Specialty Laboratories

Summary Statement of Deficiencies 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 record review and interview with General Supervisor, the laboratory failed to follow the laboratory policy in evaluating ungraded proficiency testing results for 1 (2022 Hematology Coagulation 3rd Event) of 12 events reviewed. Findings include: 1. A record review of the laboratory's proficiency testing for the 2022 Hematology Coagulation 3rd Event lacked evaluation of ungraded results that were outside of the expected results as follows: a. 2022 Hematology / Coagulation - 3rd Event: i. Platelet Estimate | Expected Result was "Adequate / Normal" and the laboratory's result was "Increased." ii. Blood Cell ID - ECI - 13 | Expected Result was "See Commentary" and the laboratory's result was "Macrocytic red blood cell." 2. The laboratory failed to document

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: . Based on record review, observation, and interview with the General Supervisor (GS), the laboratory failed to follow its policy to ensure positive patient identification for urine specimens collected for quantitative urine toxicology testing for 12 of 38 patient urine specimens present in the laboratory's refrigerator. Findings include: 1. A review of the laboratory's "Laboratory Sample Collection" policy on 7/13/22 revealed a section stating, "The specimen(s) are labeled to assure optimum patient specimen positive identification. Pre-analytic (pre-testing) phase. the specimens are labeled as follows: 1. Patient name and date of birth. 2. Time and date of collection." 2. A review of the laboratory's "Specimen Collection Procedure" on 7/13/22 revealed a section stating, "With a permanent marker write patient name and date of birth on the specimen cup." 3. The surveyor observed 38 urine specimens in the laboratory's Turbo Air refrigerator on 7/13/22 during a tour of the laboratory at 9:55 am. A total of 12 specimens did not meet the laboratory's policy and procedure requirements: a. 6/23/22 i. Three patients were missing the date of birth on the specimen. b. 6/20/22, one patient specimen had a name and date of birth written on the cup and a sticker for a patient with a different name and date of birth on the lid of the cup. c. 6/16/22, one patient had the incorrect date of birth. The year "89" was written on the cup and "1984" was on the specimen's sticker. d. 6/15/22, one patient was missing the date of birth on the specimen. e. 6/14/22 i. One patient had a discrepancy between the last name written on the cup and the specimen sticker on the cup. ii. One patient was missing the date of birth on the specimen. f. 6/10/22 i. Three patients were missing 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 3 -- date of birth on the specimen. ii. One patient had the incorrect date of birth. The year "96" was written on the cup and "1969" was on the specimen's sticker. 4. The surveyor requested

