Elsa Medical Clinic

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's quality control records from October 2020 through December 2021, the laboratory failed to provide documentation of reviewing quality control to detect errors over time for 15 of 15 months reviewed. The findings included: 1. Review of the laboratory's quality control records from December 2020 through December 2021 found the laboratory would print end of the month Levy- Jennings reports; the data was not evaluated. Therefore, the laboratory did not have a mechanism in place to detect errors over time. 2. Review of the laboratory's submitted Form CMS-116 approved by the laboratory director on January 7, 2022 listed an 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 -- annual hematology volume of 9804. 3. The findings were confirmed in interview of testing personnel 1 (as listed on Form CMS-209) at 14:30 hours in the office. She agreed that the information was printed but had not been evaluated to determine errors over time. Key: CMS - Centers for Medicaid and Medicare Services -- 2 of 2 --

Summary Statement of Deficiencies D0000 A recertification survey was performed on January 28, 2020. The laboratory was found out of compliance with the CLIA regulations. The conditions not met were: D6063 - 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel Noted deficiencies and plans of correction were discussed with the laboratory representative at the exit conference. The facility representatives were given an opportunity to provide evidence of compliance with noted deficiencies and no such evidence was provided prior to survey exit. 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 surveyor observation, review of manufacturer's instructions of the Cholestech LDX Multianalyte quality control reagents, and confirmed in interview of facility personnel, it was revealed the laboratory failed to follow the manufacturer's instructions to ensure expired supplies were not available for use. The findings were: 1. Surveyor observation made on January 28, 2020 at 09:15 hours during the initial tour of the facility found the following expired item located in the laboratory storeroom refrigerator: Cholestech LDX Multianalyte Controls Lot Number: 003452B Expiration Date: 2019-12-25 Quantity: 1 package 2. A review of the manufacturer's instructions for the Cholestech LDX Multianalyte Control (Rev. 04/11) under the section titled "Warning and Precautions" revealed: "Note: Do not use the Controls past the expiration date printed on the vial labels." 3. An interview with a testing person #1 (as listed on Form CMS 209) on 01/28/2020 at 09:30 hours in 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 7 -- laboratory revealed the laboratory did not removed the expired package. She stated they had another unopened package of controls. Key: CMS - Centers for Medicare and Medicaid Services 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 review of the laboratory's American Academy of Family Physicians (AAFP) proficiency testing (PT) records for 2018 Hematology (events 1, 2, and 3) and 2019 Hematology (events 1, 2, and 3) and confirmed in interview of facility personnel, the laboratory failed to retain 2 of 6 attestation records for a minimum of 2 years. Findings were: 1. A review of the laboratory's AAFP proficiency testing records from 2018 Hematology (events 1, 2, and 3) and 2019 Hematology (events 1, 2, and 3) found the laboratory failed to provide documentation of retaining 2 of 6 attestation statements. The missing attestation statements were as follows: 2018 Hematology (event 1) 2018 Hematology (event 2) 2. An interview with the technical consultant on 01/28/2020 at 10:40 hours in the break room confirmed the above findings. Key: CMS- Center for Medicare and Medicaid Services D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory policy, patient records and confirmed in interview of facility personnel, the laboratory failed to follow their policy for specimen labeling. Findings were: 1. Surveyor observation made in the laboratory on January 28, 2020 found 5 CBC specimens. One (1) of 5 specimens was labeled with only the patient's name and date of birth. Seq # Date 8940 01/28/2020 2. Review of the laboratory's policy titled, "Procedure for Specimen Labeling" states a specimen should be labeled with "Patient's full name, Patient's Date of Birth, Name of requesting doctor and the current date. After the specimen is logged in the laboratory logbook, the laboratory identification number is also written on the specimen." The laboratory failed to follow its own specimen labeling policy. 3. Review of patient results found the laboratory tested the improperly labeled sample as follows: Seq# Date/Time tested 8940 01/28/2020 11:37:55 WBC 6.5 HGB 12.2 HCT 36.5 RBC 4.3 PLT 258 4. An interview with the testing person #1 (listed on Form CMS 209) on 01 /28/2020 at 09:40 hours in the laboratory confirmed the above findings. She acknowledged the laboratory was not following their own policy for labeling specimens. Key: CBC - Complete Blood Count WBC - White blood count HCT - Hematocrit PLT - Platelet RBC - Red blood cell Seq - Sequence CMS - Centers for Medicare and Medicaid Services -- 2 of 7 -- 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 review of laboratory policy, review of the manufacturer's instructions for the Medonic M Hematology analyzer, review of the laboratory's environmental records from January 1, 2018 to December 31, 2019, and staff interview, the laboratory failed to include a humidity range for the laboratory. The findings were: 1. A review of the laboratory's policy titled "Reagent Management" under section B "Humidity" it states, "Some test systems are adversely affected by humidity. Establish acceptable humidity ranges. Document Humidity daily, using a hygrometer. If humidity falls outside the acceptable range, utilize a humidifier or a dehumidifier to remedy the problem." 2. A review of the manufacturer's instructions for the Medonic M Series (2017 article no1504493) under the section titled "Operating Environment" revealed humidity range 10%- 90%. 3. A review of the laboratory environmenal records from January 1, 2018 to December 31, 2019, the laboratory failed to include a humidity range. 4. An interview with the testing person # 1 (as listed on Form CMS 209) on 01/28/2020 at 15:55 hours in the conference room- after her review of the records - confirmed the findings. Key: CMS - Centers for Medicare and Medicaid Services Seq - Sequence 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 review of the laboratory's quality control (QC) records from June 2019 through January 2020, manufacturer instructions, patient test records, and confirmed in interview, the laboratory failed to verify new lot numbers of CBC (complete blood count) quality control material prior to their initial use. Findings were: 1. Review of the laboratory QC records from June 2019 to January 2020 revealed no documentation of the laboratory verifying the following Boule quality control materials prior to use: -- 3 of 7 -- Lot 21905 exp 09/20/2019 Lot 21908 exp 12/25/2019 Lot 21911 exp 03/20/2020 (current lot) 2. Review of Manufacturer instructions for Medonic M series Analyzer under "Quality Control" it states, "New lot numbers of QC materials should be overlapped with existing lot numbers at least once to ensure proper reactivity. Run the current lot number of QC materials. Run the new lot number of QC materials. Print out copies of all results and save with other QC documentation for a minimum of two years." 3. Random review of patient records from January 1, 2020 to January 31, 2020 revealed the following patients were tested when the laboratory's current lot number of quality control (lot 21911) had not been verified. Seq # Date tested 8776 01/15/20 16:53 8940 01/28/20 11:37 4. The laboratory failed to have a policy on how to perform quality control overlap studies as required by the manufacturer. 5. A review of CMS 116 signed by the laboratory director 01/28/2020, revealed the laboratory performed 12,834 hematology tests annually. 6. An interview with the testing person #1 (as listed on form CMS 209) on 01/28/2020 at 14:15 hours in the break room confirmed the above findings. She stated that she instructed the other testing person to verify the quality control 5 times prior to use. Key: Exp - expired CMS - Centers for Medicare and Medicaid Services D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of