events reviewed. Findings: 1. Review of the laboratory's "Evaluation Proficiency Testing Performance" policy revealed "Employees and the laboratory director review and evaluate the results from the proficiency testing. If all results are acceptable, the laboratory director will then sign off on the results. If any results are unacceptable, we will perform

Summary Statement of Deficiencies D0000 A Certification Survey was performed on January 22, 2019 at Lindsay York, MD, LLC, CLIA ID # 19D1075504. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review and interview with personnel, the laboratory failed to retain proficiency records for one (1) of six (6) events reviewed for at least two (2) years. Findings: 1. Review of the laboratory's American Proficiency Institute (API) Proficiency Tests (PT) records for 2017 and 2018 revealed the laboratory did not maintain the following: a) 2018 3rd Event Hematology/Coagulation: results and Laboratory Director's evaluation 2. In interview on January 22, 2019 at 10:53 am, Personnel 2 stated she received an email from API on December 20, 2018 stating results for the identified event were available. Personnel 2 further stated she did not have the correct password information to access the results. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: 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 -- I. Based on observation, record review, and interview with personnel, the laboratory failed to follow their established policy for Complete Blood Count flags. Findings: 1. Observation by the surveyor during the laboratory tour on January 22, 2019 revealed the laboratory utilizes the Medonic instrument for Complete Blood Count (CBC) testing. 2. Review of the laboratory's "Out-of-Range/Information Messages" policy revealed "Effective May 25, 2017, all CBC's containing a flag or error must be repeated in the office. If the flag is still present on repeat, the patient will be given an order to have a CBC repeated at the outpatient laboratory of West Jefferson Medical Center or Quest Diagnostics for specimen verification." 3. In interview on January 22, 2019, Personnel 2 stated for patients that refuse to have the CBC repeated at an outpatient laboratory, the laboratory places a sticker on the patient report that states" Unconfirmed/Void Specimen will not be used by the physician for patient treatment." 4. Review of random selection of eight (8) CBC final test reports from December 2018 and January 2019 revealed the following three (3) patients were not reported per laboratory policy: December 18, 2018: Patient 1: OM flag: Sample was not retested in the office or results voided due to inability to confirm result January 16, 2019: Patient 2: OM flag: Sample was not retested in the office January 18, 2019: Patient 3: BD flag: Sample was not retested in the office or results voided due to inability to confirm result 5. In interview on January 22, 2019 at 1:45 pm, Personnel 2 stated if the patient is under twelve months old then the CBC is retested in the office and if flag remains then the test is referred out. Personnel 2 further stated if the patient is older than one (1), then the parent is given the option to have CBC retested in the office or downstairs. Personnel 2 stated in both cases if the parent refuses, documentation of refusal and the order is placed in the patient's chart and the CBC results are voided. 6. In further interview on January 22, 2019, Personnel 2 confirmed the laboratory's actions for CBC flags did not follow the laboratory's policy. II. Based on record review and interview with personnel, the laboratory failed to follow their established manual review policy. Findings: 1. Review of the laboratory's "Policy and Procedure Manual" policy revealed "The policy & procedure manual will be reviewed by the laboratory director every six months and updated as needed." 2. Review of the laboratory's policy and procedure manual revealed the laboratory did not have documentation that the Laboratory Director reviewed the manual every six (6) months. 3. In interview on January 22, 2019 at 1:52 pm, Personnel 2 stated the laboratory does not have documentation that the Laboratory Director reviews the manual every six (6) months. 4. In interview on January 22, 2019, Personnel 1 stated she does not review the policy and procedure manual every six (6) months. 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 observation, record review, and interview with personnel, the laboratory failed to monitor the temperature of the closet where laboratory supplies are stored per manufacturer requirements. Findings: 1. Observation by the surveyor during the -- 2 of 3 -- laboratory tour on January 22, 2019 revealed the laboratory did not monitor the temperature of the storage closet where laboratory supplies are stored. 2. Further observation by surveyor during the laboratory tour revealed the following items were stored without temperature monitoring: a) BD BBL Culture Swab Plus, Lot #172271516, Quantity: two (2) packs b) BD BBL Culture Swab, Lot # 180807509, Quantity: three (3) packs c) RSV Now, Lot # M103782, Quantity: five (5) boxes d) Urine BD Vacutainer, Lot # 8179602, Quantity: one (1) box 3. Review of the manufacturer's requirements for the identified items revealed the following: a) BD BBL Culture Swab Plus: storage requirement 5-25 degrees Celsius b) BD BBL Culture Swab, storage requirement 5-25 degrees Celsius c) RSV Now, storage requirement 2-30 degrees Celsius d) Urine BD Vacutainer, 4-25 degrees Celsius 4. In interview on January 22, 2019, Personnel 2 stated the laboratory does not monitor the temperature of the storage closet. Personnel 2 stated she was unaware of the temperature requirements for the identified supplies. D6014 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(iii) 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)(3) Ensure that-- (e)(3)(iii) Laboratory personnel are performing the test methods as required for accurate and reliable results. This STANDARD is not met as evidenced by: Based on observation, and interview with personnel, the Laboratory Director failed to ensure laboratory personnel performed testing as required. Findings: 1. The laboratory failed to follow their established policy for Complete Blood Count flags. Refer to D5401 I. 2. The laboratory failed to follow their established manual review policy. Refer to D5401 II. 3. The laboratory failed to monitor the temperature of the closet where laboratory supplies are stored per manufacturer requirements. Refer to D5413. -- 3 of 3 --