Summary Statement of Deficiencies 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 record review and interview with the General Supervisor (GS), the laboratory failed to follow a written policy to assess testing personnel and consultant competency for 2 (March 2019 to March 2021) of 2 years reviewed. Findings include: 1. A record review of the laboratory's policies and procedures revealed a policy stating, "Training verification must be documented for all lab staff. Examples would be performing proficiency testing. All training for each employee will be indicated in the "Employee's Competency and Proficiency Evaluations Manual" and the employee's department file." 2. A record review of personnel records revealed the following personnel listed on the CMS-209 did not have documented competency assessments: a. Clinical Consultant also performing the duties of the Technical Supervisor and Technical Consultant b. Testing Personnel #3 performing high complexity toxicology testing 3. An interview on 3/29/21 at 12:30 pm with the GS confirmed the two personnel listed above did not have documented competency assessments. **This is a repeated deficiency from the 12/20/16 recertification survey** 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) 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 -- Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: . A. Based on observation, record review, and interview with the Testing Personnel #3, the laboratory failed to label reagents with the expiration dates for 4 of 4 toxicology reagent bottles in use. Findings include: 1. The surveyor observed four bottles attached to the AB Sciex Triple Quad 4500 MD toxicology analyzer with a lack of expiration dates indicated on the containers on 3/29/21 at 9:22 am. 2. A review of the laboratory's "Reagent Storage and Handling Procedure" revealed a section stating, "Laboratory generated solutions and secondary containers require the same information on them. Anything generated in the laboratory must have the full chemical name, the hazard, the date processed, and expiration date suggested by manufacturer or other literature sources." 3. An interview on 3/29/21 at 9:22 am with Testing Personnel #3 confirmed the laboratory did not have the expiration date on the toxicology reagent containers. B. Based on observation, record review, and interview with the General Supervisor (GS), the laboratory failed to label hematology stain coplin jars with the identity of the contents and expiration dates for the current containers in use. Findings include: 1. The surveyor observed three unlabeled coplin jars with purple contents during a tour of the laboratory on 3/29/21 at 9:22 am. 2. A review of the laboratory's "Reagent Storage and Handling Procedure" revealed a section stating, "Laboratory generated solutions and secondary containers require the same information on them. Anything generated in the laboratory must have the full chemical name, the hazard, the date processed, and expiration date suggested by manufacturer or other literature sources." 3. An interview on 3/29/21 at 11:55 am with the GS confirmed the coplin jars were used in staining for hematology manual differentials and were not labeled with the identity of the contents and expiration dates. **This is a repeated deficiency from the 8/20/18 recertification survey** 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, record review, and interview with the General Supervisor (GS), the laboratory failed to ensure stain for hematology manual differential counts did not exceed the expiration date for the current stain in use. Findings include: 1. The surveyor observed a bottle of QuickLink I Wright-Giemsa stain next to the hematology slide staining station with the expiration date of 11/29/2020 during a tour of the laboratory on 3/29/21 at 9:22 am. 2. A review of the laboratory's "General Quality Control" procedure revealed a section titled "Labels" stating, "All reagents, probes, antibodies are used within their indicated expiration dates. Outdated reagents are discarded." 4. A review of manual differential test records revealed the following dates when expired stain was used: a. 12/15/20 b. 1/18/21 c. 2/15/21 d. 3/16/21 3. An interview on 3/29/21 at 11:55 am with the GS confirmed the laboratory used the bottle of stain beyond its expiration date. D5433 MAINTENANCE AND FUNCTION CHECKS -- 2 of 4 -- CFR(s): 493.1254(b)(1) 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 establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: . A. Based on record review and interview with the General Supervisor, the laboratory failed to ensure microscope annual maintenance was performed for 1 (2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's maintenance records revealed an invoice for annual maintenance performed on the microscope on 12/23/19 and the next service was due 1/22/21. There was a lack of documentation for microscope service performed after 12/23/19. 2. A review of the laboratory's "General Quality Control" procedure revealed a section stating, "Microscopes are inspected and cleaned annually by qualified service representative. Documentation is kept in the "Instrument Maintenance Logbook." 3. An interview on 3/29/21 at 12:12 pm with the GS confirmed the laboratory did not have microscope maintenance performed. B. Based on record review and interview with the General Supervisor, the laboratory failed to ensure pipettes used in toxicology testing were calibrated for 1 (2020) of 2 years reviewed. Findings include: 1. A review of the laboratory's maintenance records revealed an invoice for annual calibration and repair for the seven pipettes used in toxicology testing dated 9/26/19. There was a lack of documentation for pipette calibration and repair performed after 9/26/19. 2. A review of the laboratory's "Pipette Calibration" procedure stating, "After initial verification, pipettes that are designed to deliver a preset volume and/or adjustable volumes must be calibrated annually, when they become contaminated, after major maintenance, and/or when proper operation is in question." 3. An interview on 3/29/21 at 12:12 pm with the GS confirmed the laboratory did not have pipette calibration and repair performed. D6092 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iv) The laboratory director must ensure an approved

Summary Statement of Deficiencies 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 and interview, the laboratory failed to label the chemistry, endocrinology, and toxicology reagents with the preparation and/or expiration date for the reagents used on the Beckman Coulter Access 2 and Au480 chemistry analyzers. Findings include: 1. On August 20, 2018 at 9:20 AM during a tour of the laboratory, the surveyor observed bottled reagents in use that did not have documentation of a preparation and/or expiration date as follows: a. "2% wash WI" b. "Saline" c. "W2 10% NaOH Bleach for A1C" d. "Bleach Sodium (W2) Hypochlorite 10%" e. "Wash 100% CLN-1 100% Wash" f. "H2O" g. "Contrad" h. "Citranox 1/5 dilution" i. "Access 2 wash buffer" 2. During the interview on August 20, 2018 at 9:20 AM, testing personnel #1 as listed on the CMS-209 confirmed the reagent bottles did not contain the preparation and/or expiration dates. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 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 -- 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 observation, record review, and interview, the laboratory failed to indicate the identity of the chemistry prostrate specific antigen (PSA) assay used on the test report as requested in the manufacturer insert for two (#3 and #5) of 16 patient charts audited. Findings include: 1. On August 20, 2018 at 9:20 AM during a tour of the laboratory, the surveyor observed the Beckman Coulter Access 2 chemistry analyzer in use. 2. On August 20, 2018 at approximately 11:00 AM, the procedure manual signed on August 1, 2018 for the PSA procedure revealed no reference to the Beckman Coulter Access Immunoassay Systems Hybritech PSA insert that contained the warning "results reported by the laboratory to the physician must include the identity of the PSA assay used". 3. On August 20, 2018 at 2:56 PM, record review revealed for two (#3 and #5) of 16 patient charts audited the identity of the PSA assay used was not present on the patient's final report in the computer system. 4. During the interview on August 20, 2018 at 2:56 PM, the laboratory director as listed on the CMS-209 confirmed the manufacturer warning was not included in the patients final report. -- 2 of 2 --